Abbott i-STAT 1 System Manual page 487

The below imprecision data for lyophilized plasma control material were collected during studies at an
Abbott Point of Care facility and during clinical trials. SD and %CV are typical of current performance.
Current Value Assignment Sheets should be referenced for applicable plasma control mean data.
Plasma Control
Level 1
Level 2
Reference Interval
In a study to determine a reference interval for PT/INR, venous samples from healthy volunteers were
collected in plastic tubes, and whole blood was analyzed with one lot of cartridges on the i-STAT System.
Capillary samples were obtained from the same volunteers using Softclick Pro (setting of 3) and analyzed
on the same cartridge lot. Reference intervals for INR in venous and capillary samples were determined
according to the CLSI Guideline C28-A2.
Statistic
n
Mean (INR)
SD
Reference Range (INR)
Due to the many variables that may affect PT/INR results, each laboratory should establish its own
reference interval.
Method Comparison
Method comparison data were collected at the Hemostasis Reference Laboratory (Hamilton, Ontario,
Canada). Venous samples from outpatients undergoing routine oral anticoagulation therapy were collected
in plastic tubes and analyzed in duplicate on multiple lots of cartridges on the i-STAT System; plasma from
tubes containing a citrate anticoagulant were analyzed in duplicate on the comparative instruments using
Dade Innovin , STA Neoplastine
® ®
Deming regression analysis
comparison table below, n is the number of specimens in the data set, 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. A correlation study should be performed to
establish the differences between the i-STAT PT/INR measurement and other methods used.
i-STAT vs. Siemens Sysmex
Statistic CA-1500 and Dade
n
Mean (INR)
Range (INR)
Sx (INR)
Slope
Intercept (INR)
r
Sy.x
Rev. Date: 01-Jul-13
Mean
1.1 (INR)
2.5 (INR)
The data are summarized in the table below:
3
Venous whole blood
120
1.0
0.1
0.8 - 1.2
CI Plus, and the HemosIL
®
was performed on the first replicate of each sample. In the method
4
®
i-STAT vs. STA Compact
Innovin
® ®
Neoplastine
reagent
78
2.1
0.9 - 4.5
0.843
0.981
0.084
0.963
0.233
Art: 715236-01M
SD %CV
0.05 4.5%
0.17 6.9%
Capillary whole blood
119
1.0
0.1
0.8 - 1.2
RecombiPlasTin 2G reagents.
® ®
i-STAT vs. IL ACL 7000 and
and
®
HemosIL
CI Plus reagent
®
78
2.1
0.9 - 4.1
0.772
1.074
-0.100
0.964
0.229
RecombiPlasTin
®
2G reagent
®
69
2.2
0.9 – 4.0
0.840
0.972
0.003
0.962
0.233
PT/INR - 3