Assurance Scientific Laboratories Receives EUA for Direct-to-Consumer COVID-19 At-Home Collection Kits
BIRMINGHAM, Ala., Feb. 17, 2021 /PRNewswire/ -- U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the Simplicity by Assurance Scientific LaboratoriesTM COVID-19 Test Home Collection Kit to be available direct-to-consumer without requiring a prescription.
The Simplicity by Assurance COVID-19 Test Home Collection Kit allows anyone 18 and older to purchase the kit and collect a nasal swab sample at home. After registering the kit, the sample is sent to Assurance Scientific Laboratories for testing. Results will be delivered to the consumer through an online portal within 48 hours of the lab receiving the sample.
"This new authorization will allow consumers to have kits on hand before they are sick, cutting the wait time on getting results," said Chad Austin, M.D., Co-Founder of Assurance Scientific Laboratories.
The non-prescription, direct-to-consumer, COVID-19 at-home collection kit will be available to businesses and consumers online, through the app store, and in retail stores within the next 30 days.
For more information or to speak to someone from Assurance Scientific Labs, contact Heather Jeffcoat by calling 205-515-1972 or by emailing [email protected].
About Assurance Scientific Laboratories
Assurance Scientific Laboratories began testing for COVID-19 on March 11, making them the first commercial lab in Alabama and one of the first in the country to begin testing for COVID-19. Since that time, they have tested nearly one million samples. Assurance Labs is a highly complex clinical reference lab with a robust R&D department that develops and provides rapid diagnostic services for consumers, clinicians, hospital systems, private entities, long-term care facilities, and other reference labs. They specialize in molecular diagnostics and microbiology. Assurance Labs uses PCR for the identification of pathogens that are capable of causing illness. This type of testing is the same that is used to identify COVID-19.
In addition to the COVID-19, they test for over 100 different pathogens and offer several panels including COVID Respiratory, UTI with Antibiotic Resistance Markers, wound panel, STI, Vaginitis, GI, Candida, and CMV panels. They also perform culture and Antimicrobial Sensitivity Testing. Please visit AssuranceScientificLabs.com, email [email protected], or call 855.319.4459 for additional information.
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