{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T00:44:45Z","timestamp":1792025085589,"version":"4.4.0"},"reference-count":14,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T00:00:00Z","timestamp":1774828800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Aesthetic Foundation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,10,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Breast implant\u2013associated anaplastic large cell lymphoma (BIA-ALCL) is a rare lymphoma associated with textured implants. Earlier detection and timely implant removal\/capsulectomy reduce morbidity and improve outcomes. CD30 is a sensitive biomarker for BIA-ALCL; carbonic anhydrase IX (CA9) has been identified as a complementary marker in effusion samples.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>The aim was to develop and evaluate a multiplex lateral flow assay (LFA) for CD30 and CA9 in peri-implant seroma fluid\/effusions to support rapid clinical triage of suspected BIA-ALCL.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Recombinant CD30 and CA9 were spiked into benign seroma matrix to establish assay detection range under defined conditions. A retrospective cohort of 50 seroma samples (25 pathologically confirmed BIA-ALCL; 25 benign seromas) was tested. Performance was assessed by (1) visual interpretation; (2) image-based quantification (test line\/control line ratio, TL\/CL); and (3) combined interpretation approach. Sensitivity, specificity, predictive values (study-conditional), and receiver operating characteristic\/area under the curve (ROC\/AUC) were calculated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In matrix spike-in experiments, CD30 was detectable down to 500\u2005pg\/mL; CA9 was detectable down to 1000\u2005pg\/mL. In clinical samples, both CD30 and CA9 TL\/CL were significantly higher in BIA-ALCL than benign seromas. Visual interpretation yielded 76% sensitivity and 88% specificity. Image-based interpretation increased sensitivity to 96% but reduced specificity to 80%. A prespecified combined interpretation approach maintained 96% sensitivity and 88% specificity (positive predictive value [PPV] 89%, negative predictive value [NPV] 96% within this case-control cohort). ROC analysis demonstrated AUC of 0.96 for CD30 and 0.85 for CA9.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this retrospective cohort, a multiplex CD30\/CA9 LFA distinguished BIA-ALCL from benign peri-implant seromas with high sensitivity and favorable study-conditional NPV, supporting feasibility as a rapid triage adjunct to prioritize confirmatory pathology. Prospective studies with standardized preanalytics, blinded interpretation, and prevalence-representative cohorts are required to establish real-world predictive values and clinical utility.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Level of Evidence: 3 (Therapeutic)<\/jats:title>\n                    <jats:p>For image description, please refer to the figure legend and surrounding text.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/asj\/sjag066","type":"journal-article","created":{"date-parts":[[2026,3,29]],"date-time":"2026-03-29T11:33:15Z","timestamp":1774783995000},"page":"1205-1211","source":"Crossref","is-referenced-by-count":1,"title":["Multiplex CD30\/Carbonic Anhydrase IX Lateral Flow Assay for Rapid Triage of Suspected BIA-ALCL in Peri-implant Seroma 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