Total IgE antibody (IgE) ELISA Test Kit

INTENDED USE

This kit is a quantitative detection of total IgE antibody (IgE) in human serum/plasma in vitro. This result can assist type Ⅰ allergy diagnosis. Moreover, total IgE testing may also be recommended for patients with suspected parasitic diseases.

PRINCIPLE OF THE TEST

Immediate hypersensitivity (typeⅠ allergies) is mediated by specific IgE. IgE concentration in normal serum peaks between 6 and 15 years of age. In most cases, the increase of specific IgE in patients is accompanied by the increase of total IgE titer. In this case, the titer can go up to 1,000 times. In general, international units per milliliter (IU/mL) are defined as: 1 IU/mL equals 2.4ng IgE. In patients with hereditary allergic dermatitis, IgE levels can be as high as 50,000 IU/mL. In addition, IgE titers are elevated in patients with parasitic diseases. Higher-than-normal test results should also take into account the impact of confirmed autoimmune diseases.

The reagent is not recommended for healthy people physical examination, testing results of positive or negative only on behalf of the corresponding IgE antibody test results positive or negative, uncertainty correlation with patient is sick and may not be as the only index of evaluation of patients, must be combined with patient clinical presentation and other laboratory tests for integrated analysis of the illness.

The detection method of this kit is enzyme-linked immunoassay. In this reagent, the principle of double antibody sandwich immunoassay was adopted. Monoclonal antibodies that recognize anti-IgE were pre-coated in the wells of the microplate, and human serum/plasma samples and enzyme-labeled another monoclonal antibody were added into the pores of the plate. After incubation and washing, substrate solution was added.

OD value was read and its content was calculated by a microplate reader.

INTERPRETATION OF RESULTS

Chromometry: Read the sample's optical density (OD) at 450nm/630mm with a microplate reader.

The detection range is 5～1000IU/mL. When serum/plasma samples with Total IgE antibody concentration over 1000IU/mL, accurate results can be obtained only if the sample are diluted with normal saline and tested again. The final result of the diluted sample is the test result multiplied by the dilution factor.

If the test results are out of the normal range, indicating abnormalities, the final diagnosis should be determined in combination with clinical symptoms and other indicators.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world