| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 1970874 | Clinical Biochemistry | 2009 | 8 Pages |
ObjectivesPerformance characteristics of the LOCI® cTnI, CK-MB, MYO, NTproBNP and hsCRP methods on the Dimension Vista® System were evaluated.Design and methodsImprecision (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.ResultsMethod 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.ConclusionsThe 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.
