ANP Technologies has received the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for its NIDS Covid-19 Antigen Rapid Test Kit.

The test is a lateral flow immunoassay (LFA), designed based on the company’s Nano-Intelligent Detection System (NIDS) platform technology.

ANP said that its Covid-19 test detects SARS-CoV-2 nucleocapsid protein in nasal swab specimens and provides a visible result within 15 minutes.

It showed more than 95% Positive Percent Agreement (PPA) with the RT-PCR comparator method during clinical testing.

Also, the test showed effectiveness in detecting new variants of SARS-CoV-2, including the Delta variant, said the company.

ANP president and CTO Ray Yin said: “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.

“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.”

The NIDS Covid-19 Antigen Rapid test has been validated under the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative.

The federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health partly provided funding support for the initiative.

Also, Public Health and Social Services Emergency Fund through the Biomedical Advanced Research and Development Authority (BARDA) has supported the project.

ANP Technologies is a clinical-stage biopharmaceutical company engaged in developing advanced nano-therapeutics and nano-diagnostic tests.

The company has been a provider of rapid, multiplexed lateral flow tests for the detection of various biological agents for the Department of Defence over the past decade.

ANP said that the FDA authorisation enabled it to focus on the large-scale production of the test kits and enter into partnerships to improve the production capacity and marketing.