乙型肝炎表面抗原检测结果分析及灰区设置探讨

目的通过对血液标本乙型肝炎表面抗原(HBsAg)检测反应性和弱反应性结果的分析,探讨酶联免疫吸附试验(ELISA)设置灰区的意义。方法采用高灵敏度进口和常规国产ELISA试剂对献血标本进行HBsAg血液筛查,比较两种试剂的检测结果 ;对0.7≤S/CO1灰区范围的弱反应性标本进行复检,探讨HBsAg检测灰区设置的范围及意义。结果共检测13965份无偿献血者标本,其中进口试剂检测HBsAg的阳性率为0.87%,国产试剂检测的阳性率为0.77%,进口试剂比国产试剂的检出阳性率高;对0.8≤S/CO1灰区范围的26例弱反应性标本进行再检,两种试剂合计有3份标本S/CO≥1,占11.5%。结论 HBsAg检测进口试剂比国产试剂的灵敏度高,有条件的血站在选择HBsAg检测试剂时应选择一遍进口试剂进行检测;HBsAg检测的灰区范围建议设定为域值(cut-off值)下的80%。

Analysis of HBsAg detecting results and gray area setting study

Objective To study the significance of setting up the proper gray area for enzyme-linked immunosorbent assay（ELISA） via detecting HBsAg in blood specimen and analyzing positive and weak-positive results.Methods Using imported and routine domestic ELISA reagents with high sensitivity to perform the screen detection of the surface antigen of the hepatitis B virus（HBsAg） in donators＇ blood specimen,and to compare the results.To verify（re-test） the weak-positive results in the gray area range of 0.7≤S/CO1 and to study the range of the gray area setting and its significance.Results Among the test results of 13 965 gratuitous donator blood specimens,the HBsAg positive rate detected by imported reagents was 0.87%,comparing to the detected rate 0.77% by using domestic reagents.The positive rate by imported reagents was higher.Among those 26 weak-positive results in the gray area of 0.8≤S/CO1,after verifying（re-test） the specimen with these two kinds of reagents,3 specimens with S/CO≥1 were found,accounting for 11.5%.Conclusion The imported HBsAg detecting reagents have higher sensibility than the domestic ones.For the blood collecting and supplying branches,choosing HBsAg detecting reagents,if possible,should use imported reagents to screen detect once.The HBsAg detecting gray area set to be 80% under cut-off value is recommended.