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COVID-19: No rapid test kit passed validation test – Medical Lab Council

The Medical Laboratory Science Council of Nigeria (MLSCN), yesterday said none of the COVID-19 Rapid Diagnostic Test (RDT) kits submitted by some vendors passed its validation test. MLSCN, while noting that 43 brands of RDT kits earlier submitted by some vendors for validation were in its second batch of pre-market validation of COVID-19 test kits, however, clarified that although 33 test kits and systems were validated, all the antigen and antibody test kits whether rapid or otherwise, failed to meet the minimum acceptable criteria.

However, this was contrary to recent reports that Nigeria Institute of Medical Research (NIMR) has developed a molecular rapid test kit for COVID-19 with capacity to produce results in less than 40 minutes after a COVID- 19 test was conducted. Registrar of MLSCN, Dr. Tosan Erhabor, who addressed newsmen in Abuja, said a RDT kit must be able to detect a disease causing agent when presented and return a negative result if the causative agent is absent, before it could be deployed for disease surveillance and diagnosis. Also, it must possess good sensitivity measures that will enable it detect the presence of the disease, and must, equally, have good specificity measures so that no interfering substances can lead to a false positive instead of negative results in the absence of the etiological agent of the disease.

Erhabor explained that the objective of the validation exercise was to determine the sensitivity and specificity of the kits, its accuracy, and the inter-reader variability of the test results of the kits using the real-time Polymerase Chain Reaction (PCR) method as reference standard for detection of COVID-19.

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