Abbott i-STAT 1 System Manual page 496

Method Comparison (ng/mL)
Analytical and Functional Sensitivities
The analytical sensitivity of the cTnI method is 0.02 ng/mL, which is the lowest cTnI level that can be
distinguished from zero. The analytical sensitivity is defined as the concentration at two standard deviations
from a sample at 0.00 ng/mL.
Another characteristic of an analytical measurement is the functional sensitivity, which is defined as the cTnI
level at which the test method displays a particular percent coefficient of variation (%CV). Estimates of the
20% and 10% functional sensitivity for the cTnI method were determined from whole blood measurements.
The 20% and 10% functional sensitivities for the cTnI method are 0.07 ng/mL and 0.10 ng/mL, respectively
(see graph below).
cTnI - 4
Dade Behring
Stratus
n 189
Sxx 0.28
Syy 0.31
Slope 0.883
Int't 0.029
Sy.x 1.40
Xmin 0.00
Xmax 46.27
r 0.975
Art: 715595-01R
CS
®
Rev. Date: 01-Jul-13