Biochemical triple testing to exclude monoclonal gammopathy for non-biopsy diagnosis of transthyretin amyloid cardiomyopathy

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Non-biopsy diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) using technetium bone scintigraphy is well established in patients with heart failure whose echocardiogram or cardiac magnetic resonance scan suggests amyloidosis.1 A critical component of the non-biopsy diagnostic algorithm is exclusion of cardiac AL amyloidosis, which is associated with substantial bone tracer uptake in up to 10% of patients, by excluding the presence of a monoclonal gammopathy. The original validation and current consensus for non-biopsy diagnosis of ATTR-CM require meticulous exclusion of monoclonal gammopathy, performed in parallel with bone scintigraphy, using three complementary methods—serum protein electrophoresis with immunofixation (SPEP/IFE); urine protein electrophoresis with immunofixation (UPEP/IFE); and serum free light chain (sFLC) assay. However, our real-world experience in a national amyloidosis referral centre has highlighted frequent omission of one or more of these assays, most often failure to perform immunofixation in blood and/or urine. To evaluate the requirement to use all three biochemical tests (triple testing), we analysed the results from 4949 untreated patients with proven systemic AL amyloidosis who underwent diagnostic evaluation at the UK National Amyloidosis Centre including a full biochemical screen.

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