Ferritin FIA Test

The Ferritin Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of ferritin in human serum using the RaFIA system. This test is intended for in vitro diagnostic use only.

Ferritin is an intracellular protein that stores iron and releases it in a controlled fashion. The protein is produced by almost all living organisms. In humans, it acts as a buffer against iron deficiency and iron overload. Ferritin is found in most tissues as a cytosolic protein, but small amounts are secreted into the blood where it functions as an iron carrier. Ferritin is also an indirect marker of the total amount of iron stored in the body, hence serum ferritin is used as a diagnostic test for iron-deficiency anemia. Recent studies suggest that ferritin provides a more sensitive, specific and reliable measurement for determining iron deficiency at an early stage. On the other hand, ferritin levels that are higher than the reference range may be indicative of conditions such as iron overload, infections, inflammations, collagen diseases, hepatic diseases, neoplastic diseases and chronic renal failure.

The Ferritin FIA Test was developed to detect the concentration of ferritin in serum within 15 minutes, without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel.

  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests

RANGES

  • Working range: 1.0-1000.0 ng/mL

PRECISION

  • Intra-lot Precision
    Intra-lot precision was determined by testing of Ferritin reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision
    Inter-lot precision was determined by testing of Ferritin reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

ACCURACY

  • Ferritin control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.

LINEARITY

  • A serial concentration of Ferritin reference materials at 2.0-1000.0 ng/mL was tested, and the correlation coefficient (R) is ≥0.9900.

REAGENTS AND MATERIALS PROVIDED:

  1. Individually sealed foil pouches containing:
    a. One test device
    b. One desiccant
  2. Detection buffer tubes
  3. SD card
  4. Instructions for Use

MATERIALS REQUIRED BUT NOT PROVIDED:

  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator

Catalog #

Product

Quantity

Specimen

F5010Ferritin FIA Test25/kitSerum, Plasma

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Materials required but not provided:

Catalog #

Product

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Catalog #

Product

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To learn about distribution opportunities or for additional product information, please contact info@ctkbiotech.com

FOR EXPORT ONLY