The EUA status allows to conduct Covid-19 tests using saliva samples collected by the Spectrum Solutions’ SpectrumDNA SDNA-1000 collection device on Amplitude Solution system
Thermo Fisher Scientific has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for new saliva sample collection method for high-throughput and automated Covid-19 testing system.
The EUA status allows to conduct Covid-19 tests using saliva samples collected by the Spectrum Solutions’ SpectrumDNA SDNA-1000 collection device on the molecular diagnostic system called Amplitude Solution.
SDNA saliva collection devices are developed to offer sample consistency and long-term stability while protecting DNA and RNA transcripts post-collection.
According to the company, the self-contained systems devices help deliver precise test results using only two milliliters of saliva.
Thermo Fisher Scientific genetic testing solutions senior medical director Manoj Gandhi 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 allows laboratories to scale Covid-19 PCR testing, in addition to processing up to 8,000 samples per day.
The solution enables clinical labs to expand testing capacity with minimal hands-on time, equipment and staffing.
Its high-throughput capabilities are said to help meet testing requirements for companies, schools, universities and communities.
The kit features multi-gene target design and updated interpretive software for the efficient detection of SARS-CoV-2 variants.