NEW YORK – ANP Technologies announced on Monday that its SARS-CoV-2 rapid antigen test has received Emergency Use Authorization from the US Food and Drug Administration.
The NIDS COVID-19 Antigen Rapid Test Kit is a lateral flow immunoassay that detects the SARS-CoV-2 N protein in nasal swabs and provides visual results in 15 minutes. It had 95 percent positive agreement with the RT-PCR comparator method used for clinical testing, the company said in a statement.
Using the firm's Nano-Intelligent Detection System platform technology, which was originally developed for the rapid detection of biological warfare agents for the US military, the point-of-care test can also detect different variants of the disease, including the Delta variant. It does not differentiate between SARS-CoV and SARS-CoV-2 viruses, the FDA said in its authorization letter.
The Newark, Delaware-based company is "now focusing on the large-scale production of the test kits," Greg Whitham, senior director of business development and contracts at ANP, said in a statement, and it "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."
The development of the test was funded partially by the National Institutes of Health's Rapid Acceleration of Diagnostics initiative, as well as the National Institute of Biomedical Imaging and Bioengineering at NIH. The current contract for the project is funded through the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority.