Total IgE Rapid Test (1 pc/box)

Total IgE Rapid Test

The Total IgE Rapid Test Kit offers a simple and efficient method for the rapid determination of immunoglobulin E (IgE) levels in the human body. IgE is a type of antibody that plays a central role in allergic reactions and type I hypersensitivity, which manifest in various allergic diseases such as allergic asthma, most sinusitis cases, allergic rhinitis, food allergies, as well as certain chronic urticaria and atopic dermatitis.

IgE is also critically involved in allergic conditions including anaphylactic reactions triggered by certain medications, pollens, and specific desensitizing immunotherapy antigens. This test kit measures the concentration of IgE in the body, helping healthcare professionals in diagnosis and management of allergic conditions.

Total IgE Rapid Test Specifications

Product Name: Total IgE Rapid Test Kit

Sample Type: Whole blood / Serum / Plasma

Packaging: 1 test/box

Format: Cassette

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA, imd.assuretech@diareagent.com

EC REP: Lotus NL B.V., Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands, peter@lotusnl.com

Expiration date: 2026.09.

Total IgE Rapid Test Kit Contents

• 1 test cassette

• 1 disposable pipette

• 1 buffer solution

• 1 lancet

• 1 alcohol swab
  

• 1 instruction manual in English
  

Instructions for Using the Lancet

1. Remove the yellow single-use lancet from its packaging.

2. Remove the transparent cap.

3. Press it firmly against the fingertip. The lancet will automatically release.

4. After use, dispose of the lancet in a sharps container or trash.

Test Procedure

Please read the user manual carefully before performing the test. Collect the sample according to the instructions. Before use, ensure that all devices, reagents, samples, and/or controls have reached room temperature (15°C-30°C).

After sample collection:

1. Remove the test from the sealed pouch and place it on a clean, flat surface. Label the test with the patient or control identifier. For best results, conduct the test within one hour of opening the pouch.

2.A For serum or plasma samples:
Hold the pipette vertically and dispense 2 drops of serum or plasma (approx. 50μL) into the sample well (S) on the test cassette, then start the timer.

2.B For whole blood samples:
Hold the pipette vertically and dispense 3 drops of blood (approx. 75μL) into the sample well (S), then add 1 drop of buffer solution (approx. 40μL) and start the timer.

Avoid air bubbles entering the sample well (S), and do not apply any solution onto the result area. During the process, color will migrate along the membrane.

3. Wait for the colored lines to appear. Read the result after 10 minutes. Results read after 15 minutes are invalid.

Performance Characteristics

• Relative Sensitivity: 97.9% (92.7% - 99.4%)

• Relative Specificity: 98.9% (93.8% - 99.8%)

• Overall Agreement: 98.4% (95.3% - 99.4%)

Legal Notices

Professional Use

This product is an in vitro diagnostic (IVD) and intended exclusively for professional use by medical personnel. Use for self-testing is not permitted. The manufacturer/distributor accepts no liability for damages resulting from improper or unauthorized use.

Right of Withdrawal

In accordance with § 312g (2) No. 3 of the German Civil Code (BGB), there is no right of withdrawal for sealed goods which, for reasons of health protection or hygiene, are not suitable for return if their seal has been removed after delivery.

Disclaimer

The seller assumes no responsibility for compliance with legal regulations within the buyer’s procurement process. The seller’s responsibility is limited solely to the delivery of the ordered goods and the provision of information regarding their proper use.

Instructions