Equal clinical performance of a novel point-of-care cardiac troponin I (cTnI) assay with a commonly used high-sensitivity cTnI assay

P. Venge, L. van Lippen, S. Blaschke, M. Christ, F. Geier, E. Giannitsis, E. Hagström, M. Khellaf, J. Mair, D. Pariente, V. Scharnhorst, V. Semjonow

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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 (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 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.

Original languageEnglish
Pages (from-to)119-125
Number of pages7
JournalClinica Chimica Acta
Volume469
DOIs
Publication statusPublished - 1 Jun 2017

Keywords

  • Journal Article
  • Cardiac troponin I
  • Emergency medicine
  • Acute myocardial infarction
  • Point-of-care
  • Limit of Detection
  • Troponin I/metabolism
  • Humans
  • Middle Aged
  • Male
  • Point-of-Care Systems
  • Myocardium/metabolism
  • Myocardial Infarction/metabolism
  • Female
  • Aged

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