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.