FDA Authorized COVID-19 at-Home Tests2020-12-14T15:37:06+00:00

Understanding Your At-Home Saliva COVID-19 Testing Options

How to Order Kits & Testing

Understanding Your At-Home Saliva COVID-19 Testing Options

How to Order Kits & Testing

At-Home Testing for COVID-19 is a 2-Part Solution

(1) Sample Collection + (2) Sample Processing

Spectrum is the manufacturer and supplier of the first FDA EUA authorized saliva collection device used for COVID-19 testing–part 1 (check). Theses partners listed below either use Spectrum’s SDNA-1000 saliva collection kit as part of their end-to-end COVID-19 testing solution or operate as a product distributor selling the SDNA-1000 saliva collection kits in bulk.

Based on your testing need, you can find a complete at-home testing service, order only biosample collection kits, or connect with a lab to process saliva samples for COVID-19 testing. As validations come through new and additional resources will be added to always keep these lists updated.

At-Home Testing for COVID-19 is a 2-Part Solution

(1) Sample Collection + (2) Sample Processing

Spectrum is the manufacturer and supplier of the first FDA EUA authorized saliva collection device used for COVID-19 testing–part 1 (check). The partners below either use Spectrum’s SDNA-1000 saliva collection kit as part of their COVID-19 sample processing solution or operate as a product distributor selling SDNA-1000 saliva collection kits in bulk (no sample processing).

Based on your testing need, you can find a complete at-home testing service, order only biosample collection kits, or connect with a lab to process saliva samples for COVID-19 testing. As validations come through new and additional resources will be added to always keep these lists updated.

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.

Customize my Solution

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

blank
Sterisample by Steribottle

Sterisample

By Steribottle

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

blank
StrategicLabPartners_2c-01

Strategic Lab Partners

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

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.

Documentation, Information & Certifications

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 CHANGE NOTIFICATIONS: August 2020 | February 2021

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.

EUA Documentation

COVID-19 Testing, Process, & FAQ's

Registration of your Spectrum kit is done online with your testing provider and connects the kit’s barcode ID with your individual testing sample.

Spectrum Solutions is the medical device manufacturer of this saliva collection system. We are not the lab processing your diagnostic test and do not have access or visibility into your testing results. The testing lab will deliver results assigned to, and identified by, this 12-digit ID number to the testing provider you purchased testing from. All process and result notifications are controlled by and delivered to you from the testing provider you purchased this kit from. Any test processing or result questions should be directed to this testing provider.

Go To FAQs

How-to SDNA-1000 Product Video

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

How-to SDNA-1000 Product Video

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

Spectrum
in the News

Spectrum
in the News

Asked & Answered: Product, Testing, COVID, & More

Why does the top of the SDNA-1000 collection kit say it isn’t for use in diagnostic procedures/for research use only?2021-07-07T20:03:53+00:00

This is required language by the FDA.

Outside of any “state of emergency”, in normal testing scenarios, there are generally 2 main types of tests done. You have diagnostic testing and then you have everything else. Items in that everything else category includes things like DNA testing for research-based projects to heritage or allergy tests. When you are not attempting to diagnose a health-related issue the FDA considers it more of a consumer-based product and optional, not placing or mandating any specific regulations.

On the flip side, when you are performing a diagnostic test, of any type there are very strict and enforced FDA regulations and compliance requirements to ensure the population’s safety the best it can. In this case, it would mean seeing the text “FDA Approved”. In order for a product to earn this seal of approval, it undergoes a minimum of an 18-month validation process proving its value, benefits, and safety. This category has many different “Classes” or types.

In a state of emergency like we are in, the FDA uses the very specific word “Authorized” in place of “Approved”. This means that the device or product passed an abbreviated version of the “approval” process in order to be quickly integrated into usage for the benefit of the larger good it will provide. At Spectrum, we have one saliva collection device for each of the two testing category types. The SDNA-1000 and the SDNA-2000. The SDNA-2000 is currently in the validation process for FDA Approval. Because of the pandemic, applications for FDA 510k approval are placed behind the FDA’s priority of issuing validated authorizations. This is in part because, in this state of emergency, a device EUA authorization is seen as a temporary equivalent. Spectrum’s device EUA (202432) for the SDNA-1000 can be found on and downloaded from the FDA’s website. 

Why can’t I find where to register my testing kit?2021-07-07T19:56:57+00:00

You will not be able to find a place to register your testing kit on our website because Spectrum is not a lab with the specialized equipment required to process any biological samples for any purpose. Diagnostic testing has three main steps or parts that make up its complete process: Bio-sample collection, test processing, and evaluating/reporting results. Spectrum is the medical device manufacturer of the SpectrumDNA saliva collection system, the first step in this process. A system that was created to collect and preserve the saliva sample, engineered to inactivate the virus inside that sample (if one should be present), and securely deliver that saliva sample to whichever lab the user purchased or received this collection kit from.

You will want to visit the website of the service provider you purchased or received this collection kit from and register your testing kit there.

 

Who should get a rapid (antigen) test?2021-03-26T03:51:10+00:00

While the rapid test can get you results very quickly, the results may not always be accurate. Rapid tests are considered the most accurate in a patient who is having symptoms of COVID-19.

What does a false negative or false positive mean? 
In those who don’t have symptoms, the false-negative rate — meaning my test is negative but I actually have the disease — can be as high as 50%. This can have tremendous consequences as we try to contain the spread of COVID-19.

The false-positive rate — meaning I test positive but I do not really have the disease — is quite low. So, if you test positive from a rapid test it is more likely you do have the disease.

Where do I find my test results?2021-07-07T20:04:35+00:00

Depending on where you purchased your COVID-19 test from, it will be only that company or organization that maintains the portal and process for retrieving your test results.

Spectrum Solutions is the medical device manufacturer and supplier of the saliva collection kit you may have used to collect your bio-sample. We are not a diagnostic laboratory. It is important to understand that any diagnostic test has two distinctive parts. Part one is the biosample collection. Part two is the processing of that collected biosample by an accredited lab. Often these two parts get melded together and in totality called a “test”. Spectrum’s saliva collection system is responsible for part one of this process.

What’s the difference between COVID-19 rapid and PCR tests?2021-07-07T20:01:46+00:00

There are essentially two broad categories of testing, these include:

  1. Antigen test (frequently referred to as a rapid test). This test detects protein fragments specific to the Coronavirus. It can be done in a clinic, doctor’s office, or hospital. Turnaround time for results is usually very quick and in some cases, results can be reported within 15 minutes.
  2. PCR test. PCR testing is considered the “gold standard” in SARS-CoV-2 detection. This test actually detects RNA (or genetic material) that is specific to the virus and can detect the virus within days of infection, even those who have no symptoms. The test can be done in a clinic, hospital, or even in your car. Turnaround time is longer, generally in the 2-3 day range but results can be in as little as 24 hours. When demand is high, results can take a week or longer.
What is the difference between your FDA EUA authorizations?2021-07-07T19:57:30+00:00

There are two approaches that can be taken (and we have done both here in the US) you can get a “test” authorized for COVID-19 testing which breaks down all the different contributing elements like our device, the lab doing the processing, specific assays, extraction chemistries, etc… and there is no deviation from that protocol. Meaning no other lab can copy the protocol without obtaining their own unique authorization using their own proof-points.

Since this is a long and complicated process the other option is obtaining authorization for our individual saliva collection device outside of any specific testing protocol. This provides the widest path of user accessibility offering any and all EUA authorized labs the opportunity to integrate saliva-based COVID-19 testing immediately into their current protocols without a new submission for FDA authorization.

What is RNA and why is it used to test for a coronavirus infection?2021-07-07T20:02:27+00:00

RNA is ribonucleic acid. It’s in all your body’s cells and used to make proteins.

Together, DNA and RNA make up the nucleic acids found in all living cells including within bacteria, archaea, mitochondria, chloroplasts, and viruses. These are essential for all known forms of life. The coronavirus has its own unique RNA. If you get infected with the coronavirus, it injects its RNA into your cells and forces them to make copies of the virus. The new copies burst out of the cell spread the virus to other cells in your body to make more copies.

What is involved in saliva-based COVID-19 testing?2021-08-06T21:23:09+00:00

There are two parts to a saliva-based COVID-19 test. The first is the process of saliva self-collection which is required by EUA authorization to be done with the Spectrum SDNA-1000 collection device. The second is the downstream processing of the saliva sample performed at a EUA authorized lab to detect the presence of infection.

What is COVID-19?2021-08-06T21:17:50+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.).

What does a device EUA Authorization mean for the SDNA-1000?2021-08-06T21:16:54+00:00

On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared on March 24, 2020, that circumstances exist justifying the authorization of emergency use of medical devices during the COVID-19 outbreak, subject to the terms of any authorization issued under Section 564(a) of the Act.

Based on the totality of scientific evidence available to FDA, it was concluded that the SDNA-1000 Saliva Collection Device is effective in diagnosing COVID-19 by serving as an appropriate means to collect, stabilize, and maintain during transport, unprocessed saliva specimens suspected of containing SARS-CoV-2 RNA and that the known and potential benefits of your product when used for such use, outweigh the known and potential risks of your product. It is also believed that there is no adequate, approved, and available alternative to the emergency use of your product. 

  • The SDNA-1000 sample collection device has been authorized only for the collection and maintenance of saliva as an aid in the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
  • The SDNA-1000 sample collection device is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in medical devices during the COVID-19 outbreak under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked.
  • The SDNA-1000 sample collection device has not been FDA cleared or approved, The SDNA-1000 is authorized by FDA under an EUA.
  • Spectrum Solutions was delivered EUA 202432 for its SDNA-1000 Saliva Collection Device
  • This device specific EUA officially means any lab EUA authorized to test samples for COVID-19 using one of the five EUA Authorized commercial RNA extraction chemistries can now integrated saliva as a diagnostic sample option, exclusively using the SDNA-1000, without the need to file for a new EUA specific to saliva.
Unsupervised Sample Self-Collection Granted Authorized by the FDA2021-08-19T17:03:44+00:00

Based on the totality of scientific evidence the FDA authorization has validated the Spectrum SDNA-1000’s effectiveness in diagnosing COVID-19 by serving as a successful, noninvasive means to collect, neutralize, stabilize, and transport testing samples post-collection at ambient temperatures for over 10 days with no degradation in sample efficacy. Additionally, the FDA states there is no adequate, approved or available alternative to the emergency use of this product.

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?2021-07-07T20:05:12+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.

Spectrum Solutions is not a lab and is not processing your saliva test.2021-08-06T21:22:26+00:00

Spectrum Solutions is actually only the medical device manufacturer of the SpectrumDNA saliva collection system. A system that was created to collect and preserve the saliva sample, engineered to inactivate the virus inside that sample (if one should be present), and securely deliver that saliva sample to whichever lab the user purchased or received this collection kit from.

Spectrum is not a lab with the specialized equipment required to process any biological samples for any purpose but is in fact only responsible for the first step (the sample collection) in a multi-step process.

RNA? DNA? What in my saliva tells you I have tested positive for COVID-19?2021-07-07T19:58:26+00:00

Together, DNA and RNA make up the nucleic acids found in all living cells including within bacteria, archaea, mitochondria, chloroplasts, and viruses. These are essential for all known forms of life. The coronavirus has its own unique RNA. If you get infected with the coronavirus, it injects its RNA into your cells and forces them to make copies of the virus. The new copies burst out of the cell spread the virus to other cells in your body to make more copies.

Since the pandemic began, scientists developed tests that look for coronavirus RNA in people’s saliva. This is an alternative to the swab tests that involve sticking cotton swabs deep into people’s noses.

PCR vs. Rapid Antigen Lateral Flow COVID-19 Testing2021-08-19T17:24:56+00:00
  • PCR-vs-Rapid-Kids point of view-LinkedInEarly detection of SARS-CoV-2 infection is critical to reducing the asymptomatic and pre-symptomatic spread of COVID-19.
  • PCR testing is still considered by the FDA and CDC to be the “gold standard”. It is a more sensitive, accurate, and reliable diagnostic test compared to the rapid antigen lateral flow tests (LFT).
  • Rapid antigen LFT tests continue to deliver unacceptably high rates of both false-negative and false-positive test results.
  • Saliva-based PCR testing is able to detect the presence of COVID-19 with 99.98% accuracy days before symptoms appear due to the extraction and amplification process with results in under 24 hours.
  • The patented and highly sensitive chemical formulation found only in the SDNA-1000, 2000, and 3000 saliva collection devices are able to detect infections from saliva samples measuring as low as 200 copies/ml compared to rapid antigen LFT requiring a minimum of 10,000-20,000 copies/ml.
  • In addition, when compared to traditional swab PCR tests SARS-CoV-2 RNA first appears in saliva and then later in nasal-swab samples. A high-sensitivity (limit of detection of ∼10 3 copies/mL) RNA test detected SARS-CoV-2 virus in saliva 1.5 to 4.5 days before the viral load in the paired nasal-swab samples.(1)

 

Is this saliva test for COVID-19 FDA-approved or authorized?2021-08-06T21:23:51+00:00

First, it is important to understand that any diagnostic test has two distinctive parts. Part one is the biosample collection. Part two is the processing, by an accredited lab, of that biosample to render an answer to the diagnostic question presented. Often these two parts get melded together and in totality called a “test”. Spectrum’s saliva collection kit takes care of part one. The individual parts of this process standing on their own are not a “test”.

The FDA makes a distinction between approved and authorized tests and devices. During normal conditions and states of affair, 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 integration and usage for the period of time the emergency situation exists. Because this is an accelerated procedure to fill a specific need it’s deemed a temporary authorization, however still bears the weight of an FDA validated process. This means that the FDA has taken the steps to prove its accuracy, viability, and safety in a shortened amount of time.

There are individual EUA’s for every different and authorized type of COVID-19 test available. Deviation from the individual elements or processes that have been authorized by the FDA is not allowed unless authorized by the FDA. In October, Spectrum’s SDNA-1000 saliva collection system secured individual device FDA authorization (EUA 202432). This authorization provides a path for the immediate integration of saliva-based testing into current and authorized COVID-19 testing protocols without the need to apply for new, or amend existing, FDA testing authorizations. Spectrum’s 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 for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning testing that incorporates saliva collected with the SDNA-1000 may be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA.

Is Spectrum’s SDNA-1000 device “the test”?2021-07-07T20:00:55+00:00

This is often misunderstood by test users. Our device is one element of the testing process. We are not a test by itself.

Spectrum Solutions is the medical device manufacturer of the SpectrumDNA saliva collection system. A system that was created to collect and preserve the saliva sample, engineered to inactivate the virus inside that sample (if one should be present), and securely deliver that saliva sample to whichever lab the user purchased or received this collection kit from.

Is Spectrum Solutions or SpectrumDNA using my saliva sample to collect DNA?2021-08-06T21:19:36+00:00

Spectrum Solutions is actually only the medical device manufacturer of the SpectrumDNA saliva collection system. A system that was created to collect and preserve the saliva sample, engineered to inactivate the virus inside that sample (if one should be present), and securely deliver that saliva sample to whichever lab the user purchased or received this collection kit from.

Spectrum is not a lab with the specialized equipment required to process any biological samples for any purpose but is in fact only responsible for the first step (the sample collection) in a multi-step process. Additionally, before COVID-19, saliva had not been used for any viral testing. Period. This was a new discovery (stemming from a study we initiated in March of 2020) looking for a better testing solution. Pre-COVID, saliva was primarily used by labs (again, Spectrum is not a lab) for testing applications that included DNA. This includes everything from heritage tracing to a cancer diagnosis. The packaging and instructions for the Spectrum collection kit are a reflection of its original focus and purpose and solely explain how to use the product in order to get a viable sample to a lab for processing. In the end, what is extracted from the saliva sample contained inside is determined by the test ordering doctor and performed by a lab with that type of expertise and equipment.

How quickly will I receive my results?2021-08-06T21:20:03+00:00

Spectrum is the medical device manufacturer and supplier of the saliva collection device you may have used to collect your bio-sample. We are not a diagnostic laboratory. Testing results and the time it takes to process testing are determined by the lab doing the processing. You will need to reach out to the company or organization the test was purchased from for this information.

How long is the viral RNA stable in the device?2021-07-07T20:14:36+00:00

Over 10-days of post-collection stability with no degradation of sample efficacy

How do I find a Lab in my area to set-up saliva-based diagnostic test processing using the SDNA-1000?2021-07-07T19:59:58+00:00

Now that our SDNA-1000 saliva collection kit has its own device EUA authorization from the FDA, any lab currently EUA authorized for COVID-19 diagnostic testing can now simply integrate saliva collected with our system and start testing immediately. This removes the previous requirement for the lab to individually validate and submit for its own EUA using saliva as a diagnostic biomaterial. This is a huge win for patients and opens up not only access but testing availability nationwide. This new development additionally helps keep lab test processing costs at an all-time low. Since 99% of the EUA Authorized labs are CLIA Certified labs, the easiest way to find a lab in any location is to use the CDC’s lab search tool. Here is a link to their website tool: https://www.cdc.gov/clia/LabSearch.html#

On this page, you will see the box in the center that says “Search Criteria”. If you don’t know the CLIA number or name to use in your search, right under those boxes it says “Advanced Search – Show”. If you click on this you can enter a city and state to see who is located in whichever area you choose.

How can I order a saliva-based COVID-19 test?2021-08-06T21:17:24+00:00

Spectrum is the medical device manufacturer and supplier of the saliva collection device used to collect the bio-sample for testing. In order to purchase a COVID-19 test, you can contact your doctor or local healthcare organization and ask if they are using saliva. If they aren’t you can also purchase a saliva testing kit from an authorized third-party end-to-end solutions provider. Click here to see a list of options based on your buyer profile.

Does the SDNA Saliva Collection Devices hold a European CE Mark?2021-06-04T21:43:23+00:00

Yes. The SDNA product line has received its CE Mark approval. Click here to read the press release.

The European CE Mark represents a standard of excellence and regulatory validation required to sell medical devices within the European Economic area. The equivalent mark within the United States would be an FDA medical device 510k approval. This mark demonstrates conformity with health, safety, and environmental protection standards for products sold within Europe. 

Do you have information for sample shipment and temperatures requirements?2021-08-06T21:23:39+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)

Do I have to submit for individual EUA to incorporate saliva into my testing protocol?2021-07-07T20:03:03+00:00

According to the FDA, if you are a CLIA lab already EUA authorized to process COVID-19 diagnostic tests using one of these five authorized commercial RNA extraction chemistries (Perkin Elmer, Thermo Fisher, Roche, King Fisher, and Qiagen) you can immediately integrate saliva-based testing into your current protocol. Spectrum’s SDNA-1000 EUA-202432 means your lab does not need to submit for its own individual EUA for saliva-based testing. Validations for the FDA using Spectrum’s SDNA-1000 saliva collection system are only required should your lab wish to receive its own EUA for saliva-based testing incorporating an element not previously authorized or validated by the FDA.

Can the SDNA-1000 be used for test pooling?2021-07-07T19:55:49+00:00

Yes.

If you have questions please reach out to your Spectrum contact or visit our contact us page.

Are you adding new distribution partners?2021-07-07T20:12:34+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?2021-07-07T20:09:53+00:00

Yes.

Now that our SDNA-1000 saliva collection kit has its own device EUA authorization from the FDA, any lab currently EUA authorized for COVID-19 diagnostic testing can now simply integrate saliva collected with our system and start testing immediately. This removes the previous requirement for the lab to individually validate and submit for its own EUA using saliva as a diagnostic biomaterial. This is a huge win for patients and opens up not only access but testing availability nationwide. This new development additionally helps keep lab test processing costs at an all-time low. Since 99% of the EUA Authorized labs are CLIA Certified labs, the easiest way to find a lab in any location is to use the CDC’s lab search tool. Here is a link to their website tool: https://www.cdc.gov/clia/LabSearch.html#

Are there any limitations to who can receive this saliva test for COVID-19?2021-08-06T21:22:35+00:00

No.

Contact Us

Are you a lab?
Let’s connect.

#partofthesolution

How can we help?
Let’s Chat

Looking for a customized testing or life science product solution? Benefit from our experience, industry understanding, and process support.

Go to Top