Clinical Use of a New High-Sensitivity Cardiac Troponin I Assay in Patients with Suspected Myocardial Infarction. (1st November 2019)

• Record Type: Journal Article
• Authors: Boeddinghaus, Jasper; Twerenbold, Raphael; Nestelberger, Thomas; Koechlin, Luca; Wussler, Desiree; Meier, Mario; Troester, Valentina; Zimmermann, Tobias; Badertscher, Patrick; Wildi, Karin; Rubini Giménez, Maria; Lopez-Ayala, Pedro; Potlukova, Eliska; Miró, Òscar; Martin-Sanchez, F Javier; Kawecki, Damian; Geigy, Nicolas; Keller, Dagmar I; Reichlin, Tobias; Mueller, Christian; du Fay de Lavallaz, Jeanne; Walter, Joan Elias; Freese, Michael; Puelacher, Christian; Hafner, Benjamin; Strebel, Ivo; Kozhuharov, Nikola; Rentsch, Katharina; Gualandro, Danielle M; Schaerli, Nicolas; Stelzig, Claudia; Meissner, Kathrin; Kulangara, Caroline; Hillinger, Petra; Grimm, Karin; Michou, Eleni; Flores, Dayana; Czmok, Rafael; Osswald, Stefan; López, Beatriz; Fuenzalida, Carolina; Rodriguez Adrada, Esther; Ganovská, Eva; Lohrmann, Jens; Kloos, Wanda; Christ, Michael; Steude, Jana; Fahrni, Gregor; Buser, Andreas; von Eckardstein, Arnold; Morawiec, Beata; Nowalany-Kozielska, Ewa; Muzyk, Piotr;
• Is Part Of: Clinical chemistry. Volume 65:Number 11(2019)
• Page Start: 1426
• Page End: 1436
• Publication Date: 2019-11-01
• Subjects: Clinical chemistry -- Periodicals; Pharmaceutical chemistry -- Periodicals; Biochemistry -- Periodicals; Biochimie -- Périodiques; Diagnostics biologiques -- Périodiques; Biochemistry; Clinical chemistry; Pharmaceutical chemistry; Biochemistry; Laboratory Techniques and Procedures; Klinische chemie; Periodicals; 616.075605
• DOI: 10.1373/clinchem.2019.304725
• Languages: English
• ISSNs: 0009-9147

Abstract

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. ClinicalTrials.gov Identifier: NCT00470587.