By Hassan Zaggi
The National Agency for Food and Drug Administration and Control (NAFDAC), has granted what its described as conditional and emergency use of medical devices including Personal Protective Equipment (PPEs), antibody and antigen test kits used in the fight against Covid-19 to diagnostic companies.
The Director General of the agency, Mojisola Adeyeye, disclosed this in a statement in Abuja, Thursday.
She noted that: “The current COVID-19 pandemic has necessitated that NAFDAC put measures in place to ensure access to health commodities that have the potential to impact positively on public health outcomes.
“These include, but are not limited to, diagnostics necessary to support public health infrastructure and guide the response necessary to combat and address the pandemic.
“The antibody test kits (IgG/IgM) can be used in COVID-19 confirmed individuals who can then be tested at the designated centers using the antibody kits to confirm that they have antibodies and as such may not be infected again.
“The antigen tests kits on the other hand, can detect the COVID-19 antigen in patients with or without symptoms. The results are only qualitative (positive or negative)
“There has been a global effort by innovative diagnostic companies to develop test kits to aid in detection of the virus in patients to guide the management of the disease.
“The Agency has recently received many requests for Emergency Use Authorization for some of such diagnostic test kits to support the national response and ensure expanded testing capabilities.”
Despite the conditional emergency approval, she said, NAFDAC has put in place regulatory measures to ensure that quality, safety and efficacy criteria are assessed.
These measures, according to her, are supported by documentation which include, “prior registration and approval by reference regulatory authorities such as those of Japan, USA, Germany, Canada, European Medicine Agency, etc.
“Registration by the Regulatory Authority in the Country of Manufacture; declaration of conformity and validation/ performance valuation / Clinical Evaluation Report.”
She maintained that: “In addition to these requirements, the full approval of any diagnostic/test kit by NAFDAC for COVID-19 will be subject to in-country validation to assess the sensitivity or rate of failure (i.e., indication of false positives), and specificity.
“Failure to comply could lead to revocation of any approval granted for importation of the products and forfeiture of same to the agency for destruction.”
