DOH cautions public on use of antibody test kits pending RITM validation

Kristine Sabillo, ABS-CBN News

Posted at May 27 2020 08:01 PM

MANILA — Following reports that the US Centers for Disease Control and Prevention found antibody test kits only working half the time, the Philippine Department of Health (DOH) reminded the public of its own guidelines.

“DOH reiterates its position that rapid antibody-based tests for COVID-19 should be used cautiously pending local validation studies by RITM,” Health Undersecretary Maria Rosario Vergeire said during a televised briefing.

In a new guidance posted on its website, the US CDC explained the limitations of the rapid antibody test kits, including detecting other coronaviruses such as the common cold. 

“This could result in false-positive test results,” it said. 

It explained that even tests with high sensitivity and high specificity can only work half of the time since “less than half of those testing positive will truly have antibodies.”

“Thus, serologic test results do not indicate with certainty the presence or absence of current or previous infection with SARS-"CoV-2,” the US CDC added.

Vergeire pointed out that the Philippine Food and Drug Administration “already released Memorandum no. 2020-011 directing all companies that have been issued special certification for their COVID-19 antibody test to submit their test (kit) to RITM (Research Institute for Tropical Medicine) for performance validation.”

Project ARK, a private sector-led mass testing initiative, have said that businesses shouldn’t rely on FDA approval only since the pandemic has allowed test kits with prior approval from their countries to be certified in the Philippines.

However, Vergeire explained that “all future approval of applications for special certification for COVID-19” will now have to undergo performance validation by RITM.

The FDA or the RITM has yet to announce test kits that have already been validated.