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Does the Alpha-defensin Immunoassay or the Lateral Flow Test Have Better Diagnostic Value for Periprosthetic Joint Infection? A Systematic Review

Eriksson, Hannah, K., MD; Nordström, Jakob, MS; Gabrysch, Katja, PhD; Hailer, Nils, P., MD; Lazarinis, Stergios, MD, PhD

Clinical Orthopaedics and Related Research: May 2018 - Volume 476 - Issue 5 - p 1065–1072
doi: 10.1007/s11999.0000000000000244
Clinical Research

Background Measuring alpha-defensin concentrations in synovial fluid may help to diagnose periprosthetic joint infection (PJI). There are two commercially available methods for measuring alpha-defensin in synovial fluid: the enzyme-linked immunosorbent assay-based Synovasure® alpha-defensin immunoassay, which gives a numeric readout within 24 hours, and the Synovasure lateral flow test, which gives a binary readout within 20 minutes. There is no compilation of the existing literature to support the use of one of these two tests over the other.

Questions/purposes Does the immunoassay or the lateral flow test have better diagnostic value (sensitivity and specificity) in diagnosing PJI?

Methods We followed PRISMA guidelines and identified all studies on alpha-defensin concentration in synovial fluid as a PJI diagnostic marker, indexed to April 14, 2017, in PubMed, JSTOR, Google Scholar, and OVID databases. The search retrieved 1578 records. All prospective and retrospective studies on alpha-defensin as a PJI marker (PJI classified according to the criteria of the Musculoskeletal Infection Society) after THA or TKA were included in the analysis. All studies used only one of the two commercially available test methods, but none of them was comparative. After excluding studies with overlapping patient populations, four studies investigating the alpha-defensin immunoassay and three investigating the lateral flow test remained. Alpha-defensin immunoassay studies included 482 joints and lateral flow test studies included 119. The quality of the trials was assessed according to the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. The heterogeneity among studies was evaluated by the I2 index, indicating that the heterogeneity of the included studies was low. Pooled sensitivity, specificity, positive and negative likelihood ratios, and receiver operating curves were calculated for each method and compared with each other.

Results The alpha-defensin immunoassay had superior overall diagnostic value compared with the lateral flow test (area under the curve, 0.98 versus 0.75) with higher sensitivity (96% [90%-98%] versus 71% [55%-83%], p < 0.001), but no difference in specificity with the numbers available (96% [93%-97%] versus 90% [81%-95%], p = 0.060).

Conclusions Measurement of alpha-defensin in synovial fluid is a valuable complement to existing diagnostic criteria, and the immunoassay test detects PJI more accurately than the lateral flow test. The lateral flow test has lower sensitivity, making it difficult to rule out infection, but its relatively high specificity combined with the advantage of a quick response time can make it useful to rule in infection perioperatively.

Level of Evidence Level III, diagnostic study.

H. K. Eriksson, J. Nordström, N. P. Hailer, S. Lazarinis, Department of Surgical Sciences/Orthopaedics, Uppsala University Hospital, Uppsala, Sweden

K. Gabrysch, UCR | Uppsala Clinical Research Center, Uppsala, Sweden

H. K. Eriksson, Department of Surgical Sciences/Orthopaedics, Uppsala University Hospital, SE-751 85 Uppsala, Sweden, e-mail: hannah.eriksson@surgsci.uu.se

One of the authors (SL) received advisors’ fees in the amount of less than USD 10,000 as a member of the board of infection management for Zimmer Biomet EMEA (Winterthur, Switzerland). One of the authors (NPH) received institutional support in the amount of USD 10,000 to USD 100,000 from Zimmer Biomet for an unrelated research project.

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 before clinical use.

This work was performed at Uppsala University Hospital, Uppsala, Sweden.

Received September 06, 2017

Accepted February 02, 2018

© 2018 Lippincott Williams & Wilkins LWW
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