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Synovasure PJI

Alpha Defensin Test for Periprosthetic Joint Infection

Demand More From Your Diagnosis. Call 215-219-7043

Introducing Synovasure PJI Alpha Defensin Test for Periprosthetic Joint Infection

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.

Unparalleled Accuracy

  • The Synovasure Test achieves 97% sensitivity and 96% specificity by measuring synovial fluid alpha defensin
  • 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 negatives

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 study, the Synovasure PJI 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 PJI Test correctly identified all 14 as infected

Systemic Inflammatory Conditions

  • Synovasure PJI 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 PJI was not adversely affected in this population

Superior ease of use

Simple sample submission process. Can be sent to Citrano Labs directly from practice or through affiliated hospital lab

Rapid standardized results

  • Results are usually available within 24 hours
  • Results do not require complicated interpretation like other tests with poorly defined cutoffs

Covered by most insurance companies

  • No out of pocket costs to surgeon or practice

Also available with Culture and Sensitivity Testing

Get the Whitepaper

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