[Evaluation of the analytical performance of the Tosoh HLC^®-723 G11 analyzer for HbA1c measurement in variant mode]

The reliability of HbA1c test results is essential for the screening, diagnosis, and monitoring of diabetes. The objective of our study was to evaluate the analytical performance of HbA1c testing on the HLC®-723 G11 Tosoh analyzer, as well as the impact of the absence of a sample homogenization system prior to analysis on the stability of results. The analytical performance verification protocol was developed with reference to the recommendations of the Clinical and Laboratory Standards Institute and the SH 04 guide of the French Accreditation Committee. Repeated measurements were performed on samples at the following times: initial (T0), 30 minutes, 1 h, 2 h, 3 h, 4 h, 5 h, and 6 h, without prior homogenization. Biases were calculated and compared to the acceptability limits defined by Fraser. The coefficients of variation (CV) for repeatability and intermediate precision, as well as inaccuracy, were below the limits set by the French Society of Clinical Biology and the European Federation of Clinical Chemistry and Laboratory Medicine. The contamination rate was 0.05%. An excellent correlation between HLC®-723 G11 and Capillarys Octa3® was observed, both with and without a hemoglobin variant, with R² = 0.99 and R² = 0.97, respectively. HbA1c results were stable for up to 6 hours in the absence of a stirring system. The analytical performance of the HLC®-723 G11 analyzer was verified, allowing its routine use for HbA1c testing.