ELISA检测乙型肝炎表面抗原的范围和确认试验探讨

目的探讨酶联免疫吸附试验（ELISA）测定乙型肝炎表面抗原（HBsAg）阴性样本临界结果的复检范围和确认试验的弱阳性样本检测范围。方法血清样本用国产ELISA试剂测定HBsAg，阴性样本进行复检，复检结果阳性进行确认试验。确认试验应用雅培公司的AxSYM全自动酶免疫荧光分析系统和配套试剂。结果HBsAg阴性样本547例，其中510例吸光度（A）值i〉0．0735，复检结果阳性5例，确认试验结果亦为阳性；37例A值〈0．0735，复检结果均为阴性。HBsAg阳性样本332例，其中160例A值≥1．0，确认试验均为阳性；172例A值〈1．0的样本中有7例确认试验结果为阴性。结论应用国产ELISA试剂进行HBsAg的确认试验，应先确定阴性样本的复检范围和需做确认试验的弱阳性样本范围。

Investigation on the range and confirmation test of hepatitis B surface antigen determination by ELISA

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） 〉t 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 i〉 1.0 were all positive. In 172 cases of A 〈 1.0, 7 samples were negative. Conclusions For HBsAg confirmation test using EL1SA 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.