NAFDAC okays conditional emergency use for COVID-19 test kits

The National Agency for Food, Drug Administration and Control (NAFDAC) has granted conditional emergency use approval of medical devices for COVID-19 antibody, as well as antigen test kits to manufacturing companies and importers of such devices.

It explained that the test kits (IgG/IgM) could be used on COVID-19 confirmed individuals, who could then be tested at designated centres to confirm that they have anti-bodies and as such may not be infected again.

The agency added that the antigen tests kits could also detect the COVID-19 antigen in patients with or without symptoms and that the results could only be positive or negative.

NAFDAC, however, cautioned that no vaccines have been approved for any clinical trial and that it might not happen between a year and 18 months, after clinical trials must have been conducted in different countries, followed by rigorous in-country assessment in line with laid down protocols to further ensure safety and efficacy.

Director General of NAFDAC, Professor Mojisola Adeyeye, who disclosed this in Abuja, noted that the COVID-19 pandemic necessitated that the agency put measures in place to ensure access to health commodities that have the potential to impact positively on public health outcomes.

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