Discussion on the coincidence rate and cut-off value of six domestic hepatitis B surface antibody ELISA kits

Acta Universitatis Medicinalis Anhui 2020 04 v.55 621-628     font:big middle small

Found programs:

Authors:Han Weiwei; Jin Qili; Liu Jiaqing

Keywords:hepatitis B virus surface antibody;enzyme linked immunosorbent assay;coincidence rate;cut-off val

DOI:10.19405/j.cnki.issn1000-1492.2020.04.027

〔Abstract〕 To verify the coincidence rate and evaluate the cut-off value of six kinds of domestic enzyme linked immunosorbent assay(ELISA) kits of hepatitis B virus surface antibody(HBsAb), and also to discuss the feasibility of using cut-off serum. HBsAb in clinical samples and the HBsAb standard substances were detected by electro chemiluminescence immunoassay(ECLIA) and six kinds of domestic ELISA kits of HBsAb respectively. Using the cut-off value of each kit to determine the results, the positive rates of reagent E and F were 100% when testing 10 mIU/ml of HBsAb standard substances. Reagent C and E had the highest precision. With 10 mIU/ml of HBsAb standard substances as cut-off serum, the cut-off value and grey zone of the six reagents were different. Reagent D had the lowest cut-off value and the minimum grey zone, while Reagent F had the highest cut-off value and the largest grey zone. When the HBsAb concentration of clinical samples was lower than 10 mIU/ml, 10~<50 mIU/ml and 50~<100 mIU/ml, the positive coincidence rates of the cut-off value determined by the ELISA kit of most reagent manufacturers was different from that of the cut-off serum. When clinical specimens with HBsAb concentration from 100~1 000 mIU/ml were tested, the positive coincidence rates of the two results determined by the two cut-off values of reagent A, B, C, D, E and F were all 100%. There are some differences in the detection performance of the six domestic ELISA kits of HbsAb, and there are deficiencies in the way that the cut-off value was recommended to be calculated. The use of cut-off serum will change the positive and negative coincidence rate of the ELISA kits, which needs to be fully verified by clinical samples before use.