scholarly journals Diagnostic validation of a high-sensitivity troponin I assay and its use in a guideline-consistent rapid diagnostic protocol

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
N A Soerensen ◽  
A Gossling ◽  
J T Neumann ◽  
T S Hartikainen ◽  
P M Haller ◽  
...  
Keyword(s):  
Predictive Value ◽  
Cardiac Troponin ◽  
Diagnostic Performance ◽  
Troponin I ◽  
Area Under The Curve ◽  
Diagnostic Algorithm ◽  
High Sensitivity ◽  
Final Diagnosis ◽  
Esc Guidelines ◽  
St Elevation

Abstract Background Current ESC guidelines on management of non-ST-elevation myocardial infarction (NSTEMI) recommend rapid diagnostic protocols using validated high-sensitivity cardiac troponin (hs-cTn) assays (1). While established protocols are available for several hs-cTn assays, data on the diagnostic performance of the Siemens Atellica IM High-Sensitivity Cardiac Troponin I assay is limited. Methods In a cohort study including 1,800 patients presenting with suspected acute MI. Final diagnosis of MI was adjudicated by two cardiologists separately in accordance with the fourth universal definition of MI (2). We developed and validated a 0/1h diagnostic algorithm using the Siemens Atellica assay. The algorithm was established in the first 928 patients and validated in the following 872 patients. Results ROC analyses for the diagnosis of NSTEMI revealed high discriminatory ability of the Siemens hs-cTnI assay with an area under the curve of 0.88 (95% confidence interval (CI): 0.86–0.90) at 0h, 0.93 (CI: 0.91–0.94) after 1h and 0.95 (CI: 0.93–0.96) after 3h (Figure 1). The derived algorithm consisted of a baseline rule-out of non-ST elevation MI using a cutoff <3 ng/L in patients with a symptom onset ≥3h or an admission troponin I <6 ng/L with a delta change from 0h to 1h <3 ng/L. For rule-in, an admission troponin I ≥120 ng/L or an increase within the first hour ≥12 ng/L was required. Application of the algorithm to the validation cohort showed a negative predictive value of 99.8% (CI 98.7%-100.0%), a sensitivity of 99.1% (CI 95.1%–100.0%) and 48.3% of patients ruled out, whereas 15.1% were ruled in with a positive predictive value of 68.0% (CI 59.1%-75.9%) and a specificity of 94.4% (92.5%–96.0%). The diagnostic performance was comparable to guideline-recommended application of an established hs-cTnI assay in a rapid 0/1h strategy (1). Conclusion The Siemens hs-cTnI assay is well-suited for application in rapid diagnostic stratification of patients with suspected MI and showed similar performance when compared with an established hs-cTnI assay using an algorithm recommended by recent ESC guidelines. FUNDunding Acknowledgement Type of funding sources: Foundation. Main funding source(s): German Heart foundation Figure 1

3304High sensitive cardiac troponin i at admission and 30 minutes later to rule-in or rule-out acute myocardial infarction - Preliminary results from the RACING-MI trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Bang ◽  
C Hansen ◽  
K Glerup Lauridsen ◽  
C Alcaraz Frederiksen ◽  
M Schmidt ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Predictive Value ◽  
Cardiac Troponin ◽  
Diagnostic Performance ◽  
Troponin I ◽  
Final Diagnosis ◽  
Cardiac Troponin I ◽  
Emergency Department Patients ◽  
Rule Out

Abstract Introduction Current ESC guidelines have introduced a 0h/1h algorithm for accelerated rule-in or rule-out of acute myocardial infarction (MI) when using assay specific high-sensitive cardiac troponin I (hs-cTnI). Several studies have investigated the diagnostic performance and safety of this approach using different hs-cTnI assays. However, little is known of the diagnostic performance of a 0h/30min algorithm. Purpose To evaluate the diagnostic accuracy of early rule-in or rule-out of MI after 30 minutes by applying assay specific hs-cTnI cut-off values from a recently validated 0h/1h algorithm. Methods We prospectively enrolled chest pain patients suggestive of MI admitted to the Emergency Department. Patients underwent serial hs-cTnI measurements at admission (0 hour) and after 3 hours according to clinical practice. In addition, hs-cTnI measurements were performed after 30 minutes. The assay specific cut-off values from the 0h/1h algorithm were applied to the 30 minute cohort (figure 1). Final diagnosis was adjudicated independently by two physicians. Results In total, 943 patients were included. MI was the final diagnosis in 67 (7.1%) patients. Overall, absolute hs-cTnI values after 30 minutes were significantly higher in the MI group than in the non-MI group (19.2 (Q1:Q3) 2.7–75.3) ng/L versus 0.1 (0.2–0.7) ng/L, p<0.001). When applying the assay-specific hs-cTnI cut-off valuesfor the 0h/1h algorithmto the 30 minute patient cohort, 52.4% of patients were classified as rule-out with a negative predictive value of 100% (95% CI: 99.2–100). In total, 8.5% were classified as rule-in with a positive predictive value of 83.8% (95% CI: 74.2–90.3). Sensitivity was 100% (95% CI: 94.6–100) and specificity was 97.4% (95% CI: 95.7–98.6). Overall, 39.1% were assigned to the observational zone with a 3.5% prevalence of MI. Conclusions The use of assay specific hs-cTnI measurement at admission (0h) and 30 min later can be used to safely rule-out MI. This indicates that it might be safe to develop a 0h/30min algorithm and hereby reduce time to diagnosis even further. NCT03634384. Acknowledgement/Funding Randers Regional Hospital, A.P Møller Foundation, Boserup Foundation, Korning Foundation, Højmosegård Grant, Siemens Healthcare (TNIH assays), etc.

scholarly journals Two-Hour Algorithm for Rapid Triage of Suspected Acute Myocardial Infarction Using a High-Sensitivity Cardiac Troponin I Assay

2019 ◽  
Vol 65 (11) ◽  
pp. 1437-1447 ◽  
Author(s):  
Thomas Nestelberger ◽  
Jasper Boeddinghaus ◽  
Jaimi Greenslade ◽  
William A Parsonage ◽  
Martin Than ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Predictive Value ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Validation Cohort ◽  
High Sensitivity ◽  
Final Diagnosis ◽  
Derivation Cohort ◽  
Rule Out

Abstract BACKGROUND We aimed to derive and externally validate a 0/2-h algorithm using the high-sensitivity cardiac troponin I (hs-cTnI)-Access assay. METHODS We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI) in 2 prospective diagnostic studies using central adjudication. Two independent cardiologists adjudicated the final diagnosis, including all available medical information including cardiac imaging. hs-cTnI-Access concentrations were measured at presentation and after 2 h in a blinded fashion. RESULTS AMI was the adjudicated final diagnosis in 164 of 1131 (14.5%) patients in the derivation cohort. Rule-out by the hs-cTnI-Access 0/2-h algorithm was defined as 0-h hs-cTnI-Access concentration &lt;4 ng/L in patients with an onset of chest pain &gt;3 h (direct rule-out) or a 0-h hs-cTnI-Access concentration &lt;5 ng/L and an absolute change within 2 h &lt;5 ng/L in all other patients. Derived thresholds for rule-in were a 0-h hs-cTnI-Access concentration ≥50 ng/L (direct rule-in) or an absolute change within 2 h ≥20 ng/L. In the derivation cohort, these cutoffs ruled out 55% of patients with a negative predictive value (NPV) of 99.8% (95% CI, 99.3–100) and sensitivity of 99.4% (95% CI, 96.5–99.9), and ruled in 30% of patients with a positive predictive value (PPV) of 73% (95% CI, 66.1–79). In the validation cohort, AMI was the adjudicated final diagnosis in 88 of 1280 (6.9%) patients. These cutoffs ruled out 77.9% of patients with an NPV of 99.8% (95% CI, 99.3–100) and sensitivity of 97.7% (95% CI, 92.0–99.7), and ruled in 5.8% of patients with a PPV of 77% (95% CI, 65.8–86) in the validation cohort. CONCLUSIONS Safety and efficacy of the l hs-cTnI-Access 0/2-h algorithm for triage toward rule-out or rule-in of AMI are very high. TRIAL REGISTRATION APACE, NCT00470587; ADAPT, ACTRN1261100106994; IMPACT, ACTRN12611000206921.

scholarly journals Diagnostic Evaluation of a High-Sensitivity Troponin I Point-of-Care Assay

2019 ◽  
Vol 65 (12) ◽  
pp. 1592-1601 ◽  
Author(s):  
Nils A Sörensen ◽  
Johannes T Neumann ◽  
Francisco Ojeda ◽  
Evangelos Giannitsis ◽  
Eberhard Spanuth ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Predictive Value ◽  
Diagnostic Performance ◽  
Troponin I ◽  
Point Of Care ◽  
Diagnostic Algorithm ◽  
High Sensitivity ◽  
Data Set ◽  
High Sensitivity Troponin ◽  
Point Of Care Assay

Abstract BACKGROUND Increasing numbers of patients are presenting worldwide to emergency departments with suspected myocardial infarction. The use of point-of-care troponin assays might enable faster decision-making in this high-risk population and reduce the burden on emergency facilities. Here, we evaluate the diagnostic performance of a point-of-care high-sensitivity troponin I assay. METHODS We conducted a prospective cohort study including patients presenting to the emergency department with suspected myocardial infarction from July 2013 to July 2016. A diagnostic algorithm for a high-sensitivity troponin I point-of-care assay was developed in a derivation data set with 669 patients and validated in an additional 610 patients. RESULTS The derived 0/1 h algorithm for the point-of-care assay consisted of an admission troponin I &lt;4 ng/L and a δ from 0 h to 1 h &lt;3 ng/L for rule out and an admission troponin I ≥90 ng/L or a δ from 0 h to 1 h ≥20 ng/L for rule in of non-ST-elevation myocardial infarction. Application to the validation cohort showed a negative predictive value of 99.7% (95% CI, 98.1%–100.0%) and 48.0% of patients ruled out, whereas 14.6% were ruled in with a positive predictive value of 86.5% (95% CI, 77.6%–92.8%). The diagnostic performance of the point-of-care high-sensitivity assay was highly comparable to guideline-recommended use of a laboratory-based high-sensitivity troponin assay. CONCLUSIONS The clinical application of a 0/1 h diagnostic algorithm based on a high-sensitivity troponin I point-of-care assay is safe, and diagnostic performance is comparable to a laboratory-based high-sensitivity troponin I assay.

P1735Two-hour algorithm for early diagnosis of acute myocardial infarction using a novel high-sensitivity cardiac troponin I assay

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Nestelberger ◽  
J Boeddinghaus ◽  
J Greenslade ◽  
L Cullen ◽  
W Parsonage ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Predictive Value ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Validation Cohort ◽  
High Sensitivity ◽  
Final Diagnosis ◽  
Cardiac Troponin I

Abstract Background We aimed to derive and externally validate a 0/2h-algorithm using the novel high-sensitivity cardiac troponin I (hs-cTnI-Access) assay. Methods We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI) in two prospective chest pain trials. Two independent cardiologists adjudicated the final diagnosis including all available medical information including cardiac imaging. Hs-cTnI concentrations were measured at presentation and after 2h. Primary diagnostic endpoint was the derivation and validation of an hs-cTnI-Access specific 0/2h-algorithm. Primary prognostic endpoint was overall survival of patients after 30- and 720-days of follow-up. Results AMI was the adjudicated final diagnosis in 164/1131 (14.5%) patients in the derivation and in 88/1280 (6.9%) patients in the validation cohort. Median hs-cTnI Access concentrations at presentation were significantly higher in patients with AMI as compared to patients with non-AMI in both cohorts (104 ng/L versus 3.4 ng/L and 29 ng/L vs. 2.3 ng/L, p-value both <0.001) Applying the derived hs-cTnI-Access 0/2h-algorithm (Figure 1A) to the validation cohort (Figure 1B), 77.9% of patients were ruled-out (sensitivity 97.7% [95% CI, 92–99.7], negative predictive value [NPV] 99.8% [95% CI, 99.3–100]), and 5.8% of patients were ruled-in (specificity 98.6% [95% CI, 97.7–99.2], positive predictive value [PPV] 77% [95% CI, 65.8–86]). Among 1617 patients ruled-out for AMI in both cohorts together, 3 (0.2%) patients with AMI have been missed, of whom 2 patients had type 2 myocardial infarction (both with tachyarrhythmia). Patients ruled-out by the 0/2h-algorithm had a survival rate of 98.4% and 99.9% after two years or one year of follow up in both cohorts, respectively. Figure 1 Conclusions Diagnostic performance of the hs-cTnI Access 0/2h-algorithm for triage of AMI is excellent with high safety for rule-out and high accuracy for rule-in. Acknowledgement/Funding European Union, Swiss National Foundation, University Hospital Basel, University Basel

P2675Validation of a 0/1h diagnostic algorithm using a point of care high-sensitivity troponin I assay

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
N Soerensen ◽  
J T Neumann ◽  
F Ojeda ◽  
E Giannitsis ◽  
E Spanuth ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Predictive Value ◽  
Diagnostic Performance ◽  
Troponin I ◽  
Validation Cohort ◽  
Point Of Care ◽  
Diagnostic Algorithm ◽  
High Sensitivity ◽  
High Sensitivity Troponin ◽  
Rule Out

Abstract Background The numbers of patients presenting to emergency departments with suspected acute myocardial infarction (AMI) are increasing worldwide. The use of point of care (POC) troponin assays with an increased sensitivity – equal to laboratory-based high-sensitivity immunoassays – might enable faster decision making in this high-risk population. Objective To validate a rapid diagnostic algorithm using a novel point of care (POC) high-sensitivity troponin I (hs-TnI) assay in comparison to a laboratory-based hs-TnI assay. Methods A diagnostic 0/1h algorithm for the POC hs-TnI assay (PATHFAST hs-cTnI, LSI Medience) was derived in a dataset of 669 patients with suspected AMI, aiming for a negative predictive value (NPV) ≥99.5% for rule-out and a positive predictive value (PPV) ≥75% for rule-in of non-ST-elevation myocardial infarction (NSTEMI). The performance of the developed algorithm was tested in a validation cohort of 610 patients. Diagnostic accuracy of the POC hs-TnI assay was compared to an established hs-TnI assay (Abbott ARCHITECT) using an ESC guideline-recommended 0/1h diagnostic algorithm. Results The derived 0/1h algorithm consisted of an admission POC hs-TnI <4 ng/L and a delta from 0h to 1h <3 ng/L for rule-out and an admission POC hs-TnI ≥90 ng/L or a delta from 0h to 1h ≥20 ng/L for rule-in of NSTEMI. Application of the algorithm in the validation cohort showed a NPV of 99.7% (Confidence Interval (CI) 98.1%-100.0%) and 48.0% of patients ruled out, while 14.6% were ruled in with a PPV of 86.5% (CI 77.6%-92.8%). The diagnostic performance of the POC hs-TnI assay was comparable to guideline-recommended use of a laboratory-based hs-TnI assay (Figure 1). Conclusion The clinical application of a 0/1h diagnostic algorithm based on a novel POC hs-TnI assay showed good diagnostic performance and was comparable to a laboratory-based hs-TnI assay. Acknowledgement/Funding German Center of Cardiovascular Research, Abbott Diagnostics, DIAneering GmbH, German Heart Foundation/ German Foundation of Heart Research

Analytical assessment of ortho clinical diagnostics high-sensitivity cardiac troponin I assay

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Peter A. Kavsak ◽  
Tara Edge ◽  
Chantele Roy ◽  
Paul Malinowski ◽  
Karen Bamford ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Limit Of Detection ◽  
Clinical Performance ◽  
Characteristic Curve ◽  
Area Under The Curve ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
Clinical Diagnostics ◽  
Ortho Clinical Diagnostics

AbstractObjectivesTo analytically evaluate Ortho Clinical Diagnostics VITROS high-sensitivity cardiac troponin I (hs-cTnI) assay in specific matrices with comparison to other hs-cTn assays.MethodsThe limit of detection (LoD), imprecision, interference and stability testing for both serum and lithium heparin (Li-Hep) plasma for the VITROS hs-cTnI assay was determined. We performed Passing-Bablok regression analyses between sample types for the VITROS hs-cTnI assay and compared them to the Abbott ARCHITECT, Beckman Access and the Siemens ADVIA Centaur hs-cTnI assays. We also performed Receiver-operating characteristic curve analyses with the area under the curve (AUC) determined in an emergency department (ED)-study population (n=131) for myocardial infarction (MI).ResultsThe VITROS hs-cTnI LoD was 0.73 ng/L (serum) and 1.4 ng/L (Li-Hep). Stability up to five freeze-thaws was observed for the Ortho hs-cTnI assay, with the analyte stability at room temperature in serum superior to Li-Hep with gross hemolysis also affecting Li-Hep plasma hs-cTnI results. Comparison of Li-Hep to serum concentrations (n=202), yielded proportionally lower concentrations in plasma with the VITROS hs-cTnI assay (slope=0.85; 95% confidence interval [CI]:0.83–0.88). In serum, the VITROS hs-cTnI concentrations were proportionally lower compared to other hs-cTnI assays, with similar slopes observed between assays in samples frozen <−70 °C for 17 years (ED-study) or in 2020. In the ED-study, the VITROS hs-cTnI assay had an AUC of 0.974 (95%CI:0.929–0.994) for MI, similar to the AUCs of other hs-cTn assays.ConclusionsLack of standardization of hs-cTnI assays across manufacturers is evident. The VITROS hs-cTnI assay yields lower concentrations compared to other hs-cTnI assays. Important differences exist between Li-Hep plasma and serum, with evidence of stability and excellent clinical performance comparable to other hs-cTn assays.

scholarly journals Diagnostic Performance of High Sensitivity Compared with Contemporary Cardiac Troponin I for the Diagnosis of Acute Myocardial Infarction

2017 ◽  
Vol 63 (10) ◽  
pp. 1594-1604 ◽  
Author(s):  
Yader Sandoval ◽  
Stephen W Smith ◽  
Sarah E Thordsen ◽  
Charles A Bruen ◽  
Michelle D Carlson ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Cardiac Troponin ◽  
Diagnostic Performance ◽  
Troponin I ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
Serial Testing ◽  
Safety Outcomes ◽  
Acute Mi

Abstract BACKGROUND We examined the diagnostic performance of high-sensitivity cardiac troponin I (hs-cTnI) vs contemporary cTnI with use of the 99th percentile alone and with a normal electrocardiogram (ECG) to rule out acute myocardial infarction (MI) and serial changes (deltas) to rule in MI. METHODS We included consecutive patients presenting to a US emergency department with serial cTnI onclinical indication. Diagnostic performance for acute MI, including MI subtypes, and 30-day outcomes were examined. RESULTS Among 1631 patients, MI was diagnosed in 12.9% using the contemporary cTnI assay and in 10.4% using the hs-cTnI assay. For ruling out MI, contemporary cTnI ≤99th percentile at 0, 3, and 6 h and a normal ECG had a negative predictive value (NPV) of 99.5% (95% CI, 98.6–100) and a sensitivity of 99.1% (95% CI, 97.4–100) for diagnostic and safety outcomes. Serial hs-cTnI measurements ≤99th percentile at 0 and 3 h and a normal ECG had an NPV and sensitivity of 100% (95% CI, 100–100) for diagnostic and safety outcomes. For ruling in MI, contemporary cTnI measurements had specificities of 84.4% (95% CI, 82.5–86.3) at presentation and 78.7% (95% CI, 75.4–82.0) with serial testing at 0, 3, and 6 h, improving to 89.2% (95% CI, 87.1–91.3) by using serial cTnI changes (delta, 0 and 6 h) &gt;150%. hs-cTnI had specificities of 86.9% (95% CI, 85.1–88.6) at presentation and 85.7% (95% CI, 83.5–87.9) with serial testing at 0 and 3 h, improving to 89.3% (95% CI, 87.3–91.2) using a delta hs-cTnI (0 and 3 h) &gt;5 ng/L. CONCLUSIONS hs-cTnI and contemporary cTnI assays are excellent in ruling out MI following recommendations predicated on serial testing and the 99th percentile with a normal ECG. For ruling in MI, deltas improve the specificity. ClinicalTrials.gov Identifier: NCT02060760

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