NAFDAC grants companies access to conditional use of test kits on coronavirus patients

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

NAFDAC director-general Prof Mojisola Adeyeye in a statement said the antibody test kits (IgG/IgM) can be used in COVID-19 confirmed individuals, who can then be tested at the designated centres to confirm that they have antibodies, saying that such people may not be infected again.

Adeyeye said that the antigen tests kits, on the other hand, can detect the COVID-19 antigen in patients with or without symptoms and that the results are only qualitative (positive or negative).

She, however, warned that no vaccines have been approved for any clinical trial of coronavirus as the approved vaccine may not surface in 18 months after clinical trials must have been conducted in different countries in line with laid down protocols to further ensure safety and efficacy.

The NAFDAC boss noted that the current COVID-19 pandemic has prompted the agency to put measures in place to ensure access to health commodities that have the potential to impact positively on public health outcomes. These according to her include diagnostics necessary to support public health infrastructure and guide the response necessary to combat and address the pandemic.

Adeyeye noted that the agency had 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.

She explained that 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.

The NAFDAC boss asserted that failure to comply could lead to revocation of any approval granted for the importation of the products and forfeiture of the same to the agency for destruction.

According to her, “NAFDAC has reduced the “registration to approval” time from 120 working days to 10 working days due to the COVID-19 pandemic. Thus far, the Agency has processed seventeen (17) applications using the expedited review process but has only granted Emergency approval to seven (7) companies using the criteria listed above.”

She noted that the availability of PPE for health care providers is a critical component of the effort to stem the COVID 19 pandemic.

“These PPEs include gloves, protective goggles, face shields, protective gowns and masks in the form of particulate respirators and surgical masks. These must meet certain technical requirements and specifications in order to achieve the objective and offer some measure of protection to health care providers and limit their exposure to infection,” Adeyeye said.

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