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”.
5
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,
6
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.
Содержание i-STAT 1
Страница 1: ...i STAT 1 System Manual Rev Date 20 Jan 12 Art 714336 00L ...
Страница 18: ...1 8 Art 714363 00U Rev Date 02 Aug 12 ...
Страница 44: ......
Страница 90: ......
Страница 106: ...9 12 Art 714371 00E Rev Date 06 Aug 12 ...
Страница 162: ......
Страница 166: ...Art 730292 00A Rev Date 20 Feb 12 4 ...
Страница 176: ...10 10 Art 714372 00L Rev Date 30 Jul 12 ...
Страница 182: ...11 6 Art 714373 00F Rev Date 17 Jan 11 ...
Страница 184: ...12 2 Art 714374 00J Rev Date 25 Aug 11 ...
Страница 185: ...Art 714374 00J Rev Date 25 Aug 11 12 3 ...
Страница 186: ...12 4 Art 714374 00J Rev Date 25 Aug 11 ...
Страница 187: ...Art 714374 00J Rev Date 25 Aug 11 12 5 ...
Страница 192: ......
Страница 194: ......
Страница 214: ...14 20 Art 714376 00M Rev Date 31 Jan 12 ...
Страница 216: ...14 22 Art 714376 00M Rev Date 31 Jan 12 ...
Страница 218: ...14 24 Art 714376 00M Rev Date 31 Jan 12 ...
Страница 220: ...14 26 Art 714376 00M Rev Date 31 Jan 12 ...
Страница 222: ...14 28 Art 714376 00M Rev Date 31 Jan 12 ...
Страница 224: ...14 30 Art 714376 00M Rev Date 31 Jan 12 ...
Страница 226: ......
Страница 236: ......
Страница 252: ...17 4 Art 714379 00F Rev Date 18 Jul 12 ...
Страница 254: ......
Страница 294: ...Art 725768 00E Rev Date 04 Jan 12 20 ...
Страница 336: ...22 2 Art 714384 00D Rev Date 07 18 06 ...
Страница 342: ...22 8 Art 714384 00D Rev Date 07 18 06 ...
Страница 348: ...22 14 Art 714384 00D Rev Date 07 18 06 ...
Страница 352: ...22 18 Art 714384 00D Rev Date 07 18 06 ...
Страница 364: ...22 30 Art 714384 00D Rev Date 07 18 06 ...
Страница 384: ...22 50 Art 714384 00D Rev Date 07 18 06 ...
Страница 404: ...22 70 Art 714384 00D Rev Date 07 18 06 ...
Страница 488: ...Kaolin ACT 4 Art 715878 00M Rev Date 31 Jan 12 ...
Страница 536: ......
Страница 556: ...Art 714261 00E Rev Date 10 Jan 11 8 ...
Страница 560: ...Art 716240 00D Rev Date 03 Mar 10 4 ...
Страница 572: ...Art 715617 00D Rev Date 06 11 08 ...
Страница 578: ...Art 714547 00F Rev Date 06 11 08 ...
Страница 590: ...Art 720735 00B Rev Date 06 11 08 ...
Страница 592: ...Art 721106 00B Rev Date 06 11 08 ...
Страница 598: ...Art 722831 00A Rev Date 19 Feb 09 ...
Страница 610: ...Art 720654 00B Rev Date 06 11 08 ...
Страница 614: ...Art 721317 00D Rev Date 13 Aug 12 4 ...
Страница 616: ...Art 725703 00A Rev Date 08 Mar 10 2 ...
Страница 618: ...Art 721296 00A Rev Date 07 16 08 ...
Страница 620: ...REV DATE 16 Oct 12 ART 714446 00L ...
Страница 627: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 6 REV DATE 16 Oct 12 ART 714446 00L ...
Страница 628: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 7 REV DATE 16 Oct 12 ART 714446 00L ...
Страница 629: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 8 REV DATE 16 Oct 12 ART 714446 00L ...
Страница 630: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 9 REV DATE 16 Oct 12 ART 714446 00L ...
Страница 658: ......