Clinical Use of a New High-Sensitivity Cardiac Troponin I Assay in Patients with Suspected Myocardial Infarction

We aimed to validate the clinical performance of the high-sensitivity cardiac troponin I [VITROS Immunodiagnostic Products hs Troponin I (hs-cTnI-VITROS)] assay. We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses...

Full description

Saved in:
Bibliographic Details
Published in:Clinical chemistry (Baltimore, Md.) Md.), 2019-11, Vol.65 (11), p.1426-1436
Main Authors: Boeddinghaus, Jasper, Twerenbold, Raphael, Nestelberger, Thomas, Koechlin, Luca, Wussler, Desiree, Meier, Mario, Troester, Valentina, Zimmermann, Tobias, Badertscher, Patrick, Wildi, Karin, Rubini Giménez, Maria, Lopez-Ayala, Pedro, Potlukova, Eliska, Miró, Òscar, Martin-Sanchez, F Javier, Kawecki, Damian, Geigy, Nicolas, Keller, Dagmar I, Reichlin, Tobias, Mueller, Christian
Format: Article
Language:English
Subjects:
Accuracy
Acute coronary syndromes
Adjudication
Aged
Aged, 80 and over
Algorithms
Angina pectoris
Architects
Area Under Curve
Assaying
Biological Assay - methods
Biomarkers - blood
Calcium-binding protein
Cardiology
Derivation
Diagnostic systems
Electrocardiography
Emergency medical services
Female
Heart
Heart attacks
Humans
Laboratories
Limit of Detection
Male
Medical imaging
Middle Aged
Myocardial infarction
Myocardial Infarction - blood
Myocardial Infarction - diagnosis
Patients
Prospective Studies
ROC Curve
Secondary analysis
Sensitivity
Subgroups
Troponin
Troponin I
Troponin I - blood
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:We aimed to validate the clinical performance of the high-sensitivity cardiac troponin I [VITROS Immunodiagnostic Products hs Troponin I (hs-cTnI-VITROS)] assay. We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by 2 independent cardiologists considering all clinical information, including cardiac imaging: first, using serial hs-cTnT-Elecsys (primary analysis) and, second, using hs-cTnI-Architect (secondary analysis) measurements in addition to the clinically used (hs)-cTn. hs-cTnI-VITROS was measured at presentation and at 1 h in a blinded fashion. The primary objective was direct comparison of diagnostic accuracy as quantified by the area under the ROC curve (AUC) of hs-cTnI-VITROS vs hs-cTnT-Elecsys and hs-cTnI-Architect, and in a subgroup also hs-cTnI-Centaur and hs-cTnI-Access. Secondary objectives included the derivation and validation of an hs-cTnI-VITROS-0/1-h algorithm. AMI was the adjudicated final diagnosis in 158 of 1231 (13%) patients. At presentation, the AUC for hs-cTnI-VITROS was 0.95 (95% CI, 0.93-0.96); for hs-cTnT-Elecsys, 0.94 (95% CI, 0.92-0.95); and for hs-cTnI-Architect, 0.92 (95% CI, 0.90-0.94). AUCs for hs-cTnI-Centaur and hs-cTnI-Access were 0.95 (95% CI, 0.94-0.97). Applying the derived hs-cTnI-VITROS-0/1-h algorithm (derivation cohort n = 519) to the validation cohort (n = 520), 53% of patients were ruled out [sensitivity, 100% (95% CI, 94.1-100)] and 14% of patients were ruled in [specificity, 95.6% (95% CI, 93.4-97.2)]. Patients ruled out by the 0/1-h algorithm had a survival rate of 99.8% at 30 days. Findings were confirmed in the secondary analyses using the adjudication including serial measurements of hs-cTnI-Architect. The hs-cTnI-VITROS assay has at least comparable diagnostic accuracy with the currently best validated hs-cTnT and hs-cTnI assays. NCT00470587.
ISSN:0009-9147
1530-8561
DOI:10.1373/clinchem.2019.304725