Total IgE FIA Test

Immunoglobulin E (IgE) is an antibody synthesized by the immune system in response to a perceived threat. IgE plays an essential role in type I hypersensitivity, and it is also associated with allergic responses, including asthma, and to a lesser degree with immunity to parasites.  Total IgE levels vary according to the likelihood of a patient having one or more allergies. Allergen-specific IgE levels will increase after exposure and then decline over time.

An elevated level of total IgE indicates an allergic response is likely to be present, but it will not show which allergy the patient has.  In general, the more allergies a patient has, the higher the total IgE levels are. An IgE elevation can also indicate a parasitic infection but cannot determine the type of infection.

• Quantitative, non-subjective results
• Increased sensitivity and broader detection range compared to rapid tests

  1. Range

Working range: 1.0-1000.0 IU/mL

  1. Precision

Intra-lot Precision

Intra-lot precision was determined by testing of IgE reference materials using 10 test devices from the same lot. CV ≤ 15%.

Inter-lot Precision

Inter-lot precision was determined by testing of IgE reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.

  1. Accuracy

IgE control materials with two different concentrations were tested by every lot of test device, and the deviations were within ± 15%.

  1. Linearity

A serial concentration of IgE reference materials at 1.0-1000 IU/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.

  1. Specificity

No cross reactivities were observed while testing following immunoglobulins with indicated concentrations:

ImmunoglobulinsConcentrations Test Results
IgG200 mg/mL≤ 1.0 IU/mL
IgA20 mg/mL≤ 1.0 IU/mL
IgM20 mg/mL≤ 1.0 IU mL

Reagents and Materials provided:

  1. Individually sealed foil pouches containing:
    1. One test device
    2. One desiccant
  2. Detection buffer tubes
  3. SD card
  4. Instructions for Use


Materials required but not provided:

  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator