Bassey Orji, Bond Kyle, Adedeji Adebayo, Oke Odafen, Abubakar Ado, Yakubu Kachiro, Jelpe Tapdiyel, Akintunde Ezekiel, Ikani Patrick, Ogundiran Adeniyi, Onoja Ali, Kawu Issa, Ikwulono Gabriel, Saliu Idris, Nwanyawu Okey, Deyde Varough
US Centers for Disease Control and Prevention (CDC), Nigeria.
Federal Ministry of Health (FMOH), Nigeria.
Afr J Lab Med. 2015 May 29;4(1):1-17. doi: 10.4102/ajlm.v4i1.224. eCollection 2015.
Non-cold chain-dependent HIV rapid testing has been adopted in many resource-constrained nations as a strategy for reaching out to populations. HIV rapid test kits (RTKs) have the advantage of ease of use, low operational cost and short turnaround times. Before 2005, different RTKs had been used in Nigeria without formal evaluation. Between 2005 and 2007, a study was conducted to formally evaluate a number of RTKs and construct HIV testing algorithms. The objectives of this study were to assess and select HIV RTKs and develop national testing algorithms. Nine RTKs were evaluated using 528 well-characterised plasma samples. These comprised 198 HIV-positive specimens (37.5%) and 330 HIV-negative specimens (62.5%), collected nationally. Sensitivity and specificity were calculated with 95% confidence intervals for all nine RTKs singly and for serial and parallel combinations of six RTKs; and relative costs were estimated. Six of the nine RTKs met the selection criteria, including minimum sensitivity and specificity (both ≥ 99.0%) requirements. There were no significant differences in sensitivities or specificities of RTKs in the serial and parallel algorithms, but the cost of RTKs in parallel algorithms was twice that in serial algorithms. Consequently, three serial algorithms, comprising four test kits (Bundi, Determine, Stat-Pak and Uni-Gold) with 100.0% sensitivity and 99.1% - 100.0% specificity, were recommended and adopted as national interim testing algorithms in 2007. This evaluation provides the first evidence for reliable combinations of RTKs for HIV testing in Nigeria. However, these RTKs need further evaluation in the field (Phase II) to re-validate their performance.
在许多资源有限的国家，非冷链依赖型艾滋病毒快速检测已被用作一种覆盖人群的策略。艾滋病毒快速检测试剂盒（RTK）具有使用方便、运营成本低和周转时间短的优点。2005年之前，尼日利亚曾使用过不同的RTK，但未进行正式评估。2005年至2007年期间，开展了一项研究以正式评估多种RTK并构建艾滋病毒检测算法。本研究的目的是评估和选择艾滋病毒RTK并制定国家检测算法。使用528份特征明确的血浆样本对9种RTK进行了评估。这些样本包括在全国范围内收集的198份艾滋病毒阳性标本（37.5%）和330份艾滋病毒阴性标本（62.5%）。计算了所有9种RTK单独以及6种RTK的串联和并联组合的灵敏度和特异性，并给出95%置信区间；同时估算了相对成本。9种RTK中有6种符合选择标准，包括最低灵敏度和特异性（均≥99.0%）要求。串联和并联算法中RTK的灵敏度或特异性没有显著差异，但并联算法中RTK的成本是串联算法的两倍。因此，推荐了三种串联算法，它们由四种检测试剂盒（邦迪、Determine、Stat-Pak和Uni-Gold）组成，灵敏度为100.0%，特异性为99.1% - 100.0%，并于2007年被采纳为国家临时检测算法。该评估为尼日利亚艾滋病毒检测中RTK的可靠组合提供了首个证据。然而，这些RTK需要在现场进一步评估（第二阶段）以重新验证其性能。
