The US Food and Drug Administration announces it has authorized CD Diagnostics Inc to market the Synovasure Lateral Flow Test Kit, designed to help aid in the detection of periprosthetic joint infection in the synovial fluid of patients being evaluated for failed implant revision surgery.
“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 another cause,” says 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, in the release.
“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,” he adds.
The Synovasure Lateral Flow Test Kit is designed to detect proteins called human alpha defensins in the synovial fluid of patients with a total joint replacement in approximately 10 minutes. 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.
To reach the approval decision, the FDA reviewed data from a clinical study that analyzed 305 prospective synovial fluid samples collected from individuals with a total knee or hip joint replacement who were being evaluated for revision surgery. The study showed that 89.5% of subjects with an infection diagnosis based on standard of care criteria were also identified as positive for alpha defensin by the Synovasure Lateral Flow Test Kit.
Along with this authorization, the FDA is establishing criteria, called special controls, which determine the requirements for demonstrating the safety and effectiveness of tests to detect and measure non-microbial analytes that aid in the detection and identification of localized human infections. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for these tests, the release explains.
[Source(s): US Food and Drug Administration, PR Newswire]