Immunotyping Provides Equivalent Results to Immunofixation in a Population with a High Prevalence of Monoclonal Gammopathies.

BACKGROUND: Serum immunofixation (IF) is a common laboratory test used to diagnose and monitor patients with monoclonal gammopathies. Similarly, immunotyping (IT) by capillary electrophoresis can confirm the presence of a monoclonal protein (M-protein) and determine its isotype. The goal of this study was to compare the ability of IT and IF to detect M-proteins.
METHODS: IT and IF results for 1000 waste clinical serum samples were obtained. All results were interpreted blindly by reviewers who were experienced in each technique. Results were compared by band. Results were also compared to patient history to determine if the original clone was present. We determined the sensitivity of IT and IF alone and in combination with additional tests. Finally, we evaluated the impact of reviewer training on the sensitivity of IT.
RESULTS: IT and IF were concordant in 721/773 (93%) samples with a history of an intact M-protein and in 143/172 (83%) samples with a history of a free light chain (FLC) M-protein. IF was significantly more sensitive than IT for the detection of FLC M-proteins (P < 0.0001). However, IF was not more sensitive than IT for detection of intact M-proteins (P = 0.1272) or when each test was combined with the FLC ratio or urine immunofixation (P = 0.2812 and P = 0.6171, respectively). Finally, after training, inexperienced reviewers improved their IT sensitivity by 19%.
CONCLUSION: IT provides equivalent results to IF for the detection of monoclonal proteins. Training and experience are critical to the accurate interpretation of IT. © American Association for Clinical Chemistry 2021. All rights reserved. For permissions, please email: journals.permissions@oup.com.