INDICAID™妥析™獲得美國FDA EUA緊急授權使用
新聞稿2021年8月11日
(只有英文版本)
PHASE Scientific International LTD (PHASE Scientific), today announced that its INDICAID™ COVID-19 Rapid Antigen Test (INDICAID) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on July 29, 2021. The FDA authorized the test for professional use in point of care CLIA-waived settings in the U.S. for the qualitative detection of SARS-CoV-2 antigen. Anterior nasal swab specimens may be collected by a healthcare provider or self-collected under the supervision of a healthcare professional. In regions outside of the U.S., such as Hong Kong, the test is authorized as a consumer self-test.
INDICAID requires no special instrumentation and can be performed in 20 minutes with a gentle shallow nasal swabbing vs. the deeper penetration required by other tests. INDICAID is also one of the first rapid antigen tests to enable batch sample collection and testing at the point of care due to its unique sample collection vial which protects the sample throughout the collection and staging process. The design gives healthcare professionals the option of collecting a large number of samples concurrently and then quickly testing the individual samples in batches within a two-hour timeframe. To date, there are over two million kits sold across 30 countries worldwide.
"Our test has been globally adopted and utilized to meet a variety of emergency testing needs. From the Hong Kong government using INDICAID for healthcare worker's weekly screenings to usage across shopping malls, supermarkets and schools worldwide, our rapid test has proved to be both effective and efficient," said Dr. Ricky Chiu, founder and chief executive officer of PHASE Scientific. "We see this U.S. emergency use authorization as recognition of the importance of our technology and product quality and we are eager to further expand our reach into more markets to do our part in helping combat the COVID-19 pandemic."
News Source: CISION
