Trusted HbA1c Products for Clinical & Hospital Laboratories
NGSP‑Certified, IFCC‑Traceable Systems Delivering Precision & Reliability
Why Can You Trust Your HbA1c Results with Bio-Rad HPLC?
See the Whole Picture: Why Bio-Rad HPLC Detects What Others Miss in HbA1c Testing
Your A1c system works like clockwork—samples keep coming, numbers are reported, and the cycle continues day in and day out. Until one day, a doctor questions a result that doesn’t look right—a missed common hemoglobin variant that could have led to the wrong patient treatment and clinical outcome.
If hemoglobin variants are invisible on your system, how do you know what it’s not showing? When did seeing only part of the patient picture become acceptable, especially when what’s hidden could be a ticking time bomb for someone living with diabetes? As global demographics shift and the world becomes more interconnected, doctors are facing new challenges and require more than just a number to accurately diagnose, monitor, and treat patients. Is your system ready?
There’s a reason Bio-Rad HPLC is considered the gold standard for A1c testing—because common hemoglobin variants matter, and a bad result is worse than no result. More physicians are taking note of emerging studies and realizing that not all A1c results are created equal. Increasingly, they are turning to HPLC technology, because missing even one diagnosis is one too many.
The American Diabetes Association (ADA) recommends using HbA1c to diagnose diabetes using an NGSP certified method and a cutoff of HbA1c ≥ 6.5%1,2.
Our Gold Standard HPLC technology allows you to confidently report HbA1c results to clinicians2,3,4.
Our Bio-Rad HbA1c testing systems are National Glycohemoglobin Standardization Program (NGSP) certified and traceable to International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)2,4,5.
Why Is Accurate HbA1c Testing Essential?
In 2024, an estimated 43% of adults with diabetes—approximately 253 million people—were undiagnosed, and over 3.4 million adults aged 20–79 died from diabetes-related causes worldwide6.
Hemoglobin variants can negatively impact the accuracy of HbA1c testing methods8,10,11,12. This may lead to a bias when reporting results8,10. Only HPLC and capillary electrophoresis reveal hemoglobin variants, making them more reliable in the presence of hemoglobinopathies8,10.
| Method | Hemoglobin Variants Revealed | Detection Principle |
|---|---|---|
| HPLC (Ion Exchange) | Yes | Charge-based separation |
| Capillary Electrophoresis | Yes | Electrophoretic mobility |
| Affinity Chromatography | No | Glycated hemoglobin binding |
| Immunoassays | No | Antibody-based detection |
| Enzymatic Assays | No | Enzyme-catalyzed reaction |
Featured Content
Why Method Choice Matters in HbA1c Testing
Explore how Bio-Rad’s HPLC method compares to other HbA1c testing technologies in this NGSP-reviewed study covering 49 hemoglobin variants.
Compare Hemoglobin Testing Instruments
Featured Products
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.
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 management8,9. With automated features and a multilingual user interface, the D-10 is easy to integrate into your lab workflow and train staff.
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.
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.
The VARIANT II TURBO Link Hemoglobin Testing Solution
Need a fully automated HbA1c solution? The VARIANT II TURBO Link Hemoglobin Testing Solution delivers on-demand hematology and HbA1c testing with flexible random-access capability.
*Available in the US and Canada only.
Hemoglobin A1c (HbA1c) and Diabetes Controls
Featured Products
Verify accuracy when testing for HbA1c
Detect issues with the instrument or assay or test
Set a consistent benchmark for HbA1c testing
Controls play a critical role in ensuring the accuracy and consistency of HbA1c testing for diabetes management. Regular use of controls also supports compliance with CLIA, CAP, and ISO requirements and ensures standardization across labs by aligning with international benchmarks such as NGSP and IFCC. Bio-Rad’s HbA1c controls are purpose-built for high reliability in diabetes and hemoglobinopathy testing and are fully compatible with many diagnostic testing systems.
Hemoglobin A1c (HbA1c) Learning Centers & Case Study Libraries
Library of Variants: Your Searchable Resource for Complex Hemoglobin Cases
Interpreting hemoglobin chromatograms can be challenging. That’s why Bio-Rad, with the support of clinical expert Marco Flamini, created the Library of Variants—a searchable database of real-world chromatograms, findings, and case studies submitted by laboratories around the world. This educational tool helps users recognize and compare hemoglobin variants, improving confidence in result interpretation and supporting accurate diagnosis in complex cases.
Sharpen Your Skills: HbA1c Case Studies & Chromatograms
Build confidence in interpreting hemoglobin chromatograms with real-world case studies and interactive scenarios. Explore this section of the HbA1c and Hemoglobinopathy Webinars & Variant Case Library to strengthen your expertise in identifying hemoglobin variants—perfect for lab professionals, students, and educators.
Frequently Asked Questions for HbA1c testing solutions
HbA1c reflects the average blood glucose level over the past 2–3 months and is a critical marker for monitoring diabetes8. It forms when glucose in the blood binds to hemoglobin A in red blood cells (RBCs), a process influenced by the glucose concentration and the lifespan of RBCs—typically around 120 days. Because glycation occurs over time, HbA1c provides a long-term view of glucose control, unlike daily blood glucose tests.
However, in people with hemoglobin disorders, things get more complicated. There are many types of hemoglobin variants that can affect both how HbA1c is made in the body and how accurately it’s measured7. These factors can lead to misleading results. That’s why it’s so important to consider the full clinical picture when interpreting HbA1c levels—doing so helps ensure more accurate results and better care.
HbA1c testing solutions are diagnostic methods used to measure glycated hemoglobin protein A1c (HbA1c), a key marker for long-term blood glucose control in diabetic patients. Several laboratory techniques are employed to measure HbA1c levels for diagnostic purposes including9:
- High-Performance Liquid Chromatography (HPLC): This method separates hemoglobin components based on charge differences. Cation-exchange HPLC is commonly used for its precision and ability to detect hemoglobin variants.
- Affinity Chromatography: This technique separates molecules based on specific binding interactions, offering an alternative approach to HbA1c measurement.
- Immunoassays and Enzymatic Assays: These methods use antibodies or enzymes to detect and quantify HbA1c levels.
| System | Best For | HbA1c Result Time | Variant Detection | Additional Testing Capabilities |
|---|---|---|---|---|
| D-10 | Small to medium labs | ~3 minutes | Yes | β-thalassemia (HbA2/F/A1c) and HbA1c |
| D-100 | High-volume labs | 45 seconds | Yes | HbA1c only |
| VARIANT II TURBO | High-throughput HbA1c testing | 97 seconds | Yes | HbA1c only |
| VARIANT II TURBO Link | Integrated hematology/HbA1c labs | 97 seconds | Yes | HbA1c with hematology integration |
Bio-Rad offers three key controls for HbA1c testing with HPLC systems like the D-10:
- Lyphochek® Diabetes Control – Lyophilized whole blood control for HbA1c and related fractions; assayed across 30+ methods.
- Liquichek® Diabetes Control – Ready-to-use liquid control with multiple HbA1c levels; available with barcoded vials.
- Lyphochek® A1C Linearity Set – Six-level set to verify HbA1c assay linearity across the reportable range, meeting CLIA/CAP guidelines.
References
- World Health Organization. Use of Glycated Hemoglobin (HbA1c) in the Diagnosis of Diabetes Mellitus: Abbreviated Report of a WHO Consultation. Geneva: World Health Organization; 2011. https://www.ncbi.nlm.nih.gov/books/NBK304271/
- American Diabetes Association. Classification and diagnosis of diabetes: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018;41(Suppl 1):S13-S27. doi:10.2337/dc18-S002
- Consensus statement on the worldwide standardization of the hemoglobin A1c measurement. Diabetes Care. 2007;30(9):2399-2400. doi:10.2337/dc07-9925
- National Glycohemoglobin Standardization Program. NGSP: Ensuring HbA1c Test Result Accuracy. Accessed May 19, 2025. https://ngsp.org/
- International Federation of Clinical Chemistry and Laboratory Medicine. Advancing excellence in laboratory medicine. Accessed May 20, 2025. https://ifcc.org/
- International Diabetes Federation. IDF Diabetes Atlas, 11th Edition. Brussels, Belgium: International Diabetes Federation; 2025:7. Accessed June 4, 2025. https://diabetesatlas.org
- Jeong TD, Lee W, Chun S, Min WK. Performance evaluation of the Bio-Rad D-100 system for hemoglobin A1c assay. Clin Lab. 2017;63(11):1923-1928. doi:10.7754/Clin.Lab.2017.170524
- Little RR, Roberts WL. A review of variant hemoglobins interfering with hemoglobin A1c measurement. J Diabetes Sci Technol. 2009;3(3):446-451. doi:10.1177/193229680900300307
- Khera PK, Smith EP, Lindsell CJ, et al. Use of an oral stable isotope label to confirm variation in red blood cell mean age that influences HbA1c interpretation. Am J Hematol. 2015;90(1):50-55. doi:10.1002/ajh.23866
- Little RR, Rohlfing CL, Hanson S, et al. Effects of 49 different rare Hb variants on HbA1c measurement in eight methods. J Diabetes Sci Technol. 2015;9(4):849-856. https://pubmed.ncbi.nlm.nih.gov/25691657/
- Bowen AR, Hortin GL. Choosing a test method to measure HbA1c. Med Lab Obs. 2020. https://www.mlo-online.com/disease/diabetes/article/21142641/choosing-a-test-method-to-measure-hba1c
- National Glycohemoglobin Standardization Program. Factors that interfere with HbA1c test results. Updated April 2023. Accessed June 4, 2025. https://ngsp.org/factors.asp
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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