The Food and Drugs Administration (FDA) has approved 8 antigen test kits to detect Corona Virus Disease 2019 (COVID-19).
The Department of Health (DOH) said that the approved antigen test kits have undergone a thorough regulatory process of the FDA. There are still 2 test kits to be validated by the Research Institute for Tropical Medicine (RITM) and to be approved by the FDA.
The health department will be releasing the omnibus guidelines on the use of antigen test kits after the matter has been discussed with the Inter-Agency Task Force on Emerging Infectious Diseases (IATF-EID).
The IATF-EID has approved the use of the said test kits under its issued Resolution No. 69. However, the Task Force clarified that the RT-PCR test is still considered as the gold standard in detecting Sars-CoV 2.
The antigen test may only be used on asymptomatic domestic tourists as requirement before their departure or before they can enter their destination in accordance with the protocol of the local government unit (LGU).
The antigen test kit detects only the viral protein unlike the RT-PCR that detects the virus. The test is effective 1 to 5 days after a person started experiencing a symptom. However, the antigen test kit is quicker and cheaper compared to the gold standard.
“Noong nagbigay ng recommendations ang Health Technology Assessment Council, isa roon sa recommendations nila aside from RITM, we can also adopt validations done by international reputable institutions. So ito ay pinag-uusapan sa ngayon kung maaari nating gawin para ma-fast track lang natin at magamit na yung mga kits na papasa doon sa diagnostic performance. (When the Health Technology Assessment Council gave its recommendations, one of its recommendations aside from the RITM, [is that] we can also adopt validations done by international reputable institutions. So it is currently being discussed if it is possible to fast track and use the kits that will pass the diagnostic performance).”
The result of the diagnostic performance of the test kit must be 80% sensitive, 95% specific which means that the accuracy rate is higher. It is one of the requisites that the FDA looks at before approving the test kit.
Report from Mark Fetalco
