Synovasure® Alpha Defensin Lateral Flow Test

Periprosthetic Joint Infection (PJI) is one of the most common complications following total joint arthroplasty, accounting for 25% of total knee arthroplasty failures and 16% of total hip arthroplasty failures.1

Alpha Defensin - Aiding in the Diagnosis of PJI

Alpha defensin is 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.

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

  • Prior antibiotic administration2,3
  • Comorbidities related to inflammation2
  • Type and/or virulence of the organism2,4

Since discovery, alpha defensin has aided in the diagnosis of PJI following total joint replacement. In 2018, alpha defensin biomarker was included as a minor criteria for diagnosing PJI by the International Consensus Meeting (ICM) on Joint Infection.5

When you need to know now

The Synovasure Alpha Defensin Lateral Flow Test is a standalone, rapid device for detecting alpha defensin in synovial fluid. The Synovasure Alpha Defensin Lateral Flow offers physicians:

  • 94.3% sensitivity and 94.5% specific vs. standard of care criteria6
  • Same-day results - rapid positive/negative alpha defensin result in 10 minutes
  • Low synovial fluid volume requirement – Only 15 microliters required for test performance
  • Control kit availability for proficiency and validation

In a prospective clinical study (n=305), the Synovasure Alpha Defensin Lateral Flow Test demonstrated 94.3% Sensitivity and 94.5%* Specificity when compared to the standard of care criteria. Furthermore, no statistically significant difference was observed between the Synovasure Alpha Defensin Lateral Flow Test compared to the Synovasure Alpha Defensin ELISA test.6

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References

  1. Diermengian C, et al. Diagnosing Periprosthetic Joint Infection: Has the Era of the Biomarker Arrived? Clin Orthop Relat Res. Nov;472(11):3254-62, 2014.
  2. Diermengian C, et al. Combined Measurement of Synovial Fluid a-Defensin and C-reactive Protein Levels: Highly Accurate for Diagnosing Periprosthetic Joint Infection. JBJS Am. Sep 3;96(17):1439-45, 2014.
  3. Shahi A, et al. The alpha-defensin Test for Periprosthetic Joint Infections is Not Affected by Prior Antibiotic Administration. Clin Orthop Relat Res. Jul;474(7):1610-5, 2016.
  4. Diermengian C, et al. The C-reactive Protein May Not Detect Infections Caused by Less-Virulent Organisms. Journal of Arthroplasty. 31:152-155, 2016.
  5. Amanatullah D, et al. Hip and Knee Section, Diagnosis, Definitions: Proceedings of International Consensus on Orthopedic Infections. Journal of Arthroplasty. 34(2019) S329eS337.
  6. CDD-CLI-001: Clinical Validation of CD Diagnostics Synovasure PJI ELISA Test and Synovasure PJI Lateral Flow Test for Detection of Periprosthetic Joint Infection (PJI) in Synovial Fluid.
* Excluding samples with >20% blood

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