Evaluation of the performance of four methods for detection of hepatitis B surface antigen and their application for testing 116,455 specimens

Abstract

Hepatitis B surface antigen (HBsAg) is a crucial serum marker for the diagnosis of hepatitis B virus (HBV) infection. It is imperative to compare test results from different detection methods based on different principles. Four methods, chemiluminescent microparticle immunoassay (CMIA), electrochemiluminescent immunoassay (ECLIA), enzyme-linked immunosorbent assay (ELISA) and golden immunochromato-graphic assay (GICA) were applied to test the HBsAg level in 250 specimens. According to the EP12-A2 and EP15-A2 documents from Clinical and Laboratory Standards Institute (CLSI), the concentration at which repeated results are 50% positive (C50) of HBsAg detected by CMIA, ECLIA, ELISA and GICA was 0.05, 0.08, 0.15 and 15.0IU/ml, respectively. When the detection concentration of HBsAg was 0.5IU/ml, the imprecision degree of CMIA, ECLIA and ELISA was 8.1%, 5.9% and 14.9% respectively. When detecting high HBsAg level (≥20.0IU/ml) and HBsAg negative specimens, the consistency of the four methods was high, while for the low level (0.05-20.0IU/ml), the consistency was poor (except for the CMIA and ECLIA, P<0.05). When evaluation of the four methods in qualitative diagnosis of HBsAg level in the 116,455 specimens, there was no significant discrepancy among CMIA, CMIA and ECLIA, however, GICA was significantly different from the other 3 methods. Compared with CMIA, the false negative rate of ECLIA, ELISA and GICA was 0.2%, 1.3% and 12.3% respectively. In conclusion, GICA was only suitable for the preliminary screening of HBsAg positive individuals and ELISA can be applied to the qualitative diagnosis of HBsAg. Both CMIA and ECLIA were suitable for the quantitative determination of HBsAg.

Keywords: Application value; C5; C50; C95; CLSI; CMIA; Clinical and Laboratory Standards Institute; ECLIA; ELISA; EP12-A2; EP15-A2; Evaluation Protocols 12-Approved Guideline Second Edition; Evaluation Protocols 15-Approved Guideline Second Edition; GICA; HBV; HBsAg; Method; Performance evaluation; chemiluminescent microparticle immunoassay; electrochemiluminescent immunoassay; enzyme-linked immunosorbent assay; golden immunochromato-graphic assay; hepatitis B virus; hepatitis B virus surface antigen; the concentration at which repeated results are 5% positive; the concentration at which repeated results are 50% positive; the concentration at which repeated results are 95% positive.