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All rapid COVID-19 test kits submitted by vendors fail validation test

By Iwuese Yaikyur
The Medical Laboratory Science Council of Nigeria, MLSCN, said all the COVID-19 Rapid Diagnostic Test (RDT) kits submitted by some vendors failed its validation test.
The MLSCN Registrar, Dr. Tosan Erhabor, dressing the media on 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 union however explained 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 requirement
The Registrar further explained 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 aim of the validation exercise is 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
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 punishment in accordance within the ambit of the law.
He disclosed 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 familiarize themselves with the revised guidelines to avoid severe sanctions from the Council.

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