Abbott i-STAT 1 System Manual page 479

Method comparison data were collected using a modification of the CLSI guideline EP9-A.
arterial blood samples were collected in plastic syringes and analyzed in duplicate on the i-STAT System
and in duplicate using the comparative methods. All samples were analyzed immediately upon collection.
The patient populations in the studies were those in which ACT is routinely used and included both aprotinin
and non-aprotinin receiving patients. All were undergoing cardiac surgery. Sample types included baseline,
heparin-treated, and heparin-reversed samples.
Deming regression analysis
table, n is the number of specimens in the data set, Sxx and Syy refer to estimates of the imprecision based
on the duplicates of the comparative and i-STAT methods respectively, Sy.x is the standard error of the
estimate, and r is the correlation coefficient.
Method comparisons will vary from site to site due to differences in the sample handling, reagent and
instrument systems in use, and other site-specific variables.
Factors Affecting Results*
The i-STAT ACT test is not significantly prolonged in the presence of aprotinin (Trasylol).
Kaolin
*It is possible that other interfering substances may be encountered. These results are representative and your results may differ somewhat due to
test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.
Heparin sensitivity was demonstrated using whole blood samples to which varying concentrations of
heparin were added in vitro.
The following three graphs each indicate the response of a different donor with respect to heparin
concentration:
Rev. Date: 01-Jul-13
was performed on the first replicate of each sample. In the method comparison
3
Hemochron FTK-ACT
CVOR Site 1
n 104
Sxx 9.1 %
Syy 3.6 %
Slope 0.96
Intercept -12
Xmin 68
Xmax 1286
r 0.906
Art: 715878-01M
Site 2 Site 3
118 106
6.8 % 7.6 %
4.0 % 3.6 %
1.05 0.96
-38 -39
111 81
1310 1102
0.940 0.971
Venous or
2
Kaolin ACT - 3