Field accuracy of HIV rapid diagnostic tests for blood donor screening, bukavu, eastern democratic republic of the Congo

Abstract

Introduction: Rapid diagnostic tests (RDTs) are widely used for point-of-care diagnosis of HIV infection in resource-limited settings. However, there are no data about their field diagnostic performance in Eastern Democratic Republic of the Congo (DRC), especially in the context of blood banks screening for transfusion safety purpose. Methodology: Blood specimens were collected from blood donors in Bukavu, Eastern DRC, from May the 1st to June the 30th, 2015, to evaluate the accuracy of Alere Determine HIV-1/2, Trinity Biotech Uni-Gold HIV, and DoubleCheckGold Ultra HIV 1&2 compared to the laboratory-based 4th generation ELISA apDia HIV Ag/Ab assay. Sensitivity, specificity, positive and negative predictive values, and related 95% confidence intervals were calculated using MedCalc statistical software version 15.1. Reliability was evaluated using Cohen’s Kappa Statistic, κ. Results: Of 312 participants who donated blood, 96/312 (30.7%) were female and the mean age (SD) was 31.7 years (± 8.1 years). Sensitivity for the three tests was 57.1% (95% CI: 18.4-90.1). The specificity was 99.7% (95% CI: 18.4-90.1) for Alere Determine HIV-1/2, 100% (95% CI: 98.8-100.0) for Uni-Gold HIV, and 100% (95% CI: 98.8-100.0) for DoubleCheckGold Ultra HIV 1&2. Cohen’s Kappa Statistic showed moderate agreement between the 4th generation ELISA apDia HIV Ag/Ab and either Alere Determine HIV-1/2 and Uni-Gold HIV (κ = 0.66; 95% CI: 0.55-0.76) but good agreement for DoubleCheckGold Ultra HIV1&2 (κ = 0.72; 95% CI: 0.61 – 0.82). Conclusions: Compared to the laboratory-based ELISA apDia HIV Ag/Ab assay, the currently used 3rd generation HIV RDTs showed poor field accuracy results for blood donor screening. These data support the need for 4th generation Ag-Ab RDTs in transfusion blood qualification.