Key performance indexes of two HBsAg ELISA reagents: A retrospectively comparative analysis / 中国输血杂志

ABSTRACT

【Objective】 To retrospectively analyze the key performance indicators of two hepatitis B surface antigen (HBsAg) ELISA reagents used in blood stations, so as to provide basis for reagent selection from the perspective of laboratory performance. 【Methods】 The test results, reactive rate of initial/repeat test, concordance rate of initial and repeat test, and the NAT-yield implicated in ELISA-reactive samples with one assay from 2016 to 2019 were analyzed to compare the detection performance of two ELISA reagents. 【Results】 The total ELISA reactive rate of HBsAg was 0.39%(1 863/480 741), with 0.31% and 0.29% in two reagents, respectively. The initial reactive rate were 0.44% and 0.39%, concordance rate of initial and repeat test was 70.21% and 74.55%, respectively. 43 NAT-yield samples were implicated in ELISA-reactive samples with one assay. 【Conclusion】 There are differences underlying in the detection performance of the two reagents. In order to avoid blood waste and ensure blood safety, the key performance indexes and test results should be taken into consideration when selecting reagents.