Multicenter Evaluation of a High-Sensitivity Troponin I Assay and Verification of an Early Rule-Out Algorithm

2019 ◽  
Vol 4 (1) ◽  
pp. 95-100
Author(s):  
Hayley Sharrod-Cole ◽  
Clare Ford
Keyword(s):  
Troponin I ◽  
Task Force ◽  
High Sensitivity ◽  
Analytical Performance ◽  
Coronary Syndrome ◽  
High Sensitivity Troponin ◽  
Continued Use ◽  
Good Concordance ◽  
Abbott Architect ◽  
Rule Out

Abstract Background The objectives of this study were to independently evaluate the analytical performance of the STAT high-sensitivity troponin I (hs-cTnI) assay on a recently launched and CE-marked integrated chemistry and immunoassay system, confirm acceptable performance of the assay in line with The Third Global MI Task Force recommendations, and confirm suitability of the assay for continued use of an early rule-out algorithm for acute coronary syndrome at our Trust. Methods A multicenter evaluation of the analytical performance characteristics of the hs-cTnI assay on the Abbott Alinity ci series was performed in 5 clinical laboratories across Europe. Comparison studies were performed vs the existing Abbott ARCHITECT hs-cTnI assay. Results Passing and Bablok regression analysis revealed a slope of 0.99 [95% confidence interval (CI), 0.98–1.00] and an intercept of −0.09 ng/L (95% CI, −0.21–0.11). Intermediate imprecision ranged from 3.7% to 5.4%, 2.6% to 4.5%, and 2.0% to 6.1% at concentrations of 19.1–21.1 ng/L, 196.6–205.5 ng/L, and 15229–16265 ng/L, respectively. There was good concordance between the 2 assays at the early rule-out cutoff. Conclusion Comparable analytical performance of the hs-cTnI assay on new Abbott Alinity ci series supports the continued use of the early rule out algorithm for patients with suspected ACS at our Trust.

P1730Serial high-sensitivity troponin I measurements to discriminate type 2 from type 1 myocardial infarction

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D A Psyrakis ◽  
J Bormann ◽  
B Von Jeinsen ◽  
J S Wolter ◽  
M Weferling ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Troponin I ◽  
High Sensitivity ◽  
High Morbidity ◽  
Absolute Change ◽  
Coronary Syndrome ◽  
High Sensitivity Troponin ◽  
Rule Out

Abstract Background Acute myocardial infarction (MI) is associated with high morbidity and mortality. A robust differentiation between type 1 and type 2 MI (T1/T2MI) has prognostic and therapeutic implications. We investigated whether serial high-sensitivity cardiac troponin I measurements could reliably discriminate T1MI from T2MI in patients presenting with a non-ST elevation myocardial infarction (NSTEMI). Methods We used data from a prospective acute coronary syndrome biomarker registry of patients with suspected MI that presented at or were transferred to one of two study centres. Here, we analysed an unselected group of 265 NSTEMI patients (67.2% males). Blood was drawn on admission and after 3 hours. High-sensitivity troponin I (hs-cTnI) was measured in frozen samples by a technician blinded to patient characteristics. T1MI or T2MI was defined as the gold-standard study diagnosis by two independent cardiologists based on all available data according to the Third Universal Definition of MI. Results A diagnosis of T2MI was made in 55 patients (20.8%) in the NSTEMI cohort. T2MI patients did not differ from T1MI patients regarding age, gender, traditional risk factors, or percentage of those with a history of coronary artery disease. Median baseline hs-cTnI levels were higher in T1MI (436.25; IQR 63.7–1918.8 ng/L) than in T2MI patients (48.4; IQR 11.7–305.9 ng/L; p<0.001). Absolute change in hs-cTnI concentration between 0 and 3 h was greater in T1MI than in T2MI patients with Dhs-cTnI 93.6 ng/L (IQR 13.5–815.3 ng/L) vs. 20.4 ng/L (IQR 2.5–106.5 ng/L) (p<0.001). hs-cTnI yielded an area under the receiver operator characteristics (AUROC) curve for identifying T2MI at baseline of 0.71 (IQR 0.64–0.79) and after 3 h of 0.7 (IQR 0.61–0.78).Dhs-cTnI was associated with an AUROC of 0.68 (IQR 0.6–0.76). Regarding a rule-out approach, Youden-optimized cut-offs for hs-cTnI at baseline as well as for the absolute change in hs-cTnI concentration were calculated (186.5 ng/L; 154.4 ng/L). Use of these two criteria yielded a sensitivity of 89% (78–96%) and a negative predictive value of 95% (89–98%) to exclude T2MI. 49 of 55 T2MI patients would have been ruled out using this algorithm. Conclusion Our data show that hs-cTnI concentrations differ between patients presenting with T1 and T2MI. The concentration of hs-cTnI and its change over time has the potential to rule out T2MI and therefore to identify patients who might benefit from an early invasive management. The differentiation between T1MI and T2MI by using hs-cTnI is nevertheless challenging, and further research on specific algorithms is needed. Acknowledgement/Funding 3German Center for Cardiovascular Research (DZHK), Partnersite Rhein Main, Bad Nauheim, Germany

scholarly journals Immediate Rule-Out of Acute Myocardial Infarction Using Electrocardiogram and Baseline High-Sensitivity Troponin I

2017 ◽  
Vol 63 (1) ◽  
pp. 394-402 ◽  
Author(s):  
Johannes Tobias Neumann ◽  
Nils Arne Sörensen ◽  
Francisco Ojeda ◽  
Tjark Schwemer ◽  
Jonas Lehmacher ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Troponin I ◽  
High Sensitivity ◽  
Low Risk ◽  
High Sensitivity Troponin ◽  
Testing Trial ◽  
Pain Symptoms ◽  
Electrocardiogram Ecg ◽  
Rule Out

Abstract AIMS Serial measurements of high-sensitivity troponin are used to rule out acute myocardial infarction (AMI) with an assay specific cutoff at the 99th percentile. Here, we evaluated the performance of a single admission troponin with a lower cutoff combined with a low risk electrocardiogram (ECG) to rule out AMI. METHODS Troponin I measured with a high-sensitivity assay (hs-TnI) was determined at admission in 1040 patients presenting with suspected AMI (BACC study). To rule out AMI we calculated the negative predictive value (NPV) utilizing the optimal hs-TnI cutoff combined with a low risk ECG. The results were validated in 3566 patients with suspected AMI [2-h Accelerated Diagnostic Protocol to Assess Patients With Chest Pain Symptoms Using Contemporary Troponins as the Only Biomarker (ADAPT) studies]. Patients were followed for 6 or 12 months. RESULTS 184 of all patients were diagnosed with AMI. An hs-TnI cutoff of 3 ng/L resulted in a NPV of 99.3% (CI 97.3–100.0), ruling out 35% of all non-AMI patients. Adding the information of a low risk ECG resulted in a 100% (CI 97.5–100.0) NPV (28% ruled out). The 2 validation cohorts replicated the high NPV of this approach. The follow-up mortality in the ruled out population was low (0 deaths in BACC and Stenocardia, 1 death in ADAPT). CONCLUSIONS A single hs-TnI measurement on admission combined with a low risk ECG appears to rule out AMI safely without need for serial troponin testing. Trial Registration: www.clinicaltrials.gov (NCT02355457).

scholarly journals Economic Considerations of Early Rule-In/Rule-Out Algorithms for The Diagnosis of Myocardial Infarction in The Emergency Department Using Cardiac Troponin and Glycemic Biomarkers

2017 ◽  
Vol 63 (2) ◽  
pp. 593-602 ◽  
Author(s):  
Colleen Shortt ◽  
Feng Xie ◽  
Richard Whitlock ◽  
Jinhui Ma ◽  
Natasha Clayton ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Emergency Department ◽  
Cardiac Troponin ◽  
Troponin I ◽  
High Sensitivity ◽  
Cost Effective ◽  
Coronary Syndrome ◽  
Hb A1c ◽  
The Cost ◽  
Rule Out

Abstract BACKGROUND We have previously demonstrated the utility of a rule-in/rule-out strategy for myocardial infarction (MI) using glycemic biomarkers in combination with cardiac troponin in the emergency department (ED). Given that the cost of assessing patients with possible MI in the ED is increasing, we sought to compare the health services cost of our previously identified early rule-in/rule-out approaches for MI among patients who present to the ED with symptoms suggestive of acute coronary syndrome (ACS). METHODS We compared the cost differences between different rule-in/rule-out strategies for MI using presentation cardiac troponin I (cTnI), high-sensitivity cTnI (hs-cTnI), high-sensitivity cardiac troponin T (hs-cTnT), glucose, and/or hemoglobin A1c (Hb A1c) in 1137 ED patients (7-day MI n = 133) as per our previously defined algorithms and compared them with the European Society of Cardiology (ESC) 0-h algorithm-cutoffs. Costs associated with each decision model were obtained from site-specific sources (length of stay) and provincial sources (Ontario Case Costing Initiative). RESULTS Algorithms incorporating cardiac troponin and glucose for early rule-in/rule-out were the most cost effective and clinically safest methods (i.e., ≤1 MI missed) for early decision making, with hs-cTnI and glucose yielding lower costs compared to cTnI and glucose, despite the higher price for the hs-cTnI test. The addition of Hb A1c to the algorithms increased the cost of these algorithms but did not miss any additional patients with MI. Applying the ESC 0-h algorithm-cutoffs for hs-cTnI and hs-cTnT were the most costly. CONCLUSIONS Rule-in/rule-out algorithms incorporating presentation glucose with high-sensitivity cardiac troponin are the safest and most cost-effective options as compared to the ESC 0-h algorithm-cutoffs.

scholarly journals Novel high-sensitivity cardiac troponin I assay in patients with suspected acute coronary syndrome

Heart ◽  
2018 ◽  
pp. heartjnl-2018-314093 ◽  
Author(s):  
Andrew R Chapman ◽  
Takeshi Fujisawa ◽  
Kuan Ken Lee ◽  
Jack Patrick Andrews ◽  
Atul Anand ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndrome ◽  
Risk Stratification ◽  
Cardiac Troponin ◽  
Cardiac Death ◽  
Troponin I ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
Coronary Syndrome ◽  
Rule Out

BackgroundHigh-sensitivity cardiac troponin assays enable the early risk stratification of patients with suspected acute coronary syndrome to identify those at low risk of myocardial infarction or cardiac death. We evaluated the performance of a novel high-sensitivity cardiac troponin I assay in early rule out pathways.MethodsIn 1920 patients with suspected acute coronary syndrome, cardiac troponin was measured using the Siemens Atellica high-sensitivity cardiac troponin I assay (99th centile: 34 ng/L women, 53 ng/L men). We evaluated three pathways which use either low risk-stratification thresholds of cardiac troponin (High-SensitivityTroponin in the Evaluation of patients with Acute Coronary Syndrome (High-STEACS) and the European Society of Cardiology (ESC) 1 hour pathway) or the 99th centile diagnostic threshold (ESC 3 hour pathway) to rule out myocardial infarction.ResultsThe primary outcome of myocardial infarction or cardiac death at 30 days occurred in 14.4% (277/1920). The High-STEACS pathway ruled out 63% of patients (1218/1920), with five missed events for a negative predictive value (NPV) of 99.5% (95% CI (CI) 99.1% to 99.8%). Similar performance was observed for the ESC 1 hour pathway with an NPV of 99.0% (97.6% to 99.8%). In contrast, the ESC 3 hour pathway ruled out 65% of patients (1248/1920), but missed 25 events for an NPV of 98.0% (97.1% to 98.7%).ConclusionsA novel high-sensitivity cardiac troponin I assay can safely identify patients at low risk of myocardial infarction or cardiac death. Diagnostic pathways that use low cardiac troponin concentrations for risk stratification miss fewer events than those that rely on the 99th centile to rule out myocardial infarction.Trial registrationNCT1852123.

Sign in / Sign up

Export Citation Format

Share Document