Failed Initial Quality Control Testing of Procured Malaria Rapid Diagnostic Tests in Lagos State, Nigeria

Deployment of sound diagnostic tests remains a crucial component of malaria management, prevention and control in Africa. Rapid diagnostic tests (RDTs) address the need for accurate diagnosis of malaria particularly in resource limited settings. Misdiagnosis which remains too frequent resulting in antimalarial treatment (Oladosu and Oyibo, 2013). Malaria rapid diagnostic tests (MRDTs) have the potential of significantly improving the diagnosis of malaria in developing countries, especially where there is no adequate microscopy service for the diagnosis of malaria or act as a back-up to microscopy for inexperience personnel. However, the absolute reliance of these tests remains a problem due to uncertainty of the quality of the test and lack of confidence since there is no regulation and lack of proper quality control measures on ground (Okangba, 2019a). There are different commercially available MRDTs in the market these include SD BiolineR, which detects the antibodies of Plasmodium falciparum and Plasmodium vivax using recombinant antigen of merozoite surface protein (MSP), Global DeviceR, Paracheck PfR and Wondfo BiotechR detects Pf histidine-rich proteind (HRP2) and CTK BiotechR detects parasite lactate dehydrogenase (pLDH) in all the species of Plasmodium spp. The quality assessment and heat stability of five commercially procured RDTs (SD BiolineR, Global deviceR, ParacheckR, Wondfo BiotechR and CTK BiotechR). The Quality Assurance (QA) was carried by using prepared Quality Control (QC) samples at different parasitaemia dilutions. The MRDTs failed the initial quality control testing (QC), since none had up to 100% positive as recommended by WHO. SD BiolineR had percentage positive of 83.3% while Global deviceR, ParacheckR, WondfoR, and CTK BiotechR had percentage positive of 33.3%, 16.7%, 33.3% and 8.3% respectively. For heat stability testing, the RDTs were stored at different temperatures for 50days: Global deviceR, CTK biotechR and WondfoR were kept at 400C, and 450C, ParacheckR at 450C and 500C, while SD BiolineR was kept at 400C. They all showed a substantial fall in percentage test line positivity. All the MRDTs gave a 0% positivity expect for SD Bioline, which gave percentage positive of 25% at 400C temperatures respectively. The marked decline in the performance of the MRDTs can be adversely affected by the high temperatures to which they were exposed to in a tropical country, manufacturer’s defects, poor storage facility, mishandling in the course of transportation and use of sub- standard materials in production .There is need for proper regulatory body to regulate the manufacturing and importation of RDTs against any unwholesome practice. Also, there is need to consider the importance of stability of diagnostic test during procurement.