Immunglobulin E Assay
– high-performance, extremely precise and stable immunological turbidimetric latex IgE reagent
The BIOMED IgE Reagent is intended for the quantitative, immunological turbidimetric in vitro determination of immunoglobulin E in human serum and plasma using clinical chemistry analyzers.
Performance features
- total precision or within-laboratory precision: between 1.16 – 4.50 %CV (depending on device)
- Repeatability or within-run precision: between 0.37 – 3.37 %CV (depending on device)
- Lower detection limit: 15.74 IU/mL
- No high-dose hook effect up to 15,000 IU/mL
- Measuring range: linear from 13-1000 IU/mL
- Stable at 6 °C for 24 months
- Open-vial stability: 90 days
- No interference with immunoglobulinG, hemoglobin, lipids, bilirubin C and F and sodium ascorbate
- Performance data have been checked in the last 10 years by regular participation in German round robin tests and verified by their existence
Precision and repeatability of the BIOMED IgE Assay
Results of various studies on precision and reproducibility on the DxC 700 AU and AU5800
Linearity of the IgE-Reagent
Linearity testing with BIOMED IgE reagent based on five high and low concentration pooled human serum samples with expected values from ≈ 20 IU/mL to ≈800 IU/mL was the linearity of 800 IU/mL. Measured on an AU5800 with 4 repeat measurements in one run.
Background
Human immunoglobulins are divided into four classes: Immunoglobulin A, G, M and E (IgA, IgG, IgM, IgE). The classification is based on the stage of their activity and the areas in which they are active.
Immunoglobulins consist of ypsilon-shaped proteins and their task is to detect and fend off pathogens and substances such as viruses, bacteria, toxins or allergens that enter the body. For this reason immunoglobulins are also called antibodies. The largest group of antibodies are the immunoglobulins G, whereas the immunoglobulins E are the smallest group.
The diagnosis of the biomarker immunoglobulin E is performed to identify various allergens in the body that can trigger an allergy or parasite infestation. Although IgE occurs in much lower concentrations in human blood than IgG, it can cause severe allergies, including allergic shock.
The total IgE level is given in the international literature as follows: The normal reference range for the immunoglobulin E parameter is 0-99 IU/mL. For the diagnosis of atopic diseases a result of ≧ 375 IU/mL for IgE is considered the medically relevant decision limit. The reference ranges could be confirmed on 100 patient samples on an AU5800 with the BIOMED IgE Reagent.
Keywords
antibody IgE, diagnosis of allergies, allergology, allergic immune reactions
Literature
・L. Thomas: Labor und Diagnose, 2016, e-Version