Siemens IMMULITE 2000 Mode D'emploi page 3

Sample Types for details on tubes that
have been tested.
Volume Required: 75 µL serum or
heparinized plasma.
Storage: Stable 15 days at –20°C or
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longer at –70°C. Freeze immediately.
Warnings and Precautions
For in vitro diagnostic use.
CAUTION: This device contains material
of animal origin and should be handled as
a potential carrier and transmitter of
disease.
Reagents: Store at 2–8°C. Dispose of in
accordance with applicable laws.
Follow universal precautions, and handle
all components as if capable of
transmitting infectious agents. Source
materials derived from human blood were
tested and found nonreactive for syphilis;
for antibodies to HIV 1 and 2; for
hepatitis B surface antigen; and for
antibodies to hepatitis C.
Chemiluminescent Substrate: Avoid
contamination and exposure to direct
sunlight. (See insert.)
Water: Use distilled or deionized water.
Materials Supplied
Components are a matched set. Labels on
the inside box are needed for the assay.
Calcitonin Bead Pack (L2CL12)
With barcode. 200 beads, coated with
monoclonal murine anti-calcitonin. Stable
at 2–8°C until expiration date.
L2KCL2: 1 pack
Calcitonin Reagent Wedge (L2CLA2)
With barcode. 11.5 mL alkaline
phosphatase (bovine calf intestine)
conjugated to polyclonal goat
anti-calcitonin, in a protein buffer. Stable
at 2–8°C until expiration date.
L2KCL2: 1 wedge
Before use, tear off the top of the label at
the perforations, without damaging the
barcode. Remove the foil seal from the top
of wedge; snap the sliding cover down into
the ramps on the reagent lid.
Calcitonin Adjustors (LCLL, LCLH)
Two vials (Low and High) of lyophilized
calcitonin, in a protein/buffer matrix.
IMMULITE 2000 Calcitonin (PIL2KCL-18, 2018-03-15)
Reconstitute each vial with 3.0 mL distilled
or deionized water. Aliquot and freeze.
Stable at –20°C for 3 months after
reconstitution.
L2KCL2: 1 set
Before making an adjustment, place the
appropriate Aliquot Labels (supplied with
the kit) on test tubes so that the barcodes
can be read by the on-board reader.
Kit Components
Supplied Separately
Multi-Diluent 2 (L2M2Z, L2M2Z4)
For the on-board dilution of patient
samples. One vial, concentrated
(ready-to-use), nonhuman protein/buffer
matrix, with preservative.
Storage: 30 days (after opening) at 2–8°C
or 6 months (aliquotted) at –20°C.
L2M2Z: 25 mL L2M2Z4: 55 mL
Barcode labels are provided for use with
the diluent. Before use, place an
appropriate label on a 16 × 100 mm test
tube, so that the barcodes can be read by
the on-board reader.
L2M2Z: 3 labels L2M2Z4: 5 labels
L2SUBM: Chemiluminescent Substrate
L2PWSM: Probe Wash
L2KPM: Probe Cleaning Kit
LRXT: Reaction Tubes (disposable)
L2ZT: 250 Sample Diluent Test Tubes
(16 × 100 mm)
L2ZC: 250 Sample Diluent Tube Caps
LCLCM: Bi-level, protein/buffer-based
control module
Also Required
Distilled or deionized water; test tubes;
controls.
Assay Procedure
Note that for optimal performance, it is
important to perform all routine
maintenance procedures as defined in the
IMMULITE 2000 Systems Operator's
Manual.
See the IMMULITE 2000 Systems
Operator's Manual for: preparation, setup,
dilutions, adjustment, assay and quality
control procedures.
Recommended Adjustment Interval:
4 weeks
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