Multiplex CD30/Carbonic Anhydrase IX Lateral Flow Assay for Rapid Triage of Suspected BIA-ALCL in Peri-implant Seroma Fluid.

BACKGROUND

Breast implant-associated 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.

OBJECTIVES

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.

METHODS

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.

RESULTS

In matrix spike-in experiments, CD30 was detectable down to 500 pg/mL; CA9 was detectable down to 1000 pg/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.

CONCLUSIONS

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.

LEVEL OF EVIDENCE: 3 (THERAPEUTIC): For image description, please refer to the figure legend and surrounding text.