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目的评价利用胶体金免疫层析法(GICA)复检酶联免疫吸附试验(ELISA)所检测出的乙型肝炎表面抗原(HBsAg)阳性标本的效果。方法分离用ELISA法筛选出的无黄疸、无溶血HBsAg阳性标本血清,按初检A值/cutoff值的大小分为A-E 5组,每组随机选取40例患者标本,另取40例健康者血清纳入对照组F组。每组标本分别用GICA法、ELISA法和化学发光免疫分析法(CLIA)进行复检。以CLIA法检测结果为金标准,计算并比较GICA法和ELISA法复检的假阳性率及假阴性率。结果 GICA法复检全部标本的假阳性率为0。当1≤A值/cutoff值<5时,GICA法的假阴性率为95.24%,同时,检测出1例因HBsAg滴度过高导致ELISA漏检的标本;当5≤A值/cutoff值<10时,GICA法的假阴性率降为23.68%;当A值/cutoff值≥10时,GICA法的假阴性率为0。结论 ELISA法HBsAg初检A值/cutoff值≥10时,用GICA法复检为阳性,可及时发出报告;当A值/cutoff值<10时,为保证检验结果的准确性,除胶体金法外,还应使用ELISA等方法进行复检。
Objective To evaluate the effect of HBsAg positive samples detected by enzyme-linked immunosorbent assay (ELISA) on colloidal gold immunochromatography (GICA). Methods Sera from patients without jaundice and non-hemolysis HBsAg-positive specimens were screened by ELISA, divided into 5 groups according to the initial A value / cutoff value, 40 specimens from each group and 40 healthy persons Into the control group F group. Each group of specimens were retested by GICA method, ELISA method and chemiluminescence immunoassay (CLIA). Using the CLIA method as the gold standard, the false positive rate and false negative rate of the GICA method and the ELISA method were calculated and compared. Results The false positive rate of all samples in the GICA method was 0. When 1≤A value / cutoff value <5, the false negative rate of GICA method was 95.24%. At the same time, 1 case of missed samples was detected by ELISA because of the high HBsAg titer. When 5≤A value / cutoff value < 10, the false negative rate of GICA was reduced to 23.68%. When the value of A / cutoff was ≥10, the false negative rate of GICA was 0. Conclusion When the initial value of A / cutoff value of HBsAg in ELISA is ≥10, it can be timely reported by GICA retesting. When the value of A / cutoff is less than 10, in order to ensure the accuracy of test results, In addition, ELISA and other methods should also be used for re-examination.