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Medical Council cautions against use of non-validated rapid test kits for COVlD-19 testing



Dr Tosan Erhabor, the Registrar, Medical Laboratory Council of Nigeria (MLSCN), has cautioned against the use of any non-validated rapid/Polymerase Chain Reaction (PCR) test kits for COVID-19 testing in Nigeria.

Erhabor, also the Chief Executive Officer of MLSCN, said this on Wednesday in Abuja while briefing newsmen on the outcome of the second batch of Pre-Market Validation of COVID-19 test kits.

He said that the council would sanction any importer, dealer or scientist found wanting in this regard.

“Any of them caught will be arrested and tried in the court in line with the law of the country.

“We are working with security agencies to see that the issue is properly managed.’’

On private laboratories, he said eight private-owned laboratories had been accredited to carry out COVID-19 test in the country.

He noted that no COVID-19 rapid test kit had been approved for use in Nigeria for testing of the virus.

The registrar, however, urged local and foreigner manufacturers of COVID-19 test kits to take urgent steps to improve on standardisation of their products.

He urged them to improve on the product to meet the minimum validation requirement to guarantee reliable, accurate and timely test results.

“The 22 rapid test kits being reported had not met the expected performance characteristics of sensitivity to qualify them for deployment for the purposes of testing in disease surveillance and routine diagnosis,” he said.

He noted that non-rapid detection test kits had sensitivities and specificities below the acceptable minimum of 95 per cent and are, therefore, unsuitable for use as In-Vitro Diagnostics (IVDs) in Nigeria.

Consequently, the Registrar emphasised that for diagnosis, none of the antigen or antibody detection test kits was recommended for SARS-COV-2 infection testing in Nigeria.

In addition, he said MLSCN had recommended that all indigenously-developed test kits for COVID-19 in Nigeria should be submitted for validation to support standardisation and promote reliable and accurate test results.

“In view of these findings, it is pertinent to recommend the establishment and institutional participation in External Quality Assessment Programme for COVID-19 testing in Nigeria,’’ he said.

Erhabor appreciated the Presidential Task Force on COVID-19, the Federal Ministry of Health and the Nigeria Centre for Disease Control (NCDC) for maintaining the gold standard by deploying PCR for COVID-19 testing as well as supporting MLSCN in carrying out its mandate.

NAN reports that the vision of the council is to be a world acclaimed regulatory agency driving the culture of quality and efficient health laboratory care to the public and ensuring high academic standards in training institutions.

The council aims at achieving the vision by strengthening health laboratory systems and professional practice for quality services through strategic regulations and accreditation.

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