FDA approves first diagnostic test for joint replacement infections
medwireNews: The US FDA has approved a diagnostic test to aid detection of infections in the synovial fluid surrounding prosthetic joints in patients being considered 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, from the FDA’s Center for Devices and Radiological Health, in a press release.
The assay, called the Synovasure Lateral Flow Test Kit (CD Diagnostics Inc., Claymont, Delaware, USA), measures alpha defensins released by neutrophils in the synovial fluid, indicating the presence of infection. It is not able to identify specific types of infection, however.
The approval was based on the results of a study of 305 samples taken from individuals with a total knee or hip replacement, which demonstrated that almost 90% of participants diagnosed with infection using standard methods also tested positive with the diagnostic test.
“Physicians typically evaluate for potential infections using X-ray images or laboratory analysis of joint fluid, which can take days for results,” whereas the new assay produces results “in approximately 10 minutes,” says the FDA.
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