Original title: Jiuan medical antigen rapid detection professional kit has been authorized by FDA for emergency use
The Beijing News (reporter Liu Xu) in January 17th, nine safety medical announcements, the American subsidiary iHealth Labs Inc. (referred to as "iHealth America") New Coronavirus (SARS-CoV-2) antigen rapid detection POC (Point Of Care) professional version Kit (colloidal gold immunochromatography) by the United States Food and Drug Administration (FDA) emergency use authorization (EUA).
The product is mainly used for rapid and qualitative detection of New Coronavirus (SARS-CoV-2) in human nose nose swab samples in vitro. It is necessary to collect samples of nasal swab samples from professional nurses or persons who can skillfully use the kit product under the point of care scenario according to the instructions of the products for testing. The results can be obtained in 15 minutes. After obtaining the U.S. emergency use authorization (EUA), the product can be used in the United States and countries / regions recognized by FDA EUA during the U.S. public health emergency. At present, 21 companies (including ihealth USA) have been authorized by FDA and EUA for new crown testing products in POC use scenarios.
On November 6, 2021, ihealth USA has obtained the FDA EUA authorization of ihealth new crown antigen home self-test OTC kit. Not long ago, the local epidemic of Omicron mutant strain occurred in Tianjin. As a local enterprise in Tianjin, Jiu'An medical also proposed to block the transmission of Omicron by combining "nucleic acid test (diagnosis) + family self-test (screening)" (1 + 1). Jiuan medical hopes that the above plan can be considered by the leaders of Tianjin epidemic prevention and control headquarters, and the ihealth Xinguan family self-test box can be put into the front line of prevention and control as soon as possible through the emergency approval of Tianjin drug administration.
Proofread Wei Zhuo