Warnings And Precautions; Materials Supplied - Siemens IMMULITE 2000 C-Peptide Mode D'emploi

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.
EDTA plasma and sodium fluoride plasma
are unsuitable for use.
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 C-Peptide 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.
Storage: Assay within 2-3 hours, or store
frozen at –20°C for 1 week.
Urine – Collection and Storage:
Collect a 24-hour urine, without
preservative, keeping the specimen
refrigerated at 2–8°C during collection.
Record the total volume of the collection
and retain a well-mixed aliquot for
analysis. Before assay, clear the sample
by centrifugation or filtration.
Storage: For longer storage, aliquot and
freeze: stable at –20°C for 30 days.
Dilution Factor: At least 5. Using a
dilution factor of 20 will bring normal urine
samples within the assay's reportable
range. (For urine samples, select 5 or 20
in the Dilution Factor window.)
Volume Required:
25 µL serum, plasma, or urine sample.

Warnings and Precautions

For in vitro diagnostic use.
IMMULITE 2000 C-Peptide (PIL2KPEP-9, 2018-03-15)
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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
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.
Sodium azide, at concentrations less than
0.1 g/dL, has been added as a
preservative. On disposal, flush with large
volumes of water to prevent the buildup of
potentially explosive metal azides in lead
and copper plumbing.
Chemiluminescent Substrate: Avoid
contamination and exposure to direct
sunlight. (See insert.)
Water: Use distilled or deionized water.

Materials Supplied

Components are a matched set. Labels on
the inside box are needed for the assay.
C-Peptide Bead Pack (L2PEP12)
With barcode. 200 beads, coated with
monoclonal murine anti-C-peptide. Stable
at 2–8°C until expiration date.
L2KPEP2: 1 pack.
15-17
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