FDA: No COVID-19 kits approved for commercial release yet

MANILA, Philippines — The Food and Drug Administration on Sunday reminded the public that there are no COVID-19 test kits registered and made available to the public despite "many" companies marketing such kits. 

According to the FDA, no company thus far has submitted the necessary licenses to operate and certificates of product registration from national regulatory agencies. 

The administration also warned the public against buying unregistered and unregulated testing kits.

"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," FDA director general Eric Domingo said in the statement. 

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

READ: FDA allows use of test kits developed by UP scientists as virus spreads locally

"They may also be counterfeit products that will not test for the novel coronavirus at all." 

The FDA also said that there is no delay in certifying potential testing kits as certification would be released once the necessary documents are submitted to them.

Testing woes 

The lack of testing kits has added to the uncertainty over the COVID-19 outbreak.

On Monday, Health Secretary Francisco Duque III admitted that supplies for testing were limited after Sen. Panfilo Lacson said that the Department of Health (DOH) may have underreported existing cases. 

“He said there is a possibility of underreporting, although unintentionally. This is largely because of our limited testing supplies. As soon as we get more, then we will be able to expand the coverage of who will be tested,” Duque told reporters in Malacañang.

In an earlier text message exchange, Health Secretary Francisco Duque III told Philstar.com that patients were only tested "just three times" per day while only “about 200 to 250 people” are getting tested a day at the Research Institute for Tropical Medicine.

READ: How the Department of Health processes potential COVID-19 cases

"PUIs are isolated in hospitals and tested for COVID-19. If positive [they're] manage[d] accordingly until 2 negative tests are reached and then discharged with close monitoring," he added.

Once samples are taken from PUIs, the Research Institute for Tropical Medicine (RITM) runs confirmatory tests for traces of COVID-19. The Health department says these tests can take up to 48 hours.

Kit developed by local scientists

On Tuesday, the FDA gave the green light for a detection kit developed by the University of the Philippines National Institute of Health. 

Dr. Raul Destura, who was credited with inventing the local coronavirus kit, said the university was "in the final phase" before releasing it commercially. 

"Ang ating mga Filipino scientists ay ‘di ilalabas itong kit kung walang malalim na paniniwala sa safety nito," Legaspi said at a media briefing held by officials of the University of the Philippines on Thursday.

(Our Filipino scientists will not release this kit without a deep belief in its safety.)

READ: Early screening can quell COVID-19 spread — PGH

At the same media briefing, Philippine General Hospital Director Gerardo Legaspi said that early screening could quell the spread of the virus. 

"Ang gamot po sa COVID-19 ay [pagiging] healthy individual na hiwalay po sa pasyenteng mas malala, at ang gamot po sa COVID-19 is our natural ability to combat the virus," Legaspi said. 

"Hindi po kailangan lahat ng simptomas lumabas para maging positive o negative."

(The treatment for COVID-19 is being a healthy individual separated from more severe patients, and the treatment for COVID-19 is our natural ability to combat the virus. You do not need all the symptoms to come out to become positive or negative.)