Rev. Date: 23-May-12 Art: 715595-00R cTnI - 5
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 Concentration Percent Crossreactivity
Troponin C (cardiac) 1000 ng/mL <0.002%
Troponin T (cardiac) 1000 ng/mL 0.65%
Troponin I (skeletal) 1000 ng/mL <0.002%
Troponin T (skeletal) 1000 ng/mL <0.002%
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 Concentration Diluted Concentration % Recovery
A 2.05 1.04 101%
B 6.31 3.14 100%
C 27.04 14.05 104%
Plasma
Sample Concentration Diluted Concentration % Recovery
A 2.41 ----- -----
B 7.50 ----- -----
C 29.35 ----- -----
A+B ----- 4.69 95%
B+C ----- 18.90 103%
A+C ----- 16.89 106%
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