IgE Rapid Test

Sample

whole blood, serum or plasma specimen

Intended Use

The IgE Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of human IgE antibody in whole blood, serum or plasma to aid in the diagnosis of allergy.

Storage

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

Precision

1. Intra-Assay: Within-run precision has been determined by using 3 replicates of four specimens: a negative, a low positive, a middle positive and a high positive. The negative, low positive, middle positive and high positive values were correctly identified >99% of the time. 2. Inter-Assay: Between-run precision has been determined by 3 independent assays on the same four specimens: a negative, a low positive, a middle positive and a high positive. Three different lots of the IgE Rapid Test cassette (Whole Blood/Serum/Plasma) have been tested over a 3-days period using negative, low positive, middle positive and high positive specimens. The specimens were correctly identified >99% of the time.

Detection Limit

The IgE Rapid Test Cassette (Whole Blood/Serum/Plasma) can detect totally IgE antibody as low as 200IU/ml.

Sensitivity

The IgE Rapid Test Cassette (Whole Blood/Serum/Plasma) was compared with commercial other IgE Rapid tests; the results indicate that IgE Rapid Test Cassette (Whole Blood/Serum/Plasma) has a high sensitivity and specificity. Relative Sensitivity: 98.4% (95%CI*: 94.4%-99.8%) *Confidence Interval Relative Specificity: 98.7% (95%CI*: 96.7%-99.6%) Overall Accuracy: 98.6% (95%CI*: 97.0%-99.5%)

General Description

Immunoglobulin E (IgE) is a type of antibody (or immunoglobulin (Ig) "isotype") that has only been found in mammals. IgE is synthesised by plasma cells. Monomers of IgE consist of two heavy chains (ε chain) and two light chains, with the ε chain containing 4 Ig-like constant domains (Cε1-Cε4). IgE's main function is immunity to parasites such as helminths like Schistosoma mansoni, Trichinella spiralis, and Fasciola hepatica. IgE is utilized during immune defense against certain protozoan parasites such as Plasmodium falciparum. IgE also has an essential role in type I hypersensitivity, which manifests in various allergic diseases, such as allergic asthma, most types of sinusitis, allergic rhinitis, food allergies, and specific types of chronic urticaria and atopic dermatitis. IgE also plays a pivotal role in responses to allergens, such as: anaphylactic drugs, bee stings, and antigen preparations used in desensitization immunotherapy. Although IgE is typically the least abundant isotype—blood serum IgE levels in a normal ("non-atopic") individual are only 0.05% of the Ig concentration, compared to 75% for the IgGs at 10 mg/ml, which are the isotypes responsible for most of the classical adaptive immune response—it is capable of triggering the most powerful inflammatory reactions.