Important Differences Between Manufacturers When Transitioning From a Contemporary Cardiac Troponin Assay to a High-Sensitivity Cardiac Troponin Assay.
Ontology highlight
ABSTRACT:
SUBMITTER: Kavsak PA
PROVIDER: S-EPMC8209364 | biostudies-literature | 2021 Jun
REPOSITORIES: biostudies-literature
Publications
Important Differences Between Manufacturers When Transitioning From a Contemporary Cardiac Troponin Assay to a High-Sensitivity Cardiac Troponin Assay.
Kavsak Peter A PA Um Kevin K Mondoux Shawn S Paré Guillaume G Ainsworth Craig C Worster Andrew A
CJC open 20210204 6
Similar Datasets
Project description:Study objectiveOur objective is to describe the rates of diagnostic reclassification between conventional cardiac troponin I (cTnI) and high-sensitivity cardiac troponin T (hs-cTnT) and between combined and sex-specific hs-cTnT thresholds in adult emergency department (ED) patients in the United States.MethodsWe conducted a prospective, single-center, before-and-after, observational study of ED patients aged 18 years or older undergoing single or serial cardiac troponin testing in the ED for any reason before and after hs-cTnT implementation. Conventional cTnI and hs-cTnT results were obtained from a laboratory quality assurance database. Combined and sex-specific thresholds were the published 99th percentile upper reference limits for each assay. Cases underwent physician adjudication using the Fourth Universal Definition of Myocardial Infarction. Diagnostic reclassification occurred when a patient received a diagnosis of myocardial infarction or myocardial injury with one assay but not the other assay. Our primary outcome was diagnostic reclassification between the conventional cTnI and hs-cTnT assays. Diagnostic reclassification probabilities were assessed with sample proportions and 95% confidence intervals for binomial data.ResultsWe studied 1,016 patients (506 men [50%]; median age 60 years [25th, 75th percentiles 49, 71]). Between the conventional cTnI and hs-cTnT assays, 6 patients (0.6%; 95% confidence interval 0.2% to 1.3%) underwent diagnostic reclassification regarding myocardial infarction (5/6 reclassified as no myocardial infarction) and 166 patients (16%; 95% confidence interval 14% to 19%) underwent diagnostic reclassification regarding myocardial injury (154/166 reclassified as having myocardial injury) by hs-cTnT.ConclusionCompared with conventional cTnI, the hs-cTnT assay resulted in no clinically relevant change in myocardial infarction diagnoses but substantially more myocardial injury diagnoses.
| S-EPMC7606506 | biostudies-literature
Project description:Democratizing biomarker testing at the point-of-care requires innovations that match laboratory-grade sensitivity and precision in an accessible format. Here, high-sensitivity detection of cardiac troponin I (cTnI) is demonstrated through innovations in chemiluminescence-based sensing, imaging, and deep learning-driven analysis. This chemiluminescence vertical flow assay (CL-VFA) enables rapid, low-cost, and precise quantification of cTnI, a key cardiac protein for assessing heart muscle damage and myocardial infarction. The CL-VFA integrates a user-friendly chemiluminescent paper-based sensor, a polymerized enzyme-based conjugate, a portable high-performance CL reader, and a neural network-based cTnI concentration inference algorithm. The CL-VFA measures cTnI over a broad dynamic range covering six orders of magnitude and operates with 50 µL of serum per test, delivering results in 25 min. This system achieves a detection limit of 0.16 pg mL-1 with an average coefficient of variation under 15%, surpassing traditional benchtop analyzers in sensitivity by an order of magnitude. In blinded validation, the computational CL-VFA accurately measures cTnI concentrations in patient samples, demonstrating a robust correlation against a clinical-grade FDA-cleared analyzer. These results highlight the potential of CL-VFA as a robust diagnostic tool for accessible, rapid cardiac biomarker testing that meets the needs of diverse healthcare settings, from emergency care to underserved regions.
| S-EPMC11922022 | biostudies-literature
Project description:ObjectiveIn patients with acute chest pain who have had myocardial infarction excluded, plasma cardiac troponin I concentrations ≥5 ng/L are associated with risk of future adverse cardiovascular events. We aim to evaluate the association between cardiac troponin and coronary plaque composition in such patients.MethodsIn a prespecified secondary analysis of a prospective cohort study, blinded quantitative plaque analysis was performed on 242 CT coronary angiograms of patients with acute chest pain in whom myocardial infarction was excluded. Patients were stratified by peak plasma cardiac troponin I concentration ≥5 ng/L or <5 ng/L. Associations were assessed using univariable and multivariable logistic regression analyses.ResultsThe cohort was predominantly middle-aged (62±12 years) men (69%). Patients with plasma cardiac troponin I concentration ≥5 ng/L (n=161) had a higher total (median 33% (IQR 0-47) vs 0% (IQR 0-33)), non-calcified (27% (IQR 0-37) vs 0% (IQR 0-28)), calcified (2% (IQR 0-8) vs 0% (IQR 0-3)) and low-attenuation (1% (IQR 0-3) vs 0% (IQR 0-1)) coronary plaque burden compared with those with concentrations <5 ng/L (n=81; p≤0.001 for all). Low-attenuation plaque burden was independently associated with plasma cardiac troponin I concentration ≥5 ng/L after adjustment for clinical characteristics (adjusted OR per doubling 1.62 (95% CI 1.17 to 2.32), p=0.005) or presence of any visible coronary artery disease (adjusted OR per doubling 1.57 (95% CI 1.07 to 2.37), p=0.026).ConclusionIn patients with acute chest pain but without myocardial infarction, plasma cardiac troponin I concentrations ≥5 ng/L are associated with greater burden of low-attenuation coronary plaque.
| S-EPMC10357930 | biostudies-literature
Project description:BackgroundThe diagnosis of hypertension is often preceded by cardiac structural abnormalities. Thus, we assessed whether high-sensitivity cardiac troponin T (hs-cTnT), a marker of subclinical myocardial damage, can identify individuals at risk for hypertension or left ventricular hypertrophy.Methods and resultsWe studied 6516 Atherosclerosis Risk in Communities (ARIC) Study participants who were free of prevalent hypertension and cardiovascular disease at baseline (1990-1992). We examined the association of baseline hs-cTnT categories with incident diagnosed hypertension (defined by self-report of a diagnosis or medication use during a maximum of 19.9 years of follow-up) and with incident visit-based hypertension (defined by self-report, medication use, or measured blood pressure >140/90 mm Hg over 6 years). Relative to hs-cTnT <5 ng/L, adjusted hazard ratios for incident diagnosed hypertension were 1.16 (95% confidence interval, 1.08-1.25) for individuals with hs-cTnT of 5 to 8 ng/L, 1.29 (95% confidence interval, 1.14-1.47) for hs-cTnT of 9 to 13 ng/L, and 1.31 (95% confidence interval, 1.07-1.61) for hs-cTnT ≥14 ng/L (P for trend <0.001). Associations were stronger for incident visit-based hypertension. These associations were driven by higher relative hazard in normotensive people (compared with those with prehypertension; P for interaction=0.001). Baseline hs-cTnT was also strongly associated with incident left ventricular hypertrophy by electrocardiography over 6 years (eg, adjusted hazard ratio, 5.19 [95% confidence interval, 1.49-18.08] for hs-cTnT ≥14 versus <5 ng/L). Findings were not appreciably changed after accounting for competing deaths or adjusting for baseline blood pressure levels or N-terminal probrain natriuretic peptide.ConclusionsIn an ambulatory population with no history of cardiovascular disease, hs-cTnT was associated with incident hypertension and risk of left ventricular hypertrophy. Further research is needed to determine whether hs-cTnT can identify people who may benefit from ambulatory blood pressure monitoring or hypertension prevention lifestyle strategies.
| S-EPMC4558242 | biostudies-literature
Project description:BackgroundFew data compare cardiac troponin T (cTnT) and cardiac troponin I (cTnI) in a general population. We sought to evaluate the distribution and association between cTnT, cTnI, and cardiovascular risk factors in a large general population cohort.MethodsHigh-sensitivity cTnT and cTnI were measured in serum from 19501 individuals in the Generation Scotland Scottish Family Health Study. Associations with cardiovascular risk factors were compared using age- and sex-adjusted regression. Observed age- and sex-stratified 99th centiles were compared with 99th centiles for cTnT (men, 15.5 ng/L; women, 9.0 ng/L) and cTnI (men, 34.2 ng/L; women, 15.6 ng/L) used in clinical practice.ResultscTnT and cTnI concentrations were detectable in 53.3% and 74.8% of participants, respectively, and were modestly correlated in unadjusted analyses (R 2 = 21.3%) and only weakly correlated after adjusting for age and sex (R 2 = 9.5%). Cardiovascular risk factors were associated with both troponins, but in age- and sex-adjusted analyses, cTnI was more strongly associated with age, male sex, body mass index, and systolic blood pressure (P < 0.0001 for all vs cTnT). cTnT was more strongly associated with diabetes (P < 0.0001 vs cTnI). The observed 99th centiles were broadly consistent with recommended 99th centiles in younger men and women. After the age of 60 years, observed 99th centiles increased substantially for cTnT, and beyond 70 years of age, the 99th centiles approximately doubled for both troponins.ConclusionsIn the general population, cTnT and cTnI concentrations are weakly correlated and are differentially associated with cardiovascular risk factors. The 99th centiles currently in use are broadly appropriate for men and women up to but not beyond the age of 60 years.
| S-EPMC6398571 | biostudies-literature
Project description:BACKGROUND:It is unclear if isolated postoperative cardiac-troponin elevation, often referred to as myocardial injury, represents a pathological event, as control studies in otherwise healthy adults are lacking. METHODS:In this single-centre prospective observational cohort study, serial high-sensitivity cardiac troponin T (hscTnT) plasma concentrations were obtained from young, healthy adults undergoing elective orthopaedic surgery at three time points: before operation, 2-6 h, and 18-30 h after surgery. End points were hscTnT increases after surgery: ?20% (exceeding analytical variability), ?50% (exceeding short-term biological variability), and ?85% (exceeding long-term biological variability). The secondary end point was myocardial injury, defined as new postoperative hscTnT elevation >99th % upper reference limit (URL) (women >10 ng litre-1; men >15 ng litre-1). RESULTS:Amongst the study population (n=95), no hscTnT increase ?20% was detected in 68 patients (73%). A hscTnT increase between 20% and 49% was observed in 17 patients (18%), 50-84% in seven patients (7%), and ?85% in three patients (3%). Twenty patients (21%) had an absolute ?hscTnT between 0 and 2 ng litre-1, 12 patients (13%) between 2 and 4 ng litre-1, three patients between 4 and 6 ng litre-1, and one patient (1%) between 6 and 8 ng litre-1. Myocardial injury (new hscTnT elevation >99th%) was diagnosed in one patient (1%). The median hscTnT concentrations did not increase after operation, and were 4 (3.9-5, inter-quartile range) ng litre-1 at baseline, 4 (3.9-5) ng litre-1 at 2-6 h after surgery, and 4 (3.9-5) ng litre-1 on postoperative day 1. CONCLUSIONS:One in four young adult patients without known cardiovascular disease developed a postoperative hscTnT increase, but without exceeding the 99th% URL and without evidence of myocardial ischaemia. These results may have important ramifications for the concept of postoperative myocardial injury, as they suggest that, in some patients, postoperative cardiac-troponin increases may be the result of a normal physiological process in the surgical setting. CLINICAL TRIAL REGISTRATION:NCT 02394288.
| S-EPMC6200098 | biostudies-literature
Project description:BackgroundThe diagnosis of myocardial infarction (MI) after noncardiac surgery has traditionally relied on using relatively insensitive contemporary cardiac troponin (cTn) assays. We hypothesized that using a recently introduced novel high-sensitivity cTnT (hscTnT) assay would increase the detection rate of perioperative MI.MethodsIn this ancillary study of the Vitamins in Nitrous Oxide trial, readjudicated incidence rates of myocardial injury (new isolated cTn elevation) and MI were compared when diagnosed by contemporary cTnI versus hscTnT. We probed various relative (eg, >50%) or absolute (eg, +5 ng/L) hscTnT change metrics. Inclusion criteria for this ancillary study were the presence of a baseline and at least 1 postoperative hscTnT value.ResultsAmong 605 patients, 70 patients (12%) had electrocardiogram changes consistent with myocardial ischemia; 82 patients (14%) had myocardial injury diagnosed by contemporary cTnI, 31 (5.1%) of which had an adjudicated MI. After readjudication, 67 patients (11%) were diagnosed with MI when using hscTnT, a 2-fold increase. Incidence rates of postoperative myocardial injury ranged from 12% (n = 73) to 65% (n = 393) depending on the hscTnT metric used. Incidence rates of MI using various hscTnT change metrics and the presence of ischemic electrocardiogram changes, but without event adjudication, ranged from 3.6% (n = 22) to 12% (n = 74), a >3-fold difference. New postoperative hscTnT elevation, either by absolute or relative hscTnT change metric, was associated with an up to 5-fold increase in 6-month mortality.ConclusionsThe use of hscTnT compared to contemporary cTnI increases the detection rate of perioperative MI by a factor of 2. Using different absolute or relative hscTnT change metrics may lead to under- or overdiagnosis of perioperative MI.
| S-EPMC6435292 | biostudies-literature
Project description:ObjectiveTo assess the distribution of high-sensitivity cardiac troponin T (hs-cTnT) concentrations in stable chronic obstructive pulmonary disease (COPD), and whether hs-cTnT is associated with pulmonary function.DesignProspectively designed, cross-sectional study.SettingOutpatient clinic of Norwegian teaching hospital and community-based setting.ParticipantsSample of 101 stable COPD patients from the hospital's outpatient clinic and 120 individuals derived from a random general population sample.Main outcomesRatio of hs-cTnT in stable COPD patients compared with references from the general population. Change in ratio of hs-cTnT per unit increase of relevant covariables.ResultsThe crude geometric means of circulating hs-cTnT in the cases and the references were 7.75 and 3.01 ng/l, respectively (p < 0.001); that is, a relative ratio of 2.57 (95% CI 2.05 to 3.23). After adjustment for relevant confounders, this ratio was moderately attenuated to 1.65 (1.31-2.08). In the total study cohort, as well as among stable COPD patients, we found a significant positive association between hs-cTnT and interleukin-6 concentrations (p < 0.001) and the presence of pathologic Q waves (p = 0.023). Among stable COPD patients, one quartile increase in forced expiratory volume 1 was associated with a 39% decrease in hs-cTnT and patient category (Global Initiative of Obstructive Lung Disease classification 2011) was positively associated with hs-cTnT (p trend < 0.001) after multivariate adjustment.ConclusionsStable COPD is independently associated with higher hs-cTnT compared with randomly drawn subjects from the general population. In patients with stable COPD, higher hs-cTnT seems to be associated with immune activation and the severity of the disease.
| S-EPMC3595144 | biostudies-literature
Project description:BackgroundFew data exist regarding the implementation of high-sensitivity cardiac troponin (hs-cTn) assays in the United States since their approval.ObjectivesThis study sought to explore trends in hs-cTn assay implementation over time and assess the association of their use with in-hospital cardiac testing and outcomes.MethodsThe study examined trends in implementation of hs-cTn assays among participating hospitals in the National Cardiovascular Data Registry Chest Pain-MI [Myocardial Infarction] Registry from January 1, 2019 through September 30, 2021. Associations among hs-cTn use, use of in-hospital diagnostic imaging, and patient outcomes were assessed using generalized estimating equation models with logistic or gamma distributions.ResultsAmong 550 participating hospitals (N = 251,000), implementation of hs-cTn assays increased from 3.3% in the first quarter of 2019 to 32.6% in the third quarter of 2021 (Ptrend < 0.001). Use of hs-cTn was associated with more echocardiography among persons with non-ST-segment elevation acute coronary syndrome (NSTE-ACS; 82.4% vs 75.0%; adjusted odds ratio: 1.43; 95% CI: 1.19-1.73) but not among low-risk chest pain individuals. Use of hs-cTn was associated with less invasive coronary angiography among low-risk patients (3.7% vs 4.5%; adjusted odds ratio: 0.73; 95% CI: 0.58-0.92) but similar use for patients with NSTE-ACS. There was no association between hs-cTn use and noninvasive stress testing or coronary computed tomography angiography testing. Among individuals with NSTE-ACS, hs-cTn use was not associated with revascularization or in-hospital mortality. Use of hs-cTn was associated with a shorter length of stay (median 47.6 hours vs 48.0 hours; ratio: 0.94; 95% CI: 0.90-0.98).ConclusionsImplementation of hs-cTn among U.S. hospitals is increasing, but most U.S. hospitals continue to use less sensitive assays. The use of hs-cTn was associated with modestly shorter length of stay, greater use of echocardiography for NSTE-ACS, and less use of invasive angiography among low-risk patients.
| S-EPMC10037558 | biostudies-literature
Project description:IntroductionThe blood test for high-sensitivity cardiac troponin T (HS-CTnT) has been proposed as a marker of cardiovascular risk in the general population, as it is associated with subsequent incidence of cardiovascular events and mortality. We aimed at evaluating the feasibility of HS-CTnT testing within large nationally-representative population surveys in which blood samples are collected during household visits, shipped using the standard civil postal service, and then frozen for subsequent analyses.MethodsThe Health Survey for England (HSE) consists of a series of annual surveys beginning in 1991. It is designed to provide regular information on various aspects of the nation's health and risk factors. We measured HS-CTnT in the blood of 200 people from the HSE 2016 wave, then froze and stored their blood samples at -40°C for 5-10 weeks, and then thawed and retested them to appreciate the extent of within-person agreement or test-retest reliability of the two measurements.ResultsThe Cronbach's Alpha (Scale Reliability Coefficient) and the Interclass Correlation Coefficient (two-way mixed-effects model for consistency of agreement at individual level) were 0.97 (95%CI = 0.96-0.99) and 0.95 (95%CI = 0.94-0.96) respectively. The time delay from blood withdrawal to analysis and storage (1-4 days) did not affect the results, nor did the freezing time before the retest (5-10 weeks).ConclusionThe measurement of HS-CTnT plasma concentration within large nationally-representative surveys such as the Health Survey for England is feasible.
| S-EPMC5283724 | biostudies-literature