Abbott i-STAT 1, Системное руководство

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Art: 714376-00M Rev. Date: 31-Jan-12
14-13
CLINIQA LIQUID QC™ CARDIAC MARKER CONTROLS FOR i-STAT
Intended Use CLINIQA Liquid QC™ Cardiac Marker Controls are assayed human plasma
which can be used to verify the integrity of newly received i-STAT CK-MB
cartridges. CLINIQA Liquid QC Cardiac Marker Controls are not intended to
be used as a standard.
Warning and
Precautions Each serum/plasma donor unit used in the manufacture of this product has
been tested by FDA accepted methods and found negative/non-reactive for the
presence of HBsAg and the antibody to HIV-1/2, HCV, and HIV-1 Ag. While
these test methods are highly accurate, they do not guarantee that all infected
units will be detected. Because no known test method can offer complete
assurance the hepatitis B virus, hepatitis C virus, human immunodeficiency
virus (HIV) or other infectious agents are absent, all products containing human
source material should be considered potentially infectious and handled with
the same precautions used with patient specimens.
Bacterial contamination of the control can cause an increase in turbidity. Do
not use the control material if there is visible evidence of microbial growth or
gross contamination.
Storage and Stability CLINIQA Liquid QC Cardiac Marker Control is a ready-to-use liquid control
requiring no reconstitution or frozen storage. It is stable until the expiration
date on the vial label when stored unopened at 2-8°C. Once opened, CLINIQA
Liquid QC Cardiac Marker Control is stable for 30 days when stored tightly
capped at 2-8°C.
Procedure 1. Access the i-STAT Cartridge Control option under Quality Tests in the
Administration Menu. Enter the required information. The analyzer
allows 15 minutes (or the customized timeout period) to insert the
cartridge after the last data entry.
2. Immediately before use, gently mix the contents of the control vial to
ensure homogeneity. Avoid foaming of the sample.
3. Open the vial and transfer a drop of the solution into the i-STAT CK-MB
cartridge using a plain capillary tube, plain syringe, or plastic transfer
pipette. Tightly recap the control vial and store it at 2-8°C.
4. Seal the cartridge and immediately insert it into the 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 materials and equipment are performing properly.
Should results fall outside the range, consult page 14-19 of this section for
troubleshooting recommendations.
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.