If you are having a medical emergency, please call 9-1-1 immediately. If you are experiencing severe difficulty breathing, continuous pain or pressure in your chest, feeling confused or having difficulty waking up, blue-colored lips or face, or any other emergency signs or symptoms, please seek immediate medical care.
Our At-Home Testing Process
*Simplicity by Assurance Scientific Laboratories offers this product with a FDA Emergency Use Authorization (EUA). This means that this product has not been FDA cleared or approved, but has been approved for emergency use by the FDA under an EUA. This product has only been authorized by the FDA for detection of nucleic acid from SARS-CoV-2 (i.e., the COVID-19 virus), and not for any other virus or pathogen. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Why Choose Simplicity?
At Simplicity by Assurance Scientific Laboratories, we believe our clinical lab services are second to none. We have designed our pathogen detection process with clients and patients in mind. Molecular (genetic) identification, using PCR (Polymerase Chain Reaction), is the ideal platform. Molecular testing is superior to traditional culture identification because some pathogens are just too difficult to grow. Rapid detection using Real-Time PCR increases our chances of selecting the appropriate diagnosis. Our lab identifies the pathogen(s) present using very sensitive and specific PCR assays.