Editorial Type: research-article
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Online Publication Date: 24 Nov 2025

Laboratory Workup of Amyloidosis

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Article Category: Research Article
DOI: 10.5858/arpa.2025-0275-CP
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Context.—

Treatments are available for common forms of systemic amyloidosis that show promise for extending and improving the quality of life for patients. Early diagnosis and accurate identification of amyloid fibril type are crucial for successful treatment, but the diagnosis and workup of amyloidosis, is inconsistent among pathologists and laboratories. Thus, the goal of this guideline is to offer recommendations for proper testing and workup for amyloidosis to optimize patient care.

Objective.—

To establish evidence-based recommendations for appropriate laboratory testing to detect amyloidosis and identify the specific amyloidogenic protein.

Design.—

The College of American Pathologists convened a panel of experts to develop recommendations following the standards established by the National Academy of Medicine for developing trustworthy clinical practice guidelines. The panel conducted a systematic literature review addressing 6 key questions. Using the Grading of Recommendations Assessment, Development and Evaluation framework, recommendations were created based on the available evidence, certainty of that evidence, and key judgments as defined in the framework.

Results.—

Four conditional recommendations and 3 good practice statements were established to provide guidance for proper testing and workup of amyloidosis.

Conclusions.—

This guideline summarizes the available evidence on the diagnosis and workup of systemic amyloidosis in tissue samples, including the challenges and limitations of common approaches and techniques. Recommendations for pathologists and laboratories receiving these samples are provided.

Copyright: © 2025 College of American Pathologists 2025
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Contributor Notes

Corresponding author: Dylan V. Miller, MD, Utah Pathology Services, Inc, Intermountain Healthcare Central Region Hospitals, Department of Pathology, 5252 South Intermountain Dr, Salt Lake City, UT 84107 (email: dylan.miller@imail2.org).

Supplemental digital content is available for this article. See text for hyperlink.

Author disclosures of potential conflicts of interest and author contributions are found in the Appendix at the end of this article.

Miller and Fyfe are the Guideline Expert Panel cochairs

Accepted: 15 Oct 2025
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