Abstract
BackgroundZambia’s national HIV testing algorithm specifies use of two rapid blood based antibody assays, Determine®HIV-1/2 (Inverness Medical) and if positive then Uni-GoldTM Recombigen HIV-1/2 (Trinity Biotech). Little is known about the performance of oral fluid based HIV testing in Zambia. The aims of this study are two-fold: 1) to compare the diagnostic accuracy (sensitivity and specificity) under field conditions of the OraQuick® ADVANCE® Rapid HIV-1/2 (OraSure Technologies, Inc.) to two blood-based rapid antibody tests currently in use in the Zambia National Algorithm, and 2) to perform a cost analysis of large-scale field testing employing the OraQuick®.MethodsThis was a operational retrospective research of HIV testing and questionnaire data collected in 2010 as part of the ZAMSTAR (Zambia South Africa TB and AIDS reduction) study. Randomly sampled individuals in twelve communities were tested consecutively with OraQuick® test using oral fluid versus two blood-based rapid HIV tests, Determine® and Uni-GoldTM. A cost analysis of four algorithms from health systems perspective were performed: 1) Determine® and if positive, then Uni-GoldTM (Determine®/Uni-GoldTM); based on current algorithm, 2) Determine® and if positive, then OraQuick® (Determine®/OraQuick®), 3) OraQuick® and if positive, then Determine® (OraQuick®/Determine®), 4) OraQuick® and if positive, then Uni-GoldTM (OraQuick®/Uni-GoldTM). This information was then used to construct a model using a hypothetical population of 5,000 persons with varying prevalence of HIV infection from 1–30%.Results4,458 participants received both a Determine® and OraQuick® test. The sensitivity and specificity of the OraQuick® test were 98.7 (95%CI, 97.5–99.4) and 99.8 (95%CI, 99.6–99.9), respectively when compared to HIV positive serostatus. The average unit costs per algorithm were US$3.76, US$4.03, US$7.35, and US$7.67 for Determine®/Uni-GoldTM, Determine®/OraQuick®, OraQuick®/Determine®, and OraQuick®/Uni-GoldTM, respectively, for an HIV prevalence of 15%.ConclusionsAn alternative HIV testing algorithm could include OraQuick® test which had a high sensitivity and specificity. The current Determine®/Uni-GoldTM testing algorithm is the least expensive when compared to Determine®/OraQuick®, OraQuick®/Determine®, and OraQuick®/Uni-GoldTM in the Zambian setting. From our field experience, oral fluid based testing offers many advantages over blood-based testing, especially with self testing on the horizon.
Highlights
Zambia’s national HIV testing algorithm specifies use of two rapid blood based antibody assays, DetermineWHIV-1/2 (Inverness Medical) and if positive Uni-GoldTM Recombigen HIV-1/2 (Trinity Biotech)
Blood based rapid HIV tests have become the standard of care and the basis for the national HIV testing algorithm in many developing countries, including Zambia [1,2,3]
Zambia’s HIV prevalence of 13.5% [4] makes HIV testing a national health priority and the national HIV testing algorithm specifies sequential blood-based rapid antibody tests: first DetermineWHIV-1/2 Antibody (Inverness Medical) is used, which if reactive is followed by a different antibody test, Uni-GoldTM Recombigen HIV-1/2 Antibody (Trinity Biotech)
Summary
Zambia’s national HIV testing algorithm specifies use of two rapid blood based antibody assays, DetermineWHIV-1/2 (Inverness Medical) and if positive Uni-GoldTM Recombigen HIV-1/2 (Trinity Biotech). The availability of affordable, point-of-service HIV testing is especially important in low-income, high-HIV-burden countries which lack the financial and technological resources to perform more sophisticated laboratory-based assays For these reasons, blood based rapid HIV tests have become the standard of care and the basis for the national HIV testing algorithm in many developing countries, including Zambia [1,2,3]. Seven of which were in subSaharan Africa (Democratic Republic of Congo, Kenya, Liberia, South Africa, Swaziland, Tanzania, Zambia), conducted population-based surveys during 2007 and 2008 and reported HIV testing rates These seven countries account for 32% of the people living with HIV globally and 45% of those in sub- Saharan Africa. These data underscore the challenges of implementing HIV testing and prevention that are broadly available and accessible in developing countries and suggest the need for innovations in this field
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