时间分辨荧光免疫技术测量乙肝标志物可疑结果分析与处理

Analysis and solution of suspected results of hepatitis B virus markers detection by time-resolved fluorescence immunoassay

目的对时间分辨荧光免疫技术(TRFIA)定量检测乙肝标志物中可疑结果进行分析,并提出处理对策。方法收集HBsAg"灰区"结果标本72例、"矛盾"结果标本111例、罕见模式标本156例。对"灰区"结果标本同时进行胶体金层析法检测及中和实验;对"矛盾"结果标本进行中和实验;对罕见模式标本进行双孔复查及中和实验确认。结果经中和实验确认HBsAg"灰区"阳性标本有32例真阳性,灰区阴性标本中有3例真阳性;中和实验确认,矛盾结果中,HBsAg和HBsAb双阳性均为真阳性;HBeAg和HBeAb双阳性结果中HBeAg为真阳性、HBeAb均为假阳性;罕见模式标本经双孔复查和中和实验证实,HBeAb均为假阳性。结论表面抗原灰区阳性标本只能定量双孔复查,不能采用金标法复查;确实存在HBsAg和HBsAb双阳性情况;TRFIA检测HBeAb的准确性和精密度欠佳,应审慎对待TRFIA的可疑结果。

Objective To analyze the doubtful results of hepatitis B virus markers（HBM） detection by time-resolved fluorescence immunoassay（TRFIA）,and explore the countermeasures. Methods Seventy-two specimens with HBsAg grey-zone result were confirmed by colloidal gold immunochromatography assay and neutralizing test. One hundred and nine specimens with contrary results were confirmed by neutralizing test. One hundred and fifty-six rare specimens were rechecked by double-orifice way at first,then confirmed by neutralizing test. Results Thirty-two specimens with HBsAg positive in grey zone were confirmed true positive,and 3 specimens with HBsAg negative in grey zone were confirmed true positive by neutralizing test. The specimens with both HBsAg and HBsAb positive were confirmed both true positive in specimens with the contrary results by neutralizing test,while those with both HBeAg and HBeAb positive were confirmed HBeAg true positive and HBeAb false positive. All the rare specimens were confirmed HBeAb false positive by double-orifice assay and neutralizing test. Conclusion The specimens with HBsAg positive in grey zone can only be rechecked by quantitative double-orifice assay,not by colloidal gold immunochromatographic strip test. Both HBsAg and HBsAb positive can be real in the same specimen. The precision and accuracy of HBeAb detection by TRFIA were not better,so it should be cautious to the doubtful HBM result by TRFIA.