FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections

FDA

23 May 2019 - Today, the U.S. FDA permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of peri-prosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of patients being evaluated for revision surgery, which is surgery performed to replace or compensate for a failed implant.

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 (white blood cells) 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.

The FDA reviewed data from a clinical study that analysed 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.

Read FDA press release 

Michael Wonder

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Michael Wonder

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Outcome , US , Device