Leslie Titus Bryant
December 13, 2021
SALT LAKE CITY, UTAH—Spectrum Solutions, LLC today announced that COVID-19 RT-PCR saliva tests using the Spectrum SDNA-1000 for bio-sample collection will also successfully be able to detect the additional Omicron viral variant and its mutations. Initially identified in South Africa, this variant has swiftly spread into Europe and is now being detected in North America. The Omicron variant (B.1.1.529) currently contains approximately 30 different mutations.
Spectrum’s SDNA-1000 is the advanced saliva collection breakthrough innovation that not only introduced the world to the possibility of a more accurate, noninvasive, and safer viral testing solution but was also the first saliva collection device to be EUA authorized by the FDA for saliva-based PCR COVID-19 testing as well as direct-to-patient at-home testing applications that include unsupervised sample self-collection. The FDA validation of this all-in-one, patented sample collection, preservation, and transport system highlights the device’s ability to neutralize the live virus at ambient temperatures further mitigating downstream risks of exposure and spread.
“We have intently monitored mutations of the COVID-19 virus and assessed the authorized tests using our saliva collection system with the ability to detect them. According to the WHO, CDC & ECDC, ‘S-gene dropout’ can be used as a marker or signal for identifying the Omicron variant confirmed by sequencing,” said David Vu, Spectrum Solutions Vice President of Product Development. “The SDNA-1000 saliva collection device is so effective at preserving viral genetic material, it is specifically being used in testing assays commissioned by the CDC to track and identify these and previous viral variants.”
Many tests including those using raw saliva only look at a single viral transcript (N gene). Saliva testing using the EUA approved ThermoFisher TaqPath RT-PCR COVID-19 kit that includes the Spectrum SDNA-1000 for its saliva collection and sample preservation interrogates three viral transcripts (N, S, and ORF1a/b) adding to the superior performance, heightened sensitivity, and 99.98% test accuracy.
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