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Apo A1/Apo B Calibrator
6E54-02
This package insert contains information for the use of Apo A1/Apo B
Calibrator on the ARCHITECT c Systems
NOTE: Changes Highlighted
NOTE: This package insert must be read carefully prior to product use.
Package insert instructions must be followed accordingly. Reliability of
assay results cannot be guaranteed if there are any deviations from the
instructions in this package insert.
INTENDED USE
For use in the calibration of the Apolipoprotein A1 (Apo A1) and
Apolipoprotein B (Apo B) assays.
CONTENTS / MATERIALS PROVIDED
6E54 Apo A1/Apo B Calibrator
1 x 1 mL
2 x 2 mL
Apo A1/Apo B Calibrator is prepared from human Apo A1/Apo B in
human serum.
Actual analyte concentrations for this lot of Apo A1/Apo B Calibrator
are listed in the Apo A1/Apo B Calibrator value sheet, packaged with
the calibrator. Verify that the lot number listed on each calibrator bottle
agrees with the lot number printed on the value sheet.
When converting the units for an assay, the following items must be
edited, if applicable, using the appropriate conversion factor.
• Calibrator Concentration
• Panic/Extreme Range
• Qualitative/Interpretation Range
• Retest rules ranges (ARCHITECT c Systems Only)
• Constituent assay ranges for calculated assays (ARCHITECT c Systems Only)
• Min and Max Fields (AEROSET System Only)
MATERIALS REQUIRED BUT NOT PROVIDED
• Volumetric Pipette (1 mL)
• Type II Water
STANDARDIZATION
Apo A1/Apo B Calibrator is prepared from human Apo A1/Apo B
fractions in human serum. The calibrator value assignment is determined
using a reference method calibrated against WHO/IFCC/CDC
Apolipoprotein Reference Material (Apo A1 SP1-01, Apo B SP3-07).
WARNINGS AND PRECAUTIONS
Precautions for Users
1. For in vitro diagnostic use.
2. Do not use components beyond the expiration date.
3. Do not mix components from different kit lot numbers.
4. CAUTION: Apo A1/Apo B Calibrator contains human sourced and/or
potentially infectious components. Components sourced from human
blood have been tested and found to be nonreactive for HBsAg,
anti-HCV, and anti-HIV-1/HIV-2. No known test method can offer
complete assurance that products derived from human sources or
inactivated microorganisms will not transmit infection. Therefore,
all human sourced materials should be considered potentially
infectious. It is recommended that this calibrator and human
specimens be handled in accordance with the OSHA Standard on
1
Bloodborne Pathogens. Biosafety Level 2
3,4
biosafety practices should be used for materials that contain or are
suspected of containing infectious agents.
5. Apo A1/Apo B Calibrator and Diluent contain sodium azide. Contact
with acids liberates very toxic gas. This material and its container
must be disposed of in a safe way.
NOTE: Refer to Section 8 of the instrument-specific operations
manual for proper handling and disposal of products containing
sodium azide.
TM
and the AEROSET System.
•Reference Range
•Linear Range
•Expected QC Values
2
or other appropriate
PREPARATION OF CALIBRATOR
The lyophilized serum calibrator should be reconstituted as follows:
1. Add 1.0 mL of Type II water.
2. Close bottle and let stand for at least 10 minutes.
3. Dissolve contents of bottle by swirling gently, avoiding the formation
of foam. Do not shake.
4. Prepare four calibrator dilutions using the reconstituted calibrator
and diluent according to the following protocol:
Dilution 10%
Dissolved Serum (µL) 50
Diluent (µL) 450
Total (µL) 500
INSTRUCTIONS FOR USE
Calibration is performed by running a water blank (Type II water is
provided by the instrument) and the manually prepared Apo A1/Apo B
Calibrator dilutions. Refer to the PREPARATION OF CALIBRATOR section
of this package insert.
1. Verify that the correct calibrator value (assigned value of the
reconstituted serum calibrator multiplied by the dilution) has been
entered into the calibration file.
2. Ensure dilutions are well mixed.
3. Place an appropriate amount of each calibrator in a separate sample
cup and place in the assigned positions.
4. Return any unused reconstituted stock solution to refrigerated
storage immediately after use.
5. Perform calibration as indicated in the instrument-specific operations
manual.
STORAGE AND STABILITY
Store unopened Apo A1/Apo B Calibrator at 2 to 8°C.
Unopened calibrator is stable until the expiration date when stored
at 2 to 8°C.
Reconstituted calibrator is stable for 2 weeks when stored tightly
capped at 2 to 8°C.
Diluted calibrators are stable for 1 day when stored tightly capped
at 2 to 8°C.
INDICATIONS OF INSTABILITY OR DETERIORATION
Instability or deterioration should be suspected if there are visible signs
of leakage, extreme turbidity, microbial growth, or if calibration does not
meet the appropriate reagent package insert and/or instrument-specific
operations manual criteria.
LIMITATIONS OF THE PROCEDURE
Accurate and reproducible results are dependent upon properly
functioning instruments and reagents, storage of product as directed,
and good laboratory technique.
BIBLIOGRAPHY
1. US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030. Occupational Exposure to
Bloodborne Pathogens.
2. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories. HHS Publication (CDC),
4th ed. Washington, DC: US Government Printing Office, May 1999.
3. World Health Organization. Laboratory Biosafety Manual. Geneva:
World Health Organization, 2004.
4. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved
Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and
Laboratory Standards Institute, 2005.
TRADEMARKS
AEROSET and ARCHITECT are registered trademarks of Abbott
Laboratories.
c System is a trademark of Abbott Laboratories.
All other trademarks, brands, product names, and trade names are the
property of their respective companies.
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