Hiv finger stick test: OraQuick Rapid HIV-1 Antibody Test Questions and Answers
OraQuick Rapid HIV-1 Antibody Test Questions and Answers
What is the OraQuick Rapid HIV-1 Antibody Test and how is it performed?
The OraQuick Rapid HIV-1 Antibody Test (OraQuick) is a screening test for HIV-1, the virus that causes AIDS. It is a single-use qualitative immunoassay that detects antibodies to HIV-1 in a fingerstick sample of blood. As with all HIV screening tests, a reactive test result needs to be confirmed by an additional, more specific test.
To perform the test, the fingertip is cleaned with alcohol and pricked with a lancet to get a small drop of blood. The blood is collected with a specimen loop and transferred to a vial, where it is mixed with a developing solution. The test device is then inserted into the vial. Results of the test can be read in as little as 20 minutes.
How well does the test work?
In the clinical studies by the manufacturer, OraQuick correctly identified 99.6% of people who were infected with HIV-1 (sensitivity) and 100% of people who were not infected with HIV-1 (specificity). FDA expects clinical laboratories to obtain similar results.
What are the limitations of the test? Does this test always give a correct result?
The limitations of this test are similar to the limitations of other HIV antibody tests, including:
- False Positives – although none were found in the clinical trial, a statistical analysis of the data indicates that a very small number of people who are not infected with HIV-1 will have reactive test results. As the test is used in broad outreach settings it is expected that false positives may be seen and therefore reactive results should not be considered definitive until confirmatory testing has been completed.
- False Negatives – a small number of people who are infected with HIV-1 will have negative test results.
- Delayed detection of exposure — this test will not detect HIV-1 infection in people who were exposed within about three months prior to taking the test (since it can take that long for detectable antibodies to HIV-1 to appear in the blood).
- Follow-up testing – a reactive result is interpreted as preliminarily positive for HIV-1 infection. Individuals with reactive test results should have follow-up testing using another method to confirm the initial test result.
For these reasons, all individuals taking this test must receive counseling both before being tested and after receiving their test results.
What type of counseling is done for rapid HIV tests?
Counseling for rapid HIV tests includes:
- Information about the importance of HIV testing
- Ways to reduce the risk of becoming infected with HIV
- Next steps for people who have a reactive test result
- Need for additional testing in people who have had a recent exposure to HIV
For more information about HIV counseling, see CDC’s HIV/AIDS webpage.
Does this test detect antibodies to HIV-2?
This test is approved to detect antibodies to HIV-1. Because HIV-2 is very rare in the United States, the CDC does not recommend routine screening for HIV-2 at this time.
Are blood donors allowed to be screened using the OraQuick test?
No. This test is approved to help diagnose HIV infection, not to screen blood donors.
Who is permitted to purchase and use the test?
Only clinical laboratories that meet certain quality assurance requirements may purchase OraQuick. In addition, only agents of clinical laboratories may use the test. An agent of the clinical laboratory is someone who works for the laboratory whether it is high complexity, moderate complexity, or waived. All customers will receive a letter indicating that through their purchase, they agree to meet these requirements.
Quality assurance requirements include:
- planned systematic activities to assure that requirements for quality will be met, and
- assurance that operators will receive and use the instructional materials.
What constitutes a clinical laboratory?
A clinical laboratory is a facility for the examination of materials taken from the human body, to help diagnose, prevent, or treat a human disease or condition. CLIA requires all entities that perform even one test, including waived tests on … “materials derived from the human body” to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory.
For CLIA’s definition of a clinical laboratory, see 493.257 FR 7139, Section 493.2 Definitions.
What constitutes an adequate quality assurance system?
An adequate quality assurance system consists of planned and systematic activities to ensure that a laboratory will meet certain requirements for quality. CDC is currently developing recommendations for quality assurance systems for rapid HIV tests. These recommendations should be available soon and are being developed in a manner to ensure that both quality and broader access to testing will be possible.
OraQuick was originally approved as a moderate complexity test under CLIA. What is different now that the test is waived?
As a moderate complexity test, OraQuick could only be purchased and used by laboratories that were certified to conduct moderate complexity laboratory testing. Laboratories with this level of certification must meet CLIA requirements for personnel, training, and inspections, among others.
In contrast, laboratories performing only waived tests, must only meet the following requirements under CLIA:
- Enroll in the CLIA program;
- Pay a biennial fee to obtain a Certificate of Waiver; and
- Follow manufacturers’ test instructions.
How can I obtain a Certificate of Waiver?
The CLIA program is administered by the Centers for Medicare and Medicaid Services (CMS). Information on obtaining a Certificate of Waiver can be found on the CMS CLIA Program website.
How much does the test cost?
The manufacturer and the laboratory performing the test determine the fee for the test.
Types of HIV Tests | Testing | HIV Basics | HIV/AIDS
What kinds of tests are available, and how do they work?
There are three types of tests available: nucleic acid tests (NAT), antigen/antibody tests, and antibody tests. HIV tests are typically performed on blood or oral fluid. They may also be performed on urine.
- A NAT looks for the actual virus in the blood and involves drawing blood from a vein. The test can either tell if a person has HIV or tell how much virus is present in the blood (known as an HIV viral load test). While a NAT can detect HIV sooner than other types of tests, this test is very expensive and not routinely used for screening individuals unless they recently had a high-risk exposure or a possible exposure and have early symptoms of HIV infection.
- An antigen/antibody test looks for both HIV antibodies and antigens. Antibodies are produced by your immune system when you’re exposed to viruses like HIV. Antigens are foreign substances that cause your immune system to activate. If you have HIV, an antigen called p24 is produced even before antibodies develop. Antigen/antibody tests are recommended for testing done in labs and are now common in the United States. This lab test involves drawing blood from a vein. There is also a rapid antigen/antibody test available that is done with a finger prick.
- HIV antibody tests only look for antibodies to HIV in your blood or oral fluid. In general, antibody tests that use blood from a vein can detect HIV sooner after infection than tests done with blood from a finger prick or with oral fluid. Most rapid tests and the only currently approved HIV self-test are antibody tests.
Talk to your health care provider about what type of HIV test is right for you.
How long does it take to get results?
- Laboratory tests (NATand antigen/antibody) require blood to be drawn from your vein into a tube and then that blood is sent to a laboratory for testing. The results may take several days to be available.
- With a rapid antibody screening test, usually done with blood from a finger prick or with oral fluid, results are ready in 30 minutes or less.
- The rapid antigen/antibody test is done with a finger prick and takes 30 minutes or less.
- The oral fluid antibody self-test provides results within 20 minutes.
How soon after an exposure to HIV can a test detect if I have the virus?
No HIV test can detect HIV immediately after infection. If you think you’ve been exposed to HIV in the last 72 hours, talk to your health care provider about post-exposure prophylaxis (PEP), right away.
The time between when a person may have been exposed to HIV and when a test can tell for sure whether they have the virus is called the window period. The window period varies from person to person and depends on the type of test used to detect HIV. Ask your health care provider or test counselor about the window period for the test you’re taking.
- A nucleic acid test (NAT)can usually tell you if you have HIV infection 10 to 33 days after an exposure.
- An antigen/antibody test performed by a laboratory on blood from a vein can usually detect HIV infection 18 to 45 days after an exposure. Antigen/ antibody tests done with blood from a finger prick can take longer to detect HIV (18 to 90 days after an exposure).
- Antibody tests can take 23 to 90 days to detect HIV infection after an exposure. Most rapid tests and self-tests are antibody tests. In general, antibody tests that use blood from a vein can detect HIV sooner after infection than tests done with blood from a finger prick or with oral fluid.
If you get an HIV test after a potential HIV exposure and the result is negative, get tested again after the window period. Remember, you can only be sure you are HIV-negative if:
- Your most recent test is after the window period.
- You haven’t had a potential HIV exposure during the window period. If you do have a potential exposure, then you will need to be retested.
How do HIV tests work and what’s involved?
- There are plenty of places which offer free HIV testing – you can find your nearest provider either by searching online or asking a healthcare professional.
- Testing for HIV is a simple and pain-free process. It involves giving a small sample of blood or oral fluid.
- Your results will be confidential and the healthcare provider will be able to explain the process and answer any questions you have. They are there to help you.
- HIV tests are very reliable. Some HIV tests will give a result within 20 minutes and others are sent to a lab so it may take a few weeks to get your results.
It is really common to feel a little worried about going for an HIV test, but making the decision to test is the best thing you can do for your health. The process is quick, painless, confidential and almost always free.
Where can I get an HIV test?
Depending on where you are in the world, there are a number of places that you can get tested for HIV. The best first step is to search online for “HIV testing”, plus your location. This will generally give you a good idea of where to go, or at least give you a starting point.
If you have limited internet access, it’s always worth asking local sexual health charities or health professionals what is available in your area. They should be able to direct you to somewhere where you can test for free. The image below has some examples of the types of places that might offer HIV testing.
The healthcare worker – there to help you!
Before you test, your healthcare worker will talk to you about your sexual health and why you’ve decided to test. This is to help them understand your situation so they can offer you the best services and advice.
Remember, the healthcare professional is not there to judge you. There will be nothing you can say that they haven’t heard before – so be honest with them, and ask as many questions as you want. That’s what they’re there for.
You should never feel pressured to test. The results will be completely confidential but you should only go through with it if you want to.
What happens when you go for a test?
Normally, testing involves taking a small sample of blood from your finger or your arm, or an oral swab. This is where you rub the testing pen along your gums to collect cells from your mouth.
How long it takes for HIV test results to come back will depend on the type of test you are taking. If you’re taking a rapid test, you will be given your results within 20 minutes. Other types of tests will be sent to a laboratory and it may take between a few days and a few weeks for you to receive a final result.
Tests these days are very reliable, but if your result comes back positive, you should have a second confirmatory test to double check your result. If this is also positive, you will get an HIV diagnosis, after which you can start treatment.
Remember, HIV treatment these days is very effective and people with HIV can live long and healthy lives just like anyone else.
How do HIV tests work?
There are a variety of different HIV tests and your healthcare worker should explain which test you are using and how you will get your result.
HIV antibody tests (also called third generation tests)
When you become infected with HIV, your body will start to produce specific antibodies (proteins that attach to the virus to try and destroy it). An HIV antibody test looks for these antibodies in your blood, oral fluid or urine. If these antibodies are found, it means that your body is reacting to an HIV infection and that you have HIV.
This test is only accurate three months after exposure, because this is how long it takes your body to produce enough antibodies for it to show up in a test. It usually takes a few days to a few weeks to get the results back from this type of test.
Combined antigen/antibody tests (also called fourth generation HIV tests)
Fourth generation tests look for HIV antibodies as well as something called p24 antigens. The p24 antigens are part of HIV itself. You will have a lot of these in your blood in the first few weeks after infection.
Fourth generation tests can reliably detect HIV from one month after you have been infected. It usually takes a few days to a few weeks to get results back for this type of test.
Rapid HIV tests
Rapid tests give results in just 20 minutes, so results can now be given on the spot at many healthcare centres. Most test for HIV antibodies by taking a prick of blood from your finger. These tests are only accurate three months after exposure. If you get a positive result, the healthcare professional will double-check this with a second test.
HIV self-testing offers the convenience of taking a test in the comfort of your own home. Unfortunately, self-testing hasn’t been approved everywhere, so check online to see if it is available where you are.
If you do order a self-testing kit, check that the kit has been approved with a ‘CE’ (Europe) or FDA (USA) mark on it. These tell you that the tests are regulated and will work properly. Follow the instructions that come with your kit and you should get a result in 15 – 20 minutes.
A positive result on a self-test kit isn’t enough to know for sure if you have HIV, so if you do get a positive result it must be confirmed by a healthcare worker. They will also ensure that you get the necessary follow-up care with treatment and support with counselling.
Self-tests can be more convenient for some people and they allow you privacy while you get your results. But some people prefer to see a professional; that way they can get immediate support and advice on the next steps.
Read on to find out: What happens after an HIV test and getting the results?
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How accurate are rapid, point-of-care tests for HIV?
- Rapid tests are usually reliable for long-standing infections, but are sometimes unable to detect recent HIV infections acquired in the past few weeks.
- Many tests are based on older ‘second-generation’ technology, but a ‘fourth-generation’ test with better performance is available.
- Like any screening test, a reactive (‘positive’) result must be confirmed with one or two follow-up tests.
Rapid tests are often referred to as point-of-care tests because rather than sending a blood sample to a laboratory, the test can be conducted and the result read in a doctor’s office or a community setting, without specialised laboratory equipment.
Most point-of-care tests require a tiny sample of blood (the fingertip is pricked with a lancet). Other tests require oral fluid (an absorbent pad is swabbed around the outer gums, adjacent to the teeth). They are called ‘rapid’ tests because the result can usually be given within a few minutes.
Most rapid tests detect HIV antibodies. They are not part of HIV itself, but are produced by the human body in response to HIV infection. In the weeks after exposure to HIV, the immune system recognises some components of the virus and begins to generate HIV antibodies in order to damage, neutralise or kill it (this period is known as ‘seroconversion’). These antibodies persist for life.
In contrast, the recommended laboratory tests also detect p24 antigen, a protein contained in HIV’s viral core that can be detected sooner than antibodies. Most rapid tests, with the exception of the Alere HIV Combo and Alere Determine HIV-1/2 cannot detect p24 antigen.
The accuracy of point-of-care tests is not always equal to those of laboratory tests, especially in relation to recent infection. This is for two main reasons:
- What the test looks for. While one antibody/antigen test is available, the other tests look for antibodies only. Moreover, some can only detect immunoglobulin G (IgG) antibodies, but not immunoglobulin M (IgM) antibodies, which appear sooner.
- The sample taken. Point-of-care tests are usually performed on whole blood taken from a fingerprick. This has a lower concentration of antibodies and p24 than plasma. Samples of oral fluid have a concentration of antibodies that is lower still. (Plasma is the colourless fluid part of blood, separated from whole blood using laboratory equipment. Fingerprick blood is produced by pricking the finger with a lancet, whereas oral fluid is obtained by swabbing the gums.)
As a result, the window period of commonly used rapid tests such as the Alere HIV Combo and the INSTI HIV-1/HIV-2 Antibody Test may be one to two weeks longer than for fourth-generation laboratory tests. Other rapid tests, based on older technology, may have longer window periods than this.
Rapid tests can be performed by staff with limited laboratory training. However, reading the test result relies on subjective interpretation, and when the result is borderline, experienced staff give more consistently accurate results. In a setting with low prevalence of HIV, staff may not see enough true positive samples to gain experience in interpreting test results.
It is good practice for test results to be re-read by a second member of staff, within the time frame specified on the test packaging. Organisations using point-of-care tests must maintain strong links with a pathology laboratory that provides support with clinical governance and quality assurance.
Point-of-care testing is supported is specific scenarios by the British HIV Association (BHIVA) and the National Institute for Health and Care Excellence (NICE). These include testing at community sites; when it is important to avoid a delay in receiving results; in situations where it would be difficult to give people their results; or if a person does not want to give a venous blood sample.
When used in a population with a low prevalence of HIV, false positive results can be a problem. The tests always produce a small number of false positive results, but in a setting where very few people have HIV, the majority of apparent positive results will in fact be incorrect. However, as the proportion of people with HIV being tested increases, the true positives start to outnumber false positives. This means it is more appropriate to use point-of-care tests in high-prevalence populations, such as with gay and bisexual men, than in the general population.
A protein substance (immunoglobulin) produced by the immune system in response to a foreign organism. Many diagnostic tests for HIV detect the presence of antibodies to HIV in blood.
A test in which all stages, including reading the result, can be conducted in a doctor’s office or a community setting, without specialised laboratory equipment. Sometimes also described as a rapid test.
In HIV testing, the period of time after infection and before seroconversion during which markers of infection are still absent or too scarce to be detectable. All tests have a window period, the length of which depends on the marker of infection (HIV RNA, p24 antigen or HIV antibodies) and the specific test used. During the window period, a person can have a negative result on an HIV test despite having HIV.
Refers to the mouth, for example a medicine taken by mouth.
When using a diagnostic test, the probability that a person who does have a medical condition will receive the correct test result (i.e. positive).
All HIV tests need to have reactive results (a preliminary positive result) confirmed with further tests. Most providers tell people who are testing that a negative result is definitive, but that a reactive result simply indicates the need for further laboratory testing.
The accuracy of different rapid tests
A wide range of point-of-care tests have been manufactured in many countries, but only a few of them have been subject to rigorous, independent evaluations, and even fewer are marketed in the UK. Research on HIV tests is only occasionally published in medical journals. Informally, laboratory professionals may have insights into which tests perform best.
It is important to verify that any test used is CE marked. This should mean that the test conforms to European health and safety legislation, although it does not necessarily mean that test performance has been independently evaluated.
There are variations in accuracy from one test to another, with some older tests that are not usually marketed in the UK having a sub-optimal sensitivity and specificity. However, evaluations by the World Health Organization of several rapid diagnostic tests that either have CE marks or are approved by the US Food and Drug Administration (FDA), indicate that most are extremely accurate. The key measures of accuracy are sensitivity (the percentage of results that are correctly positive when HIV is actually present) and specificity (the percentage of results that are correctly negative when HIV is not present).
Of note, in the World Health Organization data below, the tests were performed with samples of plasma or serum. However, the tests are less sensitive when testing whole blood sampled from a finger prick. Moreover, the blood was taken from people who had chronic (not recent) HIV infection, but the tests are less accurate in cases of recent infection.
OraQuick HIV-1/2 Rapid HIV-1/2 (OraSure)
HIV 1/2 STAT-PAK (Chembio)
Alere Determine HIV-1/2 (Alere)
IgG + IgM
Uni-Gold HIV (Trinity)
IgG + IgM
INSTI HIV-1/HIV-2 Antibody Test (bioLytical)
IgG + IgM
SD BIOLINE HIV-1/2 3.0 (Standard Diagnostics)
IgG + IgM
DPP® HIV 1/2 Assay (Chembio)
VIKIA HIV 1/2 (bioMérieux)
Reveal Rapid HIV Antibody Test (MedMira)
Whereas the data above relate to blood samples, the OraQuick Advance Rapid HIV-1/2 is a widely used test which can also test oral fluid samples. While this is non-invasive and highly convenient for the person testing, performance is slightly poorer when testing oral fluid samples than when testing blood samples. The key reason that there are lower quantities of HIV antibodies in oral fluid than in whole blood, especially after recent infection. In seven studies which made a direct comparison of test performance, the pooled sensitivity with oral fluid was 98.03%, compared to 99.68% with whole blood.
There is one rapid, point-of-care test that looks for both antibodies and p24 antigen, in a similar way to antibody/antigen laboratory tests. The Alere Determine HIV-1/2 Ag/Ab Combo was originally introduced in 2009, with an updated version called the Alere HIV Combo launched in Europe in 2015 (the older version is still marketed in the United States and in some parts of the world).
The promise of having a ‘fourth-generation’ point of care test that detects p24 antigen is that the window period should be shortened. However, several studies found that although the older version of this test performed well in respect of established HIV infection, its ability to detect recent HIV infection did not match that of laboratory antibody/antigen tests. The test was quite insensitive to p24 antigen, making it only marginally better than antibody-only tests in detecting acute (recent) infection.
The handful of studies published so far on the newer version suggests it has better performance in acute infection, although it still does not match that of antibody/antigen laboratory tests. The Alere HIV Combo’s sensitivity during acute infection has been variously estimated to be 28% (in three African countries), 54% (France), 65% (the Netherlands) and 88% (UK).
An analysis pooled the results of 18 separate studies in which a point-of-care test (including Determine, OraQuick, UniGold and INSTI) was compared with a more sensitive laboratory test. Compared with fourth-generation laboratory tests, the estimated sensitivity of the point-of-care tests was 94.5% (95% confidence interval 87.4-97.7) and specificity was 99.6% (99.4-99.7). Compared with RNA (viral load) tests, the estimated sensitivity was 93.7% (95% confidence interval 88.7-96.5) and specificity 98.1% (95% CI: 97.9-98.2).
Sensitivity was higher in nine studies conducted in African countries than in the nine studies conducted in the United States and other wealthy countries. This is likely to be due to different populations coming forward for screening. Whereas 4.7% of those testing positive in African studies had acute (recent) HIV infection, this figure rose to 13.6% in the high-income countries.
“All HIV tests need to have reactive results (a preliminary positive result) confirmed with further tests.”
A study in five African countries found that the performance of point-of-care tests was sub-optimal. Samples from some countries were more likely to have false positive results than others, suggesting that tests need to be locally validated and that some tests may be more accurate in relation to some HIV subtypes than others. The researchers found a high number of false positive results, whereas false negative results were relatively rare. The specificities of the First Response HIV Card Test 1–2.0, INSTI HIV-1/HIV-2 Antibody Test, Determine HIV-1/2 and Genie Fast HIV 1/2 were all between 90 and 95%. The findings confirm that the diagnosis of HIV should not be based on results from a single HIV rapid diagnostic test. A combination of HIV tests, and more specifically an algorithm (sequence) of two or three different tests, is required to make an HIV-positive diagnosis. This is recommended in testing guidelines.
All HIV tests need to have reactive (preliminary positive) results confirmed with confirmatory tests. A particular challenge healthcare workers have with rapid tests is how to communicate a reactive result to the person testing (who may be present while the result is being read) and explain that supplementary tests are needed. These problems are less frequently faced with laboratory testing – a large enough blood sample was taken to allow for it to be tested several times and for uncertainties in the diagnosis to be resolved.
Window periods of rapid tests
The window period refers to the time after infection and before seroconversion, during which markers of infection (p24 antigen and antibodies) are still absent or too scarce to be detectable. Tests cannot reliably detect HIV infection until after the window period has passed. All tests have a window period, which varies from test to test.
Delaney and colleagues estimated window periods for a handful of rapid tests in a 2017 study. However, all these estimates were based on testing blood plasma. In practice, tests are usually done on fingerprick blood (obtained by pricking the finger with a lancet) and the window period is likely to be several days longer.
The fourth-generation Determine HIV-1/2 Ag/Ab Combo was estimated to have a median window period of 19 days (interquartile range 15 to 25 days). This indicates that half of all infections would be detected between 15 and 25 days after exposure. Ninety-nine per cent of HIV-infected individuals would be detectable within 43 days of exposure.
The third-generation INSTI HIV-1/HIV-2 test was estimated to have a median window period of 26 days (interquartile range 22 to 31 days). This indicates that half of all infections would be detected between 22 and 31 days after exposure. Ninety-nine per cent of HIV-infected individuals would be detectable within 50 days of exposure.
Several second-generation tests, such as OraQuick Advance Rapid HIV 1/2, Clearview HIV 1/2 STAT-PACK and SURE CHECK HIV 1/2 were evaluated. The median window period was 31 days (interquartile range 26 to 37 days). This indicates that half of all infections would be detected between 26 and 37 days after exposure. Ninety-nine per cent of HIV-infected individuals would be detectable within 57 days of exposure. When the OraQuick Advance Rapid HIV 1/2 is used with samples of oral fluid, window periods are likely to be longer than this.
If you are testing with a rapid, point-of-care test and you are concerned that you may have been exposed to HIV during the test’s window period, you could also be tested with a fourth-generation laboratory test. This requires a blood sample, taken through a needle from a vein in the arm, which is tested in a laboratory using a more sensitive test. The results should be available after a few days.
Situations in which rapid tests may not be accurate
Performance of rapid tests is poorer in a number of situations. Results may not be accurate.
What do the test results mean?
There are three possible test results:
1) Negative (may also be described as ‘non-reactive’). The test did not find any evidence of HIV infection. You probably don’t have HIV (so long as you aren’t testing in one of the situations described in the last section).
2) Reactive (often incorrectly described as ‘positive’ by manufacturers). The test assay has reacted to a substance in your blood. This does not necessarily mean that you are HIV positive. It means you need to take more tests to confirm the result. These extra tests are best done at a healthcare facility where they have access to the most accurate HIV testing technologies.
3) ‘Indeterminate’, ‘equivocal’ or ‘invalid’. The test result is unclear. Another test needs to be done.
Results from the Universal Screening for HIV-infection in the Emergency Room (USHER-Phase II) Randomized Controlled Trial
J Acquir Immune Defic Syndr. Author manuscript; available in PMC 2013 Dec 15.
Published in final edited form as:
, MPH,1, MD, MPH,1,4, MA,1,2, BA,1, BA,1, MD, MPH,1, PhD,1,2, MD, MSc,1,3,4, PhD,1,2,4 and , MD, MPH1,4,5
Laurel A. Donnell-Fink
1Brigham and Women’s Hospital, Boston, MA
1Brigham and Women’s Hospital, Boston, MA
4Harvard Medical School, Boston, MA
Jamie E. Collins
1Brigham and Women’s Hospital, Boston, MA
2Boston University School of Public Health, Boston, MA
1Brigham and Women’s Hospital, Boston, MA
1Brigham and Women’s Hospital, Boston, MA
Mary L. Pisculli
1Brigham and Women’s Hospital, Boston, MA
William M. Reichmann
1Brigham and Women’s Hospital, Boston, MA
2Boston University School of Public Health, Boston, MA
Jeffrey N. Katz
1Brigham and Women’s Hospital, Boston, MA
3Harvard School of Public Health, Boston, MA
4Harvard Medical School, Boston, MA
1Brigham and Women’s Hospital, Boston, MA
2Boston University School of Public Health, Boston, MA
4Harvard Medical School, Boston, MA
Rochelle P. Walensky
1Brigham and Women’s Hospital, Boston, MA
4Harvard Medical School, Boston, MA
5Massachusetts General Hospital, Boston, MA
1Brigham and Women’s Hospital, Boston, MA
2Boston University School of Public Health, Boston, MA
3Harvard School of Public Health, Boston, MA
4Harvard Medical School, Boston, MA
5Massachusetts General Hospital, Boston, MA
Corresponding Author and Reprint Requests: Laurel Donnell-Fink, MPH Brigham and Women’s Hospital 75 Francis Street, BC 4-016 Boston, Massachusetts 02115 Phone: (617) 732-7897 Fax: (617) 525-7900 [email protected] other articles in PMC that cite the published article.
Oral rapid HIV testing has been reported to have a lower sensitivity and specificity than rapid HIV testing with whole-blood and has been associated with clusters of false positive results. Patient preference for oral rapid HIV testing compared to more invasive whole-blood fingerstick may influence the acceptance of rapid HIV testing.
To compare HIV test acceptance rates among patients routinely offered fingerstick compared to those routinely offered oral fluid screening in an urban hospital emergency department (ED).
USHER-Phase II was a single-center, prospective, randomized controlled trial that randomized subjects to either fingerstick or oral rapid HIV screening in an urban academic ED. From May 5, 2009 to January 4, 2010, eligible patients aged 18 to 75 years were invited to participate in the trial. The primary outcome measure was HIV test acceptance rate.
2,012 eligible patients were approached, of whom 1,651 (82%) consented to trial participation and enrolled. Among those enrolled 830 and 821 were randomized to the fingerstick and oral fluid arms, respectively. Acceptance of rapid HIV testing was similar in both arms; 67% (553/830) of subjects accepted fingerstick testing compared to 69% (565/821) who accepted oral (p=0.34).
Although fingerstick rapid HIV testing is more invasive than oral fluid testing, test acceptance rates did not differ. Given the option, preference should therefore be given to fingerstick testing because of its slightly superior test characteristics. System factors such as ease of staff use, necessary CLIA waivers, laboratory capacity, and HIV prevalence should also be considered.
Keywords: HIV Screening, Randomized trial, OraQuick, Emergency Department
In 2006, the Centers for Disease Control and Prevention (CDC) recommended expanded Human Immunodeficiency Virus (HIV) screening in U.S. emergency departments.1 Successful execution of the CDC recommendation requires two important components, minimal testing barriers (e.g. low personnel and financial costs) and high test acceptance rates. The expansion of rapid HIV testing to clinical and non-clinic settings plays an important role in the implementation of the CDC guidelines by increasing test acceptance, facilitating receipt of test results, and promoting linkage to care.2-6 Yet, the uptake of rapid tests may vary based on the testing modality offered – fingerstick versus oral swab.
Early studies demonstrate high rates of oral HIV test acceptability among patients and providers due to the noninvasiveness of the test and speed of specimen collection.7-9 These favorable test attributes have been used to maximize rates of HIV testing.7,10 However, this increase in rapid oral HIV test acceptance has been also accompanied by several reported clusters of false positive test results.11-13 A recent meta-analysis by Pai et al. examining the accuracy OraQuick rapid HIV-antibody-based point-of-care tests found that oral testing had a lower sensitivity than fingerstick testing (98.0% vs 99.7%) and a lower positive predictive value (PPV) in low-prevalence settings (88.6% vs 97.7%).14 Such reports have raised public concern among health care providers and consumers, and numerous testing clinics have replaced oral fluid testing for fingerstick due to such occurrences.
Rapid fingerstick HIV testing has limitations as well. Patients consistently demonstrate a preference for noninvasive, painless oral testing methods 7,9 which may compromise fingerstick test acceptance. Given the distinct limitations of the two testing methods – slightly poorer performance of oral fluid versus potentially lower test acceptance of fingerstick – it is not clear whether the frequency of rapid HIV test acceptance would differ between oral fluid and fingerstick tests. To address this question, we conducted a randomized controlled trial of routine rapid HIV screening in an urban hospital ED to directly evaluate the frequency of HIV test acceptance as well as test completion using oral fluid and fingerstick testing modalities.
The study was approved by the Partners Human Research Committee (2006P-000136) and was overseen by a Data Safety and Monitoring Board.
The Universal Screening for HIV in the Emergency Room (USHER)-Phase II study was conducted in the emergency department at Brigham and Women’s Hospital (BWH), a tertiary academic medical center in Boston, MA. The BWH Emergency Department (ED) is a Level 1 trauma center that treats more than 56,000 patients annually and serves a demographically diverse patient population of whom 48% are white, 25% black, and 20% Hispanic. In this ED, approximately 60% of presenting patients are women, and the median age is 44 years. Prior to the implementation of the USHER study, HIV testing was not performed in the BWH ED.
The USHER trial is an NIH-funded, single-center, randomized controlled trial. Details of the original USHER trial have been published elsewhere.15 Between May 5, 2009 and January 4, 2010, USHER-Phase II consented eligible patients for the opportunity to be offered routine opt-in, rapid HIV screening. Enrolled subjects were randomized to fingerstick whole-blood or oral fluid specimen collection. Details regarding the informed consent process have been previously reported.15 Per Massachusetts law, all subjects provided separate written informed consent for rapid HIV testing in addition to providing written informed consent for trial participation. Participants were also asked to complete a questionnaire which gathered data on age, race, ethnicity, income and high-risk behavior. Patients who were interested in HIV testing but refused trial participation were provided with a hard copy list – kept in the ED – of all locally available and Department of Public Health affiliated free HIV counseling, testing and referral sites.
Patient eligibility was assessed using the ED charts and the BWH computerized patient tracking system. Eligible patients met the following criteria: 1) 18-74 years old; 2) fluent in English or Spanish; 3) not engaged in pre-natal care; 4) not self-reportedly known to be HIV-infected; 5) not enrolled in the USHER trial in the previous three months; and 6) had an Emergency Severity Index (ESI) score of 3-5 (indicating lower clinical severity)16-18 or an ESI score of 1 or 2 (potentially higher clinical severity), with signed approval from the ED attending physician indicating participant’s clinical stability and clear mental status. During trial enrollment hours, HIV counselors (trained research assistants) assessed ED patients who had been registered, triaged, and escorted to their rooms to determine if these patients were eligible for USHER-Phase II. Enrollment times spanned from 8 a.m. to 12 a.m. and encompassed a minimum of 60 hours per week, including weekends. No financial incentives were provided to patients for trial participation.
After providing informed consent for trial participation, subjects were randomized to one of the two test modality arms: 1) fingerstick whole-blood HIV testing, or 2) oral fluid HIV testing. The fingerstick consent form stated the manufacturer-reported accuracy of the test and discussed the required blood collection methods 19 while the consent form for the rapid oral test stated the risk of false positive results associated with this test as identified in USHER-Phase I (e.g. “3 out of 4 patients with a ‘reactive’ test do not have HIV infection”).13 Since HIV test acceptance has been found to vary with sex and age groups,20 USHER-Phase II participants were randomized using computer-generated block randomization within four strata (i.e., men <40 years old; men ≥40 years old; women <40 years old; and women ≥40 years old). Neither subjects nor counselors were blinded to the assigned arms.
Counselors were trained by the Massachusetts Department of Public Health 21 in both methods of specimen collection for the OraQuick®ADVANCE™ Rapid HIV 1/2 Antibody Test (OraSure Technologies, Inc. Bethlehem, PA).
Primary and secondary outcome measures and statistical methods
The primary outcome measure was HIV test acceptance rate defined by the proportion of participants whom accepted HIV testing among those randomized within each trial arm (fingerstick or oral fluid). The secondary outcome measure was frequency of HIV test completion as defined by the proportion of participants who completed HIV testing among those randomized within each trial arm.
Data from the original cohort of the USHER trial (Phase I) were used to inform the sample size estimation for this study.15 Sample size was chosen to detect a 10% difference in acceptance rates between two testing modality arms (90% power, 0.05 level of significance) and was estimated at 992 subjects tested, 496 per arm.
We used the intention-to-treat principle in which data were analyzed according to the arm to which they were randomly allocated, irrespective of whether they actually received the assigned test. To illustrate the balance between arms achieved by randomization, we present baseline demographic information stratified by study arm. Means and standard deviations are provided for continuous variables (age) while frequencies are presented for categorical variables (gender, race/ethnicity, primary language, and education). The difference in the acceptance rates was estimated along with 95% confidence intervals and tested using the chi-square test. All analyses were performed using SAS statistical software Version 9.2 (Cary, NC).
From May 5, 2009 through January 4, 2010, 5,612 patients were screened for USHER-Phase II trial eligibility, and 2,012 (36%) were eligible for enrollment. The most frequently documented reason for ineligibility was age (n=1,767; 49% of all ineligible). Among the 2,012 eligible patients approached, 1,651 (82%) agreed to study participation (). The 361 eligible patients who refused USHER-Phase II trial enrollment were older than study participants (40 versus 34 years of age; p<0.0001) yet similar in other demographic features and ESI scores.
USHER-Phase II Trial enrollment schema. Percentages are calculated using the number stated in the cell above as the denominator.
Among those 1,651 patients who agreed to enrollment, 830 were randomized to the fingerstick arm and 821 to the oral fluid arm. Trial arms were balanced in their demographic distribution; mean age was 33 years (SD 13), 65% were female, 24% were white, 24% African-American, and 38% were Hispanic ().
Demographic characteristics of patients randomized in the USHER-Phase II Trial
|Fingerstick (N=830)||Oral Fluid (N=821)|
|Mean Age (SD)||34 (13)||33 (13)|
|Male||283 (35%)||288 (35%)|
|Female||536 (65%)||529 (65%)|
|Non-Hispanic White||198 (24%)||201 (25%)|
|Non-Hispanic Black||188 (23%)||200 (25%)|
|Hispanic||329 (40%)||297 (36%)|
|Asian/Asian-American||22 (3%)||22 (3%)|
|Native American/Alaskan Native||1 (0%)||4 (0%)|
|Multi-racial/Other||85 (10%)||92 (11%)|
|English||643 (78%)||644 (79%)|
|Spanish||148 (18%)||141 (17%)|
|Other||34 (4%)||29 (4%)|
|Less than High School||116 (14%)||96 (12%)|
|High School/General Education Diploma||255 (32%)||261 (32%)|
|Some College||198 (24%)||222 (28%)|
|College Degree||173 (21%)||144 (18%)|
|Some Post-College/Graduate Degree||67 (8%)||82 (10%)|
Test acceptance rates
Among subjects randomized to rapid HIV testing, the test acceptance did not differ meaningfully between arms, 67% (553/830) in the fingerstick arm compared to 69% (565/821) in the oral fluid arm (p=0.34). Frequencies of test acceptance did not differ by race, gender or education. The proportion of HIV tests completed – the proportion of subjects who were tested among those who were randomized – was 66% (549/830) in the fingerstick arm and 69% (563/821) in the oral fluid arm (p=0.29). More than 99% of those who accepted an HIV test received the test in both arms.
Among the 1,111 study participants who had a valid rapid HIV test result, five tests were reactive. Three of these subjects consented to confirmatory testing. Two new cases of HIV infection were identified (one fingerstick and one oral) – a yield of new case identification of 0.2% (95% CI: 0.0-0.6%). One fingerstick test was a false positive. No harm was reported in this trial.
In a randomized controlled trial of routine ED-based HIV screening, we found no meaningful difference in the acceptability of an HIV test when comparing fingerstick versus oral fluid rapid HIV test collection modalities.
Our randomized trial corroborates the 2009 study result of White and colleagues.22 White et al. allocated fingerstick vs. oral HIV testing based upon the day of the week and showed that testing modality had minimal effect on testing rates.22 Reasons for declining screening in that study were generally similar for both screening modalities and seldom related to testing method – the most common being “having recently been tested for HIV” (50%) and “lack of perceived HIV risk” (31%).22
This study is subject to several limitations. Because the USHER-Phase II trial was a single-site study with findings that are applicable to rapid HIV screening using fingerstick or oral collection modality, some of our results may not be generalizable to other settings or test kits. Failure to enroll overnight, in addition to the lengthy consent process required to conduct an IRB-approved randomized trial in Massachusetts (one for trial, one for testing per Massachusetts state law, and one for confirmation of reactive results, if necessary) may have led to selection bias. We did not collect preference data and were therefore not able to fully characterize trade-offs considered in the decision for oral testing given its ease of administration versus the decision for fingerstick testing given its reported superior test characteristics. Furthermore, the frequency of test offers as well as test acceptance may be lower in EDs that do not utilize ancillary testing personal, as we used in our trial. Finally, several important factors may also influence acceptance of HIV testing and were not measured in our study. These include system-level factors such as location convenience, confidentiality, consent processes, cost, counseling opportunities, and results disclosure.2,10
In the development of HIV screening protocols in the ED, urgent care, and primary care settings, it is critical to tailor optimal screening approaches to enhance test acceptability by decreasing testing barriers, particularly among those less approachable for the test offer and/or those less willing to accept testing. Many EDs have recently started to favor HIV screening using specimens collected for clinical purposes.23 However, this streamlined testing process fails to account for patients who refuse or do not require phlebotomy or who do not present to an ED setting, making our findings still very relevant.
In an era when public health efforts are emphasizing prevention, routine HIV screening, and early entry to care, the use of testing methods that can expand acceptability of HIV testing is essential. Our study is among the first to demonstrate the application of two rapid HIV test modalities in a randomized trial where the frequencies of test offer and acceptability are compared within the context of routine, voluntary counseling and screening in an emergency department. We find that test modality was not an important factor in test offer and acceptance rates among patients. Given the option, preference should therefore be given to fingerstick rapid HIV testing because of its slightly superior test characteristics compared to that of the oral rapid HIV test. In low prevalence settings, rapid oral testing should remain an operational solution for a subset of patients who refuse whole blood HIV testing. In addition to test characteristics, however, we believe that system factors such as ease of staff use, necessary CLIA waivers, laboratory capacity, and HIV prevalence in the testing setting should also be heavily considered.
Summary of Intent-to-Treat analysis by trial arm
|Fingerstick (N=830)||Oral Fluid (N=821)||Difference (95% CI)||P value|
|HIV test offered||778 (94%)||765 (93%)||0.6% (-1.8%, 2.9%)||0.65|
|HIV test accepted among those randomized||553 (67%)||565 (69%)||-2.2% (-6.7%, 2.3%)||0.34|
|HIV test completed among those randomized||549* (66%)||563 (69%)||-2.4% (-7.0%, 2.1%)||0.29|
The authors would like to acknowledge the co-investigators and staff of the USHER-Phase II Trial including: Carrie Braverman; Kenneth A. Freedberg, MD, MSc; Susan Larrabee; A. David Paltiel, PhD; Mariesa Ricks; Paul Sax, MD; and Ron Walls, MD. We would like to thank the faculty and staff of the Brigham and Women’s Hospital Emergency Department for their participation in the USHER-Phase II Trial and for their dedication to the identification of undiagnosed HIV infection. Dr. Walensky affirms that she has listed everyone who contributed significantly to the work in this Acknowledgment section.
Source of Funding: This research was funded by the National Institute of Mental Health (R01 MH073445, R01 MH65869) and the Doris Duke Charitable Foundation, Clinical Scientist Development Award to Rochelle P. Walensky.
Conflicts of Interest: The authors have no conflicts of interest to declare.
Abstract presented at the International AIDS Society Conference, July 2011, Rome, Italy.
Publisher’s Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
1. Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006 Sep 22;55(RR-14):1–17. quiz CE11-14. [PubMed] [Google Scholar]2. Peralta L, Deeds BG, Hipszer S, Ghalib K. Barriers and facilitators to adolescent HIV testing. AIDS Patient Care STDS. 2007 Jun;21(6):400–408. [PubMed] [Google Scholar]3. Greenwald JL, Burstein GR, Pincus J, Branson B. A rapid review of rapid HIV antibody tests. Curr Infect Dis Rep. 2006 Mar;8(2):125–131. [PubMed] [Google Scholar]4. San Antonio-Gaddy M, Richardson-Moore A, Burstein GR, Newman DR, Branson BM, Birkhead GS. Rapid HIV antibody testing in the New York State Anonymous HIV Counseling and Testing Program: experience from the field. J Acquir Immune Defic Syndr. 2006 Dec 1;43(4):446–450. [PubMed] [Google Scholar]5. Spielberg F, Branson BM, Goldbaum GM, et al. Choosing HIV counseling and testing strategies for outreach settings: a randomized trial. J Acquir Immune Defic Syndr. 2005 Mar 1;38(3):348–355. [PubMed] [Google Scholar]6. Hutchinson AB, Corbie-Smith G, Thomas SB, Mohanan S, del Rio C. Understanding the patient’s perspective on rapid and routine HIV testing in an inner-city urgent care center. AIDS Educ Prev. 2004 Apr;16(2):101–114. [PubMed] [Google Scholar]7. Peralta L, Constantine N, Griffin Deeds B, Martin L, Ghalib K. Evaluation of youth preferences for rapid and innovative human immunodeficiency virus antibody tests. Arch Pediatr Adolesc Med. 2001 Jul;155(7):838–843. [PubMed] [Google Scholar]8. Liang TS, Erbelding E, Jacob CA, et al. Rapid HIV testing of clients of a mobile STD/HIV clinic. AIDS Patient Care STDS. 2005 Apr;19(4):253–257. [PubMed] [Google Scholar]9. Kowalczyk Mullins TL, Braverman PK, Dorn LD, Kollar LM, Kahn JA. Adolescent preferences for human immunodeficiency virus testing methods and impact of rapid tests on receipt of results. J Adolesc Health. Feb;46(2):162–168. [PubMed] [Google Scholar]10. Spielberg F, Kurth A, Gorbach PM, Goldbaum G. Moving from apprehension to action: HIV counseling and testing preferences in three at-risk populations. AIDS Educ Prev. 2001 Dec;13(6):524–540. [PubMed] [Google Scholar]11. Delaney KP, Branson BM, Uniyal A, et al. Performance of an oral fluid rapid HIV-1/2 test: experience from four CDC studies. AIDS. 2006 Aug 1;20(12):1655–1660. [PubMed] [Google Scholar]12. False-positive oral fluid rapid HIV tests–New York City, 2005-2008. MMWR Morb Mortal Wkly Rep. 2008 Jun 20;57(24):660–665. [PubMed] [Google Scholar]13. Walensky RP, Arbelaez C, Reichmann WM, et al. Revising expectations from rapid HIV tests in the emergency department. Ann Intern Med. 2008 Aug 5;149(3):153–160. [PMC free article] [PubMed] [Google Scholar]14. Pai NP, Balram B, Shivkumar S, et al. Head-to-head comparison of accuracy of a rapid point-of-care HIV test with oral versus whole-blood specimens: a systematic review and meta-analysis. Lancet Infect Dis. Jan 23 [PubMed] [Google Scholar]15. Walensky RP, Reichmann WM, Arbelaez C, et al. Counselor- versus provider-based HIV screening in the emergency department: results from the Universal Screening for HIV Infection in the Emergency Room (USHER) randomized controlled trial. Annals of Emergency Medicine. 2011 Jul;58(1):S126–S132.e124. [PMC free article] [PubMed] [Google Scholar]16. Wuerz RC, Travers D, Gilboy N, Eitel DR, Rosenau A, Yazhari R. Implementation and refinement of the emergency severity index. Acad Emerg Med. 2001 Feb;8(2):170–176. [PubMed] [Google Scholar]17. Wuerz RC, Milne LW, Eitel DR, Travers D, Gilboy N. Reliability and validity of a new five-level triage instrument. Acad Emerg Med. 2000 Mar;7(3):236–242. [PubMed] [Google Scholar]18. Eitel DR, Travers DA, Rosenau AM, Gilboy N, Wuerz RC. The emergency severity index triage algorithm version 2 is reliable and valid. Acad Emerg Med. 2003 Oct;10(10):1070–1080. [PubMed] [Google Scholar]20. Liddicoat RV, Losina E, Kang M, Freedberg KA, Walensky RP. Refusing HIV testing in an urgent care setting: results from the “Think HIV” program. AIDS Patient Care STDS. 2006 Feb;20(2):84–92. [PubMed] [Google Scholar]
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Kwik Prick rapid HIV testing
Due to the current situation with Covid-19, we are currently not offering any Kwik Prick drop-in services. This includes the weekly drop-in at the Trade office as well as outreach drop-in sessions in Coalville, Hinckley or Loughborough.
You can order a free HIV home testing kit. Click here to order.
Wanted some help with taking your blood sample as part of the home testing kit? Watch out demonstration video.
We are now offering weekly remote HIV assisted testing services online every Monday between 12:00 – 17:00 via Microsoft Teams. Click here for more information
We understand that in some cases having a HIV test kit delivered to your place of residence and/or carrying out the test at home may not be feasible or convenient for several reasons. If so, please contact us to discuss other options available for you.
Take the test
Free Rapid HIV testing is being offered by Trade Sexual Health at a Monday drop-in session, available for the Leicester LGB&T communities.
The test is performed at the Trade office, with our friendly certified testers performing the test on site. The whole process should take no more than half an hour to complete.
The test is free and confidential. The HIV test uses a ‘finger prick’ blood sample, with results given within 20 minutes, and is 99% accurate at detecting any HIV exposure that may have occurred more than 12 weeks ago. However, can potentially pick up HIV infection from as little as 4 weeks ago.
With HIV still increasing at the fastest rate within the LGB&T communities, Trade are providing this testing service to increase people’s awareness of their HIV status. Earlier diagnosis is not only key to getting effective treatment, but also allows you to take control of your own sexual health and well-being.
Weekly drop-in session in Leicester
Temporarily suspended due to Covid-19 – see notice above.
Clinic day: Monday
Clinic times: 12pm – 6pm
Location: Trade Sexual health, 2nd Floor, 27 Bowling Green Street, Leicester, LE1 6AS
Appointments can be made for other days by calling 0116 254 1747.
Monthly clinics across Leicestershire
Trade also deliver rapid HIV testing clinics across Leicestershire in Coalville, Hinckley and Loughborough on a monthly/4 weekly basis, in partnership with Turning Point, the local drug and alcohol support service. These clinics run as drop-in sessions.
Temporarily suspended due to Covid-19 – see notice above.
Clinic day: Every 1st Wednesday of the month (2nd Wednesday of the month in January, February, March and April 2020 only)
Clinic times: 2:30 – 4:30pm
Location: Turning Point, 42 High Street, Coalville, LE67 3EE
Dates in 2020: 8th April, 6th May, 3rd June, 1st July, 5th August, 2nd September, 7th October, 4th November, 2nd December
Temporarily suspended due to Covid-19 – see notice above.
Clinic day: Every 1st Friday of the month
Clinic times: 2:30 – 4:30pm
Location: Turning Point, 55-56 Wood Gate, Loughborough, LE11 2TG
Dates in 2020: 3rd April, 1st May, 5th June, 3rd July, 7th August, 4th September, 2nd October, 6th November, 4th December
Temporarily suspended due to Covid-19 – see notice above.
Clinic day: Wednesday, every 4 weeks (starting 18 September 2019)
Clinic times: 2:00 – 4:00pm
Location: Hinckley Health Centre (Outpatients Room 3), 29 Hill Street, Hinckley, LE10 1DS
Dates in 2020: 1st April, 29th April, 27th May, 24th June, 22th July, 19th August, 16th September, 14th October, 11th November, 9th December
Hinckley – December 2019 and January 2020 – the next clinic in Hinckley will be on Wednesday 5th February 2020.
Coalville – December 2019 – the next clinic in Coalville will be on Wednesday 8th January 2020.
Coalville – the monthly clinic in Coalville will change to the 2nd Wednesday of the month in January, February, March and April 2020 only. The dates will be: Wednesday 8th January, Wednesday 12th February, Wednesday 11th March, Wednesday 8th April.
Frequently asked questions about the Kwik Prick Rapid HIV test
What is an HIV test?
You can find out if you become infected with HIV by having a blood test done. Your body produces antibodies to HIV in an attempt to fight the virus; the test works by looking for these antibodies as well as for HIV antigens (the virus itself).
When should I have an HIV test?
It normally takes 12 weeks (3 months) for HIV antibodies to show up in the blood. However HIV antigens (the HIV virus) may be present and detectable in your blood from as little as 4 weeks after infection.
How quickly HIV antigens or antibodies can be detected in your blood varies from person to person, and therefore HIV may not be detected, even though the infection is there, before 12 weeks from when you might have been exposed to HIV.
This is called the window period.
If you are tested during this window period and have a negative result you should also be tested after the 12 weeks have passed to be totally sure of your result.
If you are worried about an incident in the past few days or weeks where you feel you may have been exposed to HIV, you should speak to the Kwik Prick tester present at the testing site who can refer you to the local sexual health services which can carry out tests to identify HIV at this early stage.
What is PEP?
If you are worried about an incident of HIV exposure within the last 72 hours – speak to the Kwik Prick tester, who may refer you to the sexual health services for enquiries about PEP treatment, which can stop HIV entering the bloodstream after exposure. For more info about PEP click here.
How will I be tested for HIV?
It is a test which involves taking a drop of blood from your finger with a result available within 20 minutes.
What do the results mean?
This test is a SCREENING TEST: it is possible that if the result is reactive you may still not be infected with HIV. If the test is reactive we will arrange for you to be seen in at the Jarvis HIV clinic, where a blood sample will be taken and sent to the laboratory for HIV testing. You will be asked to return for an appointment at the Jarvis clinic a few days later to get the result.
If your rapid HIV test is negative, and you have not been at risk of HIV infection in the previous 12 weeks, then it is unlikely you are infected with HIV.
However, as everybody reacts differently to HIV infection, if you have been very recently infected, your antibody or antigen levels may be low but the test may still be negative.
If you have recently been at risk of HIV infection you should re-test once the window period is over (approximately 12 weeks since possible infection).
A negative result does not mean you can’t be infected in the future.
Things to think about before having an HIV test?
Only you can decide if having an HIV test is right for you. You should not be pressurised into having a test by other people. Below are some reasons to have, and not have, an HIV test; everyone is different and you may have your own reasons.
Reasons you may not test:
A positive result can mean a lot of stress and impact on your day to day life.
People may treat you differently if they know you are HIV positive.
You may be restricted on travelling and working abroad.
A positive result can make it more difficult to get a mortgage and life insurance.
If you have a negative result following risky behaviour which could have led to becoming HIV positive, you may see no reason to change your behaviour to lower the risk.
You may not be in a place to deal with a positive result emotionally.
Reasons to test:
You will know your HIV status. You won’t be worried about what you think your HIV status is.
A negative result may give you peace of mind.
A positive result will enable you to access medication, monitoring and specialist support, which can greatly improve your long-term health.
If you are HIV positive the sooner you are diagnosed the more likely you are to get the maximum benefit from HIV treatment.
You will be able to make decisions about your future.
To help you plan the type of sex you want with your partner(s). By always having protected sex you will be very unlikely to pass HIV on to someone else.
What do I need to think about after having a negative test result?
Getting a negative result doesn’t mean you are immune to HIV. You might want to think about times you have been uncomfortable with the risks you have taken and how you might deal with these in the future.
Remember it can take up to 12 weeks for antibodies and antigens to show up when you’re tested for HIV. If you have had unprotected sex or shared injecting equipment in the last 12 weeks you may want to take another test within the next three to six months.
This is a result for you and does not tell you anybody else’s status; don’t assume that your partner has the same status.
What do I need to think about after having a reactive test result?
This is a result for you and does not tell you anybody else’s status; don’t assume that your partner has the same status.
A positive result could mean that you face discrimination from some people, if they know your status.
If you are HIV positive you can pass HIV onto other people through unprotected sex or sharing injecting equipment.
You may want to make changes in your life. Remember that you may be in shock and might not be thinking very clearly; wait until things settle down before you make major decisions.
Similarly, you might want to tell lots of people about being HIV positive. It’s important you have someone you can talk to, but at this stage, try to talk to people you really trust. You can always tell people later, but you can never un-tell them.
Will the Kwik Prick Rapid HIV test check for other sexually transmitted infections (STIs)?
This test will only check for HIV. It is not a full sexual health screen. If you would like a full sexual health check you will need to visit a sexual health clinic, or if you identify as gay, bisexual or man who has sex with men, you can visit the Trade sexual health walk-in clinics at Leicester’s gay saunas. If you identify as a lesbian or bisexual woman, gay or bisexual man and/or trans, then you can access CLINIC xtra from the Trade office.
I have a question or concern that has not been answered in these FAQs
Please contact Trade on 0116 254 1747 or email us at [email protected] and we will be more than happy to answer any questions or concerns you may have.
A New Era in HIV Diagnostics
On November 7, 2002, the FDA announced approval of the OraQuick® Rapid HIV-1 Antibody Test, which can detect HIV antibodies in fingerstick whole-blood specimens in as few as 20 minutes. On January 31, 2003, the U.S. Department of Health and Human Services announced greatly expanded access to this assay through a Clinical Laboratory Improvement Amendments (CLIA) waiver. To discuss the implications of OraQuick for HIV counseling and testing, prevention efforts, and access to care, ACC Executive Editor Matthew O’Rourke spoke with Dr. Bernard Branson, Chief of the Laboratory Determinants & Diagnostics Section of the Division of HIV/AIDS Prevention at the CDC; Dr. Carlos del Rio, Chief of Medicine at Grady Memorial Hospital in Atlanta and Associate Editor of ACC; Ms. Susan Larrabee, HIV social worker at Brigham and Women’s Hospital in Boston; and Dr. Paul E. Sax, Clinical Director of the HIV Program and the Division of Infectious Diseases at Brigham and Women’s Hospital, and Research Notes Editor of ACC.
Mr. O’Rourke: How does this new rapid test work? How does it compare with conventional ELISA and the currently available rapid test-SUDS® (Single Use Diagnostic System)?
Dr. Branson: The FDA has approved OraQuick tests for use with fingerstick whole blood. The test consists of a paddle device and developer vial that you place into a stand. You obtain 5 microliters of blood from a fingerstick with something that looks like a plastic inoculating loop. You mix the specimen into the developer vial, insert the paddle device, and wait for 20 to 60 minutes. It is what’s called a “lateral-flow device” and has an internal control, so that if the test is negative, you get a single red stripe at the control location; if HIV antibody is detected, you get one stripe at the control location and one stripe at the test location; and if the test is not performed correctly or there is insufficient specimen, you get no stripes on the device.
According to the package insert, the sensitivity is 99.6%. Most of our studies have shown it to be between 99.8% and 100% sensitive. The package insert quotes a specificity of 100%, which also matches pretty closely with our studies. For instance, in the MIRIAD (Mother Infant Rapid Intervention at Delivery) study, we’ve had only 1 false-positive out of approximately 2200 pregnant women tested.
In comparison with the SUDS rapid test, there are a few key differences. First, SUDS is a “flow-through device” for use with serum or plasma, so you have to centrifuge the specimen before running the test. Second, SUDS has a number of steps where you have to add reagents to the device, whereas OraQuick requires only a single step. Third, unlike OraQuick, SUDS does not have an internal control. Therefore, labs must run a positive and negative control each time that they run a batch of SUDS tests.
Dr. Sax: How does the specificity of the new test compare with that of SUDS?
Dr. Branson: In our studies and according to the package insert, the specificity of SUDS is 99.6% – less than that of OraQuick. However, some groups have experienced considerably lower specificity with SUDS in clinical practice. The way you read the SUDS test is to look for any blue shading on the membrane at the bottom, but because there’s no comparison band available, some people have a tendency to over-read the test. As a result of these issues in test interpretation, we expect many fewer false-positives with OraQuick in low-prevalence populations.
Dr. Sax: That’s a critical difference between these two tests. Because the concern with any screening HIV test is that you’ll give a false-positive result to a patient, and this is especially true in low-prevalence settings. We were warned stringently to report a positive SUDS as “inconclusive” or “very preliminary.” But what patients hear is “you are HIV-positive,” and, as a clinician, you want to do everything possible to minimize your uncertainty.
Dr. del Rio: Interestingly, however, in the study we did here at Grady Memorial in Atlanta, we had more false-positives with ELISA than with SUDS. The problem that we had with SUDS was that it was just not rapid enough. It requires a technician to pay full attention to it during the time that it develops. We found SUDS to be an intermediate-speed test with a lot of technical complexities.
Dr. Sax: Exactly. Right now, our hospital runs ELISAs twice a day, so SUDS wasn’t really that much more rapid than conventional testing. And with a positive ELISA, you don’t give the results to the patient, whereas with a positive SUDS, that was the idea. We actually piloted SUDS here and found an unacceptably high number of false-positives, probably because of lack of technician experience with the test.
Dr. Branson: Interestingly, in the MIRIAD study, we’ve had 1 false-positive OraQuick but 4 false-positive ELISAs. But as Dr. del Rio noted, the issue with SUDS is that it requires performance in the lab, and that increases turnaround time. Sending specimens to the lab slows down the process regardless of the test’s complexity. In an abstract that was just presented at the 10th Retrovirus Conference in Boston, we showed that if you use OraQuick in a point-of-care setting, the turnaround time is 45 minutes, whereas if you send the specimen to the lab for results, the turnaround time is 3 hours.
Mr. O’Rourke: In what patient populations and clinical settings will the test be most appropriate, and in what populations will it be less appropriate?
Dr. del Rio: OraQuick clearly offers the opportunity to do more testing in general and, especially, in under-served populations, urgent care settings, emergency rooms, and new venues outside of healthcare environment. For example, this assay makes it much easier to consider testing in community centers or at events like Gay Pride. Within the clinical care setting, this test will be very useful when you need a rapid answer: source testing before initiating postexposure prophylaxis, at delivery for women who have not received prenatal care, or in the emergency room. Many ERs, including the one at Grady Memorial, don’t do HIV tests, because they cannot ensure that post-test counseling will happen; thus, many opportunities to diagnose unsuspected HIV infection are wasted. Many patients who come to ERs should be offered an HIV test because this may be the only contact they have with a healthcare setting. With OraQuick, the follow-up problem is eliminated.
Dr. Sax: Spending money on getting infected people into care is a more efficient strategy to promote health than simply spending money to expand the number of people who are tested. I think that OraQuick can help here. It has clearly been shown that 30% of HIV-infected people who get tested never return for their results and, thus, don’t get into care.
Dr. del Rio: The linkage to care is critical. Far too many people are not getting tested or not returning for the results and are learning quite late that they are infected – perhaps after having advanced to HIV disease and quite likely after having exposed others. What’s the point of testing if people aren’t going to get the results, let alone get into care?
Ms. Larrabee: I agree with you about many of the benefits of rapid testing; however, given my experience with pretest counseling, I have concerns about approaches such as setting up vans to test at Gay Pride. It would be very difficult to provide the necessary support in such situations for people who have severe reactions to a positive result. Whether the test takes 3 hours or 35 minutes, you need systems in place to help support people in the process and especially in learning that they are likely HIV-infected. The reaction to a preliminary positive result isn’t always going to be “Show me how to get into care.” Sometimes it’s going to be “Show me the George Washington Bridge.”
Dr. Sax: You have to assume that the person you are testing may be positive. Some doctors, especially in low-prevalence settings, do not schedule the 2-week follow-up for a patient they think is at low risk, and they say, “Don’t worry. I’ll call you if there’s a problem.” If the ELISA turns out to be positive, that puts the doctor and the patient in a difficult situation. So the OraQuick test will give the patient a lot more information before leaving the testing encounter.
Dr. Branson: We’ve discovered that most people who get a preliminary positive result return for their confirmation results. In the ER study we did in Chicago, we scheduled the patients with preliminary positive results to get their confirmatory results at an HIV-care site. More than 80% of people came back and got into care without any further follow-up.
In addition, although it is true that many people who hear “preliminary positive” may think “definitely positive” as Dr. Sax suggested, our qualitative studies have shown that many people feel that giving preliminary results is a way of breaking the news gently. Right now, if you are told of a positive test result, there’s no doubt. Given the hypothetical choice, some people believe that having the preliminary result, where there’s still a chance that it could be wrong, would give them coping time. The issue of counseling people who get a positive result with OraQuick is very important: You want to frame the result as cause for serious concern, but not as a definitive answer. One of the surprising findings in our ER studies was that the need for psychological support of patients in giving out preliminary positive results from rapid tests was not as great as we had feared.
Dr. Sax: It is analogous to the home test, which gives you counseling, your result, and, if positive, encourages you to seek care and have a confirmatory test. As with the ER studies of OraQuick you cite, for people who agree to the home test, a positive result is not associated with an unacceptable rate of psychological stress.
Dr. Branson: We need to keep this kind of self-selection in mind. Even when we expand testing to new venues, many people who are not prepared for the results will choose not to get tested. What settings are not appropriate for this test? The answer may be settings where a large proportion of people are not prepared for a positive result.
Ms. Larrabee: In some environments, most people aren’t prepared. I’ve heard some recommendations that this test could be used at bars and other venues where many people are under the influence of alcohol or drugs and most of these people probably aren’t in a state to deal with a positive result.
Dr. del Rio: I believe, however, that we are grossly under-testing people. Part of the problem is that we test less frequently than people think we do. I’ve been very surprised at how many patients in whom I perform an HIV test say, “I was in the hospital two months ago, and simply assumed I was tested.”
Dr. Branson: STD clinics in Houston performed blinded seroprevalence studies and discovered that they were not testing about half of the HIV-infected patients. The researchers formed focus groups with the patients and asked them, “Why aren’t you getting tested for HIV?” Universally, the patients responded, “We thought we were.” Similarly, the women’s intake unit at the Cook County detention center has signs posted that say, “We do not test you for HIV.” However, when asked when they last received an HIV test, the most common response was “last time I was here.”
Dr. Sax: In terms of the applicability of this test in particular settings, occupational postexposure prophylaxis is one area where it could be very helpful. Knowing the serostatus of the source lets you know whether prophylaxis is warranted, and determining this quickly could prevent a lot of these ultimately unnecessary 24- to 72-hour antiretroviral courses that get initiated. Of course, the delay of waiting for the source’s consent remains.
Ms. Larrabee: Although it’s unusual, victims of sexual assault sometimes are able to convince their assailant to get HIV tested, and this rapid test would certainly be an improvement for these patients considering nonoccupational PEP.
Dr. Sax: Pregnancy is another setting in which this test will make a difference. We know that antiretroviral therapy initiated at delivery can reduce the risk for transmission significantly. Thus, a rapid test of women who present at delivery without having received prenatal care or whose records are not available is critical in further limiting perinatal transmission. This was one of the main ways in which the SUDS test was used.
Dr. Branson: The difficulty with the SUDS test, however, was that in many low-prevalence settings, clinical use yielded more false- than true-positives.
Ms. Larabee: What happens to pre- and post-test counseling with the OraQuick test? Does the emphasis on speed reduce the time for these interventions?
Dr. Branson: I think that counseling and testing continue to be more a function of the environment than they are of the test.
Dr. del Rio: In our experience with SUDS, 42% of people in a walk-in clinic accepted testing, which is a very good response. Patients did not need comprehensive pre-test counseling. We had a brief discussion with them and gave them a literacy-appropriate pamphlet. Post-test counseling, of course, can’t be dealt with so quickly.
Dr. Branson: In the counseling and testing guidelines that the CDC updated in November 2001, a distinction is drawn between providing information and providing counseling. It may be appropriate in some settings, especially where prevalence is low, to just provide information, as Dr. del Rio suggests. In fact, the guidelines suggest that in certain environments it may be appropriate to deliver the information through either a pamphlet or a video.
“Opt-out” testing is another model. After the Houston STD clinics discovered how many HIV cases they were missing, all of the STD clinics in Texas moved to a protocol in which when people consent to treatment, HIV testing is included. This time, the signs say, “We test you for HIV unless you ask us not to.”
This change has had two effects. First, many more HIV-infected clinic patients have learned of their positive status. Second, the number of people receiving HIV pre-test counseling has fallen by 50%. We’re going to have to wait and see what happens with the OraQuick test, but my best guess is that the “opt-out” protocol may become more routine, especially in low prevalence environments As Dr. Sax suggested, you can’t triage for counseling and testing based on identifiable risks. In our ER studies in Atlanta and Chicago, about half of all patients who turned out to be positive did not have any identifiable risks on interview.
Mr. O’Rourke: With standard ELISA wouldn’t you have a better opportunity for risk-reduction counseling, especially in HIV-negative patients? Theoretically you see these patients twice – once for the test, once for the results.
Ms. Larrabee: However, that opportunity only exists if people return for their results. In some settings, the proportion of people who don’t return seems closer to 50% than the official CDC estimate of 38%. In addition, a large part of pre-test counseling is currently dedicated to helping patients figure out how to cope with the anxiety of waiting for the result – if that can be eliminated, all the better. If you can get people to return, however, the opportunity for post-test counseling follow-up is critical. There are a lot of myths out there, such as “if I test negative after having put myself at risk, maybe there’s something special about me and I’m immune.” Only through repeated follow-up and risk-reduction counseling can you effectively dispel these notions.
Dr. Branson: The CDC did a randomized controlled trial comparing pre- and post-test counseling separated by 2 weeks with ELISA with pre- and post-test counseling separated by less than an hour with a rapid test in 3300 individuals. The researchers then followed the HIV-negative people for a year, looking at behavior and at incident STDs. They found no significant differences between the 2 testing groups. However, 30% of the people who were randomized to ELISA did not return for their results.
In addition, the rapid assay may lead us to test many more people with low to moderate HIV risk profiles – people who would have less cause for anxiety about the result. For example, most pregnant women are at low risk for HIV, and this is a low-prevalence population overall. I don’t think that most pregnant women experience much anxiety around HIV testing or need a lot of explanation. It’s simply recommended that all pregnant women get tested for HIV regardless of risk profile.
A critical point here is that we can approach HIV prevention from two different perspectives. First, work with HIV-negative people to prevent them from acquiring HIV. Second, do a better job of identifying HIV-infected people and helping them avoid transmitting the virus to others. In the past, we may have underestimated the importance of this second strategy. In a study by Grant Colfax that looked at preventive vaccine volunteers who received counseling and testing every 6 months, these HIV-negative men still had a high level of risky behavior, even after several counseling sessions. However, in a 1-year follow-up of the participants who seroconverted, risk behavior dropped dramatically after they learned that they were HIV-positive.
Dr. Sax: If you remove the psychosocial component for a minute, and look at the issue just from a medical perspective, the question becomes this: Is there anything wrong with a rapid test that can rule out a very serious disease with a high degree of certainty? The answer has to be no. In addition to HIV, I do a lot of general infectious disease testing, and it would be very helpful to simply include HIV testing as part of an infectious-disease workup for certain patients.
Dr. del Rio: Indeed. As things stand now, I perform a variety of tests in patients and can give them the results of their hepatitis or syphilis tests over the phone, but I must have them return in 2 weeks for their HIV results.
Dr. Sax: In terms of saving time, reducing anxiety, and moving people into care, I’m interested in the combined testing strategies used internationally and alluded to in the CDC materials. It seems possible that different tests could be used in combination to both diagnose and confirm HIV infection rapidly, with a sensitivity and specificity approaching that of Western blot.
Dr. Branson: Combination approaches are reasonable in certain scenarios. The need for such strategies was more pressing when we had the less accurate SUDS test. Many of the tests that were used in the international studies to which you refer also had disparate levels of sensitivity and specificity, so it made sense to use them in combinations. In addition, if you are testing in a setting with 30% prevalence, you need to use two tests to avoid the risk for a false-negative result. In the developing world, it’s not practical to have patients return for confirmation. Because we are seeing so few false-positives with OraQuick and because it will be used in lower-prevalence settings in the developed world, the question is whether it is worthwhile to use another rapid test to repeat every one of the positives. Rapid confirmation probably won’t make sense in the U.S. until we move completely away from Western blot. Mostly for legal reasons, that seems unlikely at present. However, scientifically and economically, it would make a lot of sense to use accurate, combined strategies in place of confirmatory Western blot. Western blot is expensive, complicated, and sometimes scarce. Thus, we’ll continue to evaluate rapid test combinations.
Dr. del Rio:When HIV testing was first developed, its primary purpose was as a screening device for the blood supply rather than as a diagnostic tool. Thus, it needed to provide 100% sensitivity in huge numbers of low-risk populations. Those goals don’t necessarily apply in the clinical care setting, and rapid testing allows us to finally distinguish between testing the blood supply and diagnosing patients.
Ms. Larrabee:The prevention strategy that the CDC unveiled a couple of years ago had two major foci: First, increase the proportion of people who know their serostatus; second, get more people who are positive into care. Has there been any forethought about how people who test positive will be pulled into care, especially if this test is used in nonclinical settings?
Dr. Branson:That’s the flip side to making testing more commonplace: We must have systems to ensure that people get into care. An estimated 225,000 HIV-infected people in the U.S. are undiagnosed, and it’s been our goal to identify them and get them access to treatment. We now have a better tool for the former, so we need to make sure that we have good procedures for the latter.
Ms. Larrabee:Many people tell me that lack of insurance and money keep them from getting tested, because they fear learning that they are infected and being unable to get care. We need to have on-site providers who can help people access whatever resources are available in their state, because otherwise these people will disappear.
Dr. Sax: One way to help move people who test positive into care is to providethem with a registry of HIV-care providers in their area and, especially in nonclinical settings, a list of places where they can get confirmatory testing. It’s not a perfect system, but this is how the home-test company operates.
Dr. del Rio: The availability of the OraQuick test does raise the bar for trying to get everybody we can into care. However, the risk that people will wait to get tested until they develop an opportunistic infection is graver than the risk that they will disappear after testing positive.
Dr. Branson:We need to consider what this change in testing is going to mean for HIV-negative people. Under the current testing scenario, in which most people seek testing because they think that they are at risk or because it’s been recommend to them, many people don’t get their results. Keeping the same scenario, but using rapid testing, a million more people every year are going to be told that they are HIV-negative. If we change the scenario, and expand testing to other venues or make it more routine, that number is going to be much higher still. The importance of detecting positives and making sure that they get into care is obvious, but we need to give people who are negative strategies to stay negative. In Australia, for example, the AIDS Council of New South Wales developed a strategy of “negotiated safety,” which they defined as talk-test-test-trust: When you enter a new relationship, you use condoms or abstain from intercourse; you do a first HIV test; then do a second test 3 months later to eliminate the possibility of a window-period infection; then you can negotiate what level of safe sex is acceptable to you and your partner.
Mr. O’Rourke: What does the DHHS announcement of expanded access for OraQuick mean for the availability of this test? What will the cost of the test be?
Dr. Branson: The retail cost of the test is expected to be about $12. With the DHHS announcement, the number of sites cleared to use this test will increase from 38,000 to about 170,000. Only about 38,000 labs are authorized to do moderate- or high-complexity testing under CLIA, whereas about an additional 140,000 labs – the vast majority being physicians’ office labs – are cleared to do diagnostics under certificates of waiver. In addition, it’s relatively easy for a lab to get a certificate of waiver. Thus, a lot of community-based organizations have expressed interest in getting a lab certificate simply to be able to perform this test.
Dr. Sax: Compared with drawing blood, the fingerstick test is obviously a lot easier for the clinician and, one would guess, more acceptable to the patient, but the test was also developed for use with oral fluids (hence the name): When might the test be approved for use in oral fluids?
Dr. Branson: The oral-fluid test is still being looked at, and the preliminary data are promising. However, I’m glad that oral fluid was not the first method approved for this assay, because it will give us a little bit of time to look at expanding testing gradually. Working with fingerstick whole blood still provides some minor barriers to the use of the test. With oral fluids, we might have a really rapid expansion of testing in the U.S., and I don’t think that we can predict the impact of such widespread use yet.
Dr. Sax:How does the oral-fluid test compare with the fingerstick whole-blood test and with the current FDA-approved test for oral fluids?
Dr. Branson: The way that the rapid oral-fluid test is performed is identical to that of the fingerstick whole blood test. In parallel studies with the fingerstick test, the oral test showed excellent sensitivity and specificity. The current FDA-approved oral-fluid test uses a collection device. You collect the saliva, you send it off to the lab, they do an ELISA, and if that is positive, then they do a Western blot.
Mr. O’Rourke: What are the implications of rapid tests for HIV care in the developing world?
Dr. Branson: For the most part, rapid testing is the only form of testing that is available in the developing world. These tests’ low cost and simplicity – you don’t need refrigeration, you don’t need a sophisticated lab, you don’t need to get someone to come back for the result – make it possible to ramp up the access to diagnosis in many countries. The CDC’s Global AIDS Program has large procurement contracts just to buy and distribute rapid HIV tests for use in Africa and Asia.
Dr. Sax:One of the ironies is that the technology was developed here, exported for use and development in the developing world, and is only now becoming widely available here in the U.S.
Dr. Branson: People perceived rapid testing as a second-class approach here for a long time because it was believed that there were serious advantages to conventional testing. In addition, there were patent and market issues that slowed its introduction in the U.S.
Dr. del Rio: We tend to stigmatize any intervention that is useful in the developing world. Take directly observed therapy: People think, “That’s for developing countries – we’re more sophisticated than that.” However, the reality is that some of these developing world strategies may make more sense in general, and definitely make more sense in certain key patient populations and clinical settings that we face all the time.
Mr. O’Rourke:You’ve all alluded to some of the benefits of this test, but what are some of the major issues in HIV testing and counseling that remain, even with the widespread availability of accurate rapid testing?
Dr. Sax: The stigma associated with HIV remains a major barrier to testing and care. When HIV testing was first developed, not much could be done about a positive result. The stigma has lessened, but some of that old pessimism remains. Now that we have effective therapy, we need to move on.
Dr. del Rio:I strongly agree. The rapid test may actually help reduce the stigma, although it won’t eliminate it, by making the mechanics of HIV testing more routine.
Dr. Branson: However, I do think that there is a potential drawback with the rapid test: Its very accessibility could create new opportunities for coercion. You might imagine scenarios in which employers, for instance, could more easily coerce people into getting tested now that some of the legal and practical barriers involved in drawing blood and sending it to a lab are no longer present.
Dr. del Rio: Indeed. The ascendant issue of genetic testing underscores the increasing importance of basic informed consent.
Ms. Larrabee: Among the issues that remain is that some people who are infected are ill-prepared for a positive result. I’ve encountered people who have developmental disabilities and do not understand the test. There are also people who should wait and focus on other life issues before being tested: people who are seriously affected by a recent loss, people with active mental illness who could benefit from further work with a mental health professional before being tested, and people who are in early sobriety. The rapid test doesn’t change the fact that HIV disproportionately affects generally vulnerable populations, nor does it mitigate the struggle of coming to terms with being HIV-infected.
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90,000 HIV Testing – Hiv
HIV test result
The primary test result can be negative, positive, or indeterminate.
Test with negative result
A negative test means you do not have HIV. If you are risky and suspect you have HIV, make sure you are no longer in the window period and repeat the test when it ends. In the case of a specific exposure to HIV, a definitive answer about non-infection based on the determination of antibodies can be given after 6 months.
Test with undefined result
An uncertain test result must be confirmed by an HIV reference laboratory. If the result of the confirmatory test also does not give results, then the analysis must be repeated.
Possible causes of an uncertain test: autoimmune disease, cystic fibrosis, pregnancy, transfusion of blood or blood components, liver disease, recent vaccination, seroconversion, or end-stage disease.
Test with a positive result
A positive test means you are infected with HIV. Each primary positive result is rechecked in an HIV reference laboratory using a more accurate method, that is, a confirmatory test is done. In some cases, a primary positive result may turn out to be false positive, for example, in the case of an acute viral disease or in some systemic diseases.
A confirmation test is always performed using venous blood, regardless of which method was originally tested.The diagnosis of HIV is made only by a positive result of a venous blood test confirmed by an HIV reference laboratory.
The result of the confirmatory test is first reported by the HIV reference laboratory to the doctor who performed the test. You will get the test result from your doctor, who should refer you to an infectious disease doctor who will prescribe you HIV treatment. If you did the test anonymously, and the test is positive, then the confirmation test will be done with personal identification.According to the law, the diagnosis must be immediately registered in the infectious disease information system, which is managed by the Department of Health.
Be sure to tell that you have HIV to your partner, who you have had sex with and / or share needles and syringes with. They need to know that they have had contact with HIV and may be infected.
90,000 Specialists of the AIDS Center conducted rapid HIV testing of residents of the Klyuch v Zhizn rehabilitation center
On March 13 this year, specialists from the Altai Regional AIDS Center held an information event and rapid HIV testing among residents of the Klyuch v Zhizn rehabilitation center for drug addicts.Prior to the beginning of the testing procedure, Ilya Krasyukov, a sociologist at the AIDS Center, conducted a survey of 100 residents of the rehabilitation center to determine the level of awareness on the problem of HIV infection and preventive measures. An informational event was also held, which ended with a screening of an educational film on HIV prevention and a discussion with the participants of the issues that arose on this topic.
During the express HIV testing procedure, Nina Chukmasova, a social work specialist at the AIDS Center, conducted pre- and post-test counseling in order to determine the presence of risks of HIV infection and provide information on possible options for obtaining an HIV test result (both positive and negative).Out of 64 residents who underwent the survey, a positive result of the express test was detected in 3 people, they were offered to undergo a standard HIV test at the AIDS center.
All participants of the event received brochures “Dangerous and Safe Situations” and brochures “What you need to know about HIV”. In addition, for further preventive work among residents, information materials on various aspects of HIV infection developed by the Altai Regional AIDS Center (video clips, educational films, posters, booklets, etc.) were transferred to the rehabilitation center.).
A rapid HIV test allows you to find out the presence of the immunodeficiency virus in the human body. This test can be done on saliva; a urine sample or blood sample. A blood test is one of the most accurate rapid tests. For the analysis, a few drops of blood are taken from a fingertip and placed on a test strip. After that, you need to wait 10-15 minutes to find out the result. This method is similar to the standard ELISA examination carried out in medical organizations.However, if you receive a positive result of the express test, you need to contact the AIDS Center to go through the standard examination procedure and get advice from a highly qualified specialist. The specificity of the rapid HIV test is 99.2%, the sensitivity is 100%.
The standard procedure for detecting HIV in Russia is a test that shows the presence of antibodies to HIV, which the body produces in response to the penetration of the virus. For analysis, a small amount of blood is taken from a vein.At the beginning of the examination, an enzyme-linked immunosorbent assay (ELISA) is performed. This test is complemented by a second test, which is carried out from the same blood sample as the first. The second analysis, “immunoblot”, has a very high sensitivity and reliability (about 99.9%).
The diagnosis of HIV infection is established in the presence of 2 positive results at the same time: ELISA and immunoblot, clinical data and data from an epidemiological history. The term for standard HIV testing by ELISA is 3 days, in case of a positive result – at least a week.
Rapid HIV tests. Can trust?
Rapid HIV tests. Can trust?
According to statistics, 30% of the total number of HIV patients in our country do not even know that they have this disease. And this means that they are very at risk of starting the disease and transferring it to AIDS. But besides this, they put the people around them at risk, which means: the disease spreads, and everyone can get sick.
How can this be avoided? It’s very simple – you need to test for HIV at least once a year. To do this, in each city there are specialized centers where everyone can be examined and be confident in their status. But sometimes there are situations when it is not possible to quickly undergo full medical testing. For such situations, they came up with an excellent solution – rapid HIV tests. With the development of technology, they are becoming more accurate and in many ways are not inferior to laboratory testing.Every year there are more and more of them, the choice becomes more and more diverse. In order to guide you in this variety, we will try to tell you the main points about express tests.
To begin with, there are 3 types of rapid tests:
- after saliva pattern;
- after urine sample;
- on a blood sample.
The most popular rapid test is the saliva sample test.This is not surprising, because it is the easiest to use and does not require complex manipulations or skin damage. In addition, this test minimizes the possibility of HIV transmission. It is a device that can only be used once. To determine the presence of the human immunodeficiency virus, it is necessary to collect the pericardial fluid – saliva. The result will be ready in 20 minutes. The test determines the presence of HIV types 1 and 2 in the body. The accuracy of the test is quite high, according to some sources it is close to 99%.However, according to experts, if the test is positive, there is no need to sound the alarm and make a final diagnosis. In any case, for an accurate result, it is necessary to undergo an examination in a specialized institution.
The rapid test, which uses a urine sample to determine HIV, is less popular and is a complementary test rather than a primary test. It is very similar in form to a pregnancy test. You need to collect the urine in a jar and dip the strip into it.The result will be ready in 10-20 minutes.
And, finally, one of the most accurate, but the most “dangerous”, express tests – based on a blood sample. To determine HIV in the body, it is necessary to take blood from a finger and lower it into the device. The complexity of this test, on the one hand, is that it is necessary to violate the skin, and this means create an additional risk of infection, on the other hand, the virus in the blood from the finger can be stored for no more than 2-3 minutes, so the material must be used immediately to determine the test results …
Rapid tests can also be performed at home if there are serious reasons for this. It must be remembered that in order to increase the accuracy of testing, you need to observe precautions and disinfection, strictly follow the instructions. Well, if you read this instruction in full, you can see there information that in order to confirm the results of express tests, you need to be re-tested in a specialized center or in a polyclinic. Do not forget about this in order to have a 100% result and be confident in your status.
HIV testing. Know your HIV status!
Many people think that HIV infection, if it exists, is somewhere far away, and a modern socially adapted person cannot face it. Indeed, drug users, sexual partners of HIV-infected people, women involved in sex work, and men who have sex with men are at serious risk of becoming infected with the human immunodeficiency virus (hereinafter referred to as HIV). However, given that the main part in the structure of HIV transmission routes is currently occupied by the sexual route, no one can be insured against this infection.This means that any person engaging in sexual activity or changing sexual partners runs the risk of contracting HIV. It is impossible to become infected with HIV sexually only if in a couple both partners are not infected with HIV and both remain faithful to each other throughout the entire period of their relationship. Unfortunately, as practice shows, in most cases people in a couple not only do not know whether their partner is infected with HIV or not, but they themselves do not know about their status, since they are not tested for HIV infection.
The danger of HIV infection also lies in the fact that a person infected with HIV for a long time feels absolutely healthy. The main method of laboratory diagnosis of HIV infection is the detection of antibodies to HIV in the blood serum using an enzyme-linked immunosorbent assay (ELISA). From the moment of HIV infection to the time when the ELISA method can determine the presence of antibodies to HIV in the blood, it can take from 3 to 6 months. This period is called the window period. The test for antibodies to HIV during this period will be negative, but at the same time the person can already infect other people.
General information : HIV testing in healthcare organizations.
A passport is required for the survey (except for an anonymous survey).
Step # 1. Come to a healthcare facility where there is a treatment room.
Step # 2. Have a short interview with a specialist from the institution.
A specialist will tell you what the analysis is and what test results are, and will also help you assess how high the risk of HIV transmission was.The consultation is anonymous.
Step 3. Blood sampling from a vein (on an empty stomach) in the treatment room of a healthcare facility (during the working day). All used instruments are sterile and disposable.
Step 4. Obtain the result from a specialist or in the treatment room of the institution.
The result was not reported by phone.
After receiving the test result, it is also worth talking to a specialist.As a rule, after the test, the result obtained and the actions that are recommended to be taken in this or that case are discussed.
An HIV test is mandatory for those who :
– at least once had unprotected sexual contact with a partner whose HIV status is unknown to him;
– had experience of injecting drug use;
– got a tattoo or piercing;
– did manicure, pedicure, any injection procedures with a non-sterile instrument;
– planning the birth of a child;
– wants to be sure of the state of his health and the health of his loved ones.
Rapid HIV tests. Can trust?
According to statistics, 30% of the total number of HIV patients in our country do not even know that they have this disease. And this means that they are very at risk of starting the disease and transferring it to AIDS. But besides this, they put the people around them at risk, which means: the disease spreads, and everyone can get sick. How can we avoid this? It’s very simple – you need to test for HIV at least once a year. To do this, you can contact any healthcare organization that has a treatment room, undergo an examination and be confident in your status.But sometimes there are situations when it is not possible to quickly undergo full medical testing. For such situations, they came up with an excellent solution – rapid HIV tests. With the development of technology, they are becoming more accurate and in many ways are not inferior to laboratory testing. Every year there are more and more of them, the choice becomes more and more diverse. In order to guide you in this variety, we will try to tell you the main points about express tests.
One should start with the fact that there are 2 types of express tests:
- after saliva pattern;
- on a blood sample.
The most popular rapid test is the saliva sample test. This is not surprising, because it is the easiest to use and does not require complex manipulations or skin damage. In addition, this test minimizes the possibility of HIV transmission. It is a device that can only be used once. To determine the presence of the human immunodeficiency virus, it is necessary to collect the pericardial fluid – saliva. The result will be ready in 20 minutes. The test determines the presence of HIV types 1 and 2 in the body.The accuracy of the test is quite high, according to some sources it is close to 99%. However, according to experts, if the test is positive, there is no need to sound the alarm and make a final diagnosis. In any case, for an accurate result, it is necessary to undergo an examination at a health care institution.
One of the most accurate rapid tests – based on a blood sample. To determine HIV in the body, it is necessary to take blood from a finger and lower it into the device. The complexity of this test, on the one hand, is that it is necessary to break the skin, on the other hand, the virus in the blood from a finger can be stored for no more than 2-3 minutes, so the material must be used immediately to determine the test results.This type of testing is carried out in health care organizations.
Rapid tests can also be performed at home if there are serious reasons for this. It must be remembered that in order to increase the accuracy of testing, you need to observe precautions and disinfection, strictly follow the instructions. Well, if you read this instruction in full, you can see there information that in order to confirm the results of express tests, you need to be re-tested in a polyclinic. Do not forget about this in order to have a 100% result and be confident in your status.
Blood test for HIV | Medical center “President-Med”
HIV (Human Immunodeficiency Virus) is a slowly progressive viral disease that leads to a general weakening of the immune system, because it is affected by infections and tumors. If secondary infectious diseases develop, the virus can take on a more severe stage and develop into acquired immunodeficiency syndrome (AIDS for short).
Unfortunately, the diseases described above cannot be treated; more than two million people die from AIDS every year.The only way to protect yourself from HIV infection is to avoid getting infected.
A person infected with the immunodeficiency virus may not even suspect that he is sick for a long time, since the destruction of cells in the body occurs slowly. Over time, even the simplest diseases begin to affect the patient. Fever and diarrhea may occur. Such people are more likely to suffer from acute respiratory infections and other colds. Aggravates the condition and progression of thrush of the gastrointestinal tract, genitals or oral cavity.
There are several methods for determining HIV and AIDS through a blood test, these include:
- Rapid testing is the fastest way to determine a person’s immunodeficiency. For analysis, blood from a finger is used, the result is ready in five minutes. Not the most popular diagnostic option, since in the early stages the development of pathology may not show.
- Enzyme immunoassay – venous blood is tested. The accuracy of the analysis is 95%, the study is carried out three weeks after the probable infection of a person.The disadvantage of this technique: you need to wait a long time for the result, in some cases up to 10 days.
- Immune blotting – blood is taken from a vein for diagnosis, a nitrocellulose strip with three lines is also used, one of them appears, showing the result: negative, positive or doubtful. In the latter case, a re-examination is prescribed.
- Polymerase chain reaction is the most expensive analysis, because in the research process special equipment is used, which allows, in case of a positive result, to examine the DNA of the virus.
Doctors recommend that absolutely all people undergo periodic screening for the immunodeficiency virus, since in the early stages of development, the progression of the disease can be stopped and the patient then lives a full life for many years. Without adequate treatment, HIV spills over into AIDS rather quickly.
Indications for a blood test for HIV
Most often, doctors refer patients to a blood test for the immunodeficiency virus using the enzyme immunoassay method or to diagnostics using the polymerase chain reaction.The study is mandatory for pregnant women, as well as for people in contact with HIV-positive.
Situations when a blood test for HIV is needed:
- Rapid weight loss.
- Before the operation.
- Upon admission to the hospital.
- If non-sterile needles have been used during injection.
- After having sex without a condom with a new partner.
- If the partner has an HIV-positive test, etc.
There is no need to be afraid to take HIV tests, they will dispel doubts, and in case of a positive result, start treatment on time and stop the progress of the pathology.
How to take a blood test for HIV
Preparation for the analysis is simple – before donating blood (8 hours in advance), you should refrain from eating. Therefore, in almost all clinics, the sampling of the test material is carried out early in the morning, so it is easier for patients, they do not eat anything since the evening, and after the procedure they can go to breakfast.
Depending on the blood test method, an HIV result can be ready after 2-10 days. Even with a negative reaction, it is recommended to re-take the test after 2-3 months, since in the early stages it is difficult to diagnose the presence of a virus in the body even with the help of modern and expensive equipment.
To take a blood test for HIV, contact the President-Med medical centers in Moscow and Vidnoye
Artist: Lavrova Nina Avenirovna
Deputy General Director for Medical
Graduated from the Yaroslavl State Medical Institute with a degree in General Medicine
Medical work experience – 25 years
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With all my heart and with a kind feeling, I express my gratitude to the MIRACLE DOCTOR Artem Yuryevich Semenov, for his invaluable contribution to the return of the beauty of my legs! I didn’t even think that I could literally erase from them (legs) the “map of the world”, which maliciously limited the choice of my wardrobe, I am not stammering about the lack of aesthetics… Needless to say, sclerotherapy is a great thing in magic hands … […]
I would like to thank from the bottom of my heart and express my deepest respect to the unique doctor Artem Yuryevich Semenov for the laser surgery performed in March 2014 with miniphlebectomy on both legs. I developed varicose veins after the birth of children at the age of 30. And in the last year, the heaviness and pain in the legs, especially in the hot season, have become simply unbearable…. […]
I got tested and was very happy. Nurse Rimma takes tests so easily, I didn’t even understand when she injected me, very courteous, kind and with a sense of humor! Then I also had to bring my child, so he not only gave me blood to be taken, but did not even have time to cry, although before that we donated blood in an ordinary clinic, and even received a candy … […]
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Artem Yuryevich thank you very much for your golden hands.Artem Yuryevich gave me sclerotherapy of both limbs in 2015, this year he was on prophylaxis. I am very grateful, you can admire the legs. And my friends and acquaintances were treated by him, they are very grateful. Thank you. Recommend !!!!![…]
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Thank you very much for your work! Everything is clear, clear, understandable and fast! Without further ado, “the fate of the fatherland.” Just incredibly positive emotions after communication! […]
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Low bow, Arkady Yakovlevich! Several years ago you diagnosed me with varicocele and had an operation. Today I celebrate the first month since the birth of my son. Thank you for your professionalism, sensitivity and positiveness! […]
Wonderful doctor! There was varicose veins on the left leg.They removed everything with a laser. For now, nothing is noticeable. After the operation, they were observed for a year. Very grateful !!! […]
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O. N. Shchetinina
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90,000 Q&A – AIDS Center
19 November 2020 20:09
good afternoon.The situation is this, there was a dangerous sexual contact on November 9. (there was a drunken sex with a dubious girl) then, on November 10, itchy pimples appeared all over the body, which soon disappeared and stopped itching, but red spots naturally remained in their place. later on the 13th in the morning I felt a sore throat in the morning, I think it’s pharyngitis, I also had this before, so I didn’t attach any importance to it. the next day, one tonsil became inflamed, from that moment the throat is constantly red, I began to use all sorts of throat pads and sucking tablets to remove it at least a little, it helps, of course, but not much.then from the 15th, 16th I feel a certain weakness and fatigue, my appetite has disappeared, but not very critical, I walk, work, eat, I say this simply because I didn’t notice this before, or maybe it’s just because of paranoia, and because of the fact that I myself I impose, the mood and state are not the most positive. number 17 began to feel pain in the lymph nodes of the groin, (if you press), but they are not increased, but just sometimes hurt, which I had not noticed before. On the 18th, the joints began to hurt from time to time, and today, on the 19th, some strange itchy light pimple came out and my head ached, there is no temperature, in general there are a lot of symptoms, terribly creepy, I don’t know what it could be.So, I want to know if it is possible that these are signs of HIV? although I read that they do not appear so early, at first there is an incubation period that lasts for about 3 months from the information from the Internet, until the initial manifestations. And only 10 days have passed for me, and already so many sores have crawled out. thought maybe it was some other infection? I want to hear your thoughts on this. Yes, I know what to do the test, but I want to ask when is it better? that is, how long after a dangerous contact? like everything, thanks for reading, I look forward to your reply.Best regards
Hello, Alexey! When tested by PCR DNA / RNA HIV, HIV infection can be detected 10-14 days after the situation associated with the risk of infection. The first control test ELISA (or IHLA) HIV must be taken after 3 months, repeated – 6 and 12 months after unprotected sex.
Rapid HIV test | Health Clinic
Acquired immunodeficiency syndrome (AIDS) is now considered one of the most dangerous diseases.The difficulty lies in the peculiarities of the development of the disease.
The incubation period can last for several years, and the formation of antibodies is delayed by 3-12 weeks.
At the same time, early detection of HIV gives a good chance of a long life. For this, modern science is developing new approaches to diagnostics.
Rapid HIV test is one of the serological methods of laboratory diagnostics.It is aimed at the rapid detection of antibodies to the immunodeficiency virus in the human body. It differs from the classical analysis in its simplified conduct and high speed of obtaining the result.
Health Clinic guarantees 100% anonymity for any blood tests! We care about you and your health!
Basic characteristics of express analysis
When a rapid HIV test is required
Of course, the traditional diagnostic option is more common, but in some cases it is simply impossible to do without express analyzes.
- Emergency surgery. When it comes to saving a patient’s life, there is no way to waste time on traditional HIV testing. In this case, express research is a great alternative.
- Pregnancy. HIV testing is one of the main tests for pregnant women. To significantly reduce waiting time and simplify the procedure, it is convenient to use the expedited option.
- Manifestation of symptoms.If the patient shows symptoms (fever, sudden weight loss, enlarged lymph nodes), an immediate response is required. A quick and correct diagnosis will significantly improve the condition.
- Unprotected sex. If a person has suspicions of HIV infection, then waiting for the test results will be painful. A rapid test can quickly confirm or deny suspicions.
Cost of a blood test for HIV
|Service name||Price in rubles|
Rapid HIV test
If you did not find the service in the price list, please call us at +7 (495) 961-27-67 and
+7 (495) 951-39-09, you will be given the necessary information.