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.
Total IgE Bead Pack (L2IE12)
With barcode. 200 beads, coated with
monoclonal mouse anti-IgE. Stable at
2–8°C until expiration date.
L2KIE2: 1 pack. L2KIE6: 3 packs.
Total IgE Reagent Wedge (L2IEA2)
With barcode. 11.5 mL alkaline
phosphatase (bovine calf intestine)
conjugated to polyclonal goat anti-IgE
antibody in buffer, with preservative.
Stable at 2–8°C until expiration date.
L2KIE2: 1 wedge. L2KIE6: 3 wedges.
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.
Total IgE Adjustors (LIEL, LIEH)
Two vials (Low and High), 2.5 mL each, of
IgE in a nonhuman serum/buffer matrix,
with preservative. Stable at 2–8°C for 30
days after opening, or for 6 months
(aliquotted) at –20°C.
L2KIE2: 1 set. L2KIE6: 2 sets.
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 on-board dilution of 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. Dispose
IMMULITE 2000 Total IgE (PIL2KIE-18, 2006-12-29)
of in accordance with applicable laws.
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
IECM: Bi-level, human serum-based
control module containing IgE.
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:
2 weeks.
Quality Control Samples: Use controls
or serum pools with at least two levels
(low and high) of total IgE.
Expected Values
Based on its relationship to IMMULITE
Total IgE (see Method Comparison), the
assay can be expected to have essentially
the same reference ranges for nonatopic
individuals.
Age
Median
(years)
(IU/mL)
0–1
1–2
2–3
3–9
Adult
95%ile
(IU/mL)
6.6
29
10.1
49
12.9
45
14.4
52
20.4
87
3