Warnings And Precautions; Materials Supplied - Siemens IMMULITE 2000 Manual De Instrucciones

Dilution: It is recommended that patient
samples yielding results greater than
1200 pg/mL be diluted and reassayed. A
clinically relevant result is obtained without
dilution but the most accurate value is
obtained when tested on the sensitive
portion of the curve.

Warnings and Precautions

For in vitro diagnostic use.
CAUTION! POTENTIAL
BIOHAZARD
Contains human source
material. Each donation of
human blood or blood
component was tested by
FDA-approved methods for the
presence of antibodies to human
immunodeficiency virus type 1
(HIV-1) and type 2 (HIV-2) as
well as for hepatitis B surface
antigen (HBsAg) and antibody to
hepatitis C virus (HCV). The test
results were negative (not
repeatedly reactive). No test
offers complete assurance that
these or other infectious agents
are absent; this material should
be handled using good
laboratory practices and
universal precautions.
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.
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.
IMMULITE 2000 Estradiol (PIL2KE2-28, 2016-05-23)

Materials Supplied

Components are a matched set. Labels on
the inside box are needed for the assay.
Estradiol Bead Pack (L2E212)
With barcode. 200 beads, coated with
polyclonal rabbit anti-estradiol. Stable at
2–8°C until expiration date.
L2KE22: 1 pack L2KE26: 3 packs
Estradiol Reagent Wedge (L2E2A2)
With barcode. 11.5 mL alkaline
phosphatase (bovine calf intestine)
conjugated to estradiol, in buffer with
preservative. Stable at 2–8°C until
expiration date.
L2KE22: 1 wedge L2KE26: 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.
Estradiol Adjustors (LE2L, LE2H)
Two vials (Low and High), 2 mL each, of
estradiol in processed human serum, with
preservative. Stable at 2–8°C for 30 days
after opening, or for 6 months (aliquotted)
20-22
at –20°C.
L2KE22: 1 set L2KE26: 2 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.
Kit Components Supplied
Separately
Estradiol Sample Diluent (L2E2Z)
For the on-board dilution of patient
samples. One vial containing 25 mL of
concentrated (ready-to-use) processed
human serum (with preservative)
containing undetectable to low levels of
estradiol. Stable at 2–8°C for 30 days after
opening, or for 6 months (aliquotted) at
–20°C.
L2E2Z: 25 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.
L2E2Z: 3 labels
3