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 < 0.001), and the AccuTnI assay also identified more patients at risk (P < 0.001) and with poor outcome. Applying the 99th percentile cutoffs, AccuTnI identified more patients at risk than the Centaur TnI (P < 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 < 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.

Abstract 12260: Sex Differences in Cardiac Troponin I and the Risk of Death or Major Cardiovascular Events in Primary Prevention

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Brendan M Everett ◽  
Robert J Glynn ◽  
Tanja Zeller ◽  
Stefan Blankenberg ◽  
Paul Ridker
Keyword(s):  
Primary Prevention ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Composite Endpoint ◽  
Cardiac Troponin I ◽  
Linear Regression Models ◽  
Vascular Events ◽  
Cox Models ◽  
Reference Limit ◽  
Risk Of Death

Introduction: Circulating cardiac troponin I concentrations are higher in men than in women, but the biological causes and clinical implications of this observation are poorly understood. Methods and Results: We measured cardiac troponin I with a novel high-sensitivity assay (hsTnI) in 4696 women and 8260 men enrolled in the JUPITER trial who had LDL-C < 130 mg/dL and hsCRP ≥ 2.0 mg/L and no diabetes or clinical evidence of vascular disease. Median (IQR) hsTnI was higher in men [3.6 ng/L (2.7-5.3)] than in women [3.1 ng/L (2.3-4.5); P<0.0001]. A higher proportion of men (3.7%) than women (2.9%) were above the proposed upper reference limit of 24 ng/L (P=0.008). In linear regression models, sex remained a significant predictor of natural log normalized hsTnI after adjusting for a wide array of confounders, including age, race, height, weight, lipids, fasting glucose, blood pressure, and renal function. Across quintiles of hsTnI measured at baseline, the unadjusted incidence rate of the composite outcome of myocardial infarction, stroke, hospitalization for unstable angina, revascularization, or death increased across hsTnI categories but appeared similar in women and men (Figure 1). In adjusted Cox models stratified by sex, the increase in the relative risk of the composite endpoint across quintiles of hsTnT appeared similar in men and women (Figure 2; P-interaction=0.45). Conclusions: In a contemporary primary prevention population, women have lower baseline cardiac troponin I concentrations but similar increases in the rates of vascular events and death across troponin I categories.

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.

Emergency department triage of patients with acute chest pain: definition of cardiac troponin I decisional value to manage patients without electrocardiographic evidence of ischemia

2004 ◽  
Vol 42 (5) ◽  
Author(s):  
Pascale Beyne ◽  
Erik Bouvier ◽  
Patrick Werner ◽  
Pierre Bourgoin ◽  
Damien Logeart ◽  
...  
Keyword(s):  
Chest Pain ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Acute Chest Pain ◽  
Final Diagnosis ◽  
Cardiac Troponin I ◽  
Reference Limit ◽  
Coronary Syndrome ◽  
Definition Of ◽  
Upper Reference Limit

AbstractThe aim of this study was to define the use of a new cardiac troponin I (cTnI) assay for emergency patients with chest pain and no specific electrocardiographic changes consistent with the presence of ischemia. Patients (n=106) admitted in Emergency/Cardiology Departments for chest pain and suspicion of acute coronary syndrome (ACS) were randomized into two diagnosis groups (ACS or non-ACS) by two independent cardiologists. cTnI measurements were performed at admission, and 6 hours and 12 hours later with a new generation assay (Access AccuTnI, Beckman Coulter). Using an upper reference limit of 0.04 μg/l, 27 patients had a cTnI elevation not related to the final diagnosis of ischemia; the positive predictive value (PPV) was 67% with specificity 48%. The decisional value was re-defined and set at 0.16 μg/l, a concentration corresponding to the 99th percentile of the non-ACS patient group. Precision (coefficient of variation) was 8% at this level, PPV 97% and specificity 98%. This new decisional value is now used in our institution and could be included in standard care guidelines to improve the management of patients presenting chest pain in emergency departments.

scholarly journals Improved detection of minor ischemic myocardial injury with measurement of serum cardiac troponin I

1997 ◽  
Vol 43 (11) ◽  
pp. 2047-2051 ◽  
Author(s):  
Fred S Apple ◽  
Alireza Falahati ◽  
Pamela R Paulsen ◽  
Elizabeth A Miller ◽  
Scott W Sharkey
Keyword(s):  
Cardiac Troponin ◽  
Myocardial Injury ◽  
Troponin I ◽  
Cardiac Troponin I ◽  
Clinical Sensitivity ◽  
Reference Limit ◽  
Normal Limits ◽  
Serial Serum ◽  
Upper Reference Limit ◽  
Serum Cardiac Troponin

Abstract This study compared the diagnostic accuracy of the measurement of serum cardiac troponin I (cTnI) with creatine kinase (CK) MB mass in patients with minor myocardial injury whose measured total CK activity did not exceed twice the upper reference limit (300 U/L for men; 200 U/L for women). Forty-eight consecutive patients presenting with chest pain and with in-hospital documentation of myocardial injury were enrolled. Electrocardiogram, echocardiogram, and serial serum CK-MB mass, cTnI, and total CK were measured over 36 h after admission. Peak total CK activity was within normal limits in 28 patients (58%). The mean (±SD) peak CK-MB mass and cTnI concentrations were: 16.4 (11.8) μg/L and 132 (13.0) μg/L; respectively. The peak biochemical marker index (defined as CK-MB or cTnI divided by its respective upper reference limit) was significantly (P &lt;0.05) higher for cTnI than for CK-MB from 7 to 36 h. The clinical sensitivity for detection of myocardial injury for cTnI was 100% [95% confidence interval (CI): 87.2% to 100%], compared with 81.8% (CI: 67.3% to 91.8%) for CK-MB. Thus, cTnI was more sensitive than CK-MB mass for detection of myocardial injury in patients with small increases of total CK.

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

scholarly journals Myeloperoxidase Improves Risk Stratification in Patients with Ischemia and Normal Cardiac Troponin I Concentrations

2011 ◽  
Vol 57 (4) ◽  
pp. 603-608 ◽  
Author(s):  
Fred S Apple ◽  
Stephen W Smith ◽  
Lesly A Pearce ◽  
Karen M Schulz ◽  
Ranka Ler ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Artery Bypass ◽  
Coronary Intervention ◽  
Cardiac Troponin I ◽  
Rank Statistic ◽  
Cardiac Events ◽  
Coronary Syndrome ◽  
Patients At Risk

BACKGROUND We assessed the ability of myeloperoxidase (MPO) to identify the risk for major adverse cardiac events (MACE) in patients who present with ischemic symptoms suggestive of acute coronary syndrome and have a normal cardiac troponin I (cTnI) value. METHODS We used Siemens (n = 400) and Abbott (n = 350) assays to measure MPO and cTnI in plasma samples from 400 patients. Event rates (myocardial infarction, cardiac death, percutaneous coronary intervention, coronary artery bypass grafting) were estimated by the Kaplan–Meier method and compared with the log-rank statistic. RESULTS At the 30-day follow-up, the adjusted hazard ratios for MACE were 3.9 (P &lt; 0.001) for increased cTnI and 2.7 (P = 0.006) for increased MPO for the Siemens assays and were 5.5 (P &lt; 0.001) for increased cTnI and 2.9 (P = 0.001) for increased MPO for the Abbott assays. Similar findings were observed with 6 months of follow-up. Patients who initially had a normal cTnI value and an increased Siemens MPO value demonstrated a higher rate of MACE at 30 days than those in whom both values were normal (16.1% vs 3.6%, P = 0.002) and 6 months (18.1% vs 5.0%, P = 0.002). Similarly, patients who had an increased Abbott MPO result demonstrated a higher MACE rate at 30 days (12.3% vs 3.9%, P = 0.03) and at 6 months (16.2% vs 5.1%, P = 0.01) than those with normal values. CONCLUSIONS A combination of MPO and cTnI allowed the identification of a greater proportion of patients at risk for MACE than the use of cTnI alone. Increased MPO values remained predictive of future cardiac events even when the cTnI value was normal.

Analytical evaluation of the new Beckman Coulter Access high sensitivity cardiac troponin I immunoassay

2017 ◽  
Vol 56 (1) ◽  
Author(s):  
Giuseppe Lippi ◽  
Anna Ferrari ◽  
Giorgio Gandini ◽  
Matteo Gelati ◽  
Claudia Lo Cascio ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Limit Of Detection ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
Analytical Performance ◽  
The Novel ◽  
Reference Limit ◽  
Automated Immunoassay ◽  
Upper Reference Limit

AbstractBackground:This study was aimed to evaluate the analytical performance of the novel chemiluminescent and fully-automated Beckman Coulter Access hsTnI high-sensitivity immunoassay for measurement of cardiac troponin I (cTnI).Methods:The study, using lithium heparin samples, included assessment of limit of blank (LOB), limit of detection (LOD), functional sensitivity, linearity, imprecision (within run, between-run and total), calculation of 99th percentile upper reference limit (URL) in 175 healthy blood donors (mean age, 36±12 years; 47% women) and comparison with two other commercial cTnI immunoassays.Results:The LOB, LOD and functional sensitivity of Access hsTnI were 0.14, 0.34 and 1.35 ng/L, respectively. The within-run, between-run and total imprecision was 2.2%–2.9%, 4.6%–5.4%, and 5.4%–6.1%, respectively. The linearity was excellent in the range of cTnI values between 0.95 and 4195 ng/L (r=1.00). The 99th percentile URL was 15.8 ng/L. Measurable cTnI values were found in 173/175 healthy subjects (98.9%). Good agreement of cTnI values was found with AccuTnI+3 (r=0.97; mean bias, −9.3%), whereas less satisfactory agreement was found with Siemens Dimension Vista cTnI (r=0.95; mean bias, −55%).Conclusions:The results of our evaluation of the Beckman Coulter Access hsTnI indicate that the analytical performance of this fully-automated immunoassay is excellent.

scholarly journals Analytical validation of a highly sensitive point-of-care system for cardiac troponin I determination

2019 ◽  
Vol 58 (1) ◽  
pp. 138-145 ◽  
Author(s):  
Federica Braga ◽  
Elena Aloisio ◽  
Andrea Panzeri ◽  
Takahito Nakagawa ◽  
Mauro Panteghini
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Limit Of Detection ◽  
Clinical Performance ◽  
Point Of Care ◽  
Total Error ◽  
Method Comparison ◽  
Reference Limit ◽  
Highly Sensitive ◽  
Limit Of Quantitation

Abstract Background Highly sensitive cardiac troponin assays (hs-cTn) are not available as point-of-care (POC) measurements. As rapid testing cannot be achieved at the expense of clinical performance, there is an urgent need to develop and rigorously validate POC hs-cTn. Konica Minolta (KM) has recently developed a surface plasmon-field enhanced fluorescence spectroscopy-based POC hs-cTn I system. Methods We validated the analytical characteristics of the KM POC system according to the international guidelines. Results Limit of blank (LoB) and limit of detection (LoD) were 0.35 and 0.62 ng/L, respectively, hs-cTn I concentrations corresponding to a total CV of 20%, 10% and 5% were 1.5, 3.9 and 11.0 ng/L, respectively. Method comparison studies showed that KM calibration was successfully traced to higher-order references. Limit of quantitation (LoQ), i.e. the hs-cTn I concentration having a total error of measurement of ≤34%, was 10.0 ng/L. The upper reference limit (URL) for 600 healthy blood donors was calculated at 12.2 ng/L (90% confidence interval [CI]: 9.2–39.2), while sex-partitioned URLs were 20.6 (males) and 10.7 ng/L (females), respectively (p < 0.0001). KM assay measured hs-cTn I concentrations >LoD in 65.7% of all reference individuals, in 76.7% of males and in 54.7% of females, respectively. Conclusions The KM system joins the characteristics of POC systems to the analytical performance of hs-cTn.

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.

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