The Synovasure™ PJI Test is the first and only test specifically designed and validated for the diagnosis of Periprosthetic Joint Infection (PJI). Developed to deliver accuracy, performance and ease of use.
|Synovasure Performance||95% Confidence Interval|
|Sensitivity||97.4%||86.1% - 99.6%|
|Specificity||95.8%||90.5% - 98.6%|
In the 158 patient study, the Synovasure PJI Test maintained its performance in typically challenging situations such as:
Simple sample submission process. Can be sent to Citrano Labs directly from practice or through affiliated hospital lab
For more information including an enrollment kit and access to download the whitepaper, A New Paradigm For The Diagnosis of Perprosthetic Joint Infection, fill in the form below.
Reference: The data in this website can be found in a white paper entitled: A New Paradigm for the Diagnosis of Periprosthetic Joint Infection. CD Diagnostics. September 2013. Contact your Zimmer rep or call CD Diagnostics to receive a copy.
Intended use: The Synovasure PJI Alpha Defensin Test for Periprosthetic Joint Infection is intended to be used as an adjunct to current diagnostic methods in the diagnosis of periprosthetic joint infection (PJI). Its results should be interpreted along with the entire clinical picture in order to arrive at a definitive diagnosis.
The Synovasure PJI Test is a lab developed test offered through CD Diagnostics’ CLIA certified laboratory, Citrano Medical Laboratories (CLIA License# 21D0216863) and has been validated for the detection of PJI. 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.
The Synovasure PJI Test has not been cleared or approved by the U.S. Food and Drug Administration.
For more information contact your Zimmer Representative, call CD Diagnostics at 888-981-8378