TY - JOUR
T1 - Cardiovascular disease testing on the Dimension Vista® system
T2 - Biomarkers of acute coronary syndromes
AU - Kelley, Walter E.
AU - Lockwood, Christina M.
AU - Cervelli, Denise R.
AU - Sterner, Jamie
AU - Scott, Mitchell G.
AU - Duh, Show Hong
AU - Christenson, Robert H.
PY - 2009/9
Y1 - 2009/9
N2 - 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.
AB - 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.
KW - Acute coronary syndrome
KW - Biomarkers
KW - C-reactive protein
KW - Cardiac Troponin I
KW - Cardiovascular diseases
KW - Creatine Kinase
KW - MB isoenzyme
KW - Myoglobin
KW - NTproBNP
UR - http://www.scopus.com/inward/record.url?scp=69249213462&partnerID=8YFLogxK
U2 - 10.1016/j.clinbiochem.2009.05.020
DO - 10.1016/j.clinbiochem.2009.05.020
M3 - Article
C2 - 19523464
AN - SCOPUS:69249213462
VL - 42
SP - 1444
EP - 1451
JO - Clinical Biochemistry
JF - Clinical Biochemistry
SN - 0009-9120
IS - 13-14
ER -