Engineered to Lead the Saliva Collection Market in Molecular Diagnostic Applications
The SDNA whole saliva collection device has been engineered to lead the saliva collection market in molecular diagnostic applications.
With over 20 million collection devices manufactured and distributed worldwide this innovative and technically-superior biosample collection device has been engineered to reduce self-collection error, is 100% bacteriostatic, and consistently delivers the highest quality, protected and preserved, saliva samples for testing.
The SDNA-1000 offers single device integration for both DNA and Viral RNA applications. Spectrum’s CV3 patented blue preservation chemistry preserves both DNA and viral RNA samples during transport delivering 100% inactivation of the live virus while suspending and stabilizing RNA transcripts for sensitive and specific analysis.
The SDNA-1000’s intuitive design and minimal steps are a welcomed answer for those offering direct-to-patient diagnostic testing or any team that may have experienced clinical study or project failures due to sample self-collection errors in the past.
The SDNA saliva collection device additionally offers long-term stability and ships with verified, unique barcode serialization for biosample physical and digital chain-of-custody. Additionally, customized packaging, kitting, and fulfillment options are available to solve any special project or testing workflow requirements.
For many, choosing the wrong saliva collection device has introduced and often increased critical failure points. Spectrum’s new and technically-superior saliva collection device is the answer your teams and projects have been waiting for.
The first saliva collection device to be authorized for COVID-19 testing, the SDNA-1000 was shown to be a robust source of viral RNA and proven to deliver a more accurate and sensitive testing sample when compared to traditional swabbing.
Engineered to Lead the Saliva Collection Market in Molecular Diagnostic Applications.
The SDNA whole saliva collection device has been engineered to lead the saliva collection market in molecular diagnostic applications.
With over 20 million collection devices manufactured and distributed worldwide this innovative and technically-superior biosample collection device has been engineered to reduce self-collection error, is 100% bacteriostatic, and consistently delivers the highest quality, protected and preserved, saliva samples for testing.
The SDNA-1000 offers single device integration for both DNA and Viral RNA applications. Spectrum’s CV3 patented blue preservation chemistry preserves both DNA and viral RNA samples during transport delivering 100% inactivation of the live virus while suspending and stabilizing RNA transcripts for sensitive and specific analysis.
The SDNA-1000’s intuitive design and minimal steps are a welcomed answer for those offering direct-to-patient diagnostic testing or any team that may have experienced clinical study or project failures due to sample self-collection errors in the past.
The SDNA saliva collection device additionally offers long-term stability and ships with verified, unique barcode serialization for biosample physical and digital chain-of-custody. Additionally, customized packaging, kitting, and fulfillment options are available to solve any special project or testing workflow requirements.
For many, choosing the wrong saliva collection device has introduced and often increased critical failure points. Spectrum’s new and technically-superior saliva collection device is the answer your teams and projects have been waiting for.
The first saliva collection device to be authorized for COVID-19 testing, the SDNA-1000 was shown to be a robust source of viral RNA and proven to deliver a more accurate and sensitive testing sample when compared to traditional swabbing.
SDNA-1000 is ideal for commercial bioinformatic DNA testing applications, academic, research, biobanking, and as a biosample collection option for viral DNA/RNA COVID-19 testing for hospital networks, health departments, and clinical research organizations. Find additional documentation.
SDNA-2000 is used for medical device collections of high-quality saliva-based DNA samples used for molecular diagnostics.
SDNA-OEM is a private-label biosample collection device approved for DNA testing or molecular diagnostic applications. Product is sold without patented preservation solution but can be filled with any provided reagent solution formula. Customer is responsible for validation.
Product, Process, & Regulatory Documentation
Find the most current and available product, process, and regulatory documentation below. Don’t see what your looking for? Please contact us for access to additional information. Click here for additional study and proof-point information.
Product, Process, & Regulatory Documentation
Find the most current and available product, process, and regulatory documentation below. Don’t see what your looking for? Please contact us for access to additional information. Click here for additional study and proof-point information.
Intuitive Design
on Purpose
on Purpose
User collection error is one of the most common points of failure from saliva self-collection.
So we engineered the solution.
A whole saliva collection device shown to be so intuitive that even without instructions, biosamples are still collected correctly.
WE RECOMMEND: Do not eat, drink, chew gum, or smoke at least 30 minutes before spitting into SDNA-1000 saliva collection tube.
More Sensitive and Accurate COVID-19 Testing Using Saliva
The SDNA-1000 is the first saliva collection device FDA authorized for COVID-19 diagnostic testing and analysis. Studies performed by Rutgers’s University compared swab biosamples to saliva collected using Spectrum’s SDNA-1000 whole saliva collection device in an effort to determine the viability of saliva as a matrix to detect COVID-19 and deliver an entirely new testing solution. Results were found to be 100% equal. Additionally, research performed by Yale University concluded that saliva also yielded greater sensitivity and consistency throughout the course of infection.
The patented Spectrum blue preservation chemistry was a main focus of the FDA approval in the RUDCR groundbreaking study to evaluate its influence on viral RNA preservation. Saliva samples collected and preserved with the Spectrum device proved to not only be a robust source of viral RNA but demonstrated its unique ability of 100% inactivation of the live virus upon contact while suspending and stabilizing transcripts for weeks allowing transport options to processing CLIA testing labs.
More Sensitive and Accurate COVID-19 Testing Using Saliva
The SDNA-1000 is the first saliva collection device FDA authorized for COVID-19 diagnostic testing and analysis. Studies performed by Rutgers’s University compared swab biosamples to saliva collected using Spectrum’s SDNA-1000 whole saliva collection device in an effort to determine the viability of saliva as a matrix to detect COVID-19 and deliver an entirely new testing solution. Results were found to be 100% equal. Additionally, research performed by Yale University concluded that saliva also yielded greater sensitivity and consistency throughout the course of infection.
The patented Spectrum blue preservation chemistry was a main focus of the FDA approval in the RUDCR groundbreaking study to evaluate its influence on viral RNA preservation. Saliva samples collected and preserved with the Spectrum device proved to not only be a robust source of viral RNA but demonstrated its unique ability of 100% inactivation of the live virus upon contact while suspending and stabilizing transcripts for weeks allowing transport options to processing CLIA testing labs.
How-To Product
Video Tour
Video Tour
Huge amounts of innovative engineering developed a saliva collection device so simple and easy to use, it has been rewriting biosample collection protocols across the nation and worldwide. The intuitive design and minimal steps are a welcomed answer for those that have suffered clinical study and project failures due to self-collection errors and the lack of device options prior to Sprecturm’s new SDNA solution.
How-To Product
Video Tour
Video Tour
Huge amounts of innovative engineering developed a saliva collection device so simple and easy to use, it has been rewriting biosample collection protocols across the nation and worldwide. The intuitive design and minimal steps are a welcomed answer for those that have suffered clinical study and project failures due to self-collection errors and the lack of device options prior to Sprecturm’s new SDNA solution.
What does technically superior mean?
What does technically superior mean?
Reducing Self-Collection Errors
Proof-PointEngineered to Reduces Most Common Sources of User Error
Spectrum’s whole saliva collection device addresses the three most common sources of user error, with easy-to-understand instructions and intuitive device design.
[User Study & White Paper coming]
100% Bacteriostatic Preservation Chemistry
Proof-PointThe SDNA Breaks Down Collected Bacteria while Inhibiting New Growth
Spectrum’s whole saliva collection device delivers a cleaner DNA sample and reduces variability, resulting in increased reproducibility, fewer sample failures, and less frequent bacterial misreads.
[Proof point coming]
1 Device Integration for DNA and Viral RNA Applications
Proof-PointMagic CV3 Blue Chemistry First to Deliver Single Device Solution
Over-engineered on purpose to lead the industry and solve DNA genetic testing and molecular diagnostic industry pain-points. Set to debut 2020 Spectrum’s star regulatory team diligently walked each regulatory steps to line every compliant duck in a perfectly straight row for 510k submission. COVID-19 made its entrance and nation leaders asked for innovation under pressure solutions to help. Answering the call in a large way Spectrum introduced the full capability of our technically superior saliva collection device and its patented blue preservation chemistry.
Breakthrough studies and molecular diagnostic game-changing discoveries delivered a [Spectrum] solution no one saw coming.
[White paper under construction] [FDA Approval of EUA Authorization]
100% Inactivation of the Live COVID-19 Virus in Samples
Proof-PointPatented Chemistry Uniquely Kills the Live Virus on contact in Ambient Temperatures
Saliva samples collected with the SDNA-1000 have shown themselves to be a faster, easier, pain-free, and now safer overall solution when testing for encapsulated RNA infectious diseases like COVID-19. Study results preformed by Rutgers were able to demonstrate the ability of Spectrum’s CV3 blue preservation chemistry delivering a 100% inactivation of the live virus on contact while suspending and protecting the viral RNA transcripts for processing. Findings further protect healthcare professionals and clinical staff while allowing lab clinicians the freedom to quickly move with samples hood free.
[White Paper Under Construction]
Saliva is a Better Biosample for Infection Detection
Proof-PointStudies from Rutgers and Yale explain significant finding
Understanding the breakthrough discovery saliva has delivered goes far beyond offering sample collection options when supplies hit critical lows. Or even the ability to eliminate the over excess of PPE waste from patient to patient and saving it for those that critically need it. It offers brand new FDA approvals and authorizations, new mandates, and changes in future protocol. It delivers future opportunities moving forward that protect healthcare teams and first responders, patients, and whole companies with a much more efficient and safer way to approach testing for infectious disease.
Saliva Sample Transport Viability Study
Proof-PointTested in extreme hot and cold simulated 10-day shipping study
FDA Expands current EUA to include the at-home collection of saliva samples for COVID-19 testing. Adding to testing complexity and sample viability the FDA required a significant amount of detailed device-specific information, safety testing, and side by side study comparison work. After successful completion of all the fantastic hoop-jumping, we all know the amazing results granted of the EUA approval, but what are the stats and specifics behind the study and its groundbreaking approval? Stay tuned, we are getting it ready to share.
The SDNA Solution for Self-Collection Errors
Proof-PointSDNA Significantly Reduces Most Common Sources of User Error
Spectrum’s whole saliva collection device addresses the three most common sources of user error, with easy-to-understand instructions and intuitive device design.
[User study and proof point white paper coming soon]100% Bacteriostatic Preservation Chemistry
Proof-PointThe SDNA Breaks Down Collected Bacteria while Inhibiting New Growth
Spectrum’s whole saliva collection device delivers a cleaner DNA sample and reduces variability, resulting in increased reproducibility, fewer sample failures, and less frequent bacterial misreads.
[Proof point white paper coming soon]1 Device for DNA, RNA, & Antibody Detection
Proof-PointSDNA Chemistry Delivers it all in a Single Device
Over-engineered on purpose to solve DNA genetic testing and molecular diagnostic industry pain-points the SDNA-1000 set to debut its innovation the first part of 2020. Diligently taking the regulatory steps to line each and every compliant duck in a perfectly straight row, we turned around to find a world in crisis and nation leaders asking for innovation under pressure solutions to help with the COVID-19 pandemic. Answering the call in a large way Spectrum set out to discover the full capability of our technically superior saliva collection device and the solutions it offered. Together with Rutgers Lab, the SDNA-1000 saliva collection device and its preservation chemistry were tested, retested, and then tested again to confirm the breakthrough findings that were discovered.
[White paper currently under construction. In the meanwhile, FDA EUA summaries highlight much of this information. [FDA Approval of EUA Authorization]SDNA Chemistry Inactivates COVID-19 Virus in Saliva Collection
Proof-PointThis unique breakthrough Delivers Bigger Picture Protection For Everyone
Saliva samples collected with the SDNA-1000 have shown themselves to be a faster, easier, pain-free, and now safer overall solution when testing for infectious diseases like COVID-19. Study results preformed by Rutgers were able to demonstrate the ability of Spectrum’s blue preservation chemistry to inactivated the live virus further protecting healthcare professionals and clinical staff. The solution additionally proved to suspend and protect the encapsulated viral RNA for processing allowing lab clinicians the freedom to quickly move with samples hood free.
[Proof point white paper under construction]Saliva is a Better Biosample for Infection Detection
Proof-PointStudies from Rutgers and Yale explain significant finding
Understanding the breakthrough discovery saliva has delivered goes far beyond offering sample collection options when supplies hit critical lows. Or even the ability to eliminate the over excess of PPE waste from patient to patient and saving it for those that critically need it. It offers brand new FDA approvals and authorizations, new mandates, and changes in future protocol. It delivers future opportunities moving forward that protect healthcare teams and first responders, patients, and whole companies with a much more efficient and safer way to approach testing for infectious disease.
Saliva Sample Transport Viability Study
Proof-PointTested in extreme hot and cold simulated 10-day shipping study
FDA Expands current EUA to include the at-home collection of saliva samples for COVID-19 testing. Adding to testing complexity and sample viability the FDA required a significant amount of detailed device-specific information, safety testing, and side by side study comparison work. After successful completion of all the fantastic hoop-jumping, we all know the amazing results granted of the EUA approval, but what are the stats and specifics behind the study and its groundbreaking approval? Stay tuned, we are getting it ready to share.