Explore A1c and F/A2 testing with the D-10™ Hemoglobin Testing System

The Bio-Rad D-10 Hemoglobin Testing Solution is an ion-exchange HPLC to provide precise and reproducible results of hemoglobin binding proteins. It includes dual testing programs for HbA1c and fetal screening including HbA2, and HbF even in the presence of common hemoglobin variants such as HbS, HbC, HbD, and HbE. It is NGSP certified, IFCC traceable, and standardized to DCCT guidelines, ensuring compliance with international standards.

Yes. The D-10 HbA1c Assay is CE marked and FDA cleared as these certifications ensure the assay delivers accurate, reliable, and internationally standardized HbA1c results, including: NGSP certified (National Glycohemoglobin Standardization Program)1 IFCC traceable (International Federation of Clinical Chemistry and Laboratory Medicine)2 Standardized to DCCT guidelines, following American Diabetes Association (ADA) recommendations3

Yes. The D-10 is designed for ease of use with a compact footprint, minimal maintenance, and intuitive software. It installs quickly—often in a single service visit—and delivers walkaway operation, making it ideal for busy clinics and physician offices. Countries have clinical laboratory requirements that must be fulfilled to perform clinical diagnostic tests.

Yes, including: Built-in Software: The D-10 includes integrated software that streamlines system startup, automates quality control checks, and enables chromatogram export—reducing manual steps and improving consistency. Touchscreen Interface: An intuitive touchscreen makes navigation simple, enhancing ease of use for daily operation and data handling. LIS Integration: The D-10 supports connectivity with Laboratory Information Systems (LIS), allowing automatic data transfer for faster, more efficient workflows.

For the Bio-Rad D-10, routine operation includes a few daily checks, with minimal ongoing maintenance—only monthly and periodic replacement of the sample probe.

Accordion text: I am Dr. Shanas Kaii, Consultant Hematopathologist at the PD Hinduja Hospital in Mumbai, India. I have been associated with Hinduja Hospital for over 30 years. My role is to oversee every function of the laboratory. As the first hospital-based lab in India accredited by the College of American Pathologists, we uphold the highest standards. I also serve as the President of the Indian Society of Hematology and Blood Transfusion.

Our lab specializes in hematology, making hemoglobinopathy testing and thalassemia screening essential. These tests are critical for diagnosing anemia and are part of our hemolytic anemia profile. Over the years, results from the Bio-Rad D-10 system have enabled accurate diagnoses, allowing for timely treatment.

Before adopting the D-10 system, we relied on alkaline and acid gel electrophoresis, which was tedious, limited, and prone to variant overlap common in India. When we looked to automate hemoglobinopathy screening, we considered two Bio-Rad systems. The VARIANT II was too advanced for our moderate workload, while the D-10 system was ideal. It effectively detects nearly all hemoglobin variants and thalassemias prevalent in India, making it integral to our lab.

We chose the D-10 for its accuracy and reliability. In a hospital-based lab, prompt treatment depends on fast, accurate diagnosis. The D-10 delivers results—from calibration to printout—in about six minutes, even faster than serum iron studies. This speed allows us to quickly confirm or rule out hemoglobinopathies as a cause of anemia.

We conduct around 85 tests per month for Hemoglobin A2 and F—about 1,000 annually. This number could be higher if we had obstetrics and pediatrics specialties. The D-10 also improves lab productivity with a 6-minute turnaround for thalassemia testing and 3 minutes for HbA1c. It runs small daily batches economically, eliminating delays from waiting to accumulate samples.

The staff finds the D-10 easy to use due to its full automation, eliminating the need for sample prep or manual data entry. It requires minimal maintenance, and the touchscreen interface with onboard computer simplifies kit changes. The D-10 handles our workload efficiently, even during staff shortages.

We appreciate features like sample and hemoglobin level alerts. Chromatogram review helps identify degraded samples—such as those with high bilirubin—allowing us to reprocess or dilute for accurate results. The hemoglobinopathy chromatogram also helps us incidentally identify elevated HbA1c levels. Quality control data is easily accessible and stored, with up to 10,000 results retained, reducing backup needs.

We value Bio-Rad’s quality products and consistent after-sales support. Their courteous staff is always ready to help. In our lab, the D-10 supports three key patient scenarios: health checkups with premarital screening, prenatal screening for pregnant women, and follow-up testing for patients with thalassemia-like CBC results.

The D-10 detects both common and rare beta and alpha chain variants found in India, providing a comprehensive hemoglobinopathy screening solution. We've identified variants such as double heterozygous for HbC and beta thalassemia, HbD Punjab homozygous, sickle cell with hereditary persistence of fetal hemoglobin, and delta-beta thalassemia. We've also detected cases like homozygous thalassemia with high HbF, hemoglobin H, hemoglobin J (eluting in P3), and hemoglobin Q India (at 4.4 minutes).

Bio-Rad’s online Library of Hemoglobin Variants helps us interpret abnormal chromatograms and report with confidence. Bio-Rad also supports clinical education through partnerships like with the Thalassaemia International Federation, offering programs like TIF certification and “Test Your Knowledge.”

We’ve also used the D-10 in research, including a study on borderline Hemoglobin A2 values (3.5–3.9%) with DNA mutation analysis to detect silent mutations. We identified variants such as IVS-I-5 G>C and IVS-I-1 G>T.

In summary, the D-10 is compact, easy to use, and employs gold-standard ion-exchange HPLC for trusted, accurate results. It’s a workhorse that handles increased workloads without compromising quality—an ideal choice for small to medium-sized labs offering both hemoglobin A2/F and HbA1c testing on one platform with a single kit.