Clinical performance evaluation of HBV serological biomarkers using SYSMEX HISCL5000 chemiluminescence analyzer / 医疗卫生装备

ABSTRACT

Objective To assess the detection performance of SYSMEX HISCL5000 automatic chemiluminescence immunoassay analyzer for serum hepatitis B virus (HBV) biomarkers.Methods Serological HBV biomarkers,including HBsAg,HBsAb,HBeAg,HbeAb and HbcAb,were measured by HISCLS000 analyzer.Further,a panel of parameters were analyzed,including precision,cross contamination rate,linear range,concordance rate,biological reference interval and limit of detection.According to the guideline from Clinical & Laboratory Standards Institues (CLSI) EP system,the potential clinical application of using HISCL5000 analyzer to measure serum HBV biomarkers were evaluated.Results A panel of five serum HBV biomarkers was measure by using HISCLS000 analyzer.The coefficient of variation (CV) value of the within-run imprecision was from 0.60％ to 4.17％,and CV value of the between-run imprecision was from 0.04％ to 5.35％.Linear verification showed that r2 was between 0.980 5 and 0.998 7,and a was between 0.970 9 and 1.022 6.The ratio of cross contamination was 0.00％.The coincident rate of HISCL5000 analyzer with other methods was between 96.00％ and 100.00％.Biological reference interval and limit of detectionderived from this analyzer were also proved qualified.Conclusion HISCL5000 analyzer can be used clinically to detect HBV biomarkers.