Total IgE Fast Test Kit (Immunofluorescence Assay)

Getein Total IgE Fast Test Kit is an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.


Intended Use

The Total IgE Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of circulating total IgE antibodies in human serum, plasma, and whole blood samples. This test can be used as an aid in the clinical diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings.


About IgE

Immunoglobulin E (IgE) is an immunoglobulin with a molecular weight of approximately 190,000 Daltons. Produced by plasma cells, IgE plays a crucial role in atopic diseases such as allergic rhinitis, allergic asthma, and atopic dermatitis. It binds with high affinity to receptors on mast cells and basophils, which mediate the binding of allergens to these cells, leading to the release of vasoactive amines such as histamine. This release results in the clinical manifestations associated with atopic diseases. Measuring IgE serum levels can be important in diagnosing and treating these disorders.

In most non-atopic individuals, IgE serum levels are relatively low. However, certain parasitic or helminth infections are associated with elevated IgE levels, as IgE sensitizes macrophages, eosinophils, and other inflammatory cells. IgE concentrations in a patient are dependent on the extent of the allergic reaction and the number of allergens to which the patient is sensitized. Non-allergic individuals have IgE concentrations that vary widely, peaking between the ages of 15 and 20 and remaining constant until about age 60, when they begin to decline.


Contents

  1. For Getein1100/Getein1180:
  • Package specifications: 25 tests/box, 10 tests/box
  • Getein Total IgE test card in a sealed pouch with desiccant
  • Disposable pipet
  • Sample diluent
  • User manual: 1 piece/box
  • SD card: 1 piece/box
  1. For Getein1600:
  • Package specifications: 2×24 tests/kit, 2×48 tests/kit
  • Sealed cartridge with 24/48 Getein Total IgE test cards
  • User manual: 1 piece/box

Materials required for Getein1600:

  • Sample diluent: 1 bottle/box
  • Box with pipette tips: 96 tips/box
  • Mixing plate: 1 piece/box

Note: Do not mix or interchange different batches of kits.


Specifications

  • Test Item: Total IgE
  • Sample Types: Serum, Plasma
  • Detection Range: 1.00-2000.00 IU/mL
  • Storage Condition: 4-30℃

Methodology:

Immunofluorescence Assay

Test Time:

15 min

Cut-off Value:

1.00 IU/mL~165.00 IU/mL

Shelf Life:

24 months


Applicable Device

  • Getein1100 Immunofluorescence Quantitative Analyzer
  • Getein1180 Immunofluorescence Quantitative Analyzer
  • Getein1600 Immunofluorescence Quantitative Analyzer


Clinical Application

As an aid in the clinical diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings.



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