Per Venge1, Lian van Lippen2, Sabine Blaschke3, Michael Christ4, Felicitas Geier5, Evangelos Giannitsis6, Emil Hagström7, Pierre Hausfater8, Mehdi Khellaf9, Johannes Mair10, David Pariente11, Volkher Scharnhorst12, Veronique Semjonow2. 1. Department of Medical Sciences, University of Uppsala, Uppsala, Sweden. Electronic address: per.venge@medsci.uu.se. 2. Philips Handheld Diagnostics, Eindhoven, The Netherlands. 3. Interdisciplinary Emergency Care Unit, University Medical Center Göttingen, Germany. 4. Emergency Department, Luzerner Kantonsspital, Luzern, Switzerland; Department of Emergency and Critical Care Medicine, Paracelsus Medical University, Nuernberg General Hospital, Nuernberg, Germany. 5. Department of Emergency and Critical Care Medicine, Paracelsus Medical University, Nuernberg General Hospital, Nuernberg, Germany. 6. Medizinische Klinik III, University of Heidelberg, Germany. 7. Uppsala Clinical Research Centre, Uppsala, Sweden. 8. Emergency Department, Hôpital Pitié-Salpêtrière, AP-HP and Sorbonne Universités UPMC Univ-Paris 06, GRC-14 BIOSFAST, Paris, France. 9. Emergency Department, Hôpital Henri Mondor, Créteil, France. 10. Department of Internal Medicine III - Cardiology and Angiology, Innsbruck Medical University, Innsbruck, Austria. 11. Emergency Department, Hôpital Pitié-Salpêtrière, AP-HP, Paris, France. 12. Clinical Laboratory, Catharina Ziekenhuis Eindhoven and Technical University Eindhoven, Eindhoven, The Netherlands.
Abstract
BACKGROUND: Efficient rule-out of acute myocardial infarction (MI) facilitates early disposition of chest pain patients in emergency departments (ED). Point-of-care (POC) cardiac troponin (cTn) may improve patient throughput. We compared the diagnostic accuracy of a novel cTnI test (Minicare cTnI, Philips), with current POC cTnI (I-Stat, Abbott) and high-sensitivity central laboratory cTnI (hs-cTnI; Architect, Abbott) assays. METHODS: The clinical performance of the assays were compared in samples from 450 patients from a previous clinical evaluation of Minicare cTnI. RESULTS: Minicare cTnI correlated with Architect hs-cTnI (r2=0.85, p<0.0001) and I-Stat cTnI (r2=0.93, p<0.0001). Areas under the receiver operating characteristics curves were 0.87-0.91 at admission (p=ns) and 0.96-0.97 3h after admission (p=ns). The negative predictive values (NPV) at admission were 95% ((92-97%, 95% CI) for Minicare cTnI and increased to 99% (97-100%) at 2-4h, and similar to Architect hs-cTnI (98%, 96-100%), but higher than I-Stat cTnI (95%, 92-97%; p<0.01). Negative likelihood ratios (LR-) after 2-4h were 0.06 (0.02-0.17, 95% CI) for Minicare cTnI, 0.11 (0.05-0.24) for Architect hs-cTnI (p=0.02) and 0.28 (0.18-0.43) for I-Stat cTnI (p<0.0001). The clinical concordances between Minicare cTnI and Architect hs-cTnI were 92% (admission) and 95% (2-4h), with lower concordances between Minicare cTnI and I-Stat cTnI (83% and 78%, respectively; p=0.007). CONCLUSIONS: The Minicare cTnI POC assay may become useful for prompt and safe ruling-out of AMI in ED patients with suspected AMI using a guideline supported 0/3h sampling protocol.
BACKGROUND: Efficient rule-out of acute myocardial infarction (MI) facilitates early disposition of chest painpatients in emergency departments (ED). Point-of-care (POC) cardiac troponin (cTn) may improve patient throughput. We compared the diagnostic accuracy of a novel cTnI test (Minicare cTnI, Philips), with current POC cTnI (I-Stat, Abbott) and high-sensitivity central laboratory cTnI (hs-cTnI; Architect, Abbott) assays. METHODS: The clinical performance of the assays were compared in samples from 450 patients from a previous clinical evaluation of Minicare cTnI. RESULTS: Minicare cTnI correlated with Architect hs-cTnI (r2=0.85, p<0.0001) and I-Stat cTnI (r2=0.93, p<0.0001). Areas under the receiver operating characteristics curves were 0.87-0.91 at admission (p=ns) and 0.96-0.97 3h after admission (p=ns). The negative predictive values (NPV) at admission were 95% ((92-97%, 95% CI) for Minicare cTnI and increased to 99% (97-100%) at 2-4h, and similar to Architect hs-cTnI (98%, 96-100%), but higher than I-Stat cTnI (95%, 92-97%; p<0.01). Negative likelihood ratios (LR-) after 2-4h were 0.06 (0.02-0.17, 95% CI) for Minicare cTnI, 0.11 (0.05-0.24) for Architect hs-cTnI (p=0.02) and 0.28 (0.18-0.43) for I-Stat cTnI (p<0.0001). The clinical concordances between Minicare cTnI and Architect hs-cTnI were 92% (admission) and 95% (2-4h), with lower concordances between Minicare cTnI and I-Stat cTnI (83% and 78%, respectively; p=0.007). CONCLUSIONS: The Minicare cTnI POC assay may become useful for prompt and safe ruling-out of AMI in ED patients with suspected AMI using a guideline supported 0/3h sampling protocol.
Authors: Daniel Y Joh; Angus M Hucknall; Qingshan Wei; Kelly A Mason; Margaret L Lund; Cassio M Fontes; Ryan T Hill; Rebecca Blair; Zackary Zimmers; Rohan K Achar; Derek Tseng; Raluca Gordan; Michael Freemark; Aydogan Ozcan; Ashutosh Chilkoti Journal: Proc Natl Acad Sci U S A Date: 2017-08-07 Impact factor: 11.205
Authors: Evangelos Giannitsis; Stefan Blankenberg; Robert H Christenson; Norbert Frey; Stephan von Haehling; Christian W Hamm; Kenji Inoue; Hugo A Katus; Chien-Chang Lee; James McCord; Martin Möckel; Jack Tan Wei Chieh; Marco Tubaro; Kai C Wollert; Kurt Huber Journal: Clin Res Cardiol Date: 2021-02-26 Impact factor: 5.460