FDA approves 5 rapid test kits for COVID-19, but requires confirmatory test for samples

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FDA approves 5 rapid test kits for COVID 19

Metro Manila (CNN Philippines, March 30) — The Food and Drug Administration, rapid test kits for COVID 19 has approved five rapid test kits ​and a more accurate 5-minute test from a US manufacturer which detect COVID-19 infections, Director General Eric Domingo announced Monday.

​Domingo said the regulator has allowed five rapid test kits to be used to detect coronavirus infection, but said samples must still undergo a confirmatory test using the machine-based method. All are manufactured abroad, with four tests made in China and one from Singapore.,Rapid Test Kits for COVID 19.

FDA approves 5 rapid test kits for COVID-19 must also come with a warning label that would limit its use to medical professionals, which means these cannot be administered at home or for personal use.

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

Rapid test kits churn out results within minutes or hours after extracting a blood sample from a patient, much 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.

The biggest difference is that rapid test kits only detect the presence of antibodies, which is the body’s response to fight an infection. The 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.

The FDA earlier warned against using rapid test kits as these could give a “false negative” result. If the test is taken before the body can release antibodies to fight the infection, the kits would not be able to detect it. 

Domingo said 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. Samples must undergo confirmatory tests using the RT-PCR method, he added.

“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.

​Meanwhile, the FDA also announced the approval of Abbott Laboratories’ SARS Cov2 kit, which can detect the presence of the virus using the PCR machine within five minutes. This came days after the United States regulator also cleared this diagnostic kit for use.

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

In a separate announcement, Science and Technology Secretary Fortunato Dela Peña said the rapid test kits made by scientists from the University of the Philippines are still under field validation until Wednesday, ​while product registration is expected by Friday.

The UP-designed kits will be manufactured by The Manila HealthTek Inc. with an initial batch to be distributed in hospitals with numerous COVID-19 patients as well as in sub-national laboratories doing coronavirus testing. The kits would cost ₱1,300 each, cheaper than the units worth ₱8,000 currently used in hospitals.

Calls for mass testing have been mounting online, but the Department of Health said there was no need for that at the moment amid limited laboratory capacity.

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, FDA approves 5 rapid test kits for COVID 19..

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