BREAKING: FDA approves 5 rapid COVID-19 test kits

Updated 2:50 p.m.

MANILA, Philippines — The Food and Drug Administration (FDA) approved on Monday five rapid antibody test kits for the 2019 coronavirus disease (COVID-19), which are being used in China and in Singapore.

FDA Director-General Eric Domingo said the test kits could be useful in some instances such as testing patients with severe symptoms but have no capability to get tested in the Department of Health (DOH) laboratories.

It can also be used in health centers or clinics in areas where there are suspected outbreaks of the disease.

“Halimbawa, pwede ito gamitin sa mga lugar na matagal ng umiikot ang virus at pinaghihinalaan namaraming tao na ang may impeksyon,” Domingo said in a virtual press briefing.

(For example, this can be used in places where the virus is existing and suspected to have infected a lot of people already.)

“O kaya sa mga pasyente na may mga malubhang sintomas ng limang araw ngunit walang paraan ng mabilisang magpatest sa mga DOH laboratory,” he added.

(Or on patients with severe symptoms for already five days but have no means to get tested in a DOH laboratory.)

The test kits must bear a warning stating that it is not intended for personal use and must still be administered by a health professional.

While the test kits may provide immediate results, the patient must still undergo a confirmatory test using laboratory-based testing.

Domingo explained that the kits will only detect antibodies produced by the patient and not the virus itself. The patient could have a “false positive” or a “false negative result.”

Antibodies are produced by the body to fight off viruses or bacteria.

A false-negative result may occur when the patient that has contracted the coronavirus has not yet produced antibodies when the test was taken, while a false positive result could emanate when there are antibodies detected but it is not for COVID-19.

“Ang bilang ng antibodies ay tumataas habang lumalala ang sakit at dumadami ang sintomas kaya maaaring false negative ang resulta kung nakuhanan ang tao ng sample sa panahong hindi pa siya nagkakaroon ng antibodies laban sa COVID-19,” he explained.

“Ang false positive naman, ibig sabihin may na-detect o nakitang antibody ang test kit pero ‘yung antibody na ’yun ay hindi para sa COVID-10 kundi para sa dating naging sakit ng ibang virus o ibang bacteria,” Domingo added.

Domingo reminded that social distancing is still required for the public to avoid contracting coronavirus, especially those who are suspected of having the COVID-19.

The FDA had approved 17 COVID-19 test kits as well as the SARS Coc2 kit by Gene Xpert from Abbott Laboratories which can detect the virus in five minutes.

At present, the Philippines has 1,418 cases of COVID-19 with 71 fatalities and 42 recoveries.

Six laboratories across the country are conducting COVID-19 testing, namely San Lazaro Hospital in Manila, Baguio General Hospital and Medical Center, Vicente Sotto Memorial Medical Center in Cebu City and the Southern Philippines Medical Center in Davao City, Lung Center of the Philippines, and Research Institute for Tropical Medicine in Muntinlupa City.

With the expanded capability of the country to conduct testing for COVID-19, cases of the disease are expected to further increase to reflect the actual trend of the disease.

EDV