# Analytical performance evaluation of the Mindray enzymatic assay for hemoglobin A1c measurement

## TL;DR

This study evaluates a new enzymatic method for measuring HbA1c, showing it is accurate, precise, and reliable for diabetes management in clinical labs.

## Contribution

The study introduces a new enzymatic method for HbA1c measurement with strong analytical performance and minimal interference.

## Key findings

- The enzymatic method showed precision below 2% for intra-assay, between-assay, and total precision.
- The method demonstrated good linearity across HbA1c levels from 3.96% to 20.23%.
- Results from the enzymatic method agreed well with HPLC and immunoassay methods.

## Abstract

Hemoglobin A1c (HbA1c) plays a crucial role in diabetes management. We aimed to evaluate the analytical performance of a new enzymatic method kit for HbA1c measurement. The performance of the enzymatic method, including precision, accuracy, and linearity, was evaluated. Moreover, the interference effect from conventional interferents, Hb derivatives, Hb variants, and common drugs were assessed. In addition, the agreement of HbA1c results was compared between enzymatic methods, cation-exchange high-performance liquid chromatography (HPLC), and immunoassays. The intra-assay, between-assay, and total precision of HbA1c were all lower than 2%. HbA1c showed good linearity within the range of 3.96–20.23%. The enzymatic assay yielded results consistent with the external quality control samples, with a bias of less than ± 6% from the target values. The enzymatic method showed no interference from bilirubin, intralipid, vitamin C, Hb derivatives, common Hb variants, as well as antipyretic analgesics and hypoglycemic drugs. The HbA1c results of the enzymatic assay showed good agreement and accuracy compared to those obtained from the HPLC method and the immunoassay. The enzymatic method kit performed on the BS-600M chemistry analyzer is a reliable and robust method for measuring HbA1c. It is suitable for routine practice in clinical chemistry laboratories.