{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T01:01:44Z","timestamp":1791939704765,"version":"4.3.4"},"reference-count":38,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"2","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2021,1,20]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>The synovial fluid test for alpha defensin has been reported to have an excellent performance in diagnosing periprosthetic joint infection (PJI). The purpose of this study was to evaluate the performance of the lateral flow test for synovial fluid alpha defensin by using the methods of a formal diagnostic accuracy study and to compare its performance with that of the laboratory-based alpha defensin test for PJI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>We conducted a diagnostic accuracy study of the index lateral flow immunoassay for synovial fluid alpha defensin relative to the reference 2013 Musculoskeletal Infection Society (MSIS) multicriteria definition of PJI. The study included a prospective multicenter cohort of outpatients with a failed hip or knee arthroplasty and a supplemental control cohort of fresh synovial fluid specimens submitted by physicians for diagnostic PJI testing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Among 57 patients with PJI and 248 patients without PJI in the overall prospective patient cohort, the sensitivity and specificity of the alpha defensin lateral flow test were 89.5% (95% confidence interval [CI]: 78.5% to 96.0%) and 94.8% (95% CI: 91.2% to 97.2%), respectively. The sensitivity increased to 94.3% (95% CI: 84.3% to 98.8%) after exclusion of 17 patients with grossly bloody aspirates (&gt;1 million red blood cells\/\u00b5L). Among the supplemental control cohort of fresh synovial fluid samples, including 65 samples from patients with PJI and 397 from patients without PJI, the sensitivity and specificity of the alpha defensin lateral flow test were 98.5% (95% CI: 91.7% to 100.0%) and 98.2% (95% CI: 96.4% to 99.3%), respectively. A comparison of the sensitivity and specificity of the alpha defensin lateral flow test with those of the alpha defensin enzyme-linked immunosorbent assay (ELISA) in the combined cohort did not demonstrate a significant difference in sensitivity (94.3% [95% CI: 88.5% to 97.7%] compared with 93.0% [95% CI: 87.1% to 96.7%]) or specificity (96.9% [95% CI: 95.3% to 98.1%] compared with 97.8% [95% CI: 96.4% to 98.8%]) (both p &gt; 0.05).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>The results of this study demonstrate the solid diagnostic performance of the alpha defensin test and have resulted in the U.S. Food and Drug Administration (FDA) authorization of the lateral-flow test with an intended use as an aid in the clinical diagnosis of PJI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Level of Evidence:<\/jats:title>\n                    <jats:p>\n                      Diagnostic\n                      <jats:underline>Level II<\/jats:underline>\n                      . See Instructions for Authors for a complete description of levels of evidence.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.2106\/jbjs.20.00749","type":"journal-article","created":{"date-parts":[[2020,11,5]],"date-time":"2020-11-05T15:03:58Z","timestamp":1604588638000},"page":"115-122","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":40,"title":["Validation of the Alpha Defensin Lateral Flow Test for Periprosthetic Joint Infection"],"prefix":"10.2106","volume":"103","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2559-8809","authenticated-orcid":false,"given":"Carl","family":"Deirmengian","sequence":"first","affiliation":[{"name":"Department of Orthopaedic Surgery, Rothman Orthopaedic Institute, Lankenau Institute for Medical Research, Wynnewood, Pennsylvania"},{"name":"CD Diagnostics, Zimmer Biomet, Claymont, Delaware"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1513-2834","authenticated-orcid":false,"given":"John","family":"Madigan","sequence":"additional","affiliation":[{"name":"CD Diagnostics, Zimmer Biomet, Claymont, Delaware"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5796-6760","authenticated-orcid":false,"given":"Sujith","family":"Kallur Mallikarjuna","sequence":"additional","affiliation":[{"name":"CD Diagnostics, Zimmer Biomet, Claymont, Delaware"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5694-3081","authenticated-orcid":false,"given":"Janet","family":"Conway","sequence":"additional","affiliation":[{"name":"Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9143-2455","authenticated-orcid":false,"given":"Carlos","family":"Higuera","sequence":"additional","affiliation":[{"name":"Levitetz Department of Orthopaedic Surgery, Cleveland Clinic Florida, Weston, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6344-4141","authenticated-orcid":false,"given":"Robin","family":"Patel","sequence":"additional","affiliation":[{"name":"Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, and Division of Infectious Diseases, Department of Medicine, Mayo Clinic, Rochester, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2020,11,5]]},"reference":[{"key":"bib1-20250502","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1097\/01.blo.0000185756.17401.32","article-title":"The Mark Coventry Award: white blood cell gene expression: a new approach toward the study and diagnosis of infection","volume":"440","author":"Deirmengian","year":"2005","journal-title":"Clin Orthop Relat Res."},{"issue":"11","key":"bib2-20250502","doi-asserted-by":"crossref","first-page":"3254","DOI":"10.1007\/s11999-014-3543-8","article-title":"Diagnosing periprosthetic joint infection: has the era of the biomarker arrived?","volume":"472","author":"Deirmengian","year":"2014","journal-title":"Clin Orthop Relat Res."},{"issue":"2","key":"bib3-20250502","doi-asserted-by":"crossref","first-page":"456","DOI":"10.1016\/j.arth.2015.09.035","article-title":"\u03b1-defensin accuracy to diagnose periprosthetic joint infection-best available test?","volume":"31","author":"Frangiamore","year":"2016","journal-title":"J Arthroplasty."},{"issue":"12","key":"bib4-20250502","doi-asserted-by":"crossref","first-page":"4006","DOI":"10.1007\/s11999-014-3900-7","article-title":"The alpha defensin-1 biomarker assay can be used to evaluate the potentially infected total joint arthroplasty","volume":"472","author":"Bingham","year":"2014","journal-title":"Clin Orthop Relat Res."},{"issue":"17","key":"bib5-20250502","doi-asserted-by":"crossref","first-page":"1439","DOI":"10.2106\/JBJS.M.01316","article-title":"Combined measurement of synovial fluid \u03b1-defensin and C-reactive protein levels: highly accurate for diagnosing periprosthetic joint infection","volume":"96","author":"Deirmengian","year":"2014","journal-title":"J Bone Joint Surg Am."},{"issue":"2S","key":"bib6-20250502","doi-asserted-by":"crossref","first-page":"S325","DOI":"10.1016\/j.arth.2018.09.045","article-title":"Hip and Knee Section, what is the definition of a periprosthetic joint infection (PJI) of the knee and the hip? 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