Novel Saliva Collection Device Keeps Analytes Stable at Ambient Temperatures for Weeks
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By LabMedica International staff writers Posted on 27 Feb 2023 |
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Image: The SDNA Saliva Collection Device has received FDA 510(k) Class II Medical Device Clearance (Photo courtesy of Spectrum Solutions)
Blood-based diagnostics have been the norm since a long time. However, in the new era of healthcare, providers have adopted salivary collection and preservation to detect viral infections. The process of collecting saliva can make a huge diagnostic difference. Selecting the wrong saliva collection device can create and increase critical failure points. In order to incorporate the use of saliva into molecular diagnostic testing protocols or implement actual real-world mass-testing in scalable scenarios, there is a need for a studied, proven, validated, and supported system that eliminates the risk of exposure and a device that can enhance test precision, sensitivity, and assay reproducibility. Now, a novel saliva collection device is setting new standards of care in testing, managing, and treating diseases.
The SDNA Saliva Collection Device from Spectrum Solutions (Salt Lake City, UT, USA) has the ability to maximize detection at the lowest levels and neutralize viruses within 10-seconds of collection to mitigate unnecessary viral exposure. The company’s patented preservation media keeps analytes stable for several weeks at ambient temperatures, ensuring safe, easy, and secure specimen storage and transport. The SDNA kits do not have any special storage or transport temperature-control requirements for collected saliva samples and eliminate the need for UN3373 biohazard shipping designation. The U.S. Food and Drug Administration (FDA) has granted 510(k) Class II clearance to the SDNA saliva collection device as a microbial nucleic acid storage and stabilization device.
“This 510(k) clearance and certification as an IVD molecular diagnostic device enables physicians, hospitals, researchers and others to leverage our SDNA Saliva Collection Device in a broad array of FDA approved and LDT diagnostic testing applications,” said Stephen Fanning, CEO at Spectrum Solutions. “Those conducting screening and diagnostic tests can confidently and safely expand access and opportunity incorporating saliva as a primary or alternative biomaterial into their existing testing protocols.
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