COVID-19: All immediate kits sent through vendors failed Array validation says MLSCN

 

The ABUJA-THE Scientific Council of the Nigerian Medical Laboratory, MLSCN, stated that all COVID-19 Rapid Diagnostic Test Kits (DRRs) sent through some vendors failed their validation test.

 

MlSCN, through its registrar, Dr. Tosan Erhabor, at a press conference Tuesday in Abuja, said a TDR kit will need to be able to run into an agent who causes the disease when it occurs and return a negative result if the causative agent is absent, before it can be used for disease monitoring and diagnosis.

 

While noting that 43 TDR kits shipped in the past through some vendors for validation were part of their pre-marketing validation batch of COVID-19 verification kits, the umion noted that 33 kits and verification systems had been validated, all antigens and antibodies Testing kits, fast or not , did not meet the appropriate minimum criteria.

 

However, this is contrary to recent reports that the Nigerian Institute for Medical Research (NIMR) developed an immediate molecular control kit for COVID-19 with the ability to produce effects in less than 40 minutes after a check. CHECK COVID-19.

 

In addition, you will need to have intelligent sensitivity measures that allow you to stumble upon the presence of the disease, and you will also need to have intelligent specificity measures so that no interfering substance can produce a false positive rather than negative effects on the absence of the disease etiological agent.

 

Erhabor explained that the objective of the validation process was the sensitivity and specificity of the kits, their accuracy and the variability among readers of the verification effects of kits that employ the polymer chain reaction (PCR) approach in real time as a reference. DETECTION of COVID-19.

 

“After comprehensive validation work on the world’s most productive practices, none of the products reached 95% of the popular appropriate minimum in terms of sensitivities and specificities for a possibility of implementation for COVID-19 testing. “

 

The Registrar, who pleaded with Nigerians to oppose the TDR kits unleashed for COVID-19 testing in Nigeria because of their consequences, warned that any other activity would result in sanctions in accordance with the scope of the law.

 

He revealed that MLSCN works heavily with the Nigerian Center for Disease Control (NCDC) to ensure that the two prequalified antigen TDR kits of the World Health Organization (WHO) go through validation upon arrival in the country, and asked laboratories seeking to provide COVID-19 tests through a personal arrangement to familiarize themselves with the revised rules in order to avoid serious sanctions in the coVID-19 component Council.

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