D-10 Hemoglobin Testing Solution
The D-10 System is a compact, easy-to-use, automated HbA1c and HbF/HbA2 system that utilizes gold standard ion-exchange HPLC technology to deliver accurate results clinicians can trust.
Ordering Information
For technical specifications and ordering information for the D-10 System and accessories, click here.
Explore
Why MDs Choose D-10 HPLC
Given our history and experience in HbA1c and β-thalassemia testing, it’s no wonder over 9,000 of your peers around the world have chosen the D-10 System over other methods.
Bio-Rad ion-exchange HPLC technology provides a numerical result and a visual picture of the separated hemoglobins for more complete clinical information. A chromatogram helps clinicians see potential interferences that may affect their patients’ HbA1c results. It also helps explain discordant results in the presence of interferences, allowing clinicians to choose the appropriate treatment.
Clinicians Are Turning to HPLC for Accurate
HbA1c, HbA2, and HbF Results
Customer Experience: Endocrinology
Watch the video to learn why an endocrinology practice values the D-10 System to help improve patient outcomes.
“We have chosen the D-10 System because of its accuracy and reliability.”
Dr. David Robertson, Endocrinology
Atlanta Diabetes Associates
Customer Experience: Family Medicine
Watch the video to learn why a family practice values the D-10 System in helping to improve patient outcomes.
“The D-10 helps healthcare providers manage patients with military precision.”
Dr. William Maranto, Family Medicine
Bossier Family Medicine
Quality A1c Results
Every patient deserves quality results. You can rely on the D-10 System to provide clinically accurate, repeatable gold standard results without interference from lipemia up to 6,000 mg/dl (60g/L) and from elevated HbF up to 10%, as well as the most common heterozygous hemoglobin variants: HbS, HbC, HbD, and HbE.
Conditions Affecting A1c Measurement
Comparing different methods and potential for reporting clinically inaccurate results
For informational purposes only and not intended to provide medical advice or diagnosis.
* Up to 6,000 mg/dL
† Variable claims between 500 mg/dL and 3,000 mg/dL1,2
‡ A1c is not an appropriate analyte to determine glycemic status. For homozygous and double heterozygous cases, HbA is not present so there is no HbA1c to measure. Another analyte must be used to evaluate glycemic status, per the ADA guidelines.3
- Parker ML et al. (2018). HbA1c platforms are variably affected by increasing lipemia. Abstract A-288. 70th AACC Annual Scientific Meeting Abstracts.
- Mainali S et al. (2017). Frequency and causes of lipemia interference of clinical chemistry laboratory tests. Practical Laboratory Medicine 8, 1–9. https://doi.org/10.1016/j.plabm.2017.02.001.
- ADA (2022). Standards of medical care in diabetes—2022. Diabetes Care, 45 (Supplement 1), S17-S38.
Not All HbA1c Assays Are Equal
Effects of 49 Different Rare Hb Variants on HbA1c Measurement in Eight Methods
Randie R. Little et al. (2015) Journal of Diabetes Science and Technology¹
Introduction
This study examined analytical interference from 49 different less common variants comparing seven different HbA1c methods. HbA1c accuracy was assessed as well as the likelihood of the systems to report inaccurate results. The authors noted that previous studies with some assay methods have shown interference with HbA1c measurements from the four most common heterozygous Hb variants (HbAS, HbAE, HbAC, and HbAD).
Study Results
Bio-Rad HPLC systems outperformed other HbA1c testing systems. With the D-10 System, 100% clinically accurate results in the presence of rare hemoglobin variants would have been reported. The table below illustrates the clinical benefit of Bio-Rad ion-exchange HPLC for patient diagnosis and treatment.
Conclusion
To ensure accurate HbA1c results, it’s important to know whether patients have a hemoglobin variant and, if so, how that variant affects HbA1c results. Laboratories should take care when reporting results if a variant is suspected.
Download Brochure- Little RR et al. (2015). Effects of 49 different rare Hb variants on HbA1c measurement in eight methods. J Diabetes Sci Technol 9(4), 849-856. https://pubmedncbi.nlm.nih.gov/25691657.
Value of the Chromatogram
The D-10 System provides clinically accurate HbA1c results and a chromatogram to aid clinicians in diagnosing and monitoring patients living with diabetes.*
Watch the video to discover why clinicians value the chromatogram for additional clinical information.
“We utilize the chromatogram to confirm that the A1c is a valid measurement of the patient's glycated HbA.”
Dr. David Robertson, Endocrinology
Atlanta Diabetes Associates
Easy to Use, Easy to Train
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From easy reagent installation and replacement to results review, the D-10 System is designed to simplify HPLC so you can easily train your staff. With automated features and a multilingual user interface, it’s easy to integrate into your lab workflow.
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Watch the video to see how easy it is to operate the D-10 System.
Customer Experience: Increased Productivity
The D-10 System saves labor hours and improves productivity. It requires no sample preparation, minimal maintenance, and no manual data entry. With its touchscreen user interface and onboard computer, the D-10 is easy to use.
Watch the video to hear how easy it is to run the D-10 System.
“The D-10 rapidly changed the way we test.”
Jamie Justice, Quality Manager
Bossier Family MedicineCustomer Experience: Cost Efficiency
The D-10 System has no hidden costs and offers high-quality automated results. Save time and money with Bio-Rad ion-exchange HPLC technology.
Watch the video to learn why the D-10 System makes economic sense.
“The D-10 is 'rock solid' and makes economic sense.”
Matt Wheeler, Administrator
Bossier Family Medicine
One System, Two Tests
The D-10 System offers easy switching between HbA1c and HbA2/F/A1c testing on a single platform without changing the cartridge or reagent. Results are reported in NGSP % and/or IFCC units.
D-10 Hemoglobin A1c Program
Screen for prediabetes, diagnose, and monitor patients living with diabetes
Directly measure HbA1c with ion-exchange HPLC that meets the most stringent guidelines for diagnosing diabetes. Report high-quality, clinically relevant results without interference from common hemoglobin variants: HbS, HbC, HbD, and HbE. HbF is detectable with no interference on results at normal levels up to 10%.
Powerful Performance
HbA1c is reportable without interference from:
- Labile A1c (LA1c) ≤3.5%
- HbF ≤10%
- Carbamylated hemoglobin (CHb) ≤6%
- The most common heterozygous hemoglobin variants: HbS, HbC, HbD, and HbE*
- Acetylated hemoglobins
- Lipemia ≤6,000mg/dL (60g/L)
Confidence in Your Results
The D-10 System is FDA cleared, NGSP certified, IFCC anchored, and CE marked.
Customer Experience:
HbA1c Testing
Watch the video about the D-10 Hemoglobin HbA1c Program.
D-10 Dual Program HbA2/F/A1c
Test for diabetes and β-thalassemia in one kit
The D-10 Dual Program offers fast, fully automated HbA1c analysis (Short Method) with comprehensive β-thalassemia testing (Extended Method) in one kit. Switch between methods at the touch of a button without changing reagents or cartridges.
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Short Method
- • Rapid HbA1c results in 3 minutes
- • 400 HbA1c tests
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Extended Method
- • HbA2, HbF, and HbA1c quantifiable results in 6.5 minutes
- • HbA1c is reportable in the presence of heterozygous HbS, HbC, HbD, and HbE
- • 400 HbA1c or 200 HbA2/F/A1c tests
Customer Experience:
HbA2/F/A1c Testing
Watch the video to hear what a key opinion leader says about the D-10 Dual Program HbA2/F/A1c.
D-10 Solution
Not all HbA1c methods are equal. Bio-Rad HPLC separates HbA1c from other hemoglobins by their differing charges and reveals hemoglobin variants that may interfere with the clinical accuracy of HbA1c results.
"When reporting HbA1c results, it’s important for clinicians to know if a hemoglobin variant is present."
Little RR et al.1
- Little RR et al. (2015). Effects of 49 different rare Hb variants on HbA1c measurement in eight methods. J Diabetes Sci Technol 9(4), 849-856. https://pubmedncbi.nlm.nih.gov/25691657.
- Chart adapted from: Weykamp C (2013). HbA1c: A Review of Analytical and Clinical Aspects. Anals of Laboratory Medicine. http://dx.doi.org/10.3343/alm.2013.33.6.393.
Keep HPLC Simple
Simplify your HbA1c testing with ion-exchange HPLC technology. From early reagent preparation to results review, the D-10 System is designed to simplify HPLC so you can easily train your staff. With automated features and a multilingual user interface, it’s easy to integrate into your lab workflow.
Small System, Big Impact
The D-10 System provides comprehensive, fully automated HbA1c, HbA2, and HbF testing in a compact footprint. Designed for clinics, physician offices, and clinical laboratories with small to medium sample volumes, the D-10 System, with an integrated computer, fits almost any lab and saves valuable bench space.
Efficient Workflow
Watch the video to learn how to streamline your workflow and get more done with the D-10 System.
D-10 Rack Loader
To meet rising testing volumes, add a D-10 Rack Loader
The incidence of diabetes is increasing worldwide. At some point, you might need to expand your HbA1c testing capacity. Because the D-10 System grows with the testing needs of your lab, you won't need to buy a new system or perform another validation study.
Expand your walkaway capacity with a D-10 Rack Loader, which can be installed in a single service visit to improve your lab’s HbA1c efficiency and overall productivity.
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Offers 5× greater testing capacity than the standalone D-10 System
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Provides convenient sample loading for walkaway capability
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Brings enhanced flexibility with STAT sample processing
Product Enhancements
You asked, we listened. At Bio-Rad, we value your feedback and continually refine our products to meet your evolving needs. Your insights drive our commitment to innovation and improvement, including:
- Chromatogram export
- QC module
- Personalized report headers