ferritina irma ct ref

IMMUNORADIOMETRIC ASSAY FOR QUANTITATIVE DETERMINATION OF FERRITIN IN HUMAN
SERUM.
FOR IN VITRO DIAGNOSTIC USE ONLY
CLINICAL APPLICATIONS
The Ferritin molecule consists of 24 protein subunits, each of them with molecular weight of 20 kDa.
Ferritin functions mainly as the intracellular site of iron storage (from which iron may be rapidly
mobilized), thereby protecting cells from the toxic effects of unbound iron. Most Ferritin in the body is
found in the liver cells as well as in the cells of the reticuloendothelial system of liver, spleen and bonemarrow.
Small amounts are also found in the heart, pancreas and kidneys. Small but significant amounts
of Ferritin are found in the human serum. The exact function of serum Ferritin is unknown but there is a
well established correlation between serum Ferritin and the body's iron stores. Serum Ferritin testing
thus represents the simplest and less invasive method in monitoring any iron store change in the body.
Ferritin serum levels are also affected by body changes due to age as well as sex. Average Ferritin
levels in normal subjects (slightly higher at birth) tend to decrease during childhood, until the age of
puberty is reached. From then on, a progressive increase of the body iron stores is observed in males,
with a proportional rise in serum Ferritin. Females in the reproductive age instead tend to have lower
amounts with more stable values. A Ferritin rise is only observed after menopause.
Ferritin levels below normal ranges clearly indicate a lack of iron and allow to differentiate iron deficiency
anemia from other forms of anemia. An iron overload, either due to an increase in iron uptake (as in
idiopathic hemochromatosis) or else due to multiple transfusions, causes serum Ferritin to rise, often
beyond normal ranges. High Ferritin levels are also observed for other clinical conditions such as liver
disease, infectious as well as inflammatory processes, leukemia, Hodgkin's disease and other forms of
malignancy.
PRINCIPLE OF THE ASSAY
The present method employs two anti-Ferritin monoclonal antibodies which recognize two different
epitopes of the molecule. One antibody is adsorbed in solid phase (coated tube), the other (labeled with
iodine-125) is used as conjugate. The sample to be tested and the labeled antibody are incubated
simultaneously in the coated tube. The amount of bound conjugate will thus be directly proportional to
the antigen concentration in calibrators and samples. At the end of the incubation, the unbound material
is removed by aspiration and washing. The radioactivity in the tubes is measured in a gamma counter.
REAGENTS PROVIDED WITH THE KIT: PREPARATION AND STABILITY
− The reagents are sufficient for 100 tubes.
− Store the kit at 2-8°C.
− The expiry date of each reagent is shown on the vial label.
1 - CT Coated Tubes: 100 tubes coated with mouse monoclonal anti-Ferritin antibody. Unused tubes
should be stored at 2-8°C in the appropriate bag and accurately sealed.
2 - CAL Calibrators: 7 vials (1 mL) of Ferritin (human liver) in phosphate buffer at the following
concentrations: 0, 5, 20, 50, 250, 1000 and 2000 ng/mL. Preservative: NaN3 (