The Food and Drug Administration (FDA) has approved the use of five rapid antibody test kids for COVID-19.
However, FDA Director General Eric Domingo said the sample must still undergo confirmatory test using PCR-based test machines, since rapid test kits only detect the presence of antibodies, which is the body’s response in fighting infection.
The approved rapid tests were manufactured abroad, with four tests made in China and one from Singapore.
“Kapag ang tao ay nahawaan ng Coronavirus na nagdudulot na COVID-19, may ilang araw pa ang lilipas bago makagawa ng antibody ang ating katawan at maging detectable ang antibodies sa dugo. Ang antibodies ay panlaban ng ating katawan sa impeksyon (When a person gets infected by Coronavirus that brings COVID-19, it will take days for our body to produce antibodies that will be detectable in the blood. Antibodies are used by the body to fight infection),” Domingo said.
The FDA earlier warned against using rapid test kits as these could give a “false negative” result. If taken before the body can release antibodies to fight the infection, the kits would not be able to detect it. The FDA added a positive result due to cross reaction with other bacteria and viruses is also possible.
The FDA has asserted rapid COVID-19 tests must still be administered by doctors or health professionals to ensure samples are processed properly and for results to be interpreted correctly.
Meanwhile, the FDA also announced the approval of Abbott Laboratories’ Sars COV2 Kit that can detect the presence of the virus using a PCR machine within five minutes.
There are currently 17 PCR-based test kits accredited in the Philippines by the FDA. – Report from Mark Fetalco
