Siemens IMMULITE 2000 Manuel D'instructions page 2

IMMULITE
English
Intended Use: For in vitro diagnostic use
®
with the IMMULITE 2000 Systems
Analyzers — for the quantitative
measurement of Δ 4
androstenedione in
-
human serum.
Catalog Numbers: L2KAO2 (200 tests)
Test Code: AND Color: Brown
Summary and Explanation
Δ 4
Androstenedione is a steroid which
-
serves as a major precursor for
testosterone and estrone.
interest derives from the fact that it is often
elevated in cases of abnormal hair growth
(hirsutism) and virilization.
Unlike the adrenal androgens
dehydroepiandrosterone and its sulfate,
circulating androstenedione originates
both from the adrenals and from the
ovaries. 1,12,13 Plasma levels increase
steadily from about the seventh year of
life, then gradually decline after the third
2,4,13
decade. Androstenedione exhibits a
diurnal variation, being highest in the
morning, and also a cyclical variation
during the menstrual cycle, being highest
1,5,14,15
near midcycle. During pregnancy,
there is an increase in the plasma level.
Principle of the Procedure
IMMULITE 2000 Androstenedione is a
solid-phase, competitive
chemiluminescent enzyme immunoassay.
Incubation Cycles: 1 × 60 minutes
Time to First Result: 65 minutes
Specimen Collection
Neither EDTA nor heparinized plasma is
recommended for use.
Lipemic, hemolyzed, icteric or grossly
contaminated samples may give
erroneous results. The use of an
ultracentrifuge is recommended to clear
lipemic samples.
Centrifuging serum samples before a
complete clot forms may result in the
presence of fibrin. To prevent erroneous
2
®
2000 Androstenedione
1,2,3
Its clinical
1,6,8-12
3,11
IMMULITE 2000 Androstenedione (PIL2KAO-23, 2021-04)
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
manufactures may yield differing values,
depending on tube materials and
additives, including gel or physical
barriers, clot activators and/or
anticoagulants. IMMULITE 2000
Androstenedione has not been tested with
all possible variations of tube types.
Consult the section on Alternate Sample
Types for details on tubes that have been
tested.
Volume Required: 25 µL of serum
Storage: 24 hours at 2–8°C or 2 months
(aliquotted) at –20°C.
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
17-19