The non-invasive test for SARS-CoV-2
Saliva testing can allow earlier detection to identify people who may not know they are contagious. In addition, because patients spit into a tube or cup, saliva testing is safer for healthcare workers than taking swabs. The greatest scientific advantage is that nasal and oral swabs only collect the surface area where the swab goes, which may not be the place with most viral load. In contrast, the virus occurs throughout a saliva sample, so the test is more trustworthy.
Using saliva to test for viral infection was not something previously tried therefore was not an FDA approved testing option. Swabs had been the traditional approved standard. As testing exponentially accelerated supplies became limited and it became clear additional options needed to be discovered. A groundbreaking study done by Rutgers University determined saliva to be 100% equal to swabs for COVID-19 detection and in many cases, it proved to be a better, more sensitive option. This was further validated by an additional study done by Yale University researchers.
This delivered EUA approval for Rutgers to use saliva for SARS-CoV- 2 testing based on the very specific and documents protocols they used.
What makes the Saliva collection unique:
Engineered to reduce at-home user and self-collection errors
Preservation chemistry is 100% bacteriostatic extending sample shelf-life
Consistently delivers higher quality and quantities of DNA for medical, genetic, and
molecular diagnostic testing
Protects and suspends viral RNA transcripts for sensitive and specific analysis
Chemistry inactivates the live virus helping to shield healthcare professionals and
clinicians from exposure
Proven to stabilize & protect SARS-CoV-2 viral RNA during specimen transport in all
extreme temperatures for 14 days
This test has been authorized by the FDA under an Emergency Use Authorization for use by authorized laboratories. This test has not been FDA cleared or approved. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. (Gettestednow.com provides tests from Infinity BiologiX (formerly RUCDR), who have received an EUA from the FDA for home saliva collection. Gettestednow.com works closely with Infinity BiologiX to ensure their distribution of these authorized tests is fully compliant with the parameters of their authorization, and with any regulatory updates or changes.)