Synovasure® Alpha Defensin Lateral Flow Test

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Diagnosis of Periprosthetic Joint Infection (PJI) continues to be a major challenge in clinical practice, especially in late and delayed infections.1-3 Furthermore, due to the rising incidence and cost of PJI1, an earlier and more accurate diagnosis can have an important impact on patient treatment pathways.

With the Synovasure® Alpha Defensin Lateral Flow Test, Zimmer Biomet offers a quick turnaround test designed and validated to aid in the diagnosis of PJI. The test identifies elevated levels of Alpha Defensin, an antimicrobial peptide released by neutrophils in response to pathogens.

Synovasure Alpha Defensin Lateral Flow provides a positive or negative result in 10 minutes. When used in conjunction with a full diagnostic workup, Synovasure Alpha Defensin Lateral Flow enables orthopaedic professionals to make more informed decisions regarding treatment options.

The Synovasure Alpha Defensin Lateral Flow Test was validated against the Synovasure Alpha Defensin Laboratory Test (97% Sensitivity and 96% Specificity)4, and achieves:

  • 100% Positive agreement5
  • 95.6% Negative agreement5
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Additional Information

Legal Manufacturer:

CD Diagnostics
650 Naamans Road
Suite 100
Claymont, DE 19703 USA

 

References

  1. Kurtz SM et. al.  Infection burden for hip and knee arthroplasty in the United States. J Arthroplasty. 2008; 23: 984-991.
  2. Osmon, D. R., et al. Prosthetic Joint Infections. In Cierny III, G. et al. (eds). Orthopaedic Knowledge Update. Musculoskeletal Infection. AAOS, 2009.
  3. Aaron J., et al. Prosthetic Joint Infection. Clinical Microbiology Reviews. Apr; 27(2): 302–345, 2014.
  4. Deirmengian et al. Combined measurement of synovial fluid alpha-Defensin and C-Reactive Protein levels: highly accurate for diagnosing periprosthetic joint infection. Journal of Bone & Joint Surgery - American Volume. 96:1439-45, 2014.
  5. Method of Comparison between the CD Diagnostics HNP1-3 ELISA and CD Diagnostics Alpha-Defensins Lateral Flow Assay (12504-051-R). Data on file at CD Diagnostics.  
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