Standardisation of Troponin I Measurements: an Update

Standardization of cardiac troponin I (cTnI) measurement is important because of the central role for diagnosos of myocardial infarction. In blood, cTnI is present as a heterogeneous mixture of differnent molecular species. The analytical problem caused by this microheterogeneity may be circumvented by recognition of a unique, invariant part of the molecule that is common to all components of the mixture. Antibodies used for development of cTnI assays should selectively recognize epitopes within this invariant part, leading to a consequential increase on the homogeneity of immonuassay reactivity. This should be associated with the use of a reference material (RM) that represents the natural and major antigen in blood after tissue release, i.e. the troponin complex. Although a primary RM for cTnI is available, studies indicate that cTnI assays remain without harmony after recalibration using this material. In order to achieve closer comparability of cTnI values between assays, the use of a secondary RM, consisting of a panel of human serum pools, is proposed for use by manufacturers to calibrate their assays. To assign true cTnI concentration values to this secondary RM, establishment of a reference measurement procedure for cTnI is required. A practical approach to the development of a reference procedure could be to design an immunochemical assay with well-characterized specificity to the invariant part of the cTnI molecule and calibrated using the primary RM.

PANTEGHINI M.;  BUNK David;  CHRISTENSON Robert;  KATRUKHA Alexei;  PORTER Robert A.;  SCHIMMEL Heinz;  WANG Lili;  TATE Jilian; 

2008-12-19

WALTER DE GRUYTER & CO

JRC45665

1434-6621,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC45665,   

10.1515/CCLM.2008.291,