The Food and Drug Administration yesterday released an updated template for developers requesting emergency use authorization for antigen tests for the COVID-19 virus. Methods: The fluorescence immunochromatographic SARS-CoV-2 antigen test (Bioeasy Biotechnology Co., Shenzhen, China) was evaluated using universal transport medium with nasopharyngeal (NP) and oropharyngeal (OP) swabs from suspected COVID-19 cases. 2019-Novel Coronavirus (2019-nCoV) Antigen Rapid Test Kit (FIA) Focused and dedicated to the rapid test, PCR and FIA technology development for the medical industry, Bioeasy offer the PCR, FIA and rapid tests for Novel Coronavirus (2019-nCoV). The Key Features of Bioeasy Covid-19 Rapid Test Kit . Bioeasy – Point of care testing . On May 9, the U.S. Food and Drug Administration approved the first antigen test … A high sensitivity of 94 % and accuracy of 96 % is found (with a specificity of 100 %). Easy to use (without special technician or device) Easy to store and transport We dedicate to provide simple, reliable, … 2019-Novel Coronavirus (2019-nCoV) Antigen Rapid Test Kit (FIA) New Product for Medical Rapid Tests. Diagnostic accuracy was determined in comparison to SARS-CoV-2 real-time (RT)-PCR. 2019-Novel Coronavirus (2019-nCoV) IgG/IgM GICA Rapid Test Kit. Oct 27, 2020 - 03:12 PM. GastrointestinaI Disease. Rapid (Result in 10 Minutes) High Sensitivity . FDA updates EUA template for antigen test developers. However, for some of the popular COVID-19 PoC tests (CORIS COVID-19 Respi-Strip, BioEasy 2019-nCoV Antigen Rapid Test Kit) while their specificity was high (>99%), their sensitivity has been shown to range from 24–72% (low viral load) to 82–100% (high viral load), thereby limiting their use for patient care . Porte et a in the Lancet Infect Dis use a commercial N antigen test (Bioeasy Biotechnology Co., Shenzhen, China) on naso- and oro-pharyngeal swabs from 127 symptomatic patients, of whom 82 were RT-PCR positive. Bioeasy Biotechnology is the first company to attain CE-marking for its Covid-19 lateral-flow immunoassay test kits. Tropical Infectious Disease. Bioeasy is a biotechnology company focused on the research and developm ent of POCT. Shenzhen Bioeasy Biotechnology Co., Ltd: Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence) [1] PR China: Reader: CE-IVD: Completed: 1 country: Results updated: 20 Jan 2021: Wondfo Biotech Co., Ltd: 2019 n-CoV Antigen Test (Lateral Flow Method) PR China: Visual: RUO: Completed: 1 country: Results updated: 26 Feb 2021 Shenzen Bioeasy Biotechnology is the first company to attain CE-marking for its COVID-19 lateral-flow immunoassay test kits. Quidel Sofia-2 Flu+SARS Antigen Test Seasun Biomaterials AQ?TOP Plus COVID-19 Rapid Test (RT-LAMP) Shenzhen Bioeasy Biotechnology Bioeasy Diagnostic Kit COVID-19 Antigen Test Quidel Sofia-2 Flu+SARS Antigen Test Seasun Biomaterials AQ?TOP Plus COVID-19 Rapid Test (RT-LAMP) Shenzhen Bioeasy Biotechnology Bioeasy Diagnostic Kit COVID-19 Antigen Test An antigen test for the coronavirus could be a huge help in expanding testing.

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