Abstract:

Objective　To evaluate the performance of colloidal gold immunochromatography assay (GICA) for the determination of the serological markers of hepatitis B virus (HBV-M). Methods　Abbott i1000 immunoassay system detected 653 cases of HBV-M positive samples, and the results of 103 cases of HBV-M negative samples and HBV-M standard materials by chemiluminescence immunoassay (CLIA) were as the standard. Enzyme-linked immunosorbent assay (ELISA) reagent and 5 GICA reagents were used for the detection, and the results were analyzed statistically. Results　The sensitivity for the determination of HBV-M was analyzed. ELISA and GICA detection limits for HBV-M showed that hepatitis B surface antigen (HBsAg) 0.5 IU/mL and 4-8 IU/mL,anti-hepatitis B surface antigen antibody (anti-HBs) 10 mIU/mL and 15-30 mIU/mL, hepatitis B e antigen (HBeAg) 1 NCU/mL and 2-4 NCU/mL, anti-hepatitis B e antigen antibody (anti-HBe)2 NCU/mL and 64-256 IU/mL, anti-hepatitis B core antigen antibody (anti-HBc) 2 IU/mL and 32-256 NCU/mL. The coincidence rates of HBV-M were 87.4%, 99.0%, 87.7%, 96.6% and 100.0% by ELISA and were 69.6%-71.7%, 69.0%-72.0%, 70.5%-73.9%, 42.2%-49.1% and 50.0%-60.0% by GICA. Except the specificity for the determination of anti-HBs by GICA was slightly bad, the specificities of other HBV-M were acceptable. Conclusions　GICA for the determination of HBV-M with low concentration has high missing rate.GICA can only be used for the screening HBsAg with linear range, and its results cannot be used for the clinical diagnosis and efficacy assessment of hepatitis B.

Key words: Hepatitis B virus serological marker, Colloidal gold immunochromatography assay, Chemiluminescence immunoassay, Enzyme-linked immunosorbent assay