The Synovasure® Alpha Defensin 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 study1, the Synovasure Alpha Defensin Test maintained its performance in typically challenging situations such as:
Point of Care Test – With Rapid Results in 10 Minutes.
To receive more information or to download the white paper, A New Paradigm For The Diagnosis of Periprosthetic Joint Infection, please complete the information below.
1. CD Diagnostic - A new paradigm for the diagnosis of Periprosthetic Joint Infection - White Paper, 2013, revised 2014
Intended use: The Synovasure 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 Alpha Defensin 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 Alpha Defensin 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