Siemens IMMULITE 2000 AntiCPP IgG Mode D'emploi page 3

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 Anti-CCP IgG 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 plasma
(EDTA and Lithium Heparin). After
automatic predilution, 10 µL of diluted
sample is used for the immunoassay.
Automatic Predilution Factor: 40
Storage: Serum for 2 days at room
temperature, 7 days at 2–8°C; or
at or below –20°C up to 12 months.
Plasma for 2 days at room temperature,
7 days at 2–8°C; or at or below –20°C
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up to 8 months.
When both serum and plasma samples
were subject to 4 freeze/thaw cycles, no
clinically significant differences were
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observed.
Thoroughly mix thawed specimens and
centrifuge.
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.
IMMULITE 2000 Anti-CCP IgG (PIL2KPI-15, 2022-02)
H302 + H312,
H411
P280, P273,
P301 + P312,
P302 + P312,
P501
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Reagents: Store at 2–8°C. Dispose of in
accordance with applicable laws.
Caution: This device contains material of
animal origin and should be handled as a
potential carrier and transmitter of
disease.
Safety data sheets (MSDS/SDS) available
on siemens-healthineers.com.
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.
13-15
Materials Supplied
Components are a matched set. Labels on
the inside box are needed for the assay.
Harmful if
Warning!
swallowed or in contact
with skin. Toxic to aquatic
life with long lasting
effects.
Wear protective gloves/
protective clothing/eye
protection/face protection.
Avoid release to the
environment. IF
SWALLOWED: Call a
POISON CENTER or
doctor/physician if you
feel unwell. IF ON SKIN:
Call a POISON CENTER
or doctor/physician if you
feel unwell. Dispose of
contents and container in
accordance with all local,
regional, and national
regulations.
Contains: sodium azide,
2-methyl-2H-isothiazol-
3-one; Anti-CCP IgG
Adjustors
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