CARLSBAD, 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.
ACTUAL ARTICLE (link above).
FDA opens door to widespread at-home Covid-19 tests
By David Lim
03/16/2021 03:19 PM EDT
The Food and Drug Administration will allow some developers of Covid-19 tests to market their products for regular at-home use without first studying how well the tests perform in people without symptoms.
The agency’s announcement Tuesday is aimed at making it easier to screen Americans returning to school and work, senior FDA regulators said.
“We believe this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing,” FDA medical device director Jeff Shuren and diagnostics director Tim Stenzel said in a statement.
Some rapid Covid-19 tests are less accurate in people without symptoms than in those with symptoms. But the FDA’s new policy takes into account that repeated testing over time, for screening purposes, can improve the overall accuracy of results.
Companies can apply for permission to market an over-the-counter test for use at home or at point-of-care if there is evidence the test performs well in people with symptoms of Covid-19 and if repeated testing can help mitigate false results. The agency is issuing a new template for test developers seeking an emergency use authorization for a screening test that is used for repeated testing.
“It is important to note that testing, even serial testing, is of limited value if it is not combined with appropriate mitigations for individuals who test positive (such as quarantine), good contact tracing, and effective behavioral protocols (such as mask wearing, hand washing and social distancing), even for individuals who test negative,” an FDA fact sheet about the new policy states.
Background: Somepublic health groups, including the Rockefeller Foundation, and public health experts such as Harvard University’s Michael Mina, have argued for months that increasing the availability of Covid-19 tests could help bring the Covid-19 pandemic under control.
What’s next: FDA also released a fact sheet that aims to help groups setting up screening testing programs. The Biden administration is working to stand up four coordinating centers across the country to increase testing in K-8 schools and underserved settings.
“The fact sheet will help schools, workplaces, communities and other locations as they are selecting a test for screening and help them understand the difference between tests used for diagnosis of suspected COVID-19 compared to those used for screening asymptomatic individuals,” Shuren and Stenzel said.
About OPTEC International, Inc. With Locations in Carlsbad and Vista, California, OPTECInternational is a developer and manufacturer of electronic LED, Ultraviolet (UV) & UV-C safety products and related advanced technologies and PPE (Personal Protection Equipment) products. The company’s Safe-Scan product line is being launched at a time when HR directors and facilities managers are experiencing extreme concern with respect to keeping environments safe during the global pandemic crisis and the safe reopening of the U.S. economy. For more information, visit: www.optecintl.com www.z2o.com.
OPTEC International, Inc. investor relations at: www.optecintl.com/investor.
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SOURCE: Optec International, Inc.
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