This review highlights the analytical characteristics and clinical evaluation needs of modern high- and ultra-sensitive cardiac troponin immunoassays.
Recently, there have been some important changes in the laboratory diagnosis of patients with acute coronary syndrome, due to the introduction into routine practice of new high- and ultra-sensitive techniques for detection of myocardial damage biomarkers — cardiac troponins. Each method for cardiac troponins’ detection, among the existing wide variety of troponin immunoassays, has different analytical characteristics and allows the detection of different concentrations of troponins in the same patient. With an increasing number of companies developing high-sensitivity troponin immunoassays receiving regulatory approval, there is an urgent need for independent analytical and clinical evaluation of each method. This article discusses high- and ultrasensitive techniques for detection of cardiac troponins. The modern data on biochemical and metabolic characteristics of troponins, obtained using high- and ultra-sensitive techniques, are described: sex, age, circadian features and potential for detecting troponins in other biological fluids. Considerable attention is paid to the analytical characteristics of troponin immunoassays: limit of blank, limit of detection and limit of quantitation, coefficient of variation, as well as the 99th percentile and factors influencing it.
Chaulin et al. (Sun,) studied this question.