scholarly journals Clinical Relevance of the 99th Percentile Upper Reference Limit for High-Sensitivity Cardiac Troponin Assays

2020 ◽  
Vol 66 (3) ◽  
pp. 403-405 ◽  
Author(s):  
M Odette Gore ◽  
James A de Lemos
Keyword(s):  
Clinical Relevance ◽  
Cardiac Troponin ◽  
High Sensitivity ◽  
Reference Limit ◽  
Upper Reference Limit

scholarly journals High-Sensitivity Cardiac Troponin T for Risk Stratification in Patients With Embolic Stroke of Undetermined Source

Stroke ◽  
2020 ◽  
Vol 51 (8) ◽  
pp. 2386-2394 ◽  
Author(s):  
Jan F. Scheitz ◽  
Guillaume Pare ◽  
Lesly A. Pearce ◽  
Hardi Mundl ◽  
W. Frank Peacock ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Risk Stratification ◽  
Cardiac Troponin ◽  
Troponin T ◽  
High Sensitivity ◽  
Embolic Stroke ◽  
Cardiac Troponin T ◽  
Reference Limit ◽  
End Point ◽  
Upper Reference Limit

Background and Purpose: Optimal secondary prevention for patients with embolic stroke of undetermined source (ESUS) remains unknown. We aimed to assess whether high-sensitivity cardiac troponin T (hs-cTnT) levels are associated with major vascular events and whether hs-cTnT may identify patients who benefit from anticoagulation following ESUS. Methods: Data were obtained from the biomarker substudy of the NAVIGATE ESUS trial, a randomized controlled trial testing the efficacy of rivaroxaban versus aspirin for secondary stroke prevention in ESUS. Patients were dichotomized at the hs-cTnT upper reference limit (14 ng/L, Gen V, Roche Diagnostics). Cox proportional hazard models were computed to explore the association between hs-cTnT, the combined cardiovascular end point (recurrent stroke, myocardial infarction, systemic embolism, cardiovascular death), and recurrent ischemic stroke. Results: Among 1337 patients enrolled at 111 participating centers in 18 countries (mean age 67±9 years, 61% male), hs-cTnT was detectable in 95% and at/above the upper reference limit in 21%. During a median follow-up of 11 months, the combined cardiovascular end point occurred in 68 patients (5.0%/y, rivaroxaban 28 events, aspirin 40 events; hazard ratio, 0.67 [95% CI, 0.41–1.1]), and recurrent ischemic stroke occurred in 50 patients (4.0%/y, rivaroxaban 16 events, aspirin 34 events, hazard ratio 0.45 [95% CI, 0.25–0.81]). Annualized combined cardiovascular end point rates were 8.2% (9.5% rivaroxaban, 7.0% aspirin) for those above hs-cTnT upper reference limit and 4.8% (3.1% rivaroxaban, 6.6% aspirin) below with a significant treatment modification ( P =0.04). Annualized ischemic stroke rates were 4.7% above hs-cTnT upper reference limit and 3.9% below, with no suggestion of an interaction between hs-cTnT and treatment ( P =0.3). Conclusions: In patients with ESUS, hs-cTnT was associated with increased cardiovascular event rates. While fewer recurrent strokes occurred in patients receiving rivaroxaban, outcomes were not stratified by hs-cTn results. Our findings support using hs-cTnT for cardiovascular risk stratification but not for decision-making regarding anticoagulation therapy in patients with ESUS. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02313909.

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 Temporal Evolution of Serum Concentrations of High‐Sensitivity Cardiac Troponin During 1 Year After Acute Coronary Syndrome Admission

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Victor J. van den Berg ◽  
Rohit M. Oemrawsingh ◽  
Victor A. W. M. Umans ◽  
Isabella Kardys ◽  
Folkert W. Asselbergs ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Temporal Evolution ◽  
High Sensitivity ◽  
Interindividual Variation ◽  
Mixed Effect ◽  
Reference Limit ◽  
Coronary Syndrome ◽  
Upper Reference Limit

Background Detailed insights in temporal evolution of high‐sensitivity cardiac troponin following acute coronary syndrome (ACS) are currently missing. We aimed to describe and compare the post‐ACS kinetics of high‐sensitivity cardiac troponin I (hs‐cTnI) and high‐sensitivity cardiac troponin T (hs‐cTnT), and to determine their intra‐ and interindividual variation in clinically stable patients. Methods and Results We determined hs‐cTnI (Abbott) and hs‐cTnT (Roche) in 1507 repeated blood samples, derived from 191 patients with ACS (median, 8/patient) who remained free from adverse cardiac events during 1‐year follow‐up. Post‐ACS kinetics were studied by linear mixed‐effect models. Using the samples collected in the 6‐ to 12‐month post‐ACS time frame, patients were then considered to have chronic coronary syndrome. We determined (differences between) the average hs‐cTnI and average hs‐cTnT concentration, and the intra‐ and interindividual variation for both biomarkers. Compared with hs‐cTnT, hs‐cTnI peaked higher (median 3506 ng/L versus 494 ng/L; P <0.001) and was quicker below the biomarker‐specific upper reference limit (16 versus 19 days; P <0.001). In the post–6‐month samples, hs‐cTnI and hs‐cTnT showed modest correlation ( r spearman =0.60), whereas the average hs‐cTnT concentration was 5 times more likely to be above the upper reference limit than hs‐cTnI. The intraindividual variations of hs‐cTnI and hs‐cTnT were 14.0% and 18.1%, while the interindividual variations were 94.1% and 75.9%. Conclusions Hs‐cTnI peaked higher after ACS and was quicker below the upper reference limit. In the post–6‐month samples, hs‐cTnI and hs‐cTnT were clearly not interchangeable, and average hs‐cTnT concentrations were much more often above the upper reference limit than hs‐cTnI. For both markers, the within‐patient variation fell largely below beween‐patient variation. Registration URL: https://www.trialregister.nl ; unique identifiers: NTR1698 and NTR1106.

scholarly journals Preoperative cardiac troponin below the 99th-percentile upper reference limit and 30-day mortality after noncardiac surgery

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Jungchan Park ◽  
Cheol Won Hyeon ◽  
Seung-Hwa Lee ◽  
Sangmin Maria Lee ◽  
Junghyun Yeo ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Primary Outcome ◽  
Multivariate Analyses ◽  
Limit Of Detection ◽  
High Sensitivity ◽  
Noncardiac Surgery ◽  
Surgical Patients ◽  
Reference Limit ◽  
Risk Of Mortality ◽  
Upper Reference Limit

Abstract Preoperative high-sensitivity cardiac troponin (hs-cTn) above the 99th-percentile upper reference limit (URL) is associated with mortality after noncardiac surgery. This study aimed to evaluate whether preoperative hs-cTn concentrations above the lowest limit of detection (LOD) but below the 99th-percentile URL can predict mortality after noncardiac surgery.From January 2010 to April 2019, a total of 12,415 noncardiac surgical patients with preoperative hs-cTn I below the 99th-percentile URL were enrolled. The patients were divided into two groups according to preoperative hs-cTn I concentration: (1) [hs-cTn] below the LOD (6 ng/L), and (2) mildly elevated [hs-cTn] but below the 99th-percentile URL (40 ng/L). The primary outcome was 30-day mortality. Of the 12,415 patients enrolled, 7958 (64.1%) were in the LOD group whereas 4457 (35.9%) were in the mild elevation group. The incidence of 30-day mortality was significantly greater in the mild elevation group (2.1% vs. 4.0% hazard ratio [HR] 1.73; 95% confidence interval [CI] 1.39–2.16; p < 0.001) in the multivariate analyses. The propensity score matched analyses also produced a similar result (2.6% vs. 4.2% HR 1.61; 95% CI 1.26–2.07; p < 0.001). The threshold at which the risk of mortality increased corresponded to a preoperative hs-cTn I ≥ 12 ng/L. Patients with preoperative hs-cTn I above the LOD and below the 99th-percentile URL had greater 30-day mortality after noncardiac surgery.

scholarly journals Distribution and specificity of high-sensitivity cardiac troponin T in older adults without acute cardiac conditions: cross-sectional results from the population-based AugUR study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e052004
Author(s):  
Alexander Dietl ◽  
Martina E Zimmermann ◽  
Caroline Brandl ◽  
Stefan Wallner ◽  
Ralph Burkhardt ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cardiac Troponin ◽  
Troponin T ◽  
High Sensitivity ◽  
Left Ventricular ◽  
Cardiac Troponin T ◽  
Cross Sectional ◽  
Reference Limit ◽  
Mobile Population ◽  
Upper Reference Limit

ObjectiveEuropean guidelines recommended a uniform upper reference limit of high-sensitivity cardiac troponin T (hsTnT) to rule out non-ST segment elevation myocardial infarction. Our study aimed to provide a hsTnT reference distribution and to assess the specificity of the 14 ng/L cut-off value in the mobile population ≥70 years of age.DesignA cross-sectional analysis was performed in the German AugUR study (Altersbezogene Untersuchungen zur Gesundheit der University of Regensburg).SettingStudy population was the mobile population aged 70+ years living in the city and county of Regensburg, Germany.ParticipantsA random sample was derived from the local population registries of residence. Of the 5644 individuals invited, 1133 participated (response ratio=20.1%). All participants came to the study centre and were mentally and physically mobile to conduct the protocol (face-to-face interview, blood draw and standardised transthoracic echocardiography). None of the participants was in an acute state of myocardial infarction.ResultsAmong the 1129 individuals with hsTnT measurements (overall median=10.0 ng/L(25th, 75th percentile)=(7.0, 15.0 ng/L)), hsTnT was higher among the older individuals and higher among men (men 70–74 years median=9.6 ng/L (7.2, 13.1 ng/L); men 90–95 years median=21.2 ng/L (14.6, 26.0 ng/L); women 70–74 years median=6.3 ng/L (4.7, 8.7 ng/L); and women 90–95 years median=18.0 ng/L (11.0, 21.0 ng/L)). In participants with impaired kidney function (eGFRcrea <60 mL/min/1.73 m2), hsTnT was elevated (median=13.6 ng/L (9.4, 20.6 ng/L)).Specificity of recommended upper reference limit, 14 ng/L, is 68%. Most false positives were among men aged >79 years (specificity=34%). In a healthy subgroup (n=96, none of the following: overt heart disease, impaired renal function, blood pressure >160/100 mm Hg, left ventricular hypertrophy and diastolic/systolic dysfunction), specificity was 90%.ConclusionIn the elderly population without acute myocardial infarction, hsTnT further increases with age showing different levels for men and women. The specificity of the 14 ng/L cut-off is considerably lower than 99%, even in healthy subjects.

Impact of lipid markers and high-sensitivity C-reactive protein on the value of the 99th percentile upper reference limit for high-sensitivity cardiac troponin I

2016 ◽  
Vol 462 ◽  
pp. 193-200 ◽  
Author(s):  
Magdalena Krintus ◽  
Marek Kozinski ◽  
Tomasz Fabiszak ◽  
Magdalena Kuligowska-Prusinska ◽  
Ewa Laskowska ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
C Reactive Protein ◽  
Reference Limit ◽  
Reactive Protein ◽  
Lipid Markers ◽  
Upper Reference Limit

Estimation of age- and comorbidities-adjusted percentiles of high-sensitivity cardiac troponin T levels in the elderly

2015 ◽  
Vol 53 (5) ◽  
Author(s):  
Nils Kuster ◽  
Karine Monnier ◽  
Gregory Baptista ◽  
Anne-Marie Dupuy ◽  
Stéphanie Badiou ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Rating Scale ◽  
Troponin T ◽  
High Sensitivity ◽  
The Elderly ◽  
Elderly Subjects ◽  
Reference Limit ◽  
Reactive Protein ◽  
Ctnt Level ◽  
Upper Reference Limit

AbstractCardiac troponin level measured by high-sensitivity assays (hs-cTn) in the elderly is frequently found higher than the 99th percentile upper reference limit, making the diagnosis of acute coronary syndromes (ACS) difficult. This study aimed at: 1) identifying determinants of hs-cTnT levels in an unselected population of elderly subjects; and 2) assessing the prognosis value of increased hs-cTnT in elderly people free of ACS.Hs-cTnT was measured in 591 individuals aged over 65 years without suspicion of ACS. Comorbidities were assessed using the Cumulative Illness Rating Scale for Geriatrics (CIRS-G). C-reactive protein, αAge, gender, cardiac CIRS-G, estimated glomerular filtration rate (p<0.001 for all), albumin (p<0.028) and αHs-cTnT level is associated with inflammation and renal function in the elderly. Independently of comorbidities, hs-cTnT concentration increases exponentially with age after 65 years. Decision limits adapted to age and sex may be useful to patient management.

scholarly journals High‐Sensitivity Cardiac Troponin T and Recurrent Vascular Events After First Ischemic Stroke

2021 ◽  
Author(s):  
Jan F. Scheitz ◽  
Jess Lim ◽  
Leonie H. A. Broersen ◽  
Ramanan Ganeshan ◽  
Shufan Huo ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Cardiac Troponin ◽  
Primary Outcome ◽  
Troponin T ◽  
High Sensitivity ◽  
Hazard Ratio ◽  
Cardiac Troponin T ◽  
Vascular Events ◽  
Reference Limit ◽  
Upper Reference Limit

Background Recent evidence suggests cardiac troponin levels to be a marker of increased vascular risk. We aimed to assess whether levels of high‐sensitivity cardiac troponin T (hs‐cTnT) are associated with recurrent vascular events and death in patients with first‐ever, mild to moderate ischemic stroke. Methods and Results We used data from the PROSCIS‐B (Prospective Cohort With Incident Stroke Berlin) study. We computed Cox proportional hazards regression analyses to assess the association between hs‐cTnT levels upon study entry (Roche Elecsys, upper reference limit, 14 ng/L) and the primary outcome (composite of recurrent stroke, myocardial infarction, and all‐cause death). A total of 562 patients were analyzed (mean age, 67 years [SD 13]; 38.6% women; median National Institutes of Health Stroke Scale=2; hs‐cTnT above upper reference limit, 39.2%). During a mean follow‐up of 3 years, the primary outcome occurred in 89 patients (15.8%), including 40 (7.1%) recurrent strokes, 4 (0.7%) myocardial infarctions, and 51 (9.1%) events of all‐cause death. The primary outcome occurred more often in patients with hs‐cTnT above the upper reference limit (27.3% versus 10.2%; adjusted hazard ratio, 2.0; 95% CI, 1.3–3.3), with a dose‐response relationship when the highest and lowest hs‐cTnT quartiles were compared (15.2 versus 1.8 events per 100 person‐years; adjusted hazard ratio, 4.8; 95% CI, 1.9–11.8). This association remained consistent in sensitivity analyses, which included age matching and stratification for sex. Conclusions Hs‐cTnT is dose‐dependently associated with an increased risk of recurrent vascular events and death within 3 years after first‐ever, mild to moderate ischemic stroke. These findings support further studies of the utility of hs‐cTnT for individualized risk stratification after stroke. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01363856.

scholarly journals 99th Percentile Upper-Reference Limit of Cardiac Troponin and the Diagnosis of Acute Myocardial Infarction

2020 ◽  
Vol 66 (9) ◽  
pp. 1167-1180
Author(s):  
Yader Sandoval ◽  
Fred S Apple ◽  
Amy K Saenger ◽  
Paul O Collinson ◽  
Alan H B Wu ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cardiac Troponin ◽  
Specific Treatment ◽  
High Sensitivity ◽  
Prognostic Information ◽  
Reference Limit ◽  
Statistical Heterogeneity ◽  
Acute Mi ◽  
Upper Reference Limit ◽  
Missed Diagnoses

Abstract Background Concerns exist regarding how the 99th percentile upper reference limit (URL) of cardiac troponin (cTn) is determined and whether it should be derived from normal healthy individuals. Content The 99th percentile URL of cTn is an important criterion to standardize the diagnosis of myocardial infarction (MI) for clinical, research, and regulatory purposes. Statistical heterogeneity in its calculation exists but recommendations have been proposed. Some negativity has resulted from the fact that with some high-sensitivity (hs) cTn assays, a greater number of increases above the 99th percentile are observed when transitioning from a contemporary assay. Increases reflect acute or chronic myocardial injury and provide valuable diagnostic and prognostic information. The etiology of increases can sometimes be difficult to determine, making a specific treatment approach challenging. For those reasons, some advocate higher cutoff concentrations. This approach can contribute to missed diagnoses. Contrary to claims, neither clinical or laboratory guidelines have shifted away from the 99th percentile. To support the diagnosis of acute MI, the 99th percentile URL remains the best-established approach given the absence of cTn assay standardization. Importantly, risk stratification algorithms using hs-cTn assays predict the possibility of MI diagnoses established using the 99th percentile. Summary The 99th percentile of cTn remains the best-established criterion for the diagnosis of acute MI. While not perfect, it is analytically and clinically evidence-based. Until there are robust data to suggest some other approach, staying with the 99th percentile, a threshold that has served the field well for the past 20 years, appears prudent.

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