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The Alpha Defensin-1 Biomarker Assay can be Used to Evaluate the Potentially Infected Total Joint Arthroplasty

  • Clinical Research
  • Published:
Clinical Orthopaedics and Related Research®

Abstract

Background

Diagnosing a periprosthetic joint infection (PJI) requires a complex approach using various laboratory and clinical criteria. A novel approach to diagnosing these infections uses synovial fluid biomarkers. Alpha defensin-1 (AD-1) is one such synovial-fluid biomarker. However little is known about the performance of the AD-1 assay in the diagnosis of PJI.

Questions/purposes

We sought to (1) determine the sensitivity and specificity of the AD-1 assay in a population of patients being evaluated for PJI, using the Musculoskeletal Infection Society (MSIS) criteria as the reference standard, and (2) compare the AD-1 assay with other currently available clinical tests, specifically cell count, culture, erythrocyte sedimentation rate, and C-reactive protein.

Patients and Methods

A retrospective review was performed of all patients undergoing workup for a PJI at our institution from January to June 2013. Sixty-one AD-1 assays were done in 57 patients. The group included 51 patients with 55 painful joints and six patients who underwent aspiration before second-stage reimplantation. Patients were considered to have a PJI if they met the MSIS criteria. We calculated the sensitivity and specificity of the AD-1 synovial fluid assay, and compared it with the sensitivity and specificity of the synovial fluid cell count, culture, erythrocyte sedimentation rate, and C-reactive protein. There were 19 diagnosed infections in the 61 aspirations, with 21 positive and 40 negative AD-1 assays. There were two false positive and no false negatives AD-1 assays.

Results

The sensitivity and specificity for the AD-1 assay were 100% (95% CI, 79%–100%) and 95% (95% CI, 83%–99%), respectively. The sensitivity and specificity of the other tests ranged from 68% to 95% and 66% to 88%, respectively. The AD-1 assay results outperformed the other tests but did not reach statistical significance except for the sensitivity of the erythrocyte sedimentation rate.

Conclusion

The sensitivity and specificity of the synovial fluid AD-1 assay exceeded the sensitivity and specificity of the other currently available clinical tests evaluated here but did not reach significance. The AD-1 assay offers another test with high sensitivity and specificity for diagnosing a PJI especially in the case where the diagnosis of PJI is uncertain, but larger studies will be needed to determine significance and cost effectiveness.

Level of Evidence

Level III, diagnostic study. See the Instructions for Authors for a complete description of levels of evidence.

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Acknowledgments

We acknowledge CD Diagnostics (Wynnewood, PA, USA) for providing all the testing supplies at no cost to our institution.

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Authors and Affiliations

  1. Department of Orthopaedics, Mayo Clinic Phoenix, 5777 E Mayo Blvd., Phoenix, AZ, 85054, USA

    Joshua Bingham MD, Henry Clarke MD, Mark Spangehl MD, Adam Schwartz MD, Christopher Beauchamp MD & Brynn Goldberg RN

Authors
  1. Joshua Bingham MD
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  2. Henry Clarke MD
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  3. Mark Spangehl MD
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  4. Adam Schwartz MD
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  5. Christopher Beauchamp MD
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  6. Brynn Goldberg RN
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Corresponding author

Correspondence to Christopher Beauchamp MD.

Additional information

The institution of one or more of the authors (CB) has received, during this study period, funding support from CD Diagnostics Inc (Wynnewood, PA, USA).

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research editors and board members are on file with the publication and can be viewed on request.

Clinical Orthopaedics and Related Research neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA-approval status, of any drug or device prior to clinical use.

Each author certifies that his or her institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.

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Bingham, J., Clarke, H., Spangehl, M. et al. The Alpha Defensin-1 Biomarker Assay can be Used to Evaluate the Potentially Infected Total Joint Arthroplasty. Clin Orthop Relat Res 472, 4006–4009 (2014). https://doi.org/10.1007/s11999-014-3900-7

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  • DOI: https://doi.org/10.1007/s11999-014-3900-7

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