North American Diagnostics Receives CE Mark for SARS-CoV-2 Oral Antigen Rapid Test
North American Diagnostics, NAD announced on Tuesday that its rapid oral test for SARS-CoV-2 antigen received CE mark
– Paul Singh
DAYTONA BEACH, FLORIDA, USA, July 20, 2021 /EINPresswire.com/ – The point-of-care test does not require an instrument and returns results within 20 minutes, the company said. It is intended for use in symptomatic and asymptomatic patients. Currently, clinical trials are also underway for use in symptomatic patients with both oral (oropharyngeal and mild nasal). North American Diagnostic’s SARS-CoV-2 rapid test has a high sensitivity of 97 , 0%, and 100.0% specificity based on samples from two study centers, the US-based company noted.
Paul Singh, spokesperson, said he also plans to file an emergency use authorization with the United States Food and Drug Administration once additional clinical trials in Africa are completed. When launching the rapid chromatographic test, the company said it would have $ 10 million per month, with plans to double capacity by the end of 2021.
According to Elizabeth Lashinsky, depending on the volume, the company will offer test kits for third world countries as low as $ 2.00 and launch them in countries that accept this designation.
Paul Singh, MHA, BA
North American Diagnostics, LLC
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