Trusted HbA1c Testing Solutions for Diabetes Diagnosis and Monitoring

Bio-Rad’s HPLC instruments do more than measure HbA1c—they provide comprehensive, interference-resistant diagnostics that enhance patient outcomes, improve test confidence, and support early intervention in diabetes and hemoglobin disorders.

HbA1c Testing

D-100: SMART HbA1c Testing Without Interference

The Bio-Rad D-100 System delivers fast, single touch HPLC-based HbA1c testing with no interference from common variants⁷. Ideal for medium to high volume labs, it offers streamlined workflow for reliable diabetes and hemoglobin disorder testing.

Bio-Rad D-10 Compact HPLC Analyzer for hemoglobin and hemoglobinopathy testing

HbA1c Testing

D-10: Compact HPLC System for Accurate HbA1c Testing

The D-10 System is a compact, automated HPLC analyzer for accurate HbA1c and hemoglobin variant testing, ideal for reliable diabetes and hemoglobinopathy management^8,9. With automated features and a multilingual user interface, the D-10 is easy to integrate into your lab workflow and train staff.

Photograph of VARIANT II TURBO System as a compact HbA1c and hemoglobinopathy testing instrument

HbA1c Testing

VARIANT II TURBO: Fast HbA1c Testing System

The VARIANT II TURBO Hemoglobin Testing System from Bio-Rad is a high-throughput, fully automated HPLC analyzer optimized for accurate HbA1c and hemoglobinopathy testing in medium- to high-volume labs⁸.

HbA1c Testing

VARIANT II Hemoglobin Testing Solution

This reference HPLC system is used in many laboratories for the analysis of normal hemoglobins and as an aid in the identification of abnormal hemoglobins. It offers fully automated, high-volume hemoglobin A1c and β-thalassemia testing.

Bio-Rad's HPLC instruments do more than measure HbA1c—they provide comprehensive, interference-resistant diagnostics that enhance patient outcomes, improve test confidence, and support early intervention in diabetes and hemoglobin disorders.

Koch Case Study

The Strengths and Weaknesses of HbA1c in Diagnosing Diabetes

Dave Koch demonstrates how hemoglobin variants and other issues might impact the HbA1c result by sharing patient case studies and data from published papers.

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Improve Turnaround Time by 50% (BLINDED)

Robertson Case Study

HbA1c as a Diagnostic Test and its Role in my Endocrinology Practice

David G. Robertson, M.D. shares his insights on managing patients living with diabetes using the HbA1c diagnostic test to help guide healthcare providers.

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Higgins Case Study

The Good, the Bad, and the Ugly in HbA1c Interpretation

Trefor Higgins discusses the challenges of HbA1c interpretation when hemoglobin variants are present. He uses real world patient case studies to illustrate those challenges to help clinicians diagnose and treat patients living with diabetes.

Florkowski Case Study

Confounding Factors for HbA1c Interpretation

Chris Florkowski presents patient case studies to illustrate the challenges in reporting accurate HbA1c results in the presence of hemoglobin variants, as well as findings from published papers that clinicians should understand when treating patients with undiagnosed diabetes.

Expert Insights on HPLC HbA1c Testing

Written by William Winters, M.D., this brochure highlights the value of NGSP-certified, IFCC-traceable HbA1c testing and the reliability of Bio-Rad's HPLC systems. Backed by ADA guidelines and key studies, it supports informed decisions and early diabetes detection.

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Short guide

It is crucial to be aware of factors known to interfere with HbA1c test results when using HbA1c to manage patients with diabetes. The table below provides an overview of factors affecting clinical interpretation of HbA1c.

Factors that Interfere with HbA1c Test Results from Published Sources

		HbA1c Falsely Lowered	HbA1c Falsely Elevated
Biological Factors	Erythropoiesis	Increased erythropoiesis: Erythropoietin/Iron/Vitamin B12 Therapy^1,4,5; Reticulocytosis¹; Chronic Liver Disease^1,5	Decreased erythropoiesis¹: Iron^2,6 / Vitamin B12 Deficiency^1,4,5; Renal Failure⁷
	Glycation	Aspirin (small doses)^1,4,5; High doses of vitamin C^1,4,5 or vitamin E^1,4,5; Certain hemoglobinopathies¹	Chronic kidney disease⁵; Alcoholism^1,5
	Erythrocyte Life Span	Shortened erythrocyte life span^1,3,5: Hemolytic anemia^2,3,6; Splenomegaly^1,5; Rheumatoid arthritis¹; Nephritis³; Liver Disease³; Sepsis³; Certain hemoglobinopathies¹; Paroxysmal nocturnal hemoglobinuria³; Drugs such as antiretrovirals^1,4,5, ribavirin^1,4 and dapsone^1,4	Increased erythrocyte life span^1,5,6; Splenectomy^1,5,6
Analytical Factors	Assay Method Interference	Hypertriglyceridemia Certain hemoglobinopathies^1,5	Hyperbilirubinemia Carbamylated hemoglobin¹; Certain hemoglobinopathies^1,5; Chronic opiate usage^1,4

References

Geneva: World Health Organization. 2011. Use of Glycated Haemoglobin (HbA_1c) in the Diagnosis of Diabetes Mellitus: Abbreviated Report of a WHO Consultation. Viewed 29 April 2021. https://www.ncbi.nlm.nih.gov/books/NBK304271/
NGSP. 2019. Factors that Interfere with HbA_1c Test Results. Viewed 19 May 2021. https://ngsp.org/factors.asp
Lohmann, T. P. 2019. The impact of red blood cell lifespan on HbA_1c measurement. Viewed 20 May 2021.
Unnikrishnan, R., Anjana, R., & Mohan, V. (2012). Drugs affecting HbA_1c levels. Indian Journal of Endocrinology and Metabolism, 16, 528–531. https://doi.org/10.4103/2230-8210.98004
Goel, S., Sen, A., Sampath, S., & Tripathi, P. (2020). Hemoglobin E: a potential interferent in measurement of glycated hemoglobin. International Journal of Advances in Medicine, 7. https://doi.org/10.18203/2349-3933.ijam20203609
O’Keeffe, D., Maraka, S., & Rizza, R. (2016). HbA_1c in the Evaluation of Diabetes Mellitus. JAMA, 315(6), 605–606. https://doi.org/10.1001/jama.2015.16561
Garza, M. 2020. Your A1C May Not Be Reliable If You Have Chronic Kidney Disease. Viewed 29 July 2021.

While many of the above conditions may alter red blood cell production, red blood cell life span and rate of glycation, they can often be picked up by a review of the patient's medical record or prior laboratory results. Conditions which are clinically silent, however, like hemoglobinopathies which are highly prevalent across Asia and other parts of the world, can be missed resulting in wrong patient care decisions and treatment delays.

The use of an HbA1c assay method that reveals suspected hemoglobin variants (otherwise invisible on other methods) can help you identify patients with clinically silent hemoglobinopathies, allowing you to alert physicians of potential interference on HbA1c test results and/or suggest other methods to manage patients with hemoglobinopathies.

Specific hemoglobin variant and interfering substance claims vary by assay and can be found in the respective assays' Instructions for Use (IFU).

Unparalleled Support

Bio-Rad's world class service and support team is backed by 40 years of expertise in HbA1c testing and quality controls. Our hemoglobin testing systems can be connected to BRiCare, Bio-Rad's 24/7 instrument monitoring application to keep your system running smoothly.

Cybersecurity

Bio-Rad is committed to working with hospitals and laboratories to protect your systems and mitigate potential security risks to patients and operators.

Multiple red blood cells and two complex hemoglobin protein molecules on a light-green background.

Diabetes/Hemoglobin Controls

We offer independent human whole blood-based controls, available in multiple distinct HbA1c levels to help monitor the precision of HbA1C test methods across major platforms.

Bio-Rad believes in sharing knowledge. We’ve created dedicated resources to help you strengthen your hemoglobinopathy expertise.

Library of Variants

In this digital database, find case reports to support the interpretation of hemoglobin variant chromatograms for sickle cell disease, thalassemia, and other hemoglobinopathies. Access this invaluable resource tool for your next case.

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Test Your Knowledge

In this series of educational case studies, learn how to evaluate hemoglobinopathies and sickle cell cases and expand your knowledge of HPLC chromatograms.

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References

Weykamp, C. (2013). HbA_1c: A Review of Analytical and Clinical Aspects. Annals of Laboratory Medicine.
Gore, M., McGuire, D., et al. (2016). A Test in Context. Journal of the American College of Cardiology, 68(22), 2479–2486.
Little, R. R., et al. (2015). Effects of 49 Different Rare Hb Variants on HbA_1c Measurement in Eight Methods. Journal of Diabetes Science and Technology, I–8.
U.K. Prospective Diabetes Study (UKPDS) Group (1998). Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet, 352, 837–853.
NGSP. (March 2021). List of NGSP Certified Laboratories. https://ngsp.org/certified.asp
DCCT Research Group (1996). The absence of a glycemic threshold for the development of long-term complications: the perspective of the Diabetes Control and Complications Trial. Diabetes, 45(10), 1289–1298.
Nathan, D. M., et al. (1993). The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus. The New England Journal of Medicine, 329(14), 977–986.
American Diabetes Association (2020). Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2020. Diabetes Care, 43(Supplement 1), S98–S110.

Disclaimer

The content on this website is for educational and informational purposes only and should not be considered medical advice or a recommendation for diagnosis or treatment. Always consult a qualified specialist when needed. Bio-Rad and contributors make no warranties regarding the accuracy or completeness of the information and disclaim all liability for its use. Users should review relevant updates and regulatory guidance.

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