TY - JOUR
T1 - Analytical performance of the i-STAT cardiac troponin I assay
AU - Apple, Fred S.
AU - Murakami, Mary Ann M.
AU - Christenson, Robert H.
AU - Campbell, John L.
AU - Miller, Cary J.
AU - Hock, Karl G.
AU - Scott, Mitchell G.
PY - 2004/7
Y1 - 2004/7
N2 - Background: This study determines the analytical characteristics of the i-STAT cardiac troponin I assay (cTnI; i-STAT, Princeton, NJ), a 10-min POC assay, designed to be performed at the bedside. Methods: Three different hospitals participated in a patient specimen and analytical validation study (n=186) for the i-STAT cTnI assay carried out in real time. A total of 186 whole blood specimens (lithium heparin) were collected from patients presenting with symptoms suggestive of acute coronary syndromes (ACS) for correlation studies as well as from 162 healthy subjects for reference interval determination. Factors studied included antibody specificity, detection limit, imprecision, linearity, assay specificity, sample type stability, interferences, reference limit determination and comparison vs. the Dade Stratus CS cTnI assay. Results: Total imprecision (CV) of 10% and 20% were seen at 0.09 and 0.07 μg/l, respectively. The detection limit was 0.02 μg/l. The 99th percentile reference limit was 0.08 μg/l. The assay was not affected by common interferents. An equimolar response within 5% was found for reduced and phosphorylated forms of TIC and IC complexes. Regression analysis for the i-STAT cTnI between whole blood and plasma specimens and for whole blood between the i-STAT and Stratus CS cTnI assays demonstrated slopes of 1.06 and 0.89, respectively. Conclusions: The i-STAT cTnI assay is a sensitive and precise monitor of cTnI, poised for point-of-care/near bedside clinical utilization for triage, diagnostics and risk management of acute coronary syndrome patients.
AB - Background: This study determines the analytical characteristics of the i-STAT cardiac troponin I assay (cTnI; i-STAT, Princeton, NJ), a 10-min POC assay, designed to be performed at the bedside. Methods: Three different hospitals participated in a patient specimen and analytical validation study (n=186) for the i-STAT cTnI assay carried out in real time. A total of 186 whole blood specimens (lithium heparin) were collected from patients presenting with symptoms suggestive of acute coronary syndromes (ACS) for correlation studies as well as from 162 healthy subjects for reference interval determination. Factors studied included antibody specificity, detection limit, imprecision, linearity, assay specificity, sample type stability, interferences, reference limit determination and comparison vs. the Dade Stratus CS cTnI assay. Results: Total imprecision (CV) of 10% and 20% were seen at 0.09 and 0.07 μg/l, respectively. The detection limit was 0.02 μg/l. The 99th percentile reference limit was 0.08 μg/l. The assay was not affected by common interferents. An equimolar response within 5% was found for reduced and phosphorylated forms of TIC and IC complexes. Regression analysis for the i-STAT cTnI between whole blood and plasma specimens and for whole blood between the i-STAT and Stratus CS cTnI assays demonstrated slopes of 1.06 and 0.89, respectively. Conclusions: The i-STAT cTnI assay is a sensitive and precise monitor of cTnI, poised for point-of-care/near bedside clinical utilization for triage, diagnostics and risk management of acute coronary syndrome patients.
KW - Cardiac troponin
KW - Emergency medicine
KW - Myocardial infarction
KW - Point-of-care testing
UR - http://www.scopus.com/inward/record.url?scp=2942519369&partnerID=8YFLogxK
U2 - 10.1016/j.cccn.2004.03.010
DO - 10.1016/j.cccn.2004.03.010
M3 - Article
C2 - 15193986
AN - SCOPUS:2942519369
SN - 0009-8981
VL - 345
SP - 123
EP - 127
JO - Clinica Chimica Acta
JF - Clinica Chimica Acta
IS - 1-2
ER -