HIV基因突变检测方法的建立及应用  

Application and establishment of HIV Gene mutation detection method

作　　者：孙显光[1] 李志坚[1] 

机构地区：[1]贵州省疾病预防控制中心艾滋病性病皮肤病防治研究所,550004

出　　处：《贵州医药》2012年第11期966-968,共3页Guizhou Medical Journal

基　　金：贵州省"十一五"重点攻关社会发展资金项目[黔科合NY字(2006)-3051]

摘　　要：目的建立HIV基因突变检测方法。方法用经过FDA认证的HIV耐药基因突变检测方法(ViroSeqTM)方法作为参比法与本室自建的HIV耐药基因突变检测方法分别对10份(五个病毒载量级别)样本和50份现场HIV患者样本进行平行测定,验证本室自建HIV耐药基因突变检测方法的敏感性和特异性。结果敏感性试验结果,两法对病毒载量100UI/mL级别均未检测,对病毒载量500UI/mL级别样本、本法检出阳性8例,参比法检出阳性6例,1 000UI/mL、2 000UI/mL、10 000UI/mL 3个病毒载量级别样本,本法与参比法全部检出阳性,统计学显示两方法差异无统计学意义(P>0.05);特异性试验结果,5份质控品两法检测结果均阳性,符合率100%;现场样本检测结果,50份HIV患者样本、本法检出阳性49例,参比法检出阳性48例,两法差异无统计学意义(P=1)。结论研究结果显示本法具有良好的敏感性和特异性,并无需有基因测序仪,可外送基因公司测序,具有良好的现场实用性。Objective To study the application and establishment of HIV gene mutation detection method. Methods Following FDA certification of the HIV drug-resistance detection of gene mutation （ViroSeq） method as a reference method and the room itself was built of HIV Drug-resistance gene mutation detection method 10 （five levels of viral load） samples and 50 HIV patients to replicate sam- ples, verify that this room built HIV Drug-resistance gene mutation detection sensitivity and specificity of the method. Results sensitivity test results was shown that two laws on viral load 100 UI/mL levels were not checked out, viral load 500 UI/mL level positive samples cheek out this law 8 , cheek out positive reference method 6 Example, 1 000 UI/mL, 2 000 UI/mL , 10 000 UI/mL 3 Samples of viral- load levels, this method and the reference method was all positive. There were no statistically signifi- cance differences betwwen two ways （P〉0.05）. Specific test results was shown that 5 control two test results were positive, the coincidence rate was 100%. Sample test results was that 50 HIV Cheek out positive patient samples with this law 49 eases, cheek out positive reference method 48 cases, and there were no statistically significance differences betwwen two ways （ P= 1 ）. Conclusion research results show that this method has a good sensitivity and specificity, and without the gene sequencing instrument, outside the restaurant gene sequencing company, has a good site usability.

关 键 词：HIV 基因突变 检测方法 应用 

分 类 号：R512.91[医药卫生—内科学]