Work

Initial Results of a Lateral Flow Assay for Diagnosis of Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) in Peri-Implant Seromas

Year: 2022

Type: article

Abstract: PURPOSE: Approximately 80% of women with BIA-ALCL present with a peri-implant delayed effusion (seroma). Most peri-implant seromas are due to other (benign) causes. Current patient management involves fluid analysis by cytology supplemented with CD30 immunohistochemistry and/or flow cytometry. ELISA offers an alternative method but requires special equipment and is not suitable for point of care testing. Here we present results of a new CD30 lateral flow assay (LFA) which can distinguish BIA-ALCL from benign seromas in minutes using less than one milliliter of fluid. METHOD: We used Universal LFA strips that consist of a nitrocellulose membrane containing a test line of immobilized anti-Ulfa-Tag antibody that binds an Ulfa-Tag conjugated capture antibody which further binds the analyte, in this case CD30, in complex with a Gold-detection antibody. A red T-line appears when CD30 is present, and the line intensity varies depending on CD30 concentration. Universal LFA strips also contain a control line to show the test is valid, and an absorbent pad to promote and control flow of sample through the membrane. Previously confirmed malignant (N=5) and benign (N=5) seromas were analyzed and compared using the LFA for detection of CD30 in undiluted and 1:10 diluted seromas. Detection of CD30 at the test line was visualized in 20 minutes or less. RESULTS: Five malignant and five benign cryopreserved seromas were tested with LFA. A positive red test line was observed for all malignant seromas at undiluted and 1:10 dilutions. A faint red test line was observed in three undiluted benign seromas but not in two benign seromas. No red test line was observed in the five benign seromas at 1:10 dilution enabling distinction from malignant seromas. The current analysis was done on cryopreserved repeatedly thawed seromas; it is anticipated that decisive results will be obtained in undiluted or lower dilutions of fresh seromas. The distinction of malignant from benign seromas remained possible in clinically bloody seromas. CONCLUSION: LFA provides a rapid, easily-accessible alternative to ELISA for diagnosis of BIA-ALCL. When confirmed in a larger series of cases and made available to surgeons and radiologists, this point of care test may more readily distinguish BIA-ALCL from benign seromas.

Source: Plastic & Reconstructive Surgery Global Open

DOI: 10.1097/01.gox.0000898424.01133.4f