Evaluation of nine HIV rapid test kits to develop a national HIV testing algorithm in Nigeria.

Orji Bassey,Tapdiyel Jelpe,Varough Deyde,Gabriel Ikwulono,Adebayo Adedeji,Idris Saliu,Ezekiel Akintunde,Odafen Oke,Issa Kawu,Ali Onoja,Adeniyi Ogundiran,Kachiro Yakubu,Ado Abubakar,Okey Nwanyawu,Kyle Bond,Patrick Ikani

doi:10.4102/ajlm.v4i1.224

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.

Highlights

Nigeria is the tenth most populous country in the world and the most populous country in Africa, with an estimated population of 162.3 million.[1]
The trend of HIV infection amongst this antenatal clinics (ANC) population since the commencement showed a steady increase – 1.8% (1991), 3.8% (1993), 4.5% (1995, 1996), 5.4% (1999), to a high of 5.8% in 2001 – before declining to 5.0% in 2003 and stabilising subsequently at 4.4% in 2005, 4.6% in 2008 and 4.1% in 2010.3 Nigeria has a generalised HIV epidemic – each of the 36 States and the Federal Capital Territory has over 1.0% HIV prevalence4 – and an estimated 3.5 million people are infected with the virus in the country
A 2005 survey of types of rapid test kits (RTKs) used in facilities participating in ANC in two of the six geopolitical zones of Nigeria revealed 19 different brands ranging from cold chain-dependent to non-cold chain-dependent (Adedeji AA, personal communication, March 2005)

Summary

Introduction

Nigeria is the tenth most populous country in the world and the most populous country in Africa, with an estimated population of 162.3 million.[1]. There are about 0.4 million estimated new infections per year, 1.5 million persons requiring antiretroviral therapy and an estimated 2.2 million total AIDS orphans currently living in the country.[5,6] In 2005, the Nigeria National Action Committee on AIDS (NACA) strategic framework set out to provide antiretrovirals (ARVs) to 80.0% of adults and children with advanced HIV infection and to 80.0% of HIV-positive pregnant women, all by 2010. The implications of these efforts entail screening several million people for HIV infection. Between 2005 and 2007, a study was conducted to formally evaluate a number of RTKs and construct HIV testing algorithms

Objectives

Results

Discussion

Conclusion