Cardiovascular disease testing on the Dimension Vista system: biomarkers of acute coronary syndromes.

摘要

OBJECTIVES: Performance characteristics of the LOCI cTnI, CK-MB, MYO, NTproBNP and hsCRP methods on the Dimension Vista 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 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.