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

The Food and Drug Administration has approved five rapid test kits that detect COVID-19, but says samples must still undergo a confirmatory test using the machine-based method.

3/31/2020 9:37:00 AM

The Philippines now has more options for COVID-19 testing after the FDA approved five rapid antibody test kits. However, blood samples from the new procedure must still undergo a confirmatory test using the PCR or machine-based method

The Food and Drug Administration has approved five rapid test kits that detect COVID-19, but says samples must still undergo a confirmatory test using the machine-based method.

​The rapid test kits 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.

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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 FDAearlier warned against using rapid test kitsas 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.

READ: How a team of Filipino scientists developed a COVID-19 test kitThe 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.

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Calls for mass testinghave been mounting online, but the Department of Health said there was no need for that at the moment amid limited laboratory capacity. Read more: CNN Philippines »

Hm ang PCR Test? So double tests pa ang gagawin if using a rapid test kit? So double expense also. DOHgovph If hospitals gets a negative result using the rapid diagnostic test in a suspect case, but still needs PCR-based testing, what's the added value?

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Manny Pacquiao, negatibo sa COVID-19 gamit ang rapid test kit mula South KoreaSinuri ni Senator Many Pacquiao ang kanyang sarili gamit ang COVID-19 rapid test kit na aprubado sa South Korea. Thank God Manny. Baskog kaayo 👍👍👍 TagaMindanao Loko nsampolan k ng mga tiga Dasma,d ibig sabihin si paquiao k pwd kn mgpakalatkalatpaparty party d k special,wlng special n boksigero s kano pahiya kyong mganak dlng kyo nkguarantine may nkbantay p senyo kon sakaling mgppkalatkalat n nmn kyo Nagsariling sikap.

COVID-19 cases sa Caloocan umabot na sa 22Heal the world Lord God.

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