Clinical performance of cardiac Troponin I: A comparison between the POCT AQT90 FLEX and the Dimension Vista analyzer in an emergency setting

2017 ◽  
Vol 50 (13-14) ◽  
pp. 763-767 ◽  
Author(s):  
Monica Maria Mion ◽  
Giada Bragato ◽  
Alessandra Casarotti ◽  
Chiara Cosma ◽  
Stefania Vigolo ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Clinical Performance ◽  
Cardiac Troponin I ◽  
Emergency Setting

Analytical assessment of ortho clinical diagnostics high-sensitivity cardiac troponin I assay

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Peter A. Kavsak ◽  
Tara Edge ◽  
Chantele Roy ◽  
Paul Malinowski ◽  
Karen Bamford ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Limit Of Detection ◽  
Clinical Performance ◽  
Characteristic Curve ◽  
Area Under The Curve ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
Clinical Diagnostics ◽  
Ortho Clinical Diagnostics

AbstractObjectivesTo analytically evaluate Ortho Clinical Diagnostics VITROS high-sensitivity cardiac troponin I (hs-cTnI) assay in specific matrices with comparison to other hs-cTn assays.MethodsThe limit of detection (LoD), imprecision, interference and stability testing for both serum and lithium heparin (Li-Hep) plasma for the VITROS hs-cTnI assay was determined. We performed Passing-Bablok regression analyses between sample types for the VITROS hs-cTnI assay and compared them to the Abbott ARCHITECT, Beckman Access and the Siemens ADVIA Centaur hs-cTnI assays. We also performed Receiver-operating characteristic curve analyses with the area under the curve (AUC) determined in an emergency department (ED)-study population (n=131) for myocardial infarction (MI).ResultsThe VITROS hs-cTnI LoD was 0.73 ng/L (serum) and 1.4 ng/L (Li-Hep). Stability up to five freeze-thaws was observed for the Ortho hs-cTnI assay, with the analyte stability at room temperature in serum superior to Li-Hep with gross hemolysis also affecting Li-Hep plasma hs-cTnI results. Comparison of Li-Hep to serum concentrations (n=202), yielded proportionally lower concentrations in plasma with the VITROS hs-cTnI assay (slope=0.85; 95% confidence interval [CI]:0.83–0.88). In serum, the VITROS hs-cTnI concentrations were proportionally lower compared to other hs-cTnI assays, with similar slopes observed between assays in samples frozen <−70 °C for 17 years (ED-study) or in 2020. In the ED-study, the VITROS hs-cTnI assay had an AUC of 0.974 (95%CI:0.929–0.994) for MI, similar to the AUCs of other hs-cTn assays.ConclusionsLack of standardization of hs-cTnI assays across manufacturers is evident. The VITROS hs-cTnI assay yields lower concentrations compared to other hs-cTnI assays. Important differences exist between Li-Hep plasma and serum, with evidence of stability and excellent clinical performance comparable to other hs-cTn assays.

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

2019 ◽  
Vol 65 (11) ◽  
pp. 1426-1436 ◽  
Author(s):  
Jasper Boeddinghaus ◽  
Raphael Twerenbold ◽  
Thomas Nestelberger ◽  
Luca Koechlin ◽  
Desiree Wussler ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Diagnostic Accuracy ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Clinical Performance ◽  
High Sensitivity ◽  
Primary Objective ◽  
Cardiac Troponin I ◽  
Primary Analysis ◽  
Derivation Cohort

Abstract BACKGROUND We aimed to validate the clinical performance of the high-sensitivity cardiac troponin I [VITROS® Immunodiagnostic Products hs Troponin I (hs-cTnI-VITROS)] 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 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. RESULTS 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. CONCLUSIONS The hs-cTnI-VITROS assay has at least comparable diagnostic accuracy with the currently best validated hs-cTnT and hs-cTnI assays. ClinicalTrials.gov Identifier NCT00470587.

scholarly journals The Antibody Configurations of Cardiac Troponin I Assays May Determine Their Clinical Performance

2006 ◽  
Vol 52 (5) ◽  
pp. 832-837 ◽  
Author(s):  
Stefan James ◽  
Mats Flodin ◽  
Nina Johnston ◽  
Bertil Lindahl ◽  
Per Venge
Keyword(s):  
Monoclonal Antibodies ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Clinical Performance ◽  
Cardiac Troponin I ◽  
Unstable Coronary Artery Disease ◽  
Reference Limits ◽  
Risk Patients ◽  
Artery Disease ◽  
Roche Diagnostics

Abstract Background: Previous studies have shown superior clinical performance of the cardiac troponin I (cTnI) assay from Beckman-Coulter Diagnostics. This assay had a unique combination of monoclonal antibodies with 2 monoclonal antibodies directed against epitopes near the NH2 terminus of the heart-specific region of troponin I. The approach has been adopted by the new cTnI assay from Abbott Diagnostics. The aim of our study was to investigate whether this approach affects the clinical performance of cTnI assays. Methods: Cardiac troponin concentrations were measured in a random sample of patients with unstable coronary artery disease included in the GUSTO IV trial (n = 696) by the AccuTnI (Beckman-Coulter Diagnostics), Architect cTnI (Abbott Diagnostics), Immulite 2500 cTnI (Diagnostics Products Corporation), and Elecsys 2010 cTnT (Roche Diagnostics) assays and related to the 1-year mortality. The primary cutoff concentrations were based on the 99th percentile upper reference limits and an imprecision (CV) ≤10%. Results: The sensitivities of the AccuTnI and Architect cTnI assays in identifying patients who died within 1 year were equal and were significantly higher (P &lt;0.05) than those of the Immulite 2500 cTnI and the Elecsys cTnT assays. The concordance between the AccuTnI and Architect cTnI assays was 97%, but concordances between the Architect cTnI and the Elecsys cTnT assays were 89%–92% with more at-risk patients (P &lt;0.01 to P &lt;0.001) identified by the Architect cTnI assay. Conclusions: The Architect cTnI assay has clinical performance similar to that of the AccuTnI, probably as a result of the inclusion of a monoclonal antibody against troponin I epitope 41–49 in the assay.

scholarly journals Analytical and Clinical Performance of the Immulite Cardiac Troponin I Assay

2000 ◽  
Vol 46 (12) ◽  
pp. 1989-1990 ◽  
Author(s):  
Alain Lavoinne ◽  
Bruno Cauliez ◽  
Hélène Eltchaninoff ◽  
René Koning ◽  
Alain Cribier
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Clinical Performance ◽  
Cardiac Troponin I

Analytical and Clinical Performance of Two Cardiac Troponin I Immunoassays

1999 ◽  
Vol 37 (9) ◽  
Author(s):  
Zahur Zaman ◽  
Sandy De Spiegeleer ◽  
Mathieu Gerits ◽  
Norbert Blanckaert
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Clinical Performance ◽  
Cardiac Troponin I

scholarly journals 101 Clinical Performance of a Novel Point-of-Care Technology for Bedside Measurement of Cardiac Troponin-I

2016 ◽  
Vol 68 (4) ◽  
pp. S41
Author(s):  
P. Hausfater ◽  
S. Blaschke ◽  
E. Giannitsis ◽  
M. Khellaf ◽  
J. Mair ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Clinical Performance ◽  
Point Of Care ◽  
Cardiac Troponin I ◽  
Point Of Care Technology ◽  
Care Technology

scholarly journals Clinical Performance of Two Highly Sensitive Cardiac Troponin I Assays

2009 ◽  
Vol 55 (1) ◽  
pp. 109-116 ◽  
Author(s):  
Per Venge ◽  
Stefan James ◽  
Leif Jansson ◽  
Bertil Lindahl
Keyword(s):  
At Risk ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Clinical Performance ◽  
Composite Endpoint ◽  
Outcome Data ◽  
Cardiac Troponin I ◽  
Healthy Population ◽  
Reference Limit ◽  
Patients At Risk

Abstract Background: The aim of this study was to compare the clinical performance of 2 sensitive cTnI assays with 10% CV imprecision below the 99th percentile upper reference limit. Methods: We measured cardiac troponin and N-terminal pro-brain natriuretic peptide (NT-proBNP) concentrations in a random sample of the Global Use of Strategies To Open Occluded Coronary Arteries (GUSTO) IV cohort (n = 1251). Outcome data of 1-year mortality and the composite endpoint DMI [death and/or myocardial infarction (MI) within 30 days] were available in all patients. The 99th percentile of a healthy population was estimated from the Sweden Women and Men and Ischemic Heart Disease (SWISCH) cohort (n = 442). We measured cardiac troponin I (cTnI) using the Access AccuTnI (Beckman Coulter) and Centaur TnI Ultra (Siemens Healthcare Diagnostics) and NT-proBNP using the Elecsys 2010 (Roche Diagnostics). Results: Applying the 10% CV cutoff, the sensitivity of the Access AccuTnI assay in identifying DMI and death was higher than that of the Centaur TnI Ultra (P = 0.02 and P &lt; 0.001), and the AccuTnI assay also identified more patients at risk (P &lt; 0.001) and with poor outcome. Applying the 99th percentile cutoffs, AccuTnI identified more patients at risk than the Centaur TnI (P &lt; 0.001) and with significant differences in outcome. Significantly more patients with cardiac troponins below the cutoffs as measured by Centaur TnI had increased NT-proBNP concentrations (P &lt; 0.001) compared with AccuTnI. Conclusions: The AccuTnI assay identified more patients at risk than the Centaur cTnI Ultra assay. Our results demonstrate the clinical potential of high-sensitivity cardiac troponin assays for the identification of patients at risk of dying from cardiovascular disease.

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