金标法检测乙肝表面抗原漏检原因分析

Analysis of factors causing missing detection of HBsAg by colloidal gold method

目的分析金标法检测乙肝表面抗原(HBsAg)的漏检原因。方法采用金标法和酶联免疫吸附法(ELISA)对10 335例献血者血液标本进行HBsAg检测,计算阳性率、漏检率。采用金标法和ELISA检测HBsAg质控品,分析检测灵敏度。结果金标法检测阳性率为0.33%,ELISA为1.14%,金标法检测阳性率低于ELISA(χ2=46.76,P<0.05)。金标法漏检率为71.19%。金标法反应时间为5、10、15min时,漏检率为94.92%、88.98%、71.19%,比较差异有统计学意义(χ2=38.27,P<0.05)。金标法不能检出浓度为0.5ng/mL的HBsAg质控品。结论金标法检测灵敏度较ELISA低,并且受人为因素影响较大,适用于献血前初筛。

Objective To analyze the factors causing missing detection of hepatitis B virus surface antigen （HBsAg） by using colloidal gold method .Methods Colloidal gold method and enzyme linked immunosorbent assay （ELISA） were performed to detect HBsAg in 10 335 blood samples of donors ,and quality control materials .Positive rate ,missing rate and sensitivity were analyzed .Results The positive rate of colloidal gold method was 0 .33% ,high-er than the 1 .14% of ELISA （χ2 =46 .76 ,P〈0 .05） .The missing rate of colloidal gold method was 71 .19% .When the reaction time of colloidal gold method was 5 ,10 and 15 min ,the missing rates were 94 .92% ,88 .98% and 71 .19% ,with statistical differences （χ2 =38 .27 ,P〈0 .05） .HBsAg could not be detected by colloidal gold method , when the concentration of HBsAg was 0 .5 ng/mL .Conclusion The sensitivity of colloidal gold method might be lower than ELISA .Many factors could influence the detected results of colloidal gold method ,which could only be used for screening .