Large-Scale Human Immunodeficiency Virus Rapid Test Evaluation in a Low-Prevalence Ugandan Blood Bank Population

Abstract

The use of rapid tests for human immunodeficiency virus (HIV) has become standard in HIV testing algorithms employed in resource-limited settings. We report an extensive HIV rapid test validation study conducted among Ugandan blood bank donors at low risk for HIV infection. The operational characteristics of four readily available commercial HIV rapid test kits were first determined with 940 donor samples and were used to select a serial testing algorithm. Uni-Gold Recombigen HIV was used as the screening test, followed by HIV-1/2 STAT-PAK for reactive samples. OraQuick HIV-1 testing was performed if the first two test results were discordant. This algorithm was then tested with 5,252 blood donor samples, and the results were compared to those of enzyme immunoassays (EIAs) and Western blotting. The unadjusted algorithm sensitivity and specificity were 98.6 and 99.9%, respectively. The adjusted sensitivity and specificity were 100 and 99.96%, respectively. This HIV testing algorithm is a suitable alternative to EIAs and Western blotting for Ugandan blood donors.

To err is human, to correct is public health: a systematic review examining poor quality testing and misdiagnosis of HIV status

“…Most studies were carried out in Africa ( n  = 48) [5,7,10–14,16,22–25,29,30,32–34,36,37,39,41,43,44,46,47,49,51,52,54–59,61–65,67–72,74,75], followed by in the Americas ( n  = 7) [28,31,42,50,53,60,66], Asia ( n  = 4) [8,35,45,73] and Europe ( n  = 1) [48]. There were also four multi-country/regional studies [26,27,38,40].…”

“…Sixteen studies reported clerical errors [8,11,26,28,29,31,34,35,45,50,63–65,67,73,75]. Errors included poor record-keeping [35], data reporting problems, labelling and transcription mistakes [73] and specimen mix-ups.…”

Human Immunodeficiency Virus Type 1 Infection Is Associated with Increased NK Cell Polyfunctionality and Higher Levels of KIR3DL1+NK Cells in Ugandans Carrying the HLA-B Bw4 Motif

“…HIV-1 testing was performed on all participants as previously described (16). Briefly, HIV-1 enzyme-linked immunosorbent assay (ELISA) screening was performed using a Genetic Systems rLAV (Bio-Rad Laboratories, Redmond, WA) ELISA.…”

Performance of a Rapid and Simple HIV Testing Algorithm in a Multicenter Phase III Microbicide Clinical Trial

“…The lack of specificity of the Determine HIV-1/2 assay with specimens from Uganda has been reported previously (6,12,22). We hypothesize that in Kampala, Uganda, in particular, participants had undiagnosed endemic non-HIV infections or circulating substances in their blood that may have cross-reacted with the Determine HIV-1/2 test (12).…”