CLIA Kit for Immunoglobulin E (IgE)

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


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.


Matrices listed below were spiked with certain level of recombinant Immunoglobulin E (IgE) and the recovery rates were calculated by comparing the measured value to the expected amount of Immunoglobulin E (IgE) in samples.

Matrix Recovery range (%) Average(%)
serum(n=5) 81-90 87
EDTA plasma(n=5) 80-92 89
heparin plasma(n=5) 81-94 87


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%


The linearity of the kit was assayed by testing samples spiked with appropriate concentration of Immunoglobulin E (IgE) and their serial dilutions. The results were demonstrated by the percentage of calculated concentration to the expected.

Sample 1:2 1:4 1:8 1:16
serum(n=5) 95-102% 85-92% 86-98% 90-98%
EDTA plasma(n=5) 93-105% 78-96% 94-105% 91-98%
heparin plasma(n=5) 92-101% 80-101% 79-97% 80-90%


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.

Reagents and materials provided

Reagents Quantity Reagents Quantity
Pre-coated, ready to use 96-well strip plate 1 Plate sealer for 96 wells 4
Standard 2 Standard Diluent 1×20mL
Detection Reagent A 1×120µL Assay Diluent A 1×12mL
Detection Reagent B 1×120µL Assay Diluent B 1×12mL
Substrate A 1×10mL Substrate B 1×2mL
Wash Buffer (30 × concentrate) 1×20mL Instruction manual 1

Assay procedure summary

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



Magazine Citations
Molecular Carcinogenesis IL17A gene polymorphisms, serum IL-17A and IgE levels, and hepatocellular carcinoma risk in patients with chronic hepatitis B virus infection PubMed: 23280722
Human Immunology IL21 and IL21R polymorphisms and their interactive effects on serum IL-21 and IgE levels in patients with chronic hepatitis B virus infection PubMed: 23354321
Scand J Immunol Passive transfer of tumour-derived MDSCs inhibits asthma-related airway inflammation Pubmed: 24313384
AAPS PharmSciTech Topical Lyogel Containing Corticosteroid Decreases IgE Expression and Enhances the Therapeutic Efficacy Against Atopic Eczema PubMed: 25511806
Ann Allergy Asthma Immunol Reduced airway microbiota diversity is associated with elevated allergic respiratory inflammation PubMed: 26123423
Molecular Medicine Reports The protective role of vitamin D3 in a murine model of asthma via the suppression of TGF-β/Smad signaling and activation of the Nrf2/HO-1 pathway. pubmed:27484042
Gut Pathog. Oral administration of Clostridium butyricum CGMCC0313‐1 reduces ovalbumin‐induced allergic airway inflammation in mice pubmed:28250847
International Immunopharmacology Catalpol alleviates ovalbumin-induced asthma in mice: Reduced eosinophil infiltration in the lung pubmed:27992791
Asian Pacific Society of Respirology Oral administration of Clostridium butyricum CGMCC0313-1 reduces ovalbumin-induced allergic airway inflammation in mice pubmed:28122397
Molecular Medicine Reports Protective effects of astragaloside IV against ovalbumin-induced allergic rhinitis are mediated by T-box protein expressed in T cells/GATA-3 and forkhead box protein 3/retinoic acid-related orphan nuclear receptor γt. pubmed:28586019
Journal of Autoimmunity Commensal bacteria aggravate allergic asthma via NLRP3/IL-1β signaling in post-weaning mice 10.1016:j.jaut.2018.07.003
Water Research  Sub-chronic inhalation of reclaimed water-induced fibrotic lesion in a mouse model Pubmed:29655095
Human & Experimental Toxicology Investigation of hypersensitivity potential of diacetyl by determining cytokine profiles Pubmed:29233007
Journal of International Medical Research Changes in Th1/Th2-producing cytokines during acute exacerbation chronic obstructive pulmonary disease Pubmed:29950127
Journal Of Cellular Biochemistry Effects of catalpol on bronchial asthma and its relationship with cytokines Pubmed: 30536454
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES  Adipose Tissue-Derived Mesenchymal Stem Cell Modulates the Immune Response of Allergic Rhinitis in a Rat Model Pubmed: 30781605
Royal Society Open Science Metabolomics analysis of baicalin on ovalbumin-sensitized allergic rhinitis rats
Health and Medicine Antiallergical Effect of New Combined Nazal Aerodisperse System in the Conditions of Experimental Allergic Rhinitis
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