First FDA EUA COVID-19 Saliva Testing Kits Launched

The first FDA Emergency Use Authorization (EUA) COVID-19 saliva testing kits have been launched in the US by Accumen Inc. (Phoenix, AZ, USA) in partnership with Spectrum Solutions (Salt Lake City, UT, USA).

Saliva testing for detecting COVID-19 first received FDA EUA in April. This authorization mandated saliva collection solely using Spectrum’s SDNA-1000 saliva collection device based on a trial with Rutgers University. The Spectrum saliva collection kit has been engineered to produce more accurate and sensitive test results, reduce sample collection errors, including for at-home self-collection, reduce labor required for collection and reduce use of valuable PPE.

Additionally, the SDNA-1000 delivers 100% neutralization of the live virus mitigating risk and the threat of unnecessary exposure. It can also preserve and stabilize viral RNA transcripts for transport in extreme and varying temperatures for more than 14 days and for up to one-year post collection in ambient storage.

Accumen is offering the full kit or only the saliva collection device, as well as implementation support services. In addition to COVID-19 saliva testing kits, the company is also offering 3D-printed COVID-19 testing swabs, face shields and disposable masks, gowns, and gloves. For healthcare providers and institutions that need immediate access to other COVID-19-related resources, Accumen provides laboratory, imaging, blood management rapid response tools and other strategic pandemic resources.

“Accumen has been partnering with its clients to strengthen their laboratory supply chain for more than 10 years. Early in the COVID-19 crisis, we identified supply chain gaps and began coordinating resources to meet those evolving needs. As the crisis continued, we were able to provide critical testing supplies like nasopharyngeal (NP) swabs, media and personal protective equipment (PPE) for our clients, and we later made those resources available to other health systems and laboratories across the country to help increase testing efforts,” said Eric Jurinic, Accumen Vice President of Corporate Supply Chain.

Related Links:
Accumen Inc.
Spectrum Solutions