Art: 714377-00K Rev. Date: 31-Jan-12 15-3
Acceptable Criteria
Target values (determined by testing multiple ampules of each level using
multiple lots of i-STAT cartridges with analyzers 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 the 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 PO
2
at Extreme Altitude
under Controls for Blood Gas/Electrolyte/Metabolite Cartridges in the Quality
Control section of the manual.
Overview of Procedure
i-STAT recommends that each sensor type be included in the Calibration
Verification procedure using a selection of analyzers that have passed the
Electronic Simulator check. See the Technical Bulletin "Calibration Verfication
and the i-STAT System" for more information.
Calibration Verification
Solutions for CHEM8+
Cartridges
A five-level Calibration Verification Set is available to verify the calibration of
i-STAT CHEM8+ cartridges throughout the reportable ranges for:
Sodium TCO
2
Glucose
Potassium BUN/Urea Creatinine
Chloride Ionized Calcium
There are four 1.7mL glass ampules of each level in the set.
An additional i-STAT CHEM8+ Calibration Verification Level 1b is available for
purchase to verify the calibration of the i-STAT CHEM8+ TCO
2
at the low end
of the reportable range.
Reactive Ingredients
See the table on page 14-6 of the Quality Control section for full
information.
Storage
Refrigerated storage at 2 to 8 °C (35 to 46°F) should be maintained until
the printed expiration date on the box and ampule labels. i-STAT CHEM8+
Calibration Verification fluids may also be stored at room temperature for up
to 5 days (18 to 30 °C or 64 to 86°F). Prolonged storage at temperatures greater
than 30 °C (86°F) may cause changes in the values of some analytes. Do not
use beyond the expiration date on the box and ampule labels.
Ampule Use
A separate ampule must be used for each cartridge being tested.
i-STAT CHEM8+ CALIBRATION VERIFICATION SET
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