Clinical performance of a new point-of-care cardiac troponin I test

Michael Christ; Felicitas Geier; Sabine Blaschke; Evangelos Giannitsis; Mehdi Khellaf; Johannes Mair; David Pariente; Volkher Scharnhorst; Veronique Semjonow; Pierre Hausfater

doi:10.1515/cclm-2017-0693

Article

Clinical performance of a new point-of-care cardiac troponin I test

Michael Christ , Felicitas Geier , Sabine Blaschke , Evangelos Giannitsis , Mehdi Khellaf , Johannes Mair , David Pariente , Volkher Scharnhorst , Veronique Semjonow and Pierre Hausfater

Published/Copyright: April 9, 2018

Published by

Become an author with De Gruyter Brill

Submit Manuscript Author Information

From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 56 Issue 8

Abstract

Background:

We evaluated the clinical performance of the Minicare cardiac troponin-I (cTnI), a new point-of-care (POC) cTnI test for the diagnosis of acute myocardial infarction (AMI) in a prospective, multicentre study (ISRCTN77371338).

Methods:

Of 474 patients (≥18 years) admitted to an emergency department (ED) or chest pain unit (CPU) with symptoms suggestive of acute coronary syndrome (ACS; ≤12 h from symptom onset), 465 were eligible. Minicare cTnI was tested immediately, 3 h and 6 h after presentation. AMI diagnoses were adjudicated independently based on current guidelines.

Results:

The diagnostic performance of the Minicare cTnI test at 3 h was similar for whole blood and in plasma: sensitivity 0.92 vs. 0.90; specificity 0.91 vs. 0.90; positive predictive value (PPV) 0.68 vs. 0.66; negative predictive value (NPV) 0.98 vs. 0.98; positive likelihood ratio (LR+) 10.18 vs. 9.41; negative likelihood ratio (LR–) 0.09 vs. 0.11. The optimal diagnostic performance was obtained at 3 h using cut-offs cTnI >43 ng/L plus cTnI change from admission ≥18.5 ng/L: sensitivity 0.90, specificity 0.96, PPV 0.81, NPV 0.98, and LR+ 21.54. The area under the receiver operating characteristics (ROC) curve for cTnI whole blood baseline value and absolute change after 3 h curve was 0.93.

Conclusions:

These data support the clinical usefulness of Minicare cTnI within a 0 h/3 h-blood sampling protocol supported by current guidelines for the evaluation of suspected ACS.

Keywords: acute coronary syndrome; cardiac biomarkers; cardiac troponin I; emergency medicine; myocardial infarction; non-ST-elevation myocardial infarction; point-of-care; troponin

Corresponding author: Michael Christ, MD, Department of Emergency and Critical Care Medicine, Paracelsus Medical University, Nuernberg General Hospital, Nuernberg, Germany; and Department of Emergency, Luzerner Kantonsspital, Luzern, Switzerland, Phone: +41 41 205 11 11, Fax: +49 911 95399058

aPresent address: Department of Emergency Medicine, Luzerner Kantonsspital, Spitalstr., 6000 Luzern 16, Switzerland

Acknowledgments

The authors are grateful for the contributions of Philips staff who helped to administer the study, especially Lian van Lippen and Diederick Keizer, and the physicians and nurses at the study centres. A medical writer edited the manuscript prepared by the authors (Dr Mike Gwilt, GT Communications, funded by Philips).

Author contributions: VSe was closely involved with all aspects of study design, execution and analysis. MC was overall study Principal Investigator (PI) and PI at the Nuernburg site, and EG, SB, MK, JM, DP, VSc, and PH were PIs at other study sites; all contributed importantly to the design and execution of the study. DP contributed to the implementation of the study at the Paris site. FG performed the statistical analysis of the study and was closely involved in the interpretation of data. All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: This study was funded and administered by Philips Handheld Diagnostics, The Netherlands, Grant Number: 2015.
Employment or leadership: VSe is an employee of the study sponsor. Analysis of data was conducted by FG and MC, and validated by Philips.
Honorarium: None declared.
Competing interests: MC has received research support and speaking honoraria from Philips, Roche Diagnostics, Alere, ThermoFisher, and Novartis, and is a member of the European Cardiac Advisory Board of Philips. PH is a member of the European Cardiac Advisory Board of Philips, and has received research support and speaker honoraria from ThermoFisher Scientific, speaking honoraria from Philips and expert honoraria from BioMerieux, Roche and Radiometer. VSc has received speaking honoraria from Philips. EG reports personal fees from Roche Diagnostics, Bayer Vital, AstraZeneca, and Daiichi Sankyo, outside the submitted work. JM is a member of the European Cardiac Advisory Board of Philips Health Care Incubator. FG, SB, MK and DP report no competing interest. The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

References

1. Amsterdam EA, Wenger NK, Brindis RG, Casey DE, Jr., Ganiats TG, Holmes DR, Jr., et al. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014;130:2354–94.10.1161/CIR.0000000000000133Search in Google Scholar PubMed

2. Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, et al. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J 2016;37:267–315.10.1093/eurheartj/ehv320Search in Google Scholar PubMed

3. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, et al. Third universal definition of myocardial infarction. Eur Heart J 2012;33:2551–67.10.1093/eurheartj/ehs184Search in Google Scholar PubMed

4. Bingisser R, Cairns C, Christ M, Hausfater P, Lindahl B, Mair J, et al. Cardiac troponin: a critical review of the case for point-of-care testing in the ED. Am J Emerg Med 2012;30:1639–49.10.1016/j.ajem.2012.03.004Search in Google Scholar PubMed

5. Palamalai V, Murakami MM, Apple FS. Diagnostic performance of four point of care cardiac troponin I assays to rule in and rule out acute myocardial infarction. Clin Biochem 2013;46:1631–5.10.1016/j.clinbiochem.2013.06.026Search in Google Scholar PubMed

6. Mueller C, Giannitsis E, Christ M, Ordonez-Llanos J, de Filippi C, McCord J, et al. Multicenter evaluation of a 0-hour/1-hour algorithm in the diagnosis of myocardial infarction with high-sensitivity cardiac troponin T. Ann Emerg Med 2016;68:76–87 e4.10.1016/j.annemergmed.2015.11.013Search in Google Scholar PubMed

7. Venge P, van Lippen L, Blaschke S, Christ M, Geier F, Giannitsis E, et al. Equal clinical performance of a novel point-of-care cardiac troponin I (cTnI) assay with a commonly used high-sensitivity cTnI assay. Clin Chim Acta 2017;469:119–25.10.1016/j.cca.2017.03.023Search in Google Scholar PubMed

8. Kemper DW, Semjonow V, de Theije F, Keizer D, van Lippen L, Mair J, et al. Analytical evaluation of a new point of care system for measuring cardiac Troponin I. Clin Biochem 2017;50:174–80.10.1016/j.clinbiochem.2016.11.011Search in Google Scholar PubMed

9. Apple FS. A new season for cardiac troponin assays: it’s time to keep a scorecard. Clin Chem 2009;55:1303–6.10.1373/clinchem.2009.128363Search in Google Scholar PubMed

10. Bock JL, Singer AJ, Thode HC, Jr. Comparison of emergency department patient classification by point-of-care and central laboratory methods for cardiac troponin I. Am J Clin Pathol 2008;130:132–5.10.1309/NVXH8DL5HWFDNB74Search in Google Scholar PubMed

11. Venge P, Ohberg C, Flodin M, Lindahl B. Early and late outcome prediction of death in the emergency room setting by point-of-care and laboratory assays of cardiac troponin I. Am Heart J 2010;160:835–41.10.1016/j.ahj.2010.07.036Search in Google Scholar PubMed

12. Vafaie M, Biener M, Mueller M, Abu Sharar H, Hartmann O, Hertel S, et al. Addition of copeptin improves diagnostic performance of point-of-care testing (POCT) for cardiac troponin T in early rule-out of myocardial infarction – A pilot study. Int J Cardiol 2015;198:26–30.10.1016/j.ijcard.2015.06.122Search in Google Scholar PubMed

13. Storrow AB, Nowak RM, Diercks DB, Singer AJ, Wu AH, Kulstad E, et al. Absolute and relative changes (delta) in troponin I for early diagnosis of myocardial infarction: results of a prospective multicenter trial. Clin Biochem 2015;48:260–7.10.1016/j.clinbiochem.2014.09.012Search in Google Scholar PubMed

14. Wildi K, Gimenez MR, Twerenbold R, Reichlin T, Jaeger C, Heinzelmann A, et al. Misdiagnosis of myocardial infarction related to limitations of the current regulatory approach to define clinical decision values for cardiac troponin. Circulation 2015;131:2032–40.10.1161/CIRCULATIONAHA.114.014129Search in Google Scholar PubMed PubMed Central

15. Lindahl B, Eggers KM, Venge P, James S. Evaluation of four sensitive troponin assays for risk assessment in acute coronary syndromes using a new clinically oriented approach for comparison of assays. Clin Chem Lab Med 2013;51:1859–64.10.1515/cclm-2013-0023Search in Google Scholar PubMed

16. Goodacre SW, Bradburn M, Cross E, Collinson P, Gray A, Hall AS, et al. The Randomised Assessment of Treatment using Panel Assay of Cardiac Markers (RATPAC) trial: a randomised controlled trial of point-of-care cardiac markers in the emergency department. Heart 2011;97:190–6.10.1136/hrt.2010.203166Search in Google Scholar PubMed

17. Loten C, Attia J, Hullick C, Marley J, McElduff P. Point of care troponin decreases time in the emergency department for patients with possible acute coronary syndrome: a randomised controlled trial. Emerg Med J 2010;27:194–8.10.1136/emj.2008.069427Search in Google Scholar PubMed

18. Rooney KD, Schilling UM. Point-of-care testing in the overcrowded emergency department – can it make a difference? Crit Care 2014;18:692.10.1186/s13054-014-0692-9Search in Google Scholar PubMed PubMed Central

19. Ryan RJ, Lindsell CJ, Hollander JE, O’Neil B, Jackson R, Schreiber D, et al. A multicenter randomized controlled trial comparing central laboratory and point-of-care cardiac marker testing strategies: the Disposition Impacted by Serial Point of Care Markers in Acute Coronary Syndromes (DISPO-ACS) trial. Ann Emerg Med 2009;53:321–8.10.1016/j.annemergmed.2008.06.464Search in Google Scholar PubMed

20. Storrow AB, Lyon JL, Porter M. A systematic review of emergency department point-of-care cardiac markers and efficiency measures. Point Care 2009;8:121–5.10.1097/POC.0b013e3181b316b9Search in Google Scholar

21. Goodacre S, Bradburn M, Fitzgerald P, Cross E, Collinson P, Gray A, et al. The RATPAC (Randomised Assessment of Treatment using Panel Assay of Cardiac markers) trial: a randomised controlled trial of point-of-care cardiac markers in the emergency department. Health Technol Assess 2011;15:iii-xi, 1–102.10.3310/hta15230Search in Google Scholar PubMed

22. Guttmann A, Schull MJ, Vermeulen MJ, Stukel TA. Association between waiting times and short term mortality and hospital admission after departure from emergency department: population based cohort study from Ontario, Canada. Br Med J 2011;342:d2983.10.1136/bmj.d2983Search in Google Scholar PubMed PubMed Central

Supplementary Material:

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2017-0693).

Received: 2017-08-05

Accepted: 2018-02-06

Published Online: 2018-04-09

Published in Print: 2018-07-26

You are currently not able to access this content.

Supplementary material

Articles in the same Issue

https://doi.org/10.1515/cclm-2017-0693

Keywords for this article

acute coronary syndrome; cardiac biomarkers; cardiac troponin I; emergency medicine; myocardial infarction; non-ST-elevation myocardial infarction; point-of-care; troponin