Qualitative α-defensin test (Synovasure) for the diagnosis of periprosthetic infection in revision total joint arthroplasty

Sigmund, Irene Katharina; Holinka, Johannes; Gamper, Jutta; Staats, Kevin; Böhler, Christoph; Kubista, Bernd; Windhager, Reinhard

doi:10.1302/0301-620x.99b1.bjj-2016-0295.r1

Cited by 127 publications

(81 citation statements)

References 29 publications

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“…Gehrke et al, 21 Suda et al, 38 Sigmund et al, 26 and Kasparek et al 25 reported a sensitivity of the lateral flow assay of 92.1, 81.2, 76.5, and 75%, respectively, which is similar to our findings of 73.7% sensitivity. Our study showed that the test had a higher specificity of 92.2%, which is similar to the results shown by Suda et al, 85%, 38 Sigmund et al, 94.7%, 26 and Kasparek et al, 93.3%. 25 Only Gehrke et al reported a specificity of 100%, 21 which has not been replicated by other studies utilizing either the a-defensin laboratory-based immunoassay or lateral flow test.…”

Section: Discussionsupporting

confidence: 90%

“…39 When compared against other biomarkers utilizing the MSIS criteria, the Synovasure lateral flow assay appears to have good sensitivity and high specificity as well. 25,26 Utilizing the ROC curve, the test has an AUC of 0.938, which is similar to synovial WBC, and is only inferior in accuracy as a diagnostic test, to synovial PMN and having at least one positive culture. The Synovasure lateral flow assay measures the levels of a-defensin, which are produced by the synovial PMNs prior to sensitization and conversion to an adaptive immune response.…”

Section: Discussionmentioning

confidence: 99%

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Accuracy of the α-defensin lateral flow assay for diagnosing periprosthetic joint infection in Asians

Ding

Tan

Kau

et al. 2019

J Orthop Surg (Hong Kong)

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This study aimed to test the accuracy of the Synovasure ® , a-defensin lateral flow test kit, in diagnosing periprosthetic joint infections (PJIs) in a predominantly Asian population and to evaluate whether other patient or disease factors may affect its results. Methods: 61 Asian patients comprising 70 hip or knee prosthetic joints, performed between November 2015 and November 2018, were retrospectively evaluated. Cases were categorized as infected or not infected using Musculoskeletal Infection Society (MSIS) Criteria. Synovial fluid was tested for a-defensin using a commercially available kit.. Results: The Synovasure test had a sensitivity of 73.7% (95% confidence interval (CI): 48.8-90.9%) and specificity of 92.2% (95% CI: 81.1-97.8%) in an Asian population, which was slightly lower compared to previously reported studies in a predominantly Caucasian population. The positive predictive value was 77.8% (95% CI: 56.8-90.3%) and the negative predictive value was 90.4% (95% CI: 81.5-95.2%). The test had an area under curve (AUC) of the receiver operating characteristic (ROC) graph of 0.938, which represents an accuracy that is similar to synovial white blood cells (WBCs) and almost equivalent to that of synovial polymorphonuclear cells (PMNs). The presence of diabetes (p ¼ 0.26), systemic inflammatory joint disease (p ¼ 0.33), other metallic implants (p ¼ 0.53), immunosuppression (p ¼ 0.13), prior antibiotic usage (p ¼ 0.99), and chronicity of symptoms (p ¼ 0.34) was not significantly associated with a positive test in patients with PJI. Conclusion: The a-defensin lateral flow test kit is highly accurate in the diagnosis of PJI but with slightly lower sensitivity and specificity in an Asian population when compared with previous studies. The test should be used in conjunction with other MSIS criteria to provide clinically relevant and meaningful results for the diagnosis of PJI.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Accuracy of the α-defensin lateral flow assay for diagnosing periprosthetic joint infection in Asians

Ding

Tan

Kau

et al. 2019

J Orthop Surg (Hong Kong)

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“…The alpha defensin lateral flow (ADLF) is a rapid biomarker for test PJI, but the sensitivity and specificity are a controversial idea363738). In a recent study16), the ADLF test was detected PJI with sensitivity and specificity in the criteria of MSIS 84.4% and 96.4%, IDSA 67.3% and 95.5%, and EBJIS 54.4% and 99.3%.…”

Section: Diagnosismentioning

confidence: 99%

Management of Periprosthetic Joint Infection

2018

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Periprosthetic joint infection (PJI) is a serious complication after arthroplasty, which is associated with pain, prolonged hospital stay, multiple surgeries, functional incapacitation, and even mortality. Using scientific and efficient management protocol including modern diagnosis and treatment of PJI and eradication of infection is possible in a high percentage of affected patients. In this article, we review the current knowledge in epidemiology, classification, pathogenesis, diagnosis and treatment of PJI.

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“…To assess the performance of alpha defensin lateral flow (ADLF) test for the diagnosis of PJI three classification systems were used [15,16,17,18,19,20]. When the proposed EBJIS criteria were used, the ADLF test performed worse, especially for chronic infections.…”

Section: Discussionmentioning

confidence: 99%

New Methods in the Diagnosis of Prosthetic Joint Infection

Karbysheva

Renz

Yermak

et al. 2019

Traumatology and Orthopedics of Russia

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A timely and accurate diagnosis of periprosthetic joint infection (PJI) is crucial to plan adequate treatment. Purpose of the study. To evaluate the performance of new diagnostic tests for the diagnosis of PJI. Material and Methods. The performance of novel biomarkers in synovial fluid (i.e. D-lactate and alfa-defensin), molecular test (i.e. PCR of synovial fluid and sonication fluid), new methods to dislodge biofilm from implant surface (i.e. MicroDTTect) and sonication of explanted prosthesis were investigated in patients with PJI and aseptic loosening of the prosthesis. Results. D-lactate showed better sensitivity for the diagnosis of PJI compared to leukocyte count (86% and 80%, respectively). The optimal D-lactate cut-off value was calculated at 1.26 mmol/l. The ADLF test showed sensitivity of 84%, 67% and to 54% depending on classification criteria used for the diagnosis of PJI (Musculoskeletal Infection Society (MSIS), The Infectious Diseases Society of America (IDSA) and proposed European Bone and Joint Infection Society (EBJIS) criteria, respectively). using the proposed EBJIS definition criteria, the sensitivity of the leukocyte count was significantly higher than that of the ADLF test (86% compared with 54%; p<0,001), particularly in chronic PJI (81% compared with 44%, respectively; p<0,001). The sensitivity of synovial fluid PCR was 60% and herewith comparable with synovial fluid culture (52%, p = 0,239). The sensitivity and specificity of sonication fluid culture were 58% and 100%, which was comparable to sonication fluid PCR 51% and 94%, respectively. DTT-based method showed low sensitivity for diagnosis of PJI (40%) compared to sonication (80%, p<0,01). Conclusion. Synovial fluid D-lactate demonstrated good analytical performance and diagnostic value for the diagnosis of PJI. In particular, the high sensitivity for diagnosing infection and rapid availability of the test result make synovial fluid D-lactate suitable as screening test, whereas ADLF had limited sensitivity (54%) but high specificity (>95%) and it should therefore not be used for screening, but rather as a confirmatory test for PJI. Multiplex PCR of synovial fluid and sonication fluid has similar sensitivity and specificity compared to synovial fluid culture, having the advantage of rapid availability of results (within 5 hours) and fully automated process. With further improvement of its performance and inclusion of additional primers, multiplex PCR may complement conventional cultures, especially for rapid and accurate diagnosis of low-grade PJI. Culture of samples obtained by sonication of prostheses showed better sensitivity for the microbiologic diagnosis of prosthetic hip and knee infection compared to chemical based dislodgement such as MicroDTTect.Центр костно-мышечной хирургии Шарите -Университетский медицинский комплекс Берлина, Берлин, Германия реферат Актуальность. Своевременная и точная диагностика перипротезной инфекции суставов (ППИ) имеет решающее значение для планирования соответствующей тактики лечения. Цель исследова...

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Qualitative α-defensin test (Synovasure) for the diagnosis of periprosthetic infection in revision total joint arthroplasty

Abstract: With its ease of use and rapid results after approximately ten minutes, Synovasure may be a useful adjunct in the diagnosis of PJI. Cite this article: Bone Joint J 2017;99-B:66-72.

Cited by 127 publications

References 29 publications

Accuracy of the α-defensin lateral flow assay for diagnosing periprosthetic joint infection in Asians

Accuracy of the α-defensin lateral flow assay for diagnosing periprosthetic joint infection in Asians

Management of Periprosthetic Joint Infection

New Methods in the Diagnosis of Prosthetic Joint Infection

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