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Synovasure® Alpha Defensin Test

Alpha Defensin Test for Periprosthetic Joint Infection

Demand More From Your Diagnosis.

Introducing Synovasure® Alpha Defensin Test for Periprosthetic Joint Infection

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.

Unparalleled Accuracy

  • The Synovasure Test achieves 97% sensitivity and 96% specificity by measuring synovial fluid alpha defensin1
  • Alpha defensin is an antimicrobial peptide released by neutrophils in response to pathogens
  • Alpha defensin is an ideal biomarker for PJI due to the tremendous separation it achieves between positives and negatives1

Synovasure Performance 95% Confidence Interval
Sensitivity 97.4% 86.1% - 99.6%
Specificity 95.8% 90.5% - 98.6%

Performance backed by data

In the 158 patient study1, the Synovasure Alpha Defensin Test maintained its performance in typically challenging situations such as:

Culture Negative Infection

  • 14 of 38 patients with PJI were culture negative and the Synovasure® Alpha Defensin Test correctly identified all 14 as infected

Systemic Inflammatory Conditions

  • Synovasure® Alpha Defensin Test studies included patients with systemic inflammatory disease and its performance was maintained in this population

Antibiotic Therapy

  • 27% of patients with PJI had been treated with antibiotics prior to aspiration and the Synovasure® Alpha Defensin Test was not adversely affected in this population

Superior ease of use

Point of Care Test – With Rapid Results in 10 Minutes.

  • Draw synovial fluid into pipette
  • Mix with buffer solution
  • Deposit onto device
  • Read results in 10 minutes.

Get the Whitepaper

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