The College of American Pathologists (CAP) has published a new evidence-based guideline designed to bring greater consistency and accuracy to the diagnosis of amyloidosis—a rare but serious condition caused by the accumulation of abnormal amyloid deposits in the body. Earlier and more precise identification is essential for timely treatment, yet diagnosing amyloidosis has long posed challenges for laboratories and pathologists.
To develop the guideline, a multi-disciplinary expert panel reviewed more than 4,000 studies, ultimately establishing recommendations on the most reliable methods for detecting amyloid, determining fibril protein type, and assessing different specimen types. The guidance offers a clear framework for appropriate testing and subtyping of amyloid-positive samples.
“This guideline is meant to improve the consistency and accuracy of laboratory diagnoses for systemic amyloidosis,” said guideline co-chair Dylan V. Miller, MD, FCAP. “Clearer standards will support more reliable diagnoses and ultimately better outcomes for patients.”
Key Recommendations Include:
· Cytology: Useful for fat pad screening; minimally invasive but limited for subtyping.
· Congo Red Stain: Continues to be the gold standard for detecting amyloid; alternate stains must be validated.
· Fluorescence Microscopy: Can enhance Congo red sensitivity where available.
· Protein Typing: Mass spectrometry is recommended as the most accurate and sensitive method.
“Amyloid science is advancing rapidly, with new imaging, typing, and therapies reshaping the field,” noted guideline co-chair Billie Fyfe-Kirschner, MD, FCAP. “For pathologists, staying current is essential to ensure accurate diagnoses and guide patient care.”
CAP plans to reassess and update the guideline every five years—or sooner—based on significant scientific or clinical advancements.
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