【摘要】 目的对实验室常用的酶联免疫吸附试验(ELISA)试剂的临界(cut-off)值进行验证,判断试剂盒提供的cut-off值设置是否适合。方法各验证项目,根据试剂盒说明书及相关标准操作程序(SOP)进行检测,检测结果计算均值、标准差,并计算出x±3sd,然后与试剂盒提供方法计算出的cut-off值进行比较,如果该项目的x±3sd接近试剂盒提供的cut-off,则认为该项目的试剂盒提供的cut-off是适合的。结果HBsAg,HBeAg,抗-HBs,抗-HBe,抗-HBe,抗-HBc,抗-HBc-IgM,艾滋病毒抗体(抗-HIV),丙型肝炎病毒抗体IgG(抗-HCV-IgG),抗-TP前S1抗原(Pre-S1Ag),丙型肝炎抗原(HCVAg)验证结果为:0.057、0.078、0.125、0.730、0.765、0.032、0.070、0.037、0.097、0.047、0.017。结论抗-HBs、抗-HBe、抗-HBc项目验证结果与试剂盒提供的cut-off值接近,cut-off值设置是适合的;其他项目结果相差较远,cut-off值设置是不适合的。更多还原

【Abstract】 Objective To confirm the cut off value of commonly used laboratory reagents in ELISA.Methods According to kit introduction and related SOP,the varied verification projects were detected.The mean,standard deviation and x-±3sd were calculated and compared with those calculated by the kit provided method.If x-±3sd value of project closed to that provide by the kit,the cut off value provided by kit was suitable.Results For HBsAg,anti-HBsAg,anti-HBs,anti-HBe,anti-HBe,anti-HBc,anti-HBc-IgM,anti-HIV,anti-HCV-IgG,anti-TP,Pre-S1Ag,anti-HCV,the confirmation results were:0.057,0.125,0.078,0.730,0.765,0.032,0.070,0.037,0.097,0.047,0.017.Conclusion The confirmation results of anti-HBs,anti-HBe,anti-HBc close to those provided by kit and their cut off values are suitable,and the other cut off valuse are usnsuitable due to big discrepancy from the kit′s.更多还原