MANILA — The Food and Drug Administration (FDA) on Sunday said there are no registered coronavirus diseases 2019 (Covid-19) diagnostic test kits available to the public because no company has complied with the minimum set of requirements.
In a statement, the FDA said it only requires a License to Operate (LTO) as a distributor and a Certificate of Product Registration (CPR) from a reliable and mature national regulatory agency such as FDA counterparts in the United States, Japan, Singapore, South Korea, Europe among others or a Certificate of Prequalification or Emergency Use Listing from the World Health Organization (WHO) for or imported test kits.
The FDA added that there will be no delay in the approval of the test kits and the certification will be released immediately as soon as proper documents are submitted.
It also stressed that such is done to safeguard public interest and ensure that the available test kits for use are safe and will give useful results.
This, after many companies have been marketing test kits since the start of the Covid-19 outbreak and the source and reliability of these devices are yet to be verified.
“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 corona virus at all,” FDA Director General Eric Domingo said.
The only Covid-19 diagnostic test kits used now are PCR based lab kits at the Research Institute of Tropical Medicine (RITM) donated by WHO.
The University of the Philippines National Institutes of Health and Department of Science and Technology developed test kit for field testing on Monday.
“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.” Domingo said. (PNA)