Duque orders probe of antigen test kits
HEALTH Secretary Francisco Duque 3rd on Tuesday said he would order an investigation to find out why two rapid antigen tests for the coronavirus disease 2019 (Covid-19) were approved for use by the Food and Drug Administration (FDA) despite registering low sensitivity numbers after post-market surveillance by the Research Institute for Tropical Medicine (RITM).
Duque said he would order the FDA and the RITM to investigate why the SD Biosensor Inc. Standard Q Covid-19 Ag test and the Lumiquick Diagnostics Quickprofile Covid-19 Ag test strip were allowed to be sold in the country despite having just 71.43-percent and 27.78-percent overall clinical sensitivity rates.
“Paiimbestigahan natin ‘yan; hindi pwedeng ganun ganun lang. Kailangan maging malinaw sa mga tests na ‘yan, kung ang sensitivity mababa, hindi pwede ‘yan (We will investigate; it should
not be like this. If their sensitivity is low, they should not be used), “Duque told The Manila Times in a telephone interview on Monday.
He added that he would find out if some government offices used the two test kits despite their low sensitivity rating.
Duque said he would see if it would be possible to change the protocol of determining the sensitivity of test kits.
“Kasi ang FDA naman, walang kakayahang magvalidate; ang validation process ang RITM, So, kung ang dapat mauna na ay RITM, pwede rin ‘yun kasi sila lang ang may kakayahang mag-validate. Dapat mabilisan agad na gagamitin ang FDA para desisyunan kung anong test kits ang gagamitin or hindi (The FDA has no ability to validate; the validation process is with RITM. So, if the RITM should be the first [to validate] these, then it would be good as they have the skills to validate [test kits], The FDA should have a faster process to decide on what test kits should be used or not),” he added.
Cecilia Matienzo, director of the FDA’s Center for Device Regulation Radiation Health and Research, said the approval of antigen tests was based on their prequalification approval by the World Health Organization and other accredited third-party accreditation from countries with mature regulation such as the United States, Australia, the European Union, Canada and South Korea.
She added that the two antigen tests were given certification in September, but the certification was only for importation but not for sale.
Matienzo acknowledged that with the huge number of antigen test kits given certification by the FDA, they have a hard time making post-marketing surveillance.
“Minsan, ‘yung iba kasi, may mga binibili na without the testing, in which hindi pa namin minomonitor during that time because sa sobrang dami. So, ang nangyayari ngayon, ‘yung iba, nag-voluntary nag-surrender ng certificates. ‘Yung talagang hindi nag-subject for testing, mayroon ongoing report of violations and may summons na sila from legal. And then nag-inform na tayo sa public na ito ‘yung mga produkto na bagsak sa RITM (Others are buying it without the [confirmatory] testing, which we cannot monitor because of the sheer volume. So, what happens is others are voluntarily surrendering their certificates. Others who were not tested have ongoing reports of violations, and they were summoned by our legal office. And then we also inform the public that these products did not pass RITM [standards]), “Matienzo said.
She added that they have written to the distributors of the two antigen test kits to stop selling these after the discovery of their low sensitivity rates.
This was indicated by an advisory issued by the agency on March 5 including them in the list of test kits that should not be bought by the public.
The Times reached out to RITM Director Dr. Celia Carlos, but she said that she was on leave and would address the issue later.