8th October 2021 Product update: rapidvirology staff writer
US Defense Contracter's Rapid Antigen Test for SARS-CoV-2 is Granted EUA
ANP Technologies Inc. (“ANP”) announced that it has received Emergency Use Authorization (EUA) for its NIDS® COVID-19 Antigen Rapid Test Kit from the U.S. Food and Drug Administration (FDA). The test, providing a visual result in 15 minutes, is a lateral flow immunoassay (LFA) based on ANP’s Nano-Intelligent Detection System (NIDS) platform technology.
The NIDS® COVID-19 Antigen Rapid Test is a highly sensitive test for the detection of SARS-CoV-2 nucleocapsid protein in nasal swab specimens. In addition to over 95% Positive Percent Agreement (PPA) with the RT-PCR comparator method during clinical testing, ANP’s COVID-19 Antigen Rapid Test has also demonstrated to be effective at detecting various variants including Delta, as independently validated as a part of the National Health Institute (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative.
“The NIDS COVID-19 Antigen Rapid Test was developed using our NIDS® technology platform that was initially developed for the rapid detection of various biological warfare agents for the U.S. military more than a decade ago,” says Dr. Ray Yin, President, and CTO of ANP. “With the COVID-19 pandemic, ANP quickly configured its NIDS® platform for the detection of SARS-CoV-2 antigen and achieved outstanding performance under the funding from the Department of Defense and the RADx initiative.”
“With this pivotal FDA authorization, ANP is now focusing on the large-scale production of the test kits and welcomes all partnerships and collaborations to improve testing production capacity and speed to market which is paramount to get folks back to work/school and reopen the economy,” commented Mr. Greg Witham, Senior Director of Business Development and Contracts at ANP.
This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health.
The current contract is funded from the Public Health and Social Services Emergency Fund through the Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, under Contract No. 75N92021C00005
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Date Published: 8th October 2021
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Note: This content has been edited by a rapidvirology.com staff writer for style and content.
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