Field accuracy of HIV rapid diagnostic tests for blood donors screening, Bukavu, Eastern Democratic Republic of the Congo

  • Théophile Mitima Kashosi Evangelic University in Africa, Bukavu, Democratic Republic of the Congo
  • Céléstin Bisangamo Kyambikwa Institute of Higher Education for Medical Techniques, Bukavu, Democratic Republic of the Congo
  • Philémon Mbarabara Mulongo Institute of Higher Education for Medical Techniques, Bukavu, Democratic Republic of the Congo
  • Jean Bisimwa Nachega International Center for Advanced Research and Training (ICART), Bukavu, Democratic Republic of the Congo
Keywords: HIV, Rapid Diagnostic Tests, Accuracy, DR Congo

Abstract

Introduction: Rapid diagnostic tests (RDTs) are widely used for point-of-care. 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: Among 312 participants who provided blood bags, 96/312 (30.7%) were female and the mean age (SD) was 31.7 years (± 8.1years). 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 RDTs 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 in a context of blood donors screening. These data support the need for 4th generation Ag-Ab RDTs in transfusion blood qualification.

Author Biography

Théophile Mitima Kashosi, Evangelic University in Africa, Bukavu, Democratic Republic of the Congo

Department of Biomedical sciences, Laboratory of Medical Research and Public Health

Published
2018-06-30
How to Cite
1.
Kashosi T, Kyambikwa C, Mulongo P, Nachega J (2018) Field accuracy of HIV rapid diagnostic tests for blood donors screening, Bukavu, Eastern Democratic Republic of the Congo. J Infect Dev Ctries 12:471-476. doi: https://doi.org/10.3855/jidc.9774
Section
Original Articles