Abbott i-STAT 1 System Manual page 506

Method Comparison (ng/mL)
Analytical Sensitivities
The sensitivity of the CK-MB method is 0.6 ng/mL, which is the lowest CK-MB level that can be distinguished
from zero. The analytical sensitivity is defined as two standard deviations associated with a zero calibrator.
The analytical sensitivity was estimated using a control material with <1 ng/mL CK-MB during a 20-day
precision study in which three separate lots of CK-MB test cartridges were tested in duplicate using a pool
of six i-STAT 1 analyzers for a total of 120 test results.
Analytical Specificity
The CK-MB method is specific for the creatine kinase MB isoenzyme. The following muscle proteins were
tested and found to have an insignificant effect on the measured CK-MB.
Crossreactant Concentration
CK-MM (skeletal)
CK-BB (brain)
Recovery
The dilution linearity of the i-STAT CK-MB test was investigated using heparinized whole blood and plasma
samples derived from three separate donors. For each donor, the original CK-MB negative sample and a
CK-MB spiked sample were prepared. This process yielded three CK-MB positive whole blood samples
that were then assayed in duplicate for each of three separate i-STAT CK-MB cartridge lots. These whole
blood samples were then diluted using an equal mass of the original unspiked whole blood and assayed
in duplicate. From this whole blood data, the CK-MB recovery was calculated.
The plasma derived from these three donors was combined in equal masses and all pairwise combinations.
These combinations were then assayed in duplicate for each of three separate i-STAT CK-MB cartridge
lots. The CK-MB recovery for each pair was calculated using the average of the six results. The %
recoveries are listed in the Tables below.
CK-MB - 4
n
Sxx
Syy
Slope
Int't
Sy.x
Xmin
Xmax
r
Percent Crossreactivity
10000 ng/mL
100 ng/mL
Art: 716675-01L
Abbott AxSYM
263
1.84
2.66
1.01
-0.19
3.98
0.04
224
0.994
Not Detectable
Not Detectable
Rev. Date: 01-Jul-13