Abbott i-STAT 1, System Manual

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IONIZED CALCIUM/ICA
Rev. Date: 01-Aug-11 Art: 714179-00L
Ionized calcium is measured by ion-selective electrode potentiometry. In the calcu lation of results for ionized
calcium concentration is related to potential through the Nernst equation. Results are measured at 37°C.
See below for information on factors affecting results. Certain substances, such as drugs, may affect
analyte levels in vivo .
1
If results appear inconsistent with the clinical assessment, the patient sample should be retested using
another cartridge.
Intended Use
The test for ionized calcium, as part of the i-STAT System, is intended for use in the
in vitro quantification
of ionized calcium in arterial, venous, or capillary whole blood.
Ionized calcium measurements are used in the diagnosis, monitoring, and treatment of conditions including,
but not limited to, parathyroid disease, a variety of bone diseases, chronic renal disease, tetany, and
disturbances related to surgical and intensive care.
Contents
Each i-STAT cartridge contains one reference electrode (when potentiometric sensors are included in the
cartridge configuration), sensors for the measurement of specific analytes, and a buffered aqueous calibrant
solution that contains known concentrations of analytes and preservatives. For cartridges that contain a
sensor for the measurement of ionized calcium, a list of reactive ingredients is indicated below:
Reactive Ingredient
Calcium (Ca
2+
)
Metrological Traceability
The i-STAT System test for ionized calcium measures ionized calcium (
i.e. free calcium ion) amount-of-
substance concentration in the plasma fraction of arterial, venous, or capillary whole blood (dimension
mmol L -1 ) for in vitro diagnostic use. Ionized calcium values assigned to i-STAT’s controls and calibration
verification materials are traceable to the U.S. National Institute of Standards and Technology (NIST)
standard reference material SRM956. i-STAT System controls and calibration verification materials 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 Care Inc..
Expected Values
Reportable Reference
Test/Abbreviation Units* Range Range 2
Ionized Calcium/iCa mmol/L 0.25 – 2.50 1.12 – 1.32
mg/dL 1.0 – 10.0 4.5 – 5.3
*The i-STAT System can be configured with the preferred units.