SalivaDirect

Yale School of Public Health

INTENDED USE & DESCRIPTION: SalivaDirect is primarily designed for the rapid detection of SARS-CoV-2 using saliva as an alternative to respiratory swabs, making it a non-invasive and easily accessible method for frequent sampling.

It’s important to note that SalivaDirect is not intended to detect THC or other substances typically associated with cannabis in your saliva. The duration of weed detection in saliva varies depending on factors such as usage frequency and individual metabolism.

VALIDATION:

  • With different combinations of commonly used reagents and instruments, meaning the test could be used broadly in most high-complexity labs
  • Yale intends to provide the SalivaDirect protocol to interested laboratories as an “open source” protocol
  • Because this test does not rely on any proprietary equipment from Yale and can use a variety of commercially available testing components, it can be assembled and used in high-complexity labs throughout the country, provided they comply with the conditions of authorization in the EUA

REGULATORY PATHWAY: Emergency Use Authorization (EUA)

  • Fifth test that uses saliva as a sample for testing

Publication


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  • Manufacturers of certain devices notify FDA of permanent discontinuance in manufacture of the device
  • Interruption in the manufacture of device that is likely to lead to meaningful disruption in supply during declared public health emergency
  •  Categories of devices in the device shortage list are (1) Personal Protective Equipment (2) Testing Supplies and Equipment (3) Ventilation-Related Products

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  • Young children, adolescents and adults who drink these products as an alcohol (ethanol) substitute are at risk
  • Can cause central nervous system (CNS) depression, which can result in death
  • Exposure can include confusion, decreased consciousness, and slowed pulse and breathing
  • Skin or eye exposure can result in irritation, and rare cases of allergic skin reactions have been reported.

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Remain vigilant and take simple steps

  • Wash Your Hands
  • Wear a Mask and Avoid Crowds
  • Save Personal Protective Equipment for Those on the Front Lines
  • Follow Food Safety Guidelines
  • Donate Blood
  • If You Have Fully Recovered From COVID-19, Donate Plasma
  • Report Fraudulent Coronavirus Tests, Vaccines, and Treatments

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