North American Diagnostics, NAD announced Tuesday that its SARS-CoV-2 oral rapid antigen test received CE marking
DAYTONA BEACH, FLORIDA, UNITED STATES, July 20, 2021 /EINPresswire.com/ — The point-of-care test, doesn’t require an instrument and returns results in 20 minutes, the company said. It is intended for use in both symptomatic and asymptomatic patients. At this time, clinical trials are also being conducted for use in in symptomatic patients both Oral (Oropharyngeal and Gentle Nasal. North American Diagnostic’s SARS-CoV-2 Rapid Test has a high sensitivity of 97.0 percent and specificity of 100.0 percent based on samples from two study centers, the United States based company noted.
Paul Singh, spokesman said it also plans on filing for Emergency Use Authorization with the US Food and Drug Administration once the supplemental clinicals trials in Africa are completed. Upon launching the rapid chromatographic test, the company said it will have 10 million available per month, with plans to double capacity by the end of 2021.
According to Elizabeth Lashinsky, depending upon volume, the company will price the test kits for third world nations as low as $2.00 and will launch in countries accepting such designation.
Paul Singh, MHA, BA
North American Diagnostics, LLC
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