First FDA Authorized Saliva Collection Device for COVID 19 saliva testing

The FDA has expanded the existing EUA200090 (emergency use authorization) to now include the at-home self-collection of saliva samples for COVID 19 saliva testing exclusively using Spectrum’s SDNA-1000 saliva collection device. Any and all FDA authorized saliva-based COVID-19 tests are required to use the SDNA-1000 for biosample collection. The expansion of the FDA's authorization to include direct-to-patient at-home self-collection was granted based on the device’s ease-of-use as well as its ability to preserve and stabilize RNA transcripts for transport under extreme conditions. This marks the first, and currently only, authorization by the FDA approving doctor prescribed COVID-19 testing using at-home saliva collection.

Intuitively engineered and purpose-built to significantly reduce user collection errors, the SDNA-1000 demonstrated first-hand its ease of use advantage as COVID-19 hit our nation full force. The concept of complete self-sample collection or minimally supervised sample collection suddenly affirmed its tremendous value as PPE became increasingly harder to obtain and exposure risks exponentially grew.

The RUCDR saliva vs. swab COVID-19 study showcased the unique RNA advantages of the patented Spectrum blue preservation chemistry in addition to its superior DNA preservation capabilities. Visual confirmation is delivered immediately upon securing the cap in place that the device is doing its intended job to deliver the quality samples required for accurate testing results.