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VOLUME 04 ISSUE 05 MAY 2021

Quality of Malaria and HIV Rapid Diagnostic Test kits (RDTs) in health facilities and medicines outlets in the Greater Accra Region of Ghana
1,2*Amartey AO, 2Buabeng KO, 3Mohammed A, 4Maru SM, 5Peeling R, 6Tengey S
1Technical Operations Division, Food and Drugs Authority, Accra, Ghana
2Department of Pharmacy Practice, Faculty of Pharmacy and Pharmaceutical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
3Department of Epidemiology and Biostatistics, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
4Department of Pharmacy Practice and Pharmaceutics, School of Pharmacy, University of Nairobi, Kenya.
5London School of Hygiene and Tropical Medicine, UK
6Medical Waste Department, Zoompak Ghana Limited, Accra-Ghana
DOI : https://doi.org/10.47191/ijmra/v4-i5-04

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ABSTRACT:

Background:
Questions remain on the quality of malaria and HIV Rapid Diagnostic Test kits (RDTs) stocked and used in health facilities in Ghana. The Food and Drugs Authority (FDA) in Ghana is mandated to regulate RDTs for quality. By this, all RDTs must be registered, and each brand given a unique registration number. This study aimed to assess the quality of malaria and HIV RDTs in health facilities in the Greater Accra Region of Ghana, using FDA standards.
Method:
Data was obtained using structured questionnaire from 400 facilities in three districts in the Greater Accra region. A multi-stage sampling procedure was used to select the health facilities including retail medicine outlets. Information on the registration status of the RDTs and conditions under which they were stored were gathered. RDTs kept in air conditioned or well-ventilated rooms were considered as being stored under good condition. RDTs, registered by the FDA and appropriately stored were considered to be of good quality. Data was coded, stored, and analyzed using STATA version 15.
Results:
About 17% of the malaria RDTs stocked in the pharmacies were unregistered, 85.7% in hospitals were registered. Also, 83.3% of HIV RDTs in the Policlinics were registered. Registration status of the RDTs were associated with the districts in which the health facilities were located (p = 0.006). The RDTs were generally stored under good conditions (99.5%). Over forty percent (41.9%) of user practitioners interviewed rated the quality of the malaria RDTs as good and 59.2% rated HIV RDTs as very good.
Conclusion:
Though there were some unregistered RDTs whose quality cannot be ascertained, the quality of malaria and HIV RDTs in the facilities assessed were rated as good and likely to produce good results for malaria and HIV case detection.

KEYWORDS

Quality, Malaria, HIV, Rapid Diagnostic Tests (RDTs), Ghana.

REFERENCES

1) Baiden F., Webster J., Tivura M., et al. (2012). Accuracy of rapid tests for malaria and treatment outcomes for malaria and non-malaria cases among under-five children in rural Ghana. PLoS ONE; 7:e34073.

2) Evelyn KA, Solomon N, Harriet AB, Constance BP, Bonnie C, Christopher J M W (2015). The impact of providing rapid diagnostic malaria tests on fever management in the private retail sector in Ghana: a cluster randomized trial. BMJ; 350:h1019.

3) Ghana Health Service Facts and Figures 2017 publications http://www.ghanahealthservice.org/ghs-item-etails.php?cid=5&scid=55&iid=128 (last accessed October 30, 2018)

4) Ghana Statistical Service (GSS), Ghana Health Service (GHS), and ICF International. 2015. Ghana Demographic and Health Survey 2014. Rockville, Maryland, USA: GSS, GHS, and ICF International

5) Global Harmonization Task Force: Definition of the Terms “Medical Device” and “In Vitro Diagnostic (IVD) Medical Device GHTF/SG1/N071:2012. In Book Definition of the Terms “Medical Device” and “In Vitro Diagnostic (IVD) Medical Device GHTF/SG1/N071:2012 ; 2012

6) In vitro diagnostics and laboratory technology> Prequalification of in vitro diagnostics https://www.who.int/diagnostics_laboratory/en/(last accessed October 30, 2018)

7) Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)www.who.int/malaria/publications/atoz/978924151268/en/(last accessed October 30, 2018)

8) Nicastri E., Bevilacqua N., Schepisi MS., et al. (2009). Accuracy of malaria diagnosis by microscopy, rapid diagnostic test, and PCR methods and evidence of antimalarial overprescription in non-severe febrile patients in two Tanzanian hospitals. Am. J. Trop. Med. Hyg.; 80:712-17.

9) Pharmacy Council, Ghana. Gazette of Pharmaceutical facilities, 2018.

10) Public Health Act 2012, Act 851 Republic of Ghana

11) World Health Organization. Guidelines for the treatment of malaria. 2nd ed. Geneva:12 World Health Organization; 2010

12) WHO List of prequalified in vitro diagnostic products; Last update 4th April 2019 www.who.int/diagnostics_laboratory/evaluation/190404_prequalified_product_list.pdf

13) World Health Organization. 2019; Rapid diagnostic tests http://www.who.int/malaria/areas/diagnosis/rapid_diagnostic_tests/en/

VOLUME 04 ISSUE 05 MAY 2021

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