An overview of the quality assurance programme for HIV rapid testing in South Africa: Outcome of a 2-year phased implementation of quality assurance program

English version

Autoři: Selamawit Alemu Woldesenbet ^aff001; Mireille Kalou ^aff003; Dumisani Mhlongo ^aff004; Tendesayi Kufa ^aff001; Makhosazana Makhanya ^aff005; Adeboye Adelekan ^aff005; Karidia Diallo ^aff005; Mahlatse Maleka ^aff006; Beverley Singh ^aff001; Bharat Parekh ^aff003; Amanda Mohlala ^aff007; Peter T. Manyike ^aff007; Tim J. Tucker ^aff007; Adrian J. Puren ^aff001
Působiště autorů: Center for HIV and STI, National Institute for Communicable Diseases, Johannesburg, South Africa ^aff001; School of Public Health, University of the Witwatersrand, Johannesburg, South Africa ^aff002; International Laboratory Branch, Division of Global HIV and Tuberculosis, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America ^aff003; National Clinic Laboratory Interface programme, National Health Laboratory Service, Johannesburg, South Africa ^aff004; Laboratory Branch, Centers for Disease Control and Prevention South Africa, Pretoria, South Africa ^aff005; Academic Affairs, Research and Quality Assurance National Health Laboratory Service, Johannesburg, South Africa ^aff006; Strategic Evaluation, Advisory and Development (SEAD) Consulting, Cape Town, South Africa ^aff007; School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa ^aff008; Virology Department, University of the Witwatersrand, Johannesburg, South Africa ^aff009
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pone.0221906

Souhrn

Objective

This is the first large-scale assessment of the implementation of HIV Rapid Test Quality Improvement Initiative in South Africa.

Methods

We used a quasi-experimental one group post-test only design. The intervention implemented starting April 2014 comprised health-care worker training on quality assurance (QA) of HIV rapid testing and enrolment of the facilities in proficiency testing (PT), targeting 2,077 healthcare facilities in 32 high HIV burden districts. Following the intervention, two consecutive rounds of site assessments were undertaken. The first, conducted after a median of 7.5 months following the training, included 1,915 facilities that participated in the QA training, while the second, conducted after a median of one-year following the first-round assessment included 517 (27.0%) of the 1,915 facilities. In both assessments, the Stepwise-Process-for-Improving-the-quality-of-HIV-Rapid-Testing (SPI-RT) checklist was used to score facilities’ performance in 7 domains: training, physical facility, safety, pre-testing, testing, post-testing and external quality assessment. Facilities’ level of readiness for national certification was assessed.

Result

Between 2016 and 2017, there were four PT cycles. PT participation increased from 32.4% (620/1,915) in 2016 to 91.5% (1,753/1,915) in 2017. In each PT cycle, PT results were returned by 76%–87% of facilities and a satisfactory result (>80%) was achieved by ≥95% of facilities. In the SPI-RT assessment, in round-one, 22.3% of facilities were close to or eligible for national certification—this significantly increased to 38.8% in round-two (P-value<0.001). The median SPI-RT score for the domains HIV pre-testing (83.3%) and post-testing (72.2%) remained the same between the two rounds. The median score for the testing domain increased by 5.6% (to 77.8%).

Conclusion

Facilities performance on the domains that are critical for accuracy of diagnosis (i.e. pre-testing, testing and post-testing) remained largely unchanged. This study provided several recommendations to improve QA implementation in South Africa, including the need to improve routine use of internal quality control for corrective actions.

Klíčová slova:

South Africa – HIV diagnosis and management – HIV infections – Water resources – Quality assurance – Quality control – Health systems strengthening

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