When You Need to Know Now

The first of its kind, the Synovasure Alpha Defensin Lateral Flow Test is specifically designed as an aid for the diagnosis of periprosthetic joint infection (PJI). The test delivers same day results with speed and accuracy.

Procedures

  • Infection Diagnostics

Philosophies

  • Diagnostics

Application

  • Revision Knee 
  • Revision Hip

The Synovasure Alpha Defensin Lateral Flow Test offers a rapid and accurate positive/negative result (10 minutes) to aid in diagnosis of PJI.

 

-

94.3%

vs. sensitivity standard of care criteria1

.

94.5%

vs. specificity standard of care criteria1*

* Excluding samples with >20% blood

Product Features

The Synovasure Alpha Defensin Lateral Flow Test is a standalone, rapid device for detecting alpha defensin in synovial fluid, an antimicrobial peptide released into the body through activated neutrophils in response to an infection. In cases of PJI, a patient will have elevated levels of alpha defensin in their synovial fluid. The test received FDA authorization in 2019 as a CLIA moderately complex test.

Clinical findings show that alpha defensin test results are not influenced by: 

  • Prior antibiotic administration1,3,4
  • Comorbidities related to inflammation1,3,5
  • Type and/or virulence of the organism1,3,6

 
A clinical multi-center study also showed no statistically significant difference in test performance between the Synovasure Alpha Defensin Lateral Flow Test and Synovasure Alpha Defensin ELISA laboratory test.1

Benefits

Accurate

  • 94.3% sensitivity and 94.5% specific vs. standard of care criteria1

Timely

  • Same-day results - rapid positive/negative alpha defensin result in 10 minutes

Low Required Test Volume

  • Low synovial fluid volume requirement – Only 15 microliters required for test performance
     

Control Kit Available

  • Postitive and negative alpha defensin controls available as part of Synovasure Alpha Defensin Control Kit

Videos

Synvosure Alpha Defensin Lateral Flow Test

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Synovasure Alpha Defensin Control Kit – How to Use

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What is Alpha Defensin

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Synovasure Diagnostics Product Offerings

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Additional Information

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For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and information on this website. To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 1-800-348-2759, press 4 for 411 Technical Support.