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Four new COVID-19 testing kits receive FDA approval

Four new COVID-19 testing kits receive FDA approval

Getting tested for COVID-19 might become easier in the following days as the Food and Drug Administration (FDA) approves for commercial use four new testing kits which can detect SARS-CoV-2— the virus that causes the dreaded COVID-19.

Counting two from China and two from South Korea, these approved testing kits are the following:

  • Nucleic acid detection kit manufactured by Shanghai GenoeDx Biotech Co. Ltd. from Shanghai, China and distributed by S&S Enterprise;
  • Novel coronavirus 2019 nucleic acid detection kit (fluorescence PCR method) manufactured by Beijing Applied Biological Technologies Co. Ltd and distributed by Sahar International;
  • AllplexTM 2019-nCoV Assay manufactured by Seegene Inc. from Seoul, South Korea and distributed by Endure Medical Inc.;
  • SOLGENT DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit manufactured by Solgent Co. Ltd from Daejeon, South Korea and distributed by Wellness Pro Inc.

In their statement, the FDA also shared, “These are PCR (polymerase chain reaction)-based reagent kits used in laboratories and not point-of-care or do-it-yourself kits.” 

According to the agency’s director-general Eric Domingo, this list will be updated regularly as well.

[READ: Prioritization for DOST in creating test kits will help fight against COVID-19]

With these new testing kits’ commercial use approval, he also advised the public to be vigilant.

“We ask the public and stakeholders to be analytical of COVID-19 test kits that they may encounter as we have identified some applications which appear to be suspicious and unauthorized,” Domingo said.

“During this period of emergency, safety is still of utmost priority. We need to be vigilant of the entry of counterfeit products and be watchful of those who try to take advantage of the current situation,” he added.

Despite the announcement of the testing kits’ approval, its prices and quantity for distribution were not specified in the FDA’s statement yet. 

[READ: UPNIH testing kits for COVID-19 set to be used starting next week]

However, Health Secretary Francisco Duque III informed the public through a TV interview that the department is expecting more kits to arrive next week. Marking a total of 175,000, these kits will be coming from South Korea, China and Chinese billionaire Jack Ma behind the e-commerce and technology company Alibaba.

These will be added to the 2,500 test kits—2,000 from China and 500 from South Korea—which the country currently has.

As for the cost, the government has said that the Philippine Health Corp. (PhilHealth) would shoulder expenses for COVID-19 tests.

 

Header photo courtesy of Inquirer.net

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Yann Magcamit: