一种新型HIV-1 DNA检测试剂的临床应用评价

摘要

目的 对一种新型HIV-1 DNA检测试剂的临床应用性能进行评价.方法 本实验选择抗体确证实验确诊的HIV-1感染人群、未感染的正常人群血样,及弱阳性样本、不确定样本、特异性样本等比较考核试剂的检测结果与HIV-1感染状态结果(参考《全国艾滋病检测技术规范》2015版)的一致性,验证考核试剂在临床检测中的准确性;同时选择已上市的RNA定量检测试剂盒作为对比试剂进行平行检测,评价考核试剂与HIV RNA定量检测试剂检测结果的差异.结果 本次补充实验考核试剂检测全血样本95例,结果表明,以HIV-1感染状态为相对标准,考核试剂检测的阳性符合率为100％(95％CI:93.94％ ～100％),阴性符合率为100％(95％CI:90.26％ ～100％),总符合率为100％(95％CI:96.19％ ～100％),所得Kappa值为1(95％CI:1.00～1.00),考核试剂对于弱阳性、早期感染不确定标本均可检出,能有效区分抗原抗体试剂检测假阳性标本,特异性样本无假阳性结果.结论 考核试剂检测结果与HIV-1感染状态一致,可以认为与现在我国所采用的HIV-1检测试剂等效,能有效鉴别出感染早期的不确定标本.与RNA定量检测试剂相比,能有效检测出病毒储存库中HIV-1 DNA.%Objective To evaluate the clinical application of a novel HIV-1 DNA reagent. Methods HIV-1-infected and non-infected human blood samples were selected, as well as weakly positive samples, indeterminate samples, specific samples. Compared the result of HIV-1 DNA reagent with HIV-1 infection status (refer to the National Guideline for Detection of HIV/ AIDS (2015)),the accuracy of the HIV-1 DNA reagent was evaluated in clinical application; Meanwhile, the commercially available RNA quantification kit was selected as reference reagent for parallel detection, and then the consistency and differences were evaluated between HIV-1 DNA reagent and RNA quantification reagent. Results A total of 95 whole blood samples were tested by the HIV-1 DNA reagent. Taking the HIV-1 infection status as the reference standard, the result showed that the positive agreement rate was 100％ (95％ CI: 93. 94％ -100％ ), the negative agreement rate was 100％ (95％ CI: 90. 26％ -100％ ), and the overall agreement rate was 100％ (95％ CI: 96. 19％ -100％ ). The Kappa value was 1 (95％ CI: 1. 00-1. 00). The HIV-1 DNA reagent could detect weakly positive samples and indeterminate samples of early infection, and could effectively distinguish false-positive samples tested by the Ag-Ab reagent. The specific samples had no false-positive result . Conclusions The result of HIV-1 DNA reagent were consistent with the HIV-1 infection status. It can be considered as equivalent to the HIV-1 detection reagent commercially available in our country. It can effectively identify the indeterminate samples in the early infection. Compared with the RNA quantification reagent, it can effectively detect HIV-1 DNA of virus reservoirs.