The Synovasure™ PJI test was developed specifically for the diagnosis of periprosthetic joint infection (PJI). Synovasure™ PJI is a laboratory developed test (LDT) for the detection of infection in the synovial fluid (joint fluid) of patients experiencing pain and/or inflammation in a joint. Synovasure™ is a panel of tests. The panel capitalizes on the diagnostic characteristics of alpha-defensin, and also includes an adjustment for samples with significant amounts of bloody contamination or hemolysis. Furthermore, the inclusion of a synovial fluid CRP test in the Synovasure™ PJI panel provides for the identification of samples that are most likely to represent false positive results due to confounding conditions such as metallosis. Synovasure™ PJI maintains its diagnostic performance even among patients with systemic inflammatory diseases, patients on antibiotics and patients experiencing the effects of metal products. The sensitivity and specificity of the test is as follows:
|Synovasure™ PJI Test||95% Confidence Interval|
|Sensitivity||97.4%||86.1% – 99.6%|
|Specificity (excluding cases of metallosis)||97.1%||93.0% – 99.7%|
|Specificity (including cases of metallosis)||95.8%||90.5% – 98.6%|
Alpha defensins are biomarkers that act as the body’s natural antibiotics. They kill or inactivate a broad spectrum of bacteria, fungi, and some enveloped viruses. Alpha defensins are elevated when infection is present but normal in other causes of joint inflammation. In-house studies show that alpha defensins outperform current diagnostic tests for infection with greater than 95.8% sensitivity and specificity.
Synovasure™ PJI LDT is offered through our CLIA certified laboratory, Citrano Medical Laboratories (CLIA License# 21D0216863) and has been validated for the detection of periprosthetic joint infection. Test results are available within 24hrs. Physicians can also request a culture test along with the Synovasure™ PJI LDT. Culture will be run using the BACT/Alert FAN® blood culture bottles for both aerobic and anaerobic organisms.
The Synovasure™ PJI LDT test is intended for clinical use. It was developed and its performance characteristics determined by Citrano Medical Laboratories. Citrano Medical Laboratories is certified under the Clinical Laboratories Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity testing. Synovasure. has not been reviewed by the U.S. Food and Drug Administration. This test is covered by U.S. patent 7598080.
Your test kits will be supplied by CD Diagnostics, and will be sent to you directly at no charge to your practice. For additional information, contact your Zimmer representative or call CD Diagnostics directly at 888-981-TEST (8378).
A comprehensive white paper that summarizes our studies and details Synovasure™ PJI performance characteristics is available by contacting CD Diagnostics at 888-981-TEST (8378). The white paper summarizes data from a 95 patient study, a 158 patient study, and a pilot program consisting of over 1,000 samples.