High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction.
Journal
Clinical chemistry
ISSN: 1530-8561
Titre abrégé: Clin Chem
Pays: England
ID NLM: 9421549
Informations de publication
Date de publication:
07 2019
07 2019
Historique:
received:
10
12
2018
accepted:
25
02
2019
pubmed:
17
4
2019
medline:
9
4
2020
entrez:
17
4
2019
Statut:
ppublish
Résumé
The aim of this study was to validate the clinical performance of the Beckman Access high-sensitivity cardiac troponin I (hs-cTnI) 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 with all clinical information including cardiac imaging twice: 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 Access was measured at presentation and at 1 h. The primary objective was a direct comparison of diagnostic accuracy as quantified by the area under the ROC curve (AUC) of hs-cTnI Access vs the hs-cTnT Elecsys and hs-cTnI Architect assays. Secondary objectives included the derivation and validation of an hs-cTnI Access-specific 0/1-h algorithm. AMI was the adjudicated final diagnosis in 243 of 1579 (15.4%) patients. The AUC at presentation for hs-cTnI Access was 0.95 (95% CI, 0.94-0.96), higher than hs-cTnI Architect [0.92 (95% CI, 0.91-0.94; Diagnostic accuracy and clinical utility of the Beckman hs-cTnI Access assay are very high and at least comparable to Roche hs-cTnT and Abbott hs-cTnI assays.
Sections du résumé
BACKGROUND
The aim of this study was to validate the clinical performance of the Beckman Access high-sensitivity cardiac troponin I (hs-cTnI) assay.
METHODS
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 with all clinical information including cardiac imaging twice: 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 Access was measured at presentation and at 1 h. The primary objective was a direct comparison of diagnostic accuracy as quantified by the area under the ROC curve (AUC) of hs-cTnI Access vs the hs-cTnT Elecsys and hs-cTnI Architect assays. Secondary objectives included the derivation and validation of an hs-cTnI Access-specific 0/1-h algorithm.
RESULTS
AMI was the adjudicated final diagnosis in 243 of 1579 (15.4%) patients. The AUC at presentation for hs-cTnI Access was 0.95 (95% CI, 0.94-0.96), higher than hs-cTnI Architect [0.92 (95% CI, 0.91-0.94;
CONCLUSIONS
Diagnostic accuracy and clinical utility of the Beckman hs-cTnI Access assay are very high and at least comparable to Roche hs-cTnT and Abbott hs-cTnI assays.
Identifiants
pubmed: 30988172
pii: clinchem.2018.300061
doi: 10.1373/clinchem.2018.300061
doi:
Substances chimiques
Biomarkers
0
Troponin I
0
Troponin T
0
Banques de données
ClinicalTrials.gov
['NCT00470587']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
893-904Investigateurs
Joan Elias Walter
(JE)
Ivo Strebel
(I)
Nikola Kozhuharov
(N)
Michael Freese
(M)
Carolina Fuenzalida
(C)
Claudia Stelzig
(C)
Danielle M Gualandro
(DM)
Eleni Michou
(E)
Kathrin Meissner
(K)
Caroline Kulangara
(C)
Samyut Shrestha
(S)
Gregor Fahrni
(G)
Stefan Osswald
(S)
Beatriz López
(B)
Esther Rodriguez Adrada
(ER)
Eva Ganovská
(E)
Jens Lohrmann
(J)
Wanda Kloos
(W)
Jana Steude
(J)
Andreas Buser
(A)
Arnold von Eckardstein
(A)
Beata Morawiec
(B)
Damian Kawecki
(D)
Ewa Nowalany-Kozielska
(E)
Piotr Muzyk
(P)
Nicolas Geigy
(N)
Katharina Rentsch
(K)
Informations de copyright
© 2019 American Association for Clinical Chemistry.