Abbott i-STAT 1 System Manual page 459

*The usual warning relating to the use of regression analysis is summarized here as a reminder. For any analyte, "if the data are collected over a narrow
range, the estimate of the regression parameters is relatively imprecise and may be biased. Therefore, predictions made from these estimates may be
invalid." The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in overcoming this problem.
4
As a guide, the range of data can be considered adequate for r >0.975.
Precision Data (mg/dL)
Aqueous Control
Level 1
Level 3
Method Comparison (mg/dL)
Roche Integra 800
n
Sxx
Syy
Slope
Int't
Syx
Xmin
Xmax
r
Cartridge Comparison
The performance characteristics of the sensors are equivalent in all cartridge configurations. System
difference analysis was performed on 39 patient samples using the i-STAT CHEM8+ and i-STAT Crea
cartridges. In the 0.42-2.50 mg/dL range, the average difference was -0.01. In the 2.50-9.08 mg/dL
range, the average difference was -0.04.
Factors affecting results*
Interference studies were based on CLSI guideline EP7-A2.
CLSI guideline unles otherwise indicated.
When added to a plasma pool the following substances (at the concentrations indicated) were
found to interfere with the i-STAT Creatinine assay:
Substance
Acetaminophen
Acetylcysteine
Ascorbate
Bromide (therapeutic)
Creatine
Glycolic Acid
Hydroxyurea
Nithiodote (sodium thiosulfate)
Rev. Date: 15-Jul-16
Mean SD
4.33 0.131
0.81 0.039
Beckman LX20
30
0.029
0.112
0.929
0.237
0.204
0.4
10.3
0.997
Test Concentration
(mmol/L)
2.5
0.382
16.7
Art: 714183-01W
%CV
3.0
4.8
J & J Vitros 950
58
0.141 0.04
0.143 0.12
0.960 0.948
0.022 0.206
0.261 0.165
0.7
20.0
0.996 0.991
Test concentrations used were as per the
5
Increased i-STAT creatinine results.
1.32
Increased i-STAT creatinine results.
10.2
Increased i-STAT creatinine results
0.34
Increased i-STAT creatinine results.
6,7,8
Increased i-STAT creatinine results
Decreased i-STAT creatinine results.
10.0
Increased i-STAT creatinine results.
0.92
Increased i-STAT creatinine results.
13
Dade Dimension
RxL
31 36
0.04
0.06
0.964
0.100
0.123
0.5 0.5
7.2 5.7
0.986
Interference
See Note below.
See Note below.
by up to 0.3 mg/dL.
See Note below.
by up to 0.3 mg/dL.
See Note below.
Use another method.
Use another method.
See Note below.
Crea - 3