Evaluating the accuracy of multiple rapid diagnostic tests for HIV detection in serum samples analysed during point-of-care proficiency testing assessments.

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.