An international multi-center serum protein electrophoresis accuracy and M-protein isotyping study. Part II: Limit of detection and follow-up of patients with small M-proteins
- Jacobs J. F. M.
- Turner K. A.
- Graziani M. S.
- Frinack J. L.
- Ettore M. W.
- Tate J. R.
- Booth R. A.
- McCudden C. R.
- Keren D. F.
- Delgado J. C.
- Zemtsovskaja G.
- Fullinfaw R. O.
- Caldini A.
- De Malmanche T.
- Katakouzinos K.
- Burke M.
- Palladini G.
- Altinier S.
- Zaninotto M.
- Righetti G.
- Melki M. T.
- Bell S.
- Willrich M. A. V.
DOIAbstract
Electrophoretic methods to detect, characterize and quantify M-proteins play an important role in the management of patients with monoclonal gammopathies (MGs). Significant uncertainty in the quantification and limit of detection (LOD) is documented when M-proteins are <10 g/L. Using spiked sera, we aimed to assess the variability in intact M-protein quantification and LOD across 16 laboratories. Sera with normal, hypo- or hyper-gammaglobulinemia were spiked with daratumumab or elotuzumab, with concentrations from 0.125 to 10 g/L (n = 62) along with a beta-migrating sample (n = 9). Laboratories blindly analyzed samples according to their serum protein electrophoresis (SPEP)/isotyping standard operating procedures. LOD and intra-laboratory p...
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