ALTHOUGH many companies have been marketing test kits since the outbreak of the deadly disease, an official of the Food and Drug Administration (FDA) said on Sunday that no coronavirus 2019 (Covid-19) test kits are available to the market yet.
This is because, according to FDA Director General Eric Domingo, no company has complied with the minimum set of requirements.
The only Covid-19 diagnostic test kits used now are PCR-based lab kits at the Research Institute for Tropical Medicine donated by the World Health Organization (WHO); and the University of the Philippines-National Institute of Health; and the Department of Science and Technology-developed test kit.
“As of today, no company has submitted these (requirements),” Domingo said adding that the source and the reliability of the devices are yet to be verified.
For imported test kits, the FDA only requires a License to Operate (LTO) and distributor, and a Certificate of Product Registration (CPR) from a reliable and mature natural regulatory agency (NRA) 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).
The FDA offcial stressed that there is no delay in approval because as soon as proper documents are submitted to the agency, these will be evaluated and processed.
He said that FDA is doing everything to protect the public to ensure that the available test kits for use are “safe and will give useful results.”
“We cannot vouch for its safety and efficacy by merely accepting the stated claims of a testing kit without a proper regulatory certification from the country of origin and a reliable NRA,” he said, stressing that the kits may give “false positive” and “false negative results” which may afffect the response to the pandemic.
He also expressed concern that the kits may be counterfeit products and will not test Covid-19 at all.
“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 out for each other’s safety,” Domingo concluded.