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

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
doi: 10.1371/journal.pone.0221906



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


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.


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%).


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:

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


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