Spectrum’s SDNA-1000 device is said to make both sample collection and transport for Covid-19 testing easy
Spectrum Solutions has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SDNA-1000 saliva collection device to expand access and testing options for Covid-19 disease.
The self-contained saliva collection kit offers critical sample consistency, as well as suspends and neutralises viral RNA transcripts to completely inactivate the live virus.
Spectrum’s SDNA-1000 device also enables to stabilise and protect saliva samples, thereby making both sample collection and transport for Covid-19 testing easy.
SDNA-1000 saliva collection system serves as a better viral diagnostic biomaterial for Covid-19 detection
Spectrum and Rutgers Clinical Genomics Laboratory (RUCDR) first used the SDNA-1000 saliva collection system as a viral diagnostic biomaterial for Covid-19 detection.
The company already offers Covid-19 saliva-based tests, which are carried out using the SDNA-1000 under previous EUA authorisation held by RUCDR.
Perkin Elmer, Thermo Fisher, Roche, and Qiagen are the qualified commercial RNA extraction chemistries, said the company.
Spectrum’s biomaterial collection system facilitates mass-testing scalability and integration through validated and supported processes.
It is EUA authorised for more than 10 days of post-collection stability for Covid-19 saliva samples with no degradation in sample efficacy.
The system is said to be the first device authorised for at-home and unassisted sample self-collection.
Spectrum Solutions CEO Stephen Fanning said: “Saliva is a more robust biomaterial to facilitate molecular testing.
“Collected samples consistently demonstrate higher levels of testing accuracy, and the SDNA-1000 also offers the highest levels of safety by inactivating the live virus mitigating risks of exposure from the collection through shipping, to sample processing at the lab.”
In September, Hologic secured FDA EUA status for its Panther Fusion SARS-CoV-2 assay to detect asymptomatic Covid-19 individuals.