Synovasure Lateral Flow Test Kit has been approved by the FDA as an aid for the detection of periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of patients being evaluated for revision surgery.
“Prior to today’s 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,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “With this test, healthcare professionals now have an additional option available to aid their clinical assessment as to whether the patient has an infection and requires revision surgery.”
Potential complications of joint replacement include scarring, inflammation, blood clots and infections, the agency noted. X-rays or analysis of the joint fluid are generally used to determine infection.
The Synovasure Lateral Flow Test Kit, in comparison, detects proteins called human alpha defensins in the synovial fluid of patients with a total joint replacement in approximately 10 minutes.