viernes, 5 de junio de 2020

Transport Media Safety Risk - Use Compatible Transport Media with SARS-CoV-2 Testing Platforms that Use Bleach

https://www.fda.gov/medical-devices/letters-health-care-providers/transport-media-safety-risk-use-compatible-transport-media-sars-cov-2-tests-use-bleach-letter?utm_campaign=2020-06-04%20Transport%20Media%20Safety%20Risk%20Letter%20to%20Health%20Care%20Providers&utm_medium=email&utm_source=Eloqua


Transport Media Safety Risk - Use Compatible Transport Media with SARS-CoV-2 Tests that Use Bleach: Letter to Clinical Laboratory Staff and Health Care Providers

The U.S. Food and Drug Administration (FDA) reminds laboratory staff that some transport media (the liquid that maintains a specimen sample while it is transported to a laboratory) and SARS-CoV-2 testing platforms are not compatible. There is a risk of exposure to harmful cyanide gas, a by-product of a reaction between guanidine thiocyanate and similar chemicals used in certain transport media and bleach (sodium hypochlorite) used in certain SARS-CoV2 testing platforms or laboratory processes.
The Letter to Clinical Laboratory Staff and Health Care Providers includes important information about using transport media that are compatible with SARS-CoV-2 testing platforms, including:
  • Details on which testing platforms are not compatible with PrimeStore MTM, Zymo DNA/RNA Shield, Spectrum Solutions Saliva Collection Device, and any other transport media that contain guanidine thiocyanate and similar chemicals due to this hazardous chemical reaction.
  • Recommendations for laboratory staff. 
  • Instructions for reporting problems with a device. 

Questions?

If you have questions about the use of transport media and compatible SARS-CoV-2 testing platforms, contact COVID19DX@fda.hhs.gov .

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