Siemens IMMULITE 2000 Total IgE Manual Del Usuario página 2

IMMULITE
English
Intended Use: For in vitro diagnostic use
with the IMMULITE 2000 Analyzer — for
the quantitative measurement of
immunoglobulin type E (IgE) in serum.
Catalog Number: L2KIE2 (200 tests),
L2KIE6 (600 tests)
Test Code: TIE Color: Violet
Summary and Explanation
Modern laboratory methods for allergy
testing are based on the comparatively
recent discovery that many allergies are
mediated by immunoglobulins of the IgE
class acting as points of contact between
the allergen and specialized cells.
The IgE molecules, which have a
molecular mass of approximately 200,000,
bind to the surface of mast cells and
basophilic granulocytes.
binding of allergens to cell-bound IgE
causes these cells to release histamines
and other vasoactive substances, thereby
initiating the events which we recognize as
an allergic reaction.
In deciding on a course of therapy, it is
important to distinguish between IgE-
mediated and non-IgE-mediated
4,7
reactions. Measurement of the total
circulating IgE level, in conjunction with
other supporting diagnostic information,
can aid in making this diagnosis. The
supporting information should include
appropriate tests for allergen-specific IgE.
Measurement of the total circulating IgE
level may also be of value in the early
detection of allergy in infants, and as a
means for predicting future atopic
4,6,7
manifestations.
IgE levels normally show a slow increase
during childhood, reaching adult levels in
the second decade of life.
the total IgE level increases with the
number of allergies which a person has
and with the amount of exposure to
5,7
relevant allergens.
Significant elevations may be encountered
not only in sensitized individuals, but also
in cases of IgE myeloma, pulmonary
2
®
2000 Total IgE
4,5,7,9,10
2,3
Subsequent
10
1,8
In general,
aspergillosis, and during the active stage
of parasitic infestations.
Principle of the Procedure
IMMULITE 2000 Total IgE is a solid-
phase, chemiluminescent immunometric
assay.
Incubation Cycles: 1 × 30 minutes.
Specimen Collection
The use of an ultracentrifuge is
recommended to clear lipemic samples.
Hemolyzed samples may indicate
mistreatment of a specimen before receipt
by the laboratory; hence the results should
be interpreted with caution.
Centrifuging serum samples before a
complete clot forms may result in the
presence of fibrin. To prevent erroneous
results due to the presence of fibrin,
ensure that complete clot formation has
taken place prior to centrifugation of
samples. Some samples, particularly
those from patients receiving
anticoagulant therapy, may require
increased clotting time.
Blood collection tubes from different
manufacturers may yield differing values,
depending on materials and additives,
including gel or physical barriers, clot
activators and/or anticoagulants.
IMMULITE 2000 Total IgE has not been
tested with all possible variations of tube
types.
Volume Required: 5 µL serum.
Storage: 3 days at 2–8°C,
6 months at –20°C.
Warnings and Precautions
For in vitro diagnostic use.
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.
IMMULITE 2000 Total IgE (PIL2KIE-18, 2006-12-29)
4,5,7,9
13,15
or
15