使用干血斑进行早期婴儿诊断的罗氏CAP/CTM HIV-1定性检测版本2.0的性能
Performance of Roche CAP/CTM HIV-1 qualitative test version 2.0 using dried blood spots for early infant diagnosis.
作者信息
Gueye Sokhna Bousso, Diop-Ndiaye Halimatou, Diallo Mamadou Malick, Ly Omar, Sow-Ndoye Aissatou, Diagne-Gueye Ndèye Diabou, Kébé-Fall Khady, Diop Fatou, Gaye-Diallo Aïssatou, Belec Laurent, Mboup Souleymane, Touré-Kane Coumba
机构信息
Laboratoire de Bactériologie-Virologie CHU Aristide Le Dantec, Université Cheikh, Anta Diop, Dakar, Senegal.
Laboratoire de Virologie, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital, Européen Georges Pompidou/Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
出版信息
J Virol Methods. 2016 Mar;229:12-5. doi: 10.1016/j.jviromet.2015.12.006. Epub 2015 Dec 17.
In the context of early infant diagnosis (EID) decentralization in sub-Saharan Africa, dried blood spot (DBS) is now widely used for HIV proviral DNA detection in resource-limited settings. A new version of CAP/CTM (version 2) has been introduced, recently by Roche Diagnosis as a new real-time PCR assay to replace previous technologies on qualitative detection of HIV-1 DNA using whole blood and DBS samples. The objective of this study was to evaluate CAP/CTM version 2 compared to CAP/CTM version 1 and Amplicor on DBS. A total of 261 DBS were collected from children aged 4 weeks to 17 months born from HIV-seropositive mothers and tested by the three techniques. CAP/CTM version 2 showed 100% of agreement with Amplicor including 74 positive results and 187 negative results. CAP/CTM version 2 versus CAP/CTM version 1 as well as CAP/CTM version 1 versus Amplicor showed two discordant results giving a sensitivity of 98.6%, specificity of 99.5%, positive predictive value of 98.6% and negative predictive value of 99.5%. The concordance was 99.12% (95% of confidence interval) giving a Kappa coefficient of 0.97 (p<0.001). These findings confirmed the expected good performance of CAP/CTM version 2 for HIV-1 EID.
在撒哈拉以南非洲地区早期婴儿诊断（EID）去中心化的背景下，干血斑（DBS）目前在资源有限的环境中被广泛用于HIV前病毒DNA检测。罗氏诊断公司最近推出了新版本的CAP/CTM（版本2），作为一种新的实时PCR检测方法，以取代之前使用全血和DBS样本对HIV-1 DNA进行定性检测的技术。本研究的目的是在DBS上评估CAP/CTM版本2与CAP/CTM版本1和Amplicor的性能。共收集了261份来自HIV血清阳性母亲所生的4周龄至17个月龄儿童的DBS样本，并采用这三种技术进行检测。CAP/CTM版本2与Amplicor的检测结果一致性为100%，包括74份阳性结果和187份阴性结果。CAP/CTM版本2与CAP/CTM版本1以及CAP/CTM版本1与Amplicor相比，均有两份结果不一致，其灵敏度为98.6%，特异性为99.5%，阳性预测值为98.6%，阴性预测值为99.5%。一致性为99.12%（95%置信区间），Kappa系数为0.97（p<0.001）。这些结果证实了CAP/CTM版本2在HIV-1 EID方面预期的良好性能。
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