商品化麻疹病毒IgG抗体检测试剂盒性能评价  

Performance of commercialized kits for detecting IgG antibody to measles virus

作　　者：丰达星[1] 王文慧 李光伟[1] 肖占沛[1] 马雅婷[1] 吕宛玉 张延炀[1] Feng Daxing;Wang Wenhui;Li Guangwei;Xiao Zhanpei;Ma Yating;Lyu Wanyu;Zhang Yanyang(Henan Center for Disease Control and Prevention,Henan Provincial Key Laboratory of Immunopreventive Medicine,Zhengzhou 450016,China)

机构地区：[1]河南省疾病预防控制中心,河南省免疫预防医学重点实验室,郑州450016

出　　处：《中华实验和临床病毒学杂志》2022年第3期323-326,共4页Chinese Journal of Experimental and Clinical Virology

基　　金：河南省医学科技攻关(联合共建)(LHGJ20190680)。

摘　　要：目的比较4种麻疹IgG抗体酶联免疫吸附实验检测试剂盒的检测性能,为开展血清流行病学调查提供参考。方法选择健康人群血清176份,使用4种试剂盒平行检测,采用配对卡方检验比较结果一致性,比较4种试剂盒的Kappa值、灵敏性、特异性、阳性预测值、阴性预测值等指标,比较各试剂盒CV值,对定量试剂盒结果进行相关性检验。结果4种试剂盒检测结果与参考标准差异均无统计学意义,χ^(2)值分别为0.333、2.000、1.000和0,Kappa值C试剂盒最高(0.976),灵敏性A、C、D试剂盒最高(99.34%),特异性B、C试剂盒最高(100%),阳性预测值B、C试剂盒最高(100%),阴性预测值C试剂盒最高(96.00%),试剂盒差异无统计学意义,P>0.05。变异系数D试剂盒最低(5.30%),相关性检验显示,C和D试剂盒结果有相关性r=0.639,P=0.001。结论4种试剂盒有较好的检测性能,可用于血清流行病学调查。Objective To compare the performance of four ELISA kits for detecting measles virus IgG antibody and to provide support for sero-epidemiologic survey.Methods A total of 176 specimens were tested by four ELISA kits,respectively.The result of 4 kits were analyzed by the McNemar’s test.The values such as Kappa value,CV value,sensitivity,specificity,positive predictive value and negative predictive values were calculated and compared.Results There was no significant difference among the result from kits and references,theχ^(2)were 0.333,2.000,1.000 and 0 respectively.The Kappa value of kit C was the highest(0.976),the sensitivity of kit A,C and D were the highest(99.34%),the specificity of kit B and C were the highest(100%),the positive predictive value of kit B and C were the highest(100%)and the negative predictive value of kit C were the highest(96.00%),there was no significant difference among the indicators from 4 kits(P>0.05).The CV value of kit D was the lowest(5.30%).The correlation coefficient between the result from kit C and D was 0.639(P<0.01).Conclusions The result showed that the 4 kits were suitable for serum epidemiologic survey.

关 键 词：麻疹 试剂盒 性能 

分 类 号：R446.6[医药卫生—诊断学] R511.1[医药卫生—临床医学]