FDA Authorized COVID-19 at-Home Tests2020-06-24T23:32:11+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, so we have the saliva collection part mastered. 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 end-to-end at-home testing solution, order only sample collection kits, or connect with a lab authorized 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, so we have the saliva collection part mastered. 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 end-to-end at-home testing solution, order only sample collection kits, or connect with a lab authorized 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.

Authorized Direct-to-Patient at-Home Tests

Vault Health Logo

Order Direct-to-Patient Testing Here

Testing Product FAQ’s

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

VG-vitagene-logo_vert

Order Direct-to-Patient COVID-19 Test Here

Additional Saliva COVID-19 Testing Options

Testing Product FAQ’s (halfway down page)

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

Labs FDA Authorized for Saliva Testing

RUCDR Infinite Biologics Logo
Rutgers–New Brunswick
145 Bevier Rd, Piscataway, NJ 08854
Phone: (732) 445-1498
FDA EUA has been approved for COVID-19 saliva testing using the SDNA-1000

SoftCell Laboratories
Shipping Address:
4616 Beehive Drive, Unit 4, St. George, Utah 84790

Phone: (435) 628-2215
Fax: (435) 359-5184
Email: support@softcelllabs.com
Website: SoftCellLabs.com

Authorized lab partner offering COVID-19 saliva testing using the SDNA-1000

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

Lab Contact Form
Company Website

FDA EUA has been submitted for COVID-19 saliva testing using the SDNA-1000

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

ORDER NOW: SDNA-1000 Product Order Page

StrategicLabPartners_2c-01
40 Burton Hills Blvd Suite 350, Nashville, TN 37215

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 approval to include at-home saliva self-collection

The FDA has expanded the existing EUA200090 to now include the first approval authorization for at-home self-collection of saliva samples for COVID-19 testing using only the SDNA-1000 saliva collection device. Exclusive to the SDNA-1000 is its ability to inactivate the live virus in collected saliva samples preserving and stabilizing viral RNA transcripts for testing during transport under extreme weather conditions for 14 days. Expansion of the FDA’s authorization is a groundbreaking decision to approve COVID-19 testing using at-home saliva collection based on these unique abilities as well as the SDNA-1000’s ability to reduce sample collection errors.

Go To FAQs

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

The FDA has expanded the existing EUA200090 to now include the first approval authorization for at-home self-collection of saliva samples for COVID-19 testing using only the SDNA-1000 saliva collection device. Exclusive to the SDNA-1000 is its ability to inactivate the live virus in collected saliva samples preserving and stabilizing viral RNA transcripts for testing during transport under extreme weather conditions for 14 days. Expansion of the FDA’s authorization is a groundbreaking decision to approve COVID-19 testing using at-home saliva collection based on these unique abilities as well as the SDNA-1000’s ability to reduce sample collection errors.

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 with added downstream safety benefits including the inactivation of the live virus.

(1) EUA Summary
(2) EUA Summary

How-to SDNA-1000 Product Video

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

Watch the
SDNA-1000 How-to Product Video

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

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COVID-19 Testing FAQ's

Why was my sample tested?2020-05-09T16:12:07+00:00

You were tested because your healthcare provider believes you may have been exposed to the virus that causes COVID-19 based on your signs and symptoms (e.g., fever, cough, difficulty breathing), and/or because:

  • You live in or have recently traveled to a place where transmission of COVID-19 is known to occur, and/or
  • You have been in close contact with an individual suspected of or confirmed to have COVID-19.

Testing of the samples will help find out if you may have COVID-19.

Where is this at-home self-collection saliva-based test available?2020-05-09T18:34:49+00:00

Vitagene At-home testing using saliva collection is available in all states within the United States. This test is not available for individuals residing outside the United States.

Vault Health at-home testing using saliva collection is available in the following states: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington DC, Washington, West Virginia, Wisconsin, Wyoming. Currently not available in Alaska.

Where can I go for more information?2020-05-09T18:37:03+00:00

 CDC webpages:

General: https://www.cdc.gov/COVID19

Healthcare Professionals:

https://www.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html

Information for Laboratories: https://www.cdc.gov/coronavirus/2019-nCoV/guidance-laboratories.html

Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html

 

Isolation Precautions in Healthcare Settings:

https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html

Specimen Collection: https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical-specimens.html

Infection Control: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/index.html

 

FDA webpages:

General: www.fda.gov/novelcoronavirus

EUAs:(includes links to a patient fact sheet and manufacturer’s instructions) https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

 

Rutgers Clinical Genomics Laboratory:

RUCDR Infinite Biologics – Rutgers University

Nelson Biology Labs

604 Allison Road

Piscataway, NJ 08854

 

Customer Support:

+1 732-445-1498

commstaff@dls.rutgers.edu

 

Technical Support:

+1 848-445-7081

rucdr-cgl@dls.rutgers.edu

What is the Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay?2020-05-09T16:09:00+00:00

The test is designed to detect the virus that causes COVID-19 in respiratory specimens, for example nasal, oral swabs, or salvia. If using saliva, the collection is required using the Spectrum SDNA-1000 saliva collection device.

What is involved in saliva-based COVID-19 testing?2020-05-09T18:56:27+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?2020-05-09T16:11:01+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 is an EUA?2020-05-09T17:49:08+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).

What does it mean if the specimen tests positive for the virus that causes COVID-19?2020-05-09T17:47:01+00:00

A positive test result for COVID-19 indicates that RNA from SARS-CoV-2 was detected, and the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions. Patient management should follow current CDC guidelines.

The Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay has been designed to minimize the likelihood of false-positive test results. However, in the event of a false-positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of treatment or therapy, or other unintended adverse effects.

All laboratories using this test must follow the standard testing and reporting guidelines according to their appropriate public health authorities.

What does it mean if the specimen tests negative for the virus that causes COVID-19?2020-05-09T17:48:04+00:00

A negative test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19.

When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID-19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing should be considered by healthcare providers in consultation with public health authorities.

Risks to a patient of a false negative include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in an increased risk of spread of COVID-19 within the community, or other unintended adverse events.

What does it mean if I have a positive test result?2020-05-09T16:14:42+00:00

If you have a positive test result, it is very likely that you have COVID-19. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (a false positive result). Your healthcare provider will work with you to determine how best to care for you based on the test results along with medical history, and your symptoms.

What does it mean if I have a negative test result?2020-05-09T16:15:34+00:00

A negative test result means that the virus that causes COVID-19 was not found in your sample. For COVID-19, a negative test result for a sample collected while a person has symptoms usually means that COVID-19 did not cause your recent illness.

However, it is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. If this is the case, your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you.

It is important that you work with your healthcare provider to help you understand the next steps you should take.

What do I need to know about COVID-19 testing?2020-05-09T17:45:36+00:00

Current information on COVID-19 for healthcare providers is available at CDC’s webpage, Information for Healthcare Professionals (see links provided in “Where can I go for updates and more information” section).

  • The Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay can be used to test oropharyngeal (throat) swab, nasopharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, saliva specimens and bronchoalveolar lavage (BAL) fluid.
  • The Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay should be ordered for the detection of COVID-19 in individuals suspected of COVID-19 by their healthcare provider.
  • The Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay is only authorized for use at the Rutgers Clinical Genomics Laboratory (RCGL) at RUCDR Infinite Biologics – Rutgers University, Piscataway, NJ, that is a Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a certified high-complexity laboratory.

Specimens should be collected with appropriate infection control precautions. Current guidance for COVID-19 infection control precautions are available at the CDC’s website (see links provided in “Where can I go for updates and more information” section).

Use appropriate personal protective equipment when collecting and handling specimens from individuals suspected of having COVID-19 as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). For additional information, refer to CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19) (see links provided in “Where can I go for updates and more information” section).

What are the symptoms of COVID-19?2020-05-09T18:56:01+00:00

Many patients with confirmed COVID-19 have developed a fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). However, limited information is currently available to characterize the full spectrum of a clinical illness associated with COVID-19. Based on what is known about the virus that causes COVID-19, signs, and symptoms may appear at any time from 2 to 14 days after exposure to the virus. Based on preliminary data, the median incubation period is approximately 5 days but may range 2-14 days. See our infographic for more information.

Public health officials have identified cases of COVID-19 infection throughout the world, including the United States, which may pose risks for public health. Please check the CDC webpage for the most up to date information.

What are the known and potential risks and benefits of the test?2020-05-09T16:13:14+00:00

Potential risks include:

  • Possible discomfort or other complications that can happen during sample collection.
  • Possible incorrect test results (see below for more information).

Potential benefits include:

  • The results, along with other information, can help your healthcare provider make informed recommendations about your care.
  • The results of this test may help limit the spread of COVID-19 to your family and others in your community.
What are the collection device options EUA approved for COVID-19 saliva testing?2020-05-09T18:56:38+00:00

The FDA has only granted one EUA authorization for COVID-19 testing protocols using saliva. This is the EUA200090 granted to Rutgers Clinical Genomics Laboratory testing approval is based on saliva samples being exclusively collected using the Spectrum’s SDNA-1000 saliva collection device.

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?2020-05-09T18:19:47+00:00

The only requirement listed by the FDA is that the test is ordered or prescribed by a physician as they see fit.

Is this saliva test for COVID-19 FDA-approved or cleared?2020-05-09T17:40:04+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.

For this test, a request from the Rutgers Clinical Genomics Laboratory to revise the scope of authorization from only allowing self-saliva collection in a healthcare setting to additionally include the home collection of salvia specimens using the Spectrum Solutions LLC SDNA-1000 saliva collection device when determined to be appropriate by a healthcare provider. Approval was granted on May 8th, 2020 to include home collection of saliva samples based on additional study proofs of sample preservation and stability provided by the SDNA-1000 saliva collection device.

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).

How quickly will I receive my results?2020-05-09T18:53:48+00:00

Testing results are determined by the lab processing the test. On average results are ready between 24-72 hours from the time they are received at the lab. At-home testing will need to factor shipping into that timeline:

  • Vitagene states results for their test is available 2-4 days from the time of purchase. Priority shipping to the lab is included. The lab will send your results within 72 hours of receiving your sample.
  • Vault Health states, if you opted into results over email, you will receive an email with your test result approximately 2-3 days after your sample is received by the lab. If not, you will receive an email notification with a link to your test result approximately 2-3 days after your sample is received by the lab.
How long is the viral RNA stable in the device?2020-05-09T17:54:37+00:00

Data supports 10 days

How can you order a test?2020-05-09T18:16:04+00:00

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

Do you have information for sample shipment and temperatures requirements?2020-05-09T18:02:33+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)

Are you adding new distribution partners?2020-05-09T18:25:28+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 approved testing labs?2020-05-09T18:31:39+00:00

Yes, as labs validate the testing protocols, submit for EUA saliva testing approval, and receive approval we are adding them to the approved list on the website.

Are there any limitations to who can receive this saliva test for COVID-19?2020-05-09T18:57:19+00:00

No.

Am I at risk for COVID-19?2020-05-09T18:55:20+00:00

The virus is highly contagious and is currently spreading rapidly. Especially if you are in an area where the virus is widespread, the best way to prevent illness is to avoid exposure to the virus. This means avoiding close contact with people who are infected and public spaces where you can come into contact with many people. You should follow any national or local guidelines around social distancing, staying at home, and wearing masks. You should regularly wash your hands and disinfect any frequently touched surfaces.