不同HCV抗体检测试剂效果的比较

Efficacy comparative of different laboratory test reagents for hepatitis C virus antibody

目的对不同种类的实验室HCV抗体检测试剂进行比较。方法选取天门市第一人民医院采用国内实验室常用的HCV抗体筛查试剂(科华﹑新创﹑万泰和雅培)检测呈阳性的205份样本作为研究对象,进行HCV RNA核酸扩增检测(NAT),若NAT检测为阴性,再进行重组免疫印迹实验(RIBA)进一步确认。对4种筛查试剂的检测结果进行比较,并对其S/CO值和真阳性率进行分析。结果任一筛查试剂检测结果呈阳性反应的205份样本中,4种筛查试剂均为阳性的有191份(93.2%),4种筛查试剂结果不一致的有14份(6.8%)。新创、科华、万泰及雅培试剂的阳性预测值分别为88.2%(180/204)、93.8%(180/192)、91.4%(180/197)及90.0%(180/200)。筛查试剂阳性预测值≥95%的S/CO阈值分别为:新创9.0、科华4.0、万泰5.0及雅培7.0。结论科华、新创、万泰和雅培4种筛查试剂阳性预测值≥95%的S/CO阈值之间相差较大,与国内其他实验室比较相差也较大。当前各实验室应建立适用于自身的阳性预测值≥95%的S/CO阈值,以减少确证试验样本数量。

Objective To investigate the effects of different laboratory test reagents for hepatitis C virus（ HCV） antibody through a comparative analysis. Methods A total of 207 samples which tested positive by four anti- HCV screening reagents commonly used in the laboratories in China（ Kehua,Xinchuang,Wantai,and Abbott） were included. HCV RNA nucleic acid amplification（ NAT） was performed,and if NAT results were negative,recombinant immunoblot assay（ RIBA） was performed for further confirmation. The test results of these four screening reagents were compared,and their S/CO values and true positive rates were analyzed. Results Of all the 205 samples testing positive by any one reagent,191（ 93. 2%） tested positive by the four reagents,and 14（ 6. 8%） were tested inconsistently by the four reagents. The positive predictive values of Xinchuang,Kehua,Wantai,and Abbott reagents were 88. 2%（ 180/204）,93. 8%（ 180/192）,91. 4%（ 180/197）,and 90. 0%（ 180/200）,respectively. The S/CO thresholds with a positive predictive value of ≥95% for Xinchuang,Kehua,Wantai,and Abbott reagents were 9. 0,4. 0,5. 0,and 7. 0,respectively. Conclusion Xinchuang,Kehua,Wantai,and Abbott reagents have significantly different S/CO thresholds with a positive predictive value of ≥95%,which are significantly different from those in other domestic laboratories. Each laboratory should establish an applicable S/CO threshold with a positive predictive value of ≥95%,in order to reduce the sample size for confirmatory test.