MANILA, Philippines — South Korean SD Biosensor COVID-19 antigen test kits failed local health authorities’ evaluation, the Department of Health (DOH) said Wednesday.
According to Health Undersecretary Maria Rosario Vergeire, SD Bionsensor’s specificity and sensitivity fell short of World Health Organization (WHO) standards.
“It’s true na hindi siya umabot sa diagnostic performance na ating itinatala base sa rekomendasyon ng WHO na dapat lahat ng antigen test kits ay mayroong 80% sensitivity at 97% specificity,” Vergeire told reporters in an online briefing.
(It’s true that it not passed the diagnostic performance test we conducted based on the WHO recommendation which says that all antigen test kits should have 80% sensitivity and 97% specificity.)
“Ang SD Biosensor, base sa inilabas sa pagaaral at validation ng RITM (Research Institute of Tropical Medicine) nagkaroon lang ng 71% sensitivity,” she added.
(SD Biosensor, based on the RITM study and validation, yieled only 71% sensitivity.)
However, Vergeire said they are still coordinating with WHO regarding the next steps to take as the international body listed SD Bionsensor as among the “emergency use product” for COVID-19 testing.
The DOH is conducting a pilot study on the use of rapid antigen testing for border screening. It hopes to present before the Inter-Agency Task Force on the Management if Emerging Infectious Diseases its initial findings on the test in two-week’s time.