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Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Clinical Laboratory Staff and Health Care Providers to remind providers and clinical laboratory staff about the potential for false reactive (false positive) results in herpes simplex virus type 2 (HSV-2) serological tests for genital herpes.
According to the Centers for Disease Control and Prevention, clinical diagnosis of genital herpes can be challenging. When using current HSV tests, the chance of a false result increases if a person:
- gets a blood test too soon after infection
- has a low risk of infection
- receives test results that are near the cutoff (low positive)
The Letter to Health Care Providers includes important information about HSV-2 false reactive results including:
- Reminders and recommendations for health care providers and clinical laboratory staff who use these tests.
- Instructions for reporting problems with these tests.
Questions?
If you have questions about HSV-2 false reactive test results, contact the Division of Industry and Consumer Education (DICE).
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