HBsAg弱阳性样本的3种测定方法比较

Comparison of three measurement methods applying in HBsAg weakly positive samples

目的比较胶体金免疫层析试验(GICA)和酶联免疫吸附试验(ELISA)与微粒子化学发光检测技术(MEIA)检测HBsAg弱阳性样本的结果符合率,以了解3种方法的特异性与灵敏度等诊断指标。方法用3种方法平行检测收集的血清标本HBsAg,并相互比较。结果3种方法检测HBsAg的结果符合率为74.3%,其中ELISA与MEIA结果符合率为94.9%;GICA与MEIA结果符合率为76.9%。GICA检测HBsAg弱阳性样本时的各项诊断指标都不甚理想。结论1.GICA的灵敏度和特异性分别为81.3%和81.3%,较ELISA和MEIA低,检测HBsAg弱阳性样本时存在一定程度的漏检率和误诊率,只能起筛查作用,遇到HBsAg弱阳性的血清标本必须与ELISA法并用,实行双检。2.ELISA较MEIA灵敏度和特异性略低,当测定标本的OD值在临界值附近即检测灰区时建议用MEIA复检。

Objective T0 compare the result coincidence of HBsAg detected with gold immunochromatography assay （GICA）, enzyme linked immunosorhent assay （ELISA） and microparticle en zyme immunoassay （MEIA） in HBsAg weakly positive samples, and to understand the applicable val ue by comparing the diadynamic criteria including specificity and sensitivity. Methods The HBsAg weakly positive serum samples were detected with GICA, EI.ISA and MEIA simuhaneously and the results were compared. Results The result coincidence of HBsAg detected with three methods was 74.3%. Among them, the coincience rate of ELISA and MEIA was 95.2%, and the one of GICA and MEIA was 76.2%. The diagnosing efficiency of GICA detecting HBsAg weakly positive samples was not ideal. Conclusion The sensitivity and specificity of GICA were both 81.3%, significantly lower than those of ELIA and MEIA. GICA is only used to screen HBsAg because of its high omission rate and misdiagnosis rate in detection of HBsAg weakly positive samples. In the situation, GICA should be combined with ELISA method. Because the sensitivity and specificity of ELISA were a little lower than those of MEIA, MEIA rechecking should be performed when OD value is near to cutoff value.