Siemens IMMULITE 2000 Manual De Instrucciones página 2

IMMULITE
English
Intended Use: For in vitro diagnostic use
®
with the IMMULITE 2000 Systems
Analyzers — for the quantitative
measurement of estradiol
(estradiol-17β, E2) in serum, as an aid in
the differential diagnosis of amenorrhea,
and monitoring of ovulation induction with
and without stimulation in assisted
reproductive technology (ART).
Catalog Number: L2KE22 (200 tests),
L2KE26 (600 tests)
Test Code: E2 Color: Dark Pink
Summary and Explanation
Estradiol is a steroid hormone with a
molecular mass of 272.3 daltons which
circulates predominantly protein-bound. In
addition to estradiol, other natural steroidal
estrogens include estrone, estriol and their
conjugates. Estrogens are hormones
secreted principally by the ovarian follicles
and also by the adrenals, corpus luteum,
placenta and, in males, by the testes.
Estrogenic hormones are secreted at
varying rates during the menstrual cycle
throughout the period of ovarian activity.
The gonadotropins of the anterior pituitary
regulate secretion of the ovarian hormones,
estradiol and progesterone; hypothalamic
control of pituitary gonadotropin production
is in turn regulated by plasma
concentrations of the estrogens and
progesterone. This complex feedback
system results in the cyclic phenomenon of
ovulation and menstruation.
During pregnancy, the placenta becomes
the main source of estrogens. At the
menopause, ovarian secretion of estrogens
declines at varying rates.
Principle of the Procedure
IMMULITE 2000 Estradiol is a
solid-phase, enzyme-labeled
chemiluminescent competitive
immunoassay. The solid phase (bead) is
coated with polyclonal rabbit anti-estradiol
antibody. The liquid phase consists of
alkaline phosphatase (bovine calf
intestine) conjugated to estradiol.
2
®
2000 Estradiol
The patient sample and the reagent are
incubated together with the coated bead
for 60 minutes. During this time, estradiol
in the sample competes with enzyme
conjugated estradiol in the reagent for a
limited number of antibody binding sites
on the bead. Unbound patient sample and
enzyme conjugate are then removed by
centrifugal washes. Finally,
chemiluminescent substrate is added to
the reaction tube containing the bead and
the signal is generated in proportion to the
bound enzyme.
Incubation Cycles: 1 × 60 minutes
Time to First Result: 65 minutes
Specimen Collection
Lipemia may interfere with the assay. 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 Estradiol 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 serum
Storage: 2 days at 2–8°C, or
18
2 months at –20°C.
IMMULITE 2000 Estradiol (PIL2KE2-28, 2016-05-23)