Siemens IMMULITE 2000 Mode D'emploi page 3

B surface antigen; and for antibodies to
hepatitis C.
Sodium azide, at concentrations less than
0.1 g/dL, has been added as a
preservative. On disposal, flush with large
volumes of water to prevent the buildup of
potentially explosive metal azides in lead
and copper plumbing.
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.
HCG Bead Pack (L2CG12)
With barcode. 200 beads, coated with
monoclonal murine anti-HCG.
Stable at 2–8°C until expiration date.
L2KCG2: 1 pack.
L2KCG6: 3 packs.
L2KCG3M: 15 packs.
HCG Reagent Wedge (L2CGA2)
With barcode. 11.5 mL of alkaline
phosphatase (bovine calf intestine)
conjugated to polyclonal ovine anti-HCG,
in buffer, with preservative. Stable at
2–8°C until expiration date.
L2KCG2: 1 wedge.
L2KCG6: 3 wedges.
L2KCG3M: 15 wedges.
Before use, tear off the top of the label at
the perforation, 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.
HCG Adjustors (LCGL, LCGH)
Two vials (Low and High) 2 mL each, of
HCG in an HCG-free human serum matrix,
with preservative. Stable at 2–8°C for
30 days after opening, or for 6 months
(aliquotted) at –20°C.
L2KCG2: 1 set.
L2KCG6: 2 sets.
L2KCG3M: 3 sets.
Before running adjustors, place the
appropriate Aliquot Labels (supplied with
the kit) on test tubes, so that the barcodes
can be read by the on-board reader.
IMMULITE 2000 HCG (PIL2KCG-26, 2009-04-17)
Kit Components
Supplied Separately
HCG Sample Diluent (L2CGZ)
For the on-board dilution of high samples.
50 mL of concentrated (ready-to-use)
HCG-free human serum, with barcode
labels. Storage: 30 days (after opening) at
2–8°C or 6 months (aliquotted) at –20°C.
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.
L2CGZ: 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
CON6: Tri-level, multi-constituent control
LCGCM: HCG High Level 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 Operator's Manual.
See the IMMULITE 2000 Operator's Manual
for: preparation, setup, dilutions, adjustment,
assay and quality control procedures.
Recommended Adjustment Interval:
4 weeks.
Quality Control Samples: Use controls
or serum pools with at least two levels
(low and high) of HCG.
Qualitative Procedure for Urine
The qualitative procedure allows for
determining whether a urine sample has
an HCG concentration above or below
30 mIU/mL, within the precision of the
assay. Concentrations above this cutoff
may be considered positive for pregnancy
providing other causes of high HCG levels
have been ruled out, viz. trophoblastic and
4,9,10,15
nontrophoblastic neoplasia.
Concentrations below this cutoff are to be
expected for samples from individuals who
are not pregnant, as well as for women in
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