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目的探讨时间分辨荧光免疫分析法(TRFIA)检测乙肝少见、罕见结果模式时出现假阴性结果的原因,并提出对策。方法选取2013年1月至2015年9月间,用TRFIA法进行两对半定量检测时出现的少见、罕见和可疑的阳性结果模式样本,同时采用胶体金法对乙肝表面抗原和乙肝e抗原进行检测,并用化学发光免疫分析法(CLIA)对上述样本进行两对半定量检测。结果在73例少见和可疑的阳性结果模式中,3+5:14例,2+3+5:8例,1+2+5:17例,1+2+4:9例,1+2:6例,高浓度的4+5:19例,其中乙肝表面抗原阳性有32例,乙肝e抗原阳性有22例;胶体金法检测结果:乙肝表面抗原阳性26例,乙肝e抗原阳性21例,并检出2例TRFIA法乙肝表面抗原结果为阴性的样本,但对低浓度的7例乙肝表面抗原和2例乙肝e抗原检测不出;而用CLIA法检测该73例两对半,模式中三个抗体的结果与TRFIA法并无太大的差异,但乙肝表面抗原检出38例(P<0.05),乙肝e抗原检出24例(P>0.05)。结论乙肝病毒变异等因素可致TRFIA法出现假阴性,胶体金法可起到一定的排查作用,但对低浓度的抗原或抗体有漏检;可用CLIA法对可疑样本进行定量复核,以利于临床的诊治。
Objective To explore the causes of false negative results of time-resolved fluorescence immunoassay (TRFIA) for the detection of rare hepatitis B and rare results and to propose countermeasures. Methods From January 2013 to September 2015, TRFIA was used to detect rare, rare and suspicious samples of positive results in two and a half pairs of semi-quantitative tests. Meanwhile, colloidal gold method was used to detect hepatitis B surface antigen and hepatitis B e antigen The samples were subjected to two-and-a-half semi-quantitative detection by chemiluminescence immunoassay (CLIA). Results Of the 73 rare and suspicious positive outcome patterns, 3 + 5: 14, 2 + 3 + 5: 8, 1 + 2 + 5: 17, 1 + 2 + 4: 9, 1 + 2 : 6 cases and 4 + 5: 19 cases with high concentration, of which 32 cases were positive for hepatitis B surface antigen and 22 cases were positive for hepatitis B e antigen. Results of colloidal gold assay showed that 26 cases were positive for hepatitis B surface antigen and 21 cases were positive for hepatitis B e antigen , And 2 cases of TRFIA negative HBsAg positive samples were detected, but 7 cases of HBsAg and 2 HBeAg were undetectable; The results of the three antibodies did not differ much from that of TRFIA, but HBsAg was detected in 38 (P <0.05) and hepatitis B e antigen in 24 (P> 0.05). Conclusion The mutation of hepatitis B virus can cause false negative in TRFIA assay. Colloidal gold assay may play a role in screening, but there is no detection of antigen or antibody in low concentration. The CLIA method can be used to check the suspicious samples quantitatively for clinical benefit Diagnosis and treatment.