Multicenter analytical evaluation of a high-sensitivity troponin T assay
2011 (English)In: Clinica Chimica Acta, ISSN 0009-8981, E-ISSN 1873-3492, Vol. 412, no 9-10, 748-754 p.Article in journal (Refereed) Published
Background: High-sensitivity cardiac troponin assays are being introduced clinically for earlier diagnosis of acute myocardial infarction (AMI). We evaluated the analytical performance of a high-sensitivity cardiac troponin T assay (hscTnT. Roche Diagnostics) in a multicenter, international trial. Methods: Three US and 5 European sites evaluated hscTnT on the Modular (R) Analytics E170, cobas (R) 6000, Elecsys 2010, and cobas (R) e 411. Precision, accuracy, reportable range, an inter-laboratory comparison trial, and the 99th percentile of a reference population were assessed. Results: Total imprecision (CVs) were 4.6-36.8% between 3.4 and 10.3 ng/L hscTnT. Assay linearity was up to 10,000 ng/L and the limit of blank and detection were 3 and 5 ng/L, respectively. The 99th percentile reference limit was 14.2 ng/L (n = 533). No significant differences between specimen types, assay incubation time, or reagent lots existed. A substantial positive bias (76%) exists between the 4th generation and hscTnT assays at the low end of the measuring range (< 50 ng/L). hscTnT serum pool concentrations were within 2SD limits of the mean of means in the comparison trial, indicating comparable results across multiple platforms and laboratories. Conclusion: The Roche hscTnT assay conforms to guideline precision requirements and will likely identify additional patients with myocardial injury suspicious for AMI.
Place, publisher, year, edition, pages
2011. Vol. 412, no 9-10, 748-754 p.
Troponin, 99th percentile, High-sensitivity, Acute myocardial infarction, Cardiac biomarkers
Medical and Health Sciences
IdentifiersURN: urn:nbn:se:uu:diva-151901DOI: 10.1016/j.cca.2010.12.034ISI: 000288634500012PubMedID: 21219893OAI: oai:DiVA.org:uu-151901DiVA: diva2:411638