摘要目的 分析不同厂家丙型肝炎病毒抗体(抗HCV)化学发光法(CLIA)筛查试剂S/CO值与重组免疫印迹(RIBA)确证实验阳性结果的相关性.方法 采用病例对照研究.应用3种国产试剂(山东莱博、北京源德、北京科美)和1种进口试剂(美国雅培)对2014年3月至2015年3月山东大学齐鲁医院检验科收集的2 616例血清样本进行抗HCV筛查,反应性标本再通过RIBA进一步确证.对阳性预测值与抗HCV S/CO值的相关性分析比较.不同试剂间差异比较采用x2检验方法.结果 山东莱博1≤S/CO＜ 26.8时,阳性预测值为33.3％,S/CO ≥26.8时,阳性预测值为97.8％;北京源德1≤S/CO＜ 16.6时,阳性预测值为20％,S/CO≥16.6时,阳性预测值为96.7％;北京科美1≤S/CO＜ 16.7时,阳性预测值为9.8％,S/CO≥16.7时,阳性预测值为97.0％;美国雅培1≤S/CO＜5时,阳性预测值为12.8％,S/CO≥5时,阳性预测值为96.9％.结论 抗HCV CLIA筛查试剂盒检测S/CO值与RIBA确证实验阳性结果有一定相关性,国产试剂可参考进口试剂确定S/CO值与阳性预测值的关系.不同试剂相同阳性预测值对应不同S/CO值,提示厂家可根据情况设定产品特定S/CO值,为临床实验结果判定提供参考.

abstractsObjective To investigate relationships between signal/cutoff (S/CO) ratios of antiHCV recombinant immunoblot assay (RIBA) and their positivity with different chemiluminescence immunoassay(CLIA) reagents.Methods A case-control study was performed.From March 2014 to March 2015,anti-HCV antibody was detected in 2 616 serum of outpatients and inpatients coming from Department of Clinical Laboratory,Qilu Hospital of Shandong University by three kinds of homemade CLIA reagents and one imported CLIA reagents.The positive samples were further tested by RIBA.The correlation between the positivity and the S/CO ratios was analyzed.The difference between different reagents were compared by x2 method.Results The predicted positivities of Shandong Laibo were 97.8％ and 33.3％ with S/CO ratio ≥ 26.8 and 1 to 26.8,respectively;The predicted positivities of Beijing Yuande were 96.7％ and 20％ with S/CO ratio ≥ 16.6 and 1 to 16.6,respectively;The predicted positivities of Beijing Kemei were 97.0％ and 9.8％ with S/CO ratio ≥ 16.7 and 1 to16.7,respectively;The predicted positivities of Abbott were 96.9％ and 12.8％ with S/CO ratio≥5 and 1 to 5,respectively.Conclusions Anti-HCV CLIA S/CO ratio and RIBA confirmatory test results have some relevance.Domestic reagents also can refer to import reagents determine the relationship between the positivity and the S/CO ratio.Different domestic reagent of positivity has different S/CO ratio.Although each reagent S/CO ratio to the same positivity has large difference,suggesting each manufacturer should set their products corresponding values according to the situation,providing reference for the clinical use of unit in result determination of the clinical trials.