The Alpha-Defensin Immunoassay and Leukocyte Esterase Colorimetric Strip Test for the Diagnosis of Periprosthetic Infection

Abstract

Background: Synovial biomarkers have recently been adopted as diagnostic tools for periprosthetic joint infection (PJI), but their utility is uncertain. The purpose of this systematic review and meta-analysis was to synthesize the evidence on the accuracy of the alpha-defensin immunoassay and leukocyte esterase colorimetric strip test for the diagnosis of PJI compared with the Musculoskeletal Infection Society diagnostic criteria. Methods: We performed a systematic review to identify diagnostic technique studies evaluating the accuracy of alpha-defensin or leukocyte esterase in the diagnosis of PJI. MEDLINE and Embase on Ovid, ACM, ADS, arXiv, CERN DS (Conseil Européen pour la Recherche Nucléaire Document Server), CrossRef DOI (Digital Object Identifier), DBLP (Digital Bibliography & Library Project), Espacenet, Google Scholar, Gutenberg, HighWire, IEEE Xplore (Institute of Electrical and Electronics Engineers digital library), INSPIRE, JSTOR (Journal Storage), OAlster (Open Archives Initiative Protocol for Metadata Harvesting), Open Content, Pubget, PubMed, and Web of Science were searched for appropriate studies indexed from inception until May 30, 2015, along with unpublished or gray literature. The classification of studies and data extraction were performed independently by 2 reviewers. Data extraction permitted meta-analysis of sensitivity and specificity with construction of receiver operating characteristic curves for each test. Results: We included 11 eligible studies. The pooled diagnostic sensitivity and specificity of alpha-defensin (6 studies) for PJI were 1.00 (95% confidence interval [CI], 0.82 to 1.00) and 0.96 (95% CI, 0.89 to 0.99), respectively. The area under the curve (AUC) for alpha-defensin and PJI was 0.99 (95% CI, 0.98 to 1.00). The pooled diagnostic sensitivity and specificity of leukocyte esterase (5 studies) for PJI were 0.81 (95% CI, 0.49 to 0.95) and 0.97 (95% CI, 0.82 to 0.99), respectively. The AUC for leukocyte esterase and PJI was 0.97 (95% CI, 0.95 to 0.98). There was substantial heterogeneity among studies for both diagnostic tests. Conclusions: The diagnostic accuracy for PJI was high for both tests. Given the limited number of studies and the large cost difference between the tests, more independent research on these tests is warranted. Level of Evidence: Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence.

What is the Accuracy of Nuclear Imaging in the Assessment of Periprosthetic Knee Infection? A Meta-analysis

“…However, multiple diagnostic tests including aspiration results and laboratory tests can contribute in diagnosing periprosthetic infection, which could influence the diagnostic performance of the evaluated imaging techniques, and generally should improve their performance. During the years, important developments have been described in the diagnosis of periprosthetic infection, including the introduction of alpha defensin and synovial fluid tests [5, 54]. When the diagnostic evaluation using synovial fluid markers clearly indicates infection, there is little or no need for additional nuclear imaging tests.…”

“…The evaluation of suspected PJI is characterized by a multimodality workup including microbiologic, laboratory (elevated erythrocyte sedimentation rate, C-reactive protein [CRP]), synovial marker, and histologic tests [35, 57]. Recently, promising results have been reported regarding synovial biomarkers tests, including the alpha defensin immunoassay and synovial fluid CRP tests [5, 54]. However, these test are not yet widely available and their utility has been confirmed in only a few studies [54].…”

“…Recently, promising results have been reported regarding synovial biomarkers tests, including the alpha defensin immunoassay and synovial fluid CRP tests [5, 54]. However, these test are not yet widely available and their utility has been confirmed in only a few studies [54]. In addition to these diagnostic tests, various imaging techniques including radiographs, ultrasound, CT, MRI, bone, leukocyte, bone marrow, or antigranulocyte scintigraphy, and positron emission tomography (PET) can be used in the assessment of suspected periprosthetic knee infection [10, 11, 29, 31, 57], especially in the case of a challenging diagnosis of a chronic or low-grade infection [45–48].…”

Assessment of a Multiplex Serological Test for the Diagnosis of Prosthetic Joint Infection: a Prospective Multicentre Study

“…Both have been the subject of numerous studies. In a systematic review and meta-analysis, Wyatt et al [12] showed a high diagnostic accuracy for PJI for both tests, despite substantial heterogeneity among studies. Comparing with frozen section histology, the leukocyte esterase test strip was found to be faster and easier with low costs and has been proposed as a valuable alternative to frozen section histology [13].…”

Influence of inflammatory arthritis on leukocyte esterase strip results in the diagnosis of periprosthetic joint infection

“…Leukocyte esterase (LE) strip test has been used to detect urinary tract infections and was first applied to the diagnosis of PJI by Parvizi et al in 2011 [3]. Since then, several studies evaluated the diagnostic efficiency of the LE strip [4][5][6]. However, cases with inflammatory arthritis were always excluded in previous studies, which evaluated the diagnostic efficiency of the LE strip for PJI [7], and thus, the influence of inflammatory arthritis has not been well explored.…”