Serum Hevylite® assay in the differential diagnosis of patients with high suspicion of AL Amyloidosis

Dean Yogev, Marjorie Pick, Elena Slyusarevsky, Galina Pogrebijski, Anna Pickin, Moshe E. Gatt*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Scopus citations


Introduction: AL amyloidosis (AL) is a malignant form of plasma cell dyscrasia (PCD). It is insidious, and its end-organ damage can mimic that of common diseases. At diagnosis, routine tests for monoclonal protein are insufficient for the differential diagnosis. We hypothesized that Hevylite® (HLC) isotype patterns may help discriminate between AL and benign PCD states. Methods: Serum samples of patients with a high clinical suspicion of AL were prospectively tested for IgGκ, IgGλ, IgAκ, IgAλ, IgMκ, and IgMλ concentrations and ratios using Hevylite® assays in a blinded manner. The results were correlated with the final diagnosis. Results: Of the 99 samples analyzed, 46 were newly diagnosed AL, and the majority, 38 (82.6%), presented with suppression of at least one HLC isotype. Of the 53 benign PCD patients, 36 (67.9%) presented with elevation of at least one HLC isotype. By multivariate analysis, Hevylite® was the best independent test predictor of AL amyloidosis. HLC suppression had an odds ratio (OR) of 14.591, and elevation an OR of 10.149, and thus were significant variables in the diagnosis and exclusion of AL. Furthermore, patients with both HLC suppression, together with no elevation, had an OR of 316.69 to be diagnosed with AL rather than a benign PCD. Conclusions: Hevylite® HLC analysis for Ig isotypes patterns offers an effective non-invasive tool in the evaluation of patients with high suspicion of AL and may assist further explorative decisions for diagnosis.

Original languageAmerican English
Pages (from-to)418-425
Number of pages8
JournalInternational Journal of Laboratory Hematology
Issue number3
StatePublished - Jun 2021

Bibliographical note

Funding Information:
The serum samples were analyzed in a blinded manner and independently by the Binding Site laboratories. However, this project was not funded by The Binding site and had no external funding.

Publisher Copyright:
© 2021 John Wiley & Sons Ltd


  • AL Amyloidosis
  • Hevylite assay
  • MGUS
  • light chain


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