FDA-approved self-test antigen kits adhere to US FDA, WHO guidelines —RITM

An executive of the Research Institute for Tropical Medicine (RITM) on Wednesday said the two antigen COVID-19 self test kits recently approved by the Food and Drug Administration (FDA) adhere to the technical guidelines of the US FDA and the World Health Organization (WHO). 

"Upang matulungan ang FDA sa pagbigay ng awtorisasyon sa self-test kits, bumuo kami ng guidelines para sa technical review ng mga ito. Ginamit nating reference ang technical guidelines ng US FDA, iba pang regulatory authorities at WHO standards," said RITM laboratory chief Dr. Amado Tandoc III during the Laging Handa public briefing.

(To help the FDA in authorizing the self-test kits, we developed guidelines for their technical review. We used as reference the technical guidelines of the US FDA, other regulatory authorities and WHO standards.)

Tandoc said RITM is requiring manufacturers to submit technical documents regarding the performance and validation of their kits.

Manufacturers seeking FDA approval of self-test antigen kits should include information on their use, the studies conducted on their effectiveness, as well as visual and graphic aids, Tandoc added.

"Mas madali ang paggamit sa kaniya. Una, hindi ito nangangailangan ng isang healthcare worker na magsasagawa ng nasopharyngeal o oropharyngeal swab collection, sapagkat ang samples na ite-test ay mga nasal na samples," he said.

(Self-test kits are easier to use. First, these do not require a healthcare worker to perform nasopharyngeal or oropharyngeal swab collection, because the samples to be tested are nasal samples.)

"Kapag nasal, galing lamang sa harapan o kaya hanggang gitnang bahagi ng ilong na maaaring kunin sa sarili. Kung sa may kapansanan o sa mga bata, maaaring kunin ng isang nakatatanda," Tandoc added.

(In a nasal self-test swab, an individual could obtain the sample from the front or up to the middle part of the nose. An adult could obtain the sample if the patient is disabled or a child.)

Tandoc urged the public to carefully read the instructions when using the self-test kits, as incorrect collection may affect the accuracy of results.

The Department of Health meanwhile may release guidelines on using self-administered antigen COVID-19 test kits as early as Thursday, Health Undersecretary Maria Rosario Vergeire said Wednesday.

The RITM laboratory chief also urged the public to purchase only self-test kits that were FDA-approved.

During President Rodrigo Duterte's Talk to the People briefing on Monday, FDA officer-in-charge Oscar Gutierrez said the two approved antigen self-test kits were from Abbott and Labnovation Technologies, Inc.

He said Abbott's Panbio COVID-19 antigen self-test and Labnovation's SARS-CoV-2 antigen rapid test self-test for home use have already received special certification from the FDA.

Gutierrez said a total of 86 antigen test kits have been so far removed from the market. —KG, GMA News