Description

Product Overview

The Total IgE Test Kit is a fluorescence immunoassay designed for quantitative determination of circulating IgE antibodies. Elevated IgE levels are associated with allergic disorders, asthma, atopic dermatitis and parasitic infections. Measurement of total IgE assists clinicians in evaluating allergic disease conditions.

Intended Use

For in vitro quantitative determination of total IgE antibodies in serum, plasma or whole blood as an aid in diagnosis of IgE‑mediated allergic diseases.

Clinical Significance

Supports allergy screening, assists diagnosis of atopic conditions, helps monitor allergic disease progression and contributes to clinical risk assessment.

Test Principle

Double‑antibody sandwich fluorescence immunoassay where anti‑human IgE monoclonal antibodies capture IgE molecules and fluorescence intensity is measured quantitatively by analyzer.

Sample Type

Serum / Plasma / Whole Blood

Sample Volume

100 µL

Test Time

Approximately 15 minutes

Measuring Range

1.00 – 2000.00 IU/mL

Detection Limit

≤1.00 IU/mL

Technology

Fluorescence Immunoassay

Compatible Analyzers

GETEIN 1100
GETEIN 1160

Storage & Stability

Store at 4–30°C. Test card should be used within 1 hour after opening foil pouch.

Applications

Allergy diagnostics, hospital laboratories, diagnostic centers, paediatric clinics and preventive health screening programs.