CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
September 2019—The U.S. Food and Drug Administration permitted marketing of the Synovasure Lateral Flow Test Kit (CD Diagnostics) as an aid for the detection of periprosthetic joint infection in the synovial fluid of patients being evaluated for revision surgery. The test kit detects human alpha defensins in the synovial fluid of patients with a total joint replacement in approximately 10 minutes. The test is not intended to identify a specific type of infection.
Prior to this authorization, “there were no FDA-authorized diagnostic tests specifically designed to help health care professionals determine whether the inflammation around a prosthetic joint was due to an infection or another cause,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a press release from the FDA.