No Rapid Test Kit Approved for COVID-19 in Nigeria Yet, Council Insists



No Rapid Test Kit Approved for COVID-19 in Nigeria Yet, Council Insists
A COVID-19 test kit on display

The Medical Laboratory Science Council of Nigeria, MLSCN, has warned against the use of non-validated rapid test kits in the country, saying none is validated for use yet.

MLSCN issued the warning following outcome of the second batch of its Pre-Market Validation of COVID-19 test kits done recently.

The agency noted that out of 43 brands of test kits received for validation, 33 test kits and systems were validated, but all the antigen and antibody test kits, rapid or otherwise, failed to meet the minimum acceptable criteria.

Announcing the outcome of the exercise through a statement made available to Pharmanewsonline, the Registrar and Chief Executive Officer of MLSCN, Dr Tosan Erhabor, said for diagnosis, none of the antigen or antibody detection test kits is recommended for SARS-CoV-2 infection testing in Nigeria.

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Erhabor reiterated that “No SARS-CoV-2 rapid test kit is currently approved for use in Nigeria, therefore, MLSCN cautions against the use of any non-validated Rapid/PCR test kits for COVID-19 testing as this will attract sanctions in accordance with the law”.

However for the purpose of PCR testing, he recommended Viasure PCR kit as a first line test while Standard M may be used as second line test.
Erhabor further revealed that the two indigenous test kits developed by NIPRD and NIMR are yet to be validated by the Council, as he urged the institutions to partner with MLSCN for the best outcomes.

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He said : “For us as an organisation, when we heard of those breakthroughs we were excited and reached out to our sister organisations, congratulating them for their wonderful feat. We’re still using this medium to call on NIPRD and NIMR to subject their kits for validation. You cannot produce the kit, validate it yourself, and you say it should be used in our country. That is not the process.

“We are calling on them and we are waiting to partner with them. We will be the first to announce that Nigeria has gotten the breakthrough”, Erhabor remarked.

Pharmanewsonline had reported the launch of SARS CoV-2 Isothermal Molecular Assay, SIMA, an indigenous test kit by NIMR a month ago to boost testing capacity in the country, especially in the suburbs.

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It was stated that SIMA has the capacity to test 32 samples and produce results in less than 40 minutes.

Responding to the Council’s directive on SIMA, the Director General, Nigeria Institute of Medical Research, NIMR, Dr Babatunde Salako hinted Pharmanewsonline on the agency’s effort in getting their kit validated.

He said: “We are in the process of validation with NCDC and NAFDAC”.

The MLSCN Registrar however re-emphasised the need for all indigenously-developed test kits for COVID-19 testing in Nigeria to be submitted for validation to support standardization and promote reliable and accurate test results.



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