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COVID-19 Testing: SalivaDirect™

Regularly testing large numbers of people plays a huge role in monitoring the transmission of SARS-CoV-2. Ramping up testing for effective SARS-CoV-2 surveillance has faced several barriers such as uncomfortable nasal swabs, testing supply chain shortages, and delays in test results.

SalivaDirect™ is a new testing method for testing people suspected of SARS-CoV-2 infection. The new method still relies on a similar molecular process as earlier tests (RT-qPCR), however, it has unique advantages.

 

SalivaDirect™ is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. SalivaDirect™ was developed by the Yale School of Public Health (YSPH) and has received an Emergency Use Authorization from the United States Food and Drug Administration (FDA). FDA limits the emergency use of SalivaDirect™ testing only to high-complexity CLIA-certified laboratories formally designated as authorized laboratories by YSPH under the EUA 202097.

 

 

 

 

 

 

 

 

 

 

 


 

  • Saliva-based: Comfort. You no longer have to stick an uncomfortable swab up your nose, which increases testing compliance. This also protects healthcare workers from potential exposure to sick patients.
     

  • Extraction-free: The time-consuming and expensive nucleic acid extraction step is not needed with SalivaDirect™. This allows for cheaper and quicker test results.
     

  • Flexible: While many labs have similar equipment and testing methods, they still rely on expensive reagents and time-consuming processes. SalivaDirect™ relies on easily-accessible reagents from many different companies, whereas most test protocols rely on one company
     

  • Accurate: SalivaDirect™ method has a Clinical Sensitivity of 94% and a Clinical Specificity of 99.9%

    • Clinical Sensitivity: the ability of a test or assay to detect a target analyte (SARS-CoV-2), which is usually expressed as the minimum detectable concentration of the analyte (SARS-CoV-2) in a sample.
       

    • Clinical Specificity: the ability of a test or assay to measure on on a specific organism or substance (SARS-CoV-2) rather than others in a sample.

SalivaDirect™ is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in saliva collected

without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. SalivaDirect™ was developed by the Yale School of Public Health (YSPH) and has received an Emergency Use Authorization from the United States Food and Drug Administration (FDA). FDA limits the emergency use of SalivaDirect™ testing only to high-complexity CLIA-certified laboratories formally designated as authorized laboratories by YSPH under the EUA 202097.

News Articles & Research Papers

 

Frequently asked questions

What is COVID-19?


COVID-19 is caused by the SARS-CoV-2 virus which is a new virus in humans causing a contagious respiratory illness. COVID-19 can present with a mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Older adults and people of any age who have underlying medical conditions have a higher risk of severe illness from COVID-19. Serious outcomes of COVID-19 include hospitalization and death. The SARS-CoV-2 virus can be spread to others not just while one is sick, but even before a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.). A full list of symptoms of COVID-19 can be found at the following link: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html




What is the SalivaDirect™ assay?


Is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. SalivaDirect™ was developed by the Yale School of Public Health (YSPH) and has received an Emergency Use Authorization from the United States Food and Drug Administration (FDA). FDA limits the emergency use of SalivaDirect™ testing only to high-complexity CLIA-certified laboratories formally designated as authorized laboratories by YSPH under the EUA 202097.




Why was my sample tested?


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.




What are the known and potential risks and benefits of the test?


Potential risks include:

  • Possible discomfort or other complications that can happen during sample collection.
  • Possible incorrect test result (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 those you come in contact with.




What does it mean if I have a positive test result?


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. You should follow CDC guidance to reduce the potential transmission of disease. There is a smaller possibility that this test can give a positive result that is wrong (a false positive result) particularly when used in a population without many cases of COVID-19 infection. 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?


A negative test result means that the virus that causes COVID-19 was not found in your sample. However, it is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. You might test negative if the sample was collected early during your infection. You could also be exposed to COVID-19 after your sample was collected and then have become infected. This means that you could possibly still have COVID-19 even though the test result is negative. If your test is negative, 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.




Is this test FDA-approved or cleared?


No. This test is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). 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 are the approved alternatives?


There are no approved available alternative tests. FDA has issued EUAs for other tests that can be found at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization




Where can I go for more information?


The most up-to-date information on COVID-19 is available at the CDC General webpage at https://www.cdc.gov/COVID19. In addition, please also contact your healthcare provider with any questions/concerns.




What is included in the pricing?


$15 Sample collection fee $85 RT-PCR COVID-19 test





Need more details? Contact us

We are here to assist. Contact us by phone, email or via our Social Media channels.

Need more details? Contact us

We are here to assist. Contact us by phone, email or via our social media channels.

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