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 has secured FDA EUA for new Covid-19 saliva sample collection method. (Credit: Thermo Fisher Scientific Inc)
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.
In August this year, Thermo Fisher secured FDA EUA for its TaqPath Covid-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0 assays.