COVID-19National News

FDA Approves 2 Self-Administered Antigen Test Kits

The Food and Drug Administration (FDA) has approved two (2) self-administered COVID-19 Antigen Test Kits. In a press statement released on Tuesday, FDA said that the approval of the test kits was in compliance with the “Guidance on the Process for the Issuance of Special Certification for COVID-19 Test Kits” requirements.

By definition provided by the FDA, self-administered test kits can be used by individuals to detect SARS-CoV-2 antigen from the nasal swab of probable COVID-19 patients. More guidelines on the use of the test kits will be released by the Department of Health.

As of January 24, 2022, the following brands of self-administered antigen test kits have been granted special certification by the FDA:

Importer and
Product NameSpecimenRITM Validated
Result Sensitivity
RITM Validated
Result Specificity
Clearbridge Medical
Philippines Inc.
Antigen Rapid Test
(Self-test kit)
Nasal Swab97.45%100%
Sunfu Solutions Inc.Panbio™ COVID-19
Antigen Self-Test
Ref. 41 FK51/
Ref. 41 FK71/
Ref. 41 FK81/
Ref. 41 FK91/

Nasal Swab83.30%100%

For diagnostic test kits to be approved by the Food and Drug Administration, it undergoes a four-stage process of product performance evaluation by the Research Institute for Tropical Medicine (RITM) to ensure quality diagnostics assays for COVID-19.

The City Government of Baguio has recently announced a weeklong Antigen self-test program at six key barangays in the city starting January 24. Throughout the program, residents can avail of the Ichroma COVID-19 Ag Test imported by Vitaline Healthcare Inc. for P280.00. The said antigen test kit brand, while not included among the approved self-administered kits by the FDA, is an approved brand under the Antigen Test Kit category. According to the Public Information Office of the City of Baguio, while individuals can bring home the kits and administer self-swabbing, specimens will still be submitted to processing sites.

FDA advises the general public to be vigilant in purchasing COVID-19 test kits to ensure safety, efficacy, and quality and to purchase test kits from FDA-authorized importers.

Updated the list of approved COVID-19 test kits by the FDA can be viewed here.


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