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Manila Bulletin devider Philippines devider National devider Sokor antigen test kit fails to meet WHO norms --- DOH

Sokor antigen test kit fails to meet WHO norms --- DOH

Published Sep 30, 2020 02:47 pm

An antigen test kit for COVID-19 developed by a South Korean company has failed the Department of Health’s (DOH) evaluation after it did not meet the standards set by the World Health Organization (WHO), an official of the DOH said.

Health Assistant Secretary Maria Rosario S. Vergeire
Health Assistant Secretary Maria Rosario S. Vergeire
(PCOO / FILE PHOTO / MANILA BULLETIN)

DOH Undersecretary Maria Rosario Vergeire said that the antigen test kit by SD Biosensor did not meet the “specificity” and “sensitivity” standard of the WHO when it was recently validated by the Research Institute for Tropical Medicine (RITM).

“Yes, it’s true hindi sya umabot doon sa diagnostic performance na ating itinatala base sa recommendation ng WHO na dapat lahat ng antigen test kit ay mayroong 80 percent sensitivity at 97 percent specificity ,” said Vergeire during an online forum. 

“Ang SD Biosensor, base sa nilabas na pag-aaral at validation ng RITM ay nagkaroon lang ng 71 percent sensitivity ,” she added. 

However, Vergeire said that they are now coordinating with the WHO on what will be their next step with regards to the use of SD Biosensor’s antigen test. 

“Pinag-aaralan namin ito, nakikipag-usap kami sa WHO kung ano dapat ang hakbang  dahil nga hindi pumasa sa local validation sa sensitivity but it was approved as an emergency use product sa WHO ,” said Vergeire. 

The Health official said that the pilot testing of antigen test, to determine its effectiveness for the detection of COVID-19, will still push through in Baguio City.

“Meron tayong pilot (testing) sa Baguio, hinahantay  nalang natin (ang) result para mabigyang recommendation ng ating experts kung saan appropriate o pwede gamitin ang antigen test ,” said Vergeire.

The DOH said that antigen tests are used to “determine current or active infections among patients.” 

“They collect and use swab samples to test a person under monitoring for COVID-19 in a process similar to the Reverse Transcription Polymerase Chain Reaction (RT-PCR) tests,” it said. 

The RT-PCR test is considered the “gold-standard” in detecting the virus that causes COVID-19.  

“However, unlike RT-PCR, tests that can take up to three days to process results, said antigen tests have only about four to six hours turnaround time for release of results,” it added. 

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