Definition of hba1c. Understanding HbA1c: The Key to Monitoring Glucose Control and Diagnosing Diabetes
What is Hemoglobin A1C (HbA1c). How is the HbA1c test used in diabetes management. What are the normal, prediabetic, and diabetic ranges for HbA1c. How often should HbA1c be tested. What factors can affect HbA1c test results.
What is Hemoglobin A1C (HbA1c) and Why is it Important?
Hemoglobin A1C, also known as HbA1c or A1c, is a crucial marker in evaluating glucose control and diagnosing diabetes. This test provides valuable insights into a person’s average blood sugar levels over the past 90 days, expressed as a percentage. But how does it work?
Hemoglobin, the protein responsible for blood’s red color, is found exclusively in red blood cells. As these cells circulate in the bloodstream, glucose molecules attach to the hemoglobin, creating glycated hemoglobin. The higher the blood glucose levels, the more hemoglobin becomes glycated, resulting in a higher HbA1c percentage.
The Science Behind HbA1c
Why does HbA1c reflect a 3-month average? Red blood cells have an average lifespan of about 90 days. When an HbA1c test is performed, it measures the percentage of hemoglobin that has become glycated during this period, providing a reliable indicator of glucose control over time.
The Role of HbA1c in Diabetes Management and Diagnosis
HbA1c has become an indispensable tool in both managing existing diabetes and diagnosing new cases. How is it used in these contexts?
- Diabetes Management: Regular HbA1c testing helps healthcare providers assess the effectiveness of treatment plans and make necessary adjustments.
- Diabetes Diagnosis: An HbA1c test can be used to diagnose diabetes, offering advantages over traditional glucose testing methods.
The American Diabetes Association (ADA) recommends specific testing frequencies based on a patient’s condition:
- Twice a year for patients with stable, well-controlled diabetes
- Every 3 months for patients with recent medication changes or poor control
HbA1c Ranges: What Do They Mean?
Understanding HbA1c ranges is crucial for interpreting test results. What are the key thresholds to be aware of?
- Below 5.7%: Normal (non-diabetic) range
- 5.7% to 6.4%: Prediabetic range
- 6.5% or higher: Diabetic range
The Landmark DCCT Trial: Establishing HbA1c’s Importance
The Diabetes Control and Complications Trial (DCCT) was a pivotal study that solidified the importance of HbA1c in diabetes management. What were the key findings of this groundbreaking research?
- HbA1c levels were identified as the primary predictor of diabetic retinopathy progression
- Tighter glucose control (HbA1c around 7% or lower) correlated with a 35-76% decrease in microvascular complications in type 1 diabetes patients
- Lower HbA1c levels were associated with reduced long-term cardiovascular risk and mortality
These findings led to the establishment of the National Glycohemoglobin Standardization Program (NGSP), which defined standardized assays for HbA1c testing across laboratories.
HbA1c Testing Methods: Point of Care vs. Laboratory Analysis
HbA1c testing can be performed using two primary methods. How do they differ, and what are their respective advantages?
Point of Care (POC) Testing
POC testing offers rapid results using a STAT analyzer and a capillary fingerstick sample. While convenient, it may be less accurate than laboratory testing.
Laboratory Testing
Laboratory testing uses a venous blood sample collected in a K2 EDTA tube. This method is considered more accurate and is preferred for diagnostic purposes.
For diagnostic accuracy, it’s crucial to use NGSP-certified laboratories to ensure standardized results. Any capillary POC test results suggesting diabetes should be confirmed with a venous sample before finalizing a diagnosis.
Factors Affecting HbA1c Test Accuracy
While HbA1c is a reliable indicator of glucose control, several factors can influence its accuracy. What conditions and situations might lead to inaccurate results?
Conditions Affecting Red Blood Cell Lifespan
- Sickle cell anemia
- Thalassemia
- Hemolytic anemia
- Kidney failure
- Liver disease
Factors Leading to Falsely Low HbA1c Results
- High altitude
- Pregnancy
- Recent blood loss or transfusion
- Erythropoietin administration
- Iron supplementation
- Chronic kidney failure
- Liver cirrhosis
- Alcoholism
Factors Leading to Falsely High HbA1c Results
- Iron deficiency anemia
- Vitamin B12 deficiency
- Folate deficiency
It’s important to note that vitamin C supplementation can affect HbA1c levels in either direction, depending on the measurement method used.
Interpreting HbA1c Results: Beyond the Numbers
While HbA1c provides valuable information about glucose control, it’s essential to interpret results in the context of an individual’s overall health and circumstances. How should healthcare providers approach HbA1c interpretation?
- Consider the patient’s medical history and any conditions that might affect HbA1c accuracy
- Use HbA1c in conjunction with other glucose monitoring methods, such as fasting plasma glucose or oral glucose tolerance tests
- Take into account the patient’s age, overall health, and risk factors for diabetes complications
- Discuss results with patients, explaining their significance and implications for treatment
Individualizing HbA1c Targets
While general guidelines exist for HbA1c targets, it’s crucial to individualize goals based on each patient’s unique circumstances. What factors should be considered when setting HbA1c targets?
- Age and life expectancy
- Duration of diabetes
- Presence of comorbidities
- Risk of hypoglycemia
- Patient preferences and ability to adhere to treatment plans
The Future of HbA1c Testing and Diabetes Management
As our understanding of diabetes and glucose metabolism continues to evolve, so too does the role of HbA1c testing. What developments can we expect in the future of diabetes management and monitoring?
Emerging Technologies
- Continuous glucose monitoring (CGM) systems providing real-time glucose data
- Artificial intelligence algorithms to predict glucose trends and optimize treatment
- Novel biomarkers complementing HbA1c for more comprehensive glucose assessment
Personalized Medicine Approaches
The future of diabetes management is likely to involve increasingly personalized approaches, taking into account an individual’s genetic profile, lifestyle factors, and unique response to various interventions. How might this impact the use of HbA1c?
- Integration of HbA1c with other biomarkers for more nuanced risk assessment
- Tailored HbA1c targets based on individual genetic and metabolic profiles
- Combination of HbA1c with continuous glucose monitoring data for optimized treatment strategies
As research continues to advance our understanding of glucose metabolism and diabetes pathophysiology, the role of HbA1c is likely to evolve. However, its fundamental importance in assessing long-term glucose control and guiding diabetes management is expected to remain central to clinical practice for years to come.
Practical Implications of HbA1c Testing for Patients and Healthcare Providers
Understanding the practical implications of HbA1c testing is crucial for both patients and healthcare providers. How can this knowledge be applied in real-world settings to improve diabetes management and outcomes?
For Patients
Patients with diabetes or those at risk for the condition can benefit from understanding their HbA1c results in several ways:
- Motivation for lifestyle changes: Seeing concrete improvements in HbA1c levels can encourage patients to maintain healthy habits
- Better treatment adherence: Understanding the link between medication adherence and HbA1c results can improve compliance
- Informed decision-making: Knowledge of HbA1c levels helps patients participate more actively in their care planning
- Early intervention: Regular HbA1c testing can catch prediabetes early, allowing for preventive measures
For Healthcare Providers
Healthcare providers can leverage HbA1c testing to enhance patient care in various ways:
- Treatment optimization: Regular HbA1c monitoring allows for timely adjustments to diabetes management plans
- Risk stratification: HbA1c levels help identify patients at higher risk for complications, enabling targeted interventions
- Patient education: HbA1c results provide a tangible metric for discussing diabetes control with patients
- Quality improvement: Tracking HbA1c outcomes can help healthcare systems assess and improve their diabetes care programs
By understanding the nuances of HbA1c testing and its implications, both patients and healthcare providers can work together more effectively to manage diabetes and improve overall health outcomes.
Hemoglobin A1C – StatPearls – NCBI Bookshelf
Introduction
The hemoglobin A1c (glycated hemoglobin, glycosylated hemoglobin, HbA1c, or A1c) test is used to evaluate a person’s level of glucose control. The test shows an average of the blood sugar level over the past 90 days and represents a percentage. The test can also be used to diagnose diabetes.[1]
Hemoglobin is a protein only found in red blood cells. In fact, hemoglobin is what gives blood its bright red coloring. Since red blood cells live about an average of three months, the A1c test will reflect those red blood cells that are present in the bloodstream at the time of the test; this is why the A1c serves as an average of blood sugar control.
The main job of hemoglobin is to carry oxygen from the lungs to all the cells of the body. Hemoglobin becomes glycated or coated with glucose from the bloodstream. The amount of glucose that is present in the blood will attach to the hemoglobin protein, and increased glucose levels will reflect on the surface of the hemoglobin protein, thereby rendering a higher A1c level. [2]
Etiology and Epidemiology
The Diabetes Control and Complications Trial (DCCT)[3] was a landmark trial that provided a wealth of data on A1c and its correlation to blood glucose levels, as well as establishing specific treat to target A1c goals. From the completion of the trial, the National Glycohemoglobin Standardization Program (NGSP) was formed to define a standardized assay that was usable across laboratories.
The DCCT trial reported that a higher mean A1c level was the dominant predictor of diabetic retinopathy progression. Tighter control shown by levels of HbA1c in the 7% range or lower, were correlated with 35-76% decrease in microvascular complications, like retinopathy, nephropathy and neuropathy, in patients with type 1 diabetes. In addition to the determination of A1c levels predicting progression of microvascular complications, the extension of DCCT into EDIC study showed benefit in the cardiovascular risk and mortality in the longterm for those patients with lower levels of HbA1c. [4][5][6]
Pathophysiology
People with diabetes need to have their A1c checked regularly to determine if their average blood glucose levels are within the target range. The American Diabetes Association (ADA) recommends that the HbA1c is checked twice a year in patients that are stable and well controlled, versus every 3 months in patients with changes in their medications, or not well controlled. [7]
Specimen Requirements and Procedure
The HbA1c test can either be done as a point of care (POC), STAT test, or by sending a sample to a laboratory. The POC test uses a STAT analyzer that evaluates the A1c from a capillary fingerstick. The laboratory test uses a teaspoon of blood drawn from a venous sample into a K2 EDTA (lavender top) tube. The sample gets processed as whole blood.
Diagnostic Tests
The venous sample A1c test may be used as a diagnostic tool in clinical practice when determining diabetes risk or onset. Due to the variability of capillary point of care testing, any A1c done by capillary sample should be confirmed with a venous sample before rendering the diagnosis.
For an HbA1c test to classify as normal, or in the non-diabetic range, the value must be below 5.7 %. Anyone with an HbA1c value of 5.7 % to 6.4 % is considered to be prediabetic, while diabetes can be diagnosed with a HbA1c of 6.5% or higher.
Tests should be sent to a laboratory certified by the NGSP to ensure results are standardized.[8][9]
Testing Procedures
The HbA1c test done by a point of care machine in a doctor’s office may be less accurate than one that is drawn from a venous sample and processed in a laboratory. Typically, the results can vary by different laboratories by as much as 0.5%.
The HbA1c test should be performed using an NGSP-approved method.
Interfering Factors
There are several conditions where the HbA1c test can produce inaccurate results. People diagnosed with sickle cell anemia, thalassemia, anemia, kidney failure, liver disease, or patients receiving blood transfusions can experience altered results due to the longevity of the red blood cell. HbA1c measurement in these patients must be interpreted with caution and should be confirmed with plasma glucose samples to diagnose diabetes.[10]
A falsely low HbA1c value can result from several conditions including high altitude, pregnancy, hemorrhage, blood transfusion, erythropoietin administration, iron supplementation[11], hemolytic anemia, chronic kidney failure, liver cirrhosis, alcoholism, sickle cell anemia[12], and spherocytosis. Vitamin C supplementation can either increase or decrease the HbA1c level depending on the method used for its measurement.[15]
On the other end of the spectrum, a falsely high HbA1c can be due to a lack of available iron in the blood. This condition can result from iron deficiency anemia[13], infection-induced anemia, or tumor-induced anemia. Hemoglobinopathies such as thalassemia and B12 deficiency[11][14] can also cause a falsely high HbA1c. Other causes of falsely high HbA1c levels include hypertriglyceridemia, organ transplantation, and hyperglycation in certain ethnic groups. Medications such as immunosuppressants and protease inhibitors can sometimes lead to a falsely high HbA1c.[10][7][15][16]
Results, Reporting, and Critical Findings
Relationship Between A1c and Glucose Level
The HbA1c percentage equates to an average glucose level in the body that the patient experienced over the past 90 days.[17][18][19]
A1c (%) Average Blood Glucose (mg/dL)
6 126
8 183
10 240
12 298
14 355
Clinical Significance
Hemoglobin A1c serves as an indicator of overall glycemic control and a reflection of the average blood sugar over the past three months.[2]
Quality Control and Lab Safety
Laboratories can use several methods to determine HbA1c. High performance liquid chromatography (HPLC) method is one of the most popular methods because it can eliminate labile components that other methods such as immunoassay or affinity chromatography use. [20]
The point of care (POC) machine is widely used as well to determine HbA1c levels. The variety of POC machines on the market can make it difficult to determine the one best suited for one’s practice. Also, there is a shortage of information comparing the different machines. When using POC testing, one should keep in mind that POC values are often below results reported by a laboratory test, with the mean difference being -0.5%.
Enhancing Healthcare Team Outcomes
All clinicians who look after diabetic patients need to know what HbA1c means. In general, HbA1c provides a measure of the average glucose concentration over three months.
Hemoglobin A1c is often used as an outcome measure to determine if an intervention in a population is successful by showing a decrease in HbA1c by a certain percentage. There is a movement within the medical community to move away from using HbA1c as an exclusive standard of care test to measure patient response to treatment. The Estimated Average Glucose (eAG) and the glucose time in range are the newest proposed methods. [21] These methods use data obtained by continuous glucose monitors (CGMs) that record blood glucose 24 hours a day. They can also give providers a more accurate view of the blood sugar average and fluctuations, but these methods are not available to all patients on a wide-spread basis.
As per ADA guidelines, the levels of HA1c should be measured twice a year in stable patients and at least four times in patients who have glucose fluctuations or those who have had a change in their diabetic treatment. Hemoglobin A1c is one of the preferred diabetes diagnostic tests today. The blood draw can occur at any time, and there are no special handling requirements. However, to ensure that the A1c value is correct, clinicians need to be aware of the causes of false-positive and false-negative results.
Since many patients with diabetes have their condition managed in outpatient clinics, the diabetic nurse should be fully aware of HbA1c values and when to refer the patient to an endocrinologist for further workup and treatment. Pharmacists are also required to fully understand and interpret this test, as they will be involved in glycemic management medication agent selection, dosing, and monitoring. Both the nurse and/or pharmacist need to inform the treating physician regarding any changes in hemoglobin A1c and verify patient medication compliance. Hemoglobin A1c is a very valuable tool in the fight against diabetes and other glycemic control disorders, but to be effective, it functions best in an interprofessional healthcare team environment. [Level V]
Review Questions
Access free multiple choice questions on this topic.
Comment on this article.
References
- 1.
Gilstrap LG, Chernew ME, Nguyen CA, Alam S, Bai B, McWilliams JM, Landon BE, Landrum MB. Association Between Clinical Practice Group Adherence to Quality Measures and Adverse Outcomes Among Adult Patients With Diabetes. JAMA Netw Open. 2019 Aug 02;2(8):e199139. [PMC free article: PMC6694385] [PubMed: 31411713]
- 2.
Sherwani SI, Khan HA, Ekhzaimy A, Masood A, Sakharkar MK. Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomark Insights. 2016;11:95-104. [PMC free article: PMC4933534] [PubMed: 27398023]
- 3.
Diabetes Control and Complications Trial Research Group. Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. [PubMed: 8366922]
- 4.
Nathan DM., DCCT/EDIC Research Group. The diabetes control and complications trial/epidemiology of diabetes interventions and complications study at 30 years: overview. Diabetes Care. 2014;37(1):9-16. [PMC free article: PMC3867999] [PubMed: 24356592]
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Nathan DM. Realising the long-term promise of insulin therapy: the DCCT/EDIC study. Diabetologia. 2021 May;64(5):1049-1058. [PubMed: 33550441]
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Lachin JM, Orchard TJ, Nathan DM., DCCT/EDIC Research Group. Update on cardiovascular outcomes at 30 years of the diabetes control and complications trial/epidemiology of diabetes interventions and complications study. Diabetes Care. 2014;37(1):39-43. [PMC free article: PMC3868002] [PubMed: 24356596]
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American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S73-S84. [PubMed: 33298417]
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American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S61-S70. [PubMed: 30559232]
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Qaseem A, Wilt TJ, Kansagara D, Horwitch C, Barry MJ, Forciea MA, Clinical Guidelines Committee of the American College of Physicians. Fitterman N, Balzer K, Boyd C, Humphrey LL, Iorio A, Lin J, Maroto M, McLean R, Mustafa R, Tufte J. Hemoglobin A1c Targets for Glycemic Control With Pharmacologic Therapy for Nonpregnant Adults With Type 2 Diabetes Mellitus: A Guidance Statement Update From the American College of Physicians. Ann Intern Med. 2018 Apr 17;168(8):569-576. [PubMed: 29507945]
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Heinemann L, Freckmann G. Quality of HbA1c Measurement in the Practice: The German Perspective. J Diabetes Sci Technol. 2015 May;9(3):687-95. [PMC free article: PMC4604529] [PubMed: 25691655]
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Pilla R, Palleti SK, Rayana R, Skss SR, Abdul Razzack A, Kalla S. Glycated Haemoglobin (HbA1c) Variations in Nondiabetics With Nutritional Anemia. Cureus. 2020 Nov 13;12(11):e11479. [PMC free article: PMC7735166] [PubMed: 33329975]
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Lacy ME, Wellenius GA, Sumner AE, Correa A, Carnethon MR, Liem RI, Wilson JG, Sacks DB, Jacobs DR, Carson AP, Luo X, Gjelsvik A, Reiner AP, Naik RP, Liu S, Musani SK, Eaton CB, Wu WC. Association of Sickle Cell Trait With Hemoglobin A1c in African Americans. JAMA. 2017 Feb 07;317(5):507-515. [PMC free article: PMC5713881] [PubMed: 28170479]
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Guo W, Zhou Q, Jia Y, Xu J. Increased Levels of Glycated Hemoglobin A1c and Iron Deficiency Anemia: A Review. Med Sci Monit. 2019 Nov 07;25:8371-8378. [PMC free article: PMC6857442] [PubMed: 31696865]
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Gram-Hansen P, Eriksen J, Mourits-Andersen T, Olesen L. Glycosylated haemoglobin (HbA1c) in iron- and vitamin B12 deficiency. J Intern Med. 1990 Feb;227(2):133-6. [PubMed: 2299304]
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Radin MS. Pitfalls in hemoglobin A1c measurement: when results may be misleading. J Gen Intern Med. 2014 Feb;29(2):388-94. [PMC free article: PMC3912281] [PubMed: 24002631]
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Shepard JG, Airee A, Dake AW, McFarland MS, Vora A. Limitations of A1c Interpretation. South Med J. 2015 Dec;108(12):724-9. [PubMed: 26630892]
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van ‘t Riet E, Alssema M, Rijkelijkhuizen JM, Kostense PJ, Nijpels G, Dekker JM. Relationship between A1C and glucose levels in the general Dutch population: the new Hoorn study. Diabetes Care. 2010 Jan;33(1):61-6. [PMC free article: PMC2797987] [PubMed: 19808928]
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Sayed A, Alyafei F, De Sanctis V, Soliman A, Elgamal M. Translating the HbA1c assay into estimated average glucose values in children and adolescents with type 1 diabetes mellitus. Acta Biomed. 2018 May 23;89(S5):22-26. [PMC free article: PMC6179094] [PubMed: 30049928]
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Lai LC. Global standardisation of HbA1c. Malays J Pathol. 2008 Dec;30(2):67-71. [PubMed: 19291914]
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Saboo B, Kesavadev J, Shankar A, Krishna MB, Sheth S, Patel V, Krishnan G. Time-in-range as a target in type 2 diabetes: An urgent need. Heliyon. 2021 Jan;7(1):e05967. [PMC free article: PMC7814148] [PubMed: 33506132]
Disclosure: Emily Eyth declares no relevant financial relationships with ineligible companies.
Disclosure: Roopa Naik declares no relevant financial relationships with ineligible companies.
Hemoglobin A1C – StatPearls – NCBI Bookshelf
Introduction
The hemoglobin A1c (glycated hemoglobin, glycosylated hemoglobin, HbA1c, or A1c) test is used to evaluate a person’s level of glucose control. The test shows an average of the blood sugar level over the past 90 days and represents a percentage. The test can also be used to diagnose diabetes.[1]
Hemoglobin is a protein only found in red blood cells. In fact, hemoglobin is what gives blood its bright red coloring. Since red blood cells live about an average of three months, the A1c test will reflect those red blood cells that are present in the bloodstream at the time of the test; this is why the A1c serves as an average of blood sugar control.
The main job of hemoglobin is to carry oxygen from the lungs to all the cells of the body. Hemoglobin becomes glycated or coated with glucose from the bloodstream. The amount of glucose that is present in the blood will attach to the hemoglobin protein, and increased glucose levels will reflect on the surface of the hemoglobin protein, thereby rendering a higher A1c level.[2]
Etiology and Epidemiology
The Diabetes Control and Complications Trial (DCCT)[3] was a landmark trial that provided a wealth of data on A1c and its correlation to blood glucose levels, as well as establishing specific treat to target A1c goals. From the completion of the trial, the National Glycohemoglobin Standardization Program (NGSP) was formed to define a standardized assay that was usable across laboratories.
The DCCT trial reported that a higher mean A1c level was the dominant predictor of diabetic retinopathy progression. Tighter control shown by levels of HbA1c in the 7% range or lower, were correlated with 35-76% decrease in microvascular complications, like retinopathy, nephropathy and neuropathy, in patients with type 1 diabetes. In addition to the determination of A1c levels predicting progression of microvascular complications, the extension of DCCT into EDIC study showed benefit in the cardiovascular risk and mortality in the longterm for those patients with lower levels of HbA1c. [4][5][6]
Pathophysiology
People with diabetes need to have their A1c checked regularly to determine if their average blood glucose levels are within the target range. The American Diabetes Association (ADA) recommends that the HbA1c is checked twice a year in patients that are stable and well controlled, versus every 3 months in patients with changes in their medications, or not well controlled. [7]
Specimen Requirements and Procedure
The HbA1c test can either be done as a point of care (POC), STAT test, or by sending a sample to a laboratory. The POC test uses a STAT analyzer that evaluates the A1c from a capillary fingerstick. The laboratory test uses a teaspoon of blood drawn from a venous sample into a K2 EDTA (lavender top) tube. The sample gets processed as whole blood.
Diagnostic Tests
The venous sample A1c test may be used as a diagnostic tool in clinical practice when determining diabetes risk or onset. Due to the variability of capillary point of care testing, any A1c done by capillary sample should be confirmed with a venous sample before rendering the diagnosis.
For an HbA1c test to classify as normal, or in the non-diabetic range, the value must be below 5.7 %. Anyone with an HbA1c value of 5.7 % to 6.4 % is considered to be prediabetic, while diabetes can be diagnosed with a HbA1c of 6.5% or higher.
Tests should be sent to a laboratory certified by the NGSP to ensure results are standardized.[8][9]
Testing Procedures
The HbA1c test done by a point of care machine in a doctor’s office may be less accurate than one that is drawn from a venous sample and processed in a laboratory. Typically, the results can vary by different laboratories by as much as 0.5%.
The HbA1c test should be performed using an NGSP-approved method.
Interfering Factors
There are several conditions where the HbA1c test can produce inaccurate results. People diagnosed with sickle cell anemia, thalassemia, anemia, kidney failure, liver disease, or patients receiving blood transfusions can experience altered results due to the longevity of the red blood cell. HbA1c measurement in these patients must be interpreted with caution and should be confirmed with plasma glucose samples to diagnose diabetes.[10]
A falsely low HbA1c value can result from several conditions including high altitude, pregnancy, hemorrhage, blood transfusion, erythropoietin administration, iron supplementation[11], hemolytic anemia, chronic kidney failure, liver cirrhosis, alcoholism, sickle cell anemia[12], and spherocytosis. Vitamin C supplementation can either increase or decrease the HbA1c level depending on the method used for its measurement.[15]
On the other end of the spectrum, a falsely high HbA1c can be due to a lack of available iron in the blood. This condition can result from iron deficiency anemia[13], infection-induced anemia, or tumor-induced anemia. Hemoglobinopathies such as thalassemia and B12 deficiency[11][14] can also cause a falsely high HbA1c. Other causes of falsely high HbA1c levels include hypertriglyceridemia, organ transplantation, and hyperglycation in certain ethnic groups. Medications such as immunosuppressants and protease inhibitors can sometimes lead to a falsely high HbA1c.[10][7][15][16]
Results, Reporting, and Critical Findings
Relationship Between A1c and Glucose Level
The HbA1c percentage equates to an average glucose level in the body that the patient experienced over the past 90 days.[17][18][19]
A1c (%) Average Blood Glucose (mg/dL)
6 126
8 183
10 240
12 298
14 355
Clinical Significance
Hemoglobin A1c serves as an indicator of overall glycemic control and a reflection of the average blood sugar over the past three months.[2]
Quality Control and Lab Safety
Laboratories can use several methods to determine HbA1c. High performance liquid chromatography (HPLC) method is one of the most popular methods because it can eliminate labile components that other methods such as immunoassay or affinity chromatography use. [20]
The point of care (POC) machine is widely used as well to determine HbA1c levels. The variety of POC machines on the market can make it difficult to determine the one best suited for one’s practice. Also, there is a shortage of information comparing the different machines. When using POC testing, one should keep in mind that POC values are often below results reported by a laboratory test, with the mean difference being -0.5%.
Enhancing Healthcare Team Outcomes
All clinicians who look after diabetic patients need to know what HbA1c means. In general, HbA1c provides a measure of the average glucose concentration over three months.
Hemoglobin A1c is often used as an outcome measure to determine if an intervention in a population is successful by showing a decrease in HbA1c by a certain percentage. There is a movement within the medical community to move away from using HbA1c as an exclusive standard of care test to measure patient response to treatment. The Estimated Average Glucose (eAG) and the glucose time in range are the newest proposed methods. [21] These methods use data obtained by continuous glucose monitors (CGMs) that record blood glucose 24 hours a day. They can also give providers a more accurate view of the blood sugar average and fluctuations, but these methods are not available to all patients on a wide-spread basis.
As per ADA guidelines, the levels of HA1c should be measured twice a year in stable patients and at least four times in patients who have glucose fluctuations or those who have had a change in their diabetic treatment. Hemoglobin A1c is one of the preferred diabetes diagnostic tests today. The blood draw can occur at any time, and there are no special handling requirements. However, to ensure that the A1c value is correct, clinicians need to be aware of the causes of false-positive and false-negative results.
Since many patients with diabetes have their condition managed in outpatient clinics, the diabetic nurse should be fully aware of HbA1c values and when to refer the patient to an endocrinologist for further workup and treatment. Pharmacists are also required to fully understand and interpret this test, as they will be involved in glycemic management medication agent selection, dosing, and monitoring. Both the nurse and/or pharmacist need to inform the treating physician regarding any changes in hemoglobin A1c and verify patient medication compliance. Hemoglobin A1c is a very valuable tool in the fight against diabetes and other glycemic control disorders, but to be effective, it functions best in an interprofessional healthcare team environment. [Level V]
Review Questions
Access free multiple choice questions on this topic.
Comment on this article.
References
- 1.
Gilstrap LG, Chernew ME, Nguyen CA, Alam S, Bai B, McWilliams JM, Landon BE, Landrum MB. Association Between Clinical Practice Group Adherence to Quality Measures and Adverse Outcomes Among Adult Patients With Diabetes. JAMA Netw Open. 2019 Aug 02;2(8):e199139. [PMC free article: PMC6694385] [PubMed: 31411713]
- 2.
Sherwani SI, Khan HA, Ekhzaimy A, Masood A, Sakharkar MK. Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomark Insights. 2016;11:95-104. [PMC free article: PMC4933534] [PubMed: 27398023]
- 3.
Diabetes Control and Complications Trial Research Group. Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. [PubMed: 8366922]
- 4.
Nathan DM., DCCT/EDIC Research Group. The diabetes control and complications trial/epidemiology of diabetes interventions and complications study at 30 years: overview. Diabetes Care. 2014;37(1):9-16. [PMC free article: PMC3867999] [PubMed: 24356592]
- 5.
Nathan DM. Realising the long-term promise of insulin therapy: the DCCT/EDIC study. Diabetologia. 2021 May;64(5):1049-1058. [PubMed: 33550441]
- 6.
Lachin JM, Orchard TJ, Nathan DM., DCCT/EDIC Research Group. Update on cardiovascular outcomes at 30 years of the diabetes control and complications trial/epidemiology of diabetes interventions and complications study. Diabetes Care. 2014;37(1):39-43. [PMC free article: PMC3868002] [PubMed: 24356596]
- 7.
American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S73-S84. [PubMed: 33298417]
- 8.
American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S61-S70. [PubMed: 30559232]
- 9.
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Disclosure: Emily Eyth declares no relevant financial relationships with ineligible companies.
Disclosure: Roopa Naik declares no relevant financial relationships with ineligible companies.
Glycated hemoglobin HbA1c, laboratory equipment, description and characteristics
Hemoglobin glycation is a non-enzymatic reaction between intra-erythrocyte glucose and amino groups of hemoglobin chains. This reaction occurs throughout the lifetime of erythrocytes. Glycated hemoglobin accumulates in erythrocytes during all 120 days of their life. The level of glycated hemoglobin, corresponding to the “combined” value of all glycemic changes in recent weeks, is used as a target in the treatment of diabetes, as well as in the diagnosis of diabetes mellitus.
In accordance with IFCC guidelines, HbA 1 c refers to a stable compound of glucose with the N-terminal amino acid of the β-chain of hemoglobin “A”. And its value is calculated according to the formula
HbA1c = HbA1c / (HbA1c + HbA0)
altered erythrocyte life time, i. e. cause physiological interference.
Results. The result of the assay is an HbA1c quantification expressed in units of IFCC (mmol/mol) and/or NGSP (%) depending on the choice of the operator. As well as a complete hemoglobin profile of the patient, indicating normal or abnormal hemoglobin synthesis.
Research material. whole blood with anticoagulant K2EDTA or K3EDTA.
Sample preparation. hemolysis and sample dilution are fully automated, performed on board.
Compatible with | Part No. | Kit name | Number of tests per set |
Capillaries 2 Flex piercing | 2015 | Protein fractions of hemoglobin CAPILLARYS (CAPILLARYS Hb A1C) | 720* |
MINICAP | 2215 | Hemoglobin protein fractions MINICAP (MINICAP Hb A1c) | 185* |
* The number of tests in the set may vary depending on the flow | |||
Control materials | |||
All Sebia appliances | 4774 | Electrophoresis control serum Hb A1c (Hb A1c CONTROLS) | 2 x 0. 6 ml |
Control materials | |||
All Sebia 9 appliances0003 | 4755 | Hb A1c Electrophoresis Calibrators (Hb A1c CALIBRATORS) | 2 x 0.6 ml |
Additional reagents and consumables (as required) | |||
All Sebia appliances | 9202 | Control tubes | 20/pk |
2058 | CAPICLEAN Solution | 25 ml |
Catalogs and leaflets
- HbA1c meta-analysis
- HbA1c determination by capillary electrophoresis
Automatic analyzer Lifotronic H9
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Products
Express Diagnostics
Glycated hemoglobin analyzers (HbA1c)
The company was founded in 2008 in Shenzhen, China. It is a major manufacturer and seller of a wide range of medical devices for diagnostics and therapy. Exports products to more than 90 countries of the world, including Russia.
- Characteristics
- Reagent kits
- Information materials
Maximum throughput
37 tests per hour
Sample type
Venous whole blood
Measured parameter
Glycated hemoglobin (HbA1c)
Calcium cap
Yes
Column capacity
1600 tests
Samples on board
110+1 (STAT)
Test execution speed
96 sec
Analyzer type
Benchtop
Technology
9000 2 HPLC (High Performance Liquid Chromatography)
Sample volume
1 ml
Tube feeding
Automatic
Calibration
Automatic and manual
Thermal printer
Integrated, 48 mm wide
Country of origin
3
China
Display
8″
Memory
4000 results
Warranty
18 months
Sample dosing system and reagent a
Syringe
Measuring range
3-20%
Reproducibility
CV ≤ 3%
Linearity
≥ 0. 99
Certificates
IFCC, NGSP
Tube type
K2EDTA 13×75 mm or Eppendorf 1.5 ml (diluted sample)
Dimensions, mm (L × W × H)
790 × 780 × 720
Weight, kg
51.7
Specifications Lifotronic H9
PDF – 88 Kb
Leaflet Lifotronic H9
PDF — 6508 Kb
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Elution buffer A for quantitative determination of glycated hemoglobin by high performance liquid chromatography for in vitro diagnostics (HbA1C Elution Buffer)
03-R02B110-00025
800 ml
HbA1C Elution Buffer, Elution Buffer B
03-R02B110-00026
800 ml 9000 3
Elution buffer C for the quantitative determination of glycated hemoglobin by the high performance in vitro diagnostic liquid chromatography (HbA1C Elution Buffer)
03-R02B110-00027
800 ml
In Vitro Diagnostic Glycated Hemoglobin Quantification Calibrator Kit (HbA1C Calibrator), HbA1C Calibrator
03-R02A000-00011
2 x 0.