Biotin interference in high-sensitivity cardiac troponin T testing: a real-world evaluation in acute cardiac care.
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ABSTRACT:
SUBMITTER: Vroemen WHM
PROVIDER: S-EPMC9186258 | biostudies-literature | 2019 Dec
REPOSITORIES: biostudies-literature
Publications
Biotin interference in high-sensitivity cardiac troponin T testing: a real-world evaluation in acute cardiac care.
Vroemen Wim H M WHM van Doorn William P T M WPTM Kimenai Dorien M DM Wodzig Will K W H WKWH de Boer Douwe D Bekers Otto O Meex Steven J R SJR
Cardiovascular research 20191201 14
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| S-EPMC10985545 | biostudies-literature
Project description:BACKGROUND:Symptoms indicating acute coronary syndrome are commonly seen in emergency rooms, but only 10% of patients are actually diagnosed with acute myocardial infarction (AMI). The Guidelines for the diagnosis of patients with suspected AMI include either multiple testing of cardiac troponin (cTN) or a single combined test of cTN and copeptin, which facilitates earlier diagnosis or exclusion of AMI. The aim of the present analysis was to investigate the impact of combined copeptin/cTN testing on health care resource consumption and related costs both during and after initial hospital treatment. METHODS AND RESULTS:The analysis was based on the BIC-8 trial and financial data of participating study sites. A cost analysis was carried out primarily from the hospital perspective and secondarily from the perspective of German statutory health insurers. The underlying assumptions of the investigation were tested for robustness in additional sensitivity analyses. In total, the data of 713 patients (n = 359 combined copeptin/cTN testing, n = 354 serial cTN testing) were evaluated. From a hospital perspective, the combined copeptin/cTN testing showed a reduced number of medical procedures and a lower frequency of inpatient admissions. The average staff time was significantly reduced by a mean of 49 minutes (95% confidence interval (CI) 46 to 53) per patient, accompanied by a significant mean reduction of 131 minutes (95%CI 104 to 158) in the time patients stayed in the emergency room. The initial hospital treatment was less cost-intensive. Over the entire study period, no significant cost differences were observed between the groups for health insurance. CONCLUSION:The combined copeptin/cTN testing has the potential to save costs and staff time in acute care and for the entire hospital stay. The primary explanations for these findings are early identification and ruling out patients without AMI along with the associated reduced need for acute medical treatment. TRIAL REGISTRATION:ClinicalTrials.gov NCT01498731.
| S-EPMC6107144 | biostudies-literature
Project description:BackgroundIdentifying low-risk acute heart failure patients safe for discharge from the emergency department is a major unmet need.Methods and resultsA prospective, observational, multicenter pilot study targeting lower risk acute heart failure patients to determine whether hsTnT (high-sensitivity troponin T) identifies emergency department acute heart failure patients at low risk for rehospitalization and mortality. hsTnT was drawn at baseline and 3 hours. Phone follow-up occurred at 30 and 90 days. The primary end point composite of all-cause mortality, rehospitalization, and emergency department visits at 90 days (changed from 30 days because of lack of mortality events), analyzed using logistic regression. Secondary end points: 30- and 90-day all-cause mortality. hsTnT values less than the 99th percentile were defined as low hsTnT. Out of 527 enrolled patients, 499 comprised the initial analysis set. Of these, 332 had both 0- and 3-hour hsTnT drawn, of whom 319 completed 30 day follow-up. The average age was 62, 60% male, and 57% black. Median hsTnT was 26.4 ng/L (interquartile range, 15.1-44.3). There were 99 (21%) 30-day composite events, 13 (2.7%) deaths at 30 days, and 25 deaths (8.2%) at 90 days. Serial hsTnT values below the 99th percentile were not associated with a lower risk for the 90-day primary composite end point (odds ratio, 0.79; 95% CI, 0.42-1.50; P=0.4736). However, no deaths occurred in the low hsTnT group at 30 days with 1 death at 90 days.ConclusionshsTnT did not identify patients at low risk for the primary outcome of rehospitalization, emergency department visits, and mortality at 90 days.Clinical trial registrationURL: https://www.clinicaltrials.gov . Unique identifier: NCT02592135.
| S-EPMC6719714 | biostudies-literature
Project description:AimsHigh-sensitivity cardiac troponin (hs-cTn) assays provide higher diagnostic accuracy for acute myocardial infarction (AMI) when compared with conventional assays, but may result in increased use of unnecessary coronary angiographies due to their increased detection of cardiomyocyte injury in conditions other than AMI.Methods and resultsWe evaluated the impact of the clinical introduction of high-sensitivity cardiac troponin T (hs-cTnT) on the use of coronary angiography, stress testing, and time to discharge in 2544 patients presenting with symptoms suggestive of AMI to the emergency department (ED) within a multicentre study either before (1455 patients) or after (1089 patients) hs-cTnT introduction. Acute myocardial infarction was more often the clinical discharge diagnosis after hs-cTnT introduction (10 vs. 14%, P < 0.001), while unstable angina less often the clinical discharge diagnosis (14 vs. 9%, P = 0.007). The rate of coronary angiography was similar before and after the introduction of hs-cTnT (23 vs. 23%, P = 0.092), as was the percentage of coronary angiographies showing no stenosis (11 vs. 7%, P = 0.361). In contrast, the use of stress testing was substantially reduced from 29 to 19% (P < 0.001). In outpatients, median time to discharge from the ED decreased by 79 min (P < 0.001). Mean total costs decreased by 20% in outpatients after the introduction of hs-cTnT (P = 0.002).ConclusionThe clinical introduction of hs-cTn does not lead to an increased or inappropriate use of coronary angiography. Introduction of hs-cTn is associated with an improved rule-out process and thereby reduces the need for stress testing and time to discharge.Clinical trial registration informationwww.clinicaltrials.gov. Identifier, NCT00470587.
| S-EPMC5177796 | biostudies-literature
Project description:BackgroundA proportion of patients with acute ischemic stroke have elevated cardiac troponin levels and ECG changes suggestive of cardiac injury, but the etiology is unclear. The aims of this study were to assess the frequency of high sensitivity cardiac troponin T (hs-cTnT) elevation, to identify determinants and ECG changes associated with hs-cTnT elevation, to identify patients with myocardial ischemia and to assess the impact of hs-cTnT elevation on in-hospital mortality.MethodsPatients discharged with a diagnosis of acute ischemic stroke during a 1-year period, were included. Patients diagnosed with acute myocardial infarction (MI) within the last 7 days before admission or during hospitalization were excluded.ResultsIn all, 156 (54.4%) of 287 patients had elevated hs-cTnT. The factors independently associated with hs-cTnT elevation were age???76 years (OR 3.71 [95% CI 2.04-6.75]), previous coronary heart disease (CHD) (OR 2.61 [1.23-5.53]), congestive heart failure (OR 4.26 [1.15-15.82]), diabetes mellitus (OR 4.02 [1.50-10.76]) and lower eGFR (OR 0.97 [0.95-0.98]). Of the 182 patients who had two hs-cTnT measurements, 12 (6.6%) had both a rise or fall of hs-cTnT with at least one elevated value, and ECG manifestations of myocardial ischemia, e.g. meeting the criteria of acute MI. Both dynamic relative change (p?=?0.026) and absolute change (p?=?0.032) in hs-cTnT were significantly associated with higher in-hospital mortality.ConclusionsEstablished CHD and cardiovascular risk factors are associated with hs-cTnT elevation. Acute MI is likely underdiagnosed in acute ischemic stroke patients. Dynamic changes in troponin levels seem to be related to poor short-term prognosis.
| S-EPMC4107722 | 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:The strong non-covalent interaction between biotin and streptavidin places streptavidin-based assays, used by many laboratories, at an increased risk of interference by biotin. At present, a few manufacturers have developed fully automated anti-biotin interference methods, although compared with many detection platforms, these remain insufficient. Additionally, there is a need for more methods that can achieve fully automated anti-biotin interference. We sought to develop and evaluate a new biotin interference-resisting method based on a biotin-streptavidin chemiluminescence immunoassay. Streptavidin-coated magnetic microparticles (M) of different concentrations were prepared and tested for their biotin-resistance capabilities in an automated setting (Cobas e 601). The precision, accuracy, and detection capability were also assessed. Higher concentrations of M were found to have a stronger ability to resist biotin interference. A 2.16 mg/mL concentration of M was able to resist 500 ng/mL of biotin in samples while simultaneously having a relatively weak shielding effect on the optical signals. Moreover, the total precision and accuracy of this method, designated as M3, met acceptable standards. M3 has an improved ability to resist biotin interference, can achieve full automation, and its detection performance can meet the general laboratory quality requirements.
| S-EPMC9324022 | biostudies-literature
Project description:BackgroundNormal high sensitivity cardiac troponin (hs-cTn) assays rule out acute myocardial infarction (AMI) with great accuracy, but additional non-invasive testing is frequently ordered. This observational study evaluates whether clinical characteristics can contribute to risk stratification and could guide referral for additional testing.Methods918 serial patients with acute chest pain and normal hs-cTnT levels were prospectively included. Major adverse cardiac events (MACE) and non-invasive test results were assessed during one-year follow-up. Patients were classified as low and high risk based on clinical characteristics.ResultsMACE occurred in 6.1% of patients and mainly comprised revascularizations (86%). A recent abnormal stress test, suspicious history, a positive family history and higher baseline hs-cTnT levels were independent predictors of MACE with odds ratios of 16.00 (95%CI:6.25-40.96), 16.43 (6.36-42.45), 2.33 (1.22-4.42) and 1.10 (1.01-1.21), respectively. Absence of both recent abnormal stress test and suspicious history identified 86% of patients. These patients were at very low risk for MACE (0.4% in 30-days and 2.3% in one-year). Despite this, the majority (287/345 = 83%) of additional tests were performed in low risk patients, with <10% abnormal test findings. The diagnostic yield was significantly higher in the remaining higher risk patients, 40% abnormal test findings and a positive predictive value of 70% for MACE. Similar results were observed in patients without known coronary artery disease.ConclusionsClinical characteristics can be used to identify low risk patients with acute chest pain and normal hs-cTnT levels. Current strategies in the emergency department result in numerous additional tests, which are mostly ordered in patients at very low risk and have a low diagnostic yield.
| S-EPMC6128560 | biostudies-literature
Project description:ObjectivesWe aimed to assess the diversity and practices of existing studies on several assays and algorithms for serial measurements of high-sensitivity cardiac troponin (hs-cTn) for risk stratification and the diagnosis of myocardial infarction (MI) and 30-day outcomes in patients suspected of having non-ST-segment elevation MI (NSTEMI).MethodsWe searched multiple databases including MEDLINE, EMBASE, Science Citation Index, the Cochrane Database of Systematic Reviews and the CENTRAL databases for studies published between January 2006 and November 2021. Studies that assessed the diagnostic accuracy of serial hs-cTn testing in patients suspected of having NSTEMI in the emergency department (ED) were eligible. Data were analysed using the scoping review method.ResultsWe included 86 publications, mainly from research centres in Europe, North America and Australasia. Two hs-cTn assays, manufactured by Abbott (43/86) and Roche (53/86), dominated the evaluations. The studies most commonly measured the concentrations of hs-cTn at two time points, at presentation and a few hours thereafter, to assess the two-strata or three-strata algorithm for diagnosing or ruling out MI. Although data from 83 studies (97%) were prospectively collected, 0%-90% of the eligible patients were excluded from the analysis due to missing blood samples or the lack of a final diagnosis in 53 studies (62%) that reported relevant data. Only 19 studies (22%) reported on head-to-head comparisons of alternative assays.ConclusionEvidence on the accuracy of serial hs-cTn testing was largely derived from selected research institutions and relied on two specific assays. The proportions of the eligible patients excluded from the study raise concerns about directly applying the study findings to clinical practice in frontline EDs.Prospero registration numberCRD42018106379.
| S-EPMC9685223 | biostudies-literature
Project description:BackgroundAmong persons presenting to the emergency department with suspected acute myocardial infarction (MI), cardiac troponin (cTn) testing is commonly used to detect acute myocardial injury. Accelerated diagnostic protocols (ADPs) guide clinicians to integrate cTn results with other clinical information to decide whether to order further diagnostic testing.ObjectiveTo determine the change in the rate and yield of stress test or coronary CT angiogram following cTn measurement in patients with chest pain presenting to the emergency department pre- and post-transition to a high-sensitivity (hs-cTn) assay in an updated ADP.MethodsUsing electronic health records, we examined visits for chest pain at five emergency departments affiliated with an integrated academic health system 1-year pre- and post-hs-cTn assay transition. Outcomes included stress test or coronary imaging frequency, ADP compliance among those with additional testing, and diagnostic yield (ratio of positive tests to total tests).ResultsThere were 7564 patient-visits for chest pain, including 3665 in the pre- and 3899 in the post-period. Following the updated ADP using hs-cTn, 862 (23.5 per 100 patient visits) visits led to subsequent testing versus 1085 (27.8 per 100 patient visits) in the pre-hs-cTn period, (P < 0.001). Among those who were tested, the protocol-compliant rate fell from 80.9% to 46.5% (P < 0.001), but the yield of those tests rose from 24.5% to 29.2% (P = 0.07). Among tests that were noncompliant with ADP guidance, yield was similar pre- and post-updated hs-cTn ADP implementation (pre 13.0%, post 15.4% (P = 0.43).ConclusionImplementation of hs-cTn supported by an updated ADP was associated with a lower rate of stress testing and coronary CT angiogram.
| S-EPMC10616758 | biostudies-literature