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Diagnosis of prosthetic joint infection with alpha-defensin using a lateral flow device: a multicentre study
P Berger1, M Van Cauter2, R Driesen3
1University Hospitals Leuven, Weligerveld 1, 3212 Pellenberg, Belgium.
Aims:
The purpose of this current multicentre study is to analyse the presence of alpha-defensin proteins in synovial fluid using the Synovasure lateral flow device and to determine its diagnostic reliability and accuracy compared with the prosthetic joint infection (PJI) criteria produced by the Musculoskeletal Infection Society (MSIS).
Patients And Methods:
A cohort of 121 patients comprising 85 total knee arthroplasties and 36 total hip arthroplasties was prospectively evaluated between May 2015 and June 2016 in three different orthopaedic centres. The tests were performed on patients with a chronically painful prosthesis undergoing a joint aspiration in a diagnostic pathway or during revision surgery.
Results:
Based on the MSIS criteria, 34 patients (28%) would have had a PJI, and 87 patients had no PJI. Testing with the lateral flow device had a sensitivity of 97.1% (95% confidence intervals (CI) 84.5 to 99.9) and a specificity of 96.6% (95% CI 90.3 to 99.2). The positive predictive value was 91.7% (95% CI 77.7% to 98.3), and the negative predictive value was 98.8% (95% CI 93.6 to 99.9). Receiver operator characteristics analysis demonstrated an area under the curve for the Synovasure test of 0.97 (95% CI 0.93 to 1.00).
Conclusion:
Our findings suggest that the Synovasure test has an excellent diagnostic performance to confirm or reject the diagnosis of a PJI. The results are promising for the care of the painful or problematic knee and hip joint arthroplasty and the test should be considered as part of the diagnostic toolbox for PJIs. Cite this article: Bone Joint J 2017;99-B:1176-82.
Insights
The Synovasure lateral flow device accurately detects alpha-defensin proteins in synovial fluid, offering a reliable method for diagnosing prosthetic joint infections (PJI). This test shows excellent performance for painful knee and hip arthroplasties.
Area of Science:
- Orthopaedic surgery
- Infectious disease diagnostics
- Biomarker analysis
Background:
- Prosthetic joint infection (PJI) is a significant complication following joint replacement surgery.
- Accurate and timely diagnosis of PJI is crucial for effective patient management and treatment.
- Current diagnostic criteria, such as those from the Musculoskeletal Infection Society (MSIS), are essential but can be complex.
Purpose of the Study:
- To evaluate the diagnostic accuracy of the Synovasure lateral flow device for detecting alpha-defensin proteins in synovial fluid.
- To compare the Synovasure test's performance against established MSIS criteria for diagnosing PJI.
- To assess the reliability of alpha-defensin testing in patients with painful prosthetic joints.
Main Methods:
- A prospective multicentre study involving 121 patients with painful knee or hip arthroplasties.
- Synovial fluid samples were analyzed using the Synovasure lateral flow device.
- Results were compared with diagnoses based on the MSIS criteria for PJI.
Main Results:
- The Synovasure test demonstrated high sensitivity (97.1%) and specificity (96.6%) for PJI detection.
- Positive and negative predictive values were 91.7% and 98.8%, respectively.
- Receiver operator characteristics analysis showed an area under the curve of 0.97, indicating excellent diagnostic performance.
Conclusions:
- The Synovasure test exhibits excellent diagnostic performance for confirming or excluding PJI.
- This alpha-defensin test is a promising tool for managing painful knee and hip arthroplasties.
- The Synovasure test should be considered a valuable addition to the diagnostic armamentarium for PJIs.
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