FDA Authorized COVID-19 Updates2020-08-12T21:22:47+00:00

First Saliva Collection Device FDA Authorized for COVID-19 Testing

Product Distribution List
Product Documentation

First Saliva Collection Device FDA Authorized for COVID-19 Testing

Product Distribution List
Product Documentation

3 ways to purchase SDNA-1000 saliva collection kits

Select the purchase profile below that best fits your needs. 

Spectrum is the manufacturer and supplier of the first FDA EUA authorized saliva collection kit used for COVID-19 testing. The partners below either use the SDNA-1000 saliva collection kit as part of their COVID-19 test offering or operate as a product distributor selling our SDNA-1000 saliva collection kit in larger volumes to individuals, organizations, and corporations looking to incorporate saliva collection into their testing solutions.

As validations come through new resources will be added to these lists.

There are 3 ways to purchase SDNA-1000 saliva collection kits.

Select the purchase profile below that best fits your needs. 

Spectrum is the manufacturer and supplier of the first FDA EUA authorized saliva collection kit used for COVID-19 testing. The partners below either use the SDNA-1000 saliva collection kit as part of their COVID-19 test offering or operate as a product distributor selling our SDNA-1000 saliva collection kit in larger volumes to individuals, organizations, and corporations looking to incorporate saliva collection into their testing solutions.

As validations come through new resources will be added to these lists.

COVID-19 At-Home Testing Services

Vault Health Logo

Vault Health

Vault Health streamlines the process for prescribing, supervising, and reporting results for the test:
  • Complete an online form with personal information and questions about exposure to SARS-CoV-2 and COVID-19 symptoms (must be at least 18 years old)
  • Receive test kit via UPS overnight shipping
  • Open-box and follow instructions for a Zoom video conference for supervised saliva collection with a Vault healthcare provider
  • The Vault medical professional walks through the process on how to provide the saliva sample and provides instructions on how to return the kit to the lab for testing
  • Ship back to lab in the provided pre-addressed UPS overnight clinical sample pouch
  • Upon receipt at RUCDR’s New Jersey facility, the sample will be processed and lab results will be available within 48-72 hours
Authorized COVID-19 saliva testing service partner under EUA200090 through RUCDR Infinite Biologics Laboratory
VG-vitagene-logo_vert

Vitagene

Visit the Vitagene website and complete a questionnaire to assess your risk of infection. Based on conditions set by the CDC, our system may qualify you for at-home testing. This is not a telemedicine experience. Strictly a self-collection.
  • “Questionnaire’ is immediately read by a registered physician.
  • If determined that the individual is a candidate for an at-home self-collected COVID-19 test the website opens access to the order kit page.
  • The Individual then places an order for a kit and it is then shipped directly to their location.
  • The individual follows the provided instructions on how to self-collect their saliva sample and how to ship back to the lab for processing.
  • Expected testing results in 3 days
Authorized COVID-19 saliva testing service partner under EUA200090 through RUCDR Infinite Biologics Laboratory

Labs Processing Saliva for COVID-19

RUCDR Infinite Biologics Logo

RUCDR Infinite Biologics Laboratory

Rutgers–New Brunswick
145 Bevier Rd, Piscataway, NJ 08854
Phone: (732) 445-1498
FDA EUA200090 authorized for COVID-19 saliva testing using the SDNA-1000

SoftCell Laboratories

Shipping Address: 4616 Beehive Drive, Unit 4, St. George, Utah 84790
> Website: SoftCellLabs.com
SMRTL-Salt Lake City Utah

Sports Medicine Research Testing Laboratory

(SMRTL is located in the Bryan S. Finkle building in South Jordan, Utah)
10644 South Jordan Gateway
South Jordan, UT 84095
> Phone: 801-994-9454

SDNA-1000 Kit Distribution Partners

REMOTE HEALTH- logo-03

Remote Health Solutions

15721 Wc Main Street, Midlothian, Virginia 23113, United States
Phone: (804) 893-0890
StrategicLabPartners_2c-01

Strategic Lab Partners

40 Burton Hills Blvd Suite 350, Nashville, TN 37215
Phone: (800) 985-3422
Thermo Fisher Scientific

Thermo Fisher Scientific

> Phone: +1-800-766-7000

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.

FDA expands EUA to include at-home saliva self-collection

The FDA has expanded the existing EUA200090 to now include the first authorization for at-home self-collection of saliva samples for COVID-19 testing exclusively using the SDNA-1000 saliva collection device. Decision by the FDA to expand authorization to include at-home saliva collection was to deliver greater testing access based on the SDNA-1000’s unique ability to inactivate the live virus after the pain-free self-collection of saliva samples while preserving and stabilizing viral RNA transcripts for testing during transport for over two weeks.

Go To FAQs

FDA expands EUA to include at-home saliva self-collection

The FDA has expanded the existing EUA200090 to now include the first authorization for at-home self-collection of saliva samples for COVID-19 testing exclusively using the SDNA-1000 saliva collection device. Decision by the FDA to expand authorization to include at-home saliva collection was to deliver greater testing access based on the SDNA-1000’s unique ability to inactivate the live virus after the pain-free self-collection of saliva samples while preserving and stabilizing viral RNA transcripts for testing during transport for over two weeks.

Go To FAQs

FDA Requirements & Updates

EUA200090 states, “Saliva specimens must be collected, transported, and stored using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.”

The foundation of the RUDCR study was to evaluate the Spectrum patented preservation chemistry to understand its ability in maintaining and stabilizing the RNA transcripts in saliva for sensitive and specific qPCR analysis. The side-by-side study compared results from the saliva matrix to those from the standard swab. The groundbreaking 100% equal results quickly delivered EUA authorization offering an entirely better COVID-19 testing solution. 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 infection.

(1) EUA Summary
(2) EUA Summary

Why was the SDNA-1000 the first EUA authorized device for saliva collection?

Intuitively engineered and purpose-built to significantly reduce user collection errors the SDNA-1000 demonstrated first hand its tremendous value as the pinch of PPE shortages is felt and exposure risks grow.

The RUDCR study showcased the unique viral RNA advantages of the patented Spectrum blue preservation chemistry in addition to its understood superior DNA preservation capabilities. Visual confirmation is delivered immediately upon securing the cap in place that the device is doing its intended job inactivating the live virus and delivering the quality samples needed for accurate testing results.

Why was the SDNA-1000 the first authorized device for saliva collection?

Intuitively engineered and purpose-built to significantly reduce user collection errors the SDNA-1000 demonstrated first hand its tremendous value as the pinch of PPE shortages is felt and exposure risks grow.

The RUDCR study showcased the unique viral RNA advantages of the patented Spectrum blue preservation chemistry in addition to its understood superior DNA preservation capabilities. Visual confirmation is delivered immediately upon securing the cap in place that the device is doing its intended job inactivating the live virus and delivering the quality samples needed for accurate testing results.

Technically Superior Saliva Collection Device

What makes the SDNA-1000 unique:

  • Engineered to reduce at-home user and self-collection errors
  • Preservation chemistry is 100% bacteriostatic extending sample shelf-life
  • Consistently delivers higher quality and quantities of DNA for medical, genetic, and molecular diagnostic testing
  • Protects and suspends viral RNA transcripts for sensitive and specific analysis
  • Chemistry inactivates the live virus helping to shield healthcare professionals and clinicians from exposure
  • First authorized saliva collection device for COVID-19 testing and first device authorized for at-home self-collection
  • Proven to stabilize & protect COVID-19 viral RNA during specimen transport in all extreme temperatures for 14 days

How-to SDNA-1000
Product Video

Remember: Do NOT eat, drink, smoke, or chew gum for 30-minutes before collecting your saliva sample.

SDNA-1000 How-to
Product Video

Remember: Do NOT eat, drink, smoke, or chew gum for 30-minutes before collecting your saliva sample.

Spectrum FAQs-blk

Biosample Collection FAQ's

Do you have information for sample shipment and temperatures requirements?2020-08-01T04:03:43+00:00

There are no temperature requirements for shipping.

The following results demonstrate that SARS-CoV-2 RNA saliva specimens are stable in the SDNA-1000 Saliva Collection Device when exposed to a broad range of temperature conditions. These data support the use of the SDNA-1000 Saliva Collection Device for transport and storage of specimens following home collection of saliva.

To support home use of the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device, a Simulated Shipping Study was performed that was designed to evaluate the effect of temperature variation on the stability of SARS-CoV-2 RNA during transport of saliva specimens. The study was conducted using residual clinical specimens that had previously been reported as SARS-CoV-2 positive or negative using the Rutgers TaqPath SARS-CoV-2 Assay, and which were stored at -80°C until the start of the study. The SARS-CoV-2 positive specimens were selected based on the Ct values obtained upon initial testing and covered the spectrum of Ct values observed with the assay.

To perform the study, the specimens were thawed and then subjected to the thermal profiles outlined in Tables 10 and 11 which were intended to simulate the extreme temperature conditions that may be experienced in the shipment of specimens during the summer and winter, respectively. At the conclusion of each thermal profile, the samples were retested with the Rutgers TaqPath SARS-CoV-2 Assay, and the results obtained were compared to those reported upon initial testing at the time the specimens were received. A summary of the mean Ct values observed for each SARS-CoV-2 specific target gene is provided in Table 12. The Ct values for each individual sample are presented graphically in Figure 1. (See EUA summary)

What is COVID-19?2020-08-01T04:04:24+00:00

COVID-19 is caused by the SARS-CoV-2 virus. The virus, which can cause mild to severe respiratory illness, was first identified in Wuhan, China, and has now spread globally, including the United States. There is limited information available to characterize the spectrum of clinical illness associated with COVID-19 but it likely spreads to others when a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.).

Is this saliva test for COVID-19 FDA-approved or authorized?2020-08-13T01:12:30+00:00

The FDA makes a distinction between approved and authorized tests and devices. During normal conditions and states of affairs, applications for approval on tests and devices are submitted to the FDA for approval. This is a lengthy process that requires many levels of validation, verification, and test trials for both the device manufacturer and/or test provider. This process in general spans anywhere from 18 months to many years. In situations like this COVID-19 pandemic, exceptions are made in the form of “authorizations” the FDA calls them Emergency Use Authorizations (EUAs). The intent of these authorizations is to place new innovative solutions that answer a specific need at the front of the validation line to fast-tracking their approval of use for the period of time deemed the emergency situation exists. Because this is an accelerated process to fill a specific need it is a temporary approval. It means that the FDA has taken the steps to prove its accuracy, viability, and safety in the short amount of time it had to do so. For formal FDA approval, the traditional process is required to provide the time and testing required to determine long-term viability.

Understanding the difference, using saliva to test for viral infection was not something previously tried therefore not an FDA approved testing option. Swabs had been the traditional approved standard. As testing exponentially accelerated supplies became limited and it became clear additional options needed to be discovered. A groundbreaking study done by Rutgers University determined saliva to be 100% equal to swabs for COVID-19 detection and in many cases, it proved to be a better, more sensitive option. This was further validated by an additional study done by Yale University researchers. This delivered EUA approval for Rutger to use saliva for COVID-19 testing based on the very specific and documents protocols they used. This authorization names the SDNA-1000 saliva collection device, manufactured and supplied by Spectrum Solutions, the only sample collection device approved for use. EUA approvals are specific and limited to the processes and procedures outlined in the application for approval. Any deviation from the procedures, devices, or protocols requires additional approval from the FDA.

The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).

What is an EUA?2020-08-01T04:01:31+00:00

The United States (U.S.) FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.

An IVD made available under a EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue a EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in the detection of the virus that causes COVID-19.

The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs unless terminated or revoked (after which the test may no longer be used).

How long is the viral RNA stable in the device?2020-08-01T03:42:16+00:00

Data supports over 14 days

Are there any limitations to who can receive this saliva test for COVID-19?2020-08-01T03:54:45+00:00

No.

How can you order a test?2020-08-01T03:52:48+00:00

This depends on your purchase profile. Click here to see the options.

To obtain the saliva test for COVID-19 can you go through a private company or do you have to utilize your health insurance and physician?2020-08-01T03:52:18+00:00

The only requirement listed by the FDA is that the test is ordered or prescribed by a physician as they see fit. Telehealth facilitates this process easily from those quarantined or unable to leave home.

Are you adding new distribution partners?2020-08-01T03:48:04+00:00

Yes, we are adding new distribution partners and listing them on the website as they become available. We will also send out email notifications to our contact lists when new distributors are added.

Are you adding new COVID-19 authorized saliva testing labs?2020-08-13T01:02:35+00:00

Yes. As labs submit for EUA saliva testing authorization and receive it we are adding them to the contact list on the website. In an effort to maintain our own compliance we are not listing lab unless they have received a EUA number. Labs may be processing COVID-19 saliva tests while they are awaiting FDA EUA authorization after submitting for it, however, without being assigned an authorization number they will not yet be listed on our website. Please contact us if you would like more information on labs that fall into this category. 

Press Releases & News

When you deliver answers, innovative solutions, and worldwide impact during the COVID-19 pandemic everyone takes notice. We couldn’t be more passionate or grateful for the incredible story being told by these recent headlines, partnerships, and press releases.

Press Releases & News

When you deliver answers, innovative solutions, and worldwide impact during the COVID-19 pandemic everyone takes notice. We couldn’t be more passionate or grateful for the incredible story being told by these recent headlines, partnerships, and press releases.

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Are you a lab? Let’s connect.

Spectrum is currently working to get SDNA-1000 saliva collection kits into the hands of private processing, university, state, and hospital labs that are working to validate the established saliva-based COVID-19 testing protocols for FDA EUA saliva testing authorization. Please contact us directly if your use case includes this goal.

#partofthesolution

Contact Us

Are you a lab? Let’s connect.

Spectrum is currently working to get SDNA-1000 saliva collection kits into the hands of private processing, university, state, and hospital labs that are working to validate the established saliva-based COVID-19 testing protocols for FDA EUA saliva testing authorization. Please contact us directly if your use case includes this goal.

#partofthesolution

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