Abbott i-STAT 1, Системное руководство

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Kaolin ACT - 2
Art: 715878-00M Rev. Date: 31-Jan-12
The test is to be used with the i-STAT Portable Clinical Analyzer and the i-STAT 1 Analyzer, but not the
Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM).
Contents
Each i-STAT
Kaolin
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
Kaolin
Thrombin Substrate
Metrological Traceability
The i-STAT System test for Kaolin Activated Clotting Time measures the time interval required for complete
activation, by kaolin, of the coagulation cascade in arterial or venous whole blood (dimension seconds)
for
in vitro monitoring of high-level heparin therapy. Presently, no international conventional reference
measurement procedure or international conventional calibrator for
Kaolin
ACT is available.
Kaolin
ACT values
assigned to i-STAT’s controls are traceable to i-STAT’s selected reference measurement procedure, which
employs 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 - 137 82- 152
*
The range from 77 - 1000 seconds (PREWRM mode) 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 i-STAT 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 1 119 169 seconds 4 seconds 2.0
Level 2 113 409 seconds 21 seconds 5.2