scholarly journals Validation of High sensitivity cardiac troponin (HsTnI) – a breakthrough in diagnostic accuracy of acute coronary syndromes

2021 ◽  
Vol 156 (Supplement_1) ◽  
pp. S35-S35
Author(s):  
S Dalal ◽  
J M Petersen ◽  
D Jhala
Keyword(s):  
Cardiac Troponin ◽  
Acute Coronary Syndromes ◽  
Troponin I ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Method Comparison ◽  
Heart Association ◽  
High Sensitivity ◽  
Coronary Syndromes ◽  
European Society Of Cardiology

Abstract Introduction/Objective Cardiac troponin (cTn) testing is an essential component of the diagnostic workup and management of acute coronary syndromes (ACS). Rapid advances in immunoassay technologies has led to the development of high sensitivity troponin (HsTnl) assays with unprecedented analytic sensitivity and precision. These assays are FDA approved and the use of HsTnl assays is recommended by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), the Joint European Society of Cardiology (ESC), the American College of Cardiology (ACC), and the American Heart Association (AHA) in the Fourth Universal Definition of Myocardial Infarction (2018). The incidence of ACS and its mimics in emergency room visits are much more prevalent in veterans due to increased medical comorbidities. We report here our experience with its validation on two Unicel DXI 800 Access Immunoassays as it has not been well published, particularly in a Veterans Healthcare Clinical Laboratory setting. Methods/Case Report The quality assurance goal of the validation is to demonstrate that the Unicel DXI 800 Access Immunoassay HsTnl assay performs as expected on two analyzers and can be put into clinical use. Method to method correlation with a validated conventional Troponin I, within run precision, day to day precision, and a linearity study were performed as part of this validation. Results (if a Case Study enter NA) For the total of 60 specimens run for the method comparison, Data was plotted and evaluated against EP evaluator, both hsTnI and Troponin I were within the 95% confidence intervals of the method. The linearity study demonstrated results are linear with results as expected. Two levels of cardiac control were tested in a run of 60 replicates each in one day for within run precision, with all results as expected. The day to day precision with three levels of control run daily over 10 days also yielded results as expected. Conclusion The HsTnI is a highly accurate, faster test for the detection of ACS allowing earlier detection of smaller infarcts with much better precision, and there by reducing the morbidity and mortality. It allows rapid discharge of the patients with reducing the cost of hospital stay. This is an example of excellence in laboratory practice by extending the best quality laboratory care with proper validation of instrument methods conducive to laboratory workflow.

scholarly journals Strategy of IFCC standardization and use of cardiac markers in acute coronary syndromes

2003 ◽  
Vol 22 (4) ◽  
pp. 303-309 ◽  
Author(s):  
Svetlana Ignjatovic
Keyword(s):  
Cardiac Troponin ◽  
Acute Coronary Syndromes ◽  
Clinical Chemistry ◽  
Clinical Event ◽  
Control Group ◽  
Clinical Use ◽  
Cardiac Damage ◽  
Creatine Kinase Mb ◽  
Coronary Syndromes ◽  
Definition Of

Although the use of troponin to diagnose acute myocardial infarction (AMI) has been previously proposed, the Committee on Standardization of Markers of Cardiac Damage (C-SMCD) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) made a recommendation in 1999 to expand on the enzyme diagnostic criteria for AMI to include cardiac-specific proteins. In September 2000, a joint committee of the European Society of Cardiology and the American College of Cardiology (ESC/ACC) published a new definition of AMI that for first time officially included troponin. According to these criteria, as the best biochemical indicator for detecting myocardial necrosis is "a concentration of cardiac troponin exceeding the decision limit (defined as the 99th percentile of a reference control group) on at least one occasion during the first 24 hours after the onset of clinical event". The use of creatine kinase MB (CK-MB), measured by mass assays, is still considered as an acceptable alternative only if cardiac troponin assays are not available. It is very important to standardize the clinical use of troponin in diagnosis and management of acute coronary syndromes and to clearly define decision thresholds. Two strategies have competed as the most appropriate for the use of new markers. The first relies on the use of a combination of two markers - a rapid rising marker such as myoglobin, and a marker that takes longer to rise but is more specific, such as cardiac troponin - to enable detection of AMI in patients who present early and late after symptom onset. In the second strategy, only measurement of cardiac troponin is suggested. One of the most important problems in the practical use of the cardiac-specific troponin is the right definition of decision limits. As diagnostic cut-off for clinical use, the IFCC C-SMCD recommends for troponin assays a total imprecision, expressed as coefficient of variation (CV), of <10% at the 99th percentile of a reference control group. For troponin assays that cannot presently meet the 10% CV at the 99th percentile value, a predetermined higher concentration that meets this imprecision goal should be used as cut-off for AMI until the goal of a 10% CV can be achieved at the 99th percentile. It is very important that clinically relevant biomarker, such as cardiac troponin, on which critical decisions will rest, can be measured with highly reliable and standardized methods. There are problems in assay standardization, imprecision interference, and of pre-analytical variability. Cardiac troponin is currently the most sensitive and specific biochemical marker of myocardial damage and is the best marker for diagnosis, risk stratification, and guidance of therapy in acute coronary syndromes.

scholarly journals The Use of Biochip Cardiac Array Technology for Early Diagnosis of Acute Coronary Syndromes

2009 ◽  
Vol 28 (4) ◽  
pp. 293-299 ◽  
Author(s):  
Grazyna Sypniewska ◽  
Marcin Sawicki ◽  
Magdalena Krintus ◽  
Marek Kozinski ◽  
Jacek Kubica
Keyword(s):  
Early Diagnosis ◽  
Cardiac Troponin ◽  
Acute Coronary Syndromes ◽  
Myocardial Injury ◽  
Troponin I ◽  
Reference Population ◽  
Coronary Syndrome ◽  
Carbonic Anhydrase Iii ◽  
Array Technology ◽  
Coronary Syndromes

The Use of Biochip Cardiac Array Technology for Early Diagnosis of Acute Coronary SyndromesSerum troponin is the best biomarker for the diagnosis of acute coronary syndrome, but it takes considerable time before a definitive diagnosis is available. The purpose of this study was to evaluate whether a multimarker approach, using the biochip cardiac array, would facilitate the early diagnosis. Serum biomarkers were determined on admission (≤6 hrs) and after 6 hours in 42 patients suspected for ACS. Cardiac troponin I was measured by a sensitive assay (STATcTnI) and cardiac markers (H-FABP, myoglobin, cTnI, CK-MB mass, carbonic anhydrase III) were assayed with the use of Biochip Array Technology.STATcTnI concentrations, within the first 6 hours, were elevated >99thpercentile for the reference population in 83.3% of subjects, but none reached the cut-off for AMI. On admission H-FABP was the only marker with 90.5% sensitivity in all ACS cases and 100% sensitivity in STEMI/NSTEMI patients. The sensitivity of myoglobin at presentation was 71.4% in ACS, however, combined sensitivity of myoglobin and H-FABP reached 95.2%. Lowering the cut-off for cTnI allowed early diagnosis (≤6 hrs) in only 26.2% of ACS patients and 95.2% after the next 6 hours. In unstable angina the cardiac panel was not sufficiently accurate for early risk stratification. In conclusion, testing for both markers, H-FABP and sensitive cardiac troponin, available with the cardiac array may facilitate the early detection of myocardial injury in clinical practice.

scholarly journals Evaluation of standardization capability of current cardiac troponin I assays by a correlation study: results of an IFCC pilot project

2015 ◽  
Vol 53 (5) ◽  
Author(s):  
Jillian R. Tate ◽  
David M. Bunk ◽  
Robert H. Christenson ◽  
Julian H. Barth ◽  
Alexey Katrukha ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Clinical Chemistry ◽  
Measurement Equivalence ◽  
Method Comparison ◽  
Pilot Project ◽  
Correlation Study ◽  
Cardiac Troponin I ◽  
High Concentration ◽  
Study Results

AbstractAs a part of an International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) project to prepare a commutable reference material for cardiac troponin I (cTnI), a pilot study evaluated current cTnI assays for measurement equivalence and their standardization capability.cTnI-positive samples collected from 90 patients with suspected acute myocardial infarction were assessed for method comparison by 16 cTnI commercial assays according to predefined testing protocols. Seven serum pools prepared from these samples were also assessed.Each assay was assessed against median cTnI concentrations measured by 16 cTnI assays using Passing-Bablok regression analysis of 79 patient samples with values above each assay’s declared detection limit. We observed a 10-fold difference in cTnI concentrations for lowest to highest measurement results. After mathematical recalibration of assays, the between-assay variation for patient samples reduced on average from 40% to 22% at low cTnI concentration, 37%–20% at medium concentration, and 29%–14% at high concentration. The average reduction for pools was larger at 16%, 13% and 7% for low, medium and high cTnI concentrations, respectively. Overall, assays demonstrated negligible bias after recalibration (y-intercept: –1.4 to 0.3 ng/L); however, a few samples showed substantial positive and/or negative differences for individual cTnI assays.All of the 16 commercial cTnI assays evaluated in the study demonstrated a significantly higher degree of measurement equivalence after mathematical recalibration, indicating that measurement harmonization or standardization would be effective at reducing inter-assay bias. Pooled sera behaved similarly to individual samples in most assays.

scholarly journals NILAI DIAGNOSTIK UJI TROPONIN I KUANTITATIF METODE IMMUNOKROMATOGRAFI

2018 ◽  
Vol 14 (1) ◽  
pp. 20
Author(s):  
Siti Fatonah ◽  
Anik Widijanti ◽  
Tinny Endang Hernowati
Keyword(s):  
Cardiac Troponin ◽  
Biochemical Markers ◽  
Acute Coronary Syndromes ◽  
Troponin I ◽  
Myocardial Damage ◽  
Diagnostic Value ◽  
Cardiac Troponin I ◽  
Coronary Syndromes ◽  
Sensitivity Specificity ◽  
Cardiac Troponins

Cardiac troponins are the most sensitive and specific biochemical markers of myocardial damage but there is no standardization of WHO for cardiac troponin I, resulting in a variability for diagnostic value. It is necessary to determine diagnostic value for a new kitof troponin I. To evaluate a new quantitative immunochromatography assay for troponin I at a various cut off level. A cross sectionalstudy was conducted in 64 patients with acute myocardial infarction (AMI) and 55 non-AMI as control from February to September2007. The level of cardiac troponin I (cTnI) was measured and determined it diagnostic value at a various cut off level. The sensitivity,specificity, PPV and NPV of this assay were 91%, 91%, 92% and 89% at cut off level of 1,0 ng/ml (according to the kit), respectively.The cut off of cTnI were divided into five levels: 0.8, 1.0, 1.2, 1.5, and 2.0 with the area under curve were 0.923, 0.908, 0.912, and0.897, respectively. The sensitivity were 94%, 91%, 86%, 81% and 72%, respectively, the specificity were 91%, 91%, 96%, 98% and98%, respectively. This rapid diagnostic test is sensitive and specific to diagnose an acute coronary syndromes.

Routine Invasive Strategy Compared with a Selective Invasive Strategy in Women with Non-ST-elevation Acute Coronary Syndromes

2009 ◽  
Vol 5 (1) ◽  
pp. 81
Author(s):  
Joakim Alfredsson ◽  
Eva Swahn ◽  
◽  
Keyword(s):  
Gender Differences ◽  
Acute Coronary Syndromes ◽  
Heart Association ◽  
Invasive Treatment ◽  
Invasive Strategy ◽  
Class 1 ◽  
Coronary Syndromes ◽  
St Elevation ◽  
Early Invasive Strategy ◽  
European Society Of Cardiology

Cardiovascular disease is the leading cause of death in both men and women in the developed world. Non-ST-elevation acute coronary syndromes (NSTE-ACS) are the most prevalent acute manifestations of coronary heart disease. Revascularisation is performed in the NSTEACS setting to relieve symptoms and prevent progression to myocardial ischaemia and death. Today, early invasive treatment with coronary angiography and revascularisation if feasible has become the strategy of choice in patients with NSTE-ACS, and is a class 1 recommendation in both American College of Cardiology/American Heart Association (ACC/AHA) and European Society of Cardiology (ESC) guidelines on NSTE-ACS, at least for patients with medium- or high-risk indications. However, gender differences in terms of benefit from an early invasive strategy have been intensively debated and the data are conflicting. In this article, we will discuss possible gender differences in randomised trials addressing this matter.

Sign in / Sign up

Export Citation Format

Share Document