抗-HIV、抗-HCV、抗-TP、HBsAg联合检测试剂盒的临床应用评价

目的 同时用参比试剂和评价试剂检测433例血清样本,探讨评价试剂与参比试剂检测结果的符合率.方法 评价试剂采用免疫层析法;参比试剂中的人类免疫缺陷病毒抗体(抗-HIV)、丙型肝炎抗体(抗-HCV)和乙型肝炎病毒表面抗原(HBsAg)检测采用酶联免疫法,梅毒螺旋体抗体(抗-TP)检测采用明胶凝集法,共检测血清标本433例.结果 抗-HIV评价试剂与参比试剂的总符合率、阳性符合率和阴性符合率均为100.00% ,两种方法比较差异无统计学意义(P>0.05);抗-HCV评价试剂与参比试剂的总符合率、阳性符合率和阴性符合率分别为99.54%、100.00%和99.50%,两种方法比较差异无统计学意义(P>0.05);HBsAg评价试剂与参比试剂的总符合率、阳性符合率和阴性符合率分别为97.92%、96.55%和98.13%,两种方法比较差异无统计学意义(P>0.05).抗-TP评价试剂与参比试剂的总符合率、阳性符合率和阴性符合率分别为99.31%、96.30%和99.51%,两种方法比较差异无统计学意义(P>0.05).结论 评价试剂与参比试剂的检测结果具有很好的一致性.

Clinical performance of combination detection reagent kits of anti-HIV,anti-HCV,anti-TP and HBsAg

Objective To study the coincidence rate of detection results in reference reagent and testing reagent for simultaneously detecting 433 serum samples.Methods There were three different methods used.Control group was tested by tmmunochromatography method,anti-HIV,anti-HCV antibody and HBsAg by enzyme-linked immunosorbent assay and anti-TP antibody by gelatin agglutination method.Totally,433 samples were used.Results The total coincidence rate,positive coincidence rate and negative coincidence rate in the test...