Mpamugo Augustine O, Iriemenam Nnaemeka C, Bashorun Adebobola, Okunoye Olumide O, Bassey Orji O, Onokevbagbe Edewede, Jelpe Tapdiyel, Alagi Matthias A, Meribe Chidozie, Aguolu Rose E, Nzelu Charles E, Bello Segun, Ezra Babatunde, Obioha Christine A, Ibrahim Baffa S, Adedokun Oluwasanmi, Ikpeazu Akudo, Ihekweazu Chikwe, Croxton Talishiea, Adebajo Sylvia B, Okoye McPaul I J, Abimiku Alash'le
Center for International Health, Education and Biosecurity, Maryland Global Initiatives Corporation, University of Maryland, Baltimore (UMB), Abuja, Nigeria.
Division of Global HIV and TB, United States Centers for Disease Control and Prevention, Abuja, Nigeria.
Afr J Lab Med. 2024 Aug 28;13(1):2339. doi: 10.4102/ajlm.v13i1.2339. eCollection 2024.
HIV testing remains an entry point into HIV care and treatment services. In 2007, Nigeria adopted and implemented a two-test rapid HIV testing algorithm of three HIV rapid test kits, following the sequence: Alere Determine (first test), Unigold (second test), and STAT-PAK as the tie-breaker. Sub-analysis of the 2018 Nigeria HIV/AIDS Indicator and Impact Survey data showed significant discordance between the first and second tests, necessitating an evaluation of the algorithm. This manuscript highlights lessons learnt from that evaluation.
A two-phased evaluation method was employed, including abstraction and analysis of retrospective HIV testing data from January 2017 to December 2019 from 24 selected sites supported by the United States President's Emergency Plan for AIDS Relief programme. A prospective evaluation of HIV testing was done among 2895 consecutively enrolled and consented adults, aged 15-64 years, accessing HIV testing services from three selected sites per state across the six geopolitical zones of Nigeria between July 2020 and September 2020. The prospective evaluation was performed both in the field and at the National Reference Laboratory under controlled laboratory conditions. Stakeholder engagements, strategic selection and training of study personnel, and integrated supportive supervision were employed to assure the quality of evaluation procedures and outcomes.
The algorithm showed higher sensitivity and specificity in the National Reference Laboratory compared with the field. The approaches to quality assurance were integral to the high-quality study outcomes.
We recommend comparison of testing algorithms under evaluation against a gold standard.
This study provides context-specific considerations in using World Health Organization recommendations to evaluate the Nigerian national HIV rapid testing algorithm.
艾滋病毒检测仍然是艾滋病毒护理和治疗服务的切入点。2007年,尼日利亚采用并实施了一种使用三种艾滋病毒快速检测试剂盒的两步快速艾滋病毒检测算法,顺序如下:Alere Determine(第一次检测)、Unigold(第二次检测),以及作为决胜手段的STAT-PAK。对2018年尼日利亚艾滋病毒/艾滋病指标和影响调查数据的子分析显示,第一次和第二次检测之间存在显著不一致,因此有必要对该算法进行评估。本手稿重点介绍了从该评估中吸取的经验教训。
采用了两阶段评估方法,包括从2017年1月至2019年12月从由美国总统艾滋病紧急救援计划支持的24个选定地点提取和分析回顾性艾滋病毒检测数据。2020年7月至2020年9月期间,在尼日利亚六个地缘政治区每个州的三个选定地点,对2895名连续登记并同意参与的15至64岁成年人进行了艾滋病毒检测的前瞻性评估。前瞻性评估在现场和国家参考实验室的受控实验室条件下进行。通过利益相关者参与、研究人员的战略选拔和培训以及综合支持性监督,确保评估程序和结果的质量。
与现场相比,该算法在国家参考实验室中显示出更高的灵敏度和特异性。质量保证方法对于高质量的研究结果至关重要。
我们建议将正在评估的检测算法与金标准进行比较。
本研究提供了在使用世界卫生组织建议评估尼日利亚国家艾滋病毒快速检测算法时的具体情况考虑因素。