INTENDED USE
The Ceruloplasmin reagent is a quantitative turbidimetric test for the
measurement of Ceruloplasmin in human serum or plasma.
PRINCIPLE OF THE METHOD
Anti-human Ceruloplasmin antibodies when mixed with samples containing
Ceruloplasmin, form insoluble complexes. These complexes cause an
absorbance change, dependent upon the Ceruloplasmin concentration of the
patient sample, that can be quantified by comparison from a calibrator of known
Ceruloplasmin concentration.
CLINICAL SIGNIFICANCE
Caeruloplasmin is an α2-globulin that contains approximately 95% of total
serum copper. Each molecule of caeruloplasmin contain six to eight copper
atoms. The high content of copper ions gives caeruloplasmin a blue color.
Caeruloplasmin can also bind, and possible transport, other cations such as
magnesium. The molecule of caeruloplasmin has a single polypeptide chain
and carbohydrate, and results a molecular mass of 132 kD. Caeruloplasmin is
synthesized primarily by the hepatic cells and small quantities by macrophages
and lymphocytes.
Caeruloplasmin is most often quantified as a screening test for Wilson’s
disease. However, it is important to realize that several other factors, including
diet, hormone levels, and other genetic disorders, can influence plasma levels.
Synthesis of caeruluplasmin is increased modestly in the acute-phase
response, peaking at 4 to 20 days after a single, cute insult. Synthesis is also
stimulated by estrogens, and during pregnancy.
Low plasma caeruloplasmin levels are due to lack of incorporation of Cu2+ into
the molecule during synthesis. The causes are, the dietary insufficiency
(including malabsorption), inability to release Cu2+ from gastrointestinal
epithelium into circulation, or inability to insert Cu2+ into developing
caeruloplasmin molecule. Levels may also be low in blood loss or
gastrointestinal or renal proteinlosing syndromes.
STORAGE AND STABILITY
All the components of the kit are stable until the expiration date on the label
when stored tightly closed at 2-8ºC and contaminations are prevented during
their use. Do not use reagents over the expiration date.
Reagent deterioration: The presence of particles and turbidity. Do not use.
Do not freeze; frozen Antibody or Diluent could change the funcitionality of the
test.
ADDITIONAL EQUIPMENT
- Thermostatic bath at 37ºC.
- SPIN 800 Autoanalyzer.
SAMPLES
Fresh serum or plasma. EDTA or heparin should be used as anticoagulant.
Stable 7 days at 2-8ºC or 3 months at –20ºC.
The samples with presence of fibrin should be centrifuged.
Do not use highly hemolized or lipemic samples.
REFERENCE VALUES
Between 15 – 60 mg/dL. Each laboratory should establish its own reference
range.
QUALITY CONTROL
Control sera are recommended to monitor the performance of manual and
automated assay procedures. Spinreact PROT CONTROL (Cod.:1102004).
Each laboratory should establish its own Quality Control scheme and corrective
actions if controls do not meet the acceptable tolerances.
