Ferrtin in Human Serum with Roche e801

Detection of Ferrtin in Human Serum with Roche e801

Test Name: This immunoassay is for the in vitro quantitative determination of ferritin (FERR) in human serum and plasma.
Method Name: The Elecsys FERR assay makes use of a sandwich principle using a monoclonal antibody specifically directed against FERR. Endogenous FERR in the sample, a biotinylated monoclonal ferritin‑specific antibody, and a monoclonal ferritin‑specific antibody labeled with a ruthenium complex form a sandwich complex.
Results: Technical Range: 0.5-2000 ng/mlL
Reportable Range: 2.36-1584 ng/mL
Reference Ranges:     Male Age Ferritin ng/mL
0-5 months 13-273
6-12 months 12-95
1-5 years 12-64
6-11 years 16-77
12-19 years 16-124
≥ 20 years 30-400

Female Age Ferritin ng/mL
0-5 months 12-219
6-12 months 12-110
1-5 years 12-71
6-11 years 15-79
12-19 years 15-77
≥ 20 years 13-150

        Clinical Significance: Ferritin is a macromolecule with a molecular weight of at least 440 kD (depending on the iron content) and consists of a protein shell (apoferritin) of 24 subunits and an iron core containing an average of approximately 2500 Fe3+ ions (in liver and spleen ferritin).

Ferritin tends to form oligomers, and when it is present in excess in the cells of the storage organs there is a tendency for condensation to semicrystalline hemosiderin to occur in the lysosomes.

At least 20 isoferritins can be distinguished with the aid of isoelectric focusing. This microheterogeneity is due to differences in the contents of the acidic H and weakly basic L subunits. The basic isoferritins are responsible for the long term iron storage function, and are found mainly in the liver, spleen, and bone marrow.

Acidic isoferritins are found mainly in the myocardium, placenta, and tumor tissue. They have a lower iron content and presumably function as intermediaries for the transfer of iron in various syntheses.

The determination of ferritin is a suitable method for ascertaining the iron metabolism situation. Determination of ferritin at the beginning of therapy provides a representative measure of the body’s iron reserves. A storage deficiency in the reticulo endothelial system (RES) can be detected at a very early stage.

Clinically, a threshold value of 20 µg/L (ng/mL) has proved useful in the detection of prelatent iron deficiency. This value provides a reliable indication of exhaustion of the iron reserves that can be mobilized for hemoglobin synthesis. Latent iron deficiency is defined as a fall below the 12 µg/L (ng/mL) ferritin threshold. These two values necessitate no further laboratory elucidation, even when the blood picture is still morphologically normal. If the depressed ferritin level is accompanied by hypochromic, microcytal anemia, then manifest iron deficiency is present.

When the ferritin level is elevated and the possibility of a distribution disorder can be ruled out, this is a manifestation of iron overloading in the body. 400 µg/L (ng/mL) ferritin is used as the threshold value. Elevated ferritin values are also encountered with the following tumors: acute leukemia, Hodgkin’s disease and carcinoma of the lung, colon, liver and prostate. The determination of ferritin has proved to be of value in liver metastasis. Studies indicate that 76 % of all patients with liver metastasis have ferritin values above 400 µg/L (ng/mL). Reasons for the elevated values could be cell necrosis, blocked erythropoiesis or increased synthesis in tumor tissue.

Submission Criteria: For specimen collection and preparation, only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Plasma: Li-heparin and K2-EDTA plasma
Do not use fluoride plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, therefore not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases.  When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.
Storage and Stability:    12 months at -20°C
7 days at 2-8°C
48 hours at 20-25 °C

Rejection Criteria: Rejection criteria include but are not limited to:
1. Specimens containing fibrin or clots.
2. Excessive platelet clumping
3. Leaking specimens
4. Substandard mixing or collection
5. Expired or improperly stored collection tubes.
6. Improperly filled tubes based on collection tube manufacturer’s guidelines.
7. Contaminated specimens (IV fluid, foreign particles, etc.)
8. Specimens not analyzed within the appropriate time frame.
9. Samples not shipped at appropriate temperature.
10. Samples without 2 proper identifiers or samples having identifiers that do not match the electronic or paper lab requisition.
Authorization: Diagnostic testing can only be performed with approval from an authorized provider/agency.
Turn Around Time: 1 day.