Thermo Fisher Scientific has received Emergency Use Authorisation (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 millilitres of saliva. The Amplitude Solution gives laboratories the ability to scale COVID-19 PCR testing and process up to 8,000 samples in a single day.
Manoj Gandhi, senior medical director of genetic testing solutions, Thermo Fisher Scientific, said: "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. 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."
The Amplitude Solution is a molecular diagnostic system that empowers clinical labs to expand testing capacity with minimal hands-on time, equipment, and staffing. 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.