Jasper Boeddinghaus1,2,3, Raphael Twerenbold1,3, Thomas Nestelberger1,3, Luca Koechlin1,4, Desiree Wussler1,2,3, Mario Meier1,3, Valentina Troester1,3, Tobias Zimmermann1,3, Patrick Badertscher1,3,5, Karin Wildi1,3,6, Maria Rubini Giménez1,3, Pedro Lopez-Ayala1,3, Eliska Potlukova1,2, Òscar Miró3,7, F Javier Martin-Sanchez3,8, Damian Kawecki3,9, Nicolas Geigy10, Dagmar I Keller11, Tobias Reichlin1,3,12, Christian Mueller13,3. 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. 4. Department of Cardiac Surgery, University Hospital Basel, University of Basel, Basel, Switzerland. 5. Division of Cardiology, University of Illinois at Chicago, Chicago, IL. 6. Critical Care Research Group, the Prince Charles Hospital, Brisbane and the University of Queensland, Brisbane, Australia. 7. Emergency Department, Hospital Clinic, Barcelona, Catalonia, Spain. 8. Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Spain. 9. 2nd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Katowice, Katowice, Poland. 10. Emergency Department, Kantonsspital Liestal, Liestal, Switzerland. 11. Emergency Department, University Hospital Zurich, Zurich, Switzerland. 12. Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. 13. Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; christian.mueller@usb.ch.
Abstract
BACKGROUND: We aimed to validate the clinical performance of the high-sensitivity cardiac troponin I [VITROS® Immunodiagnostic Products hs Troponin I (hs-cTnI-VITROS)] assay. 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 considering all clinical information, including cardiac imaging: first, using serial hs-cTnT-Elecsys (primary analysis) and, second, using hs-cTnI-Architect (secondary analysis) measurements in addition to the clinically used (hs)-cTn. hs-cTnI-VITROS was measured at presentation and at 1 h in a blinded fashion. The primary objective was direct comparison of diagnostic accuracy as quantified by the area under the ROC curve (AUC) of hs-cTnI-VITROS vs hs-cTnT-Elecsys and hs-cTnI-Architect, and in a subgroup also hs-cTnI-Centaur and hs-cTnI-Access. Secondary objectives included the derivation and validation of an hs-cTnI-VITROS-0/1-h algorithm. RESULTS: AMI was the adjudicated final diagnosis in 158 of 1231 (13%) patients. At presentation, the AUC for hs-cTnI-VITROS was 0.95 (95% CI, 0.93-0.96); for hs-cTnT-Elecsys, 0.94 (95% CI, 0.92-0.95); and for hs-cTnI-Architect, 0.92 (95% CI, 0.90-0.94). AUCs for hs-cTnI-Centaur and hs-cTnI-Access were 0.95 (95% CI, 0.94-0.97). Applying the derived hs-cTnI-VITROS-0/1-h algorithm (derivation cohort n = 519) to the validation cohort (n = 520), 53% of patients were ruled out [sensitivity, 100% (95% CI, 94.1-100)] and 14% of patients were ruled in [specificity, 95.6% (95% CI, 93.4-97.2)]. Patients ruled out by the 0/1-h algorithm had a survival rate of 99.8% at 30 days. Findings were confirmed in the secondary analyses using the adjudication including serial measurements of hs-cTnI-Architect. CONCLUSIONS: The hs-cTnI-VITROS assay has at least comparable diagnostic accuracy with the currently best validated hs-cTnT and hs-cTnI assays. CLINICALTRIALSGOV IDENTIFIER: NCT00470587.
BACKGROUND: We aimed to validate the clinical performance of the high-sensitivity cardiac troponin I [VITROS® Immunodiagnostic Products hs Troponin I (hs-cTnI-VITROS)] assay. 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 considering all clinical information, including cardiac imaging: first, using serial hs-cTnT-Elecsys (primary analysis) and, second, using hs-cTnI-Architect (secondary analysis) measurements in addition to the clinically used (hs)-cTn. hs-cTnI-VITROS was measured at presentation and at 1 h in a blinded fashion. The primary objective was direct comparison of diagnostic accuracy as quantified by the area under the ROC curve (AUC) of hs-cTnI-VITROS vs hs-cTnT-Elecsys and hs-cTnI-Architect, and in a subgroup also hs-cTnI-Centaur and hs-cTnI-Access. Secondary objectives included the derivation and validation of an hs-cTnI-VITROS-0/1-h algorithm. RESULTS:AMI was the adjudicated final diagnosis in 158 of 1231 (13%) patients. At presentation, the AUC for hs-cTnI-VITROS was 0.95 (95% CI, 0.93-0.96); for hs-cTnT-Elecsys, 0.94 (95% CI, 0.92-0.95); and for hs-cTnI-Architect, 0.92 (95% CI, 0.90-0.94). AUCs for hs-cTnI-Centaur and hs-cTnI-Access were 0.95 (95% CI, 0.94-0.97). Applying the derived hs-cTnI-VITROS-0/1-h algorithm (derivation cohort n = 519) to the validation cohort (n = 520), 53% of patients were ruled out [sensitivity, 100% (95% CI, 94.1-100)] and 14% of patients were ruled in [specificity, 95.6% (95% CI, 93.4-97.2)]. Patients ruled out by the 0/1-h algorithm had a survival rate of 99.8% at 30 days. Findings were confirmed in the secondary analyses using the adjudication including serial measurements of hs-cTnI-Architect. CONCLUSIONS: The hs-cTnI-VITROS assay has at least comparable diagnostic accuracy with the currently best validated hs-cTnT and hs-cTnI assays. CLINICALTRIALSGOV IDENTIFIER: NCT00470587.
Authors: Peter A Kavsak; Joshua O Cerasuolo; Dennis T Ko; Jinhui Ma; Jonathan Sherbino; Shawn E Mondoux; Natasha Clayton; Stephen A Hill; Matthew McQueen; Lauren E Griffith; Shamir R Mehta; Richard Perez; Hsien Seow; P J Devereaux; Andrew Worster Journal: CMAJ Open Date: 2020-11-02
Authors: Tania Coscia; Thomas Nestelberger; Jasper Boeddinghaus; Pedro Lopez-Ayala; Luca Koechlin; Òscar Miró; Dagmar I Keller; Ivo Strebel; Ana Yufera Sanchez; Bernhard Okamura; Desiree Wussler; Samyut Shrestha; Katharina Hausknecht; F Javier Martín-Sánchez; Michael Christ; Damian Kawecki; Raphael Twerenbold; Karin Wildi; Maria Rubini Gimenez; Christian Mueller Journal: JAMA Cardiol Date: 2022-04-01 Impact factor: 30.154
Authors: Peter A Kavsak; Shawn E Mondoux; Janet Martin; Mark K Hewitt; Lorna Clark; Nadia Caruso; Ching-Tong Mark; V Tony Chetty; Craig Ainsworth; Andrew Worster Journal: J Cardiovasc Dev Dis Date: 2021-03-23
Authors: Ryan Wereski; Dorien M Kimenai; Caelan Taggart; Dimitrios Doudesis; Kuan Ken Lee; Matthew T H Lowry; Anda Bularga; David J Lowe; Takeshi Fujisawa; Fred S Apple; Paul O Collinson; Atul Anand; Andrew R Chapman; Nicholas L Mills Journal: Circulation Date: 2021-06-25 Impact factor: 29.690