Abstract:

Ensuring high-quality HIV rapid testing is critical to accurate diagnosis and effective treatment, especially in resource-limited settings like Cameroon. This study conducted a stratified evaluation of quality management systems (QMS) in HIV rapid testing laboratories across the South Region of Cameroon using the WHO Stepwise Process for Improving the Quality of HIV Rapid Testing (SPI-RRT) tool. The objective was to assess adherence to quality standards across facility types and support levels, and to identify critical gaps in implementation. A total of 99 laboratories were audited between 2022 and 2024, stratified by ownership (government, private, faith-based, and community-based organizations) and PEPFAR support. Results showed that PEPFAR-supported laboratories had significantly higher mean SPI-RRT scores (59) compared to non-supported sites (14), p < 0.001. Community-based organizations demonstrated the highest compliance (28 ± 21), followed by faith-based (25 ± 23), private (25 ± 17), and government-owned facilities (14 ± 21). Notably, only 12% of laboratories reached SPI-RRT Level 3 or 4, indicating limited readiness for certification. The lowest-scoring elements included quality control, document management, and corrective actions, highlighting systemic weaknesses in QMS implementation. District-level disparities were also evident, with Sangmelima and Kribi outperforming other districts in readiness scores. These findings provide essential insights into quality assurance challenges in decentralized HIV testing programs and underscore the need for targeted interventions, including technical mentorship, continuous quality improvement, and enhanced supervision to improve diagnostic reliability.

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