Siemens IMMULITE 2000 AntiCPP IgG Mode D'emploi page 4

Anti-CCP IgG Bead Pack (L2PI12)
With barcode. 200 beads, coated with
cyclic citrullinated peptide (CCP) antigen.
Stable at 2–8°C until expiration date.
L2KPI2: 1 pack
Anti-CCP IgG Reagent Wedge (L2PIA2)
With barcode. 11.5 mL protein-buffer
matrix and 11.5 mL alkaline phosphatase
(bovine calf intestine) conjugated to a
monoclonal murine anti-human IgG
antibody in buffer. Stable at 2–8°C until
expiration date.
L2KPI2: 1 wedge
Before use, tear off the top of the label at
the perforations, without damaging the
barcode. Remove the foil seal from the top
of wedge; snap the sliding cover down into
the ramps on the reagent lid.
Anti-CCP IgG Adjustors (LPIL, LPIH)
Two vials (Low and High) of
lyophilized human serum with IgG reactive
to CCP, in buffer with preservative. At
least 30 minutes before use reconstitute
each vial with 2.0 mL distilled or deionized
water. Mix by gentle swirling or inversion
until the lyophilized material is fully
dissolved. (No further dilution is required.)
Stable at 2–8°C for 30 days after
reconstitution or for 12 months (aliquotted)
at –20°C.
L2KPI2: 1 set
Anti-CCP IgG Controls (LPIC1, LPIC2)
Two vials containing 2 mL each. LPIC1
(Negative Control): human serum
nonreactive to anti-CCP IgG, with
preservative. LPIC2 (Positive Control):
human serum with IgG reactive to CCP,
with preservative. Stable at 2–8°C for
30 days after opening or for 12 months
(aliquotted) at –20°C.
L2KPI2: 1 set
For the current control ranges in U/mL,
please refer to the control insert.
Aliquot Labels with barcodes are supplied
with the kit, for use with the Adjustors and
Controls. Before use, place the
appropriate Aliquot Labels on test tubes,
so the barcodes can be read by the
barcode reader on the IMMULITE 2000.
Autoantibody Sample Diluent (L2A1Z)
For the on-board dilution of patient
samples and controls. 50 mL concentrated
(ready-to-use) protein/buffer matrix. Stable
4
at 2–8°C for 30 days after opening or for
6 months (aliquotted) at –20°C.
L2KPI2: 1 vial
Barcode labels are provided for use with
the diluent. Before use, place an
appropriate label on a 16 × 100 mm test
tube, so that the barcodes can be read by
the on-board reader.
L2KPI2: 3 labels
Kit Components
Supplied Separately
L2SUBM: Chemiluminescent Substrate
L2PWSM: Probe Wash
L2KPM: Probe Cleaning Kit
LRXT: Reaction Tubes (disposable)
L2ZT: 250 Sample Diluent Test Tubes
(16 × 100 mm)
L2ZC: 250 Sample Diluent Tube Caps
Also Required
Distilled or deionized water; test tubes.
Assay Procedure
Note that for optimal performance, it is
important to perform all routine
maintenance procedures as defined in the
IMMULITE 2000 Systems Operator's
Manual.
See the IMMULITE 2000 Systems
Operator's Manual for: preparation, setup,
dilutions, adjustment, assay and quality
control procedures.
Recommended Adjustment Interval:
2 weeks
Quality Control Samples: The controls
supplied with the kit should be used as
quality control material to monitor assay
performance.
Follow government regulations or
accreditation requirements for quality
control frequency.
Interpretation of Results
The cutoff of the IMMULITE 2000
Anti-CCP IgG assay was determined with
positive and negative patient samples by a
ROC analysis, with a balanced
consideration of sensitivity and specificity.
Reactive: A result greater than or equal to
4.00 U/mL is considered to be "reactive",
and indicates that anti-CCP IgG antibodies
were detected in the sample.
IMMULITE 2000 Anti-CCP IgG (PIL2KPI-15, 2022-02)