US-based mobile point-of-care (PoC) diagnostics company Nanomix has received the CE mark for its eLab Covid-19 rapid antigen test.
The rapid antigen test has been designed to qualitatively detect the nucleocapsid antigen from SARS-CoV-2, using an anterior nasal swab.
It runs on the Nanomix eLab Analyzer, a mobile, hand-held immunoassay and chemistry diagnostic device, and provides the test results within 15 minutes.
Nanomix chief commercial officer John Hardesky said: “Receiving the CE mark for our Covid-19 rapid antigen test is a key milestone which further validates our rapid and accurate point-of-care (POC) testing technology.
“This assay complements our S1 Critical Infection Panel which provides valuable insight to clinicians as they diagnose and monitor severe, co-infections including those of Covid-19 patients.”
The nasal swab samples can be collected using a swab and sample collection tube provided with the test kit, and then transferred to the single-use microfluidic cartridge.
The cartridge is then run on the Nanomix eLab Analyzer, which displays the results, or can print or send results electronically via Bluetooth.
In addition, the system can publish the Nanomix eLab Covid-19 rapid antigen test results in the form of QR code to maintain patient confidentiality.
The company has received funding support from the Department of Health and Human Services, and the Biomedical Advanced Research and Development Authority (BARDA), Division of Research Innovation and Ventures.
Nanomix president and chief executive officer David Ludvigson said: “Development of our Covid-19 rapid antigen test is a testament to the hard work of our R&D team and the quality of our technology.
“The Nanomix eLab is a comprehensive diagnostic platform that has enormous potential in time-sensitive diagnostic applications.”
In February last year, Nanomix initially filed an application seeking the US Food and Drug Administration (FDA) emergency use authorisation (EUA) for its eLab Covid-19 rapid antigen test.
