Cardiovascular disease testing on the Dimension Vista system: biomarkers of acute coronary syndromes.
OBJECTIVE
Performance characteristics of the LOCI cTnI, CK-MB, MYO, NTproBNP and hsCRP methods on the Dimension Vista System were evaluated.


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.
Kelley
Walter E
WE
Clinical Chemistry Labs, University of Maryland School of Medicine, Baltimore, MD 21201, USA. wkelley@umm.edu
Lockwood
Christina M
CM
Cervelli
Denise R
DR
Sterner
Jamie
J
Scott
Mitchell G
MG
Duh
Show-Hong
SH
Christenson
Robert H
RH
D054058:Acute Coronary Syndrome / Q000097:blood* / Q000175:diagnosis; D015415:Biomarkers / Q000097:blood*; D002097:C-Reactive Protein / Q000032:analysis; D002318:Cardiovascular Diseases / Q000097:blood* / Q000175:diagnosis; D052279:Creatine Kinase, MB Form / Q000097:blood; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods*; D009211:Myoglobin / Q000097:blood; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010446:Peptide Fragments / Q000097:blood; D015203:Reproducibility of Results; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D019210:Troponin I / Q000097:blood
D015415:Biomarkers; D009211:Myoglobin; D010446:Peptide Fragments; D019210:Troponin I; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain; D002097:C-Reactive Protein; D052279:Creatine Kinase, MB Form