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Published on: November 13, 2021
CD30 Lateral Flow and Enzyme-Linked Immunosorbent Assays for Detection of BIA-ALCL: A Pilot Study
Victoria G Zeyl1, Haiying Xu2, Imran Khan3
1Division of Plastic Surgery, Department of Surgery, Brown Alpert School of Medicine, Providence, RI 02903, USA.
Insights
A new CD30 lateral flow assay (LFA) can rapidly distinguish Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) from benign seromas. This cost-effective test shows promise for point-of-care diagnosis by non-specialized personnel.
Area of Science:
- Oncology
- Immunology
- Biotechnology
Background:
- Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) often presents as a peri-implant effusion (seroma).
- CD30 is a key tumor marker, but its expression can also occur in benign conditions, complicating diagnosis.
- Current diagnostic methods for BIA-ALCL require specialized equipment and expertise.
Purpose of the Study:
- To develop and evaluate a rapid, cost-effective CD30 lateral flow assay (LFA) for BIA-ALCL diagnosis.
- To assess the feasibility of using LFA for point-of-care testing by non-specialized personnel.
- To differentiate BIA-ALCL seromas from benign seromas using CD30 detection.
Main Methods:
- Lateral Flow Assay (LFA) and Enzyme-Linked Immunosorbent Assay (ELISA) were performed on seroma samples from patients with confirmed BIA-ALCL and benign seromas.
- The dynamic range of CD30 detection by LFA was determined using recombinant CD30 protein.
- LFA was applied to cryopreserved seromas from BIA-ALCL and benign cases.
Main Results:
- LFA detected CD30 in BIA-ALCL seromas, with positive results in undiluted and 1:10 diluted samples.
- Benign seromas showed positive LFA results only when undiluted, becoming negative upon dilution.
- ELISA confirmed significantly higher CD30 levels in BIA-ALCL seromas compared to benign seromas.
Conclusions:
- CD30 ELISA and LFA can differentiate BIA-ALCL seromas from benign seromas.
- LFA offers a rapid (<20 min) and equipment-independent method for CD30 detection.
- The LFA shows potential for future point-of-care diagnostic applications for BIA-ALCL.
Introduction:
Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) commonly presents as a peri-implant effusion (seroma). CD30 (TNFRSF8) is a consistent marker of tumor cells but also can be expressed by activated lymphocytes in benign seromas. Diagnosis of BIA-ALCL currently includes cytology and detection of CD30 by immunohistochemistry or flow cytometry, but these studies require specialized equipment and pathologists' interpretation. We hypothesized that a CD30 lateral flow assay (LFA) could provide a less costly rapid test for soluble CD30 that eventually could be used by non-specialized personnel for point-of-care diagnosis of BIA-ALCL.
Methods:
We performed LFA for CD30 and enzyme-linked immunosorbent assay (ELISA) for 15 patients with pathologically confirmed BIA-ALCL and 10 patients with benign seromas. To determine the dynamic range of CD30 detection by LFA, we added recombinant CD30 protein to universal buffer at seven different concentrations ranging from 125 pg/mL to 10,000 pg/mL. We then performed LFA for CD30 on cryopreserved seromas of 10 patients with pathologically confirmed BIA-ALCL and 10 patients with benign seromas.
Results:
Recombinant CD30 protein added to universal buffer produced a distinct test line at concentrations higher than 1000 pg/mL and faint test lines at 250-500 pg/mL. LFA produced a positive test line for all BIA-ALCL seromas undiluted and for 8 of 10 malignant seromas at 1:10 dilution, whereas 3 of 10 benign seromas were positive undiluted but all were negative at 1:10 dilution. Undiluted CD30 LFA had a sensitivity of 100.00%, specificity of 70.00%, positive predictive value of 76.92%, and negative predictive value of 100.00% for BIA-ALCL. When specimens were diluted 1:10, sensitivity was reduced to 80.00% but specificity and positive predictive values increased to 100.00%, while negative predictive value was reduced to 88.33%. When measured by ELISA, CD30 was below 1200 pg/mL in each of six benign seromas, whereas seven BIA-ALCL seromas contained CD30 levels > 2300 pg/mL, in all but one case calculated from dilutions of 1:10 or 1:50.
Conclusions:
BIA-ALCL seromas can be distinguished from benign seromas by CD30 ELISA and LFA, but LFA requires less time (<20 min) and can be performed without special equipment by non-specialized personnel, suggesting future point-of-care testing for BIA-ALCL may be feasible.
