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:
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:
HIV diagnosis and management – HIV infections – Quality assurance – Quality control – South Africa – Water resources – Health systems strengthening
Zdroje
1. UNAIDS data 2018. Source: UNAIDS special analysis. [cited 12/ 12/2018]. http://aidsinfo.unaids.org/
2. Massyn N, Padarath A, Peer N, Day C. District Health Barometer 2016/17. 2018. http://www.hst.org.za/publications/Pages/District-Health-Barometer-201617.aspx.
3. Johnson CC, Fonner V, Sands A, Ford N, Obermeyer CM, Tsui S, et al. To err is human, to correct is public health: a systematic review examining poor quality testing and misdiagnosis of HIV status. J Int AIDS Soc. 2017;20(Suppl 6):21755. doi: 10.7448/IAS.20.7.21755 28872271
4. Moodley D, Moodley P, Ndabandaba T, Esterhuizen T. Reliability of HIV rapid tests is user dependent. S Afr Med J. 2008;98(9):707–9. 19113051
5. Hsiao NY, Zerbe A, Phillips TK, Myer L, Abrams EJ. Misdiagnosed HIV infection in pregnant women initiating universal ART in South Africa. J Int AIDS Soc. 2017;20(Suppl 6):21758. doi: 10.7448/IAS.20.7.21758 28872277
6. Shanks L, Klarkowski D, O’Brien DP. False positive HIV diagnoses in resource limited settings: operational lessons learned for HIV programmes. PLoS One. 2013;8(3):e59906. doi: 10.1371/journal.pone.0059906 23527284
7. WHO Consolidated guidelines on HIV testing services 2015. [cited 18/ 7/2018]. www.who.int.
8. Black V, von Mollendorf CE, Moyes JA, Scott LE, Puren A, Stevens WS. Poor sensitivity of field rapid HIV testing: implications for mother-to-child transmission programme. BJOG. 2009;116(13):1805–8. doi: 10.1111/j.1471-0528.2009.02357.x 19781042
9. Kufa T, Kharsany AB, Cawood C, Khanyile D, Lewis L, Grobler A, et al. Misdiagnosis of HIV infection during a South African community-based survey: implications for rapid HIV testing. J Int AIDS Soc. 2017;20(Suppl 6):21753. doi: 10.7448/IAS.20.7.21753 28872274
10. Kufa T, Lane T, Manyuchi A, Singh B, Isdahl Z, Osmand T, et al. The accuracy of HIV rapid testing in integrated bio-behavioral surveys of men who have sex with men across 5 Provinces in South Africa. Medicine (Baltimore). 2017;96(28):e7391.
11. Mayaphi SH, Martin DJ, Quinn TC, Laeyendecker O, Olorunju SA, Tintinger GR, et al. Detection of Acute and Early HIV-1 Infections in an HIV Hyper-Endemic Area with Limited Resources. PLoS One. 2016;11(10):e0164943. doi: 10.1371/journal.pone.0164943 27764165
12. Bock P, Phiri C, Piwowar-Manning E, Kosloff B, Mandla N, Young A, et al. Understanding low sensitivity of community-based HIV rapid testing: experiences from the HPTN 071 (PopART) trial in Zambia and South Africa. J Int AIDS Soc. 2017;20(Suppl 6):21780. doi: 10.7448/IAS.20.7.21780 28872272
13. Jaya Z, Drain PK, Mashamba-Thompson TP. Evaluating quality management systems for HIV rapid testing services in primary healthcare clinics in rural KwaZulu-Natal, South Africa. Plos One. 2017;12(8):e0183044. doi: 10.1371/journal.pone.0183044 28829801
14. Mashamba-Thompson TP, Moodley P, Sartorius B, Drain PK. Evaluation of antenatal rapid human immunodeficiency virus testing in rural South Africa. Southern African Journal of HIV Medicine. 2018;19(1).
15. Kosack CS, Page AL, Beelaert G, Benson T, Savane A, Ng’ang’a A, et al. Towards more accurate HIV testing in sub-Saharan Africa: a multi-site evaluation of HIV RDTs and risk factors for false positives. J Int AIDS Soc. 2017;19(1):21345. doi: 10.7448/IAS.20.1.21345 28364560
16. Yao K, Wafula W, Bile EC, Cheignsong R, Howard S, Demby A, et al. Ensuring the quality of HIV rapid testing in resource-poor countries using a systematic approach to training. Am J Clin Pathol. 2010;134(4):568–72. doi: 10.1309/AJCPOPXR8MNTZ5PY 20855637
17. Wolpaw BJ, Mathews C, Chopra M, Hardie D, de Azevedo V, Jennings K, et al. The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field. BMC health services research. 2010;10:73. doi: 10.1186/1472-6963-10-73 20307310
18. PEPFAR country/regional operational plan (COP/ROP)2017 guidance
19. PEPFAR. Achieving epidemic control in South Africa: A PEPFAR perspective. 2015.
20. WHO/CDC. HIV rapid test training package: trainer materials 2005 http://www.who.int/diagnostics_laboratory/documents/guidance/rt_training/en/.
21. Maleka M. NHLS HIV PROFICIENCY TESTING SCHEME SURVEY NO. 0216. NATIONAL SUMMARY REPORT. 2016.
22. Maleka M. NHLS HIV PROFICIENCY TESTING SCHEME SURVEY NO. 0117. NATIONAL SUMMARY REPORT. 2017.
23. Maleka M. NHLS HIV PROFICIENCY TESTING SCHEME SURVEY NO. 0217. NATIONAL SUMMARY REPORT. 2017.
24. QA/ QI Stakeholders Meeting. 22nd and 23rd October 2015.Birchwood Hotel and Conference Centre OR Tambo.
25. Matsoso MP, Hunter JR, Brijlal V. Embedding quality at the core of universal health coverage in South Africa. The Lancet Global Health. 2018;6(11):e1153–e4. doi: 10.1016/S2214-109X(18)30323-1 30196092
26. Hunter J, Asmali S, Ravhengani N, Chandran T, Tucer J, Mokgalagadi Y. The ideal clinic in South Africa: progress and challenges in implementation. in: Padarath A Barron P South African Health Review 2017. Health Systems Trust, Durban; 2017 2017 [http://www.hst.org.za/publications/South%20African%20Health%20Reviews/11_The%20Ideal%20Clinic%20in%20South%20Africa_progress%20and%20challenges%20in%20implementation.pdf.
27. NDOH. Ideal clinic manual version 18 2017.
28. Tucker TJ, Manyike PT. Improving the clinic-laboratory-interface in the context of HIV diagnosis, treatment, and monitoring. Curr Opin HIV AIDS. 2017;12(2):105–11. doi: 10.1097/COH.0000000000000350 28079593
29. Mhlongo D, Puren AM, R., Khumalo P. The use of an internal quality control programme to monitor quality assurance of HIVrapid testing in the Limpopo province, South Africa 2014.
30. SEAD. Analysis of POCT/VCT performed at South African primary health care clinics. 2010 [updated 2010; cited 2014 July 14]; http://www.sead.co.za/downloads/POCT-clinics-2011.pdf.
31. Mwisongo A, Peltzer K, Mohlabane N, Tutshana B. The quality of rapid HIV testing in South Africa: an assessment of testers’ compliance. Afr Health Sci. 2016;16(3):646–54. doi: 10.4314/ahs.v16i3.2 27917195
32. Balisanga H, Mutagoma M, Remera E, Kayitesi C, Kayirangwa E, Dee J, et al. HIV surveillance in Rwanda: readiness assessment to transition from antenatal care-based to prevention of mother-to-child transmission program-based HIV surveillance. Int J Infect Dis. 2016;52:62–7. doi: 10.1016/j.ijid.2016.08.029 27616035
33. Meyers AFA, Sandstrom P, Denny TN, Hurlston M, Ball TB, Peeling RW, et al. Quality assurance for HIV point-of-care testing and treatment monitoring assays. Afr J Lab Med. 2016;5(2):557. doi: 10.4102/ajlm.v5i2.557 28879133
Článek vyšel v časopise
PLOS One
2019 Číslo 9
- S diagnostikou Parkinsonovy nemoci může nově pomoci AI nástroj pro hodnocení mrkacího reflexu
- Je libo čepici místo mozkového implantátu?
- Pomůže v budoucnu s triáží na pohotovostech umělá inteligence?
- AI může chirurgům poskytnout cenná data i zpětnou vazbu v reálném čase
- Nová metoda odlišení nádorové tkáně může zpřesnit resekci glioblastomů
Nejčtenější v tomto čísle
- Graviola (Annona muricata) attenuates behavioural alterations and testicular oxidative stress induced by streptozotocin in diabetic rats
- CH(II), a cerebroprotein hydrolysate, exhibits potential neuro-protective effect on Alzheimer’s disease
- Comparison between Aptima Assays (Hologic) and the Allplex STI Essential Assay (Seegene) for the diagnosis of Sexually transmitted infections
- Assessment of glucose-6-phosphate dehydrogenase activity using CareStart G6PD rapid diagnostic test and associated genetic variants in Plasmodium vivax malaria endemic setting in Mauritania
Zvyšte si kvalifikaci online z pohodlí domova
Všechny kurzy