Siemens IMMULITE 2000 AntiCPP IgG Mode D'emploi page 2

IMMULITE
English
Intended Use: The IMMULITE
Anti-CCP IgG assay is an in vitro
diagnostic immunoassay for the semi-
quantitative determination of the IgG class
of autoantibodies specific to cyclic
citrullinated peptide (CCP) in human
serum (including Serum Separator Tubes)
or plasma (EDTA or lithium heparin) on
the IMMULITE 2000 Systems Analyzers.
Detection of anti-CCP antibodies is used
as an aid in the diagnosis of Rheumatoid
Arthritis (RA) and should be used in
conjunction with other clinical information.
Autoantibody levels represent one
parameter in a multi-criteria diagnostic
process, encompassing both clinical and
laboratory-based assessments.
Catalog Number: L2KPI2 (200 tests)
Test Code: CCP Color: Red
Summary and Explanation
Anti-cyclic citrullinated peptide (anti-CCP)
IgG is a specific marker for rheumatoid
arthritis, a disease that affects one percent
of the population worldwide.
show that the presence of anti-CCP IgG
can be detected in the early stages of
rheumatoid arthritis 2–4 and that it is
indicative of a more progressive form of
4
the disease.
The epitope for CCP is derived from a
precursor protein belonging to filaggrin, a
group of filament aggregating proteins.
During the final stage of epidermal cell
differentiation, arginine residues in
filaggrin are deiminated to citrulline.
Autoantibodies targeting citrulline-
containing peptide sequences in the major
antigenic epitopes are markers for
rheumatoid arthritis in affected patients.
Various studies have shown between
41–89% sensitivity and 89–99% specificity
of anti-CCP for RA diagnosis.
anti-cyclic citrullinated protein antibodies
(ACPA) is more specific than Rheumatoid
Factor (RF), it is used to distinguish
various causes of arthritis.
2
®
2000 Anti-CCP IgG
®
2000
1 Studies
5
5,6
7
Given that
8
Principle of the Procedure
IMMULITE 2000 Anti-CCP IgG is a solid-
phase, two-cycle sequential
chemiluminescent immunometric assay.
The solid phase, a polystyrene bead, is
coated with a cyclic citrullinated peptide
(CCP) antigen. The liquid phase consists
of two reagents: 1) protein-based buffer
and 2) alkaline phosphatase (bovine calf
intestine) conjugated to a monoclonal
murine anti-human IgG antibody in buffer.
In the first cycle, the patient sample and
the buffer are incubated together with the
coated bead for 30 minutes. During this
time, human IgG in the sample binds to
CCP on the bead. Unbound sample is
then removed by centrifugal washes.
In the second cycle, the enzyme-
conjugated monoclonal murine anti-
human IgG is added to the original
reaction tube for additional 30 minutes
incubation. The enzyme conjugated
monoclonal murine anti-human IgG
antibody binds to immobilized anti-CCP
IgG on the bead. The unbound enzyme
conjugate is 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: 2 × 30 minutes
Time to First Result: 65 minutes
Specimen Collection
The use of an ultracentrifuge is
recommended to clear lipemic samples.
Hemolyzed or grossly contaminated
samples may give erroneous results.
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.
IMMULITE 2000 Anti-CCP IgG (PIL2KPI-15, 2022-02)