NEW DEVICE FDA AUTHORIZATION For UNSUPERVISED Bio-Sample Collection

Benefits of Saliva-Based PCR Testing Using the SDNA-1000

It’s the early & accurate detection of COVID-19 infections – Critical to reducing the asymptomatic and pre-Symptomatic spread

Testing using Spectrum’s saliva collection devices is:

  1. Able to accurately detect the presence of COVID-19 days before symptoms appear (benefit of the extraction and amplification process using our patented preservation chemistryr
  2. Highly sensitive RNA testing (limit of detection of ∼10 3 copies/mL) detects the SARS-CoV-2 virus in saliva 1.5 to 4.5 days before the viral load in the paired nasal-swab sample(1)
  3. Our highly sensitive formulation detects an infection from saliva samples measuring as low as 200 copies/ml (compared to rapid antigen lateral flow tests requiring a minimum of 10,000-20,000 copies/ml – get the facts) neat or raw saliva virtually eliminates this early detection window from skipping the extraction and amplification process having fewer detectable copies.

Benefits of Saliva-Based PCR Testing Using the SDNA-1000

It’s the early & accurate detection of COVID-19 infections – Critical to reducing the asymptomatic and pre-Symptomatic spread

Testing using Spectrum’s saliva collection devices is:

  1. Able to accurately detect the presence of COVID-19 days before symptoms appear (benefit of the extraction and amplification process using our patented preservation chemistryr
  2. Highly sensitive RNA testing (limit of detection of ∼10 3 copies/mL) detects the SARS-CoV-2 virus in saliva 1.5 to 4.5 days before the viral load in the paired nasal-swab sample(1)
  3. Our highly sensitive formulation detects an infection from saliva samples measuring as low as 200 copies/ml (compared to rapid antigen lateral flow tests requiring a minimum of 10,000-20,000 copies/ml – get the facts) neat or raw saliva virtually eliminates this early detection window from skipping the extraction and amplification process having fewer detectable copies.

Identify Your Purchase Profile

Major League Baseball Testing solution testimonialAre you an individual looking for a single at-home testing option? Possibly an organization looking to create, deploy, or manage a recurring and scalable mass-testing scenario?

Are you looking for more information on our K-12 return to the classroom program or just don’t see an option that fits your testing plan? Not a problem, let’s customize a solution with our partners that works perfectly for your team.

Together, frankly, anything is possible. But, you don’t have to take our word for it just ask Major League Baseball.

Home & Employee Testing Services

AnyPlace MD Logo

AnyPlace MD Full Service At-Home Testing

Tel. 877-474-1318
Fax. 512-430-5832
Email: getbacktowork@ap-md.com
2001 Windy Terrace
Cedar Park, Texas  78613
AnyPlace MD offers full-service COVID-19 testing & care solutions, including bulk tests for purchase and free symptom monitoring.

DxTerity Logo

DxTerity Diagnostics Clinical Laboratory

Phone: 310.537.7857
Fax: 310.356.3154 19500
South Rancho Way, Suite 116
Rancho Dominguez, CA 90220
FDA EUA authorized for COVID-19 saliva testing using the SDNA-1000
E7 Health Logo

E7 Health

Chicago: 312-997-5522
Las Vegas: 702-800-2723

e7 Health now offers an FDA EUA Authorized at-home / at-work saliva test kit that checks for active COVID-19 infection. If you are currently experiencing any signs and/or symptoms of COVID-19 or have been recently exposed to someone with COVID-19, you may want to take this test.

The test is performed through a simple saliva sample that you can collect in the safety of your own home and ship to the lab. Results are usually received within 2-3 business days once the lab receives your specimen.

Corporations, schools, and other organizations may order the saliva tests to keep on-hand in the workplace to easily provide testing as needed. Quick and easy COVID-19 saliva testing helps to minimize the delay for your team to get tested and receive results.

Purlab logo

purlab.

info@purlab.com
(212) 537-9380

1178 Broadway, 3rd Floor, #1403
New York, NY 10001

At-Home COVID-19 Testing for your company. Supporting the safety of our schools, businesses & institutions, introducing COVID-19 testing for employers. Employers will have access to a secure portal allowing them to check the status of tests as well as real-time data of positive and negative results.

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

DxTerity Logo

DxTerity Diagnostics Clinical Laboratory

Phone: 310.537.7857
Fax: 310.356.3154

19500 South Rancho Way Suite 116
Rancho Dominguez, CA 90220

FDA EUA authorized for COVID-19 saliva testing using the SDNA-1000

IBX-Infinity Biologix Clinical Laboratory

Infinity BiologiX Laboratory – IBX (formerly RUCDR Infinite Biologics)

Rutgers University Campus–New Brunswick

145 Bevier Rd, Piscataway, NJ 08854
Phone: (732) 445-1498

FDA EUA200090 authorized for COVID-19 saliva testing using the SDNA-1000

 Predictive Laboratories

Predictive Laboratories

2749 E Parleys Way #100
Salt Lake City, UT 84109
Phone: 855-497-3636

Authorized for COVID-19 saliva testing using the SDNA-1000 EUA202432

 ProPhaseDiagnostics-Logo

ProPhase Labs/ProPhase Diagnostics

42 Throckmorton Ln
Old Bridge, NJ 08857
Phone: 732-705-6400
Fax: 732-753-9998

> Sales@ProPhaseDX.com

Authorized for COVID-19 saliva testing using the SDNA-1000 EUA202432

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
RXBio Logo

RxBio

Canada HQ
74-556 Edward Ave
Richmond Hill, Ontario
L4C 9Y5
Phone: +1-905-883-4333

Ireland HQ
Northwest Business Park, Unit 506 B
Ballycoolin, Dublin 15
Ireland, D15 KP21
Phone: +353 (1) 963-1100

Sterisample by Steribottle

Sterisample

By Steribottle

London HQ
Kemp House
152-160 City Road
London, EC1V 2NX

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

Spectrum Solutions is the medical device manufacturer of this/the first FDA authorized saliva collection system. In addition, the first device also FDA authorized for unsupervised at-home sample self-collection. We partner with the above CLIA certified laboratories and testing service providers to create and customize our supported and validated COVID-19 testing programs. We are pioneering saliva-based diagnostic technology for viral infections, autoimmune disorders, cancer, and more. We are not a COVID testing laboratory and will not have access to any individual user testing information or test results.

#SpitMatters

Contact us with any questions or if you feel you should be added to this list.

Understanding the Testing Process, Test Results, & FAQ’s

Spectrum Solutions is the medical device manufacturer of the saliva collection system. We partner with the above CLIA certified laboratories and testing service providers to create and customize COVID-19 testing programs using our saliva collection devices. We are pioneering saliva-based diagnostic technology for viral infections, autoimmune disorders, cancer, and more.

We are not a COVID testing laboratory and will not have access to any individual user testing information or test results. Please reach out to the testing service provider or healthcare organization you purchased this test from. Any test processing or result questions should be directed to this testing provider.

#partoftheSolution

Understanding the Testing Process, Test Results, & FAQ’s

Spectrum Solutions is the medical device manufacturer of the saliva collection system. We partner with the above CLIA certified laboratories and testing service providers to create and customize COVID-19 testing programs using our saliva collection devices. We are pioneering saliva-based diagnostic technology for viral infections, autoimmune disorders, cancer, and more.

We are not a COVID testing laboratory and will not have access to any individual user testing information or test results. Please reach out to the testing service provider or healthcare organization you purchased this test from. Any test processing or result questions should be directed to this testing provider.

#partoftheSolution

Spectrum Secures Device EUA for COVID-19 Testing

Marking the first device-specific EUA for Spectrum, new FDA authorization expands access and availability for saliva-based COVID-19 testing options. Validation of Spectrum’s SDNA-1000 provides authorized COVID-19 testing labs an easy integration path with no additional saliva-testing FDA requirements. Unique device factors in this consideration were the SDNA-1000’s exclusive ability to inactivate the live virus after the pain-free self-collection of saliva samples while preserving and stabilizing viral RNA transcripts over 10 days with no degradation of sample efficacy.

Bye, Bye, Swab

Saliva-based diagnostics changes everything.

Engineered to eliminate sample self-collection errors, Spectrum’s spit test is non-invasive, ideal for those needing repeat testing, and mitigates any risk of infection throughout the testing process. Say hello to the new gold standard.

SDNA-1000 Video
Product Instructions

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

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