CLIA Kit for Immunoglobulin E (IgE)

Product Specifications

Product Name Alternative

IGHE; Immunoglobulin Heavy Constant Epsilon; Ig epsilon chain C region

Applications

Chemiluminescent immunoassay for Antigen Detection.

Assay Principle

The microplate provided in this kit has been pre-coated with an antibody specific to Immunoglobulin E (IgE) . Standards or samples are then added to the appropriate microplate wells with a biotin-conjugated antibody specific to Immunoglobulin E (IgE) . Next, Avidin conjugated to Horseradish Peroxidase (HRP) is added to each microplate well and incubated. Then the mixture of substrate A and B is added to generate glow light emission kinetics. Upon plate development, the intensity of the emitted light is proportional to the Immunoglobulin E (IgE) level in the sample or standard.;

Assay Protocol

1. Prepare all reagents, samples and standards; 2. Add 100µ L standard or sample to each well. Incubate 2 hours at 37° C; 3. Aspirate and add 100µ L prepared Detection Reagent A. Incubate 1 hour at 37° C; 4. Aspirate and wash 3 times; 5. Add 100µ L prepared Detection Reagent B. Incubate 30 minutes at 37° C; 6. Aspirate and wash 5 times; 7. Add 100µ L Substrate Solution. Incubate 10 minutes at 37° C; 8. Read RLU value immediately.

Assay Performance Time

2H, 40min

Sample Type

Serum, plasma, tissue homogenates, cell lysates, cell culture supernates and other biological fluids

Detection Range

0.14 - 100 ng/mL

Precision

Intra-assay Precision (Precision within an assay) : 3 samples with low, middle and high level Immunoglobulin E (IgE) were tested 20 times on one plate, respectively. Inter-assay Precision (Precision between assays) : 3 samples with low, middle and high level Immunoglobulin E (IgE) were tested on 3 different plates, 8 replicates in each plate. CV (%) = SD/meanX100 Intra-Assay: CV<10% Inter-Assay: CV<12%

Sensitivity

The minimum detectable dose of this kit is typically less than 0.05ng/mL

Stability

The stability of kit is determined by the loss rate of activity. The loss rate of this kit is less than 5% within the expiration date under appropriate storage condition. To minimize extra influence on the performance, operation procedures and lab conditions, especially room temperature, air humidity, incubator temperature should be strictly controlled. It is also strongly suggested that the whole assay is performed by the same operator from the beginning to the end.

Specificity

This assay has high sensitivity and excellent specificity for detection of Immunoglobulin E (IgE) . No significant cross-reactivity or interference between Immunoglobulin E (IgE) and analogues was observed.