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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
The FDA issued a safety communication advising people to use swab samples taken directly from a lesion (rash or growth) when testing for the monkeypox virus. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing. Testing samples not taken from a lesion may lead to false test results.
This safety communication provides:
- Recommendations for test users, caregivers, health care personnel, test developers, and laboratory personnel.
- Potential risks of false monkeypox test results.
- FDA actions to make monkeypox tests more readily available.
- Instructions for reporting problems to the FDA.
Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).
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