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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Jarolim, Petr Patel, Purvish P. Conrad, Michael J. Chang, Lei Melenovsky, Vojtech Wilson, David H. |
| Description | Author Affiliation: Jarolim P ( Brigham and Women's Hospital and Harvard Medical School, Boston, MA); Patel PP ( Quanterix Corporation, Lexington, MA); Conrad MJ ( Brigham and Women's Hospital and.); Chang L ( Quanterix Corporation, Lexington, MA); Melenovsky V ( Institute for Clinical and Experimental Medicine, Prague, Czech Republic.); Wilson DH ( Quanterix Corporation, Lexington, MA) |
| Abstract | BACKGROUND: The association between increases in cardiac troponin and adverse cardiac outcomes is well established. There is a growing interest in exploring routine cardiac troponin monitoring as a potential early indicator of adverse heart health trends. Prognostic use of cardiac troponin measurements requires an assay with very high sensitivity and outstanding analytical performance. We report development and preliminary validation of an investigational assay meeting these requirements and demonstrate its applicability to cohorts of healthy individuals and patients with heart failure. METHODS: On the basis of single molecule array technology, we developed a 45-min immunoassay for cardiac troponin I (cTnI) for use on a novel, fully automated digital analyzer. We characterized its analytical performance and measured cTnI in healthy individuals and heart failure patients in a preliminary study of assay analytical efficacy. RESULTS: The assay exhibited a limit of detection of 0.01 ng/L, a limit of quantification of 0.08 ng/L, and a total CV of 10% at 2.0 ng/L. cTnI concentrations were well above the assay limit of detection for all samples tested, including samples from healthy individuals. cTnI was significantly higher in heart failure patients, and exhibited increasing median and interquartile concentrations with increasing New York Heart Association classification of heart failure severity. CONCLUSIONS: The robust 2-log increase in sensitivity relative to contemporary high-sensitivity cardiac troponin immunoassays, combined with full automation, make this assay suitable for exploring cTnI concentrations in cohorts of healthy individuals and for the potential prognostic application of serial cardiac troponin measurements in both apparently healthy and diseased individuals. |
| File Format | HTM / HTML |
| ISSN | 00099147 |
| e-ISSN | 15308561 |
| Journal | Clinical Chemistry |
| Issue Number | 10 |
| Volume Number | 61 |
| Language | English |
| Publisher | American Association for Clinical Chemistry |
| Publisher Date | 2015-10-01 |
| Publisher Place | United States |
| Access Restriction | Open |
| Subject Keyword | Immunoassay Research Support, Non-u.s. Gov't Discipline Laboratory Medicine Blood Limit Of Detection Discipline Clinical Chemistry Troponin I Heart Failure Protein Array Analysis Diagnosis |
| Content Type | Text |
| Resource Type | Article |
| Subject | Biochemistry (medical) Clinical Biochemistry |
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