Medical technology company Canary Global Inc reported on Monday the receipt of the CE Mark for a 25-second Pelican COVID-19 saliva test that delivers real-time results with 98% sensitivity and 100% specificity based on its nano-sensing technology in viral detection in saliva.
The company added that the Pelican COVID-19 Ultra-Rapid Mobile Test for the detection of SARS-CoV-2 is now cleared for sale and distribution in the European Union (EU). The test is under review at the US Food and Drug Administration (FDA) under Emergency Use Authorization (EUA) for Over-the-Counter (OTC), non-prescription use and as a self-test.
According to the company, the testing kit consists of handheld reusable digital reader and disposable testing cartridges with direct detection technology to analyze multiple targets,spike (S) and nucleocapsid (N) proteins in saliva, to detect SARS-CoV-2. The POC test detects the virus without lab equipment or amplification processes in both symptomatic and asymptomatic users, including new variants.
In addition, the device can also be wirelessly connected to a smartphone-based app for automated reporting. The cloud-based testing system is HIPAA compliant which protects the integrity of protected health information of users, concluded the company.
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