Evaluation of the Analytical Performance of Lifotronic H9 Glycated Hemoglobin Analyzer and its Effect on Clinical Decision Making

Background We aimed to analyze the analytical performance of Lifotronic H9 glycated hemoglobin analyzer (Lifotronic H9) with Arkray Adams HA-8160 glycated hemoglobin analyzer (Arkray HA8160), which is currently used for measurement of HbA1c test in our laboratory. Methods The verification studies of the Lifotronic H9 were performed by comparison with the Arkray HA8160, which has been verified and is already used in our laboratory, and in accordance with the CLSI EP5-A3 and CLSI 15-A3 guidelines. The method comparison study was performed with 316 subjects. Results Both instruments demonstrated perfect repeatability (within-run) CVs (0.8% - 1.6%), between-run CVs (0.2% - 1.0%), within-day CVs (0.8% - 1.7%), between-day CVs (0.3% - 0.6%), and within laboratory (total im-precision) CVs (0.8% - 1.8%) with two levels of quality control materials. Very good linearity was observed in the method-comparison studies based on Passing-Bablok regression analysis (y = -0.03 + 1.02 x, CUSUM test p = 0.07). Intraclass correlation coefficient (ICC = 0.995) for results and Kappa value (κ = 0.86) for classification of results according to the American Diabetes Association recommendations showed almost perfect agreement. Conclusions The Lifotronic H9 analyzer shows good precision with lower than recommended total CV 2% and linearity with Arkray HA8160. The Lifotronic H9 is a suitable analyzer for the diagnosis of diabetes and monitoring diabetic control.