Clinical evaluation of a new sensitive calcitonin assay: study of specificity

Background: Calcitonin (CT) is the most sensitive marker available for medullary thyroid carcinoma. but it lacks specificity, Procalcitonin is the precursor protein of calcitonin. Infections are known to be associated with elevations of procalcitonin, The aim of this study was to evaluate a new sensitive calcitonin assay in a large population and to study the assay specificity in two particular populations: patients with renal failure and patients hospitalized in intensive care units with a high procalcitonin level. Methods: Using two immunometric assays (A and B) to detect only mature calcitonin. we evaluated the calcitonin level in 488 sera (46 stimulation tests) from 340 subjects. Results: The clinical evaluation showed that the calcitonin concentrations obtained with the two assays were similar for all patients except those with high procalcitonin levels. Among the patients, 12% (n = 13) had basal calcitonin concentrations greater than 10 pg/ml with method A and 25.7% (n = 25) with kit B. No correlation was found between calcitonin and procalcitonin concentrations. Conclusion: The new sensitive calcitonin assay tested is very efficient especially for the low concentrations. The cross-reaction for high procalcitonin levels exists and is variable according to the kits used. The procalcitonin evaluation can help the interpretation of ambiguous calcitonin levels. (C) 2001 Elsevier Science B.V. All rights reserved.