FDA authorizes new saliva sample collection method for high-throughput, automated Covid-19 testing system

October 18, 2021  –  Thermo Fisher Scientific has received Emergency Use Authorization (EUA) from the U.S. 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 allows clinical labs to expand testing capacity with minimal hands-on time, equipment and staffing, the company says. 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 Amplitude Solution, laboratories can scale COVID-19 PCR testing and process up to 8,000 samples in a single day.

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