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Phl’s first antigen test fails scrutiny

Based on the study and validation, it only acquired a 71 percent sensitivity so now we are still continuing our examination of the test.

Gabbie Parlade

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The Philippines’ first examined antigen test failed the evaluation of the Research Institute for Tropical Medicine (RITM), the Department of Health (DoH) disclosed on Wednesday.

Health Undersecretary Maria Rosario Vergeire said that the SD Biosensor antigen test did not meet the standards by the World Health Organization (WHO) of having 80 percent sensitivity and 97 percent specificity to detect the coronavirus disease.

“This SD Biosensor was validated by the RITM and this is actually the first antigen test kit that has been validated by RITM and yes it’s true it did not reach the diagnostic performance set by WHO,” she said.

“Based on the study and validation, it only acquired a 71 percent sensitivity so now we are still continuing our examination of the test,” she added.

With this, she said that it will instead be considered as an approved emergency use product which was mandated by the WHO.

“We talked to WHO on what other measures we do since it did not pass the supposed amount of sensitivity but it was approved as an emergency use product,” she said.

The SD Biosensor antigen test is manufactured by one of South Korea’s healthcare companies, SD Biosensor Inc., who specializes also in various research and development of molecular diagnostics.

In July, the Department of Foreign Affairs received around 5,000 units of antigen test kits along with other essential medical equipment that were delivered and donated by the Korean Trade-Investment Promotion Agency (KOTRA).

Meanwhile, Vergeire said that other testing methods such as the saliva testing is still being examined by experts as another means to fast-track the detection of the coronavirus disease.

The saliva testing consists of two types which uses it as a specimen instead of the current nasal and oropharyngeal, and as a direct means of testing.

She said that both the Philippine Red Cross and the RITM are currently conducting their studies on this type of test for its possible utilization.

At present, the RT-PCR remains to be the gold standard of testing as stated based on the WHO standards.

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