CK-MB - 4
Art:
716675-00
L
Rev. Date: 03-Aug-12
Method Comparison (ng/mL)
Abbott AxSYM
n
263
Sxx
1.84
Syy
2.66
Slope
1.01
Int’t
-0.19
Sy.x
3.98
Xmin
0.04
Xmax
224
r
0.994
Analytical Sensitivities
The sensitivity of the CK-MB method is 0.6 ng/mL, which is the lowest CK-MB level that can be
distinguished from zero. The analytical sensitivity is defined as two standard deviations associated with
a zero calibrator. The analytical sensitivity was estimated using a control material with < 1 ng/mL CK-
MB during a 20 day precision study in which three separate lots of CK-MB test cartridges were tested in
duplicate using a pool of 6 i-STAT 1 analyzers for a total of 120 test results.
Analytical Specificity
The CK-MB method is specific for the creatine kinase MB isoenzyme. The following muscle proteins
were tested and found to have an insignificant effect on the measured CK-MB.
Crossreactant
Concentration
Percent Crossreactivity
CK-MM (skeletal)
10000 ng/mL
Not Detectable
CK-BB (brain)
100 ng/mL
Not Detectable
Recovery
The dilution linearity of the i-STAT CK-MB test was investigated using heparinized whole blood and
plasma samples derived from 3 separate donors. For each donor, the original CK-MB negative sample
and a CK-MB spiked sample were prepared. This process yielded three CK-MB positive whole blood
samples that were then assayed in duplicate for each of three separate i-STAT CK-MB cartridge lots.
These whole blood samples were then diluted using an equal mass of the original unspiked whole blood
and assayed in duplicate. From this whole blood data, the CK-MB recovery was calculated.
The plasma derived from these three donors was combined in equal masses and all pairwise
combinations. These combinations were then assayed in duplicate for each of three separate i-STAT
CK-MB cartridge lots. The CK-MB recovery for each pair was calculated using the average of the 6
results. The % recoveries are listed in the Tables below.
Summary of Contents for i-STAT 1
Page 1: ...i STAT 1 System Manual Rev Date 20 Jan 12 Art 714336 00L ...
Page 18: ...1 8 Art 714363 00U Rev Date 02 Aug 12 ...
Page 44: ......
Page 90: ......
Page 106: ...9 12 Art 714371 00E Rev Date 06 Aug 12 ...
Page 162: ......
Page 166: ...Art 730292 00A Rev Date 20 Feb 12 4 ...
Page 176: ...10 10 Art 714372 00L Rev Date 30 Jul 12 ...
Page 182: ...11 6 Art 714373 00F Rev Date 17 Jan 11 ...
Page 184: ...12 2 Art 714374 00J Rev Date 25 Aug 11 ...
Page 185: ...Art 714374 00J Rev Date 25 Aug 11 12 3 ...
Page 186: ...12 4 Art 714374 00J Rev Date 25 Aug 11 ...
Page 187: ...Art 714374 00J Rev Date 25 Aug 11 12 5 ...
Page 192: ......
Page 194: ......
Page 214: ...14 20 Art 714376 00M Rev Date 31 Jan 12 ...
Page 216: ...14 22 Art 714376 00M Rev Date 31 Jan 12 ...
Page 218: ...14 24 Art 714376 00M Rev Date 31 Jan 12 ...
Page 220: ...14 26 Art 714376 00M Rev Date 31 Jan 12 ...
Page 222: ...14 28 Art 714376 00M Rev Date 31 Jan 12 ...
Page 224: ...14 30 Art 714376 00M Rev Date 31 Jan 12 ...
Page 226: ......
Page 236: ......
Page 252: ...17 4 Art 714379 00F Rev Date 18 Jul 12 ...
Page 254: ......
Page 294: ...Art 725768 00E Rev Date 04 Jan 12 20 ...
Page 336: ...22 2 Art 714384 00D Rev Date 07 18 06 ...
Page 342: ...22 8 Art 714384 00D Rev Date 07 18 06 ...
Page 348: ...22 14 Art 714384 00D Rev Date 07 18 06 ...
Page 352: ...22 18 Art 714384 00D Rev Date 07 18 06 ...
Page 364: ...22 30 Art 714384 00D Rev Date 07 18 06 ...
Page 384: ...22 50 Art 714384 00D Rev Date 07 18 06 ...
Page 404: ...22 70 Art 714384 00D Rev Date 07 18 06 ...
Page 488: ...Kaolin ACT 4 Art 715878 00M Rev Date 31 Jan 12 ...
Page 536: ......
Page 556: ...Art 714261 00E Rev Date 10 Jan 11 8 ...
Page 560: ...Art 716240 00D Rev Date 03 Mar 10 4 ...
Page 572: ...Art 715617 00D Rev Date 06 11 08 ...
Page 578: ...Art 714547 00F Rev Date 06 11 08 ...
Page 590: ...Art 720735 00B Rev Date 06 11 08 ...
Page 592: ...Art 721106 00B Rev Date 06 11 08 ...
Page 598: ...Art 722831 00A Rev Date 19 Feb 09 ...
Page 610: ...Art 720654 00B Rev Date 06 11 08 ...
Page 614: ...Art 721317 00D Rev Date 13 Aug 12 4 ...
Page 616: ...Art 725703 00A Rev Date 08 Mar 10 2 ...
Page 618: ...Art 721296 00A Rev Date 07 16 08 ...
Page 620: ...REV DATE 16 Oct 12 ART 714446 00L ...
Page 627: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 6 REV DATE 16 Oct 12 ART 714446 00L ...
Page 628: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 7 REV DATE 16 Oct 12 ART 714446 00L ...
Page 629: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 8 REV DATE 16 Oct 12 ART 714446 00L ...
Page 630: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 9 REV DATE 16 Oct 12 ART 714446 00L ...
Page 658: ......