Total IgE Fast Test Kit 

(Immunofluorescence Assay)

Intended Use

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

IgE is an immunoglobulin with a molecular weight of approximately 190,000 daltons. Produced by plasma cells, IgE has a significant role in atopic diseases such as allergic rhinitis, allergic asthma, and atopic dermatitis. IgE has a high affinity for receptors on mast cells and basophils, mediating the binding of allergens to these cells. The subsequent release of vasoactive amines, such as histamine, produce the clinical manifestations associated with atopic disease. Measurement of IgE serum levels can be important in the diagnosis and treatment of these disorders.

In most nonatopic patients, IgE serum levels are relatively low. However, certain parasitic or helminth infections have been associated with elevated IgE levels due to IgE sensitization of macrophages, eosinophils, and other inflammatory cells. The IgE concentration in a patient is dependent on both the extent of the allergic reaction and the number of different allergens to which the patient is sensitized. Nonallergic normal individuals have IgE concentrations that vary widely and increase steadily during childhood, reaching their highest levels at age 15 to 20, and thereafter remaining constant until about age 60 when they slowly decline.

Contents

1. A kit for Getein1100/Getein1180 contains:

Package specifications: 25 tests/box, 10 tests/box

1) Getein Total IgE test card in a sealed pouch with desiccant

2) Disposable pipet

3) Sample diluent

4) User manual: 1 piece/box

5) SD card: 1 piece/box

2. A kit for Getein1600 contains:

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:

1) Sample diluent: 1 bottle/box

2) Box with pipette tips: 96 tips/box

3) Mixing plate: 1 piece/box

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

Specifications

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.