Taiwan's first 3-in-1 home test for COVID, flu to hit pharmacies by late May

Taipei, May 9 (CNA) Taiwan could see the launch of its first at-home 3-in-1 rapid test for COVID-19, influenza A and influenza B by the end of May, according to the Federation of Taiwan Pharmacists Associations on Saturday.

Federation spokesperson Huang Yen-ju (黃彥儒) told reporters that existing 3-in-1 rapid tests and standalone influenza tests are currently professional-use products that can only be administered by medical personnel at healthcare facilities.

At present, the only rapid home tests available on the market in Taiwan are for COVID-19, Huang said.

Taiwan's Food and Drug Administration (FDA) approved a medical device registration certificate for the combined COVID-19 and influenza A/B antigen home test kit in November 2025, he added.

The first batch of kits could arrive at pharmacies by the end of May, allowing consumers to purchase and use them at home, Huang said.

He added that the new tests are less invasive than earlier versions, requiring users to insert the swab only about 2 centimeters into the nostril rather than deep into the nasal cavity.

Wu Cheng-ning (吳正寧), a senior technical special at the FDA's Division of Medical Devices and Cosmetics, said the agency adopted international standards to ensure the safety, effectiveness and accuracy of the tests.

Wu said the FDA requires the products to meet standards for sensitivity and specificity in detecting the three viruses.

For home-use test kits, manufacturers must also demonstrate that ordinary users can correctly collect samples and interpret results without professional assistance by following the instructions alone, Wu said.

The FDA emphasized that rapid test kits are intended as preliminary screening tools.

People whose symptoms continue to worsen should seek medical attention promptly so doctors can make diagnoses based on clinical symptoms and contact history and provide timely treatment, the agency said.