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|Author(s):||James E. Noble; David M. Bunk; R. H. Christenson; Kenneth D. Cole; Hua-Jun He; Alexei Katrukha; Mauro Panteghini; Robert Porter; Heinz Schimmel; Jillian Tate; Lili Wang;|
|Title:||Development of a Candidate Secondary Reference Procedure (immunoassay based measurement procedure of higher metrological order) for Cardiac Troponin I: I. Antibody Characterization and Preliminary Validation|
|Published:||November 01, 2010|
|Abstract:||The development of a reference measurement procedure to support the cardiac troponin I (cTnI) standardization initiative is described. The reference measurement procedure will be used to assign reference values to serum-based secondary standards. A multiplexed bead-based assay and SDS-PAGE were used to identify the optimum antibody pair; clones 560 and 19C7 for the reference assay. Described is current progress on the development of the ELISA based procedure that will need to accurately measure all isoforms of cTnI present in serum. The current RMP appears to show no bias when tested with purified samples representing various troponin complexes, phosophorylated states and heparin interference. The candidate assay displays suitable linearity and sensitivity (limit of detection of 52 ng/L) for the measurement of the proposed cTnI serum standards. Limited data with patient samples and comparison with commercial analyzers is provided to support its suitability for reference value assignment. Full validation and assessment of the procedure will be determined through round-robin studies.|
|Citation:||Clinical Chemistry and Laboratory Medicine|
|Pages:||pp. 1603 - 1610|
|Keywords:||Antigen-Antibody Reactions, Antibody Specificity, Candidate reference procedure, ELISA, Reference standards, Troponin I.|