FDA Grants Access to At Home COVID-19 Self-Testing: Ensure it arrives safely with OpticalLock Inc.’s New Product, OPTICALSHIELD
“…the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.”
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
“The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only.”
Given this ground-breaking test is authorized for prescription only and everyone is so desperate to know their health status, loss, theft and counterfeiting are likely to occur during the journey of these critical tests to their intended households. OpticalLock Inc. has developed a security envelope called OpticalShield that will soon be released which ensures no tampering or counterfeiting has occurred while also logging the temperatures the envelope has encountered along the way. OpticalLock has a reputation for being an innovation company of Internet of Things (IoT) devices and now is expanding to protect items being mailed or express shipped.
“We look forward to proactively working with test developers to support the availability of more at-home test options.” Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.
More breaking news from the New York Times includes an article byNoah WeilandandKatie Thomas which states that the first Americans may have access to the Pfizer vaccine by December. Combing home self-testing sent securely via OpticalShield envelopes with access to a vaccine sent with the reassurance of the OpticalLock Monitoring & Security System, demonstrates how technology and science saves lives and ensures the authenticity of critical products and high value goods.
OpticalLock Inc. provides innovative technology that provides peace of mind. Congratulations to Lucira, Pfizer and Moderna as well as many others who are working to provide lifesaving solutions.