Abstract:

Objective　To investigate the retesting range of borderline results for hepatitis B surface antigen (HBsAg) negative samples determined by enzyme-linked immunosorbent assay(ELISA) and the result range of weakly positive samples for confirmation test. Methods　Serum HBsAg was detected by ELISA reagents made in China. Negative samples were retested. Positive samples were carried on confirmation test using Abbott AxSYM system and reagents. Results　There were 547 cases of HBsAg negative samples, including 510 cases of absorbance (A)≥0.073 5. After retesting, 5 cases were positive, and the results of confirmation test were positive. In 37 cases of A＜0.073 5, all retested negative. A total of 332 positive samples were carried on confirmation test, and 160 cases of A≥1.0 were all positive. In 172 cases of A＜1.0, 7 samples were negative. Conclusions　For HBsAg confirmation test using ELISA reagents made in China, it is useful to definite the retesting range of negative samples, and is necessary for weakly positive samples to identify confirmation test range.

Key words: Enzyme-linked immunosorbent assay, Hepatitis B surface antigen, Retesting range, Confirmation test