Evaluation of the Lifotronic H100 Plus analyzer for HbA1c determination

Hemoglobin A1c (HbA1c) is a key biomarker for assessing long-term glycemic control. This study evaluated the analytical performance of the Lifotronic H100 Plus analyzer for HbA1c determination, including precision, linearity, and method comparison with the Tosoh G11 system, in accordance with CLSI guidelines. The analyzer demonstrated high precision, with low within-run and between-day variability. A strong linear relationship was observed across the tested range, with no significant deviation from linearity. Method comparison showed good overall agreement, although both proportional and constant differences were identified. Bland-Altman analysis revealed a negligible mean bias with relatively narrow limits of agreement. No significant interference from bilirubin, triglycerides, or hemoglobin variants was observed. These findings indicate that the Lifotronic H100 Plus provides reliable HbA1c measurements suitable for routine clinical use, although the observed systematic differences suggest that results obtained with different methods should not be used interchangeably.