PFDA released FDA Advisory No. 2021-0684 to update stakeholders of the changes in the procedure and requirements for the issuance of the special certification of COVID-19 test kits brought about by the release of FDA Memorandum No. 2021-009.
In FDA Memorandum No. 2021-009, the minimum performance requirements for the different types of COVID-19 test kits were set to the following:
Table 1. Minimum COVID-19 Test Kit Performance Requirements
|
Type of COVID-19 Test Kit |
Minimum Performance Requirements |
Reference |
|
RT-PCR |
≥ 95% sensitivity and ≥ 99% specificity |
Existing document used by National Regulatory Agencies which prescribe value for used sensitivity and specificity. |
|
Antibody |
>90% sensitivity and >95% specificity |
Department Memorandum No. 2020-0439 entitled “Omnibus Interim Guidelines on Prevention, Detection, Isolation, Treatment, Reintegration Strategies for COVID—l 9” |
|
Antigen |
≥ 80% sensitivity and ≥ 97% specificity |
WHO Interim Guidance entitled “Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays” |
The copy of the product profile that meets the requirements in Table 1 must be provided during the initial application in addition to the previous requirements listed in FDA Memorandum 2020-006.
After evaluation of provided documents, compliant applications will be endorsed to the Research Institute for Tropical Medicine (RITM), and must pass the performance evaluation in order to obtain the certificate. Separate technical evaluation fee in RITM must be settled and samples must be provided according to the RITM Guidelines on the Evaluation of In Vitro Diagnostic Medical Devices and other related Laboratory Diagnostic Supplies for COVID-19. Failed performance evaluation would mean disapproval of the application. Re-testing can be requested within 20 days upon receipt of disapproval provided that the applicant presents positive results of the performance validation from a reputable organization or reference laboratory.
References: