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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SPSS 19.0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 evaluate the consistency of In-house method and commercialized Abbott RealTime HIV-1 qualitative test kit (Abbott kit) in the early diagnosis of infantile heel blood spot (DBS). Methods A total of 217 DBS samples from infants born to HIV-positive mothers in Sichuan, Chongqing, Jiangsu and Xinjiang were collected and HIV-1 provirus DNA was detected by In-house method. Boxes were qualitatively tested and statistically analyzed with SPSS 19.0 to assess the consistency of the test results between the two methods. RESULTS: Of 217 infants with DBS samples, 10 were positive by In-house method and 207 were negative by Abbott kit, 9 were positive and 208 were negative by Abbott kit, and 3 were inconsistent with the two methods The agreement rate was 98.6% (214/217), Kappa value was 0.835, 95% confidence interval (CI): 0.652-1.000, P <0.05. Conclusions In-house and Abbott kit detection by DBS has good consistency in the early diagnosis of infants. Both of them can be used in the early diagnosis of infants in China and provide the choice of detection methods for early detection of HIV in infants in China Scientific basis.