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.
- MINDRAY BS-120 / BS-200E 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.
