Siemens IMMULITE 1000 Cortisol Manual Del Usuario página 2

®
IMMULITE /IMMULITE 1000 Cortisol
English
Intended Use: For in vitro diagnostic use
®
with the IMMULITE and IMMULITE 1000
Analyzers — for the quantitative
measurement of cortisol (hydrocortisone,
Compound F) in serum, as an aid in the
clinical assessment of adrenal status.
Catalog Number: LKCO1 (100 tests)
Test Code: COR Color: Dark Pink
Summary and Explanation
Cortisol (hydrocortisone, Compound F) is
the most abundant circulating steroid and
the major glucocorticoid secreted by the
adrenal cortex. Physiologically effective in
anti-inflammatory activity and blood
pressure maintenance, cortisol is also
involved in gluconeogenesis, calcium
absorption and the secretion of gastric
acid and pepsin.
As an indicator of adrenocortical function,
measurement of blood cortisol levels is
useful in the differential diagnosis of
Addison's and Cushing's disease,
hypopituitarism, and adrenal hyperplasia
4
and carcinoma.
A variety of stimulation and suppression
tests — ACTH Stimulation, ACTH
Reserve, Dexamethasone Suppression —
can supply supportive information on
adrenocorticol function.
Anomalous cortisol concentrations have
been shown to exist in patients with acute
infections, severe pain, diabetes mellitus
or heart failure, and in women either
pregnant or on estrogen therapy. In
addition, certain virilizing syndromes and
iatrogenic conditions raise other naturally
occurring steroid levels to high
(nonphysiologic) concentrations that may
interfere with assaying cortisol directly,
unless a highly specific antiserum is used.
Principle of the Procedure
IMMULITE/IMMULITE 1000 Cortisol is a
solid-phase, competitive
chemiluminescent enzyme immunoassay.
Incubation Cycles: 1 × 30 minutes
2
4,5,6
IMMULITE/IMMULITE 1000 Cortisol (PILKCO-16, 2016-02-08)
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/IMMULITE 1000 Cortisol has
not been tested with all possible variations
of tube types.
Volume Required: 10 µL serum (Sample
cup must contain at least 100 µL more
than the total volume required.)
Storage: 7 days at 2–8°C or
8
3 months 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
11-13
precautions.