Engineered to Lead the Saliva Collection Market in Molecular Diagnostic Applications
How you collect saliva makes a big diagnostic difference. To incorporate the use of saliva into COVID-19 diagnostic testing protocols or implement actual real-world mass-testing in scalable scenarios requires an authorized, proven, validated, and supported system that actually mitigates risk of exposure and a device engineered to increase testing accuracy.
A validated and authorized process saves time and money. The SDNA saliva collection system has been engineered to lead the saliva collection market in molecular diagnostic applications. This self-contained saliva collection system provides critical sample consistency while suspending and neutralizing viral RNA transcripts post collection for sensitive and specific analysis completely inactivating the live virus at ambient temperatures.
Spectrum’s CV3 patented blue preservation chemistry is 100% bacteriostatic, preserves both DNA and viral RNA transcripts, and offers over 10 days of post-collection stability with no degradation in sample efficacy. The SDNA saliva collection kit 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.
Choosing the wrong saliva collection device can introduce and increase critical failure points. As the first saliva collection device to be authorized for COVID-19 testing, the SDNA-1000 mitigates any risk of infection throughout the testing process and doesn’t require any special UN3373 designation for USPS, FedEx, or UPS sample shipping.
Engineered to Lead the Saliva Collection Market in Molecular Diagnostic Applications
How you collect saliva makes a big diagnostic difference. To incorporate the use of saliva into COVID-19 diagnostic testing protocols or implement actual real-world mass-testing in scalable scenarios requires an authorized, proven, validated, and supported system that actually mitigates risk of exposure and a device engineered to increase testing accuracy.
A validated and authorized process saves time and money. The SDNA saliva collection system has been engineered to lead the saliva collection market in molecular diagnostic applications. This self-contained saliva collection system provides critical sample consistency while suspending and neutralizing viral RNA transcripts post collection for sensitive and specific analysis completely inactivating the live virus at ambient temperatures.
Spectrum’s CV3 patented blue preservation chemistry is 100% bacteriostatic, preserves both DNA and viral RNA transcripts, and offers over 10 days of post-collection stability with no degradation in sample efficacy. The SDNA saliva collection kit 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.
Choosing the wrong saliva collection device can introduce and increase critical failure points. As the first saliva collection device to be authorized for COVID-19 testing, the SDNA-1000 mitigates any risk of infection throughout the testing process and doesn’t require any special UN3373 designation for USPS, FedEx, or UPS sample shipping.
SDNA-1000 Saliva Collection Kit for research only molecular diagnostic commercial DNA and viral RNA testing applications.
Under the current COVID-19 state of emergency, the FDA has granted special authorization (EUA202432) and device use for COVID-19 testing beyond research only applications to additionally include clinical diagnostics. This first-of-its-kind device authorization not only validates the technically-superior device capabilities but effectively paves the way for easy device integration and the addition of saliva-based testing into existing EUA authorized clinical diagnostic testing protocols. When using FDA validated device data no additional EUA submission is required [request right of reference letter].
Device application include:
- Clinical and academic research projects
- COVID-19 saliva-based diagnostic testing
- Personalized skincare, health & wellness
- Biobanking
- Direct-to-consumer biosample collection
SDNA-2000 reserved for DNA/viral RNA molecular diagnostic testing applications requiring a saliva collection system qualified as a class II medical device holding FDA 510k approval.
[510k application currently under FDA review. Product availability information coming soon.]
Product, Process, and Documentation
Find the most current and available product, process, and regulatory documentation below. Don’t see what you’re looking for? Just reach out below.
Product, Process, & Documentation
Find the most current and available product, process, and regulatory documentation below. Don’t see what you’re looking for? Just reach out below.
Intuitive Design 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.
Painless, More Accurate, Safer COVID-19 Testing
First saliva collection device FDA authorized (EUA202432) for COVID-19 diagnostic testing and analysis. The pioneering innovation of the SDNA-1000, and its growing list of benefits, are not only leading the way to a new era of at-home biosample self-collection for the diagnosis of viral infections but additionally deliver the most accurate testing results.
- 100% Inactivation of the live virus within the device at ambient temps
- Safest & most robust biomaterial for detecting COVID-19
- Over 10 days of post-collection stability no degradation of sample efficacy
- Painless collection system maintains biosample consistency
- Mitigates any risk of infection throughout the testing process
- Shipping clearance for collection system from USPS, FedEx, and UPS eliminating required UN3373 sample designation & additional costs
- Pinpoint life-cycle stage of active viral infection
- Delivers highest levels of testing accuracy using qualified extraction chemistries
- Qualified commercial RNA extraction chemistries include Perkin Elmer, Thermo Fisher, Roche, Qiagen, and more
Painless, More Accurate, Safer COVID-19 Testing
First saliva collection device FDA authorized for COVID-19 diagnostic testing and analysis. The pioneering innovation of the SDNA-1000, and its growing list of benefits, are not only leading the way to a new era of at-home biosample self-collection for the diagnosis of viral infections but additionally delivers the most accurate testing results.
- 100% Inactivation of the live virus within the device at ambient temps
- Safest & most robust biomaterial for detecting COVID-19
- Over 10 days of post-collection stability no degradation of sample efficacy
- Painless collection system maintains biosample consistency
- Mitigates any risk of infection throughout the testing process
- Shipping clearance for collection system from USPS, FedEx, and UPS eliminating required UN3373 sample designation & additional costs
- Pinpoint life-cycle stage of active viral infection
- Delivers highest levels of testing accuracy using qualified extraction chemistries
- Qualified commercial RNA extraction chemistries include Perkin Elmer, Thermo Fisher, Roche, Qiagen, and more
How-To Product 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
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?
Solution for Self-Collection Errors
Proof-PointSignificantly Reduce 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 coming soon]
100% Bacteriostatic Chemistry
Proof-PointSDNA 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.
[White paper coming soon]
Is it COVID-19? The Flu? H1N1? or...
Proof-PointAt-Home Saliva Collection Offers Easy Answers
Over-engineered on purpose to solve genetic testing and molecular diagnostic industry pain-points, the SDNA-1000 is leading the way to a new era of at-home biosample self-collection for the diagnosis of different viral infections.
[White paper coming soon]
Device Inactivates COVID-19 Virus
Proof-PointSafer, Pain-free, & more Accurate
The inactivation of the virus in the SDNA-1000 saliva collection device creates the most robust and safest biomaterial collection approach for the detection of COVID-19 infections and leads the way to a new era of at-home biosample self-collection for the diagnosis of viral infections.
Saliva is a Better Biosample for Detecting Infection
Proof-PointStudies Echo Rutgers Significant Saliva Findings
Understanding the breakthrough discovery saliva has delivered goes far beyond expanding COVID-19 testing options. It offers the safest & most robust biomaterial for detecting viral infections and mitigates any risk of infection throughout the entire testing process.
Saliva Sample Viability Transport Study
Proof-PointTested in extreme hot and cold temperatures
FDA Expands current EUA to include the at-home collection of saliva samples for COVID-19 testing. Direct-to-patient at-home collection adds testing complexity and risks sample consistency, sample viability, and sample stability. See the stats and specifics behind the FDA EUA authorization.
Solution for Self-Collection Errors
Proof-PointSignificantly Reduce 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 coming soon]
100% Bacteriostatic Chemistry
Proof-PointSDNA 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.
[White paper coming soon]
Is it COVID-19? The Flu? H1N1? or...
Proof-PointAt-Home Saliva Collection Offers Easy Answers
Over-engineered on purpose to solve genetic testing and molecular diagnostic industry pain-points, the SDNA-1000 is leading the way to a new era of at-home biosample self-collection for the diagnosis of different viral infections.
[White paper coming soon]
Device Inactivates COVID-19 Virus
Proof-PointSafer, Pain-free, & more Accurate
The inactivation of the virus in the SDNA-1000 saliva collection device creates the most robust and safest biomaterial collection approach for the detection of COVID-19 infections and leads the way to a new era of at-home biosample self-collection for the diagnosis of viral infections.
Saliva is a Better Biosample for Detecting Infection
Proof-PointStudies Echo Rutgers Significant Saliva Findings
Understanding the breakthrough discovery saliva has delivered goes far beyond expanding COVID-19 testing options. It offers the safest & most robust biomaterial for detecting viral infections and mitigates any risk of infection throughout the entire testing process.
Saliva Sample Viability Transport Study
Proof-PointTested in extreme hot and cold temperatures
FDA Expands current EUA to include the at-home collection of saliva samples for COVID-19 testing. Direct-to-patient at-home collection adds testing complexity and risks sample consistency, sample viability, and sample stability. See the stats and specifics behind the FDA EUA authorization.