FDA okays 5 rapid test kits to slow virus spread

The Food and Drug Administration approved the use of five rapid test kits for COVID-19 on Monday in support of government efforts to slow the spread of the novel coronavirus, the agency’s director general, Health Undersecretary Eric Domingo said.

He said these point-of-care test kits are registered for use in countries with reliable regulatory agencies such as China and Singapore.

“We approve kits that are registered and used in countries with advanced technology and wide experience with COVID-19. We want the people to have access to testing but of course, proper evaluation and safeguards will still be in place,” Domingo said.

He noted the rapid test kits will yield a faster result compared to polymerase chain reaction (PCR)-based kits, but it is important that the results are evaluated and interpreted by a trained health professional.

“We have to be very cautious in using these rapid test kits because they measure antibodies and not the viral load itself. The body takes time to develop antibodies and this might give a negative result for patients who have been infected but antibodies have not yet developed antibodies,” he said.

The test kits will bear a warning that they are not intended for personal use, and that they must be administered by a trained health professional. Comfirmatory testing is also required.

The FDA called on local government chief executives, heads of agencies, hospitals and private companies to be cautious in the use the these test kits.

The FDA has also approved the SARS Cov2 kit by Gene Xpert, a PCR-based test kit from Abbott Laboratories that can detect the virus within five minutes.

To date, FDA has approved 17 PCR-based test kits for commercial use.

Science and Technology Secretary Fortunato de la Peña announced that the public can expect the approval for the locally made COVID-19 test kits this week.

“The field validation for the COVID-19 testing kits is ongoing and is expected to be finished by Wednesday, April 1,” he said.

The SARS-CoV-2 PCR Detection Kit, which is the first locally-made COVID-19 test kit, was developed by scientists from the University of the Philippines National Institute of Health (UP-NIH) and the Philippine Genome Center with the support of the Department of Science and Technology. It is being manufactured by Healthtek Inc.

The kit earlier received a Certificate of Exemption from the Food and Drug Administration (FDA) so it could proceed with field testing.

De la Peña said the Certificate of Product Registration, which will allow its commercial sale, is expected on Friday, April 3.

“We have informed the FDA that requirements for CPR Certification will be submitted on Wednesday, April 1 at the latest,” said Dela Pena, adding that a total of 120,000 test kits have already been ordered for manufacturing.

“The company has also reported that the first batch of reagents arrived, which will enable them to start the manufacturing process,” De la Peña said.

He said an initial 26,000 test kits funded by the DOST and UP-NIH project will be used from April 4 to 25. He said these will be distributed to the Philippine General Hospital, Makati Medical Center, The Medical City, Vicente Sotto Memorial Medical Center, Southern Philippines Medical Center, and Baguio General Hospital.

“The remaining 94,000 testing kits will be sold commercially by Manila HealthTek at around P1,300 per kit, which is cheaper than the units currently being used in hospitals, which cost about P8,000,” De la Peña said.

“Manila HealthTek said they have enough orders from the private sector who intend to donate them in turn to the Department of Health (Philippines) and hospitals,” he said.

The SARS-CoV-2 PCR Detection Kit is a real-time PCR-based test kit. This is the same as the World Health Organization test kits donated to the Philippine government. PCR-based test kits can only be used in the laboratory.

The test itself lasts for a couple of hours but the whole process, including the transportation of samples, can last for 24 to 48 hours for patients expecting their test results.

Meanwhile, Health Secretary Francisco Duque III denied the Department or Health (DOH) barred the entry of Chinese doctors who were supposedly coming to the Philippines to help in the fight against COVID-19.

Earlier, Foreign Affairs Secretary Teodoro Locsin Jr. disclosed in a now-deleted Twitter post that the DOH blocked the entry of Chinese doctors sent by Chinese Ambassador Huang Xilian to the Philippines.

“DOH is blocking their arrival. DON’T PISS ME OFF. LET THEM IN,” he wrote on Twitter.

This weekend, Locsin said he sought the help of Huang Xilian to bring in the Chinese doctors.

Locsin later took down this tweet.

“That’s not true,” Duque said about Locsin’s post. He said they were waiting for 12 experts from China with experience in the Wuhan lockdown to arrive.

The doctors will not practiuce medicine here, but will offer only their expert advice on quarantine measures and he clinical management of patients.

Also on Monday, the Department of Justice said it will pave the way for the immediate use and

distribution of seized and impounded medical items for use by frontline agencies battling the spread of COVID-19 pending criminal investigation against persons involved in the smuggling, overpricing and hoarding of the confiscated medical supplies.

Justice Secretary Menardo Guevarra said state prosecutors who are handling cases filed against smugglers, hoarders and price manipulators, would just retain a small portion of the seized goods to serve as sample evidence.

“Our prosecutors, pending investigation, will allow the release of seized and impounded medical supplies to the frontline agencies (such as the Department of Health) for proper disposition without prejudice to the outcome of the investigation,” Guevarra said.

Justice Undersecretary Markk Perete, who also serves as spokesman for DOJ, said they are now coordinating with concerned agencies to have the confiscated personal protective equipment and medical supplies auctioned off to the government for immediate use and distribution to health care workers.

Topics: COVID-19 , Eric Domingo , China , Singapore , polymerase chain reaction , Department of Health , Food and Drug Administration
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