The U.S. Food and Drug Administration (FDA) is reminding healthcare 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.
FDA Recommendations
The FDA recommends that healthcare providers and clinical laboratory staff do the following:
- Review the CDC guidelines before ordering HSV-2 serological 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.
Further reading: QuidelOrtho Gets FDA Clearance for Multiplex Molecular Platform and Herpes Simplex Virus Assay
More on HSV Tests
According to the Centers for Disease Control and Prevention, clinical diagnosis of genital herpes can be challenging. When using the 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)
FDA Actions
The FDA says it is providing this information to help educate health care providers and clinical laboratory staff and reduce the risk of false results. The FDA will continue to keep health care providers and clinical laboratory staff informed if new or additional information becomes available.