The U.S. Food and Drug Administration (FDA) is 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.
Recommendations
Use lesion swab samples when testing for the monkeypox virus.
- Test users and caregivers:
o Be familiar with the Centers for Disease Control and Prevention’s (CDC’s) information on monkeypox, including the current outbreak.
o Talk with your healthcare provider if you have symptoms of monkeypox or if you think you had contact with someone who has monkeypox.
o Talk with your healthcare provider if you were tested for the monkeypox virus using a sample type other than a lesion swab sample.
- Healthcare personnel:
o Be aware of the CDC’s Information for Health Care Professionals, including clinician FAQs and preparing and collecting specimens for monkeypox virus testing.
o If your patient was tested for the monkeypox virus using an alternate sample type and you suspect an inaccurate result, consider retesting your patient using a lesion swab sample.
- Test developers and laboratory personnel:
o Be aware of the CDC’s Information for Laboratory Personnel that includes information about procedures, testing, preparing and collecting specimens, and recommendations for clinicians.
o Contact the FDA at [email protected] to discuss new test development and alternate testing approaches, and to share validation data from saliva, blood, or any other sample types.
- Report any problems you experience with monkeypox virus tests to the FDA, including suspected false results.
