Evaluation of analytical performance of a new high-sensitivity immunoassay for cardiac troponin I

• Published in: Clinical chemistry and laboratory medicine Vol. 56; no. 3; pp. 492 - 501
• Main Authors: Masotti, Silvia, Prontera, Concetta, Musetti, Veronica, Storti, Simona, Ndreu, Rudina, Zucchelli, Gian Carlo, Passino, Claudio, Clerico, Aldo
• Format: Journal Article
• Language: English
• Published: Germany De Gruyter 01.03.2018; Walter De Gruyter & Company
• Subjects: analytical sensitivity; Architects; automated immunometric assays; Calcium-binding protein; cardiac biomarkers; cardiac troponins; Chemiluminescence; Coronary artery disease; Ethylenediaminetetraacetic acids; Evaluation; Female; Heart diseases; Heparin; high-sensitivity methods; Humans; Immunoassay; Immunoassay - methods; Male; Mathematical analysis; Methods; methods comparison; Middle Aged; myocardial infarction; Parameter sensitivity; Quality assessment; Quality Control; quality control materials; quality specifications; Quantitation; Regression analysis; Sensitivity; Sensitivity analysis; Sensitivity and Specificity; Troponin; Troponin I; Troponin I - blood; methods comparison; quality control materials; myocardial infarction; automated immunometric assays; cardiac biomarkers; high-sensitivity methods; analytical sensitivity; cardiac troponins; quality specifications
• ISSN: 1434-6621; 1437-4331; 1437-4331
• DOI: 10.1515/cclm-2017-0387

The study aim was to evaluate and compare the analytical performance of the new chemiluminescent immunoassay for cardiac troponin I (cTnI), called Access hs-TnI using DxI platform, with those of Access AccuTnI+3 method, and high-sensitivity (hs) cTnI method for ARCHITECT platform. The limits of blank (LoB), detection (LoD) and quantitation (LoQ) at 10% and 20% CV were evaluated according to international standardized protocols. For the evaluation of analytical performance and comparison of cTnI results, both heparinized plasma samples, collected from healthy subjects and patients with cardiac diseases, and quality control samples distributed in external quality assessment programs were used. LoB, LoD and LoQ at 20% and 10% CV values of the Access hs-cTnI method were 0.6, 1.3, 2.1 and 5.3 ng/L, respectively. Access hs-cTnI method showed analytical performance significantly better than that of Access AccuTnI+3 method and similar results to those of hs ARCHITECT cTnI method. Moreover, the cTnI concentrations measured with Access hs-cTnI method showed close linear regressions with both Access AccuTnI+3 and ARCHITECT hs-cTnI methods, although there were systematic differences between these methods. There was no difference between cTnI values measured by Access hs-cTnI in heparinized plasma and serum samples, whereas there was a significant difference between cTnI values, respectively measured in EDTA and heparin plasma samples. Access hs-cTnI has analytical sensitivity parameters significantly improved compared to Access AccuTnI+3 method and is similar to those of the high-sensitivity method using ARCHITECT platform.