两种早期诊断婴儿HIV-1感染方法的一致性评价

The consistency evaluation of two methods for HIV-1 early infant diagnosis

目的评价In-house方法与商品化雅培RealTime艾滋病病毒I型（HIV-1）定性检测试剂盒（简称雅培试剂盒），检测婴儿足底血干血斑（DBs）早期诊断的一致性。方法收集217份来自四川、重庆、江苏、新疆等地寄送的HIV阳性母亲所生婴儿的待检DBS样本，用In-house方法检测HIV-1前病毒脱氧核糖核酸（DNA），用雅培试剂盒进行定性检测，并用SPSS19．0进行统计学分析，从而评价两种方法检测结果的一致性。结果217份婴儿DBS样本，用In-house方法检测结果为10例阳性和207例阴性，用雅培试剂盒检测结果为9例阳性和208例阴性，两种方法检测不一致的有3例，分析得一致率为98．6％（214／217），Kappa值为0．835，95％可信区间（CI）：0．652-1．000，P〈0．05。结论用DBS进行In—house与雅培试剂盒检测，对婴儿早期诊断具有较好的一致性，二者均可用于中国婴儿的早期诊断，为中国HIV婴儿早期诊断（EID）检测方法的选择提供了科学依据。

Objective To compare the consistency in early infant diagnosis （EID） between In-house method and Abbott RealTime HIV-1 Qualitative method. Methods Two hundred and seventeen dried blood spot （DBS） exam- ples of HIV exposed infants collected from Sichuan, Chongqing, Jiangsu, Xinjiang, and were detected by In-house and Abbott RealTime methods, respectively. Then we compared the consistency of the results and performed statistical analysis by Spss19.0. Results For the 217 infant DBS examples, results of In-house methods are 10 positive and 207 negative, results of Abbott methods are 9 positive and 208 negative, the consistency rate is 98.6% （214/ 217） and Kappa index is 0. 835 which shows a excellent consistency, P〈0.05. Conclusion In-house EID method has a excellent accordance with commercial Abbott RealTime HIV-1 Qualitative method for HIV-1 early infant diagnosis by using DBS, which shows that they both can be used for EID in China and this can be a scientific basis for EID test methods choosing.