What are the key features of different PCR tests for SARS-CoV-2? How do they work and what are their capabilities. Get the facts.

Understanding the Basics of PCR Tests for SARS-CoV-2

Polymerase Chain Reaction (PCR) tests have played a crucial role in the detection and management of the SARS-CoV-2 pandemic. These molecular diagnostic tests are designed to identify the presence of the SARS-CoV-2 virus, the causative agent of COVID-19, in clinical samples such as nasopharyngeal swabs, oropharyngeal swabs, or saliva.

Types of PCR Tests for SARS-CoV-2

There are several types of PCR tests that have been authorized for emergency use by the FDA to detect SARS-CoV-2. These include:

• Real-time RT-PCR: These tests use reverse transcription and real-time PCR to detect and quantify the presence of SARS-CoV-2 genetic material. They provide rapid and sensitive results.
• Reverse Transcription and Amplification: These tests use reverse transcription to convert viral RNA into DNA, followed by amplification to detect the presence of SARS-CoV-2.
• Nested Multiplex PCR: These tests use a two-stage PCR process to improve the specificity and sensitivity of SARS-CoV-2 detection.
• Isothermal Amplification: These tests use isothermal amplification methods, such as loop-mediated isothermal amplification (LAMP), to detect SARS-CoV-2 without the need for thermal cycling equipment.

Key Features of PCR Tests for SARS-CoV-2

PCR tests for SARS-CoV-2 can have various features that make them suitable for different testing scenarios. Some of the key features include:

• Home Collection: Some PCR tests allow for self-collection of the sample at home, which can improve accessibility and convenience for individuals.
• Pooling: Certain PCR tests can pool multiple samples together for testing, which can increase testing efficiency and throughput in high-volume settings.
• Screening: Some PCR tests are designed for screening purposes, providing rapid and cost-effective ways to identify potential SARS-CoV-2 infections in a population.
• Multi-analyte: A few PCR tests can detect multiple pathogens, including SARS-CoV-2, in a single test, which can help differentiate between COVID-19 and other respiratory illnesses.

Authorizations and Availability of PCR Tests

The FDA has issued Emergency Use Authorizations (EUAs) for numerous PCR tests to detect SARS-CoV-2. These authorizations provide guidance on the intended use, performance characteristics, and limitations of each test. The availability of these tests can vary depending on factors such as supply chain, demand, and regional distribution.

Interpreting PCR Test Results

It is important to understand the interpretation of PCR test results. A positive result indicates the presence of SARS-CoV-2 genetic material, while a negative result suggests the absence of detectable virus. However, it is crucial to consider factors such as the timing of the test, the viral load, and the test’s sensitivity and specificity when interpreting the results.

Factors Affecting PCR Test Performance

The performance of PCR tests for SARS-CoV-2 can be influenced by various factors, including:

• Sample Quality: The quality and collection method of the clinical sample can impact the test’s accuracy.
• Viral Load: The amount of SARS-CoV-2 virus present in the sample can affect the test’s sensitivity.
• Genetic Variability: The emergence of new SARS-CoV-2 variants may require test updates to maintain accurate detection.
• Test Specificity: The ability of the test to differentiate SARS-CoV-2 from other pathogens is crucial for accurate diagnosis.

Ongoing Developments in PCR Testing

The field of PCR testing for SARS-CoV-2 is continuously evolving, with researchers and developers working to enhance the performance, accessibility, and versatility of these tests. Advancements in areas such as sample collection, multiplexing, and data analysis are expected to further improve the utility of PCR tests in the ongoing battle against COVID-19.

In Vitro Diagnostics EUAs – Molecular Diagnostic Tests for SARS-CoV-2

08/11/2021	STS Lab Holdco (a subsidiary of Amazon.com Services LLC)	Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test 08/11/2021	Real-time RT-PCR, Home Collection, Pooling, Screening	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
08/11/2021	STS Lab Holdco (a subsidiary of Amazon.com Services LLC	Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test 08/11/2021	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening	H	HCP, Individuals, EUA Summary, IFU (Home Collect), FAQ	None	None
08/09/2021	Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute	SelfCheck COVID-19 TaqPath Multiplex PCR 08/09/2021	Real-time RT-PCR, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
02/09/2021	SEASUN BIOMATERIALS	U-TOP COVID-19 Detection Kit 04/27/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
04/23/2020	SD Biosensor, Inc.	STANDARD M nCoV Real-Time Detection Kit 04/23/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
07/15/2021	altona Diagnostics GmbH	RealStar SARS-CoV02 RT-PCR Kits U.S. 04/22/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
07/21/2021	Centers for Disease Control and Prevention’s (CDC)	CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) 02/04/2020	Real-time RT-PCR, Pooling	H	HCP, Patients, IFU		None
05/20/2021	Wadsworth Center, New York State Department of Public Health	New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel 02/29/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
03/29/2021	BGI Genomics Co. Ltd	Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 03/26/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
01/07/2021	Cepheid	Xpert Xpress SARS-CoV-2 test 03/20/2020	Real-time RT-PCR	H, M, W	HCP, Patients, IFU for Labs, IFU for Point-of-Care		None
01/05/2021	Primerdesign Ltd.	Primerdesign Ltd COVID-19 genesig Real-Time PCR assay 03/20/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
08/18/2020	GenMark Diagnostics, Inc.	ePlex SARS-CoV-2 Test 03/19/2020	RT-PCR and electrochemical detection	H, M	HCP, Patients, IFU		None
07/22/2021	DiaSorin Molecular LLC	Simplexa COVID-19 Direct assay 03/19/2020	Real-time RT-PCR	H, M	HCP, Patients, IFU		None
07/30/2020	Abbott Molecular	Abbott RealTime SARS-CoV-2 assay 03/18/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
11/13/2020	Quest Diagnostics Infectious Disease, Inc.	Quest SARS-CoV-2 rRT-PCR 03/17/2020	Real-time RT-PCR, Home Collection, Pooling	H	HCP, Patients, IFU, IFU (Home Collect)		None
04/21/2021	Quidel Corporation	Lyra SARS-CoV-2 Assay 03/17/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
05/11/2021	Laboratory Corporation of America (Labcorp)	COVID-19 RT-PCR Test 03/16/2020	Real-time RT-PCR, Home Collection, Pooling, Screening	H	HCP, Patients, EUA Summary, IFU (Home Collect)		None
07/23/2021	Hologic, Inc.	Panther Fusion SARS-CoV-2 Assay 03/16/2020	Real-time RT-PCR, Pooling, Screening	H	HCP, Patients, IFU		None
02/23/2021	Thermo Fisher Scientific, Inc.	TaqPath COVID-19 Combo Kit 03/13/2020	Real-time RT-PCR, Home Collection	H	HCP, Patients, IFU		None
05/14/2021	Roche Molecular Systems, Inc. (RMS)	cobas SARS-CoV-2 03/12/2020	Real-time RT-PCR, Pooling, Screening	H, M, H-Pooling	HCP, Patients, IFU		None
02/03/2021	Mesa Biotech Inc.	Accula SARS-Cov-2 Test 03/23/2020	RT and amplification	H, M, W	HCP, Patients, IFU		None
06/17/2021	BioFire Defense, LLC	BioFire COVID-19 Test 03/23/2020	RT, Nested multiplex PCR, Pooling	H, M	HCP, Patients, IFU		None
07/15/2021	PerkinElmer, Inc.	PerkinElmer New Coronavirus Nucleic Acid Detection Kit 03/24/2020	Real-time RT-PCR, Pooling, Screening, Saliva	H	HCP, Patients, IFU		None
09/25/2020	Avellino Lab USA, Inc.	AvellinoCoV2 test 03/25/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary		None
10/28/2020	Luminex Molecular Diagnostics, Inc.	NxTAG CoV Extended Panel Assay 03/27/2020	RT-PCR	H	HCP, Patients, IFU	None	None
09/17/2020	Abbott Diagnostics Scarborough, Inc.	ID NOW COVID-19 03/27/2020	RT, Isothermal amplification	H, M, W	HCP, Patients, IFU		None
07/29/2021	QIAGEN GmbH	QIAstat-Dx Respiratory SARS-CoV-2 Panel 03/30/2020	Real-time RT-PCR, Multi-analyte	H, M	HCP, Patients, IFU	None	None
01/22/2021	NeuMoDx Molecular, Inc.	NeuMoDx SARS-CoV-2 Assay 03/30/2020	RT-PCR, Collection Kit, Saliva	H, M	HCP, Patients, IFU, IFU (Collect)		None
04/01/2020	Ipsum Diagnostics, LLC	COV-19 IDx assay 04/01/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
09/22/2020	Becton, Dickinson & Company (BD)	BioGX SARS-CoV-2 Reagents for BD MAX System 04/02/2020	Real-time RT-PCR	H, M	HCP, Patients, IFU		None
04/03/2020	Co-Diagnostics, Inc.	Logix Smart Coronavirus Disease 2019 (COVID-19) Kit 04/03/2020	RT-PCR, CoPrimer technology	H	HCP, Patients, IFU	None	None
09/22/2020	ScienCell Research Laboratories	ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit 04/03/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
10/28/2020	Luminex Corporation	ARIES SARS-CoV-2 Assay 04/03/2020	RT-PCR	H, M	HCP, Patients, IFU		None
04/28/2020	Gnomegen LLC	Gnomegen COVID-19 RT-Digital PCR Detection Kit 04/06/2020	Real-time RT-digital PCR	H	HCP, Patients, IFU		None
05/21/2021	InBios International, Inc	Smart Detect SARS-CoV-2 rRT-PCR Kit 04/07/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
02/03/2021	DiaCarta, Inc	QuantiVirus SARS-CoV-2 Test kit 04/08/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
04/29/2021	Becton, Dickinson and Company (BD)	BD SARS-CoV-2 Reagents for BD MAX System 04/08/2020	Real-time RT-PCR, Serial Screening	H, M	HCP, Patients, IFU		None
12/28/2020	Atila BioSystems, Inc.	iAMP COVID-19 Detection Kit 04/10/2020	RT, Isothermal amplification	H	HCP, Patients, IFU		None
12/28/2020	Maccura Biotechnology (USA) LLC	SARS-CoV-2 Fluorescent PCR Kit 04/15/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
04/16/2020	GenoSensor, LLC	GSӢ COVID-19 RT-PCR KIT 04/16/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
12/28/2020	Fosun Pharma USA Inc.	Fosun COVID-19 RT-PCR Detection Kit 04/17/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
06/24/2021	OSANG Healthcare	GeneFinder COVID-19 Plus RealAmp Kit 04/18/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
08/08/2020	Trax Management Services Inc.	PhoenixDx 2019-CoV 04/20/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
04/15/2021	Seegene, Inc.	Allplex 2019-nCoV Assay 04/21/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
09/22/2020	LabGenomics Co., Ltd.	LabGun COVID-19 RT-PCR Kit 04/29/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
07/01/2021	Rheonix, Inc.	Rheonix COVID-19 MDx Assay 04/29/2020	RT-PCR, Saliva	H	HCP, Patients, IFU	None	None
12/09/2020	Bio-Rad Laboratories, Inc	Bio-Rad SARS-CoV-2 ddPCR Test 05/01/2020	RT-droplet PCR	H	HCP, Patients, IFU		None
05/04/2020	Sansure BioTech Inc.	Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) 05/04/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
04/07/2021	Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)	FTD SARS-CoV-2 05/05/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
04/20/2021	OPTI Medical Systems, Inc.	OPTI SARS-CoV-2 RT PCR Test 05/06/2020	Real-time RT-PCR, Screening, Pooling	H	HCP, Patients, IFU		None
01/14/2021	Sherlock BioSciences, Inc.	Sherlock CRISPR SARS-CoV-2 Kit 05/06/2020	RT-LAMP, CRISPR	H	HCP, Patients, IFU	None	None
11/06/2020	BioMérieux SA	SARS-COV-2 R-GENE 05/06/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
08/18/2021	Infinity BiologiX LLC	Infinity BiologiX TaqPath SARS-CoV-2 Assay 04/10/2020	Real-time RT-PCR, Home Collection, Saliva, Pooling	H	HCP, Patients, IFU (Home Collect), EUA Summary		Vault Health COVID-19 Test USGC Saliva Test Kit, hims/hers Saliva Test Kit BioIQ COVID-19 Saliva Test Concentric by Ginkgo 1health. io Zero Contact Base10 Saliva Test Kit Purlab. Saliva Test Kit Reliant Saliva Test Kit E7 Health Saliva Test Kit miinehealth Saliva Test Kit Maverick Saliva Test Kit SDTL Saliva Test Kit AZOVA At-Home COVID-19 Test Collection Kit Wellness 4 Humanity SDNA-1000 Saliva Collection Kit
12/30/2020	Zymo Research Corporation	Quick SARS-CoV-2rRT-PCR Kit 05/07/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
05/08/2020	Gnomegen LLC	Gnomegen COVID-19-RT-qPCR Detection Kit 05/08/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
05/11/2020	1drop Inc.	1copy COVID-19 qPCR Multi Kit 05/11/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
08/18/2021	Abbott Molecular Inc.	Alinity m SARS-CoV-2 assay 05/11/2020	Real-time RT-PCR, Pooling, Screening	H, M	HCP, Patients, IFU		None
07/21/2021	Applied DNA Sciences, Inc.	Linea COVID-19 Assay Kit 05/13/2020	Real-time RT-PCR, Serial Screening	H	HCP, Patients, IFU		None
07/22/2021	Hologic, Inc.	Aptima SARS-CoV-2 assay 05/14/2020	TMA, chemiluminescent, Pooling, Screening	H	HCP, Patients, IFU		None
01/26/2021	GeneMatrix, Inc.	NeoPlex COVID-19 Detection Kit 05/14/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
06/22/2021	Fulgent Therapeutics	Fulgent COVID-19 by RT-PCR Test 05/15/2020	Real-time RT-PCR, Home Collection, Screening	H	HCP, Patients, EUA Summary, IFU (Home Collect)		None
06/03/2021	Everlywell, Inc.	Everlywell COVID-19 Test Home Collection Kit 05/15/2020	Home Collection Kit	N/A	IFU, EUA Summary		None
07/01/2021	Assurance Scientific Laboratories	Assurance SARS-CoV-2 Panel 05/15/2020	Real-time RT-PCR, Home Collection	H	HCP, Patients, EUA Summary	None	None
05/25/2021	Quidel Corporation	Lyra Direct SARS-CoV-2 Assay 05/18/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
04/01/2021	P23 Labs, LLC.	P23 Labs TaqPath SARS-CoV-2 Assay 05/21/2020	Real-time RT-PCR, Home Collection, Saliva	H	HCP, Patients, IFU1 (Home Collect), IFU2 (Home Collect)  EUA Summary		AZOVA P23 At-Home COVID-19 Test Collection Kit binx health (powered by P23) At-home Saliva COVID-19 Test Collection Kit for the Group Setting
02/23/2021	Seasun Biomaterials, Inc.	AQ-TOP COVID-19 Rapid Detection Kit 05/21/2020	RT-LAMP	H	HCP, Patients, IFU	None	None
12/28/2020	SolGent Co., Ltd	DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit 05/21/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
08/18/2021	INVITES BIOCORE CO., LTD.	BioCore 2019-nCoV Real Time PCR Kit 05/21/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
08/11/2020	dba SpectronRX	Hymon SARS-CoV-2 Test Kit 05/22/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
05/19/2021	LetsGetChecked, Inc.	LetsGetChecked Coronavirus (COVID-19) Test 05/28/2020	Direct to Consumer (DTC), TMA, chemiluminescent, Home Collection, Screening	H	HCP, Individuals, EUA Summary, IFU (Home Collect)		None
05/17/2021	Phosphorus Diagnostics LLC	Phosphorus COVID-19 RT-qPCR Test 06/04/2020	Real-time RT-PCR, Home Collection, Saliva, Screening	H	HCP, Patients, EUA Summary, IFU (Home Collect), IFU (Clinic)		Wheeler Labs COVID-19 RT-qPCR Test
05/20/2021	Genetron Health (Beijing) Co. , Ltd.	Genetron SARS-CoV-2 RNA Test 06/05/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
04/22/2021	Euroimmun US, Inc.	EURORealTime SARS-Cov-2 06/08/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
04/22/2021	Illumina, Inc.	Illumina COVIDSeq Test 06/09/2020	Sequencing	H	HCP, Patients, IFU		None
09/21/2020	ChromaCode Inc.	HDPCR SARS-CoV-2 Assay 06/09/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
06/10/2020	Tide Laboratories, LLC	DTPM COVID-19 RT-PCR Test 06/10/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
01/06/2021	TBG Biotechnology Corp.	ExProbe SARS-CoV-2 Testing Kit 06/10/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
03/26/2021	Cue Health Inc.	Cue COVID-19 Test 06/10/2020	RT, Isothermal amplification, Screening	H, M, W	HCP, Patients, IFU		None
06/12/2020	RTA Laboratories Biological Products Pharmaceutical and Machinery Industry	Diagnovital SARS-CoV-2 Real-Time PCR Kit 06/12/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
06/08/2021	Applied BioCode, Inc.	BioCode SARS-CoV-2 Assay 06/15/2020	RT-PCR, Pooling	H	HCP, Patients, IFU		None
06/17/2021	Kaiser Permanente Mid-Atlantic States	KPMAS COVID-19 Test 06/13/2020	Real-time RT-PCR, Home Collection, Screening	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
05/10/2021	Jiangsu Bioperfectus Technologies Co. , Ltd.	COVID-19 Coronavirus Real Time PCR Kit 06/18/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
06/17/2020	The Ohio State University Wexner Medical Center	OSUWMC COVID-19 RT-PCR test 06/17/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
12/28/2020	Omnipathology Solutions Medical Corporation	Omni COVID-19 Assay by RT-PCR 06/17/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
06/24/2021	3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.	TRUPCR SARS-CoV-2 Kit 06/18/2020	Real-time RT-PCR, Saliva	H	HCP, Patients, IFU		None
09/21/2020	HealthQuest Esoterics	HealthQuest Esoterics TaqPath SARS-CoV-2 Assay 06/23/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
06/23/2020	University of Alabama at Birmingham Fungal Reference Lab	FRL SARS CoV-2 Test 06/23/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
12/28/2020	Gencurix, Inc.	GenePro SARS-CoV-2 Test 06/23/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
06/24/2020	University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory	MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay 06/24/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
01/29/2021	Diagnostic Solutions Laboratory, LLC	DSL COVID-19 Assay 06/25/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
06/25/2020	PreciGenome LLC	FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR) 06/25/2020	RT-digital droplet PCR	H	HCP, Patients, IFU	None	None
08/19/2021	PlexBio Co. , Ltd.	IntelliPlex SARS-CoV-2 Detection Kit 06/25/2020	RT-PCR	H	HCP, Patients, IFU		None
06/26/2020	Inform Diagnostics, Inc.	Inform Diagnostics SARS-CoV-2 RT-PCR Assay 06/26/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
06/29/2020	LifeHope Labs	LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel 06/29/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
09/24/2020	Acupath Laboratories, Inc.	Acupath COVID-19 Real-Time (RT-PCR) Assay 06/29/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
09/21/2020	Psomagen, Inc.	Psoma COVID-19 RT Test 06/30/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
05/28/2021	BioTNS Co. Ltd.	COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit 06/30/2020	RT-PCR	H	HCP, Patients, IFU	None	None
05/19/2021	The Kroger Co.	Kroger Health COVID-19 Test Home Collection Kit 06/30/2020	Home Collection Kit, Direct to Consumer (DTC), Screening	N/A	Individuals, IFU, EUA Summary	None	None
08/13/2021	CENTOGENE US, LLC	CentoFast-SARS-CoV-2 RT-PCR Assay 07/01/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
08/05/2021	Centers for Disease Control and Prevention (CDC)	Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay 07/02/2020	Real-time RT-PCR, Multi-analyte	H	HCP, Patients, IFU		None
12/28/2020	Laboratorio Clinico Toledo	Laboratorio Clinico Toledo SARS-CoV-2 Assay 07/06/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
07/16/2021	Enzo Life Sciences, Inc.	AMPIPROBE SARS-CoV-2 Test System 07/07/2020	Real-time RT-PCR, Pooling	H	HCP, Patients, IFU		None
02/05/2021	Access Bio, Inc.	CareStart COVID-19 MDx RT-PCR 07/07/2020	Real-time RT-PCR	H	HCP, Patients, IFU		KarmaCare COVID-19 MDx RT-PCR AQGene COVID-19 MDx RT-PCRv
12/28/2020	Gene By Gene	Gene By Gene SARS-CoV-2 Detection Test 07/07/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
06/10/2021	Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard	CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay 07/08/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary		None
07/09/2020	UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin	SARS-CoV-2 RNA DETECTR Assay 07/09/2020	RT-LAMP	H	HCP, Patients, EUA Summary	None	None
12/28/2020	BioSewoom, Inc.	Real-Q 2019-nCoV Detection Kit 07/09/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
07/10/2020	Boston Medical Center	BMC-CReM COVID-19 Test 07/10/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
09/21/2020	KogeneBiotech Co., Ltd.	PowerChek 2019-nCoV Real-time PCR Kit 07/13/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
06/25/2021	Trax Management Services Inc.	PhoenixDx SARS-CoV-2 Multiplex 07/13/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
07/13/2020	Compass Laboratory Services, LLC	Compass Laboratory Services SARS-CoV2 Assay 07/13/2020	Real-time RT-PCR, Home Collection	H	HCP, Patients, EUA Summary	None	None
08/21/2020	Quest Diagnostics Infectious Disease, Inc.	Quest Diagnostics PF SARS-CoV-2 Assay 07/15/2020	Real-time RT-PCR, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
11/27/2020	Quest Diagnostics Infectious Disease, Inc.	Quest Diagnostics RC SARS-CoV-2 Assay 07/15/2020	Real-time RT-PCR, Home Collection, Pooling	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
08/21/2020	Quest Diagnostics Infectious Disease, Inc.	Quest Diagnostics HA SARS-CoV-2 Assay 07/15/2020	TMA, chemiluminescent, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
09/21/2020	Boston Heart Diagnostics	Boston Heart COVID-19 RT-PCR Test 07/16/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary		None
07/28/2021	Access Genetics, LLC	OraRisk COVID-19 RT-PCR 07/17/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
12/28/2020	DiaCarta, Inc.	QuantiVirus SARS-CoV-2 Multiplex Test Kit 07/21/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
10/22/2020	Helix OpCo LLC	Helix COVID-19 Test 07/23/2020	Real-time RT-PCR, Home Collection, Screening	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
07/24/2020	Jiangsu CoWin Biotech Co., Ltd.	Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 07/24/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
07/09/2021	Color Health, Inc.	Color SARS-CoV-2 RT-LAMP Diagnostic Assay 05/18/2020	RT, LAMP, Home Collection, Screening	H	HCP, Patients, EUA Summary		None
09/21/2020	Eli Lilly and Company	Lilly SARS-CoV-2 Assay 07/27/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary		None
01/29/2021	Sandia National Laboratories	SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay 07/27/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
07/30/2020	Clinical Reference Laboratory, Inc.	CRL Rapid Response 07/30/2020	Real-time RT-PCR, Home Collection, Saliva	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
11/10/2020	Xiamen Zeesan Biotech Co., Ltd.	SARS-CoV-2 Test Kit (Real-time PCR) 07/31/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
07/31/2020	University of California San Diego Health	UCSD RC SARS-CoV-2 Assay 07/31/2020	Real-time RT-PCR, Pooling	H	HCP, Patients, EUA Summary	None	None
06/17/2021	WREN Laboratories LLC	WREN Laboratories COVID-19 PCR Test 08/03/2020	Real-time RT-PCR, Home Collection, Saliva, Screening	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
09/21/2020	Ethos Laboratories	Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay 08/03/2020	RT-PCR and MALDI-TOF Mass Spec. , Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)		None
01/19/2021	Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute	Cleveland Clinic SARS-CoV-2 Assay 08/03/2020	Real-time RT-PCR, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
08/03/2020	Poplar Healthcare	Poplar SARS-CoV-2 TMA Pooling assay 08/03/2020	TMA, chemiluminescent, Pooling	H	HCP, Patients, EUA Summary	None	None
09/21/2020	Exact Sciences Laboratories	SARS-CoV-2 (N gene detection) Test 05/22/2020	Real-time RT-PCR, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)		None
07/14/2021	ISPM Labs, LLC dba Capstone Healthcare	Genus SARS-CoV-2 Assay 08/03/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
08/06/2020	Helix OpCo LLC (dba Helix)	Helix COVID-19 NGS Test 08/06/2020	Sequencing	H	HCP, Patients, EUA Summary	None	None
06/24/2021	Vela Operations Singapore Pte Ltd	ViroKey SARS-CoV-2 RT-PCR Test 08/05/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
08/07/2020	George Washington University Public Health Laboratory	GWU SARS-CoV-2 RT-PCR Test 08/07/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
12/28/2020	Solaris Diagnostics	Solaris Multiplex SARS-CoV-2 Assay 08/10/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
01/28/2021	Alpha Genomix Laboratories	Alpha Genomix TaqPath SARS-CoV-2 Combo Assay 08/10/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
06/22/2021	Biomeme, Inc.	Biomeme SARS-CoV-2 Real-Time RT-PCR Test 08/11/2020	Real-time RT-PCR, Pooled Serial Screening – Swab, Pooled Serial Screening – Media	H	HCP, Patient, IFU		None
12/28/2020	LumiraDx UK Ltd.	LumiraDx SARS-CoV-2 RNA STAR 08/11/2020	RT, non-isothermal nucleic acid amplification qSTAR	H	HCP, Patient, IFU	None	None
05/28/2021	Pro-Lab Diagnostics	Pro-AmpRT SARS-CoV-2 Test 08/13/2020	RT, Isothermal amplification	H	HCP, Patient, EUA Summary		None
06/03/2021	Yale School of Public Health, Department of Epidemiology of Microbial Diseases	SalivaDirect 08/15/2020	Real-time RT-PCR, Saliva, Home Collection, Screening	H	HCP, Patients, EUA Summary		None
08/17/2020	ZhuHai Sinochips Bioscience Co. , Ltd.	COVID-19 Nucleic Acid RT-PCR Test Kit 08/17/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
12/09/2020	DxTerity Diagnostics, Inc.	DxTerity SARS-CoV-2 RT-PCR Test 08/21/2020	Real-time RT-PCR, Saliva	H	HCP, Patients, EUA Summary		None
12/28/2020	Texas Department of State Health Services, Laboratory Services Section	Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay 08/21/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
02/26/2021	Fluidigm Corporation	Advanta Dx SARS-CoV-2 RT-PCR Assay 08/25/2020	Real-time RT-PCR, Saliva, Home Collection	H	HCP, Patients, IFU, IFU (Home Collect)		None
02/08/2021	QDx Pathology Services	QDX SARS-CoV-2 Assay 08/25/2020	Real-time RT-PCR, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)		None
10/02/2020	Cuur Diagnostics	Cuur Diagnostics SARS-CoV-2 Molecular Assay 08/26/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
09/21/2020	Patients Choice Laboratories, LLC	PCL SARS-CoV-2 Real-Time RT-PCR Assay 08/28/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
04/27/2021	DxTerity Diagnostics, Inc.	DxTerity SARS-CoV-2 RT PCR CE Test 08/28/2020	RT-PCR, Home Collection, Saliva	H	HCP, Patients, EUA Summary, IFU (Home Collect)		None
12/28/2020	T2 Biosystems, Inc.	T2SARS-CoV-2 Panel 08/31/2020	RT, amplification, T2 Magnetic resonance	H, M	HCP, Patients, IFU	None	None
08/31/2020	MiraDx	MiraDx SARS-CoV-2 RT-PCR assay 08/31/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
07/07/2021	Mammoth Biosciences, Inc.	SARS-CoV-2 DETECTR Reagent Kit 08/31/2020	RT-LAMP, CRISPR	H	HCP, Patients, IFU	None	None
01/28/2021	BayCare Laboratories, LLC	BayCare SARS-CoV-2 RT PCR Assay 08/31/2020	Real-time RT-PCR, Pooling	H	HCP, Patients, EUA Summary	None	None
06/17/2021	MobileDetect Bio Inc.	MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit 09/01/2020	RT-LAMP	H, M	HCP, Patients, IFU	None	None
12/28/2020	OPTOLANE Technologies, Inc.	Kaira 2019-nCoV Detection Kit 09/01/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
03/19/2021	Color Health, Inc.	Color COVID-19 Self-Swab Collection Kit 08/31/2020	Home Collection Kit, Screening	N/A	EUA Summary, IFU	None	None
05/24/2021	Bioeksen R&D Technologies Inc.	Bio-Speedy Direct RT-qPCR SARS-CoV-2 09/02/2020	Real-time RT-PCR	H	HCP, Patients, IFU		BioeXsen SARS-CoV-2 RT PCR
06/08/2021	Roche Molecular Systems, Inc.	cobas SARS-CoV-2 & Influenza A/B 09/03/2020	Real-time RT-PCR, Multi-analyte	H, M	HCP, Patients, IFU		None
06/23/2021	BillionToOne, Inc.	qSanger-COVID-19 Assay 09/04/2020	Sequencing	H	HCP, Patients, IFU	None	None
04/01/2021	Verily Life Sciences	Verily COVID-19 RT-PCR Test 09/08/2020	Real-time RT-PCR, Pooling, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
10/31/2020	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.	Wantai SARS-CoV-2 RT-PCR Kit 09/09/2020	Real-time RT-PCR	H	HCP, Patients, IFU		None
06/24/2021	Roche Molecular Systems, Inc.	cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System 09/14/2020	Real-time RT-PCR, Multi-analyte	H, M, W	HCP, Patients, IFU		None
12/28/2020	Visby Medical, Inc.	Visby Medical COVID-19 09/16/2020	RT-PCR	H, M	HCP, Patients, IFU	None	None
09/18/2020	GK Pharmaceuticals Contract Manufacturing Operations	GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT 09/18/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
07/15/2021	KimForest Enterprise Co., Ltd.	KimForest SARS-CoV-2 Detection Kit v1 09/21/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
05/06/2021	Quadrant Biosciences Inc.	Clarifi COVID-19 Test Kit 09/22/2020	Real-time RT-PCR, Saliva, Pooling	H	HCP, Patients, IFU	None	None
07/08/2021	Vela Operations Singapore Pte. Ltd.	ViroKey SARS-CoV-2 RT-PCR Test v2.0 09/22/2020	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
12/28/2020	Clear Labs, Inc.	Clear Dx SARS-CoV-2 Test 09/23/2020	RT-PCR and Sequencing	H	HCP, Patients, IFU	None	None
01/27/2021	Cepheid	Xpert Xpress SARS-CoV-2/Flu/RSV 09/24/2020	Real-time RT-PCR, Multi-analyte	H, M, W	HCP, Patients, IFU for Labs, IFU for Point-of-Care		None
04/27/2021	Genetrack Biolabs, Inc.	Genetrack SARS-CoV-2 Molecular Assay 09/25/2020	Real-time RT-PCR, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)		None
09/30/2020	Aeon Global Health	Aeon Global Health SARS-CoV-2 Assay 09/30/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
08/13/2021	CENTOGENE US, LLC	CentoSure SARS-CoV-2 RT-PCR Assay 09/29/2020	Real-time RT-PCR, Screening	H	HCP, Patients, EUA Summary	None	None
09/29/2020	Akron Children’s Hospital	Akron Children’s Hospital SARS-CoV-2 Assay 09/29/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
09/29/2020	National Jewish Health	SARS-CoV-2 MassArray Test 09/29/2020	RT-PCR and MALDI-TOF Mass Spec.	H	HCP, Patients, EUA Summary	None	None
04/02/2020	Alimetrix, Inc.	Alimetrix SARS-CoV-2 RT-PCR Assay 09/30/2020	RT-PCR, Microarray Hybridization, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
03/24/2021	Tempus Labs, Inc.	iC SARS-CoV2 Test 10/01/2020	Real-time RT-PCR, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
12/28/2020	UMass Memorial Medical Center	UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel 10/01/2020	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
04/27/2021	BioFire Diagnostics, LLC	BioFire Respiratory Panel 2. 1-EZ (RP2.1-EZ) 10/02/2020	RT, Nested multiplex PCR, Multi-analyte	H, M, W	HCP, Patients, IFU		None
04/29/2021	SEASUN BIOMATERIALS, Inc.	AQ-TOP COVID-19 Rapid Detection Kit PLUS 10/05/2020	RT-LAMP	H	HCP, Patients, IFU	None	None
10/08/2020	University of California, Los Angeles (UCLA)	UCLA SwabSeq COVID-19 Diagnostic Platform 10/06/2020	RT-PCR and Sequencing	H	HCP, Patients, EUA Summary	None	None
07/28/2021	GenMark Diagnostics, Inc.	ePlex Respiratory Pathogen Panel 2 10/07/2020	RT-PCR and electrochemical detection, Multi-analyte	H, M	HCP, Patients, IFU	None	None
08/04/2021	Spectrum Solutions LLC	SDNA-1000 Saliva Collection Device 10/08/2020	Saliva Collection Device	N/A	EUA Summary, IFU	None	None
03/29/2021	LumiraDx UK Ltd.	LumiraDx SARS-CoV-2 RNA STAR Complete 10/14/2020	RT, qSTAR amplification	H	HCP, Patients, IFU		None
06/10/2021	Clinical Enterprise, Inc.	EmpowerDX COVID-19 Home Collection Kit DTC 10/15/2020	Home Collection Kit, Direct to Consumer (DTC), Screening	N/A	EUA Summary, Individuals, IFU	None	None
06/23/2021	Viracor Eurofins Clinical Diagnostics	Viracor SARS-CoV-2 assay 04/06/2020	Real-Time RT-PCR, Pooling, Screening, Pooled Serial Screening – Swab	H	HCP, Patients, EUA Summary		None
08/13/2021	binx health, Inc.	binx health At-Home Nasal Swab COVID-19 Sample Collection Kit 10/20/2020	Home Collection Kit	N/A	EUA Summary, IFU		None
05/04/2021	Agena Bioscience, Inc.	MassARRAY SARS-CoV-2 Panel 10/26/2020	RT-PCR, chip array and MALDI-TOF Mass Spec.	H	HCP, Patients, IFU		None
10/28/2020	DNA Genotek Inc.	ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 saliva collection devices 10/28/2020	Saliva Collection Device	N/A	EUA Summary, IFU	None	None
10/28/2020	DNA Genotek Inc.	OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices 10/14/2020	Saliva Collection Device	N/A	EUA Summary, IFU	None	None
11/18/2020	Lucira Health, Inc.	Lucira COVID-19 All-In-One Test Kit 11/17/2020	Prescription Home Testing	Home, H, M, W	HCP, IFU, IFU (Home Test)	None	None
01/22/2021	Express Gene LLC, DBA: Express Gene Molecular Diagnostics Laboratory	Express Gene 2019-nCoV RT-PCR Diagnostic Panel 05/22/2020	Real-time RT-PCR, Collection Kit, Saliva	H	HCP, Patients, EUA Summary, IFU	None	None
11/23/2020	RapidRona, Inc.	RapidRona Self-Collection Kit 11/23/2020	Home Collection Kit	N/A	EUA Summary, IFU (Collection)	None	None
08/13/2021	Gravity Diagnostics, LLC	Gravity Diagnostics SARS-CoV-2 RT-PCR Assay 11/23/2020	Real-time RT-PCR, Home Collection, Saliva, Screening	H	HCP, Patients, EUA Summary	None	None
11/24/2020	Stanford Health Care Clinical Virology Laboratory	SARS-CoV-2 RT-PCR Assay 04/08/2020	Real-time RT-PCR, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collection)	None	None
04/20/2021	Cepheid	Xpert Omni SARS-CoV-2 11/27/2020	Real-time RT-PCR	H, M, W	HCP, Patients, IFU		None
12/04/2020	Quest Diagnostics Infectious Disease, Inc.	Quest Diagnostics RC COVID-19+Flu RT-PCR 12/04/2020	Real-time RT-PCR, Multi-analyte, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collection)	None	None
05/11/2021	Laboratory Corporation of America (LabCorp)	Pixel by LabCorp COVID-19 Test Home Collection Kit 12/09/2020	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening	H	HCP, Individuals, EUA Summary, IFU (Home Collect)	None	None
05/14/2021	RCA Laboratory Services LLC dba GENETWORx	GENETWORx Covid-19 Nasal Swab Test 12/15/2020	Real-time RT-PCR, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)		None
12/11/2020	ResearchDx, Inc., DBA Pacific Diagnostics	PacificDx Covid-19 12/11/2020	TMA, chemiluminescent, Home Collection	H	HCP, Patients, EUA Summary	None	None
05/06/2021	Hologic, Inc.	Aptima SARS-CoV-2/Flu assay 12/16/2020	Real-time TMA, chemiluminescent, Multi-analyte	H	HCP, Patients, IFU		None
03/25/2021	Quidel Corporation	Solana SARS-CoV-2 Assay 12/23/2020	Isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA)	H, M	HCP, Patients, IFU		None
12/23/2020	Cepheid	Xpert Xpress SARS-CoV-2 DoD 12/23/2020	Real-time RT-PCR, Pooling	H, M, W	HCP, Patients, EUA Summary	None	None
04/30/2021	SML GENETREE Co., Ltd.	Ezplex SARS-CoV-2 G Kit 01/13/2021	Real-time RT-PCR, Pooling	H	HCP, Patients, IFU		None
05/06/2021	Bio-Rad Laboratories, Inc.	Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit 01/15/2021	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
07/16/2021	Ambry Genetics Laboratory	Ambry COVID-19 RT-PCR Test 01/22/2021	Real-time RT-PCR, Home Collection, Saliva	H	HCP, Patients, IFU (Home Collect), EUA Summary		None
NoneNo01/19/2021	Hospital of the University of Pennsylvania	BD MAX COVID-19 ASSAY (Authorized by HHS/OASH) 01/19/2021	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
01/19/2021	INNO Diagnostics Reference Laboratory, Ponce Medical School	PMSF-INNO SARS-CoV-2 RT-PCR Test (Authorized by HHS/OASH) 01/19/2021	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
06/24/2021	Clinomics USA Inc.	Clinomics TrioDx RT-PCR COVID-19 Test 02/04/2021	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
02/08/2021	Visby Medical, Inc.	Visby Medical COVID-19 Point of Care Test 02/08/2021	RT-PCR	H, M, W	HCP, Patients, IFU, IFU (Collect)	None	None
02/11/2021	Bio-Rad Laboratories, Inc.	Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit 02/11/2021	Real-time RT-PCR, Multi-analyte	H	HCP, Patients, IFU	None	None
04/29/2021	Becton, Dickinson and Company (BD)	BD SARS-CoV-2/Flu for BD MAX System 02/10/2021	Real-time RT-PCR, Multi-analyte	H, M	HCP, Patients, IFU		None
08/03/2021	Thermo Fisher Scientific	TaqPath COVID-19, FluA, FluB Combo Kit 02/10/2021	Real-time RT-PCR, Multi-analyte	H	HCP, Patients, IFU	None	None
02/10/2021	Grifols Diagnostic Solutions Inc.	Procleix SARS-CoV-2 Assay 02/10/2021	TMA	H	HCP, Patients, IFU	None	None
05/10/2021	Gravity Diagnostics, LLC	Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits 02/13/2021	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	H	HCP, Individuals, EUA Summary	None	None
07/01/2021	Assurance Scientific Laboratories	Assurance SARS-CoV-2 Panel DTC 02/13/2021	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	H	HCP, Individuals, EUA Summary, IFU (Home Collect)	None	None
07/01/2021	Everlywell, Inc.	Everlywell COVID-19 Test Home Collection Kit DTC 02/13/2021	Home Collection Kit, Direct to Consumer (DTC), Screening	N/A	Individuals, EUA Summary, IFU (Home Collect)	None	None
04/02/2021	University of Illinois Office of the Vice President for Economic Development and Innovation	covidSHIELD 02/24/2021	Real-time RT-PCR, Saliva, Serial Screening	H	HCP, Patients, EUA Summary	None	None
05/18/2021	Viracor Eurofins Clinical Diagnostics	Viracor SARS-CoV-2 assay DTC 02/26/2021	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	H	HCP, Individuals, EUA Summary	None	None
03/05/2021	Cue Health Inc.	Cue COVID-19 Test for Home and Over The Counter (OTC) Use 03/05/2021	RT, Isothermal amplification, Over the Counter (OTC) Home Testing, Screening	Home, H, M, W	HCP, Individuals, IFU, IFU (Home Test), FAQ	None	None
07/01/2021	Abbott Molecular Inc.	Alinity m Resp-4-Plex 03/04/2021	Real-time RT-PCR, Multi-analyte	H, M	HCP, Patients, IFU		None
03/03/2021	Luminex Molecular Diagnostics, Inc.	NxTAG Respiratory Pathogen Panel + SARS-CoV-2 03/03/2021	RT-PCR, Multi-analyte	H	HCP, Patients, IFU	None	None
06/15/2021	Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard	CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3) 03/05/2021	Real-time RT-PCR, Home Collection, Pooled Serial Screening – Swab	H	HCP, Patients, EUA Summary, IFU (Home Collect)		None
05/26/2021	GetMyDNA	GetMyDNA COVID-19 Test Home Collection Kit 03/09/2021	Home Collection Kit, Direct to Consumer (DTC), Screening	N/A	EUA Summary, Individuals, IFU	None	None
03/19/2021	Color Health, Inc.	Color COVID-19 Self-Swab Collection Kit DTC 03/19/2021	Home Collection Kit, Direct to Consumer (DTC), Screening	N/A	EUA Summary, Individuals, IFU	None	None
07/09/2021	Color Health, Inc.	Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC 03/19/2021	Direct to Consumer (DTC), RT, LAMP, Home Collection, Screening	H	EUA Summary, Individuals, HCP	None	None
06/25/2021	Twist Bioscience Corporation	SARS-CoV-2 NGS Assay 03/23/2021	Sequencing	H	HCP, Patients, IFU		None
04/23/2021	NeuMoDx Molecular, Inc.	NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay 03/25/2021	Real-time RT-PCR, Multi-analyte	H, M	HCP, Patients, IFU	None	None
05/28/2021	STS Lab Holdco (a subsidiary of Amazon. com Services LLC)	Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 03/25/2021	Real-time RT-PCR, Home Collection, Pooling, Screening	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
01/19/2021	University of Louisville Infectious Diseases Laboratory	SARS-CoV-2 real time RT-PCR test (Authorized by HHS/OASH) 01/19/2021	Real-time RT-PCR	H	HCP, Patients, EUA Summary	None	None
04/09/2021	Lucira Health, Inc.	Lucira CHECK-IT COVID-19 Test Kit 04/09/2021	RT, LAMP, Over the Counter (OTC) Home Testing, Screening	Home, H, M, W	HCP, IFU, IFU (Home Test)	None	None
04/09/2021	Thermo Fisher Scientific	Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit 04/09/2021	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
04/12/2021	PerkinElmer Genomics	PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit 04/12/2021	Real-time RT-PCR, Home Collection	H	HCP, Patients, EUA Summary	None	None
06/24/2021	Clinical Enterprise, Inc.	Clinical Enterprise SARS-CoV-2 RT-PCR Assay 04/13/2021	Real-time RT-PCR, Screening, Pooled Serial Screening – Swab	H	HCP, Patients, EUA Summary		None
04/13/2021	Clinical Enterprise, Inc.	Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC 04/13/2021	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	H	HCP, Individuals, EUA Summary	None	None
05/06/2021	Yale School of Public Health, Department of Epidemiology of Microbial Diseases	SalivaDirect At-Home Collection Kit 04/09/2021	Home Collection Kit, Saliva, Screening	N/A	EUA Summary, IFU-1, IFU-2		None
04/16/2021	Color Health, Inc.	Color COVID-19 Self-Swab Collection Kit with Saline 04/14/2021	Home Collection Kit, Screening	N/A	EUA Summary, IFU	None	None
05/18/2021	LGC, Biosearch Technologies	Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test 04/15/2021	Real-Time and End-Point RT-PCR	H	HCP, Patients, IFU	None	None
06/02/2021	Synergy Diagnostic Laboratory, Inc., DBA SynergyDx	SynergyDx SARS-CoV-2 RNA Test DTC 04/16/2021	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	H	HCP, Individuals, EUA Summary, IFU (Home Collect)		None
06/02/2021	Synergy Diagnostic Laboratory, Inc., DBA SynergyDx	SynergyDx SARS-CoV-2 RNA Test 04/16/2021	Real-time RT-PCR, Home Collection, Screening	H	HCP, Patients, EUA Summary, IFU (Home Collect)		None
04/20/2021	Southern California Permanente Medical Group	Kaiser Permanente High Throughput SARS-CoV-2 Assay 04/19/2021	Real-Time RT-PCR, Saliva, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
07/22/2021	PathogenDx, Inc.	DetectX-Rv 04/20/2021	RT-PCR, DNA Microarray Hybridization	H	HCP, Patients, IFU	None	None
05/17/2021	Phosphorus Diagnostics LLC	Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC 05/17/2021	Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening	N/A	Individual, EUA Summary, IFU	None	None
05/17/2021	Phosphorus Diagnostics LLC	Phosphorous COVID19 RT-qPCR Test DTC 05/17/2021	Real-time RT-PCR, Direct to Consumer (DTC), Screening, Salvia	H	HCP, Individuals, EUA Summary	None	None
07/08/2021	Harvard University Clinical Laboratory (HUCL)	Quaeris SARS-CoV-2 Assay 05/21/2021	Real-time RT-PCR, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
05/25/2021	Thermo Fisher Scientific Inc.	TaqPath COVID-19 Pooling Kit 05/25/2021	Real-time RT-PCR, Pooling	H	HCP, Patients, IFU	None	None
08/09/2021	STS Lab Holdco (a subsidiary of Amazon.com Services LLC)	Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 05/28/2021	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening	H	HCP, Individuals, EUA Summary, IFU, FAQ	None	None
06/17/2021	WREN Laboratories LLC	WREN Laboratories COVID-19 PCR Test DTC 06/17/2021	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Saliva Screening	H	HCP, Individuals, EUA Summary	None	None
06/17/2021	WREN Laboratories LLC	WREN Laboratories COVID-19 Saliva Test Collection Kit DTC 06/17/2021	Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening	N/A	Individuals, EUA Summary, IFU	None	None
06/17/2021	Roche Molecular Systems	cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) 06/17/2021	Real-time RT-PCR, Screening	H, M, W	HCP, Patients, IFU	None	None
06/29/2021	BioGX, Inc.	BioGX Xfree COVID-19 Direct RT-PCR 06/29/2021	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
07/14/2021	Exact Sciences Laboratories	COVID-Flu Multiplex Assay 07/01/2021	Real-time RT-PCR, Multi-analyte, Home Collection	H	HCP, Patients, EUA Summary, IFU (Home Collect)	None	None
07/01/2021	Everlywell, Inc.	Everlywell COVID-19 & Flu Test Home Collection Kit 07/01/2021	Home Collection Kit, Multi-analyte	N/A	IFU, EUA Summary	None	None
07/08/2021	Thermo Fisher Scientific Inc.	TaqPath COVID-19 RNase P Combo Kit 2.0 07/08/2021	Real-time RT-PCR, Serial Screening	H	HCP, Patients, IFU	None	None
07/30/2021	Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.)	TaqPath COVID-19 Fast PCR Combo Kit 2.0 07/30/2021	Real-time RT-PCR, Saliva	H	HCP, Patients, IFU	None	None
08/02/2021	Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.)	TaqPath COVID-19 MS2 Combo Kit 2.0 08/02/2021	Real-time RT-PCR	H	HCP, Patients, IFU	None	None
08/13/2021	Kwokman Diagnostics, LLC	Kwokman Diagnostics COVID-19 Home Collection Kit 08/13/2021	Home Collection Kit	N/A	IFU, EUA Summary	None	None

Welcome to Valley Medical Laboratory!

Welcome to Valley Medical Laboratory!

Nasopharyngeal RT-PCR Swab Testing is performed to detect if someone is currently infected with the COVID-19 Virus.

PCR Testing is available in Minneapolis, Woodbury, and Burnsville from Monday – Friday

Valley Medical Laboratory proudly offers Covid-19 testing services designed to meet the needs of travelers. Please scroll down to see our travel guidelines section for additional information.

Please select from the testing options below:

RT-PCR (NAAT) Swab Test
Option 1 – Self-Pay: $119

SCHEDULE NOW

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Test Purpose: To determine if you have an active Covid-19 Infection

About Test: Nucleic Acid Amplification Test (NAAT) can use many different methods to amplify Nucleic Acids and detect the Covid-19 virus, including but not limited to RT-PCR.

*Results Turn Around Time: Before Midnight

Payment Option: $119**

Available Appointments:  Immediate/Same-Day

**Pay using your FSA or HSA card. You may also submit a claim on your own to your insurance provider using the itemized statement that will be posted when your results are ready.

You may login to your portal account to reschedule or cancel your test. Any cancelled test will be automatically refunded.

RT-PCR (NAAT) Swab Test
Option 2 – Insurance

SCHEDULE NOW

LOG IN

Test Purpose: To determine if you have an active Covid-19 Infection

About Test: Nucleic Acid Amplification Test (NAAT) can use many different methods to amplify Nucleic Acids and detect the Covid-19 virus, including but not limited to RT-PCR.

*Results Turn Around Time: Before Midnight

Payment Option: Insurance Coverage

Available Appointments: Within 24 hours

You may login to your portal account to reschedule or cancel your test. Any cancelled test will be automatically refunded. 

 
How it Works

1. Click the “Schedule Now” button above.
2. First time users will then select “Register Here” and receive an email with a link to create a password.
3. Choose option 1 in the portal user for Self-pay or Option 2 to use your health insurance to cover the test.
4. Complete a 3-minute questionnaire
5. Select your appointment date, time, and location.
6. If you choose Option 2 (Insurance) you will have 3 tries to validate your insurance information. If you are unable to validate your insurance through our portal, you will have the option to pay with your credit card and send us your insurance information for us to validate for you. If we are able to validate your insurance after your register with your credit card, we will refund your payment and bill your insurance. We can only bill your insurance if you select Option 2.

Questions or concerns, please call (612) 286-8366 or email us at [email protected]. You may also securely text us at (612)-453-1965.

*Due to normal lab processes, a result of “indeterminate” is possible. In these instances, the laboratory will re-run samples and/or reach out to the patient to recollect the sample. These situations are rare, but may cause a delay in turn-around times.

**If you have already visited a Valley Medical and Wellness location and provided your sample(s) for testing, we cannot cancel your order or refund your payment. Testing will be completed and results will be available in your Valley Medical Laboratory patient portal account or will be sent to you via secure text messaging.

Travelers 

If you are traveling to a destination which requires a negative Covid-19 test prior to entry, Valley Medical Laboratory is a CLIA-certified lab and is authorized to provide this type of testing to meet most travel requirements. Please check with your travel destination or airline for their specific testing requirements. 

Passport Numbers on Results: While registering for your test you will have the option to enter your passport number as you want it to appear on your test results.

Stamps and Signatures: Valley Medical is happy to offer signatures and/or stamps on required travel forms, documents, and on results. Please follow the instructions below to request signatures or stamps on your travel documents:

1. Please allow up to 1 business day for stamped or signed results and travel forms. Valley Medical cannot sign or stamp any form until your result is ready. Results are ready by Midnight on the day of your test. (Please note that Friday tests may not be signed or stamped until the next business day – Monday).

2. To request a stamp or signature, please pre-fill out your demographic information on the form prior to sending it (Note: Valley Medical does not supply travel forms – you must supply your own travel forms). Text the form you need signed/stamped to (612)-453-1965 or email it to [email protected]. You may also present the form during your test to a staff member.

3. The completed form will be emailed or texted back to you after your test results are completed the following business day. You may also pick up a physical copy at our Burnsville location during normal business hours. (Please note that Friday tests may not be signed or stamped until the next business day – Monday).

Valley Medical does NOT provide QR or bar codes on test results. QR codes are generated through third-party applications. Please check with your airline or destination country for more information on their specific travel testing requirements.

This test has been validated in accordance with the FDA’s Guidance Document (Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA# 24D2072541 during the Public Health Emergency issued on February 29th, 2020.

About the COVID-19 (coronavirus) Test

The COVID-19 virus (coronavirus) gathers in an infected person’s nose and throat. In order to collect a sample of the virus for testing, a 6-inch long swab (like a long Q-tip) is inserted into a person’s nasal cavity. The swabbing takes only a few seconds and causes only minor discomfort. The sample swab is then sent to the Valley Medical Laboratory in Burnsville, MN to be analyzed by our team of highly skilled technicians.

There are multiple strains of coronavirus, and currently RT-PCR is the best method to properly distinguish the COVID-19 strain. It is highly sensitive, accurate, and is the most effective method to deliver reliable diagnoses. RT-PCR is a laboratory technique that allows us to amplify and measure the specific genetic material (RNA) of the COVID-19 virus by using various steps and markers. This process takes about 4 hours in the lab. Results are sent back to patients in 24 hours.

What sets COVID-19 Testing At Valley Medical Apart

At Valley Medical Laboratories, our team of high skilled PCR technicians can delivery certified, accurate test results in 24 hours. We have a submitted EUA application that is under review with the FDA – we are authorized to operate and provide this test using the guidance and testing protocols approved by the FDA.

Because we do not rely on testing kits and are able to keep testing in house, we are able to provide easy access to testing for ALL – anyone wanting a test can obtain a test, regardless of work status, age, or pre-existing conditions. We can test patients of all ages!

Not symptomatic but need a test to get back to work, prepare for a surgery, want to visit a loved-one, or don’t have insurance? – No problem! We have self-pay testing options available for anyone based on their need.

Questions or concerns, please call (612) 286-8366 or email [email protected]

If you’ve been exposed to the coronavirus

If you’ve been exposed, are sick, or are caring for someone with COVID-19

If you’ve been exposed to someone with COVID-19 or begin to experience symptoms of the disease, you may be asked to self-quarantine or self-isolate. What does that entail, and what can you do to prepare yourself for an extended stay at home? How soon after you’re infected will you start to be contagious? And what can you do to prevent others in your household from getting sick?

What are the symptoms of COVID-19?

Some people infected with the virus have no symptoms. When the virus does cause symptoms, common ones include fever, body ache, dry cough, fatigue, chills, headache, sore throat, loss of appetite, and loss of smell. In some people, COVID-19 causes more severe symptoms like high fever, severe cough, and shortness of breath, which often indicates pneumonia.

People with COVID-19 may also experience neurological symptoms, gastrointestinal (GI) symptoms, or both. These may occur with or without respiratory symptoms.

For example, COVID-19 affects brain function in some people. Specific neurological symptoms seen in people with COVID-19 include loss of smell, inability to taste, muscle weakness, tingling or numbness in the hands and feet, dizziness, confusion, delirium, seizures, and stroke.

In addition, some people have gastrointestinal (GI) symptoms, such as loss of appetite, nausea, vomiting, diarrhea, and abdominal pain or discomfort associated with COVID-19. The virus that causes COVID-19 has also been detected in stool, which reinforces the importance of hand washing after every visit to the bathroom and regularly disinfecting bathroom fixtures.

What should I do if I think I or my child may have a COVID-19 infection?

First, call your doctor or pediatrician for advice.

If you do not have a doctor and you are concerned that you or your child may have COVID-19, contact your local board of health. They can direct you to the best place for testing and treatment in your area.

If you have a high or very low body temperature, shortness of breath, confusion, or feeling you might pass out, you need to seek immediate medical evaluation. Call the urgent care center or emergency department ahead of time to let the staff know that you are coming, so they can be prepared for your arrival.

How do I know if I have COVID-19 or the regular flu?

COVID-19 often causes symptoms similar to those a person with a bad cold or the flu would experience. And like the flu, the symptoms can progress and become life-threatening.

So far there has been much less than the usual number of cases of influenza, likely due to the enhanced public health measures to prevent the spread of COVID.

Therefore, at the current time, people with “flulike” symptoms should assume they have COVID. That means isolating and contacting your doctor or local board of health to arrange testing.

I recently spent time with someone who tested positive for COVID-19. I’m fully vaccinated. Do I need to get tested?

Yes, you do. In July 2021, the CDC recommended that anyone who is fully vaccinated and comes into contact with someone who has, or is suspected of having, COVID-19 should get tested three to five days after exposure. In addition, you should wear a mask in public indoor settings for 14 days or until you receive a negative test result. If you are vaccinated, you do not need to quarantine, but you should isolate if you develop symptoms or receive a positive test result.

Previously, the CDC had said that someone who was fully vaccinated only needed to get tested after exposure if they were experiencing symptoms. The change follows new evidence regarding the Delta variant, which shows that people who are vaccinated and then get infected (breakthrough infections) can spread the virus to others, perhaps to the same extent as those who are unvaccinated.

If you are not fully vaccinated, a 14-day quarantine remains the best way to avoid spreading the virus to others after you’ve been exposed to someone with COVID-19. According to CDC guidelines, you may discontinue quarantine after a minimum of 10 days if you do not have any symptoms, or after a minimum of seven days if you have a negative COVID test within 48 hours of when you plan to end quarantine.

How is someone tested for COVID-19?

A specialized diagnostic test must be done to confirm that a person has an active coronavirus infection. Most often a clinician takes a swab of your nose (or both your nose and throat). Some tests may be done using a saliva sample. The sample is then checked for the virus’s genetic material (PCR test) or for specific viral proteins (antigen test).

Antibody tests can tell if someone has been infected with COVID-19. But the infected person doesn’t begin producing antibodies immediately. It can take as long as three weeks for a blood antibody test to turn positive. That’s why it is not useful as a diagnostic test for someone with new symptoms.

Are there at-home tests for COVID-19?

Available over the counter, without a doctor’s prescription

The FDA has granted emergency use authorization (EUA) to the first COVID-19 test that can be obtained without a doctor’s prescription and fully performed at home. The Ellume COVID-19 Home Test is approved for use in adults and in children age 2 and older, with or without COVID-19 symptoms.

To take the test, you collect a nasal swab, stir it in a vial of processing fluid, then place a drop of the fluid in an analyzer. The device, which detects coronavirus antigens, delivers a positive or negative test result to your smartphone within 20 minutes.

Like other antigen tests, this test is less accurate than “gold standard” PCR tests, but initial studies suggest the accuracy comes close to PCR testing. Until there is much more real-world experience with this home test, the FDA recommends interpreting any result with caution.

If you have COVID-like symptoms, you should self-isolate and contact your doctor whether your test is positive or negative. Your doctor will likely suggest a PCR test for confirmation. You should also self-isolate and call your doctor if you get a positive test result, even if you don’t have symptoms. A negative test if you don’t have symptoms makes it very unlikely that you are infected. However, you should continue to follow standard prevention strategies.

This test will be available in drugstores and is expected to cost about $30.

Available with a doctor’s prescription

The FDA has approved a diagnostic test for COVID-19 that can be completed entirely at home, from sample collection to receiving the results. Other FDA-approved COVID-19 tests allow at-home sample collection, but still have to be shipped to a laboratory for processing.

The Lucira COVID-19 All-In-One Test Kit is approved for people ages 14 and older who are suspected of having COVID-19. It requires a doctor’s prescription. The company does not expect the test to be widely available until the spring of 2021.

To perform the test, you swirl a swab in both nostrils, then stir the swab in a vial of chemicals. The vial is then plugged into a battery-powered test unit, which returns a positive or negative test result within 30 minutes.

The test works by making copies of the virus’s genetic material (if present) until it reaches detectable levels. It does this using a technique called loop-mediated isothermal amplification (LAMP). The method is similar to PCR, the gold standard of COVID-19 diagnostic testing. The LAMP test provides much faster results, but it is less accurate. In a head-to-head comparison, the Lucira test missed 6% of people who tested positive for COVID by PCR.

Because a person can be infected and have a negative LAMP test, you should always self-quarantine if you have symptoms consistent with COVID, or have had recent contact with someone who has the infection, until you can get a PCR test.

The FDA has granted emergency use authorization to a rapid antigen test for COVID-19. How is it different from other tests on the market?

The BinaxNOW COVID-19 Ag Card, as the test is known, detects antigen proteins on the surface of SARS-CoV-2, the virus that causes COVID-19. Unlike other diagnostic tests for COVID-19, BinaxNOW does not require a laboratory or other equipment to process or analyze the test results. This makes it portable and fast — results are available within 15 minutes.

This test is approved for use in people who are suspected of having COVID-19, and must be done within seven days of when their symptoms began. A prescription is needed to get this test, which can be performed in authorized locations including doctor’s offices and emergency rooms.

To perform the test, a sample obtained using a nasal swab is inserted into the BinaxNOW test card. The test is a lateral flow immunoassay, which works like a pregnancy test. The appearance of colored lines on the test strip indicates whether or not you have tested positive for COVID-19. The test comes with a smartphone app that can be used to share test results.

Positive test results are highly specific, meaning that if you test positive you are very likely to be infected, particularly if you are tested during the first week of infection when you are experiencing symptoms. False negatives are a bigger concern. As with other antigen tests, BinaxNOW can miss infections, producing negative test results in people who are actually infected.

Still, this test could have an important role during this pandemic. It offers a quick, easy, and inexpensive way to test more people, more quickly.

What is the difference between a PCR test and an antigen test for COVID-19?

PCR tests and antigen tests are both diagnostic tests, which means that they can be used to determine whether you currently have an active coronavirus infection. However, there are important differences between these two types of tests.

PCR tests detect the presence of the virus’s genetic material using a technique called reverse transcriptase polymerase chain reaction, or RT-PCR. For this test, a sample may be collected through a nasal or throat swab, or a saliva sample may be used. The sample is typically sent to a laboratory where coronavirus RNA (if present) is extracted from the sample and converted into DNA. The DNA is then amplified, meaning that many of copies of the viral DNA are made, in order to produce a measurable result. The accuracy of any diagnostic test depends on many factors, including whether the sample was collected properly, when during the course of illness the testing was done, and whether the sample was maintained in appropriate conditions while it was shipped to the laboratory. Generally speaking, PCR tests are highly accurate. However, it can take days to over a week to get the results of a PCR test.

Antigen tests detect specific proteins on the surface of the coronavirus. They are sometimes referred to as rapid diagnostic tests because it can take less than an hour to get the test results. Positive antigen test results are highly specific, meaning that if you test positive you are very likely to be infected. However, there is a higher chance of false negatives with antigen tests, which means that a negative result cannot definitively rule out an active infection. If you have a negative result on an antigen test, your doctor may order a PCR test to confirm the result.

It may be helpful to think of a COVID antigen test as you would think of a rapid strep test or a rapid flu test. A positive result for any of these tests is likely to be accurate, and allows diagnosis and treatment to begin quickly, while a negative result often results in further testing to confirm or overturn the initial result.

How do saliva tests compare to nasal swab tests for diagnosing COVID-19?

Samples for COVID-19 tests may be collected through a long swab that is inserted into the nose and sometimes down to the throat, or from a saliva sample.

The saliva test is easier to perform — spitting into a cup versus submitting to a swab — and more comfortable. Because a person can independently spit into a cup, the saliva test does not require interaction with a healthcare worker. This cuts down on the need for masks, gowns, gloves, and other protective equipment.

Either saliva or swab samples may be used for PCR tests, which detect genetic material from the coronavirus. Swab or saliva samples can also be used for antigen tests, which detect specific proteins on the surface of the coronavirus.

A systematic review and meta-analysis published in JAMA Internal Medicine found that saliva- and nasal swab-based tests that used a technique similar to PCR were similarly accurate. A positive result on either test meant that it was accurate at diagnosing the infection 99% of the time. However, approximately 16 out of 100 people who are infected will be missed.

These results are very similar to prior studies, reinforcing that a single negative swab or saliva test does not mean you don’t have COVID. If you have symptoms suggestive of COVID, presume you may still be infected to avoid transmitting the virus to others.

How reliable are the tests for COVID-19?

Two types of diagnostic tests are currently available in the US. PCR tests detect viral RNA. Antigen tests, also called rapid diagnostic tests, detect specific proteins on the surface of the coronavirus. Antigen test results may come back in as little as 15 to 45 minutes; you may wait several days or longer for PCR test results.

The accuracy of any diagnostic test depends on many factors, including whether the sample was collected properly. For PCR tests, which are typically analyzed in a laboratory, test results may be affected by the conditions in which the test was shipped to the laboratory.

Results may also be affected by the timing of the test. For example, if you are tested on the day you were infected, your test result is almost guaranteed to come back negative, because there are not yet enough viral particles in your nose or saliva to detect. The chance of getting a false negative test result decreases if you are tested a few days after you were infected, or a few days after you develop symptoms.

Generally speaking, if a test result comes back positive, it is almost certain that the person is infected.

A negative test result is less definite. There is a higher chance of false negatives with antigen tests. If you have a negative result on an antigen test, your doctor may order a PCR test to confirm the result.

If you experience COVID-like symptoms and get a negative PCR test result, there is no reason to repeat the test unless your symptoms get worse. If your symptoms do worsen, call your doctor or local or state healthcare department for guidance on further testing. You should also self-isolate at home. Wear a mask when interacting with members of your household. And practice physical distancing.

I’ve heard that the immune system produces different types of antibodies when a person is infected with the COVID-19 coronavirus. How do they differ? Why is this important?

When a person gets a viral or bacterial infection, a healthy immune system makes antibodies against one or more components of the virus or bacterium.

The COVID-19 coronavirus contains ribonucleic acid (RNA) surrounded by a protective layer, which has spike proteins on the outer surface that can latch on to certain human cells. Once inside the cells, the viral RNA starts to replicate and also turns on the production of proteins, both of which allow the virus to infect more cells and spread throughout the body, especially to the lungs.

While the immune system could potentially respond to different parts of the virus, it’s the spike proteins that get the most attention. Immune cells recognize the spike proteins as a foreign substance and begin producing antibodies in response.

There are two main categories of antibodies:

Binding antibodies. These antibodies can bind to either the spike protein or a different protein known as the nucleocapsid protein. Binding antibodies can be detected with blood tests starting about one week after the initial infection. If antibodies are found, it’s extremely likely that the person has been infected with the COVID-19 coronavirus. The antibody level declines over time after an infection, sometimes to an undetectable level.

Binding antibodies help fight the infection, but they might not offer protection against getting reinfected in the future. It depends on whether they are also neutralizing antibodies.

Neutralizing antibodies. The body makes these antibodies specifically against the spike protein. In the laboratory, scientists have observed that neutralizing antibodies block the virus from getting into live cells. And human studies have shown that neutralizing antibodies made against other coronaviruses help prevent re-infection.

Scientists are optimistic that the same will be true for the COVID-19 coronavirus, and that neutralizing antibodies will block cell-to-cell transmission of this virus in humans, and offer protection against reinfection, at least for two to three months.

In November 2020, the FDA authorized emergency use of a test for COVID-19 neutralizing antibodies.

Can a person who has been infected with coronavirus get infected again?

Natural immunity to COVID-19 is the protection that results from having been sick. But we don’t know how long natural immunity lasts, or how strong it is. So can we count on natural immunity to protect us from reinfection? If so, for how long? Unfortunately, we don’t know the answer to either of those questions.

There have been some confirmed cases of reinfection with COVID-19. In other words, a person got sick with COVID-19, recovered, and then became infected again. This is rare, but it can happen.

The CDC states that people who have gotten sick with COVID-19 may still benefit from getting vaccinated. For now, people are eligible to get the COVID-19 vaccine whether or not they were previously infected. Vaccination criteria may change in the future as scientists learn more about natural immunity after COVID illness.

It’s also worth noting that someone who has been re-infected — even someone with no symptoms — has the potential to spread the virus to others. That means that everyone, even those who have recovered from coronavirus infection, and those who have been vaccinated, should continue to follow CDC guidance on mask wearing and other prevention measures.

Can a person who has been infected with coronavirus get infected again?

Natural immunity to COVID-19 is the protection that results from having been sick. But we don’t know how long natural immunity lasts, or how strong it is. We are learning that vaccination strengthens the natural immune response and reduces the risk that you will get infected again.

There have been confirmed cases of reinfection with COVID-19. In other words, a person got sick with COVID-19, recovered, and then became infected again. It’s also worth noting that someone who has been reinfected — even someone with no symptoms — has the potential to spread the virus to others.

We have also learned that people who have gotten sick with COVID-19 benefit from getting vaccinated. A study published in MMWR reported that people who were unvaccinated were about twice as likely to be reinfected as people who were fully vaccinated.

The bottom line? Get vaccinated whether or not you’ve already had COVID-19.

What is serologic (antibody) testing for COVID-19? What can it be used for?

A serologic test is a blood test that looks for antibodies created by your immune system. There are many reasons you might make antibodies, the most important of which is to help fight infections. The serologic test for COVID-19 specifically looks for antibodies against the COVID-19 virus.

Your body takes one to three weeks after you have acquired the infection to develop antibodies to this virus. For this reason, serologic tests are not sensitive enough to accurately diagnose an active COVID-19 infection, even in people with symptoms.

However, serologic tests can help identify anyone who has recovered from coronavirus. This may include people who were not initially identified as having COVID-19 because they had no symptoms, had mild symptoms, chose not to get tested, had a false-negative test, or could not get tested for any reason. Serologic tests will provide a more accurate picture of how many people have been infected with, and recovered from, coronavirus, as well as the true fatality rate.

Serologic tests may also provide information about whether people become immune to coronavirus once they’ve recovered and, if so, how long that immunity lasts.

The accuracy of serologic tests varies depending on the test and when in the course of infection the test is performed.

How soon after I’m infected with the new coronavirus will I start to be contagious?

The time from exposure to symptom onset (known as the incubation period) is thought to be two to 14 days, though symptoms typically appear within four or five days after exposure.

We know that a person with COVID-19 may be contagious 48 hours before starting to experience symptoms. People may actually be most likely to spread the virus to others during the 48 hours before they start to experience symptoms.

For people who are not fully vaccinated, wearing masks, particularly indoors, can help reduce the risk that someone who is infected but not yet experiencing symptoms may unknowingly infect others. As of July 2021, the CDC is also advising people who are fully vaccinated to wear masks in public indoor places in areas of the country with substantial or high transmission of the virus.

Can people without symptoms spread the virus to others?

“Without symptoms” can refer to two groups of people: those who eventually do have symptoms (pre-symptomatic) and those who never go on to have symptoms (asymptomatic). During this pandemic, we have seen that people without symptoms can spread the coronavirus infection to others.

A person with COVID-19 may be contagious 48 hours before starting to experience symptoms. In fact, people without symptoms may be more likely to spread the illness, because they are unlikely to be isolating and may not adopt behaviors designed to prevent spread.

But what about people who never go on to develop symptoms? A published in JAMA Network Open found that almost one out of every four infections may be transmitted by individuals with asymptomatic infections.

We are learning that people who are vaccinated are less likely to infect others. However, even people who are fully vaccinated can carry greater amounts of the Delta variant (now the dominant virus in the US), making it more likely that they could spread the virus to others. That’s one reason why, in July 2021, the CDC advised people who are fully vaccinated to wear masks in public indoor places in areas of the country with substantial or high transmission of the virus.

People who are not vaccinated remain at increased risk for becoming infected and infecting others. For this group, the CDC continues to recommend mask wearing and other preventive measures in some outdoor settings and in most indoor settings.

For how long after I am infected will I continue to be contagious? At what point in my illness will I be most contagious?

People are thought to be most contagious early in the course of their illness, when they are beginning to experience symptoms, especially if they are coughing and sneezing. But people with no symptoms can also spread the coronavirus to other people. In fact, people who are infected may be more likely to spread the illness if they are asymptomatic, or in the days before they develop symptoms, because they are less likely to be isolating or adopting behaviors designed to prevent spread.

By the 10th day after COVID symptoms begin, most people will no longer be contagious, as long as their symptoms have continued to improve and their fever has resolved. People who test positive for the virus but never develop symptoms over the following 10 days after testing are probably no longer contagious, but again there are documented exceptions.

A full, 14-day quarantine remains the best way to avoid spreading the virus to others after you’ve been exposed to someone with COVID-19. However, according to CDC guidelines, you may discontinue quarantine after a minimum of 10 days if you do not have any symptoms, or after a minimum of seven days if you have a negative COVID test within 48 hours of when you plan to end quarantine.

If you are fully vaccinated and have been around someone with or suspected of having COVID-19 you do not need to quarantine. However, as of July 2021, the CDC recommends that you be tested thre to five days after exposure, and wear a mask in public indoor settings for 14 days or until you receive a negative test result.

If I get sick with COVID-19, how long until I will feel better?

It varies. Most people with mild cases appear to recover within one to two weeks. However, recent surveys conducted by the CDC found that recovery may take longer than previously thought, even for adults with milder cases who do not require hospitalization. The CDC survey found that one-third of these adults had not returned to normal health within two to three weeks of testing positive for COVID-19. Among younger adults (ages 18 to 34) who did not require hospitalization and who did not have any underlying health conditions, nearly one in five had not returned to normal health within two to three weeks after testing positive for COVID-19. With severe cases, recovery can take six weeks or more.

Some people may experience longer-term physical, cognitive, and psychological problems. Their symptoms may alternately improve and worsen over time, and can include a variety of difficulties, from fatigue and trouble concentrating to anxiety, muscle weakness, and continuing shortness of breath.

I had COVID-19 a few months ago. Am I at increased risk for health problems in the future?

It does appear that people who recover from COVID-19 have an increased risk of developing other medical conditions, at least in the short term.

One study, published in The BMJ, collected laboratory test and hospital admissions data from a health plan in the US. The researchers compared data from more than 190,000 adults, ages 18 to 65 years, who tested positive for the SARS-CoV-2 virus in 2020, to data from a control group that was collected in 2019, before the pandemic. The researchers followed the participants for six months after they tested positive for SARS-CoV-2 and recorded any new health complications.

They found that 14% of people who had had COVID-19 developed a new medical issue during the following six months; this was nearly 5% higher than the pre-pandemic control group, a significant difference. New medical problems affected a range of body systems and included respiratory failure, abnormal heart rhythms, diabetes, neurological problems, and liver and kidney problems. Increased risk was seen in younger, previously healthy people, but was higher in older people and those with pre-existing medical problems.

Another study, published in Nature, compared the health records of more than 73,000 users of the Veteran’s Health Administration (VHA) who tested positive for SARS-CoV-2 but were never hospitalized, to those of nearly five million other VHA users who never tested positive for COVID-19 and were never hospitalized. For six months following the first 30 days after infection, people who had had COVID-19 were significantly more likely to die or to experience a medical or mental health problem that they had never had before.

These studies provide yet another reason to get a COVID-19 vaccine if you are eligible.

Who are long-haulers? And what is post-viral syndrome?

Long haulers are people who have not fully recovered from COVID-19 weeks or even months after first experiencing symptoms. Some long haulers experience continuous symptoms for weeks or months, while others feel better for weeks, then relapse with old or new symptoms. The constellation of symptoms long haulers experience, sometimes called post-COVID-19 syndrome or post-acute sequelae of SARS-CoV-2 infection (PASC), is not unique to this infection. Other infections, such as Lyme disease, can cause similar long-lasting symptoms.

Emerging research may help predict who will become a long hauler. One study found that COVID-19 patients who experienced more than five symptoms during their first week of illness were significantly more likely to become long haulers. Certain symptoms — fatigue, headache, difficulty breathing, a hoarse voice, and muscle or body aches — experienced alone or in combination during the first week of illness also increased the chances of becoming a long hauler, as did increasing age and higher body mass index (BMI).

Though these factors may increase the likelihood of long-term symptoms, anyone can become a long hauler. Many long haulers initially have mild to moderate symptoms — or no symptoms at all — and do not require hospitalization. Previously healthy young adults, not just older adults with coexisting medical conditions, are also experiencing post-COVID-19 syndrome.

Symptoms of post-COVID-19 syndrome, like symptoms of COVID-19 itself, can vary widely. Some of the more common lasting symptoms include fatigue, worsening of symptoms after physical or mental activity, brain fog, shortness of breath, chills, body ache, headache, joint pain, chest pain, cough, and lingering loss of taste or smell. Many long haulers report cognitive dysfunction or memory loss that affects their day-to-day ability to do things like make decisions, have conversations, follow instructions, and drive. The common thread is that long haulers haven’t returned to their pre-COVID health, and ongoing symptoms are negatively affecting their quality of life.

There’s already some speculation, but no definite answers, about what is causing these ongoing symptoms. Some researchers suspect that SARS-CoV-2 infection triggers long-lasting changes in the immune system. Others propose that it triggers autonomic nervous system dysregulation, which can impact heart rate, blood pressure, and sweating, among other things.

In February 2021, the National Institutes of Health announced a $1.15 billion initiative to support research into the causes and ultimately the prevention and treatment of long-haul COVID.

Many long haulers never had laboratory confirmation of COVID-19, which can make it tricky to diagnose post-COVID-19 syndrome. Early on in the pandemic, tests were scarce. Many people who suspected they had COVID-19 self-isolated without getting a test, or were refused a COVID test when they requested one. And the tests themselves have not been entirely reliable; both diagnostic tests and antibody tests may return false negative results if taken too early or too late in the course of illness.

How long after I start to feel better will be it be safe for me to go back out in public again?

The most recent CDC guidance states that someone who has had COVID-19 can discontinue isolation once they have met the following criteria:

1. It has been more than 10 days since your symptoms began.
2. You have been fever-free for more than 24 hours without the use of fever-reducing medications.
3. Other symptoms have improved.

The CDC is no longer recommending a negative COVID-19 test before going back out in public.

Anyone who tested positive for COVID-19 but never experienced symptoms may discontinue isolation 10 days after they first tested positive for COVID-19.

What’s the difference between self-isolation and self-quarantine, and who should consider them?

Self-isolation is voluntary isolation at home by those who have or are likely to have COVID-19 and are experiencing mild symptoms of the disease (in contrast to those who are severely ill and may require hospitalization). The purpose of self-isolation is to prevent spread of infection from an infected person to others who are not infected. If possible, the decision to isolate should be based on physician recommendation. If you have tested positive for COVID-19, you should self-isolate.

You should strongly consider self-isolation if you

• have been tested for COVID-19 and are awaiting test results
• have been exposed to the COVID-19 virus and are experiencing symptoms consistent with COVID-19 (fever, cough, difficulty breathing), whether or not you have been tested.

You may also consider self-isolation if you have symptoms consistent with COVID-19 (fever, cough, difficulty breathing) but have not had known exposure to the new coronavirus and have not been tested for it. In this case, it may be reasonable to isolate yourself for a minimum of 10 days from when you begin to experience symptoms.

Self-quarantine is advised for anyone who has been exposed to the COVID-19 virus, regardless of whether you are experiencing symptoms. The purpose of self-quarantine (as with self-isolation) is to prevent the possible spread of COVID-19. A full, 14-day quarantine remains the best way to ensure that you don’t spread the virus to others. However, according to CDC guidelines, you may discontinue quarantine after a minimum of 10 days if you do not have any symptoms, or after a minimum of seven days if you have a negative COVID test within 48 hours of when you plan to end quarantine. If you are fully vaccinated and have been around someone with or suspected of having COVID-19, you do not need to quarantine. However, as of July 2021, the CDC recommends that you be tested three to five days after exposure and wear a mask in public indoor settings for 14 days or until you receive a negative test result.

What does it really mean to self-isolate or self-quarantine? What should or shouldn’t I do?

If you are sick with COVID-19 or think you may be infected with the COVID-19 virus, it is important not to spread the infection to others while you recover. While home-isolation or home-quarantine may sound like a staycation, you should be prepared for a long period during which you might feel disconnected from others and anxious about your health and the health of your loved ones. Staying in touch with others by phone or online can be helpful to maintain social connections, ask for help, and update others on your condition.

Here’s what the CDC recommends to minimize the risk of spreading the infection to others in your home and community.

Stay home except to get medical care

• Do not go to work, school, or public areas.
• Avoid using public transportation, ride-sharing, or taxis.

Call ahead before visiting your doctor

• Call your doctor and tell them that you have or may have COVID-19. This will help the healthcare provider’s office to take steps to keep other people from getting infected or exposed.

Separate yourself from other people and animals in your home

• As much as possible, stay in a specific room and away from other people in your home. Use a separate bathroom, if available.
• Restrict contact with pets and other animals while you are sick with COVID-19, just like you would around other people. When possible, have another member of your household care for your animals while you are sick. If you must care for your pet or be around animals while you are sick, wash your hands before and after you interact with pets and wear a face mask.

Wear a face mask if you are sick

• Wear a face mask when you are around other people or pets and before you enter a doctor’s office or hospital.

Cover your coughs and sneezes

• Cover your mouth and nose with a tissue when you cough or sneeze and throw used tissues in a lined trash can.
• Immediately wash your hands with soap and water for at least 20 seconds after you sneeze. If soap and water are not available, clean your hands with an alcohol-based hand sanitizer that contains at least 60% alcohol.

Clean your hands often

• Wash your hands often with soap and water for at least 20 seconds, especially after blowing your nose, coughing, or sneezing; going to the bathroom; and before eating or preparing food.
• If soap and water are not readily available, use an alcohol-based hand sanitizer with at least 60% alcohol, covering all surfaces of your hands and rubbing them together until they feel dry.
• Avoid touching your eyes, nose, and mouth with unwashed hands.

Don’t share personal household items

• Do not share dishes, drinking glasses, cups, eating utensils, towels, or bedding with other people or pets in your home.
• After using these items, they should be washed thoroughly with soap and water.

Clean all “high-touch” surfaces every day

High touch surfaces include counters, tabletops, doorknobs, bathroom fixtures, toilets, phones, keyboards, tablets, and bedside tables.

• Clean and disinfect areas that may have any bodily fluids on them.
• A list of products suitable for use against COVID-19 is available here. This list has been pre-approved by the US Environmental Protection Agency (EPA) for use during the COVID-19 outbreak.

Monitor your symptoms

• Monitor yourself for fever by taking your temperature twice a day and remain alert for cough or difficulty breathing.
  • If you have not had symptoms and you begin to feel feverish or develop fever, cough, or difficulty breathing, immediately limit contact with others if you have not already done so. Call your doctor or local health department to determine whether you need a medical evaluation.
• Seek prompt medical attention if your illness is worsening, for example if you have difficulty breathing. Before going to a doctor’s office or hospital, call your doctor and tell them that you have, or are being evaluated for, COVID-19.
• Put on a face mask before you enter a healthcare facility or any time you may come into contact with others.
• If you have a medical emergency and need to call 911, notify the dispatch personnel that you have or are being evaluated for COVID-19. If possible, put on a face mask before emergency medical services arrive.

What types of medications and health supplies should I have on hand for an extended stay at home?

Try to stock at least a 30-day supply of any needed prescriptions. If your insurance permits 90-day refills, that’s even better. Make sure you also have over-the-counter medications and other health supplies on hand.

Medical and health supplies

• prescription medications
• prescribed medical supplies such as glucose and blood-pressure monitoring equipment
• fever and pain medicine, such as acetaminophen
• cough and cold medicines
• antidiarrheal medication
• thermometer
• fluids with electrolytes
• soap and alcohol-based hand sanitizer
• tissues, toilet paper, disposable diapers, tampons, sanitary napkins
• garbage bags.

When can I discontinue my self-quarantine?

If you have not been vaccinated, a full, 14-day quarantine remains the best way to ensure that you don’t spread the virus to others after you’ve been exposed to someone with COVID-19.

However, according to CDC guidelines, you may discontinue quarantine after a minimum of 10 days if you do not have any symptoms, or after a minimum of seven days if you have a negative COVID test within 48 hours of when you plan to end quarantine.

If you are fully vaccinated and have been around someone with or suspected of having COVID-19, you do not need to self-quarantine. However, as of July 2021, the CDC recommends that you be tested three to five days after exposure and wear a mask in public indoor settings for 14 days or until you receive a negative test result.

How can I protect myself while caring for someone that may have COVID-19?

You should take many of the same precautions as you would if you were caring for someone with the flu:

• Stay in another room or be separated from the person as much as possible. Use a separate bedroom and bathroom, if available.
• Make sure that shared spaces in the home have good air flow. If possible, open a window.
• Wash your hands often with soap and water for at least 20 seconds or use an alcohol-based hand sanitizer that contains 60 to 95% alcohol, covering all surfaces of your hands and rubbing them together until they feel dry. Use soap and water if your hands are visibly dirty.
• Avoid touching your eyes, nose, and mouth with unwashed hands.
• Extra precautions:
• You and the person should wear a face mask if you are in the same room.
• Wear a disposable face mask and gloves when you touch or have contact with the person’s blood, stool, or body fluids, such as saliva, sputum, nasal mucus, vomit, urine.
  • Throw out disposable face masks and gloves after using them. Do not reuse.
  • First remove and throw away gloves. Then, immediately clean your hands with soap and water or alcohol-based hand sanitizer. Next, remove and throw away the face mask, and immediately clean your hands again with soap and water or alcohol-based hand sanitizer.
• Do not share household items such as dishes, drinking glasses, cups, eating utensils, towels, bedding, or other items with the person who is sick. After the person uses these items, wash them thoroughly.
• Clean all “high-touch” surfaces, such as counters, tabletops, doorknobs, bathroom fixtures, toilets, phones, keyboards, tablets, and bedside tables, every day. Also, clean any surfaces that may have blood, stool, or body fluids on them. Use a household cleaning spray or wipe.
• Wash laundry thoroughly.
  • Immediately remove and wash clothes or bedding that have blood, stool, or body fluids on them.
  • Wear disposable gloves while handling soiled items and keep soiled items away from your body. Clean your hands immediately after removing your gloves.
• Place all used disposable gloves, face masks, and other contaminated items in a lined container before disposing of them with other household waste. Clean your hands (with soap and water or an alcohol-based hand sanitizer) immediately after handling these items.

My parents are older, which puts them at higher risk for COVID-19, and they don’t live nearby. How can I help them if they get sick?

Caring from a distance can be stressful. Start by talking to your parents about what they would need if they were to get sick. Put together a single list of emergency contacts for their (and your) reference, including doctors, family members, neighbors, and friends. Include contact information for their local public health department.

You can also help them to plan ahead. For example, ask your parents to give their neighbors or friends a set of house keys. Have them stock up on prescription and over-the counter medications, health and emergency medical supplies, and nonperishable food and household supplies. Check in regularly by phone, Skype, or however you like to stay in touch.

Can people infect pets with the COVID-19 virus?

The virus that causes COVID-19 does appear to spread from people to pets, according to the FDA, though this is uncommon. Research has found that cats and ferrets are more likely to become infected than dogs.

If you have a pet, do the following to reduce their risk of infection:

• Avoid letting pets interact with people or animals that do not live in your household.
• Keep cats indoors when possible to prevent them from interacting with other animals or people.
• Walk dogs on a leash maintaining at least six feet from other people and animals.
• Avoid dog parks or public places where a large number of people and dogs gather.

If you become sick with COVID-19, restrict contact with your pets, just like you would around other people. This means you should forgo petting, snuggling, being kissed or licked, and sharing food or bedding with your pet until you are feeling better. When possible, have another member of your household care for your pets while you are sick. If you must care for your pet while you are sick, wash your hands before and after you interact with your pets and wear a face mask.

At present, it is considered unlikely that pets can spread the COVID-19 virus to humans. However, pets can spread other infections that cause illness, including E. coli and Salmonella, so wash your hands thoroughly with soap and water after interacting with your animal companions.

Blog posts:

Podcast:

You think you’ve got COVID-19. Here’s what you need to do (recorded 4/10/20)

We asked Dr. Mallika Marshall, medical reporter for CBS-affiliate WBZ TV in Boston and an instructor at Harvard Medical School, how we should react when we start to experience a dry cough or perhaps spike a fever. Who do you call? How do you protect your family? When does it make sense to move toward an emergency department, and how should we prepare? Dr. Marshall is the host of Harvard Health Publishing’s online course series, and an urgent care physician at Mass General Hospital.

Visit our Coronavirus Resource Center for more information on coronavirus and COVID-19.

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should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.

Considerations for physicians ordering SARS-CoV-2 PCR diagnostic testing

Updated Aug. 20, 2020

This is the first article of a two-part series on considerations for SARS-CoV-2 PCR diagnostic testing. Read the previous articles from the series Considerations for SARS-CoV-2 PCR diagnostic testing.

Polymerase chain reaction (PCR) diagnostic testing for SARS-CoV-2, the virus that causes COVID-19, has been fraught with challenges since the current pandemic reached the United States. Learn more about the considerations for physicians ordering PCR diagnostic testing for SARS-CoV-2.

Download the Considerations for Physicians Ordering SARS-CoV-2 PCR Diagnostic Testing 

Download the Considerations for Physicians Ordering SARS-CoV-2 PCR Diagnostic Testing 

1. Considerations for Physicians Ordering SARS-CoV-2 PCR Diagnostic Testing (PDF)

   1. Download the complete overview of the considerations for physicians ordering PCR diagnostic testing for SARS-CoV-2.

Considerations for ordering physicians

Considerations for ordering physicians

As demand for PCR diagnostic testing services continues to outpace capacity, the AMA recommends ordering physicians carefully consider when to recommend PCR diagnostic testing for SARS-CoV-2. At this time, the AMA recommends that physicians consider prioritizing testing services for those individuals with a medically indicated need for diagnostic testing. These individuals include those exhibiting COVID-19 symptoms, those with a known exposure to SARS-CoV-2, those requiring a negative SARS-CoV-2 test to pursue medical treatment or procedures, and health care workers¹.

For other individuals not at an immediate-risk of illness or other medically indicated need for testing, at-home quarantine would likely serve the purpose of limiting risk of transmission to others while easing demand on the testing capacity. Individuals not at immediate-risk of illness or other medically indicated need may include those wishing to engage in social gatherings, those who have previously participated in social gatherings but do not have a known exposure, those wishing to engage in non-essential travel and those returning to work or school. Where there is no medically indicated need for testing, we encourage physicians to consider recommending at-home quarantine in lieu of testing. As the demand for testing services is dynamic, these recommended considerations may change should demand for testing ease, availability of testing supplies improve, or if new tests with acceptable performance become widely available.

We further encourage physicians to provide certain counseling to patients seeking testing for SARS-SoV-2. If a patient presents with symptoms of COVID-19 or a known exposure to COVID-19, it is critical that providers counsel patients on the importance of at-home quarantine until test results are received. Potentially infected patients choosing not to quarantine during this time risk transmission to others and clear counseling to this effect is critical to help limit spread of this disease. The Centers for Medicare and Medicaid Services and the Centers for Disease Control have announced their intent to reimburse physicians for these counseling services².

Physicians should further counsel their patients about what a negative SARS-CoV-2 test result means. It should be made clear to patients that a negative test result means only that patients were SARS-CoV-2 negative at the moment in time when the sample was collected and that they will not necessarily continue to be negative in to the future. It is possible that patients could be infected in the hours or days after receiving the test result or were tested too early during the course of illness. Those with negative test results must continue to follow all public health protocols, including physical distancing, employing good hand hygiene practice and wearing face masks in public and/or where physical distancing is not possible.
The AMA recognizes that there is likely need for testing of asymptomatic individuals as part of public health surveillance efforts. The AMA continues to advocate for the development of a well-defined surveillance strategy for COVID-19 infections. Patients participating in such efforts should be included as those with a prioritized need for testing services.

Read more articles in the series

Read more articles in the series

¹This list is not exhaustive and other individuals may have legitimate medically indicated needs for testing services. These requests should be considered on a case-by-case basis.

² CMS and CDC announce provider reimbursement available for counseling patients to self-isolate at time of COVID-19 testing

Testing for COVID-19 | Available at select locations

COVID-19 testing: questions and answers

Which tests can I get through UCHealth?

UCHealth is offering two types of COVID-19 testing. All testing is voluntary. One type of test, called a PCR test, can tell you if you have COVID-19 now. This test requires a nasal swab. UCHealth is also offering an antibody test. This test can tell you if you’ve been exposed or if you were sick with COVID-19 in the past. This test requires a blood draw.

What is the difference between these two tests?

A nasal swab PCR test for COVID-19 looks for the presence of the virus in someone who is sick right now or has recently gotten better. An antibody test can see if someone has been exposed to COVID-19 and now has antibodies to the illness.

Why should I get the COVID-19 test?

If you have symptoms of COVID-19 now, a nasal swab test can determine if you have COVID-19, the illness caused by the new coronavirus. These signs include:

• Fever
• Cough
• Difficulty breathing
• Exhaustion
• Body aches
• Sudden loss of taste or smell

If you are experiencing flu or COVID-19 symptoms, take the following steps:

• Call your provider and describe your symptoms. Your provider may order a COVID-19 or flu test. If they submit the order, you can schedule an appointment through My Health Connection.
• If you do not have a provider, schedule an appointment through our virtual urgent care. That provider will determine if you need a flu or COVID-19 test. If they submit the order, you can schedule an appointment through My Health Connection.
• If you do not speak to any providers, and still want a test, you will only be able to order a COVID-19 test. The cost is $85. You may not self-schedule a flu test.

Also, some people who are not sick might need to get a COVID-19 test before returning to work.

If you need a copy of a negative COVID-19 test in order to travel or return to work, please reach out to medical records.

What if I get a positive result from a COVID-19 test?

If you learn that you have COVID-19, you should isolate yourself at home right away and contact your health care provider. You may be able to heal at home. But, you should get medical help right away if you are having serious problems like trouble breathing.

After being quarantined for testing positive for COVID-19, should I get another test after my quarantine period is over?

People who have tested positive for COVID-19 and finished their quarantine period, do not need to get tested again for up to 3 months as long as they do not develop symptoms again. People who develop symptoms again within 3 months of their first case of COVID-19 may need to be tested again, if there is no other cause identified for their symptoms.

I’ve tested positive for COVID-19 in the past, but I have been recently exposed to someone who tested positive for COVID-19. Should I get another COVID-19 test?

You do not need to get another COVID-19 test and you do NOT need to stay home if you meet the following criteria:

• • Has had COVID-19 illness within the previous 3 months and
  • Has recovered and
  • Remains without COVID-19 symptoms (for example, no cough, shortness of breath or fever)
• If you do develop symptoms, you should immediately self-isolate and contact your healthcare provider

Where is UCHealth offering testing?

All the testing sites locations and hours of operation are located on this page.

How can I make an appointment to get a COVID-19 test, an antibody test or both?

Currently test scheduling is done via My Health Connection, UCHealth’s free, convenient patient portal.

How do I create a My Health Connection account? And how do I order a test on MHC?

Find detailed instructions on this web page.

How do I schedule a COVID-19 test for children younger than 14?

Find detailed instructions on this web page.

How do I schedule a COVID-19 test for children 14 and older?

Find detailed instructions on this web page.

Will my health insurance cover testing?

Many insurance providers will cover COVID-19 and antibody testing, but you should check on the details for your insurance plan. If you have not met the yearly deductible for your plan, you could be charged. And, for antibody testing, it’s also possible that the cost of the test itself may be covered, but that you will be charged for the blood draw.

If I don’t have health insurance, can I still get tested?

Yes, you can pay out of pocket for testing. If you pay yourself, a nose swab to test for COVID-19 will cost $85 and an antibody test will cost $100. You must use a credit card to pay for the tests.

Do I need to be a current UCHealth patient to get tested?

No. You are welcome to get tested even if you are not a current UCHealth patient. You will need to sign up for a My Health Connection account to schedule a test and get your results.

Can I come and get a test even though I don’t have any symptoms?

Yes. COVID-19 tests are available for people experiencing symptoms, for patients with a provider’s order, and for people who need a test for work, travel or because they were recently in close contact with someone who tested positive.

How long will it take to get my results?

Results will be available within approximately 72 hours, but may take longer than expected due to high demand and/or processing times.

Will my test results be used for research?

Your test results are private. But researchers may use anonymous testing data to find how widely COVID-19 has spread throughout the community and to assist public health experts and government leaders as they try minimize the spread of COVID-19.

What should I do while I wait for results?

If you were tested because of symptoms or an exposure, you should stay in your home (isolation or quarantine) while you wait for your results. This is important because other people, including elderly and those with major medical problems, are more at risk to get severe symptoms from this infection if they are exposed.

If you had symptoms and were seen in a clinic, urgent care or emergency department, you are well enough to go home today. Treat your symptoms with fluids by mouth and over-the-counter medicine.

If your symptoms get worse, call your provider or go to the emergency room. Make sure to let your health care providers know that you have been tested for COVID-19.

Where can I find my results?

Results will be sent to your My Health Connection account. Results will be available within approximately 72 hours, but may take longer than expected due to high demand and/or processing times. Positive and negative results are shown. Please do not call the lab or testing site, as they are unable to check on or share individual results.

If your result is positive (you have the virus), and you don’t have My Health Connection or have not viewed your results, you will be called.

What if I don’t have a phone?

If we cannot contact you by phone, we will send you a letter with your results.

I took a COVID test today and I received my test results. I have questions about my results.

You were given instructions when you arrived for your test. These instructions included information on what to do if you test positive. If you still have questions, please call your primary care physician. If you do not have a primary care physician, we recommend you schedule a Virtual Urgent Care appointment.

Visit https://www.uchealth.org/services/virtual-urgent-care/

I took a COVID test several days ago and I have not received my results. I need them to return to work or travel to a foreign country.

We’re sorry it’s taking so long. The time it takes to get results back depends on how many other people have also taken tests. Rest assured, your results will be posted as soon as the laboratory completes them. Thanks for your patience.

Can I get a rapid test?

We do not have rapid tests available for most patients. Most test results are back within 24-72 hours. If you were tested because of symptoms or an exposure, you should stay in your home (isolation or quarantine) while you wait for your results. This is important because other people, including elderly and those with major medical problems, are more at risk to get severe symptoms from this infection if they are exposed.

If your symptoms get worse, call your provider or go to the emergency room. Make sure to let your health care providers know that you have been tested for COVID-19.

My surgery or procedure is in the morning and I have not taken the test or I have not received my results?  Can I still come to the hospital?

Yes, you can still come to the hospital for your surgery. We recommend patients be tested for COVID-19 at 2-5 days before their scheduled procedure or surgery. This is to ensure the safety of patients, visitors and all of our staff. Patients who do not get the required testing may have their surgery or procedure delayed or canceled. If you have questions, please call your provider.

How can I protect myself from getting COVID-19?

• Wash your hands regularly.
• Stay at least six feet away from people in public.
• Stay home if you are sick.

If you need medical advice, please contact your provider.

What are antibodies?

When we get infections, our bodies create proteins to fight infections. These are called antibodies.

How long does it take for a person to create antibodies?

It can take days or weeks for a person to develop antibodies.

How long do antibodies to COVID-19 last?

Researchers don’t know yet how long antibodies to COVID-19 last or whether they protect people from getting sick in the future.

Why should I get an antibody test?

An antibody test can tell you if you have been exposed to the virus that causes COVID-19. If you test positive and you have fully recovered from COVID-19, you might be able to donate what’s known as convalescent plasma to patients who are currently sick with COVID-19.

Also, results from antibody tests might help medical experts understand how widely the new coronavirus has spread in our communities. But, it’s important to know that a positive test result to an antibody test does not mean you are safe (immune) from getting COVID-19 in the future. Researchers are still working to understand how protective these antibodies to COVID-19 will be.

If I get a positive test result from an antibody test, what does that mean?

Since COVID-19 is such a new illness, medical experts are still learning how COVID-19 antibodies work. If your test shows that you have antibodies (a positive result), that means that it’s likely you have been exposed to the virus that causes COVID-19. But, a positive result does not mean you are immune or less likely to get COVID-19 in the future.

Even if your results from an antibody test are positive, you should still follow social distancing guidelines. These include:

• Stay at least six feet away from people outside of your household.
• Wash your hands often.
• Wear a mask in public.
• Stay home if you’re sick.

I heard antibody tests can be inaccurate. Is that true?

Yes, there are many commercial antibody tests found at drug stores, labs and at medical facilities. Many of these tests are not accurate and have not been authorized by the FDA. UCHealth is only offering tests that our medical experts have tested and verified. UCHealth COVID-19 tests are high-quality, accurate, FDA-authorized tests.

What if I get an antibody test elsewhere?

You should be very careful about the type of antibody test you get. If you get tested outside of UCHealth, ask questions about the type of test you will be getting. UCHealth experts found that antibody tests that only required a finger prick were not accurate. You will want an antibody test that:

• Requires a full blood draw.
• Has been tested and proven to be accurate.
• Is approved by the FDA.

Why is an inaccurate antibody test concerning?

The virus that causes COVID-19 is what’s known as a coronavirus. These viruses are very common, and some are not dangerous. A different type of coronavirus causes the common cold. An inaccurate antibody test might find antibodies to other common coronaviruses. If you get results from an inaccurate antibody test, you might wrongly believe you have immunities to COVID-19.

Regardless or the results you get from any antibody test, do not assume that you are immune from COVID-19. This illness is serious and can cause people to become critically ill. Please take all precautions to protect yourself and others from getting and spreading the virus that causes COVID-19.

COVID-19 Testing and Screening | Sharp HealthCare

Last update: 2021-08-24

Frequently asked questions.

Read our frequently asked questions below to learn more about Sharp HealthCare’s COVID-19 testing and screening for patients.

Testing

Screening

Is Sharp testing patients for the coronavirus?

If the patient meets the criteria for a COVID-19 test, a caregiver will take a nasal swab and send it to a Sharp laboratory. In some cases, the patient will be instructed to self-test under the guidance of a caregiver. This is currently the protocol that is in place for all Sharp HealthCare facilities.

If the sample is positive, Sharp will notify Public Health Services and a care plan will be determined.

Sharp patients are encouraged to use FollowMyHealth® or the patient portal their doctor uses to communicate with their providers and learn their test results.

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Can anyone be tested for the coronavirus?

Not everyone will be tested for coronavirus. People who think they need to be tested due to a confirmed exposure should contact their primary care doctor. If appropriate, your doctor will advise you on where to go for testing.

To determine who should be tested, we use the guidelines and criteria set forth by the CDC and California Department of Public Health. If you do not meet any of the criteria but would like a test, please find information for free testing options on 2-1-1 San Diego.

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Where can I get tested if I’m not able to get a doctor’s order for a COVID-19 test?

Free tests and walk-in tests are available through the County of San Diego.

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Is there a fee for COVID-19 screening or testing?

The California Department of Managed Health Care directed all commercial health plans and Medi-Cal health plans to cover the cost for medically necessary screening and testing for COVID-19. This includes waiving the member’s share of costs for the emergency room, urgent care or visits with a doctor. In addition, the Centers for Medicare and Medicaid Services has directed that Medicare Part B will cover all medically necessary COVID-19 testing only. Patients with Medicare Part B plans are still responsible for emergency, urgent care or doctor’s office visit fees, even if related to COVID-19. Patients who do not have health insurance may get a COVID-19 test at Sharp Laboratories for $104 or an antibody test for $55. Regardless of insurance, all patients must have a physician order to be tested at a Sharp Laboratory.

Free tests and walk-in tests (no physician order) are available through the County of San Diego and other organizations.

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Where do I get the test if I don’t have insurance?

If you have a primary care doctor, we suggest that you contact your doctor to be evaluated. Not every patient will be tested for coronavirus, so we recommend that you receive an evaluation by a doctor before coming to the hospital or an urgent care center.

If you do not have a primary care physician, we can provide you a referral to a low- or no-cost community clinic.

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Does Sharp offer “drive-thru” testing or “testing tents”?

Sharp does not currently provide “drive-thru” testing or “testing tents”. If you think you need to be tested, please call your primary care doctor, who will advise you on where to go for testing.

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How are Sharp labs handling the coronavirus pandemic?

Sharp is practicing social distancing whenever and wherever possible. If you are concerned about having room to distance yourself from other patients in the lab, we suggest that you call ahead. We are not taking every patient’s temperature because patients can be contagious even without a fever.

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I don’t work at Sharp and my employer told me that I need to get tested.

Your employer’s occupational health (sometimes called employee health) department can refer you to the occupational medicine program they prefer. Sharp Occupational Health has locations across San Diego. Please have your occupational health or human resources department contact your occupational health provider.

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How do I request documentation of my COVID-19 test results?

The easiest way to access documentation of your COVID-19 test results is through FollowMyHealth. You can also request your hospital or Sharp Rees-Stealy COVID-19 test results.

Read fact sheet about the COVID-19 test you received.

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What should I do if I think I have the coronavirus?

If you have had close contact with someone who is confirmed to have, or is being evaluated for, coronavirus, and think you may be sick, the CDC recommends self-isolation within your home.

You should also:

• Monitor your health starting from the day you first had close contact with the person
• Continue monitoring for 14 days after you last had close contact with the person
• Watch for these signs and symptoms:
  -Fever (take your temperature twice a day)
  -Cough
  -Congestion or runny nose
  -Sore throat
  -Shortness of breath or difficulty breathing
  -Chills
  -Repeated shaking with chills
  -Muscle pain
  -Headache
  -New loss of taste or smell
  -Fatigue
  -Nausea or vomiting
  -Diarrhea

If you develop a fever or any of these symptoms, call your health care provider immediately and inform them of your close contact with someone who is confirmed to have, or being evaluated for, coronavirus. If you don’t have a primary care doctor, call 1-800-82-SHARP ( 1-800-827-4277) to find one today.

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What should I do if I am being evaluated for the coronavirus?

If you’re being evaluated for the virus and don’t need to be hospitalized, you should take the following steps:

• Stay home except to get necessary medical care
• If you must go out, avoid any kind of public transportation, ridesharing or taxis
• Separate yourself from any other people in your home; if possible, use a separate bathroom
• Cover coughs and sneezes with a tissue, and then wash hands for at least 20 seconds with soap and water, or use an alcohol-based hand sanitizer
• Throw used tissues into a lined trash can immediately
• Avoid sharing household items such as dishes, utensils, cups, towels and bedding
• Stay hydrated with water; drinks designed to supply the body with carbohydrates, fluids and sodium; and clear soup broths
• Take acetaminophen as needed for body aches and pains as directed by the manufacturer
• Wear a face covering or face mask when you are within six feet of other people
• Clean all high-touch surfaces daily, such as counters, tabletops, doorknobs, bathroom fixtures, phones, tablets, keyboards and bedside tables
• Monitor symptoms and seek prompt medical attention if the illness is worsening or your symptoms become more severe (e.g., difficulty breathing, persistent pain or pressure in the chest, new confusion or inability to arouse, bluish lips or face)

If you have an upcoming medical appointment, call ahead and let your doctor know if you have been directed by a health care professional to self-quarantine due to exposure to COVID-19 or to isolate because you have or are suspected of having COVID-19. Please wear a face covering and advise the staff. You will be given a standard mask if you are wearing a gaiter, bandana, single-layer cloth mask or mask with exhalation valves.

If you require 911 services, please inform the dispatcher that you may have COVID-19.

You can stop home isolation when you meet all the following:

• You have had no fever for at least 72 hours (three full days of no fever without the use of fever-reducing medicine)
• Other symptoms have improved, such as cough or shortness of breath
• At least 10 days have passed since your symptoms first appeared

Please continue to adhere to national, state and local stay-at-home orders.

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How is Sharp screening patients for the coronavirus?

Surgical and procedural areas will continue to conduct pre-visit testing based on vaccination status and other clinical factors. Inpatients will still require testing upon admission to a unit, if testing is not performed prior to their stay.

Fully vaccinated outpatients, who are not immunocompromised, will no longer be tested unless it is determined by their provider that it is necessary for their care.

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How to get care if you have COVID-19 symptoms.

Call your doctor’s office or health care provider if you think you need to be evaluated. We will advise you on the best way to receive the care you need. At Sharp hospitals and clinics, patients with COVID-19 symptoms are treated separately from patients with other medical concerns.

We’re here to help.

Sharp is ready to answer your questions about COVID-19. Call us at 1-800-82-SHARP (1-800-827-4277), Monday through Friday, 7 am to 7 pm.

COVID-19 Testing Information – UChicago Medicine

COVID-19 Testing Locations and Resources

How to get tested for COVID-19

• You must be screened before your test by calling our COVID-19 triage hotline at 773-702-2800 or logging in to your MyChart account to complete a virtual screening.
• The healthcare provider who is on the triage line or who reviews your virtual screening will determine if you should schedule an appointment to be tested at a curbside testing clinic.
• You can schedule your curbside testing appointment on the phone or through your MyChart account.

You may be able to be tested if you have any symptoms of COVID-19. These include: fever, cough, stuffy nose, difficulty breathing, body aches, new loss of sense of smell or taste, fatigue, headache, sore throat, nausea/vomiting or diarrhea.

UChicago students are encouraged to first call UChicago Student Wellness at 773-834-9355 for consultation and screening.

Testing is available to patients of any age provided they meet screening criteria. Limited curbside blood work/laboratory services are also available to current patients at Orland Park.

Please note, hours may vary based on demand.

• Telephone Triage Hours: Monday – Friday, 8 a.m. – 4 p.m. 
• E-Visit Hours: You will receive a response within one hour if the questionnaire is submitted between 8 a.m. and 6 p.m. Otherwise, you will receive a reply by 9 a.m. the following day. 

COVID-19 Testing at UChicago Medicine (Hyde Park and Orland Park)

Curbside testing is not available without an appointment. Drive-up swab collection visits typically take several minutes to complete. You will receive information on how to self-isolate and monitor for symptoms after your visit and will get a follow-up phone call with your test results in 1-2 days.

Hyde Park Testing Hours – effective Monday, February 22

• Monday: 8:00 a.m. – 3:30 p.m.
• Tuesday: 8:00 a.m. – 3:30 p.m.
• Wednesday: 8:00 a.m. – 3:30 p.m. Inside ONLY, Curbside closed
• Thursday: 8:00 a.m. – 3:30 p.m. Inside ONLY, Curbside closed
• Friday: 8:00 a.m. – 3:30 p.m.
• Saturday: 8:00 a.m. – 3:30 p.m.
• Sunday: CLOSED

Orland Park Testing Hours – effective Monday, March 1

• Monday: 8:30 a.m. – 12:30 p.m.
• Tuesday: 8:30 a.m. – 12:30 p.m.
• Wednesday: 8:30 a.m. – 12:30 p.m.
• Thursday: CLOSED
• Friday: 8:30 a.m. – 12:30 p.m.
• Saturday: 8:00 a.m. – 12:00 p.m

Orland Park Curbside Testing Hours – effective Monday, July 26

• Monday: 8:30 a.m. – 12:30 p.m.
• Wednesday: 8:30 a.m. – 12:30 p.m.
• Friday: 8:30 a.m. – 12:30 p.m.

COVID-19 Testing Information at Orland Park

Please contact your healthcare provider for COVID-19 testing information.

The following information is for patients who have been seen virtually through a MyChart e-visit or have been screened in our RN telehealth call center.

Patient Education

Other Viral Illnesses

To our valued patients: We are all facing challenging times during this COVID-19 pandemic. We understand and are empathetic to the financial hardships our patients may be facing. We would like to encourage our patients to call us at 844-843-3594 (option 2) to ask about increased flexibility regarding payment plans or to inquire about our financial assistance options during this stressful time.

With the Families First Coronavirus Response Act, the federal government has eliminated patient cost sharing for certain COVID-19 testing-related services, including the associated physician visit, E-visit, or emergency department services, until the end of the public health emergency. This means that you will not receive a bill from UCMC or pay anything out of pocket when these services are provided. This does NOT mean that insurance companies would not be responsible for paying whatever is covered under your policy. Therefore, we still require you to provide your insurance information when receiving COVID-19 testing-related services.

YOU WILL NOT BE EXPECTED TO PAY OUT OF POCKET FOR ANY COVID-19 TESTING-RELATED SERVICES FOR WHICH COST SHARING IS WAIVED.

We recommend that if you have been tested for COVID-19 and have questions regarding your specific benefits, contact your insurance company to get an explanation of your coverage. If you have received a bill related to COVID-19 testing and you have questions, please call us at 844-843-3594 (option 2). Thank you for your patience.

Main

08/22/2021
Dmitry
Hello! Please tell me what kind of CT machine you have?
Name: Dmitry

Detailed description: Hello.
In our Center we have the most modern CT apparatus (64 slices)

08/12/2021
Maria
Hello. When should I be tested for Covid-19 by PCR to get a certificate on Saturday (for traveling abroad)? Do you open patient information when you read the QR code?
Name: Maria

Detailed description: Hello.
If you take the test before 12.00 on Friday, you will get the result on Saturday. When you hover over the QR code, the result of the PCR test with patient identification opens.

08/10/2021
Leila Kazimova
Hello!
Tell me, is there an opportunity for you to visit the treatment room on a referral from another clinic for the setting of IVs?
If so, until what time is the treatment room open? Can I visit it on weekends?

Name: Leila Kazimova

Detailed description: Hello.
The treatment room is open daily from 8.00-19.00, on Saturday from 8.00-14.00, droppers can be made on a referral from any hospital

08/09/2021
123nt
hello, tell me please, I heard you have a special offer for an MRI in the evening, the price is lower than usual, is that really so ???
Name: 123nt

Detailed description: Hello.
During the week, the promotion is valid after 24.00 when examining two departments (3000 rubles)

08/03/2021
Elena
Good afternoon. Tell me until when you can take the PCR test for COVID?
Name: Elena

Detailed description: Hello.
Until 19.00 on weekdays, and until 14.00 on Saturday.

08/02/2021
Tatiana
Good afternoon! Can you undergo an OD + EFI ultrasound examination at your center under the compulsory medical insurance policy?
Name: Tatiana

Detailed description: Hello.
There is no such possibility.

07/28/2021
sergey
Do you have thyroid tabs under compulsory medical insurance or only for a fee and what is the cost?
Name: sergey

Detailed description: Hello.
We do not do compulsory medical insurance, the cost is 2600 rubles

07/25/2021
Natalya
Tell me, please, is it possible in your medical center to do FGDS with OBD using medication sleep and how much will it cost?
Name: Natalia

Detailed description: Hello.
What is OBD? FGDS can be done, the cost is 5000 rubles with anesthesia.

07/22/2021
Aleksandr
I called the phone numbers indicated on the site five times, listened in good faith to the same information five times, listened to all the music, then a long beep and the end of the “conversation”! Are you kidding your patients like that? I wanted to know if you received my e-mail with a request to send the result of the PCR test to this e-mail address.Just in case, I duplicate my information here: Aleksandr Artamoshin, was tested on 07/22/2021 at 8 am. Please send your results in English. If I suddenly have a surprise and I do not get the result tomorrow evening, I am not allowed on the plane, then I will sue you!
Name: Aleksandr

Detailed description: Hello.
Your finished results were sent at 14.20 by email on 22.07.21

19.07.2021
Galina
Good afternoon. Is it possible to make an appointment with a neurologist with a granddaughter, without a mother, or is it necessary for a mother to be present? (Mom with her second child on maternity leave).
Name: Galina

Detailed description: Kind.
Of course, you can take your granddaughter with you, be sure to take your grandmother’s passport and the child’s birth certificate with you.

07/18/2021
Burkhon
Good afternoon! I need to take a PCR test for covid to fly abroad.It must be with a QR code. Are you doing tests like this? I plan to take it in the morning of 08/02/2021, when and at what time will the test result be ready?
Name: Burkhon

Detailed description: Hello.
We have PCR tests with a QR code, if you take the analysis before 12.00, in a day the result will be ready

07/17/2021
Elena at
Hello. We need a PCR test for covid. Departure 27 at 4 am. If I hand over 26 ‘, will you email the result?mail?

Name: Elena in

Detailed description: Hello.
We send the result of the PCR test to the e-mail you specified, but in your case the result will be ready only on July 27 by the evening, subject to the analysis being submitted by 12.00 on 26.07

07/15/2021
Natalya
Do you conclude (hand out) contracts when applying for COVID-19 tests? Or just checks and something like an act?
Name: Natalia

Detailed description: Hello.
We always conclude a contract, if you need the original, go to the registry and they will print it out for you

07/14/2021
Damir
Good afternoon! Tell me why does the reception require a signature on the tablet? Is it possible to get medical services without a signature on the tablet? If you signed up earlier, what is the procedure for deleting all my data? Thanks.
Name: Damir

Detailed description: Hello.
The signature is placed exclusively at the conclusion of an agreement on the provision of paid medical services.If you refuse to put your signature, we reserve the right to refuse your admission (service). The data remains only in the program, it cannot be deleted in accordance with the Law of the Russian Federation.

07/14/2021
Daria
Is it possible to take the test without a passport? Are the results also available the next day?
Name: Daria

Detailed description: Hello.
PCR test can be taken without a passport, if you do not need a certificate in English.If you take the test before 12.00, the result is the next day.

07/13/2021
Daria
Do I have to make an appointment in advance for the PCR test?
Name: Daria

Detailed description: Hello.
Recording for PCR is not carried out, on a first come, first served basis.

07/13/2021
Daria
Good afternoon! Tell me if you need a passport to get the results of the PCR test (if you do not need a translation of the certificate into English)? And do I understand correctly, if you come and take the test on a first-come, first-served basis on a weekday before 12:00, you can pick up the result the next day?
Name: Daria

Detailed description: Hello.
A foreign passport is needed for the error-free filling of a certificate in English, you can take the result with a passport of the Russian Federation. We put a QR code for inquiries for those flying abroad. Yes, it is better to pass it before 12.00 to get the test result the next day.

07/12/2021
Love
Hello! Tell me, what time can I take a PCR test for coronavirus? how long will the result be ready?

Name: Love

Detailed description: Hello.
The test can be taken on weekdays from 8.00-12.00, then the result will be ready the next day, if you take it after 12.00, then the result is ready only in a day. If you hand over on Saturday – the result is only on Tuesday at 8.00

07/10/2021
Natalya
Good afternoon! Tell me, do your doctors go home?

Do you perform a CT scan and is there an opportunity in your clinic to open a sick leave? How much will it cost? Thanks!
Name: Natalia

Detailed description: Hello.
Doctors do not go home. We do SKT every day, we open certificates of incapacity for work, the cost of all services is indicated in the price list on the website http://www.media-service-mc.ru/upload/price.pdf

06/30/2021
Julia
Hello!
Please tell me if we need to do a PCR test for children (10 and 16 years old) to fly abroad. The result must be in English and Russian, with a QR code, stamp. Do I need to register to take the test? and Do you do PCR for children? The cost is 1500 rubles.?
Thank you in advance!

Name: Julia

Detailed description: Hello. Children are given a PCR test from infancy, no entry is needed, on a first come, first served basis, we comply with all the criteria for flying abroad. The cost is 1500 rubles, the result is ready within 24 hours.

Question-answer

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90,000 Tests for COVID-19, get tested for coronavirus COVID-19 in MEDSI clinics

In MEDSI clinics, you can take a test for the presence of SARS-CoV-2 coronavirus infection, the causative agent of COVID-19, by the polymerase chain reaction (PCR) method.

Pay attention! It is possible to issue a test certificate in English.

Terms of readiness of test results: 1 day to complete, not counting the day of application.

The result of a swab from an oropharynx (a highly sensitive rapid test for RNA virus) will be ready the next day.

Cost of the PCR test for the diagnosis of coronavirus infection:

• In the clinic – 2 300 p ¹
• At home – from 5050 p ²

You can sign up for diagnostics or get more detailed information by calling +7 (495) 7-800-500.

Receive the QR code , confirming the vaccination.

You can take the analysis in the following clinics:

• Clinical and Diagnostic Center MEDSI on Krasnaya Presnya (Krasnopresnenskaya metro station, Krasnaya Presnya, 16)
• Clinical and diagnostic center MEDSI on Belorusskaya (metro station “Belorusskaya”, Gruzinsky per., 3a)
• Clinical and diagnostic center MEDSI in Grokholsky lane (metro station “Prospekt Mira”, Prospekt Mira, d.26, building 6, entrance from Grokholsky lane)
• Clinical and Diagnostic Center MEDSI on Solyanka (metro station “Kitay-Gorod”, Solyanka, 12, building 1)
• MEDSI Clinic on Leninsky Prospekt (Leninsky Prospekt metro station, Leninsky Prospekt, 20, building 1)
• MEDSI clinic in Blagoveshchensky lane (Mayakovskaya metro station, Blagoveshchensky lane, 6, building 1)
• Children’s clinic MEDSI on Pirogovskaya (metro station “Park Kultury”, st.Bolshaya Pirogovskaya, 7)
• Children’s clinic MEDSI in Blagoveshchensky lane (metro station “Mayakovskaya”, Blagoveshchensky lane, 2/16, bldg. 1) – the analysis is taken in children and adults
• MEDSI Clinic on Dubininskaya (Paveletskaya metro station, Dubininskaya st., 57, building 8)
• MEDSI clinic in Khoroshevsky proezd (Begovaya metro station, 3rd Khoroshevsky proezd, 1, building 2)
• MEDSI clinic in Maryino (Maryino metro station, Marshal Golovanov st., Bld.1, b. 2)
• MEDSI Clinic on Pokryshkina (Yugo-Zapadnaya metro station, Pokryshkina str., 7)
• MEDSI clinic in Butovo (metro station “Bulvar Dmitriya Donskoy”, Starokachalovskaya st., 3, building 3)
• MEDSI Clinic in Shchelkovo (Shchelkovo, Komsomolskaya St., 5)
• MEDSI Clinic in Krasnogorsk (Moscow Region, Krasnogorsk, Uspenskaya St., 5)
• MEDSI Clinic in Stupino (Stupino, 64 Andropova st.)
• MEDSI Clinic on Aviation (St.Moscow, st. Aviation, 77, building 2)

Preparation for taking a swab from the oropharynx for SARS-CoV-2, the causative agent of COVID-19

Swabbing is best done in the morning, right after a night’s sleep.

Not recommended:

• Eat, drink, brush your teeth, rinse your mouth / throat, chew gum, smoke 3-4 hours before, eat, drink, brush your teeth
• 6 hours before the study, use drugs for irrigation of the oropharynx and preparations for resorption
• Use breath freshener lozenges immediately prior to sampling

¹ The cost in the MEDSI clinics in Stupino and Shchelkovo is 3,000 p
² The cost depends on the distance from the Moscow Ring Road and the type of test.

To clarify the conditions for passing the test and sign up for the procedure, just call + 7 (495) 7-800-500. Our specialist will answer your questions and suggest the best time to visit the clinic. Also, registration for the study and its payment can be made through the SmartMed application.

Diagnosis of coronavirus infection COVID-19

90,000 Pass the test, do the analysis for coronavirus Covid 19 / Covid-19 SPb

Take a test in the laboratory for Corona / SARS-CoV-2 coronavirus cheap

Difficulty breathing, coughing, fever are some of the signs of the virus, in which you need to see a doctor.If you have symptoms, you can call the courier home with the test pack. If there are no symptoms, but for work or study you need to make sure that you are not infected, then at MedProf you can get tested, do a test for coronavirus Covid-19 / Covid-19 in St. Petersburg. Within a day you will find out if there are traces of the pathogen in the body.

Addresses where you can take / do a test for coronavirus Covid for a fee

A referral for a free of charge examination is issued by a doctor in the presence of symptoms of the disease or in case of confirmed contact with an infected person.In other cases, if there is no referral, but there is a need to get a certificate with the result of the analysis, this is done for a fee.

When visiting medical centers, you can only do an antibody test – to find out if you have been ill. The company “MedProf” in St. Petersburg has several addresses where you can take inexpensively, take a test for coronavirus Covid 19 – these are the Central, Frunzensky and Vyborgsky districts of the city. The exact information and directions are indicated on the website in the Contacts section.

If the disease is in the active phase or it is important for you to protect yourself from possible infection, it is better to order a home test.

Sign up for a paid analysis / take a test for coronavirus Covid 19

In order not to sit in long lines at the hospital and not endanger yourself and others, you can use the online registration for the test and be tested for Covid coronavirus at a convenient time without leaving your apartment.

To do this, order a test kit from MedProf and take a smear at home yourself. A courier will contactlessly deliver a kit for collecting biomaterial, and then take it to the laboratory.

No need to worry about how to find out the results of the test: within 24 hours after the transfer of the biomaterial to the courier, a link to the result of the test will be sent to the courier.

There are several ways to take a test for Corona (this is the name the virus received among the people). The main ones are the identification of traces of a microorganism in the nasopharynx, which is mentioned on the current page, as well as a test for antibodies – you can go to MedProf.

You can take a test in a laboratory for the presence of SARS-CoV-2 coronavirus cheaply and get a reliable result if you contact MedProf.

What is the difference between the PCR test for COVID and the analysis for antibodies

What is the difference between the PCR test for COVID and the analysis for antibodies

The coronavirus pandemic continues to spread around the world. For effective treatment and prevention of complications of the disease, early and accurate diagnosis is necessary. In order to reliably establish the presence of the virus, it is not enough just a general examination of patients and an analysis of the symptoms of the disease. In many patients, the disease is asymptomatic, therefore, without knowing about the infection, they can lead a normal life, infecting others.

The coronavirus pandemic continues to spread around the world. For effective treatment and prevention of complications of the disease, early and accurate diagnosis is necessary. In order to reliably establish the presence of the virus, it is not enough just a general examination of patients and an analysis of the symptoms of the disease. In many patients, the disease is asymptomatic, therefore, without knowing about the infection, they can lead a normal life, infecting others.

The presence of the disease can be determined using PCR testing.This is the most reliable method of diagnosis today.

What is COVID PCR Test and

Antibody Test

A PCR (polymerase chain reaction) test detects the DNA of the virus in the patient’s genetic material. Usually, saliva is taken from a person’s oral cavity for analysis. The test is highly sensitive and detects the presence of the virus even at an early stage of the disease.

An ELISA test for the presence of antibodies allows you to determine the presence of a specific material that forms as a result of a past disease.The presence of a certain amount of antibodies indicates that a person has suffered a coronavirus. The higher the antibody titer in the blood, the higher the human immunity and resistance to the action of pathogenic viruses.

Antibody testing is most important for healthcare workers in infectious disease wards, as well as for categories of the population who, due to their professional activities, spend a lot of time in contact with other people.

The main difference between the ELISA test and PCR diagnostics is the purpose of its conduct.PCR helps detect the presence of a virus in a swab from the oropharynx or nasopharynx. The ELISA test shows the response of the immune system to the invasion of infection. It, like the PCR test, shows the presence of a virus, but refers to less reliable and accurate diagnostic methods.

There is also a difference in the cost of tests. ELISA testing is much more affordable.

Indications for PCR diagnostics

• the appearance in the patient of signs typical of coronavirus infection;
• pneumonia as a possible complication of infection;
• work of medical workers in departments where patients with coronavirus infection are treated;
• work as a pathologist or work in a forensic medical bureau;
• in preparation for surgery.

These persons are included in the list of persons subject to mandatory testing. Anyone who is not included in this group can do a PCR test at will in medical centers and clinics.

A PCR test is required upon entry to most countries as proof of the absence of infection.

A positive result of PCR testing allows timely detection of the disease, prescribing the necessary treatment and achieving isolation of the patient, which will save other people from the risk of infection.

If material is taken from the nasopharynx for the PCR test, the material for the ELISA test is blood. It is applied to a test strip to analyze the presence of antibodies. The detection of IgM indicates that a person is sick with coronavirus or has had it relatively recently. The presence of IgG indicates that the infection occurred a long time ago and there is practically no immunity. But even a high titer of antibodies is not a guarantee of protection against re-infection.

There are some precautions to take when giving an ELISA test.Do not eat or smoke for 2-3 hours prior to testing. Patients with acute symptoms of acute respiratory viral infections or acute respiratory infections are not admitted to the study.

A negative ELISA result indicates a lack of immunity. This situation is possible if the patient did not have contact with sick people, in case of disturbances in the functioning of the immune system, at a too early period of infection.

Processing time of analyzes

It takes very little time to do ELISA testing.It will take no more than 15 minutes to get a reaction on the test strip. Thus, the result can be obtained on the day of the analysis.

It will take longer to get the result of the PCR test. The timing of the tests depends largely on the clinic. Most often, the waiting time for the test is 24-48 hours. In most clinics, you will need to pre-register on the official website for the test.

What other tests are there

In addition to the PCR test, there is an even faster diagnosis.In the early stages of the disease, antigenic tests are used to detect a specific protein in the virus. For analysis, take a sample of material from the oropharynx or nasopharynx.

Unlike the PCR test, this analysis is much faster, its results are ready after 15-30 minutes. But today, PCR diagnostics is much more reliable and informative.

Benefits of testing for coronavirus infection at Baby Plus

In Odintsovo and Golitsyno, you can take tests to detect coronavirus infection or determine the antibody titer at our medical center.We carry out analyzes in the shortest possible time and guarantee their accuracy and reliability.

Anyone can take COVID tests. Check out the prices for tests in our price list. To carry out the analysis, you must register by phone or on the official website of our center.

Date of publication: 04/05/2021 13:16:42

PCR for COVID-19

PCR test for coronovirus: how they take it, which shows

PCR is a complex chemical and biological chain reaction, which allows the determination of foreign components, viral and bacterial structures, fungi in the tissues of the human body by the method of step-by-step research.

The SARS-CoV-2 virus belongs to respiratory agents and enters the body through mucous membranes – nose, eyes, mouth. In the cells of mucous tissues, it is fixed by attaching the spines of the membrane to the cell membranes. But there is no virus in the blood and lymph. A blood test becomes indicative only with a prolonged illness, when the body’s immune response to a viral attack appears. In this case, PCR is no longer informative, and if you suspect COVID, it is worth taking an enzyme-linked immunosorbent assay (ELISA) of the blood – to determine antibodies to a viral infection.

In the early days of infection, when the symptoms of the disease are absent or mild, SARS-CoV-2 is already actively multiplying in the nasopharynx. The infection is easily detected in mucosal tissues and even in saliva. Carriers of the virus may not even be aware of its presence, and only PCR analysis can determine whether a person is infectious.

A swab for detecting coronavirus by PCR is taken from the oropharynx and nasopharynx. To do this, use a probe with a sterile brush or swab.The nurse painlessly and accurately conducts several times over the mucous membranes of the patient, and then the biomaterial is packed and transferred to the laboratory for thorough examination.

Indications for diagnosis: who should take PCR for covid

There are several categories for whom diagnostics for coronavirus by PCR method is indicated:

1. Conditionally healthy people. Research for them is an opportunity to receive a certificate of absence of a covid for departure or other purposes.
2. Contact – those who communicated with the sick without knowing about it. After laboratory confirmation of the disease in relatives, acquaintances or employees, it is recommended to diagnose the “corona” by PCR.
3. Pensioners and persons at risk for health reasons.
4. Corporate diagnostics – when a sick person is identified in the team or as a routine examination.

The analysis is carried out in the absence of symptoms of a new coronavirus infection – for patients without high fever, cough, weakness, shortness of breath.

PCR for COVID-19: preparation for analysis

The test is sensitive, therefore, in order to avoid the risk of getting an incorrect result, certain rules should be followed before the PCR is performed:

1. 2-3 hours before taking oropharyngeal swabs, the patient should not eat, smoke, gargle or gargle, brush his teeth, or chew gum.
2. Use vasoconstrictor nasal sprays, apply hormonal, antiseptic or antiviral ointments, and also do not use sprays for topical throat treatment during the day before the test is taken.

Diagnostic results

The test performed is:

• negative – the SARS-CoV-2 virus is not detected, there is no COVID-19 infection;
• positive – SARS-CoV-2 virus found, COVID-19 infection confirmed.

The LM Clinic Medical Center conducts PCR tests for coronavirus infection for individuals and organizations. The qualified approach and attentiveness of the medical staff guarantee the high accuracy of each study.To make an appointment for a PCR analysis, just call the clinic or leave a request on the website.

Test – analysis for coronavirus COVID-19 (Sergiev Posad)

Test – analysis for coronavirus COVID-19 in the clinic “Paracelsus”, Sergiev Posad

Where to get a test, get tested for coronavirus COVID-19 in Sergiev Posad?

In the clinic “Paracelsus” you can take tests for coronavirus every day at the address: Sergiev Posad, avenue of the Red Army 212 A, 4th floor.

Important! Testing is intended for patients without ARVI symptoms. A prerequisite is the absence of contact with patients with COVID-19 for 14 days.

• Patients need to have a passport with them, for children – a birth certificate.
• If you plan to travel abroad – a passport, a passport for a child.
• A mask is required to visit the health center.
• Diagnostics is carried out in compliance with all the rules of the sanitary and epidemiological regime.

WARNING! Before passing the analysis by the PCR method and the test for IgM antibodies, you will need to fill out a questionnaire. When filling out the information “Traveling abroad within 14 days”, it is necessary to indicate in the “Country of stay” line not only the name of the country itself, but also the obligatory flight number of arrival in Russia (this requirement is dictated by the Office of Rospotrebnadzor).
In order to save processing time, you can print and fill out the questionnaire in advance.It is important to fill in all the items in detail.

If there is an actual result of PCR analysis for COVID-19 in our center, you can issue a certificate of the epidemiological environment .

Tests for coronavirus at home

Home delivery of tests for coronavirus COVID-19 is available.

To sign up for tests and learn more about research, you can:

Sergiev Posad 8-496-551-66-66

• on the website: leave a request (we will call you back soon)
• via direct to Instagram, VK, Facebook

Price of tests for coronavirus COVID-19 in Sergiev Posad

The price of tests for COVID-19 coronavirus can be found on the analyzes page.

You can learn more about the diagnostic methods from the video interview with the senior nurse Daria Valentinovna Golovanova:

Group testing of employees of organizations

Medical Center “Paracelsus” conducts group testing of employees of organizations.

The cost of services depends on the number of employees. Group testing of employees of organizations is issued on a special request.

Please send requests for group testing / corporate services to: [email protected].

What should be in the application:

• City
• Organization name
• Number of employees
• Contacts of the person in charge (full name, phone, e-mail)

For group testing of employees, please contact us by phone:

Sergiev Posad 8-496-540-84-44

G.Alexandrov 8-49244-6-97-88

What is the new coronavirus COVID-19

The new coronavirus COVID-19 belongs to the family of RNA viruses of the Coronaviridae family, Beta-CoV B.

The main source of infection is a sick person, including those in the incubation period of the disease.

The transmission of infection is carried out by airborne droplets, airborne dust and contact. The leading route of transmission of COVID-19 is airborne, which is realized when coughing, sneezing and talking at a close (less than 2 meters) distance.The contact route of transmission is carried out during handshakes and other types of direct contact with an infected person, as well as through food, surfaces and objects contaminated with the virus.

The incubation period is from 2 to 14 days, on average 5-7 days.

The diagnosis is established on the basis of a clinical examination, data from an epidemiological history, the results of instrumental and laboratory studies.