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

Device Shortage List

FDA monitoring healthcare landscape and supply chain for resulting shortages, or meaningful disruptions to U.S. supply, of certain medical devices

  • 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

Device shortage and discontinuance list

FDA Insights: Your Digital Health

Discission on telemedicine, digital health tools, and FDA’s new Digital Health Center of Excellence

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Hand Sanitizers Consumers Should Not Use

Hand sanitizer products labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol and methanol contamination

  • 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.

READ

Help Stop the Spread of Coronavirus and Protect Your Family

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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The Fight Is In Us: Convalescent Plasma Fact Sheets and Toolkit

FDA working together with health care organizations and other partners to slow spread and meeting the challenge of COVID-19

Image credits: Yale, FDA

Published by Drug & Device Advisory Group