15-6 Art: 714377-00K Rev. Date: 31-Jan-12
Control Target Values
and Ranges
See value assignment sheet posted on the APOC website at
www.abbottpointofcare.com. The value assignment sheet displays target values
and ranges expected when controls and equipment are performing properly.
Always ensure that the lot number and software revision on the value
assignment sheet matches the lot number of the vial in use and the software
revision in the analyzer.
Target values are specific to the i-STAT System. Results may differ if used with
other methods.
i-STAT BNP CALIBRATION VERIFICATION CONTROL (LEVELS 1, 2, AND 3)
Intended Use i-STAT BNP Calibration Verification Controls are assayed liquid plasma used to
verify the calibration of the BNP test throughout the reportable range.
Warning and
Precautions
Handle the products using the same safety precautions used when handling any
potentially infectious material. The human plasma used in the preparation of
these products has been tested by FDA approved test methods and found negative/
non-reactive for HIV-I, HIV-2, HBsAg, and HCV. However, no known test method
can offer complete assurance that products derived from human blood will not
transmit infectious disease.
Each 1.0 mL vial contains <0.1% sodium azide as a preservative. Dispose of this
product according to 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 calibration verification materials arrive thawed or uncapped.
Bacterial contamination of the control can cause an increase in turbidity. Do not
use the calibration verification material 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 thawing, 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 1. Remove vial from freezer and thaw at room temperature (18-30˚C) for
15 minutes.
2. Gently invert the vial 10 times, then swirl the vial 10 times. Inspect
the sides of the vial to ensure that no particulate matter is clinging to
the sides of the vial. If solids are observed in the control fluid or on
the vial wall, repeat the mixing procedure. If further mixing does not
homogenize the sample, discard the vial and thaw a fresh vial.
3. Open the vial and transfer a drop of solution directly from the vial into
the BNP cartridge and seal the cartridge. If short-term storage (<4 hrs)
is desired, tightly recap the bottle immediately after all sampling is
complete, and store at 2-8˚C.
4. Insert cartridge into an i-STAT 1 Analyzer.
Target Values and
Ranges
See Value Assignment Sheet posted on the APOC website at
www.abbottpointofcare.com. The value assignment sheet displays target values
and ranges expected when controls and equipment are performing properly.
To Next Page
Loading...
Need help?
General
