Diagnostic accuracy of monoclonal antibody based serum immunoglobulin free light chain immunoassays in myeloma cast nephropathy

BACKGROUND: The development of serum immunoassays for the measurement of immunoglobulin free light chains has led to a paradigm shift in the diagnosis, assessment and monitoring of patients with plasma cell dyscrasias. The impact of these immunoassays which employ polyclonal antibodies was most notable for those patients who were previously classified as non-secretory multiple myeloma. Recently new monoclonal antibody based assays have become available. The purpose of this study was to compare the diagnostic sensitivity of these new assays with those already in clinical practice. METHODS: Sera from 30 patients who present with severe acute kidney injury and multiple myeloma were identified for analysis. A head to head comparison of the two commercially available free light chains assays was then undertaken to determine if their diagnostic sensitivity and specificity were comparable. RESULTS: In this first assessment of the utility of these new assays, we found that one of 17 patients with a lambda monoclonal free light chain resulting in acute kidney injury were not identified and a further 12% of patients were wrongly classified as having levels below those associated with disease specific acute kidney injury. CONCLUSION: These results suggest that caution should be applied to the use of new free light chain assays in the assessment of patients with a monoclonal gammopathy.