“Ang naidagdag po doon sa Labnovation Technologies, Inc. na manufacturer at Abbot po ay yung tinatawag natin na Getein Biotech, Inc., ito po yung manufacturer. Pareho po silang self-antigen test kits,” said FDA officer-in-charge Oscar Gutierrez in a public briefing on Wednesday. The Getein Biotech kit is called One Step Test for SARS-CoV-2 Antigen.
[Translation: Aside from the Labnovation Technologies, Inc. and Abbot, we also approved the one from Getein Biotech, Inc. They are all self-antigen test kits.]
The FDA earlier approved two other self-test kits—Panbio, which is manufactured by Abott, and the SARS-CoV-2 Antigen Rapid Test Kit made by Labnovation Technologies, Inc. The kits can be used to detect SARS-CoV-2 antigen from nasal swab of probable COVID-19 patients, FDA said.
The regulating body has also certified a total of 125 coronavirus test kits of different types so far, including RT-PCR, antibody, and antigen.
The Department of Health advised that self-administered antigen tests are only for those exhibiting symptoms within seven days from their onset, if an RT-PCR test is not possible.
The test is not ideal for close contacts or those with no symptoms.
Metro Manila (CNN Philippines, February 9) — The Food and Drug Administration has approved the use of another brand of self-administered COVID-19 antigen test kit, this time manufactured by Getein Biotech, Inc.
