3-3
Rev. Date: 06-Aug-12 Art: 714365-00G
Standardization and
Calibration
Standardization is the process by which a manufacturer establishes “true”
values for representative samples. The sensors in the i-STAT cartridges are
standardized against plasma methods used by major laboratory systems or,
for blood gases, against tonometry. A multi-point calibration curve, the
slope or sensitivity of which is defined by coefficients in the CLEW software,
is derived for each sensor by this standardization process. These calibration
curves are stable over many lots and only need to be adjusted if a change in a
manufacturing process affects the curve or if the relationship between results
on the i-STAT System and other major laboratory systems drifts. For the
convenience of users, CLEW updates are scheduled two times a year.
A one-point calibration is performed each time a cartridge requiring calibration
is used. During the first part of the testing cycle, the calibrant solution is
automatically released from its foil pack and is positioned over the sensors.
The signals produced by the sensors’ responses to the calibrant solution
are measured. This one-point calibration adjusts the offset of the stored
calibration curve. Next, the analyzer automatically moves the sample over the
sensors and the signals produced by the sensors’ responses to the sample are
measured. While coefficients are used rather than graphic calibration curves,
the calculation of the result is equivalent to reading the sample’s concentration
from adjusted calibration curve.
Packaging
Each cartridge is sealed in a foil pouch or clear plastic portion pack for
protection during storage.
Labeling on the carton, box and pouch/portion pack identify:
• the panel name.
• the tests included in the panel.
• the lot number.
• the expiration date of the cartridge.
If the pouch/portion pack has been punctured, the cartridge should not be
used.
14
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Abbott Point of Care Inc.
Abbott Park, IL 60064, USA
Product of Canada
Room Temperature Storage
Lagerung bei Raumtemperatur • Stockage à température ambiante • Conservazione a temperatura ambiente •
Almacenamiento a temperatura ambiente • Armazenamento da temperature da sala • Opslag bij kamertemper-
atuur • Opbevaring ved stuetemperatur • Förvaring i rumstemperatur • Säilytys huoneenlämmössä • Oppbevar-
ing ved romtemperatur • Φυλάσσεται σε θερμοκρασία δωματίου • Oda Sıcaklığında Saklama
EC8
+
Na K Cl Glu pH PCO
2
BUN/Urea Hct
HCO
3
TCO
2
BE AnGap Hb
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