B-030 Analytical Performance Evaluation of the Maccura Glycosylated Hemoglobin Analyzer G 02 (High-Performance Liquid Chromatography)

Abstract

Background The Glycosylated Hemoglobin Analyzer G 02 (High-Performance Liquid Chromatography) is a next-generation product independently developed by Maccura Biotechnology. It features two testing modes (Standard Mode/ Variant Mode) with the advantage of one-touch switching between modes without replacing the reagent chromatography column. This study aimed to evaluate the analytical performance of the G 02 analyzer to determine whether it meets the requirements for clinical application. Methods In accordance with the Clinical and Laboratory Standards Institute (CLSI) EP09-A3 guidelines and other relevant specifications, the accuracy, precision, and other analytical performance indicators of the G 02 were assessed. Additionally, the analyzing performance of the G 02 analyzer was compared with that of Tosoh HLC-723 G11 system in 143 clinical samples, and the consistency between the two systems was evaluated. Results In Standard Mode, the within-laboratory precision coefficient of variation (CV) ranged from 0.3% to 0.9%, and the relative bias for accuracy ranged from -2.48% to -0.14%. For clinical comparison, the expected relative biases at medical decision levels (MDLs) of 6.5%, 7.0%, and 10.0% were -0.19% (95% CI: -0.53% to 0.32%), -0.21% (95% CI: -0.54% to 0.18%), and -0.31% (95% CI: -0.92% to 0.30%), respectively. In Variant Mode, the within-laboratory precision CV ranged from 0.4% to 0.7%, and the relative bias for accuracy ranged from -1.96% to 0.00%. For clinical comparison, the expected relative biases at medical decision levels of 6.5%, and 10.0% were -1.25% (95% CI: -1.52% to -0.78%), -0.90% (95% CI: -1.13% to -0.50%), and 0.45% (95% CI: 0.074% to 0.84%), respectively. In both modes, the within-run repeatability met the requirement of CV < 0.5%. Conclusion The Maccura G 02 analyzer offers high-speed detection, with each test taking 30 seconds in Standard Mode and 50 seconds in Variant Mode. Both testing modes demonstrate excellent fundamental performance and show high consistency with the clinical results from the Tosoh G11. These characteristics meet the requirements for clinical laboratory use.