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Screening and Diagnosis of Monoclonal Gammopathies: An International Survey of Laboratory Practice
Jonathan R Genzen, David L Murray, Gyorgy Abel
1From the Department of Pathology, University of Utah, Salt Lake City, and ARUP Laboratories, Salt Lake City, Utah (Drs Genzen and Delgado); the Department of Laboratory Medicine, Mayo Clinic, Rochester, Minnesota (Dr Murray); the Department of Laboratory Medicine, Lahey Hospital & Medical Center, Burlington, Massachusetts (Dr Abel); the Department of Laboratory Medicine, University of Texas MD Anderson Cancer Center, Houston (Dr Meng); the Department of Pathology and Laboratory Medicine, East Carolina University, Greenville, North Carolina (Dr Baltaro); the Department of Pathology, Case Western Reserve University, Cleveland, Ohio (Dr Rhoads); the Department of Surveys, College of American Pathologists, Northfield, Illinois (Mss Souers and Bashleben); the Department of Pathology, University of Michigan, Ann Arbor (Dr Keren); and the Department of Pathology and Laboratory Medicine, Louis Stokes Veterans Affairs Medical Center, Cleveland, Ohio (Dr Ansari).
Context:
- Serum tests used for the screening and diagnosis of monoclonal gammopathies include serum protein electrophoresis (SPE; agarose gel or capillary zone), immunofixation (IFE) and immunosubtraction capillary electrophoresis, serum free light chains, quantitative immunoglobulins, and heavy/light-chain combinations. Urine protein electrophoresis and urine IFE may also be used to identify Bence-Jones proteinuria.
Objective:
- To assess current laboratory practice for monoclonal gammopathy testing.
Design:
- In April 2016, a voluntary questionnaire was distributed to 923 laboratories participating in a protein electrophoresis proficiency testing survey.
Results:
- Seven hundred seventy-four laboratories from 38 countries and regions completed the questionnaire (83.9% response rate; 774 of 923). The majority of participants (68.6%; 520 of 758) used agarose gel electrophoresis as their SPE method, whereas 31.4% (238 of 758) used capillary zone electrophoresis. The most common test approaches used in screening were SPE with reflex to IFE/immunosubtraction capillary electrophoresis (39.3%; 299 of 760); SPE only (19.1%; 145 of 760); SPE and IFE or immunosubtraction capillary electrophoresis (13.9%; 106 of 760); and SPE with IFE, serum free light chain, and quantitative immunoglobulins (11.8%; 90 of 760). Only 39.8% (305 of 767) of laboratories offered panel testing for ordering convenience. Although SPE was used by most laboratories in diagnosing new cases of myeloma, when laboratories reported the primary test used to follow patients with monoclonal gammopathy, only 55.7% (403 of 724) chose SPE, with the next most common selections being IFE (18.9%; 137 of 724), serum free light chain (11.7%; 85 of 724), and immunosubtraction capillary electrophoresis (2.1%; 15 of 724).
Conclusions:
- Ordering and testing practices for the screening and diagnosis of monoclonal gammopathy vary widely across laboratories. Improving utilization management and report content, as well as recognition and development of laboratory-directed testing guidelines, may serve to enhance the clinical value of testing.
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