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Original Research
Evaluation of nine HIV rapid test kits to develop a national HIV testing algorithm in Nigeria
Submitted: 20 August 2014 | Published: 29 May 2015
About the author(s)
Orji Bassey, US Centers for Disease Control and Prevention (CDC), NigeriaKyle Bond, US Centers for Disease Control and Prevention (CDC), Nigeria
Adebayo Adedeji, Federal Ministry of Health (FMOH), Nigeria
Odafen Oke, US Centers for Disease Control and Prevention (CDC), Nigeria
Ado Abubakar, US Centers for Disease Control and Prevention (CDC), Nigeria
Kachiro Yakubu, Federal Ministry of Health (FMOH), Nigeria
Tapdiyel Jelpe, US Centers for Disease Control and Prevention (CDC), Nigeria
Ezekiel Akintunde, US Department of Defense (DOD), Nigeria
Patrick Ikani, Global HIV AIDS Initiative in Nigeria (GHAIN), Nigeria
Adeniyi Ogundiran, World Health Organization (WHO), Nigeria
Ali Onoja, African Health Project (AHP), Nigeria
Issa Kawu, Federal Ministry of Health (FMOH), Nigeria
Gabriel Ikwulono, Federal Ministry of Health (FMOH), Nigeria
Idris Saliu, Safe Blood for Africa Foundation (SBFAF), Nigeria
Okey Nwanyawu, US Centers for Disease Control and Prevention (CDC), Nigeria
Varough Deyde, US Centers for Disease Control and Prevention (CDC), Nigeria
Abstract
Background: 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.
Objectives: The objectives of this study were to assess and select HIV RTKs and develop national testing algorithms.
Method: 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.
Results: 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 (BundiTM, DetermineTM, Stat-Pak® and Uni-GoldTM) with 100.0% sensitivity and 99.1% – 100.0% specificity, were recommended and adopted as national interim testing algorithms in 2007.
Conclusion: 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.
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