Abstract
ObjectivesRecent reference interval studies of the serum free light chain (FLC) test using contemporary instruments display divergence with the diagnostic range generally adopted as the international standard. In this study, we perform a retrospective reference interval analysis with risk predictions for monoclonal gammopathy. MethodsRetrospective laboratory and clinical data for 8,986 patients were included in the study. Reference intervals were generated against a set of inclusion/exclusion criteria for two time periods representing the use of different instruments. The presence of monoclonal gammopathy was established from diagnostic test interpretations and EHR diagnosis codes in the patient problem lists and medical history. ResultsThe 95% FLC ratio reference intervals were 0.76–2.38 for SPAPLUS®, and 0.68–1.82 for Optilite® instruments. These intervals varied considerably from the current diagnostic range of 0.26–1.65 and mapped approximately to the FLC ratios beyond which risk of monoclonal gammopathy substantially increased. ConclusionsThese findings corroborate recent reference interval studies and support recommendations for independent re-evaluation of intervals by institutions as well as an update of international guidelines.
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