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

Abstract

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.

• Authors: Walter E Kelley, Christina M Lockwood, Denise R Cervelli, Jamie Sterner, Mitchell G Scott, Show-Hong Duh, Robert H Christenson
• Journal: Clinical biochemistry (Clin Biochem) Vol. 42 Issue 13-14 Pg. 1444-51 (Sep 2009) ISSN: 1873-2933 [Electronic] United States
• PMID: 19523464 (Publication Type: Journal Article)

Chemical References

• Biomarkers
• Myoglobin
• Peptide Fragments
• Troponin I
• pro-brain natriuretic peptide (1-76)
• Natriuretic Peptide, Brain
• C-Reactive Protein
• Creatine Kinase, MB Form

Topics

• Acute Coronary Syndrome (blood, diagnosis)
• Biomarkers (blood)
• C-Reactive Protein (analysis)
• Cardiovascular Diseases (blood, diagnosis)
• Creatine Kinase, MB Form (blood)
• Humans
• Immunoassay (instrumentation, methods)
• Myoglobin (blood)
• Natriuretic Peptide, Brain (blood)
• Peptide Fragments (blood)
• Reproducibility of Results
• Risk Assessment
• Sensitivity and Specificity
• Troponin I (blood)