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Optec Prepares for Launch of Antigen Nasal 10-Minute Rapid Test Kits for Widespread Home & Business Use
CARLSBAD, CA / ACCESSWIRE / March 29, 2021 / OPTEC International, Inc. (OTC PINK:OPTI) , a ...
About this update from Optimi Health Corp.
[{"type":"text","content":"Optec Prepares for Launch of Antigen Nasal 10-Minute Rapid Test Kits for Widespread Home & Business UseCARLSBAD, CA / ACCESSWIRE / March 29, 2021 / OPTEC International, Inc. (OTC PINK:OPTI), a developer of UV and UV-C safety products using related advanced technologies specific to Personal Protection Equipment (PPE), today announced the company is now preparing and stockpiling FDA EUA approved inventory for the launch of the Antigen 10-minute rapid test kits to be made available for use at home & business nationwide.Due to a recent FDA relaxation of the \"emergency use\" (EUA) rules applicable for Rapid Test Kit use, most FDA/EUA approved Antigen and Antibody Test Kits will soon be available for purchase by consumers and businesses, both online and over the counter at affordable prices compared to the current Medical facility/Pop-Up medical staff supervised locations with 24-72-hour results.OPTEC is providing 2 versions of the Nasal CoV-2 Antigen FDA EUA authorized 10-minute rapid test kits. The kits are clinically proven to be reliable and accurate (Clinical evaluation: Positive Percent Agreement (PPA): 88.37% (95% CI: 75.52% - 94.93%), Negative Percent Agreement (NPA): 100% (95% CI: 94.25% - 100%).The Nasal swab tests detect viral shedding of the RNA of the virus. Using the Antigen Rapid Test Kits provides the ability for all necessary resources to help keep the pandemic at bay for personal family satisfaction, business employee monitoring, schools, senior care centers, medical & dental facilities, government divisions and more.OPTEC will be offering both versions of the 10 Minute Antigen Nasal Rapid Test Kits: online, via distributors, media channels and bulk PPE networks upon receipt of final approval by FDA.What is an EUA? The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service's (HHS's) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes the pandemic.Important Links:https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#covid19ivdTemplates.https://subscriber.politicopro.com/article/2021/03/f...