Abbott i-STAT 1 System Manual page 470

Contents
Each i-STAT ACT cartridge provides a sample collection chamber, sensors to detect the coagulation
Celite
endpoint, and dry reagents necessary to initiate and allow coagulation. Stabilizers and reagents are coated
on a section of the sensor channel and include the following reactive ingredients:
Reactive Ingredient
Diatomaceous Earth
Thrombin Substrate
Metrological Traceability
The i-STAT System test for Celite Activated Clotting Time measures the time interval required for complete
activation, by Celite , of the coagulation cascade in arterial or venous whole blood (dimension seconds) for
®
in vitro monitoring of moderate- and high-level heparin therapy. Presently, no international conventional
reference measurement procedure or international conventional calibrator for
ACT values assigned to i-STAT's controls are traceable to i-STAT's selected reference measurement
Celite
procedure, which employs diatomaceous earth (Celite) activated glass reagent tubes, an automated timer
and traditional viscometric clot detection and is run under specified temperature and sample conditions.
i-STAT System controls are validated for use only with the i-STAT System and assigned values may not be
commutable with other methods. Further information regarding metrological traceability is available from
Abbott Point of Care Inc.
Expected Values
Test/Abbreviation
Activated Clotting
Time/ACT
*
The range from 80 - 1000 seconds has been verified through method comparison studies.
Clinical Significance
The ACT is primarily used to monitor a patient's state of anticoagulation due to heparin that is administered
during a medical or surgical procedure. It is commonly employed in cardiac catheterization, Percutaneous
Transluminal Coronary Angioplasty (PTCA), renal dialysis, hemodialysis, and extra-corporeal circulation
during bypass.
Performance Characteristics
The typical performance data summarized below were collected in health care facilities by health care
professionals trained in the use of the i-STAT System and comparative methods. All data use the PREWRM
calibration, unless otherwise noted.
Precision data were collected at Abbott Point of Care Inc. and during clinical trials following a protocol
recommended by i-STAT and using plasma control material. Similar results can be expected in future
performance studies provided the same experimental design and data analysis procedures are followed.
Plasma Control
Level 1
Level 2
Celite ACT - 2
Minimum Quantity
14.4 μg
0.36 μg
Units Reportable Range
seconds 50 - 1000*
n Mean
329 221 seconds
438 456 seconds
Art: 714185-01P
ACT is available.
Celite
Reference Range Reference Range
(PREWRM) (NONWRM)
74 - 125
SD
18 seconds
22 seconds
Rev. Date: 01-Jul-13
84 - 139
%CV
8.1
4.8