26th April 2021 Product update: rapidmicrobiology staff writer
CovClear™ COVID-19 Rapid Antigen Test is CE-Marked
Empowered Diagnostics LLC has received CE marking for its CovClear™ COVID-19 Rapid Antigen Test.
CovClear is a lower-cavity nasal swab test that can detect active COVID-19 infection within about two days of exposure to SARS-CoV-2 before a person becomes contagious.
"The test produces highly accurate results within minutes and is quick, comfortable, and simple to use. It has been researched, developed, and manufactured in the U.S. and is produced using the highest quality materials available.CovClear has 99.7% accuracy, 98.5% sensitivity, and 100% specificity," the company said in a recent press release.
According to Empowered Diagnostics, their manufacturing capacity is at 20 million tests per month. In addition to CovClear, the company developed the ImmunoPass™ COVID-19 Neutralizing Antibody Rapid Test, which measures levels of virus-neutralizing antibodies that indicate immunity.
CovClear was developed and engineered for at-home testing. FDA Emergency Use Authorization, in addition to authorization in the United Kingdom and Canada, is anticipated in the coming weeks.
The CovClear test will be available at doctors' offices, pharmacies, and other point-of-care locations throughout the European Union.
Date Published: 26th April 2021
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Note: This content has been edited by a rapidvirology.com staff writer for style and content.
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