scholarly journals Point-of-Care Compatibility of Ultra-Sensitive Detection Techniques for the Cardiac Biomarker Troponin I—Challenges and Potential Value

Biosensors ◽  
2018 ◽  
Vol 8 (4) ◽  
pp. 114 ◽  
Author(s):  
Brian Regan ◽  
Richard O’Kennedy ◽  
David Collins
Keyword(s):  
Troponin I ◽  
Point Of Care ◽  
Well Being ◽  
Small Sample ◽  
Cardiac Biomarkers ◽  
Sensitive Detection ◽  
Biomarker Detection ◽  
Cardiac Biomarker ◽  
Detection Techniques ◽  
Cardiac Symptoms

Cardiac biomarkers are frequently measured to provide guidance on the well-being of a patient in relation to cardiac health with many assays having been developed and widely utilised in clinical assessment. Effectively treating and managing cardiovascular disease (CVD) relies on swiftly responding to signs of cardiac symptoms, thus providing a basis for enhanced patient management and an overall better health outcome. Ultra-sensitive cardiac biomarker detection techniques play a pivotal role in improving the diagnostic capacity of an assay and thus enabling a better-informed decision. However, currently, the typical approach taken within healthcare depends on centralised laboratories performing analysis of cardiac biomarkers, thus restricting the roll-out of rapid diagnostics. Point-of-care testing (POCT) involves conducting the diagnostic test in the presence of the patient, with a short turnaround time, requiring small sample volumes without compromising the sensitivity of the assay. This technology is ideal for combatting CVD, thus the formulation of ultra-sensitive assays and the design of biosensors will be critically evaluated, focusing on the feasibility of these techniques for point-of-care (POC) integration. Moreover, there are several key factors, which in combination, contribute to the development of ultra-sensitive techniques, namely the incorporation of nanomaterials for sensitivity enhancement and manipulation of labelling methods. This review will explore the latest developments in cardiac biomarker detection, primarily focusing on the detection of cardiac troponin I (cTnI). Highly sensitive detection of cTnI is of paramount importance regarding the rapid rule-in/rule-out of acute myocardial infarction (AMI). Thus the challenges encountered during cTnI measurements are outlined in detail to assist in demonstrating the drawbacks of current commercial assays and the obstructions to standardisation. Furthermore, the added benefits of introducing multi-biomarker panels are reviewed, several key biomarkers are evaluated and the analytical benefits provided by multimarkers-based methods are highlighted.

Assessing the Performance of a Novel Point-of-Care Qualitative Assay for Early Diagnosis of Acute Coronary Syndrome

Cardiology ◽  
2020 ◽  
pp. 1-8
Author(s):  
Ronny Alcalai ◽  
Boris Varshisky ◽  
Ahmad Marhig ◽  
David Leibowitz ◽  
Larissa Kogan-Boguslavsky ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Chest Pain ◽  
Diagnostic Accuracy ◽  
Diagnostic Performance ◽  
Troponin I ◽  
Point Of Care ◽  
Final Diagnosis ◽  
Cardiac Biomarkers ◽  
Fatty Acid Binding ◽  
Coronary Syndrome

<b><i>Background:</i></b> Early and accurate diagnosis of acute coronary syndrome (ACS) is essential for initiating lifesaving interventions. In this article, the diagnostic performance of a novel point-of-care rapid assay (SensAheart<sup>©</sup>) is analyzed. This assay qualitatively determines the presence of 2 cardiac biomarkers troponin I and heart-type fatty acid-binding protein that are present soon after onset of myocardial injury. <b><i>Methods:</i></b> We conducted a prospective observational study of consecutive patients who presented to the emergency department with typical chest pain. Simultaneous high-sensitive cardiac troponin T (hs-cTnT) and SensAheart testing was performed upon hospital admission. Diagnostic accuracy was computed using SensAheart or hs-cTnT levels versus the final diagnosis defined as positive/negative. <b><i>Results:</i></b> Of 225 patients analyzed, a final diagnosis of ACS was established in 138 patients, 87 individuals diagnosed with nonischemic chest pain. In the overall population, as compared to hs-cTnT, the sensitivity of the initial SensAheart assay was significantly higher (80.4 vs. 63.8%, <i>p</i> = 0.002) whereas specificity was lower (78.6 vs. 95.4%, <i>p</i> = 0.036). The overall diagnostic accuracy of SensAheart assay was similar to the hs-cTnT (82.7% compared to 76.0%, <i>p</i> = 0.08). <b><i>Conclusions:</i></b> Upon first medical contact, the novel point-of-care rapid SensAheart assay shows a diagnostic performance similar to hs-cTnT. The combination of 2 cardiac biomarkers in the same kit allows for very early detection of myocardial damage. The SensAheart assay is a reliable and practical tool for ruling-in the diagnosis of ACS.

scholarly journals Value of Cardiac Biomarkers in the Early Diagnosis of Takotsubo Syndrome

2020 ◽  
Vol 9 (9) ◽  
pp. 2985
Author(s):  
Charlotte Dagrenat ◽  
Jean Jacques Von Hunolstein ◽  
Kensuke Matsushita ◽  
Lucie Thebaud ◽  
Stéphane Greciano ◽  
...  
Keyword(s):  
Psychiatric Disorders ◽  
Troponin I ◽  
Early Stage ◽  
Cardiac Biomarkers ◽  
Takotsubo Syndrome ◽  
Gender History ◽  
Cardiac Biomarker ◽  
History Of ◽  
St Elevation ◽  
Bedside Diagnosis

Background: Bedside diagnosis between Takotsubo syndrome (TTS) and ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction remains challenging. We sought to determine a cardiac biomarker profile to enable their early distinction. Methods: 1100 patients (TTS n = 314, STEMI n = 452, NSTEMI n = 334) were enrolled in two centers. Baseline clinical and biological characteristics were compared between groups. Results: At admission, cut-off values of BNP (B-type natriuretic peptide)/TnI (Troponin I) ratio of 54 and 329 distinguished respectively STEMI from NSTEMI, and NSTEMI from TTS. Best differentiation was obtained by the use of BNP/TnI ratio at peak (cut-of values of 6 and 115 discriminated respectively STEMI from NSTEMI, and NSTEMI from TTS). We developed a score including five parameters (age, gender, history of psychiatric disorders, LVEF, and BNP/TnI ratio at admission) enabling good distinction between TTS and STEMI (77% specificity and 92% sensitivity, AUC 0.93). For the distinction between TTS and NSTEMI, a four variables score (gender, history of psychiatric disorders, LVEF, and BNP at admission) achieved a good diagnostic performance (89% sensitivity, 85% specificity, AUC 0.94). Conclusion: A distinctive cardiac biomarker profile enables at an early stage a differentiation between TTS and ACS. A four (NSTEMI) or five variables score (STEMI) permitted a better discrimination.

scholarly journals Redefining Cardiac Biomarkers in Predicting Mortality of Inpatients With COVID-19

Hypertension ◽  
2020 ◽  
Vol 76 (4) ◽  
pp. 1104-1112 ◽  
Author(s):  
Juan-Juan Qin ◽  
Xu Cheng ◽  
Feng Zhou ◽  
Fang Lei ◽  
Gauri Akolkar ◽  
...  
Keyword(s):  
Natriuretic Peptide ◽  
Troponin I ◽  
Cox Model ◽  
Cardiac Injury ◽  
High Sensitivity ◽  
Cardiac Biomarkers ◽  
Cardiac Biomarker ◽  
Increased Risk ◽  
Poor Outcomes ◽  
Prognostic Power

The prognostic power of circulating cardiac biomarkers, their utility, and pattern of release in coronavirus disease 2019 (COVID-19) patients have not been clearly defined. In this multicentered retrospective study, we enrolled 3219 patients with diagnosed COVID-19 admitted to 9 hospitals from December 31, 2019 to March 4, 2020, to estimate the associations and prognostic power of circulating cardiac injury markers with the poor outcomes of COVID-19. In the mixed-effects Cox model, after adjusting for age, sex, and comorbidities, the adjusted hazard ratio of 28-day mortality for hs-cTnI (high-sensitivity cardiac troponin I) was 7.12 ([95% CI, 4.60–11.03] P <0.001), (NT-pro)BNP (N-terminal pro-B-type natriuretic peptide or brain natriuretic peptide) was 5.11 ([95% CI, 3.50–7.47] P <0.001), CK (creatine phosphokinase)-MB was 4.86 ([95% CI, 3.33–7.09] P <0.001), MYO (myoglobin) was 4.50 ([95% CI, 3.18–6.36] P <0.001), and CK was 3.56 ([95% CI, 2.53–5.02] P <0.001). The cutoffs of those cardiac biomarkers for effective prognosis of 28-day mortality of COVID-19 were found to be much lower than for regular heart disease at about 19%–50% of the currently recommended thresholds. Patients with elevated cardiac injury markers above the newly established cutoffs were associated with significantly increased risk of COVID-19 death. In conclusion, cardiac biomarker elevations are significantly associated with 28-day death in patients with COVID-19. The prognostic cutoff values of these biomarkers might be much lower than the current reference standards. These findings can assist in better management of COVID-19 patients to improve outcomes. Importantly, the newly established cutoff levels of COVID-19–associated cardiac biomarkers may serve as useful criteria for the future prospective studies and clinical trials.

Effects of environmental conditions on point-of-care cardiac biomarker test performance during a simulated rescue: Implications for emergency and disaster response

2013 ◽  
Vol 8 (3) ◽  
pp. 205-212 ◽  
Author(s):  
Richard F. Louie, PhD, FACB ◽  
William J. Ferguson, BS ◽  
Corbin M. Curtis, BS ◽  
John H. Vy, BS ◽  
Chloe S. Tang, BS ◽  
...  
Keyword(s):  
Test Performance ◽  
Troponin I ◽  
Point Of Care ◽  
False Negative ◽  
Environmental Stresses ◽  
Marshall Islands ◽  
Rank Test ◽  
Cardiac Biomarker ◽  
Mortality And Morbidity ◽  
The Impact

Objective: To characterize the effects of environmental stress on point-of-care (POC) cardiac biomarker testing during a simulated rescue.Design: Multiplex test cassettes for cardiac troponin I (cTnI), brain natriuretic peptide (BNP), CKMB, myoglobin, and D-dimer were exposed to environmental stresses simulating a 24-hour rescue from Hawaii to the Marshall Islands and back. We used Tenney environmental chambers (T2RC and BTRC) to simulate flight conditions (20°C, 10 percent relative humidity) and ground conditions (22.3-33.9°C, 73-77 percent). We obtained paired measurements using stressed versus control (room temperature) cassettes at seven time points (T1-7 with T1,2,6,7 during flight and T3-5 on ground). We analyzed paired differences (stressed minus control) with Wilcoxon signed rank test. We assessed the impact on decision-making at clinical thresholds.Results: cTnI results from stressed test cassettes (n = 10) at T4 (p 0.05), T5 (p 0.01), and T7 (p 0.05) differed significantly from control, when testing samples with median cTnI concentration of 90 ng/L. During the ground rescue, 36.7 percent (11/30) of cTnI measurements from stressed cassettes generated significantly lowered results. At T5, 20 percent (2/10) of cTnI results were highly discrepant—stressed cassettes reported normal results, when control results were 100 ng/L. With sample median concentration of 108 pg/mL, BNP results from stressed test cassettes differed significantly from controls (p 0.05).Conclusion: Despite modest, short-term temperature elevation, environmental stresses led to erroneous results. False negative cTnI and BNP results potentially could miss acute myocardial infarction and congestive heart failure, confounded treatment, and increased mortality and morbidity. Therefore, rescuers should protect POC reagents from temperature extremes.

scholarly journals Evaluation of the Efficiency of N-terminal Pro-B-type Natriuretic Peptide for Diagnosis of Acute Myocardial Infarction

2020 ◽  
Author(s):  
Abuagla M. Dafalla ◽  
Leena A. Dafalla ◽  
ShamsEldein M. Ahmed ◽  
Yousif A. Mohammed ◽  
Adam D. Abakar ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Natriuretic Peptide ◽  
Predictive Value ◽  
Troponin I ◽  
Venous Blood ◽  
Cardiac Biomarkers ◽  
Control Group ◽  
Heart Cell ◽  
Cardiac Biomarker

Background: Cardiac diseases are one of the major causes of death worldwide with increasing incidence rate per year, particularly in developing countries such as Sudan owing to urbanization and changing lifestyle. Myocardial infarction is a consequence of the imbalance between the heart blood supply and the required heart cell; this disorder leads to necrosis of myocardium and may cause death. It could be diagnosed by at least two of the following criteria: chest pain, electrocardiography (ECG) elevation, and levels on cardiac biomarkers. This study aimed to evaluate the efficiency of N-terminal pro-B-type natriuretic peptide (NTproBNP) for the diagnosis of acute myocardial infarction (AMI).  Methods: This analytical case–control hospital-based study was conducted on a total of 70 individuals, of which 40 participants were suspected of or diagnosed with AMI, while 30 healthy subjects  were included as a control group. Three ml of venous blood were collected in lithium heparin containers. Troponin I (TnI) as a cardiac biomarker was measured by TOSOH AIA-360, while the NTproBNP level was detected using I-Chroma II. Personal and clinical data were collected directly from each participant using a predesigned questionnaire. Results: A significant increase in the TnI level (mean: 13.13 ± 18.9 ng/ml) and NTproBNP (mean: 5756.5 ± 8378.2 pg/mL) in AMI patients were detected when compared with control mean (0.02 ± 0.00 ng/ml and 57.8 ± 42.32 pg/mL, respectively). Conclusions: NTproBNP gave a high sensitivity (87.5%), specificity (100%), positive predictive value (100%), and negative predictive value (85.7%) in the diagnosis of AMI when compared with another cardiac biomarker such as TnI. Keywords: acute myocardial infarction, NTproBNP, troponin I, Medani Heart Center, Sudan

Abstract P375: Secular Trends in Validity of Troponin I Assays for Myocardial Infarction Classification Among Four US Communities: Findings From the ARIC Study

Circulation ◽  
2018 ◽  
Vol 137 (suppl_1) ◽  
Author(s):  
Matthew S Loop ◽  
Jason P Fine ◽  
Aaron R Folsom ◽  
Wayne Rosamond
Keyword(s):  
Myocardial Infarction ◽  
Sensitivity And Specificity ◽  
Troponin I ◽  
Cardiac Biomarkers ◽  
Computer Algorithm ◽  
Assay Sensitivity ◽  
Cardiac Biomarker ◽  
Upper Limit ◽  
Aric Study

Introduction: The Atherosclerosis Risk In Communities (ARIC) study conducted community surveillance of hospitalized myocardial infarction (MI) from 1987 to 2014 among four US communities (Jackson MS, Forsyth County NC, Washington County MD, and Minneapolis MN). Surveillance of MI during the troponin era (1996 - ) has been complicated by increasing sensitivity of troponin I assays. It is unclear to what extent increased assay sensitivity has affected the validity of event classification. We hypothesized that among events that would have been classified as a definite/probable MI or a suspect/no MI regardless of cardiac biomarkers, the sensitivity and specificity of troponin I assays to identify abnormal enzyme levels (ARIC community surveillance criterion: 2x upper limit of normal) has changed over time in hospitals participating in ARIC community surveillance. Methods and results: From 33,995 community hospitalizations with suspicion of MI or coronary heart disease with a troponin I measurement that occurred between 1996 and 2014, 2,143 met ARIC criteria as MI cases (ARIC computer algorithm classification of definite or probable MI regardless of cardiac biomarker levels) and 9,909 we considered noncases (ARIC computer algorithm classification of no or suspect MI regardless of cardiac biomarker levels). In order to be an MI case, the event had to include an evolving diagnostic ECG. To be an noncase, the event had to include no chest pain and an equivocal or absent/uncodable ECG. We used survey-weighted logistic regression models to predict sensitivity and specificity from 1996 - 2014. The sensitivity of troponin I assay being abnormal was approximately 50% for most of the time period, with a potential increase to 70% after 2010. The specificity was approximately 90% in the late 1990s and early 2000s, but fell to 68% (95% confidence interval: 63% - 73%) by 2014. The median upper limit normal (ULN) for troponin I among all 33,995 hospitalizations dropped from 1.4 ng/mL in 1996 to 0.045 ng/mL in 2014. Conclusions: For most of the troponin era among the four ARIC communities, hospitalizations that were classified as an MI regardless of cardiac biomarker levels were equally likely to have or not have abnormal troponin I. In recent years, the likelihood that hospitalizations that were classified as no MI regardless of cardiac biomarker levels had normal troponin I decreased, potentially affecting the usefulness of troponin I measurements to separate hospitalized MIs from non-MIs in the context of community surveillance, particularly among hospitalizations with few other signs of MI. These shifts in assay validity were likely due in part to a decrease in ULN for troponin I in the four ARIC communities.

scholarly journals Microfluidic Overhauser DNP Chip for Signal-enhanced Compact NMR

2020 ◽  
Author(s):  
Sebastian Kiss ◽  
Neil MacKinnon ◽  
Jan Korvink
Keyword(s):  
Point Of Care ◽  
Power Level ◽  
Sample Volume ◽  
Spectroscopic Technique ◽  
Small Sample ◽  
Biomarker Detection ◽  
Low Field ◽  
Equilibrium Level ◽  
Microwave Power Level

Abstract Nuclear magnetic resonance at low field strength is an insensitive spectroscopic technique, precluding portable applications with small sample volumes, such as needed for biomarker detection in body fluids. Here we report a compact double resonant chip stack system that implements in situ dynamic nuclear polarisation of a 130 nL sample volume, achieving a signal enhancement of 54 w.r.t. the thermal equilibrium level at a microwave power level of 0.5W. This work overcomes instrumental barriers to the use of NMR detection for point-of-care applications.

scholarly journals Cardiac biomarkers by point-of-care testing – back to the future?

2020 ◽  
Vol 44 (2) ◽  
pp. 89-95 ◽  
Author(s):  
Paul Collinson
Keyword(s):  
Decision Making ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Troponin T ◽  
Point Of Care ◽  
Patient Flow ◽  
High Sensitivity ◽  
Cardiac Biomarkers ◽  
Point Of Care Testing ◽  
Diagnostic Laboratory

AbstractThe measurement of the cardiac troponins (cTn), cardiac troponin T (cTnT) and cardiac troponin I (cTnI) are integral to the management of patients with suspected acute coronary syndromes (ACS). Patients without clear electrocardiographic evidence of myocardial infarction require measurement of cTnT or cTnI. It therefore follows that a rapid turnaround time (TAT) combined with the immediacy of results return which is achieved by point-of-care testing (POCT) offers a substantial clinical benefit. Rapid results return plus immediate decision-making should translate into improved patient flow and improved therapeutic decision-making. The development of high sensitivity troponin assays offer significant clinical advantages. Diagnostic algorithms have been devised utilising very low cut-offs at first presentation and rapid sequential measurements based on admission and 3 h sampling, most recently with admission and 1 h sampling. Such troponin algorithms would be even more ideally suited to point-of-care testing as the TAT achieved by the diagnostic laboratory of typically 60 min corresponds to the sampling interval required by the clinician using the algorithm. However, the limits of detection and analytical imprecision required to utilise these algorithms is not yet met by any easy-to-use POCT systems.

scholarly journals Variability in Cardiac Biomarkers during Hemodialysis: A Prospective Cohort Study

2020 ◽  
Author(s):  
David Collister ◽  
Andrea Mazzetti ◽  
Anuja Bhalerao ◽  
Jessica Tyrwhitt ◽  
Peter Kavsak ◽  
...  
Keyword(s):  
Troponin I ◽  
Treatment Time ◽  
High Sensitivity ◽  
Cardiac Biomarkers ◽  
Linear Regression Models ◽  
Fatty Acid Binding ◽  
Cardiac Biomarker ◽  
Hemodialysis Treatment ◽  
Galectin 3 ◽  
Multilevel Linear Regression

Abstract Background The effect of hemodialysis on cardiac biomarkers is unclear. We sought to evaluate the degree and causes of intradialytic variability of high sensitivity troponin I (hs-TnI), galectin-3 (gal-3), and heart-type fatty acid binding protein (hFABP). Methods hs-TnI, gal-3, and hFABP were prospectively measured pre-dialysis and post-dialysis for 1 week every month for 6 months in 178 prevalent adult hemodialysis patients at a single center in Hamilton, Canada. The degree of change from pre-dialysis to post-dialysis for each cardiac biomarker was estimated with multilevel linear regression models. Results The median change in the concentration of hs-TnI during hemodialysis was −1 ng/L (interquartile range [IQR] −1 to 2 ng/L) while gal-3 and hFABP changed by −36.3 ng/mL (IQR −27.7 to −46.8 ng/mL) and −19.41 ng/mL (IQR −13.61 to −26.87 ng/mL), respectively. The median (IQR) percentage intradialytic changes for hs-TnI, gal-3, and hFABP were 2.6% (−4.4% to 12.5%), −59.8% (−54.7% to −64.8%) and −35.3% (−28.4% to −42.1%), respectively. Ultrafiltration was associated with an increase in concentration of hs-TnI, gal-3, and hFABP (mean 0.99 ng/L, 1.05 ng/mL, and 1.9 ng/mL per L ultrafiltration, respectively, P &lt; 0.001). Both gal-3 and hFABP concentrations decreased in association with the volume of blood processed (P &lt; 0.001) and with hemodialysis treatment time (P  = 0.02 and P  = 0.04) while hs-TnI concentration decreased only in association with hemodialysis treatment time (P  &lt; 0.001). Conclusions Ultrafiltration volume and hemodialysis treatment time influenced hs-TnI, gal-3, and hFABP concentrations during hemodialysis and should be considered when interpreting their measurement.

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