The Department of Health on Wednesday said it will confer with the World Health Organization after one COVID-19 antigen test it has endorsed for emergency use did not pass the standards of local researchers.
Health spokesperson Maria Rosario Vergeire confirmed that the SD Biosensor rapid antigen test kit from South Korea did not meet the diagnostic performance required. Based on the validation study conducted by the Research Institute for Tropical Medicine, she said the test kit only has 71% sensitivity; WHO has required that the sensitivity should be at at least 80%.
“Hindi pumasa sa local validation sa sensitivity but it was approved as an emergency use product sa WHO,” she said in an online media forum. She said DOH will ask for guidance if it can still be used.
[Translation: It did not pass the local validation for sensitivity, but it was approved by the WHO to be used in emergencies.]
SD Biosensor’s “STANDARD Q COVID-19 Ag Test” was the first antigen test kit reviewed by the RITM.
This South Korean brand donated 1,500 of its antigen test kits to Cebu City in August. It is also among the 120 million antigen rapid diagnostic tests that will be distributed by WHO to low- and middle-income countries without extensive laboratory facilities to conduct RT-PCR tests, which remains to be the “gold standard” in detecting the virus.
The company promises that its antigen tests can produce results in less than 30 minutes after getting the specimen through a nasopharyngeal swab, similar to the RT-PCR — but results usually take days. Antigen tests are used to determine if a patient is currently infected.