Abbott ARCHITECT Bedienungsanleitung

Iron/Magnesium Calibrator
1E69-03
This package insert contains information for the use of Iron/Magnesium
Calibrator on the ARCHITECT c Systems™ and the AEROSET System.
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 Iron and Magnesium assays.
CONTENTS / MATERIALS PROVIDED
1E69 Iron/Magnesium Calibrator,
Iron/Magnesium Calibrator is prepared in an aqueous solution.
Preservatives are also present.
Actual analyte concentrations for this lot of Iron/Magnesium Calibrator
are listed in the Iron/Magnesium Calibrator value sheet, packaged with
the calibrator. Verify that the lot number listed on each calibrator carton
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)
STANDARDIZATION
Using gravimetric methods, a stock solution of ACS grade iron and
magnesium is prepared in an aqueous solution. The Iron/Magnesium
Calibrator is standardized as described in the table below.
Analyte Reference Material*
Iron NIST SRM937
Magnesium NIST SRM956b
*NIST - National Institue of Standards and Technology
SRM - Standard Reference Materials
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.
PREPARATION OF CALIBRATOR
Iron/Magnesium Calibrator requires no preparation prior to use.
3 x 5 mL
• Reference Range
• Linear Range
• Expected QC Values
Reference Method
Gravimetric
ID-ICP-MS
INSTRUCTIONS FOR USE
Calibration is performed by running a water blank and Iron/Magnesium
Calibrator set. Water for the blank is provided by the instrument.
1. Verify that the correct calibrator values have been entered into
the calibration file.
2. Allow calibrator to come to room temperature.
3. Mix bottle several times by gentle inversion.
4. Open the bottle, place an appropriate amount of each calibrator
in a separate sample cup, and place in the assigned positions.
5. Cap bottle tightly and return to refrigerated storage immediately after
use.
6. Perform the calibration as indicated in the instrument-specific
operations manual.
STORAGE AND STABILITY
Store unopened Iron/Magnesium Calibrator at 2 to 8°C.
Unopened calibrator is stable until the expiration date when stored
at 2 to 8°C.
Opened calibrator is stable for 30 days when stored at 2 to 8°C and
kept tightly capped.
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.
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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