# The Performance of Three Systems of Glycated Hemoglobin Measurements Among Patients With Sickle Cell Trait in Basrah, Iraq

## TL;DR

This study compares three HbA1c testing methods in patients with sickle cell trait in Basrah, Iraq, finding significant differences in results that could affect diabetes management.

## Contribution

The study evaluates the performance of three HbA1c measurement systems in a population with sickle cell trait, highlighting method limitations in this specific group.

## Key findings

- Roche Cobas Integra Gen.2 and Bio-Rad Variant II Turbo showed significant differences in HbA1c levels compared to Bio-Rad D-10 in patients with sickle cell trait.
- HbA1c results were higher in Bio-Rad Variant II Turbo and lower in Roche Cobas Integra Gen.2 across all HbA1c strata in both SCT and control groups.
- The study suggests that current HbA1c measurement methods may not be reliable for glycemic control monitoring in areas with high sickle cell trait prevalence.

## Abstract

Background

Hemoglobin variants may cause mismanagement of diabetes resulting from false glycated hemoglobin (HbA1c) results. The aim of this study was to compare the results obtained from three different HbA1c assay systems among patients with sickle cell trait (SCT) at Faiha Specialized Diabetes, Endocrine, and Metabolism Center (FDEMC) in Basrah.

Methods

A cross-sectional observational study was done in FDEMC in Basrah on patients with established diagnoses of diabetes mellitus. All samples were analyzed at FDEMC laboratory by using three different systems: Roche Cobas Integra Gen.2 (COBAS INTEGRA® 400 plus analyzer immunoassay) (Roche Diagnostics, Indianapolis, IN), a turbidimetric inhibition immunoassay (TINIA), Bio-Rad Variant II Turbo (Bio-Rad, Hercules, CA) Ion exchange HPLC method, and Bio-Rad D-10 (A1c program) (Bio-Rad, Hercules, CA) Ion exchange HPLC method.

Results

We enrolled 139 persons with diabetes and SCT compared with 70 controls with diabetes and no SCT. A significant difference in the mean HbA1c levels between Roche Cobas Integra Gen.2 and Bio-Rad Variant II Turbo in comparison with Bio-Rad D-10 (A1c program) across all strata of HbA1c in SCT. The highest difference was -0.5% in the stratum of HbA1c 7 to 9% group in Roche Cobas Integra Gen.2, while it was +0.8% in the stratum of HbA1c less than 7% in the SCT group. For the control group, the highest difference was -1.3%, seen in the stratum of HbA1c, more than 9% in the Roche Cobas Integra Gen.2, while the highest difference in the Bio-Rad Variant II Turbo was +0.5% in the same stratum. In both groups, the results of HbA1c were mostly higher in the Bio-Rad Variant II Turbo and lower in Roche Cobas Integra Gen.2.

Conclusion

Roche Cobas Integra Gen.2 and Bio-Rad Variant II Turbo methods are not preferred to be used in HbA1c estimation in areas where SCT is prevalent. Diagnosing or follow-up of glycemic control in patients with SCT needs critical reappraisal because of the limitation of methods used to measure HbA1c in Basrah.