In its recent issuance, the Food and Drug Administration of the Philippines (“FDA”) reports that the agency has approved sixteen (16) COVID-19 Rapid Antibody test kits for commercial use as of 16 April 2020.
The FDA stated in its Advisory No. 2020-671 (“Advisory”) that these test kits, which detect the presence of antibodies (against the novel coronavirus) in an individual’s blood or serum, have technical specifications and validation techniques that are unique from each other and reminds the public that, although these are packaged as easy to use, they should be administered by trained health professionals, and the results should be interpreted by licensed physicians. In addition, confirmatory polymerase chain reaction (“PCR”)-based testing is still gold standard. The agency also emphasized that the kits are strictly for medical professional use, and not intended for personal use.
Lastly, the FDA assures the public that surveillance measures are in place to monitor performance and effectiveness of the approved test kits. Despite the expedited measures currently imposed to address the pandemic, the agency continuously conducts evaluation of the approved kits, as well as post marketing surveillance. On this note, the FDA invites the public to send an email to email@example.com for any reports related to FDA-approved COVID-19 health products.
This article is intended for informational purposes only and should not be construed as legal advice.