Siemens IMMULITE 2000 C-Peptide Mode D'emploi page 4

C-Peptide Reagent Wedge (L2PEPA2)
With barcode. 11.5 mL alkaline
phosphatase (bovine calf intestine)
conjugated to monoclonal murine
anti-C-peptide in buffer. Stable at 2–8°C
until expiration date.
L2KPEP2: 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.
C-Peptide Adjustors (LPEPL, LPEPH)
Two vials (Low and High) of lyophilized
C-peptide in buffered human albumin, with
preservative. Reconstitute each vial with
4.0 mL distilled or deionized water. Let
stand for 30 minutes. Mix by gentle
swirling or inversion until the lyophilized
material is fully dissolved. After
reconstitution, aliquot and freeze. Stable
at –20°C for 6 months. Discard aliquots
after use.
L2KPEP2: 1 set.
Before making an adjustment, place the
appropriate Aliquot Labels (supplied with
the kit) on test tubes so that the barcodes
can be read by the on-board reader.
Kit Components Supplied
Separately
C-Peptide Sample Diluent (L2PEZ)
For the on-board dilution of urine samples
and high serum/plasma samples. 25 mL of
concentrated (ready-to-use), processed,
C-peptide-free buffered human albumin,
with preservative. Stable at 2–8°C for
30 days after opening, or for 6 months
(aliquotted) at –20°C.
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 barcode can be read by
the on-board reader.
L2PEZ: 3 labels.
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
PECM: Tri-level C-Peptide Control Module
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Also Required
Distilled or deionized water; test tubes;
controls.
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: Use controls
or serum pools with at least two levels
(low and high) of C-peptide.
Expected Values
Serum and Heparinized Plasma:
Serum samples were collected from 136
fasting laboratory volunteers and analyzed
by the IMMULITE 2000 C-Peptide
procedure yielding a median of 2.2 ng/mL
(0.7 nmol/L; 728 pmol/L) and a
nonparametric central 95% reference
range of
0.9 – 7.1 ng/mL
(0.3 – 2.4 nmol/L; 298 – 2,350 pmol/L)
Urine: 24-hour urine samples were
collected from 82 apparently healthy
volunteers and analyzed by the
IMMULITE 2000 C-Peptide procedure
yielding a mean ± SD of 77 ± 59 µg/day,
with a range of 3.6 to 253 µg/day,
representing the central 95% of the
observations.
Consider these limits as guidelines only.
Each laboratory should establish its own
reference ranges.
Limitations
Because metabolism of C-peptide differs
from that of insulin, C-peptide levels are at
best a semi-quantitative index of insulin
secretion. The half-life of C-peptide in
plasma has been estimated as
approximately 30 minutes, compared to
approximately 5 minutes for insulin.
Because of the difference in half-life,
C-peptide circulates in plasma at a level
IMMULITE 2000 C-Peptide (PIL2KPEP-9, 2018-03-15)