COVID-19 Testing: SalivaDirect™

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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.

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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.

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• 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.
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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.

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News Articles & Research Papers

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