两种方法检测丙型肝炎病毒抗体的一致性比较

Comparison of the concordance of two methods for the detection of anti-HCV

目的用Kappa检验分析两种方法检测丙型肝炎病毒(hepatitis C virus,HCV)抗体的一致性,为安全输血提供最佳的HCV抗体筛查方法。方法选取2015年2月至2016年6月在我院就治而有可能需输血患者的丙型肝炎病毒抗体待检标本,用胶体金法HCV抗体检测试剂盒检测,将可疑结果和阳性结果标本再用酶联免疫吸附试验HCV抗体诊断试剂盒(ELISA)和化学发学测定法HCV抗体检测试剂盒CLIA)分别进行复检。用SPSS17.0软件分别对可疑和阳性结果、可疑结果、阳性结果进行Kappa分析一致性程度,并用U检验对Kappa系数进行统计分析。结果胶体金法HCV抗体检测试剂盒检测全部标本共448例可疑阳性和阳性结果,其中112例为可疑结果,336例为阳性结果;用ELISA方法检测448例初检为可疑和阳性结果,结果为阴性、可疑和阳性的例数分别是54例(12%)、18例(4%)、376例(84%),用CLIA方法检测结果分别为42例(9.4%)、11例(2.5%)、395例(88.1%);用ELISA方法检测112例初检为可疑阳性结果,结果为阴性、可疑和阳性的例数分别是11例(9.8%)、30例(26.8%)、71例(63.4%),用CLIA方法检测结果分别为13例(11.6%)、21例(18.7%)、78例(69.7%);用ELISA方法检测336例初检为阳性结果,结果为阴性、可疑和阳性的例数分别是12例(3.6%)、28例(8.3%)、296例(88.1%),用CLIA方法检测结果分别为11例(3.3%)、19例(5.6%)、306例(91.1%)。两种方法对可疑和阳性标本、可疑标本、阳性标本的Kappa系数分别为Kappa=0.730(u=16.22,P<0.01)、Kappa=0.497(u=6.81,P<0.05)、Kappa=0.705(u=11.56,P<0.01)。结论两种方法对可疑和阳性标本、阳性标本的检测结果有较好的一致性,而对可疑标本的检测结果一致性为中等,对可疑阳性结果应用更为敏感和特异的试验验证。

Objective To evaluate the concordance of the two methods for detection of antibodies to hepatitis C virus （anti-HCV）, and to provide the best HCV antibody screening method for safe blood transfusion. Methods All the anti-HCV inspected samples which were collected from the patients, who admitted to our hospital for treatment and un-derwent blood transfusion from February 2015 to June 2016, were detected by HCV antibody detection kit with colloi-dal gold method. The suspicious and positive samples were re-inspected by enzyme-linked immunosorbent assay （ELI-SA） and chemiluminescent immunoassay （CLIA）. Kappa consistency analysis of the re-inspected results of suspicious and positive specimens was carried out with SPSS17.0 software, and the Kappa coefficient was statistically analyzed by U test. Results A total of 448 suspicious and positive samples were detected by HCV antibody detection kit with col-loidal gold method among all the samples, which included 112 suspicious and 336 positive specimens. The negative, suspicious, positive specimens re-inspected out by ELISA in 448 samples were 54 （12%）, 18 （4%）, 376 （84%）, respec-tively; The negative, suspicious, positive specimens re-inspected out by CLIA in 448 samples were 42 （9.4%）, 11 （2.5%）, 395 （88.1%）, respectively. The 112 suspicious samples re-inspected by ELISA showed negative, suspicious, positive specimens were 11 （9.8%）, 30 （26.8%）, 71 （63.4%）, respectively;The re-inspected results by CLIA showed that negative, suspicious, positive specimens were 13 （11.6%）, 21 （18.7%）, 78 （69.7%）, respectively. The 336 positive samples re-inspected by ELISA showed negative, suspicious, positive specimens were 12 （3.6%）, 28 （8.3%）, 296 （88.1%）, respectively. The re-inspected results by CLIA were 11 （3.3%） negative, 19 （5.6%） suspicious, 306 （91.1%） positive, respectively. Kappa coefficient of suspicious-positive specimens, suspicious specimens and positive speci-mens by the two assays of anti-HCV were 0.730 （u=16.22, P〈0.01）, 0.497 （u=6.81, P〈0.05）, 0.705 （u=11.56, P〈0.01）, respectively. Conclusion There is a good consistency of suspicious-positive and positive specimens by the two assays of anti-HCV. The consistency of the two assays for suspicious specimens was medium, and other more sensitive and spe-cific methods should be used in the suspicious specimens.