FDA Alerts Healthcare Workers That HSV-2 Tests for Genital Herpes Can Produce False Reactive Results

January 02, 2024

On December 27, 2023, the U.S. Food and Drug Administration (FDA) sent a letter (https://www.fda.gov/medical-devices/letters-health-care-providers/hsv-2-tests-genital-herpes-can-produce-false-reactive-results-letter-clinical-laboratory-staff-and) to healthcare providers and clinical laboratory staff about the potential for false reactive (false positive) results in herpes simplex virus type 2 (HSV-2) serologic tests for genital herpes. 

FDA update

FDA recommended that healthcare workers:   

When using the current HSV tests, the chance of a false result increases if a person:

FDA encouraged users, manufacturers, and healthcare personnel and clinical laboratory staff to report false-reactive HSV-2 serologic test results.  

For questions about the letter, contact FDA’s Division of Industry and Consumer Education (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice).


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