FDA OKs 5 rapid COVID-19 test kits

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FDA OKs 5 rapid COVID-19 test kits
In this March 12, 2020 photo, the Philippine Genome Center and Manila HealthTek Inc. present to the media the COVID-19 test kit developed by scientists from the University of the Philippines.
The STAR / Michael Varcas, File

MANILA, Philippines (Update 1:57 p.m.) — The country's Food and Drug Administration approved the use of five rapid test kits for the new coronavirus as public clamor for mass testing continues to grow.

In a statement Monday, FDA Director General Eric Domingo said the agency approved rapid test kits registered and used in countries with advanced technology and wide experience with COVID-19 such as China and Singapore.

Rapid test kits will yield a faster result than polymerase chain reaction-based kits currently being used in laboratories across the archipelago. But Domingo stressed the importance of having a trained health professional to evaluate and interpret the test results. 

“We have to be cautious in using these rapid test kits because they measure antibodies and not the viral load itself. The body takes time to develop antibodies and this might give a negative result for patients who have been infected but antibodies have not yet developed,” he said.

“A positive result due to cross reaction and with other bacteria or viruses is also possible, which is why a confirmatory PCR-based test is still required,” the FDA director general added.

The Department of Health earlier rejected the use of rapid test kits because such tests can give patients a false sense of confidence that they are not infected with the highly-contagious illness.

The FDA will require the label of the rapid test kits to state the following: “This product is strictly for medical professional use only and not intended for personal use. The administration of the test and the interpretation of results should be done by a trained health professional. Confirmatory testing is required.”

The agency also approved an additional PCR-based test kit from Abbott Laboratories, which can detect the virus within five minutes. This brought the total number of PCR-based test kits approved by FDA for commercial use to 17.

Big jumps in the number of COVID-19 cases in the Philippines were attributed to the arrival of donated test kits and opening of new laboratories processing samples across the archipelago.

The Philippines lags behind its regional peers in terms of testing, with only 3,113 people tested since late January.

In virus-hit countries like South Korea and Singapore, widespread testing is crucial in their fight against the pandemic as it allows authorities to isolate and treat infected people. 

Approval of locally-made test kits seen this week

The FDA is expected to issue the locally-made test kits a certificate of product registration— which allows its commercial sale—on April 3, the Department of Science and Technology said Monday. 

“The field validation for the COVID-19 testing kits is ongoing and is expected to be finished by Wednesday, April 1,” DOST said, adding requirements for CPR certification will be also submitted on Wednesday. 

The SARS-CoV-2 PCR detection kit was developed by scientists from the University of the Philippines National Institutes of Health and the Philippine Genome Center. It is manufactured by Manila HealthTek Inc. 

“The Manila HealthTek Inc. reported that the first batch of reagents has arrived which will enable them to start the manufacturing process to create additional kits that can accommodate 120,000 tests,” DOST said. 

A total of 1,300 testing kits good for 26,000 tests will be manufactured and prioritized for field implementation and distribution to the Philippine General Hospital, Makati Medical Center, The Medical City, Vicente Sotto Memorial Medical Center in Cebu City, Southern Philippines Medical Center in Davao City and Baguio General Hospital.

Manila HealthTek will sell the remaining kits good for 94,000 test commercially at around P1,300 per kit—cheaper than the units currently being used in hospitals which cost about P8,000. 

The DOH on Sunday reported 343 new COVID-19 cases, marking the country’s largest daily increase in infections. This raised the nation’s total number of infections to 1,418 with 71 deaths.

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