Clinical Validation of a Novel High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction-Reference-Cited by-同舟云学术

Clinical Validation of a Novel High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction

Published:2018-09-01 Issue:9 Volume:64 Page:1347-1360
ISSN:0009-9147
Container-title:Clinical Chemistry
language:en
Short-container-title:

Author:

Boeddinghaus Jasper¹²³,Twerenbold Raphael¹³⁴,Nestelberger Thomas¹³,Badertscher Patrick¹³,Wildi Karin¹³,Puelacher Christian¹³,du Fay de Lavallaz Jeanne¹²³,Keser Elif¹³,Rubini Giménez Maria¹³,Wussler Desiree¹²³,Kozhuharov Nikola¹³,Rentsch Katharina⁵,Miró Òscar³⁶,Martin-Sanchez F Javier³⁷,Morawiec Beata³⁸,Stefanelli Sabrina¹,Geigy Nicolas⁹,Keller Dagmar I¹⁰,Reichlin Tobias¹³,Mueller Christian¹³,Sanchez Ana Yufera¹¹¹³,Breidthardt Tobias¹¹¹³,Mueller Deborah¹,Sazgary Lorraine¹,Marbot Stella¹,Sabti Zaid¹³,Flores Dayana¹³,Mahfouz Riham¹³,Osswald Stefan¹,Schaerli Nicolas¹¹¹³,Freese Michael¹³,Stelzig Claudia¹³,Meissner Kathrin¹³,Kulangara Caroline¹³,Shrestha Samyut¹³,Grimm Karin¹¹¹³,Hartmann Beate¹³,Ferel Ina¹³,López Beatriz³⁶,Fuenzalida Carolina³⁶,Adrada Esther Rodriguez⁷,Ganovská Eva³¹²,Lohrmann Jens¹,Kloos Wanda¹,Buser Andreas¹³,von Eckardstein Arnold¹⁴,Muzyk Piotr³¹⁵,Nowalany-Kozielska Ewa¹⁵,Kawecki Damian³¹⁵,Parenica Jiri³¹²,

Affiliation:

1. Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland

2. Division of Internal Medicine, University Hospital Basel, University of Basel, Basel, Switzerland

3. GREAT network, Rome, Italy

4. Department of General and Interventional Cardiology, Hamburg University Heart Center, Hamburg, Germany

5. Laboratory Medicine, University Hospital Basel, Basel, Switzerland

6. Emergency Department, Hospital Clinic, Barcelona, Catalonia, Spain

7. Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Spain

8. 2nd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Katowice, Katowice, Poland

9. Emergency Department, Kantonsspital Liestal, Switzerland

10. Emergency Department, University Hospital Zurich, Zurich, Switzerland

11. Department of Internal Medicine, University Hospital Basel, University of Basel, Basel, Switzerland

12. Department of Cardiology, University Hospital Brno, Brno, Czech Republic and Medical Faculty, Masaryk University, Brno, Czech Republic

13. Blood Transfusion Centre, Swiss Red Cross, Basel, Switzerland and Department of Hematology, University Hospital Basel, University of Basel, Basel, Switzerland

14. Emergency Department of Laboratory Medicine, University Hospital Zurich, Zurich, Switzerland

15. Second Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Katowice, Katowice, Poland

Abstract

Abstract BACKGROUND Clinical performance of the novel high-sensitivity cardiac troponin I (Siemens-hs-cTnI-Centaur) assay is unknown. We aimed to clinically validate the Siemens-hs-cTnI-Centaur assay and develop 0/1-h and 0/2-h algorithms. METHODS We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by 2 independent cardiologists including all clinical information twice: first, using serial hs-cTnT (Roche-Elecsys, primary analysis); second, using hs-cTnI (Abbott-Architect, secondary analysis) measurements in addition to the clinically applied (hs)-cTn. Siemens-hs-cTnI-Centaur was measured at presentation, 1 h, and 2 h. The primary objective was a direct comparison of diagnostic accuracy, quantified by the area under the ROC curve (AUC), of Siemens-hs-cTnI-Centaur vs the 2 established hs-cTn assays (Roche-hs-cTnT-Elecsys, Abbott-hs-cTnI-Architect). Secondary objectives included the development of Siemens-hs-cTnI-Centaur-specific 0/1-h and 0/2-h algorithms. RESULTS AMI was the final diagnosis in 318 of 1755 (18%) patients (using Roche-hs-cTnT-Elecsys for adjudication). The AUC at presentation for Siemens-hs-cTnI-Centaur was 0.94 (95% CI, 0.92–0.96) and comparable with 0.95 (95% CI, 0.93–0.97) for Roche-hs-cTnT-Elecsys and 0.93 (95% CI, 0.90–0.96) for Abbott-hs-cTnI-Architect. Applying the derived Siemens-hs-cTnI-Centaur 0/1-h algorithm to the validation cohort, 46% of patients were ruled out (sensitivity, 99.1%; 95% CI, 95.3–100), and 18% of patients were ruled in (specificity, 94.1%; 95% CI, 91.8–95.9). The Siemens-hs-cTnI-Centaur 0/2-h algorithm ruled out 55% of patients (sensitivity, 100%; 95% CI, 94.1–100), and ruled in 18% of patients (specificity, 96.0%; 95% CI, 93.1–97.9). Findings were confirmed in the secondary analyses using serial measurements of Abbott-hs-cTnI-Architect for adjudication. CONCLUSIONS Diagnostic accuracy and clinical utility of the novel Siemens-hs-cTnI-Centaur assay are high and comparable with the established hs-cTn assays. ClinicalTrials.gov Identifier: NCT00470587

Publisher

Oxford University Press (OUP)

Subject

Biochemistry, medical,Clinical Biochemistry

Link

http://academic.oup.com/clinchem/article-pdf/64/9/1347/32642912/clinchem1347.pdf

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