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Rapid test kits okayed

Elmer N. Manuel @tribunephl_lmer

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As health workers continue to combat the coronavirus disease 2019’s (COVID-19) local outbreak, the Food and Drug Administration (FDA) on Monday announced its approval of five rapid test kits to detect infections.

Eric Domingo, FDA director general, said that aside from the five rapid test kits approved, it also greenlighted the use of an accurate five-minute test kit from a United States maker.

Domingo explained that while the FDA has approved the five rapid test kits, the samples must still undergo confirmatory tests using the machine-based method.

He noted that the kits are all manufactured abroad, with four made in China and one from Singapore.

The FDA chief also clarified that the rapid test kits must come with a warning label that would limit its use only by medical professionals – which means these cannot be administered at home or for personal use.

Domingo stressed that the tests can be done in health clinics or hospitals, supervised by a doctor and the equipment used for the test must also be disposed of properly to prevent the spread of COVID-19 and other diseases.

He also disclosed the approval of Abbott Laboratories’ SARS Cov2 kit – which can detect the presence of the virus using the PCR machine within five minutes – just days after the United States regulator also cleared this diagnostic kit for use.

There are now 17 PCR-based test kits accredited by the FDA.

Domingo explained that the rapid test kits churn out results within minutes or hours after extracting blood sample from a patient, faster than the 24 to 48-hour window needed by the Research Institute for Tropical Medicine to find out if a person is positive for COVID-19, based on swab samples from the throat and nose.

He also noted that the biggest difference is that rapid test kits only detect the presence of antibodies, which is the body’s response to fight an infection, as traditional kits processed through a real-time polymerase chain reaction or RT-PCR machine detect the presence of the actual coronavirus, which are deemed more accurate.

Previously, the FDA warned against using rapid test kits as these could give “false negative” results and if the test is taken before the body can release antibodies to fight the infection, the kits will not be able to detect them.

The FDA chief stressed that the rapid COVID-19 tests must still be administered by doctors or health professionals to ensure that the samples are processed properly and the results are interpreted correctly, adding that samples must undergo confirmatory tests using the RT-PCR method.

“A positive result due to cross reaction with other bacteria or viruses is also possible, which is why a confirmatory PCR based test is still required,” Domingo said. But he warned that health workers should use the rapid test kits with caution as they only measure antibodies and not the viral load itself.

Domingo stressed that the tests can be done in health clinics or hospitals, supervised by a doctor and the equipment used for the test must also be disposed of properly to prevent the spread of COVID-19 and other diseases.

While the Department of Health (DoH) rejected an earlier recommendation to use rapid test kits, Domingo said these kits can still be used in some cases, like in a community with a high number of suspected COVID-19 cases.

“For instance, in areas where the virus has been spreading for some time now and it is believed that many have already been infected, or for patients with severe symptoms but are unable to get immediate tests done at DoH laboratories,” Domingo said.

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