On December 27, 2023, the U.S. Food and Drug Administration (FDA) sent a letter 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 recommended that healthcare workers:
- Review the Centers for Disease Control and Prevention guidelines before ordering HSV-2 serologic testing to reduce the risk of false reactive results.
- Be aware that false reactive results can occur.
- Counsel patients about the limitations of available testing before obtaining HSV-2 serologic tests.
- Perform confirmatory testing for reactive results as provided in the test’s labeling and in accordance with professional guidelines, such as Biokit or Western blot tests.
When using the current HSV tests, the chance of a false result increases if a person:
- Is tested too soon after infection
- Has a low risk of infection
- Receives test results that are near the cutoff (low positive)
FDA encouraged users, manufacturers, and healthcare personnel and clinical laboratory staff to report false-reactive HSV-2 serologic test results.
- Submit voluntary reports through MedWatch, FDA’s Safety Information and Adverse Event Reporting program.
- Comply with the applicable Medical Device Reporting (MDR) regulations.
- Follow their facility's established reporting procedures if it is subject to FDAs user facility reporting requirements.
For questions about the letter, contact FDA’s Division of Industry and Consumer Education.