Abbott i-STAT 1 System Manual page 453

Intended Use
The test for TCO , as part of the i-STAT System, is intended for use in the in vitro quantification of total
2
carbon dioxide in arterial, venous, or capillary whole blood.
Carbon dioxide is used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders
associated with changes in body acid-base balance.
Method Explanation
The measured TCO test method is calibrated to the International Federation of Clinical Chemistry (IFCC)
2
TCO reference method
1
2
PCO
, and ionic strength (Na) measurements.
2
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
calibration solution that contains known concentrations of analytes and preservatives. For cartridges that
contain sensors for the measurement of TCO
Reactive Ingredient
Carbon Dioxide (CO )
2
Metrological Traceability
The i-STAT System test for total carbon dioxide (TCO
concentration of all forms of carbon dioxide in the plasma fraction of arterial, venous, or capillary whole
blood (dimension mmol L
and calibration verification materials are traceable to the International Federation of Clinical Chemistry and
Laboratory Medicine (IFCC) Reference Measurement Procedure for Substance Concentration Determination
for Total Carbon Dioxide in Blood, Plasma or Serum.
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
TEST UNITS
Total Carbon
mmol/L
Dioxide/TCO
2
*Calculated from Siggard-Andersen nomogram.
Rev. Date: 01-Jul-13
TOTAL CARBON DIOXIDE/
(TCO )
2
with an algorithm, based on the Henderson-Hasselbalch equation, which uses pH,
, a list of reactive ingredients is indicated below:
2
Minimum Quantity
25.2 mmHg
) for in vitro diagnostic use. TCO
-1
REPORTABLE
RANGE
5 – 50
2
Art: 716661-01G
) measures the amount-of-substance total
2
values assigned to i-STAT System controls
2
i-STAT System controls and calibration verification
1
REFERENCE
RANGE
(arterial)
23 – 27*
(venous)
24 – 29*