FDA Allows Marketing of First Diagnostic Test to Detect Prosthetic Joint Infections

May 24, 2019

On May 23, the U.S. Food and Drug Administration (FDA)  permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint infection in the synovial fluid of patients being evaluated for surgery performed to replace or compensate for a failed implant. Prior to the 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 due to another cause. The test kit detects human alpha defensins in the synovial fluid of patients with a total joint replacement in approximately 10 minutes. To learn more about this test kit, see this FDA press release.