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

• Tác giả: Nozuko P Blasich, Mduduzi B Buthelezi, Tendesayi Kufa, Mahlatse M Maleka, Sarvashni Moodliar, Nqobile Ngoma, Jerom Okot, Artur Ramos, Dumisani F Shabangu
• Ngôn ngữ: eng
• Ký hiệu phân loại: 577.22 *Biometeorology (Bioclimatology)
• Thông tin xuất bản: United States : Diagnostic microbiology and infectious disease , 2025
• Bộ sưu tập: NCBI
• ID: 679091

Tóm tắt

 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.