Taipei: 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 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.
According to Focus Taiwan, 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. 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, 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 stated that 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.
