By Joseph Erunke
ABUJA–THE Medical Laboratory Science Council of Nigeria,MLSCN,has said all the COVID-19 Rapid Diagnostic Test (RDT) kits submitted by some vendors failed its validation test.
MLSCN,through its Registrar, Dr. Tosan Erhabor, at a media briefing, Tuesday,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.
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, the umion 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.
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.
“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.”
The Registrar who advised Nigerians against the use of any non-validated RDT kits for COVID-19 testing in Nigeria due to its consequences,warned that any contrary activity would attract sanctions in accordance within the ambit of the law.
He revealed that MLSCN was 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 the country, and asked private medical laboratories seeking to provide COVID-19 testing through private arrangement to acquaint themselves with the revised guidelines to avoid severe sanctions from the Council.
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