Abbott i-STAT 1 System Manual page 497

Analytical Specificity
The cTnI method is specific for cardiac troponin I. The following muscle proteins were tested and found to
have an insignificant effect on the measured cTnI.
Crossreactant
Troponin C (cardiac)
Troponin T (cardiac)
Troponin I (skeletal)
Troponin T (skeletal)
Recovery
The dilution linearity of the i-STAT cTnI test was investigated using heparinized whole blood and plasma
samples derived from 3 separate donors. For each donor, the original cTnI negative sample and a cTnI
spiked sample were prepared. This process yielded three cTnI positive whole blood samples that were then
assayed in duplicate for each of three separate i-STAT cTnI 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 cTnI 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 cTnI cartridge lots.
The cTnI recovery for each pair was calculated using the average of the 6 results. The % recoveries are
listed in the Tables below.
Whole blood
Sample
A
B
C
Plasma
Sample
A
B
C
A+B
B+C
A+C
Test Limitations
The frequency of suppressed results is affected by atmospheric pressure.
increase with higher elevations (decreased barometric pressure) and may become persistent if testing is
performed at more than 7500 feet above sea level. Where unavailability of results is unacceptable, i-STAT
recommends having an alternate test method available.
Rev. Date: 01-Jul-13
Concentration
1000 ng/mL
1000 ng/mL
1000 ng/mL
1000 ng/mL
Concentration Diluted Concentration
2.05
6.31
27.04
Concentration Diluted Concentration
2.41
7.50
29.35
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Art: 715595-01R
Percent Crossreactivity
<0.002%
0.65%
<0.002%
<0.002%
% Recovery
1.04
3.14
14.05
% Recovery
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-----
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4.69
18.90
16.89
Suppressed result rates may
101%
100%
104%
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95%
103%
106%
cTnI - 5