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目的评价国产化学发光法检测单纯疱疹病毒HSV1/2型及HSV-2型抗体,和市售进口同类产品进行临床比对试验,了解该产品在临床使用中的效果。方法收集华西医院送检检测HSV 1/2型IgG抗体350例、HSV 1/2型IgM抗体350例及HSV-2型IgG抗体样本353例,以进口HSV1/2 IgG、HSV1/2 IgM及HSV-2 IgG试剂作为比对系统,分别评价国产化学发光法HSV1/2 IgG、HSV1/2 IgM及HSV-2 IgG试剂盒的诊断性能,结果不一致的标本运用第三方试剂进行复核。采用Kappa一致性检验分析定性结果的一致性,运用Bland-Altman分析定量数据的结果一致性。结果与进口试剂相比,HSV1/2 IgG评价试剂的总符合率是99.71%,Kappa值是0.986,P<0.05;HSV1/2 IgM评价试剂的总符合率是98.57%,Kappa值0.972,P<0.05;HSV-2 IgG评价试剂的总符合率是98.30%,Kappa值为0.971,P<0.05;此外,Bland-Altman分析结果显示,对于HSV1/2 IgG和HSV-2 IgG 2个定量项目,国产试剂和进口试剂之间量值差值(偏倚)均处于95%的一致限内,符合方法学比对一致性的统计学要求(<5%)。结论国产试剂盒与进口试剂盒在检测HSV1/2型及HSV-2型抗体方面具有良好的一致性,可以满足临床需求。
OBJECTIVE: To evaluate the clinical efficacy of HSV1 / 2 and HSV-2 antibodies by chemiluminescence assay in domestic and compare with the imported similar products on the market to find out the effect of this product in clinical use. Methods We collected 350 samples of HSV 1/2 IgG, 350 HSV 1/2 IgM and 353 HSV-2 IgG antibodies tested in West China Hospital for detection of HSV1 / 2 IgG, HSV1 / 2 IgM and HSV -2 IgG reagent as a comparison system to evaluate the diagnostic performance of the domestic chemiluminescence immunoassay for HSV1 / 2 IgG, HSV1 / 2 IgM and HSV-2 IgG respectively. The inconsistent samples were evaluated with third-party reagents. The Kappa consistency test was used to analyze the consistency of qualitative results and Bland-Altman was used to analyze the consistency of the quantitative data. Results The overall coincidence rate of HSV1 / 2 IgG evaluation reagent was 99.71%, Kappa value was 0.986, P <0.05. The total coincidence rate of HSV1 / 2 IgM evaluation reagent was 98.57%, Kappa value was 0.972, P < 0.05. The overall coincidence rate of HSV-2 IgG evaluation reagent was 98.30%, Kappa value was 0.971, P <0.05. In addition, Bland-Altman analysis showed that for HSV1 / 2 IgG and HSV-2 IgG two quantitative items, The difference in values (bias) between the reagent and the imported reagent is within 95% of the consensus limit, meeting the statistical requirements (<5%) for alignment of methodologies. Conclusion Domestic and imported kits have good consistency in detecting HSV1 / 2 and HSV-2 antibodies, which can meet the clinical needs.