Multiplex Lateral Flow Assay Combining CD30 and IL-10 for the Detection of BIA-ALCL.

Abstract

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has affected more than 1700 women. Treatment morbidity is reduced and survival improved by early detection and removal of implant and capsule. To address the need for early detection, we developed a multiplex lateral flow assay (LFA) for soluble IL-10 and CD30 in seromas surrounding implants. The range of detection was determined with recombinant CD30 or IL-10 added to a benign seroma to simulate clinical conditions. Then clinical samples from 23 women with BIA-ALCL and 17 benign seromas were analyzed with a multiplex LFA detecting soluble IL-10 and CD30. When recombinant proteins were added to benign seromas, CD30 was detected down to a concentration of 0.5 ng/mL, and IL-10 could be detected to down to 5 ng/mL. Significant differences were found between CD30 and IL-10 test line/control line ratios (TL/CL) of 23 BIA-ALCL and 17 benign seromas. Visual inspection of LFAs resulted in 65% sensitivity, and improved to 87% with image analysis. We conclude that the multiplex IL-10/CD30 can detect BIA-ALCL with 100% specificity and 65% sensitivity in this group of 40 clinical seromas based on visual assessment of LFA strips. Sensitivity was improved to 87% with image analysis, which can provide a screening test for BIA-ALCL. The multiplex LFA demonstrated a perfect positive predictive value (100%), indicating that all positive results correctly identified BIA-ALCL cases. The negative predictive value of 99% can exclude BIA-ALCL.