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

Area of Science:

• Oncology
• Biomarker Discovery
• Medical Diagnostics

Background:

• Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) affects over 1700 women.
• Early detection and removal of implants/capsules improve BIA-ALCL patient outcomes.
• A need exists for non-invasive diagnostic tools for BIA-ALCL.

Purpose of the Study:

• To develop a multiplex lateral flow assay (LFA) for detecting soluble IL-10 and CD30 in seroma fluid.
• To enable early detection of BIA-ALCL through biomarker analysis.
• To create a potential screening tool for BIA-ALCL.

Main Methods:

• Developed a multiplex LFA to detect IL-10 and CD30.
• Determined assay detection limits using recombinant proteins in benign seroma fluid.
• Analyzed clinical seroma samples from 23 BIA-ALCL patients and 17 benign cases.

Main Results:

• Assay detected CD30 at 0.5 ng/mL and IL-10 at 5 ng/mL in simulated conditions.
• Significant differences in IL-10 and CD30 levels were observed between BIA-ALCL and benign seromas.
• Visual LFA assessment yielded 65% sensitivity, improving to 87% with image analysis.

Conclusions:

• The multiplex IL-10/CD30 LFA demonstrated 100% specificity and 65% sensitivity (visual) for BIA-ALCL detection in 40 clinical seromas.
• Image analysis enhanced sensitivity to 87%, offering a promising screening method for BIA-ALCL.
• The assay showed a 100% positive predictive value and 99% negative predictive value, effectively identifying and excluding BIA-ALCL.