Art: 714377-00K Rev. Date: 31-Jan-12 15-5
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 i-STAT CHEM8+ 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 i-STAT CHEM8+ Calibration
Verification Set are not intended or prepared to be equally spaced.
i-STAT CARDIAC MARKER CALIBRATION VERIFICATION SET
A three level Calibration Verification Set is available to verify the calibration of
cTnI cartridges throughout the reportable range.
There are two 1.0 mL plastic vials of each level in the set.
Intended Use
i-STAT
®
Cardiac Markers Calibration Verification Controls are assayed human
sera used to verify the calibration of the cTnI test throughout the reportable
range.
Warnings and
Precautions
Handle this product using the same safety precautions used when handling any
potentially infectious material. The human sera used in the preparation of this
product have been tested by FDA approved test methods and found negative/
non-reactive for HIV-1, HIV-2, HBsAg, HCV, HTLV-1 and HTLV-2. However, no
known test method can offer complete assurance that products derived from
human blood will not transmit infectious disease.
Each vial contains < 0.1% sodium azide as a preservative. Dispose of this product
according to all local, state and national regulations. If disposed down a drain,
the sodium azide in this product may react with lead and copper plumbing to
form highly explosive metal azides. Flush drain with large amounts of water
to prevent azide build-up.
Do not use if the controls arrive thawed or uncapped.
Bacterial contamination can cause an increase in turbidity. Do not use the control
if there is visible evidence of microbial growth or gross contamination.
Storage and Stability
Store at ≤ –18°C (-1°F) in a non-defrosting freezer. After thaw, the opened or
unopened vial is stable for 4 hours when capped and stored at 2-8°C (35-46°F).
Do not re-freeze
Procedure
Step Action
1 Remove vial from freezer and thaw at room temperature (18-30°C) for 15 minutes.
2 Thoroughly mix by gently swirling the bottle. Avoid foaming of the sample.
3 Dispense a drop of sample directly from vial into the i-STAT cTnI cartridge and seal the
cartridge. Tightly recap the bottle immediately after all sampling is complete and store
at 2-8°C.
4 Insert cartridge into an i-STAT analyzer.
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