Sufian S Ahmad1,2, Michael T Hirschmann3, Roland Becker4, Ahmed Shaker5, Atesch Ateschrang6, Marius J B Keel5,7, Christoph E Albers5, Lukas Buetikofer8, Sithombo Maqungo9, Ulrich Stöckle6, Sandro Kohl5,7. 1. Department of Orthopaedic Surgery and Traumatology, Inselspital, University Hospital of Bern, Bern, Switzerland. sufian@ahmadortho.com. 2. Department of Orthopaedic Surgery and Traumatology, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa. sufian@ahmadortho.com. 3. Department of Orthopaedic Surgery and Traumatology, Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Bruderholz, Switzerland. 4. Department of Orthopedics and Traumatology, Centre of Joint Replacement, Hospital Brandenburg, Medical School "Theodor Fontane", Hochstrasse 2, 14770, Brandenburg/havel, Germany. 5. Department of Orthopaedic Surgery and Traumatology, Inselspital, University Hospital of Bern, Bern, Switzerland. 6. Department of Traumatology and Reconstructive Surgery, BG Trauma Center Tübingen, Eberhard-Karls University of Tübingen, Tübingen, Germany. 7. Trauma Center Hirslanden, Clinic Hirslanden, Zurich, Switzerland. 8. Clinical trials unit, University of Bern, Bern, Switzerland. 9. Department of Orthopaedic Surgery and Traumatology, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.
Abstract
PURPOSE: (1) To determine the overall accuracy of synovial alpha-defensin, synovial C-reactive protein (sCRP), interleukin-6 (sIL-6), and leukocyte esterase (sLE) as diagnostic markers for periprosthetic joint infection (PJI) and (2) to independantly evaluate the accuracy of both the laboratory-based ELISA alpha-defensin test and the Synovasure™ alpha-defensin test kit. METHODS: An EMBASE and MEDLINE (PubMed) database search was performed using a set of professionally set search terms. Two independent reviewers rated eligible articles. Sensitivity and specificity were meta-analysed using a bivariate random-effects model. RESULTS: Accuracy values were extracted from 42 articles. Pooled sensitivity and specificity of the represented biomarkers were: alpha-defensin ELISA 0.97 (95% CI 0.91-0.99) and 0.97 (95% CI 0.94-0.98), respectively; Synovasure™ test kit assay 0.80 (95% CI 0.65-0.89) and 0.89 (95% CI 0.76-0.96), respectively; sLE 0.79 (95% CI 0.67-0.87) and 0.92 (95% CI 0.87-0.92), respectively; sIL-6 0.76 (95% CI 0.65-0.84) and 0.91 (95% CI 0.88-0.94), respectively; sCRP 0.86 (95% CI 0.81-0.91) and 0.90 (95% CI 0.86-0.93), respectively. CONCLUSION: The labararory-based alpha-defensin ELISA test showed the highest ever reported accuracy for PJI diagnosis. However, this did not apply for the Synovasure™ alpha-defensin test, which was comparable in its overall diagnostic accuracy to sCRP, sIL-6 and sLE. The later biomarkers also did not yield an overall diagnostic accuracy higher than that previously reported for synovial white cell count (sWBC) or culture bacteriology. Based on current evidence, no synovial biomarker should be applied as a standalone diagnostic tool. Furthermore, the use of the laboratory-based alpha-defensin ELISA test should be encouraged, still, the Synovasure™ alpha-defensin test kit should be critically appreciated. LEVER OF EVIDENCE: III.
PURPOSE: (1) To determine the overall accuracy of synovial alpha-defensin, synovial C-reactive protein (sCRP), interleukin-6 (sIL-6), and leukocyte esterase (sLE) as diagnostic markers for periprosthetic joint infection (PJI) and (2) to independantly evaluate the accuracy of both the laboratory-based ELISA alpha-defensin test and the Synovasure™ alpha-defensin test kit. METHODS: An EMBASE and MEDLINE (PubMed) database search was performed using a set of professionally set search terms. Two independent reviewers rated eligible articles. Sensitivity and specificity were meta-analysed using a bivariate random-effects model. RESULTS: Accuracy values were extracted from 42 articles. Pooled sensitivity and specificity of the represented biomarkers were: alpha-defensin ELISA 0.97 (95% CI 0.91-0.99) and 0.97 (95% CI 0.94-0.98), respectively; Synovasure™ test kit assay 0.80 (95% CI 0.65-0.89) and 0.89 (95% CI 0.76-0.96), respectively; sLE 0.79 (95% CI 0.67-0.87) and 0.92 (95% CI 0.87-0.92), respectively; sIL-6 0.76 (95% CI 0.65-0.84) and 0.91 (95% CI 0.88-0.94), respectively; sCRP 0.86 (95% CI 0.81-0.91) and 0.90 (95% CI 0.86-0.93), respectively. CONCLUSION: The labararory-based alpha-defensin ELISA test showed the highest ever reported accuracy for PJI diagnosis. However, this did not apply for the Synovasure™ alpha-defensin test, which was comparable in its overall diagnostic accuracy to sCRP, sIL-6 and sLE. The later biomarkers also did not yield an overall diagnostic accuracy higher than that previously reported for synovial white cell count (sWBC) or culture bacteriology. Based on current evidence, no synovial biomarker should be applied as a standalone diagnostic tool. Furthermore, the use of the laboratory-based alpha-defensin ELISA test should be encouraged, still, the Synovasure™ alpha-defensin test kit should be critically appreciated. LEVER OF EVIDENCE: III.
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