两种不同人乳头瘤病毒核酸检测试剂的性能比较  

Comparison of two assays for the detection and genotyping of HPV

作　　者：田亚宾[1] 周海卫[1] 刘东来[1] 石大伟[1] 沈舒[1] 张春涛[1] TIAN Ya-bin;ZHOU Hai-wei;LIU Dong-lai;SHI Da-wei;SHEN Shu;ZHANG Chun-tao(DivisionⅡof In Vitro Diagnostics for Infectious Diseases,National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院传染病诊断试剂二室,北京100050

出　　处：《中国病毒病杂志》2020年第4期263-266,共4页Chinese Journal of Viral Diseases

基　　金：国家“艾滋病和病毒性肝炎等重大传染病防治”科技重大专项(2018ZX10102001)。

摘　　要：目的评价Cobas4800和INNO-LiPA两种人乳头瘤病毒(human papillomavirus,HPV)核酸检测试剂检测宫颈脱落细胞样本中14种高危型HPV(high-risk HPV,HR-HPV)的一致性。方法采用Cobas4800和INNO-LiPA两种HPV核酸检测试剂,分别对收集的489份宫颈脱落细胞样本进行一对一检测。通过计算κ值和配对χ~2检验比较2种试剂检测14种HR-HPV的特异性、灵敏度和一致率。结果Cobas4800和INNO-LiPA两种核酸检测试剂,检测HPV16和HPV18的一致性较好,总符合率为94.4%和97.3%(κ>0.8,P>0.1);检测其他12种HR-HPV的一致性为83.44%(κ=0.670,P<0.001)。进一步分析检测结果不一致样本,发现INNO-LiPA试剂比Cobas4800试剂检出更多的HR-HPV型别(HPV52、HPV58和HPV68)。结论Cobas4800和INNO-LiPA两种HPV核酸检测试剂,检测HPV16和HPV18的一致性较高。在检测其他12种HR-HPV型别上,INNO-LiPA的灵敏度优于Cobas4800。Objective To compare the performance of Cobas4800 and INNO-LiPA HPV assays for the detection of 14 high-risk HPV strains.Methods A total of 489 cervical samples were collected and tested one-by-one using both Cobas4800 and INNO-LiPA HPV assays,respectively.Results The results showed that the coincidence rate between Cobas 4800 and INNO-LiPA was 94.4%and 97.3%in detection for HPV16 and HPV18 types,respectively(κ>0.8,P>0.1).For detection of other 12 high-risk(HR)HPVs,these two assays showed a consistency with a kappa value of 0.670(P<0.001),indicating that INNO-LiPA could detect more HPV52,HPV58 and HPV68 positive samples compared with Cobas4800.Conclusions The performance of these two assays was similar in detecting HPV16 and HPV18.For the detection of other 12 HR-HPV,INNO-LiPA is more sensitive than Cobas4800.

关 键 词：人乳头瘤病毒 检测试剂 灵敏度 特异性 检测一致性 Cobas4800 INNO-LiPA 

分 类 号：R737[医药卫生—肿瘤]