MANILA, Philippines — The Food and Drug Administration (FDA) has reiterated that there are no registered COVID-19 diagnostic test kits that are now available to the public yet.
In a statement issued on Sunday (March 15), the FDA said this is so “because no company has complied with the minimum set of requirements.”
The FDA added that they are only asking for a License to Operate (LTO) as a distributor and a Certificate of Product Registration (CPR) from a reliable and mature national regulatory agency (NRA) such as FDA counterparts in the United States, Japan, Singapore, South Korea, Europe, among others, from those who want to import test kits.
In the absence of such, a Certificate of Prequalification or Emergency Use Listing from the World Health Organization (WHO) is also admissible.
As of Sunday, the FDA said, no company has submitted these.
The agency also denied that there is a delay in the approval of the test kits, adding that as soon as proper documents are submitted to the FDA, the certification will be immediately released.
The FDA stressed that the submission of proper documents relative to the test kits will safeguard the public interest and ensure that the available test kits for use are safe and will give useful results.
“Many companies have been marketing test kits since the start of the COVID outbreak, however, the source and reliability of these devices are yet to be verified,” the statement reads.
Director-General Eric Domingo explained, “We cannot vouch for its safety and efficacy by merely accepting the stated claims of a testing kit without the proper regulatory certification from the country of origin and a reliable NRA. These kits may give false positive and false negative results which may affect the response to this pandemic. They may also be counterfeit products that will not test for the novel coronavirus at all.”
The FDA added that the only COVID-19 diagnostic test kits used now are PCR based lab kits at the Research Institute of Tropical Medicine (RITM) which were donated by the WHO, and the University of the Philippines National Institutes of Health (UP NIH) and Department of Science and Technology (DOST) developed test kit which is scheduled to start field testing on Monday, 16 March 2020.
The FDA ensures that it is committed to staying true to its mandate of safeguarding public health.
“During these difficult times, we strongly request everybody to cooperate and to be vigilant. This is not the time to take advantage of the scarcity of resources by allowing unregulated items into the system. Let us continue to look after each other’s safety.” DG Domingo concluded. — /mbmf
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