Optec Applies for CLIA Certification as FDA Opens Door to Widespread Home Use of Antigen Rapid Tests

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CARLSBAD, CA / ACCESSWIRE / April 8, 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 has applied for CLIA certification to ensure the test results are meeting and exceeding industry standards for clinical laboratory testing of the medical-related products distributed by the company.

What is CLIA

"The Clinical Laboratory Improvement Amendment (CLIA) has been the industry standard ever since its beginning that started in 1966; the reason for the birth of CLIA was due to elevated laboratory testing errors. CLIA began as regulations for primarily hospital laboratories and independent laboratories. Through the years, there have been a few regulations passed to for CLIA in order for it become more encompassing of different laboratories and the level of testing they were conducting. Since the implementation of these amendments and regulations, the quality of laboratory testing has been on the rise, with quality deficiencies on the downfall. CLIA certified entities have stringent standards they must meet in order to maintain their status as a CLIA certified facility. The CDC, CMS, and FDA all support CLIA and encourage consumers to look for this certification when it comes to Laboratory testing and tests. This certification is beneficial for our COVID Antigen & Antibody tests, as it provides consumers with the peace of mind in knowing their test is certified and meets the federal regulations and quality standards of the country."

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 Antigen 10 Minute Nasal Rapid Test Kits: online, via distributors, media channels, and bulk PPE networks.

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.oraldna.com/trends-in-salivary-testing/index.php/2018/03/09/definition-clia-certified-cap-accredited-what-does-this-mean/

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/fda-opens-door-to-widespread-at-home-covid-19-tests-3987603

About OPTEC International, Inc. With Locations in Carlsbad and Vista, California, OPTEC International 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

OPTEC International, Inc. investor relations at www.optecintl.com/investor

Safe Harbor Statement: Safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by phrases such as Opti, OPTEC, or its management "believes," "expects," "anticipates," "foresees," "forecasts," "estimates," or other words or phrases of similar import. Similarly, statements herein that describe the Company's business strategy, outlook, objectives, plans, intentions, or goals also are forward-looking statements. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in forward-looking statements. OPTEC International Inc.

OPTEC International, Inc.

Investor Relations Contact:

Andrew Barwicki
516-662-9461 / [email protected]

SOURCE: Optec International, Inc.



View source version on accesswire.com:
https://www.accesswire.com/639515/Optec-Applies-for-CLIA-Certification-as-FDA-Opens-Door-to-Widespread-Home-Use-of-Antigen-Rapid-Tests

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