Abstract
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Performance Evaluation of the Newly Developed H-120 HbA1c Analyzer
by Anping Xu, Hui Yu, Rui Ji, Yueying Huang, Weijie Xie, Peng Ye, Rong He, HouLong Luo, Ling Ji
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Background: The aim of this study is to evaluate the analytical performance of Mindray H-120, a newly developed and launched Hemoglobin A1c (HbA1c) analyzer that is based on ion-exchange high-performance liquid chroma-tography (HPLC).
Methods: In both standard and variant modes of the H-120 analyzer, precision, accuracy, linearity, and potential interference from Hb variants were assessed. In addition, the consistency of results between the H-120 analyzer and other commonly used analyzers was evaluated.
Results: The H-120 analyzer showed excellent precision and accuracy. The coefficients of variation (CVs) of repeatability and reproducibility were not greater than 0.5%. The H-120 analyzer provided results that were consistent with IFCC-assigned external quality control samples with a bias of ± 2.0%. The HbA1c level showed a good linear relationship between 3.0% and 20.1%. The results from the standard and variant modes for the H-120 analyzer were in perfect agreement (r = 1.000), and the HbA1c results showed a high level of consistency (r ≥ 0.998) when comparing the H-120 with the other two analyzers, D100 and Capillarys 3 TERA. The H-120 analyzer can detect nine of the ten most common Hb variants, and 83.8% of the variant samples do not affect HbA1c measurements.
Conclusions: The H-120 analyzer offers outstanding fundamental performance, robust variant detection capabilities, and user-friendly, efficient operation, making it suitable for the requirements of clinical laboratories.
DOI: 10.7754/Clin.Lab.2025.250530
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