Fred Ezeh, Abuja
Medical Laboratory Science Council of Nigeria (MLSCN), has confirmed that none of the Rapid Diagnostic Test (RDT) kits submitted by some vendors for validation and approval for COVID-19 testing in Nigeria passed its validation test.
This was contrary to report that Nigeria Institute of Medical Research (NIMR) recently developed a molecular rapid test kit for COVID-19 that can produce result in less than 40 minutes.
The Council disclosed that no fewer than 43 brand of RDT kits was submitted to MLSCN by vendors for validation in its second batch of pre-market validation of COVID-19 test kits.
The Council said that, out of the figure, 33 test kits and systems were validated, but was disappointed that all the antigen and antibody test kits, rapid or otherwise, failed to meet the minimum acceptable criteria.
It, however, explained that, for a RDT kit to be deployed for disease surveillance and diagnosis, it must be able to detect a disease causing agent when presented, and to return a negative result if the causative agent is absent.
Additionally, 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.
Registrar of MLSCN, Dr. Tosan Erhabor, who spoke at a press conference in Abuja, on Tuesday, 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.
He explained: “After thorough and careful validation exercise that was done with regards to global best practices, none of the products met 95 percent generally acceptable minimum standard in terms of sensitivities and specificities to stand a chance of deployment for COVID-19 testing.”
He strongly advised Nigerians against the use of any non-validated RDT kits for COVID-19 testing in Nigeria expressing concerns about the consequences, adding that it will attract sanctions in accordance with the law.
The Registrar, thus disclosed that MLSCN is working closely with the Nigeria Centre for Disease Control (NCDC) to ensure that the two World Health Organization (WHO) pre-qualified antigen RDT kits will go through validation as soon as they arrive Nigeria.
He also asked private medical laboratories seeking to provide COVID-19 testing through private arrangement to acquaint themselves with the revised guidelines for such operations to avoid severe sanctions from the Council.