Press Release Summary:
- Self-contained systems that provide sample consistency and long-term stability
- Ensures accurate test results with two milliliters of saliva
- Can be used to address testing needs for companies, schools, universities and communities
Original Press Release:
FDA Authorizes New Saliva Sample Collection Method for COVID-19 Testing
Thermo Fisher Scientific received emergency use authorization from the U.S. Food and Drug Administration to run COVID-19 tests from saliva samples collected with the Spectrum Solutions SpectrumDNA SDNA1000 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. According to the company, the Amplitude Solution gives laboratories the ability to scale COVID-19 PCR testing and process up to 8,000 samples in a single day.
“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,” says Manoj Gandhi, senior medical director of genetic testing solutions for 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.”
The Amplitude Solution is a molecular diagnostic system designed to help clinical labs expand testing capacity with minimal hands-on time, equipment, and staffing. Its high-throughput capabilities can be used to address testing needs for companies, schools, universities, and communities. The kit’s multi-gene target design and updated interpretive software are also designed to help labs detect SARS-CoV-2 variants.
For more information, visit Thermo Fisher Scientific.