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Equal clinical performance of a novel point-of-care cardiac troponin I (cTnI) assay with a commonly used high-sensitivity cTnI assay
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
Philips Handheld Diagnost, Eindhoven, Netherlands..
Univ Med Ctr Gottingen, Interdisciplinary Emergency Care Unit, Gottingen, Germany..
Luzerner Kantonsspital, Emergency Dept, Luzern, Switzerland.;Paracelsus Med Univ, Nuernberg Gen Hosp, Dept Emergency & Crit Care Med, Nurnberg, Germany..
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2017 (English)In: Clinica Chimica Acta, ISSN 0009-8981, E-ISSN 1873-3492, Vol. 469, p. 119-125Article in journal (Refereed) Published
Abstract [en]

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 (r(2) = 0.85, p < 0.0001) and I-Stat cTnI (r(2) = 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 3 h 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 2-4 h, 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 2-4 h 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% (2-4 h), 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 0/3 h sampling protocol.

Place, publisher, year, edition, pages
ELSEVIER SCIENCE BV , 2017. Vol. 469, p. 119-125
Keywords [en]
Cardiac troponin I, Acute myocardial infarction, Point-of-care, Emergency medicine
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:uu:diva-326220DOI: 10.1016/j.cca.2017.03.023ISI: 000401879100019PubMedID: 28347675OAI: oai:DiVA.org:uu-326220DiVA, id: diva2:1120613
Available from: 2017-07-06 Created: 2017-07-06 Last updated: 2017-07-06Bibliographically approved

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