FDA warns against imported rapid COVID-19 testing kits

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Metro Manila (CNN Philippines, March 27) — The Food and Drug Administration has not approved any rapid testing kits for coronavirus disease as there is still “no clear evidence” they are reliable, FDA Director General Eric Domingo said Thursday.

Domingo also stressed that COVID-19 testing kits based on real time polymerase chain reaction or RT-PCR are recommended. Currently, 15 imported COVID-19 test kits have regulatory approval from FDA.

He then warned suppliers who are seeking to sell and distribute point-of-care or rapid COVID-19 test kits.

“Businessmen should not import these products before they are certified by the FDA,” Domingo said.

While health authorities swear by the effectivity of a RT-PCR analysis, others argue it is not enough of a response during an outbreak situation.

Pleas for mass testing have received support on social media, especially after senators and some high-ranking officials demanded to be prioritized for testing despite the limited number of kits and the long line of sick patients waiting to be processed in hospitals.

Under the latest guidelines issued by the DOH, only those with severe symptoms of the viral disease, such as difficulty in breathing, prolonged cough and fever will be tested. Elderly people, pregnant women and immunocompromised persons or those with weakened immune system will also be tested even if they show only mild symptoms. That's because they are groups that are at higher risk of infection or have a higher percentage of fatalities.

Health Secretary Francisco Duque III said previously they may change their current protocol and test people with mild symptoms as the government expands its testing centers and acquire more test kits.

The World Health Organization Director-General Tedros Adhanom Ghebreyesus earlier this month appealed to countries to “test every suspected case.”

Other solutions

But FDA assured it is “continuously reviewing all applications on COVID-19 test kits,” and expediting processes such as simplifying entry process for importers of certain products deemed essential to address the COVID-19 outbreak.

Foreign donors are now not required to secure clearance from FDA. This is to expedite their release from the custody of Customs. DOH already received around 108,000 donated test kits from Korea, China and Singapore, Domingo said.

Typically, products from overseas need to have a certificate of registration, notification or exemption from the Philippines’ FDA before they could be sold in the country.