Rev. Date: 30-Jan-12 Art: 714185-00N Celite ACT - 3
Method comparison data were collected using a modification of the CLSI guideline EP9-A
2
. Venous or
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. This includes baseline,
heparin-treated, and heparin-reversed samples from from patients undergoing cardiac catheterization and
cardiac bypass.
Deming regression analysis
3
was performed on the first replicate of each sample. In the method comparison
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.
Cath Lab Medtronic
HR-ACT
Hemochron
CA510/FT CA510
n 270 418
Sxx 10.1 19.7
Syy 10.7 13.5
Slope 1.15 0.86
Int’t -30 -3
Sy.x 32.5 22.5
Xmin 73 63
Xmax 523 763
r 0.848 0.903
Hemchron CA510/FT CA510
CVOR Site 1 Site 2 Site 3
n 35 30 24
Sxx 15.8 34.2 24.4
Syy 13.0 11.5 20.8
Slope 0.85 1.10 1.19
Int’t 4 -52 -73
Sy.x 43.8 17.4 62.1
Xmin 118 94 125
Xmax 671 735 767
r 0.912 0.952 0.891
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