FDA has permitted marketing of the Synovasure lateral-flow test kit from CD diagnostics, Claymont, De, as an aid in the detection of periprosthetic joint infection in the synovial fluid of patients being evaluated for revision surgery to replace or compensate for a failed implant.
“Prior to today’s authorization, there were no FDA-authorized diagnostic tests specifically designed to help healthcare professionals determine whether the inflammation around a prosthetic joint was due to an infection or another cause,” said Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in 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. Whereas before surgeons may have opted for surgery when the presence of an infection was unclear, with this test they have more information and could potentially reduce patient risk by avoiding unnecessary revision operations for replacement joints.”
The Synovasure lateral-flow test kit, showing positive test and control lines.
During a joint replacement surgery, the surgeon removes damaged cartilage and bone from the surface of the joint and replaces it with a prosthetic joint implant. Potential complications of joint replacement include scarring, inflammation, blood clots, and infections. If an infection occurs, it can lead to pain, redness, swelling, and decreased joint function and potentially require antibiotics and revision surgery to treat the infection and install a new prosthetic implant. Physicians typically evaluate potential infections using x-ray images or laboratory analysis of joint fluid, which can take days for results.
The Synovasure lateral-flow test kit detects proteins called human alpha defensins in the synovial fluid of patients with a total joint replacement in approximately 10 minutes. Alpha defensins are antimicrobial proteins released by activated neutrophils in response to infection.
The Synovasure lateral-flow test kit is intended as an aid to determine whether there is an infection present in synovial fluid. It is not intended to identify a specific type of infection. The test results are also intended to be used in conjunction with other clinical and diagnostic findings to aid in a patient’s diagnosis of prosthetic joint infection.
For further information, visit CD Diagnostics.
Featured image: A lab operator conducts testing with the Synovasure lateral-flow test kit from CD Diagnostics.
