The National Agency for Food and Drug Administration and Control has granted conditional emergency use approval of COVID-19 Antibody and Antigen Test Kits, PPEs.
The agency reportedly said that 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 test 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).
The agency reportedly said that there has been a global effort by innovative diagnostic companies to develop test kits to aid in the 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.
NAFDAC has put in place regulatory measures to ensure quality, safety and efficacy criteria are assessed.
These measures are supported by documentation which includes the following:
- 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
- Validation/performance evaluation /Clinical Evaluation Report
NAFDAC reportedly said it will continue to stay abreast of current best global practices in this area and monitor updates to the WHO collated a list of medical devices being used by different countries.
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., an indication of false positives), and specificity.
NAFDAC reportedly said that failure to comply could lead to revocation of any approval granted for the importation of the products and forfeiture of same to the agency for destruction.
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.