Summary And Explanation; Warnings And Precautions - Siemens HCG IMMULITE 2000 Manual Del Usuario

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IMMULITE 2000 HCG
English
Intended Use: For in vitro diagnostic use
with the IMMULITE 2000 Analyzer — for
the quantitative measurement of human
chorionic gonadotropin (HCG) in serum,
and for strictly qualitative determinations in
urine, as an aid in the detection of
pregnancy.
Catalog Number: L2KCG2 (200 tests),
L2KCG6 (600 tests),
L2KCG3M (3000 tests)
Test Code: HCG Color: Orange
CDC Analyte Identifier Code: 2502
CDC Test System Identifier Code: 10418
CLIA Complexity Category: Moderate

Summary and Explanation

Human chorionic gonadotropin (HCG) is a
two-chain glycoprotein hormone (MW
~37,000) normally found in blood and
urine only during pregnancy. It is secreted
by placental tissue, beginning with the
primitive trophoblast, almost from the time
of implantation, and serves to support the
corpus luteum during the early weeks of
pregnancy.
According to the literature, circulating
HCG typically reaches levels of
approximately 2,000 mIU/mL one month
after conception. A peak level on the order
of 100,000 mIU/mL is attained in the third
month, after which a gradual decline sets
in. Following delivery, the HCG level
normally undergoes rapid descent,
reaching nonpregnant concentrations
(usually less than 5 mIU/mL) some two
weeks later.
Ectopic pregnancies and pregnancies
terminating in spontaneous abortion tend
to have lower than normal circulating HCG
levels, while somewhat higher levels are
often seen in multiple pregnancies.
Principle of the Procedure
IMMULITE 2000 HCG is a solid-phase,
two-site chemiluminescent immunometric
assay.
Incubation Cycles: 1 × 30 minutes.
2
Time to First Result: 35 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 HCG 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: 5 µL serum or urine.
Urine: A freshly voided, first-morning
22
specimen is preferred. Centrifuging or
filtering (Whatman #1) is recommended to
clear cloudy samples.
Storage
Serum: 7 days at 2–8°C, or
18
2 months at –20°C.
22
Urine: 48 hours at 2–8°C, or
13
at –20°C until assayed.

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
IMMULITE 2000 HCG (PIL2KCG-26, 2009-04-17)