February 9, 2022
MANILA — The Department of Health (DOH) has set the price cap for self-administered antigen test kits at P350, according to DOH Circular No. 2021-0323-B dated Jan. 28 and released to the media on Tuesday.
The DOH said the amount is inclusive of the materials and accessories necessary for the procedure such as the appropriate swab, test kit cartridge, dropper and instruction leaflets, among others.
The Food and Drug Administration (FDA) has so far approved only two brands of self-administered antigen test kits: the Panbio COVID-19 Antigen Self-test of Abbott Laboratories Philippines, and the SARS-CoV-2 Antigen Rapid Test of Chinese company Labnovation Technologies Inc.
Apart from the self-administered antigen test kits, the DOH also adjusted the price cap for the antigen test kits used by laboratories as well as its testing service costs.
The DOH lowered the price of an antigen rapid diagnostic test kit to P350 from the previous P500.
The price cap of antigen testing service conducted by medical personnel has been capped at P660 from P960.
The new price is inclusive of the P350 price ceiling for a test kit, P250 worth of operational cost, and P60 as 10-percent allowable mark-up.
“Antigen rapid diagnostic test kits subsidized or donated by the DOH and other government agencies to DOH-licensed public and private health facilities and clinical laboratories shall be provided at zero cost to individuals. Only items directly procured by DOH-licensed health facilities and clinical laboratories and not provided by DOH can be charged,” the DOH said in its circular.
Dubious test kits
“Licensed health facilities and clinical laboratories may have prices lower than the prescribed price cap for antigen rapid diagnostic testing, provided that quality of services is maintained,” it added.
According to the health department, the updated price caps will be effective starting Feb. 20.
The DOH earlier warned consumers against using dubious kits that make false claims, citing products purportedly approved by the Research Institute for Tropical Medicine (RITM).
Health Undersecretary Maria Rosario Vergeire said the RITM does not approve test kits and only the FDA issues the approval for such products.
She explained that only the FDA receives applications, which will then undergo an initial evaluation before they are passed on to the RITM, which validates the efficacy of medical devices such as testing kits.
The RITM then determines whether the test kits meet the required specificity of 97 percent and sensitivity of 80 percent in identifying only the virus causing COVID-19.
“This takes four to five days with RITM and then will be returned to the FDA. So, all in all, the process can take up to seven days,” she added.
“What we need to look for in the labels should be the registration of FDA. This means that it has been certified by the FDA already. RITM is just part of the process of evaluation by the FDA. But it’s the FDA that issues the registration,” Vergeire explained.
“The reliability of antigen test kits will depend on its use. The most accurate result of an antigen test comes if you use it at the right time and appropriate use,” she said.
“The antigen tests can only be used if a person has symptoms, and this is within the first five days of illness. That’s when the results are most accurate,” Vergeire added.