Cardiovascular disease testing on the Dimension Vista® system: Biomarkers of acute coronary syndromes

Objectives: Performance characteristics of the LOCI(R) cTnI, CK-MB, MYO, NTproBNP and hsCRP methods on the Dimension Vista(R) System were evaluated. Design and methods: Imprecision (following CLSI EP05-A2 guidelines), limit of quantitation (cTnI), limit of blank, linearity on dilution, serum versus plasma matrix studies (cTnI), and method comparison studies were conducted. Results: Method imprecision of 1.8 to 9.7% (cTnI), 1.8 to 5.7% (CK-MB), 2.1 to 2.2% (MYO), 1.6 to 3.3% (NTproBNP), and 3.5 to 4.2% (hsCRP) were demonstrated. The manufacturer's claimed imprecision, detection limits and upper measurement limits were met. Limit of Quantitation was 0.040 ng/mL for the cTnI assay. Agreement of serum and plasma values for cTnI (r = 0.99) was shown. Method comparison study results were acceptable. Conclusions: The Dimension Vista(R) cTnI, CK-MB, MYO, NTproBNP, and hsCRP methods demonstrate acceptable performance characteristics for use as an aid in the diagnosis and risk assessment of patients presenting with suspected acute coronary syndromes. (C) 2009 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.