Characterization of Casirivimab Plus Imdevimab, Sotrovimab, and Bamlanivimab Plus Etesevimab-Derived Interference in Serum Protein Electrophoresis and Immunofixation Electrophoresis.
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2022-10
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Abstract
Background
Therapeutic monoclonal antibodies can be a source of assay interference in clinical serum protein electrophoresis (SPEP) and immunofixation electrophoresis (IFE), producing monoclonal bands that can be misinterpreted as a monoclonal gammopathy related to a B-cell or plasma cell neoplasm. The extent to which new anti-COVID-19 monoclonal antibodies produce this interference is unknown.Methods
Casirivimab plus imdevimab, sotrovimab, and bamlanivimab plus etesevimab were spiked into patient serum samples to evaluate for SPEP/IFE interference, to characterize the position of therapy-derived bands relative to a reference band (either combined beta band or beta 1 band, depending on instrument platform), and to confirm heavy and light chain utilization of each medication. Serum samples from patients who had recently received casirivimab plus imdevimab or sotrovimab were also evaluated for comparison.Results
When spiked into serum samples, all tested anti-COVID-19 monoclonal antibodies generated interference in SPEP/IFE. Importantly, the patterns of interference differed between spiked serum samples and serum from patients who had recently received casirivimab plus imdevimab or sotrovimab.Conclusions
Imdevimab can be added to the growing list of therapeutic monoclonal antibodies that produce sustained interference in SPEP/IFE. Although casirivimab and sotrovimab also produce assay interference in vitro, these antibodies are not reliably detected in serum from recently infused patients. The value of relative band position in recognizing bands that may represent therapeutic monoclonal antibodies is also emphasized. Clinicians and laboratorians should consider therapeutic monoclonal antibody interference in diagnostic SPEP/IFE and review a patient's medication list when new or transient monoclonal bands are identified.Type
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Scholl, Ashley Rose, Dimitrios Korentzelos, Taylor E Forns, Ethan K Brenneman, Matthew Kelm, Michael Datto, Sarah E Wheeler, Eric D Carlsen, et al. (2022). Characterization of Casirivimab Plus Imdevimab, Sotrovimab, and Bamlanivimab Plus Etesevimab-Derived Interference in Serum Protein Electrophoresis and Immunofixation Electrophoresis. The journal of applied laboratory medicine, 7(6). pp. 1379–1387. 10.1093/jalm/jfac064 Retrieved from https://hdl.handle.net/10161/26975.
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Michael Bradley Datto
Dr. Datto is an AP/CP/MGP board certified pathologist who specializes in molecular pathology. He is the Associate Vice President for Duke University Health System Clinical Laboratories, the Vice Chair for Clinical Pathology and Medical Director for Duke University Health System Clinical Laboratories.
In these roles, he is responsible for maintaining the standards of the College of American Pathologists and CLIA/CMS within all Clinical Laboratories at Duke. Specifically, Dr. Datto oversees clinical testing and reporting, develops quality management systems and proficiency testing programs, provides consultation with ordering physicians, ensures educational programs, develops strategic plans that are in line with the needs of our patient population, physicians and health system leadership, coordinates research and development, ensures adequate and appropriately trained personnel, and provides profession interpretation for molecular diagnostic testing including the wide range of PCR, quantitative PCR, sequencing and FISH based tests for inherited genetic diseases, hematologic malignancies, solid tumors and infectious diseases.
Dr. Datto also serves as the chair of the Accreditation Committee (AC) for the College of American Pathologists (CAP). The CAP is the largest accreditor of hospital based laboratories in the US and serves as a ‘deemed entity’ by the Center for Medicare Services. In his role of chair of the AC, Dr. Datto oversees the committee that makes clinical accreditation decisions for approximately 7,000 clinical domestic and international laboratories.
Finally, Dr. Datto has an active academic program developing data system to aggregate, normalize and utilize high complexity and high volume laboratory data. Dr. Datto and his team have developed the Molecular Registry of Tumors (Mr.T); a software solution that supports clinical trials matching, engagement with the AACR GENIE Project and the Molecular Tumor Board for Duke University Health System. The ultimate goal of this work is to ensure that the vast amount of laboratory data generated on our Duke patients can be put to use, driving better patient care, research and education.
Eric D. Carlsen
I'm a hematopathologist with interest in cutaneous and small B-cell lymphomas, molecular methods for diagnosis and prognostication of myeloid and lymphoid neoplasms, minimal residual disease modalities, infectious hematopathology, medical and GME trainee education, and emerging technology and automation in laboratory hematology. I serve as a CLIA director for several clinical laboratories on DUH's campus, including our specialty laboratories performing clinical electrophoresis and bone marrow biopsy processing. I also serve as the Program Director for Duke's Hematopathology Fellowship.
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