Abbott i-STAT 1 System Manual page 409

CHLORIDE/CL
Chloride is measured by ion-selective electrode potentiometry. In the calculation of results for chloride,
concentration is related to potential through the Nernst equation.
The i-STAT System uses direct (undiluted) electrochemical methods. Values obtained by direct methods
may differ from those obtained by indirect (diluted) methods.
1
See below for information on factors affecting results. Certain substances, such as drugs, may affect
analyte levels in vivo.
2
If results appear inconsistent with the clinical assessment, the patient sample should be retested using
another cartridge.
Intended Use
The test for chloride, as part of the i-STAT System, is intended for use in the in vitro quantification of
chloride in arterial, venous, or capillary whole blood.
Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and
metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders.
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 chloride, a list of reactive ingredients is indicated below:
Reactive Ingredient Minimum Quantity
Chloride (Cl ) 91 mmol/L
-
Metrological Traceability
The i-STAT System test for chloride measures chloride amount-of-substance concentration in the plasma
fraction of arterial, venous, or capillary whole blood (dimension mmol L ) for in vitro diagnostic use.
-1
Chloride 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 of Care Inc.
Expected Values
Reportable Reference
Test/Abbreviation Units* Range Range
3
Chloride/CL mmol/L (mEq/L) 65 – 140 98 – 109
*The i-STAT System can be configured with the preferred units.
Rev. Date: 15-Jul-16 Art: 714175-01O