Rapid Saliva 2 Min Antigen Test.CE approved For Over the Counter Sales

Rapid Saliva 2 Min Antigen Test.CE approved For Over the Counter Sales

25-Second, 98% Sensitivity, Digital COVID-19 Saliva Test Achieves CE Mark

Non-invasive ultra-rapid test delivers 98% sensitivity and 100% specificity in symptomatic and

asymptomatic individuals with SARS-CoV-2 including variants

Designed for point-of-care (POC) diagnosis, ease of use and rapid mass-screening, the digital

platform enables efficient track & trace and has potential to open up the economy

New York.Med tech companyhas received CE Markfor a 25-second COVID-19 saliva test, delivering real-time resultswith 98% sensitivity and 100% specificity. The Pelican COVID-19Ultra-Rapid Mobile Test for the detection of SARS-CoV-2 is nowcleared for sale and distribution in the European Union (EU). Thetest is also under review at the U.S. Food and Drug Administration(FDA) under Emergency Use Authorization (EUA) for Over-the-Counter (OTC), non-prescription use and as a self-test.The testing kit consists of a handheld reusable digital reader anddisposable testing cartridges with direct detection technology toanalyze multiple targets – spike (S) and nucleocapsid (N) proteinsin saliva - to detect SARS-CoV-2. With a limit of detection of 1fg/ml, it correlates well with RT-PCR reference assay, the current gold standard. Taking less than 2minutes for the entire testing process, the digital antigen saliva test has high sensitivity in bothsymptomatic and asymptomatic users, including detection of the known new variants. The POC testdetects the virus without the need for lab equipment or amplification processes.Using cutting-edge nano-sensing technology in viral detection in saliva, the Pelican test hasoverhauled the need for invasive nasal sampling, previously thought to be the best way to detect thevirus. Recent studies have indicated that using saliva can be an accurate detection method and canprovide more information on the virus than a nasal swab test.i Most conventional rapid antigen testswhich takes up to 30 minutes for a result suffer from accuracy challenges, particularly inasymptomatic individuals as demonstrated in a recent CDC studyi