Spectrum Solutions™ SDNA-1000 Molecular Diagnostic Saliva Collection Device

Description

Engineered to lead the saliva collection market in molecular diagnostic applications. This self-contained, EUA authorized saliva collection system provides sample consistency while suspending and neutralizing viral RNA transcripts post-collection for sensitive and specific analysis.

• Creates the most robust and safest biomaterial collection approach for the detection of COVID-19 infections
• Leads the way to a new era of at-home biosample self-collection for the diagnosis of viral infections
• First EUA authorized saliva collection kit for COVID-19 testing
• First EUA authorized device for direct-to-patient at-home saliva sample self-collection
• Intuitive, 3-step design is proven to reduce customer collection errors
• Single device for both DNA & viral RNA applications
• 100% inactivation of the live virus at ambient temps with EUA validated viral inactivation data
• Delivers the safest & most robust biomaterial for detecting COVID-19 
• Provides over 10 days of post-collection stability with no degradation in sample efficacy
• Collection system maintainence of biosample consistency significantly reduces costs associated with sample failures & recollection
• Mitigates any risk of infection throughout the testing process 
• Pinpoints life-cycle stage of active viral infection
• In device viral neutralization eliminates UN3373 designation delivering UPS and Fedex shipping clearance
• Patented preservation chemistry enables easy extraction & purification for sensitivity boost & optimal accuracy in molecular analysis
• Tube compatible with automated platforms & customizable for incremental efficiency improvements
• Qualified commercial RNA extraction chemistries include Perkin Elmer, Thermo Fisher, Roche, Qiagen, and more

Specifications

• Certifications/Compliance: FDA, EUA Device Certification (EUA202432)
• For Use With (Application): COVID-19 Diagnostic Testing, Clinical Research, Molecular Diagnostic Applications, Personalized Skincare, Health & Wellness, Direct-to-Consumer Biosample Collection, and Biobanking
• Includes: Sealed Blister Pack with Spectrum Tyvek Label, Spit Tube with Attached Funnel, Spectrum’s Patented Blue Preservation Chemistry Filled Cap, Device Instructions for use (IFU) in 3 Languages, and Unique Barcode Serialization for Identification and Sample Chain-of-Custody
• Quantity: 360/Cs.