COVID-19 DIY test kits sold online have 'very low reliability, accuracy' - FDA

ABS-CBN News

Posted at Mar 20 2020 10:33 AM

Samples are tested for respiratory viruses during a visit of Britain's Chancellor of the Exchequer Rishi Sunak to the pathology labs at Leeds General Infirmary, in Leeds, Britain March 12, 2020. Danny Lawson, Pool/Reuters

MANILA - The Food and Drug Administration on Friday cautioned the public against buying coronavirus disease 2019 (COVID-19) testing kits as these do-it-yourself tools have "very low reliability and accuracy."

COVID-19 testing kits sold online are not approved by the FDA, the agency's Director General and Health Usec. Eric Domingo told DZMM.

"Pinag-iingat po namin sila... Wala pong ganitong mga produktong registered sa FDA at pag ginamit nila ay hindi naman po natin masisigurado ang quality nito at accuracy," he said.

(We are asking the public to be cautious. These are not registered with the FDA and if they use it, we cannot guarantee the quality and accuracy of the results.)

"Ang test po na mga instant, kung totoo man po siya ay very low po ang reliability at accuracy ng mga ito," he said.

(Tests that produce instant results, if true, have very low reliability and accuracy.)

While the FDA recently approved the commercial sale of 4 brands of testing kits from South Korea and China, these can only be brought by government and private hospitals, Domingo said.

"Sa mga ospital at sa mga laboratory lang siya puwede ibenta kasi hindi naman siya instant do-it-yourself kit," he said.

(These can only be sold to hospitals and laboratories because these are not instant do it yourself kits.) 

"Kailangan ang Department of Health (DOH) ay magde-designate ng mga laboratory kung saan maaari nang gamitin itong mga test kits na ito," he said.

(The Department of Health needs to designate laboratories where the tests can be used.)

The DOH is expected to authorize more hospitals to process COVID-19 tests next week, Domingo said.

The Philippines has confirmed 217 cases of COVID-19, but thousands of suspected virus carriers have yet to be tested due to the lack of test kits in the country.

A Senate hearing in early March found that the DOH only had 2,000 COVID-19 kits shortly before the country was placed under a state of public health emergency due to the rapid spread of the virus from Wuhan, China.

As of March 19, 17 coronavirus patients in the country died, 8 recovered, while the rest are still recuperating from the disease.