三种HIV-1基因型耐药检测方法的一致性评价  

Evaluation of the consistency of three methods for testing HIV-1 genotype drug resistance

作　　者：李晶[1] 蒋岩[1] 吕超[1] 汪静[1] 姚均[1] 

机构地区：[1]中国疾病预防控制中心性病艾滋病预防控制中心参比实验室,北京102206

出　　处：《中华预防医学杂志》2013年第11期1050-1055,共6页Chinese Journal of Preventive Medicine

摘　　要：目的 比较In-house HIV-1基因型耐药检测方法与TRUGENETM、ViroSeqTM两种商品化耐药检测方法结果的一致性.方法 选取25份2009-2013年来自美国Rush大学的HIV-1基因型耐药检测血浆国际考核样本,分别使用In-house、TRUGENETM和ViroSeqTMHIV-1基因型耐药检测方法,对其耐药相关突变位点及17种药物的耐药性进行检测 另取15份来自中国CDC性病艾滋病预防控制中心的待检血浆样本用In-house和TRUGENETM两种方法补充证实所得结论.对三种方法所得检测结果进行一致性评价.结果 耐药相关突变位点检测结果的一致性评价：25份国际考核样品中,三种方法对耐药相关突变位点检测结果的一致率为99.42％（2933/2950）,两两间比较一致性均为极强（Kappa值均＞0.81,P值均＜0.01）；耐药报告检测结果的一致性评价：三种方法两两间比较的不一致结果主要集中在核苷类逆转录酶抑制剂的齐多夫定（zidovudine,AZT）、去羟肌苷（didanosine,ddl）、司他夫定（stavudine,d4T）、阿巴卡韦（abacavir,ABC）4种药物,且主要为轻微不一致.其中In-house与 ViroSeqTM方法结果的轻微不一致率分别为28％ （7/25） 、28％ （7/25）、16％（4/25）、20％ （5/25）；In-house与TRUGENETM方法分别为44％（11/25）、28％（7/25）、36％（9/25）、28％ （7/25）；TRUGENETM与ViroSeqTM方法分别为24％（6/25）、8％（2/25）、28％（7/25）、8％（2/25）.In-house与ViroSeqTM比较时药物AZT,In-house与TRUGENETM比较时药物ddI、d4T、ABC、替诺福韦（tenofovir,TDF）为中度一致（加权Kappa系数分别为0.54,0.44,0.52,0.42,0.59,P值均＜0.01）,其余的比较结果均为高度一致（加权Kappa系数为0.61 ～ 0.80）或一致性极强（加权Kappa系数＞0.80）.15份待检样本的耐药相关突变位点的一致性为99.55％（1762/1770）,17种药物耐药结果的不一致也主要集中在AZT、ddI、d4T、ABC四种药物.结论 In-house HIV-1基因型耐药Objective To compare the concordance in predicting genotype HIV-1 drug resistance between In-house method and TRUGENETM or ViroSeqTM method.Methods 25 international proficiency testing（PT） samples received from 2009 to 2013 were detected by three methods,then pairwise comparison results was analyzed to validate their concordance on drug resistance mutation and drug resistance report.To further confirm the results,another 15 serum specimens were detected by In-house and TRUGENETM methods,then compared their results concordance.Results The evaluation of the consistency of resistanceassociated mutations showed that for 25 PT samples,the consistency was 99.42％ （2933/2950） in testing drug resistance mutation sites among the three methods; all pairwise comparison Kappa values ＞ 0.81（P ＜ 0.01）.The evaluation of the consistency of drug resistance test showed that inconsistent comparison results mainly concentrated in the four nucleoside reverse transcriptase inhibitors zidovudine （AZT）,didanosine （ddI）,stavudine （d4T）,abacavir （ABC）,and the inconsistencies were mainly minor.Where the minor inconsistencies between In-house and ViroSeqTM methods were 28％ （7/25）,28％ （7/25）,16％ （4/25） and 20％ （5/25）,respectively.And the inconsistencies between In-house and TRUGENETM method were separately 44％ （11/25）,28％ （7/25）,36％ （9/25） and 28％ （7/25） ; while the inconsistencies between TRUGENETM and ViroSeqTM method were separately 24％ （6/25）,8％ （2/25）,28％ （7/25） and 8％ （2/25）.AZT in the comparison between In-house and ViroSeqTM methods,ddl,d4T,ABC and TDF in the comparison]between In-house and TRUGENETM methods were moderately consistent （weighted Kappa values were separately 0.54,0.44,0.52,0.42,0.59,all the P value ＜ 0.01）.The other compared results were all highly-consistent （weighted Kappa values were 0.61-0.80） or extremely high-consistent （weighted Kappa values were ＞ 0.80）.For 15 serum specimens,99.55％ （1762

关 键 词：获得性免疫缺陷综合征 HIV-1 基因型 耐药性 

分 类 号：R440[医药卫生—诊断学]