No registered COVID-19 diagnostic test kits from private companies available to the public, only WHO-donated kits at RITM



No registered coronavirus disease 2019 (COVID-19 ) diagnostic test kits are available to the public, said the Food and Drug Administration (FDA) on Sunday.

FDA  Director General Eric Domingo said no company has complied with the minimum set of requirements for the COVID-19 testing kits.

For imported test kits, he said the FDA 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 (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).

As of Sunday, Domingo said no company has submitted these.

The agency under the Department of Health (DOH) also assured there is no delay in approval because as soon as proper documents are submitted to the FDA, the certification will be immediately released.

This is done to safeguard 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 have 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,” said Domingo.

“These kits may give false positive and false negative results which may affect the response to this pandemic,” he added.

He also warned there may also be counterfeit products that will not test for the novel corona virus at all.

According to Domingo, only COVID-19 diagnostic test kits used now are PCR based lab kits at the Research Institute of Tropical Medicine (RITM) donated by WHO.

TheUniversity of the Philippines National Institutes of Health (UP-NIH) and the  Department of Science and Technology (DOST) developed test kits scheduled to start field testing on Monday, March 16, 2020.

The FDA  assured it is committed to staying true to its mandate of safeguarding the 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,” he added./ Stacy Ang

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