The Medical Laboratory Council of Nigeria (MLSCN) says it has not approved any Rapid Test Kits for the purpose of diagnosis and surveillance of Coronavirus (COVID-19) in the country.
The Registrar and Chief Executive Officer of MLSCN, Dr Tosan Erhabor, stated this at a news conference on the Report of Pre-market Validation of SARS-COV-2 Infection (COVID-19) Rapid Test Kits in Nigeria on Friday in Abuja.
According to the registrar, the council has validated four Rapid Test Kits and did not meet expected performance to be used in the country.
Erhabor said the four kits in the report had not met the expected performance characteristics of sensitivity and specificity to qualify their deployment for the purposes of testing in disease surveillance and routine diagnosis.
“The four rapid test kits validated so far are not approved for the purpose of diagnosis and surveillance of SARS-CoV-2 infection in Nigeria.
“They are therefore not approved for marketing in Nigeria; No SARS-COV-2 Rapid Test is currently approved for use in Nigeria.
“We are using this opportunity to caution against the use of any non-validated Rapid Kits for COVID-19 testing in Nigeria as this will attract sanctions in accordance with the law,’’ he said.
According to him, validation of other Rapid Test Kits for SARS-COV-2 infection is ongoing, as Nigerians will be informed when suitable test kits meet minimum validation requirements.
“MLSCN assures the Federal and State Ministries of Health and indeed the government of Nigeria of its commitment to ensuring quality healthcare delivery as enshrined in the statute books,’’ Erhabor said.
Erhabor explained that the council had issued a guideline for private sector medical laboratories that seek to provide testing through completely private arrangements.
“Let me use this opportunity to unveil the guideline; this document has been developed by MLSCN in collaboration with the Nigeria Centre for Disease Control (NCDC).
“It has been developed to guide engagement with private sector medical laboratories to help accelerate the availability of COVID-19 diagnostic testing for the duration of the public health emergency in Nigeria.
“For these private medical laboratories, providing a public sector function, NCDC and its partners will continue to support the provision of reagents and consumables so that testing is conducted at no cost to the patient,” he said.
Erhabor said prospective private medical laboratories for COVID-19 testing should be granted approval by MLSCN in collaboration with NCDC in accordance with these Guidelines.
“However, those not granted this special approval and proceed to conduct COVID-19 testing will be considered to have contravened the provisions of Section 4 (h) of MLSCN Act.
“Medical Laboratories Regulations for Inspection, Approval, Monitoring and Accreditation, and will be sanctioned in line with the provisions of the said regulation,’’ he said.
Also speaking, Mrs Nwandu Mba, the Director of Laboratory Services, NCDC, emphasised that no rapid test kit had been approved for use in the country.
“Even if we have rapid test kits approved later; it will only serve as a guide. We will still continue to use Polymerase Chain Reaction (PCR) for testing the virus,’’ she said.
She said that NCDC was also working to validate GeneXpert machines for testing of COVID-19 to complement the PCR being currently used.
