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Updated: May 3, 2026
Comprehensive & Cost Effective Laboratory Monitoring of HIV/AIDS: an African Role Model
Published on: October 31, 2010
Evaluating the accuracy of multiple rapid diagnostic tests for HIV detection in serum samples analysed during
Nozuko P Blasich1, Jerom Okot2, Artur Ramos3
1Academic Affairs, Research and Quality Assurance, National Health Laboratory Service, Johannesburg, South Africa.
Background:
HIV rapid diagnostic tests are crucial for timely diagnosis, especially in resource-limited settings. The World Health Organization recommends sensitivity ≥99 % and specificity ≥98 %. This study assessed RDT performance across South Africa's provinces using a proficiency testing program.
Methods:
From April to June 2023, 25,458 blinded serum samples were sent to testing facilities for screening and confirmatory testing. Sensitivity, specificity, predictive values, and concordance (Cohen's Kappa) were evaluated.
Results:
The response rate was 98.25 %. Sensitivity and specificity were both 98.7 %, with agreement at 98.7 % (kappa 0.97, p < 0.001). Northern Cape showed the lowest sensitivity (91.8 %) and specificity (92.0 %), while Gauteng, KwaZulu-Natal, and Mpumalanga exceeded 99 %.
Conclusion:
Although national RDT performance met WHO standards, Northern Cape's results reveal the need for improved training, quality assurance, and proficiency testing to strengthen diagnostic accuracy.
