COVID News: SalivaDirect, Device shortage list, Your digital health, Hand sanitizer warning, Steps to stop spread, Convalescent plasma toolkit
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SalivaDirect
Yale School of Public Health
INTENDED USE & DESCRIPTION: For rapid detection of SARS-CoV-2 using saliva instead of respiratory swabs, which enables non-invasive frequent sampling and reduces the need for trained healthcare professionals during collection.
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
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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
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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.
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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