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Intraoperative Diagnosis of Periprosthetic Joint Infection Using a Novel Alpha-Defensin Lateral Flow Assay
Maximilian F Kasparek1, Michael Kasparek2, Friedrich Boettner1
1Department of Adult Reconstruction and Joint Replacement Division, Hospital for Special Surgery, New York, New York.
Background:
The present study investigates the novel Synovasure periprosthetic joint infection (PJI) lateral flow test device for detection of alpha-defensin and attempts to determine its diagnostic accuracy for the intraoperative diagnosis of PJI and compares it to frozen section.
Methods:
Forty consecutive patients, who underwent revision surgery, between September 2014 and September 2015 were included. The patients underwent 29 revision total knee arthroplasties and 11 revision total hip arthroplasties. Twelve patients had a confirmed PJI based on Musculoskeletal Infection Society criteria, and 28 patients were considered aseptic.
Results:
The overall accuracy to detect PJI using the lateral flow assay was 85% (95% CI 70%-93%). The device has a positive predictive value of 80% (95% CI 44%-96%) and a negative predictive value of 87% (95% CI 68%-96%) and showed a sensitivity of 67% (95% CI 35%-89%) and specificity of 93% (95% CI 75%-99%). Frozen section had a lower sensitivity (58% [95% CI 29%-84%]) but a higher specificity (96% [95% CI 80%-100%]). Receiver operator curve analysis demonstrates an area under the curve of the Synovasure PJI Lateral Flow Test Kit and frozen section of 0.80 and 0.77, respectively.
Conclusion:
The present study suggests that the intraoperative lateral flow test is at least equivalent to intraoperative frozen section and is a useful tool to confirm the absence of PJI. Although the clinical results are promising, they are not as good as previous studies using alpha-defensin levels measured in a laboratory.
Insights
The Synovasure lateral flow test aids in diagnosing periprosthetic joint infection (PJI) during surgery. This test is comparable to frozen section, proving useful for ruling out PJI.
Area of Science:
- Orthopedic surgery
- Infectious disease diagnostics
Background:
- Periprosthetic joint infection (PJI) is a severe complication of arthroplasty.
- Accurate intraoperative diagnosis of PJI is crucial for effective treatment.
- Novel diagnostic tools are needed to improve PJI detection rates.
Purpose of the Study:
- To evaluate the diagnostic accuracy of the Synovasure lateral flow test for intraoperative PJI diagnosis.
- To compare the Synovasure test's performance against intraoperative frozen section analysis.
- To assess the utility of alpha-defensin detection in diagnosing PJI.
Main Methods:
- A prospective study included 40 patients undergoing revision arthroplasty (29 knee, 11 hip).
- Synovasure lateral flow test results were compared with frozen section and final PJI diagnosis based on established criteria.
- Patient samples were analyzed for alpha-defensin levels.
Main Results:
- The Synovasure test demonstrated an overall accuracy of 85% for PJI detection.
- Sensitivity was 67% and specificity was 93% for the lateral flow test.
- Frozen section showed lower sensitivity (58%) but higher specificity (96%).
Conclusions:
- The intraoperative lateral flow test is a valuable tool for confirming the absence of PJI.
- Its diagnostic performance is comparable to intraoperative frozen section.
- While promising, further research is needed to optimize alpha-defensin-based diagnostics for PJI.
