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

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.

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

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VOLUME 04 ISSUE 05 MAY 2021