Evaluation of simple rapid HIV assays and development of national rapid HIV test algorithms in Dar es Salaam, Tanzania

Abstract

BackgroundSuitable algorithms based on a combination of two or more simple rapid HIV assays have been shown to have a diagnostic accuracy comparable to double enzyme-linked immunosorbent assay (ELISA) or double ELISA with Western Blot strategies. The aims of this study were to evaluate the performance of five simple rapid HIV assays using whole blood samples from HIV-infected patients, pregnant women, voluntary counseling and testing attendees and blood donors, and to formulate an alternative confirmatory strategy based on rapid HIV testing algorithms suitable for use in Tanzania.MethodsFive rapid HIV assays: Determine™ HIV-1/2 (Inverness Medical), SD Bioline HIV 1/2 3.0 (Standard Diagnostics Inc.), First Response HIV Card 1–2.0 (PMC Medical India Pvt Ltd), HIV1/2 Stat-Pak Dipstick (Chembio Diagnostic System, Inc) and Uni-Gold™ HIV-1/2 (Trinity Biotech) were evaluated between June and September 2006 using 1433 whole blood samples from hospital patients, pregnant women, voluntary counseling and testing attendees and blood donors. All samples that were reactive on all or any of the five rapid assays and 10% of non-reactive samples were tested on a confirmatory Inno-Lia HIV I/II immunoblot assay (Immunogenetics).ResultsThree hundred and ninety samples were confirmed HIV-1 antibody positive, while 1043 were HIV negative. The sensitivity at initial testing of Determine, SD Bioline and Uni-Gold™ was 100% (95% CI; 99.1–100) while First Response and Stat-Pak had sensitivity of 99.5% (95% CI; 98.2–99.9) and 97.7% (95% CI; 95.7–98.9), respectively, which increased to 100% (95% CI; 99.1–100) on repeat testing. The initial specificity of the Uni-Gold™ assay was 100% (95% CI; 99.6–100) while specificities were 99.6% (95% CI; 99–99.9), 99.4% (95% CI; 98.8–99.7), 99.6% (95% CI; 99–99.9) and 99.8% (95% CI; 99.3–99.9) for Determine, SD Bioline, First Response and Stat-Pak assays, respectively. There was no any sample which was concordantly false positive in Uni-Gold™, Determine and SD Bioline assays.ConclusionAn alternative confirmatory HIV testing strategy based on initial testing on either SD Bioline or Determine assays followed by testing of reactive samples on the Determine or SD Bioline gave 100% sensitivity (95% CI; 99.1–100) and 100% specificity (95% CI; 96–99.1) with Uni-Gold™ as tiebreaker for discordant results.

Dynamic bowel obstruction: aetiology, clinical presentation, management and outcome at Bugando Medical Centre, Mwanza, Tanzania

“…Relevant preoperative investigations included serum electrolytes, urea and creatinine, blood grouping and cross-matching and ESR. Patients were also screened for HIV testing using Tanzania HIV Rapid Test Algorithm (Lyamuya et al, 2009) and CD 4+ count using FACS or FACSCALIBUR from BD Biosciences USA. A determination of CD 4 count was only performed in HIV positive patients.…”

Seroprevalence of hepatitis B virus infection among antenatal clinic attendees at a tertiary hospital in Dar es Salaam, Tanzania

“…The anti-HBcIgM antibodies as well as anti-HBs anti-HBsAb were determined using MEIA (Abbott AxSYM, Germany). HIV serostatus was determined using the National rapid HIV testing algorithm (Lyamuya et al, 2009). Samples were initially tested with SD HIV-1/2 3.0 Bioline followed by testing of reactive samples on Determine HIV-1/2 test.…”

Declining HIV-1 prevalence and incidence among Police Officers – a potential cohort for HIV vaccine trials, in Dar es Salaam, Tanzania

“…For the HIV Incidence study: HIV serostatus was determined using the National rapid HIV testing algorithm where initial testing was performed using SD Bioline (Standard Diagnostic Inc, Korea) followed by confirmation of reactive samples on Determine (Inverness Medical, Japan) as used previously [10]. Sera reactive on both tests were considered as positive.…”