Ferritin CLIA Test CE

The Ferritin (FTN) Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence-based immunoassay for the quantitative detection of FTN in human serum or plasma (sodium heparin, K2EDTA or K3EDTA) using the ALTA CLIAlyzer.

Ferritin is a 24-subunit, intracellular protein core that functions to store and release iron. Under normal circumstances, serum ferritin concentration is positively correlated with the total amount of iron stored in the body. While normal serum ferritin concentrations vary with age and sex, if serum ferritin concentration is low it usually indicates iron deficiency. Iron deficiency is one of the major causes of anemia, which is characterized by low levels of hemoglobin and functioning red blood cells. Anemia is most prevalent in highly susceptible populations, which include pregnant women and children.

If serum ferritin concentration is high, it may indicate iron overload. Alternatively, elevated ferritin may be the result of a variety of other factors, including high body mass index (BMI), aging (post-menopausal women), or the presence of inflammation, infection, certain malignancies, or liver or kidney disease. Thus, high serum ferritin concentrations usually require further investigation.

The Ferritin CLIA Test is intended to be used for the quantitative measurement of ferritin in human serum or plasma. Measurement of iron status by serum ferritin is important for accurate classification of iron status in individuals, in order to provide treatment for iron deficiency, or to initiate further testing and a plan of care for elevated serum ferritin concentrations.

  • Individual ready-to-use cartridges
  • Combines the sandwich immunoassay technique with enzyme-catalyzed chemiluminescence detection
  • Calibration kit follows the national standard for ferritin
  • Sample volume: 60 μL


Working range: 1-2000 ng/mL

Detection Limits

Limit of Blank (LOB): 1 ng/mL


Intra-lot Precision

CV less than 10%

Inter-lot Precision

CV less than 15%


Accuracy of ± 10% in comparison to the control


Linearity between 1 and 2000 ng/mL


No significant interference was detected up to the concentrations mentioned below:

Hemoglobin500 mg/dL
Bilirubin20 mg/dL
Triglyceride3000 mg/dL
Total Protein10 g/dL
Rheumatoid Factor1500IU/mL

HAMA Interference

Patient specimens containing human anti-mouse antibodies (HAMA) may give falsely elevated or decreased values.  Although HAMA-neutralizing agents are added, extremely high HAMA serum concentrations may occasionally affect the results.

Hook effect

There is no high-dose hook effect at FTN concentration up to 30,000 ng/mL.

Reagents and materials provided:

  1. 19-well BNP reagent cartridge
    1. Sample well (1st well)
    2. Reading well for chemiluminescent signal (19th well)
    3. Foil-sealed wells (2nd to 18th wells) comprised of a barcode indicating reagent assay information, the reagent lot number and the expiration date
  2. 3 Calibrators recombinant FTN antigen at:
    1. 0 ng/Ml
    2. 50 ng/mL
    3. 500 ng/mL
  3. Two-level quality controls Recombinant FTN antigen at:
    1. 50 ng/mL
    2. 500ng/mL
  4. Registration card
  5. Calibrator card
  6. Instructions for Use

Materials required but not provided:

  1. Pipette with disposable tip to dispense up to 100 μL.
  2. For other specific materials and disposables, refer to CLIAlyzer user manual.
  3. CLIAlyzer instrument
  4. Powderless gloves
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