By Onyebuchi Ezigbo
The federal government on Friday said it will no longer condone the marketing and use of non validated rapid diagnostic test kits in the country.
It said that so far no rapid diagnostic test kit has met the standard certification for use in testing for Covid-19 or any infectious disease control in Nigeria.
While presenting approved guidelines for private sector medical laboratory participation in the testing for Covid-19 virus, the Registrar and Chief Executive Officer of the Medical Laboratory Science Council of Nigeria (MLSCN), Tosan Erhabor, said that none of the four variance of the rapid diagnostic test kits that so far scaled initial hurdle for validation has met the required standards.
He said: “We are using this opportunity to caution against the use non-validated test kits for Covid-19 testing in Nigeria as this will attract sanctions in accordance with the law.”
Erhabor said that the council will henceforth employ the services of security agencies to fish out all those behind the importation and marketing of rapid test kits without validation by MLSCN.
The federal government had insisted that it will only recognise tests conducted at the molecular laboratory which has been endorsed by the World Health Organization (WHO) for its accuracy and reliability.
The Director General of the Nigeria Centre for Disease Control (NCDC), Dr. Chikwe Ihekweazu, also raised the alarm last Wednesday that substandard rapid diagnostic test kits have now flooded the black market across the country.
Speaking on the outcome of the pre-market validation of Covid-19 rapid test kits carried out by the council, Erhabor said that out of the seven antibody-based rapid test kits submitted by the manufacturers or their representatives, only four met validation inclusion criteria.
He said that the validation of the nine Polymerase chain reaction-based kits and Antigen-based rapid test kits were ongoing.
Erhabor explained that the four rapid test kits that have scaled the prequalification hurdle, are not approved for the purposes of diagnosis and surveillance of SARS-Covid-19 infection in Nigeria.
“They are therefore not approved for marketing in Nigeria. No SARS-2 rapid test kits is currently approved for use in Nigeria,” he said.
On the guideline for the participation of private sector medical laboratories in Covid-19 testing, Erhabor said MLSCN in collaboration with NCDC will grant approval in accordance with the guidelines.
He said that the laboratory guidelines have been posted on the council’s website, adding that one of the key aspects of the guidelines is that such a private laboratory must provide evidence of implementation of quality management system to demonstrate the ability to produce accurate result.
The laboratory test should be offered only when prescribed as per NCDC national guidelines on covid-19 case definition.
Also, the private laboratory must show evidence of biosafety and biosecurity precautions.
