2025 Mar 15, 02:47
December 27, 2023 - The U.S. Food and Drug Administration (FDA) is issuing a reminder to health care providers and clinical laboratory staff regarding the possibility of false positive results in herpes simplex virus type 2 (HSV-2) serological tests for genital herpes. The FDA is advising health care providers and clinical laboratory staff to take certain precautions in order to avoid false results. According to the Centers for Disease Control and Prevention, diagnosing genital herpes can be difficult. The current HSV tests have a higher likelihood of producing false results if certain conditions are present
To prevent this, the FDA is recommending that health care providers and clinical laboratory staff take specific actions. The FDA's goal is to educate health care providers and clinical laboratory staff while reducing the risk of false results. If any new information becomes available, the FDA will communicate it to the relevant parties. The FDA also encourages users to report any false reactive results with HSV-2 serological tests. Reporting adverse events promptly is important as it helps the FDA identify and understand the risks associated with medical devices. The FDA routinely monitors the performance and results of tests, including any problems that may arise. For further inquiries or concerns, individuals can contact the Division of Industry and Consumer Education (DICE)
The FDA remains committed to safeguarding the public's health and will continue to provide updates and guidance as needed.