FDA warns public vs unregistered coronavirus home test kits sold online

 

MANILA, Philippines – The Food and Drug Administration (FDA) on Friday, March 13, warned the public against buying home test kits for the novel coronavirus being sold online, as none of these products had been registered and tested by the regulatory agency.

Health Undersecretary Eric Domingo, FDA officer-in-charge, issued the warning in a news briefing on Friday after the FDA received reports that unregistered home test kits supposedly to check for infection with COVID-16, were being sold online.

“Gusto lang naming ipaalam sa publiko na sa ngayon, wala pang registered na testing kit para dito sa COVID-19. So kung anumang binebenta diyan, nakikita nilang mga advertisement, o makikita nila online, ito pong mga produktong ito unregistered,” Domingo said in a phone interview with reporters.

(We just want to let the public to know that for now, there are no registered testing kits here for COVID-19. So if you see anything being sold out there, any advertisements, or any posts online, these products are unregistered.)

The FDA chief said that since the unregistered test kits are untested, the accuracy of their results are questionable.

“Ang babala lang natin, kahit po gamitin ‘nyo ito, hindi naman natin alam kung valid at acceptable ang mga resulta na ito at kung sino naman pong doktor ang maniniwala sa resulta ng mga ito at gagamitin siya to manage a patient. So baka masayang lang ang pera ninyo,” Domingo said. 

(We are just warning that even if you use this, we don't know if the results are valid and acceptable and if any doctor would even believe in the results to manage a patient. So you would just waste your money.)

Currently, there are only two types of test kits in the Philippines that have been approved by the FDA – the sophisticated machine at the Research Institute for Tropical Medicine (RITM) that takes 24 to 48 hours to confirm a 2019-nCoV case and the new and much faster test kits developed by the University of the Philippines-National Institute for Health (UP-NIH). 

The FDA had issued a certificate of exemption for the UP-NIH test kits, which means that starting March 16, the test kits can be used for field testing coupled with gene sequencing at the Philippine Genome Center. 

The results of this field testing will determine if the UP-NIH test kits will get a certificate of product registration from the FDA – the document needed to allow the mass use of these kits. (READ: #SalamatUP: Netizens laud U.P. scientists for developing coronavirus test kits)

“At 'pag nakumpleto na ‘yung datos, at mapakita na talagang very valid na ang test na ito, saka siya i-ro-roll out na maaari na iyang puwedeng gamitin sa mga pasyente at puwede na siyang gamitin sa ibang mga laboratory,” Domingo said.

(Once we complete the data and determine that this test is very valid, then that's the only time we can roll it out among patients and let other laboratories use it.)

The RITM is the country’s sole laboratory for now that can test samples for COVID-19. But the DOH is targeting to get accreditation from the World Health Organization for 4 other laboratories across the country in anticipation of more cases. – Rappler.com

Mara Cepeda

Mara Cepeda writes about politics and women’s rights for Rappler. She covers the House of Representatives and the Office of the Vice President. Got tips? Send her an email at mara.cepeda@rappler.com or shoot her a tweet @maracepeda.

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