Avoiding Misdiagnosis: The FDA's Warning on False Positive Results in Genital Herpes Testing

Could your genital herpes test results be misleading? The U.S. Food and Drug Administration (FDA) wants to ensure that healthcare providers and clinical laboratory staff are aware of the potential for false reactive (false positive) results in serological tests for herpes simplex virus type 2 (HSV-2) – the virus responsible for genital herpes.

To minimize the risk of false results, the FDA has issued recommendations for healthcare providers and clinical laboratory staff to follow:

1. Familiarize yourself with the CDC guidelines: Before ordering HSV-2 serological testing, it is crucial to review the guidelines provided by the Centers for Disease Control and Prevention (CDC). These guidelines can help reduce the chances of false reactive results.

2. Understand the possibility of false reactive results: False positive results can occur in HSV-2 serological tests. Being aware of this potential will help healthcare providers interpret the test results accurately and avoid unnecessary anxiety for patients.

3. Educate patients about testing limitations: Before obtaining HSV-2 serologic tests, it is essential to counsel patients about the limitations of available testing methods. Patients should understand that false results can happen and that confirmatory testing may be necessary.

4. Perform confirmatory testing: When reactive results are obtained, it is crucial to follow the testing procedures outlined in the test's labeling and adhere to professional guidelines. Tests such as Biokit or Western blot can provide confirmatory results, ensuring accurate diagnoses.

The clinical diagnosis of genital herpes can be challenging, and false results are more likely when certain factors are present, such as testing too soon after infection, having a low risk of infection, or receiving results that are near the cutoff for positivity.

The FDA is committed to providing this information to educate healthcare providers and clinical laboratory staff and reduce the risk of misdiagnosis. As new information becomes available, the FDA will continue to keep healthcare providers and clinical laboratory staff informed.

Ensuring accurate and reliable testing is essential for effective patient care. By following the FDA's recommendations, healthcare professionals can minimize the risk of false positive results in genital herpes testing and ensure accurate diagnoses for their patients.