Abbott i-STAT 1 System Manual

Rev. Date: 03-Aug-12 Art: 714183-00T Crea - 3
*The usual warning relating to the use of regression analysis is summarized here as a reminder: For any analyte, “if the data is collected over a narrow
range, the estimate of the regression parameters are relatively imprecise and may be biased. Therefore, predictions made from these estimates
may be invalid”.
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The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in overcoming this
problem. As a guide, the range of data can be considered adequate if r>0.975.
Precision Data (mg/dL)
Aqueous Control Mean SD %CV
Level 1 4.33 0.131 3.0
Level 3 0.81 0.039 4.8
Method Comparison (mg/dL)
Roche Integra 800 Beckman LX20 J & J Vitros 950 Dade Dimension
RxL
n
30 58 31 36
Sxx
0.029 0.141 0.04 0.04
Syy
0.112 0.143 0.12 0.06
Slope
0.929 0.960 0.948 0.964
Int’t
0.237 0.022 0.206 0.100
Syx
0.204 0.261 0.165 0.123
Xmin
0.4 0.7 0.5 0.5
Xmax
10.3 20.0 7.2 5.7
r
0.997 0.996 0.991 0.986
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*
Test concentrations used were as per the CLSI guidance document,
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unless otherwise indicated.
The following substances are known to interfere with the i-STAT Creatinine assay:
Substance
Test Concentration
(mmol/L)
Interference
Acetaminophen 1.32
Increased i-STAT creatinine results.
See Note below.
Acetylcysteine 10.2
Increased i-STAT creatinine results.
See Note below.
Ascorbate 0.34
Increased creatinine results by
approximately 0.3 mg/dL.
Bromide 37.5
Increased i-STAT creatinine results.
See Note below.
Creatine 0.382
Increased i-STAT creatinine results
by approximately 0.2 mg/dL.
See Note Below.
Hydroxyurea 0.92
Increased i-STAT creatinine results.
Use another method.

Abbott i-STAT 1 Specifications

General

Brand	Abbott
Model	i-STAT 1
Category	Measuring Instruments
Language	English