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Thermo Fisher’s New Saliva Sample Collection Method for High-Throughput, Automated COVID-19 Testing System Granted FDA EUA

By LabMedica International staff writers
Posted on 19 Oct 2021
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Image: SDNA-1000 Saliva Collection Device (Photo courtesy of Spectrum Solutions)
Image: SDNA-1000 Saliva Collection Device (Photo courtesy of Spectrum Solutions)

Thermo Fisher Scientific Inc. (Waltham, MA, USA) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to run COVID-19 tests from saliva samples collected with the Spectrum Solutions SpectrumDNA SDNA-1000 collection device on the Amplitude Solution.

SDNA saliva collection devices are self-contained systems that provide sample consistency and long-term stability while protecting DNA and RNA transcripts post-collection to help ensure accurate test results with only two milliliters of saliva. The Amplitude Solution is a molecular diagnostic system that empowers clinical labs to expand testing capacity with minimal hands-on time, equipment and staffing. It gives laboratories the ability to scale COVID-19 PCR testing and process up to 8,000 samples in a single day. Its high-throughput capabilities can be flexed to address testing needs for companies, schools, universities and communities to help them return to pre-pandemic life. The kit's multi-gene target design and updated interpretive software is also designed to help labs detect SARS-CoV-2 variants.

"With the increase of COVID-19 cases due to more transmissible variants such as the Delta variant, routine testing for SARS-CoV-2 remains an effective strategy to curb the pandemic," said Manoj Gandhi, senior medical director of genetic testing solutions, Thermo Fisher Scientific. "By enabling labs and public health officials with additional flexibility in sample collection on a high-throughput system, we are improving their ability to meet the increased demand which helps to monitor the spread of COVID-19 and, eventually, save lives."

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