Evaluation of a rapid whole blood ELISA for quantification of troponin I in patients with acute chest pain.
BACKGROUND
Troponin I (cTnI) provides important prognostic information in patients with chest pain. We wished to evaluate a rapid, whole-blood analyzer for quantitative point-of-care testing.


METHODS
A quantitative point-of-care test system (Stratus CS((R)); Dade-Behring) for cTnI with an incorporated centrifuge was evaluated in 412 patients with chest pain less than 12 h.


RESULTS
Results were available within 15 min. CVs were 4.5% at 0.1 microgram/L, 4.2% at 0.25 microgram/L, and 6.5% at 0.82 microgram/L. The detection limit was 0. 01 microgram/L. The 97.5% percentile in a healthy population was 0.08 microgram/L. Based on ROC curve analysis, a threshold of 0.15 microgram/L was calculated for the detection of acute myocardial infarction (AMI). With it, sensitivity for the detection of patients with AMI (n = 62) was 63% at arrival and 98% after 4 h (Stratus II((R)), 48% and 85%, respectively; P <0.01). In 42% of patients with unstable angina (n = 121), cTnI was >/=0.08 microgram/L (Stratus II, 28%; P <0. 01). During 30 days, death or AMI occurred in 25.5% of these cTnI-positive vs 2.9% of cTnI-negative patients (Stratus II, 29.4% vs 5.8%).


CONCLUSIONS
The Stratus CS provided better analytical performance and comparable or better prognostic information than the Stratus II.
Heeschen
C
C
Stanford University Medical School, Department of Cardiovascular Medicine, Stanford, CA 94305-5406, USA. heeschen@stanford.edu
Goldmann
B U
BU
Langenbrink
L
L
Matschuck
G
G
Hamm
C W
CW
D000208:Acute Disease; D000789:Angina, Unstable / Q000175:diagnosis*; D015415:Biomarkers / Q000097:blood; D002637:Chest Pain / Q000175:diagnosis*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D015200:Fluoroimmunoassay; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis*; D019095:Point-of-Care Systems; D012372:ROC Curve; D019210:Troponin I / Q000097:blood*
D015415:Biomarkers; D019210:Troponin I