Work

Assessing the Effectiveness of the Human Immunodeficiency Virus Point‐of‐Care Proficiency Testing Scheme: Analysis of the Data From 2021 to 2022 in South Africa

Year: 2026

Type: article

Abstract: ABSTRACT Background Point‐of‐care rapid diagnostic testing plays a critical role in HIV detection and timely linkage to care, particularly in decentralized healthcare settings. To support testing reliability, the National Health Laboratory Service in South Africa conducts a national proficiency testing (PT) program as part of its broader quality assurance framework. This study assessed national PT performance and explored interprovincial differences. Methods A retrospective analysis was conducted using data from three PT survey rounds (0121, 0221, and 0122) carried out between January 2021 and October 2022. Each participating facility tested six blinded serum samples per round using routinely available HIV rapid diagnostic tests. Performance was categorized as acceptable ( ≥ 80%) or unacceptable ( < 80%) in accordance with ISO 17043 standards. Descriptive statistics were used to summarize participation and performance. Chi‐square tests assessed differences by province, and binary logistic regression was used to explore factors associated with unacceptable performance. Results Of the 12,636 PT panels distributed across three survey rounds to approximately 4200 facilities per round, 12,447 (98.50%) were returned with valid results. Acceptable results ( ≥ 80%) were consistently high, with 97.89% in Survey 0121, 98.37% in Survey 0221, and 98.31% in Survey 0122, yielding an overall average of 98.19% (12,222/12,447) of facility–panel submissions achieving acceptable performance scores, with a mean score of 98% across rounds. A total of 793 errors (1.05%) were identified, including 351 false‐negative results (0.46%) and 442 false‐positive results (0.58%). In addition, 46 discordant results ( < 0.10%) were recorded. Significant interprovincial variation in PT performance was observed ( p < 0.001), with the Northern Cape consistently reporting the highest proportion of unacceptable scores. In contrast, Limpopo and Mpumalanga achieved 100% acceptable performance across all three rounds. Logistic regression did not identify any statistically significant predictors of underperformance, although facilities in the Northern Cape showed increased odds of unacceptable scores. Conclusion The HIV PT program demonstrated high national uptake and strong overall performance in decentralized settings. However, persistent regional disparities underscore the need for targeted quality assurance interventions and strengthened oversight in underperforming provinces to ensure comparable diagnostic quality across the national HIV testing program.

Source: Health Science Reports

DOI: 10.1002/hsr2.71521

Authors: Nozuko P. Blasich, Adeboye M. Adelekan

Institutions: National Health Laboratory Service, Centers for Disease Control and Prevention

Language: English

Topic: Clinical Laboratory Practices and Quality Control

Subfield: Physiology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,280