Canary Digital COVID-19 Memory Test Receives CE Marking, Requires Only …

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15.03.2021 – 20:21

Canary Global Inc.

New York (ots/PRNewswire)

Non-invasive ultra-rapid test provides 98% sensitivity and 100% specificity in symptomatic and asymptomatic patients with SARS-CoV-2 including the variants

The digital solution was developed for point-of-care diagnosis (POC), simple application and fast mass screening. It enables efficient follow-up and can potentially allow economic life to normalize soon

Med-tech company Pelican Diagnostics, a Canary Global Inc. company, has received CE Mark for a 25-second COVID-19 saliva test that provides real-time results with 98% sensitivity and 100% specificity. Pelican’s Ultra Rapid Mobile Device Test for SARS-CoV-2 is now approved for sale and distribution in the European Union. The test is also checked by the US Food and Drug Administration (FDA) under the Emergency Use Authorization (EUA) for suitability for over-the-counter use (OTC), non-prescription use and as a self-test.

The test kit consists of a reusable digital handheld reader and disposable test cartridges. To detect SARS-CoV-2, the technology analyzes several target sequences in saliva, more precisely: Spike (S) and nucleocapsid (Nc) proteins. With a detection limit of 1fg / ml, the technology correlates well with the RT-PCR reference test, the current gold standard. The digital antigen-saliva test takes less than 2 minutes for the entire test process and has a high sensitivity for both symptomatic and asymptomatic patients, as well as for the detection of the known new variants. The POC test does not require laboratory equipment or amplification procedures to detect the virus.

“The Pelican CV19 test combines the power of nanosensors and digital detection technology. It is the first point-of-care test that can give an accurate result in less than 2 minutes with a sensitivity of 98% and a specificity of 100% “said Raj Reddy, President and CEO of Canary Global Inc. Currently, rapid tests often only give results after the patient has infected others – this is a problem. The more sensitive PCR tests take too much time and are not suitable as point-of-care tests. The pandemic can be defeated with fast, accurate and frequent testing and the tracing of the positive tested cases, as well as with the introduction of vaccines. With its networked platform, Pelican offers this opportunity. ”

Pelican uses state-of-the-art nano-sensor technology for virus detection in saliva, thereby eliminating the need for invasive nasal sampling, which was previously considered the best method for detecting the virus. Recent studies have shown that saliva tests can provide accurate detection and provide more information about the virus than a nasal swab test (i). Most conventional rapid antigen tests, which give their results after up to 30 minutes, are not accurate enough, especially in asymptomatic people, as a recent CDC study (ii) shows.

“The ability to detect SARS-CoV-2 early, before symptoms appear, or in asymptomatic individuals can reduce household and community transmission and enable quick clinical decisions for patient triage and care,” added Reddy . “The tests can allow stores, schools and venues to be opened safely. Therefore, they have the potential to usher in a meaningful turnaround.”

The device can also be wirelessly connected to a smartphone-based app and generate automatic reports. The result is displayed as “positive” or “negative” on the screen of the reader, while further information is provided for the patient on the app. Each single-use test cassette contains multiple sensors and a unique QR code associated with the user’s cell phone or other connected device. The cloud-based test system is HIPAA compliant, so users’ sensitive health information is protected.

www.pelicandetect.com/

The full power of smart sensors & deep learning in the service of early disease detection

Press contact:

Anna Wang |
SVP, Corporate Affairs
[email protected]
i https://www.medrxiv.org/content/10.1101/2021.01.04.21249236v1
ii https://www.cdc.gov/mmwr/volumes/70/wr/mm7003e3.htm

Original content by Canary Global Inc., transmitted by news aktuell





[ source link ]
https://www.presseportal.de/pm/154200/4864652

Canary Digital COVID19 Memory Test Receives Marking Requires

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