The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for ANP Technologies’ NIDS COVID-19 Antigen Rapid Test Kit.
The test is a lateral flow immunoassay (LFA) that is developed using ANP’s Nano-Intelligent Detection System (NIDS) platform technology for the detection of SARS-CoV-2 from direct nasal swabs using NIDS Swab Buffer.
It uses highly sensitive antibodies for the detection of the SARS-CoV-2 nucleocapsid protein in nasal swab specimens.
ANP chief technology officer and president 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 US 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 Kit provides a visual result in 15 minutes based on the presence or absence of pink/purple-coloured lines.
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The company stated that the test is also effective in the detection of many other Covid-19 variants, including Delta.
ANP business development and contracts senior director Greg Whitham said: “With this pivotal FDA authorisation, 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.”
The NIDS test is authorised for use at the point of care and does not differentiate between SARS-CoV and SARS-CoV-2.