Abbott i-STAT 1, System Manual

Page: 234 / 658

Art: 723270-00A Rev. Date: 20-Apr-12 8
Acceptable Criteria
Target values (determined by testing multiple ampules of each level using multiple lots
of cartridges and i-STAT handhelds that have passed the Electronic Simulator test) are
printed on a Value Assignment Sheet posted on the APOC website at
www.abbottpointofcare.com.
Calibration throughout the reportable range of each analyte is verified if each analyte
value falls within the corresponding range in the Value Assignment Sheet.
If a result for a level is outside the range published in the Value Assignment Sheet,
two additional cartridge runs should be performed on this level and the three results
averaged and then compared to the Value Assignment Sheet range. If this average
value is still outside the acceptable range, troubleshooting may be required.
Note:
If the Calibration Verification Set is to be used to assess linearity, plot the analyte
value against the mean value of the acceptable range. The concentrations of
analytes in the Calibration Verification Set are not intended or prepared to be
equally spaced.
If testing at extreme altitude refer to Correction of
P
O
2
at Extreme Altitude paragraph
in section CONTROLS FOR BLOOD GAS/ELECTROLYTE/METABOLITE CARTRIDGES
(i-STAT TriControls) above.
PRECISION
The additive used in the aqueous-based TriControls to simulate the effect of hematocrit
in blood samples results in reduced precision in repeat measurement of electrolytes
relative to the precision obtained when assaying with either standard control/calibration
verification materials or whole blood. The imprecision is related to the concentration of
additive. The increase is pronounced at higher levels of indicated hematocrit.
Internal testing of non-Abbott aqueous control materials on the i-STAT System which
have hematocrit, blood gas and chemistry functionalities exhibit similar precision to
that observed for TriControls.
The acceptance limits which have been established for these control solutions are
wider than analogous limits established for the current i-STAT and CHEM8+ control and
calibration verification solutions, reflecting the precision effect highlighted above.
The situation where better precision will be obtained in clinical samples than in control
solutions is not unusual. A similar effect is observed in control solutions for the i-STAT
measurement of
P
O
2
.