INSTI HIV-1/-2 抗体检测试剂在南非两家产前门诊的现场表现。
Field performance of the INSTI HIV-1/-2 antibody test in two South African antenatal clinics.
机构信息
Department of Medical Virology, University of Pretoria, Tshwane, South Africa.
National Health Laboratory Service-Tshwane Academic Division (NHLS-TAD), Tshwane, South Africa.
出版信息
J Med Virol. 2019 Jul;91(7):1355-1359. doi: 10.1002/jmv.25447. Epub 2019 Mar 18.
This was a prospective study that assessed field performance of the INSTI HIV-1/-2 antibody test (INSTI test) in two antenatal clinics in South Africa (SA). INSTI test was evaluated against rapid tests used at these clinics, and pooled nucleic acid amplification testing (NAAT) performed for individuals with negative rapid tests. Three hundred and eighty-six pregnant women were enrolled; 334 (86.5%) with negative results on the screening rapid test, and 52 (13.5%; 95% confidence interval [CI]: 10.2-17.3%) with positive results on screening and confirmatory rapid tests. INSTI test yielded the same results as other rapid tests in all participants, thus showing a 100% sensitivity (95% CI: 93.2-100.0%) and specificity (95% CI: 98.9-100.0%). Pooled NAAT was performed for 290 participants who had negative rapid tests, and yielded negative results in all pools. These data show excellent field performance of the INSTI test, and highlight that this test can be implementedat SA clinics.
这是一项前瞻性研究，评估了 INSTI HIV-1/-2 抗体检测（INSTI 检测）在南非（SA）两个产前诊所的现场性能。INSTI 检测与这些诊所使用的快速检测进行了评估，并对快速检测阴性的个体进行了聚合酶链反应（PCR）检测。共纳入 386 名孕妇；334 名（86.5%）筛查快速检测结果为阴性，52 名（13.5%；95%置信区间[CI]：10.2-17.3%）筛查和确认快速检测结果为阳性。INSTI 检测在所有参与者中的结果与其他快速检测相同，因此显示出 100%的敏感性（95%CI：93.2-100.0%）和特异性（95%CI：98.9-100.0%）。对 290 名快速检测阴性的参与者进行了聚合酶链反应检测，所有检测结果均为阴性。这些数据表明 INSTI 检测具有出色的现场性能，并强调该检测可在 SA 诊所实施。
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