By Okeke Jane
The Medical Laboratory Science Council of Nigeria (MLSCN) has said that there is no SARS-CoV-2 Rapid Test Kit that is currently approved for use in Nigeria.
In a press briefing on Friday, on the Report of Pre-market Validation of SARS-CoV-2 infection (COVID-19), the Registrar/Chief Executive Officer, MLSCN), Dr Tosin Erhabor revealed that the Council has validated for Rapid Test Kits which did not meet expected performance to be used in the country.
According to Erhabor, the four Kits in the report had not met the expected performance characteristics of sensitivity and specificity to qualify for their use for testing in disease surveillance and routine diagnosis.
He said,”The four rapid test kits validated so far are not approved for the purpose of diagnosis and surveillance in Nigeria.
“They are therefore not approved for marketing in Nigeria. No SARS-CoV-2 Rapid Test Kit is currently approved for use in Nigeria.
“We are using this opportunity to caution against the use of any non-validated Rapid Test Kits for COVID-19 testing in Nigeria as this will attract sanctions in accordance with the law.”
Erhabor pointed out that validation of Rapid Test Kits for SARS-CoV-2 infections is ongoing, adding that Nigerians will be informed when suitable test kits meet minimum validation requirements.
According to him, the MLSCN has assured the Federal and state Ministry of Health and the Nigerian government of its commitment to ensuring quality healthcare delivery as enshrined in the statute books.
He added that the council has issued a guideline for private sector medical laboratories that seek to prove 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,” Erhabor said.
He equally mentioned that prospective private medical laboratories for COVID-19 testing should be granted approval by MLSCN in collaboration with NCDC in line with these guidelines.
He however, warned that those not granted this approval and proceed to conduct COVID-19 testing will be considered to have contravened the provisions of Section 4(h) of MLSCN Act.
