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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
Summary of Contents for i-STAT 1
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