Celite ACT - 2 Art: 714185-00N Rev. Date: 30-Jan-12
Contents
Each i-STAT
Celite
ACT cartridge provides a sample collection chamber, sensors to detect the coagulation
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
Celite
ACT is available.
Celite
ACT values assigned to i-STAT’s controls are traceable to i-STAT’s selected reference measurement
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 Units Reportable Range Reference Range
(PREWRM)
Reference Range
(NONWRM)
Activated Clotting
Time/ACT
seconds 50 - 1000* 74 - 125 84 - 139
*
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 was collected in health care facilities by health care
professionals trained in the use of the i-STAT System and comparative methods. All data uses 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 n Mean SD %CV
Level 1 329 221 seconds 18 seconds 8.1
Level 2 438 456 seconds 22 seconds 4.8
To Next Page
Loading...
Need help?
General
