Rapid antibody test kits not sold in drug stores; needs to be administered by doctor, DOH clarifies

Published July 11, 2020, 9:42 PM

by Analou de Vera

The Department of Health (DOH) clarified on Saturday that the rapid antibody test kits for coronavirus disease (COVID-19) are not being sold commercially to the public.  

Health Assistant Secretary Maria Rosario S. Vergeire
Health Assistant Secretary Maria Rosario S. Vergeire (PCOO / MANILA BULLETIN)

“I stand corrected. Rapid Antibody Tests cannot be bought in pharmacies as it cannot be self administered. Only facilities with the guidance of a doctor can provide the tests,” DOH Undersecretary Maria Rosario Vergeire told reporters.

Vergeire issued the clarification after she said during the “Laging Handa” press briefing that the sale of rapid antibody test kits in drug stores is allowed as long as it is registered with the Food and Drug Administration (FDA). 

“These are just with facilities and with the guidance of doctors. [It] can’t be self administered,” the Health official clarified.

Last April, the FDA said that these kits “are strictly for medical professional use only and not intended for personal use.”

“The test should be administered by trained health professionals and the results should be interpreted by licensed physicians,” it said. 

The FDA said that  it has approved a total of  204 test kits for COVID-19 as of July 10. These include 71 polymerase chain reaction (PCR)-based test kits, 77 rapid antibody test kits, 51 immunoassay test kits, and five others.