Background: Capillary electrophoresis and Immunodisplacement assays are used clinically in the evaluation of monoclonal immunoglobulins, similar to assays using gel electrophoresis. In a side-by-side comparison, the performance of a predicate technology and a novel instrument was compared to assess the suitability of the new equipment for clinical use. Methods: 340 venous blood serum samples were analyzed by the two methods at two sites in two different countries. The same protocol and reagents were employed at each site. Results: The new instrument, V8 UltraCE ID, identified seven additional specimens with monoclonal immunoglobulins, yielding 157 positive results by V8 UltraCE ID and 150 by V8 Nexus ID. The new equipment had the added advantage of a shorter run time. Conclusions: The V8 UltraCE ID has superior analytical performance over the existing method and provides greater operational efficiency in analyzing serum samples for the identification of monoclonal gammopathic lesions.
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