Egg White Allergy Rapid Test (1 pc/box)

Egg White Allergy Rapid Test

The Egg White Allergy Rapid Test is suitable for the qualitative detection of egg white-specific E immunoglobulin (sIgE) in human serum, plasma, or whole blood. Together with other clinical observations, the test can identify allergy caused by egg white-specific E class immunoglobulin (IgE) type I hypersensitivity.

Allergy has become an increasingly common chronic condition. It is estimated that one in three people worldwide is affected at some point in their lives, and in Hungary approximately 2 million people annually seek treatment for allergic diseases. In healthy adults, digestion of egg white proteins is generally problem-free. However, in individuals allergic to eggs, certain egg proteins trigger allergies, primarily causing eczema-like skin symptoms. Gastrointestinal symptoms may also occur, but skin manifestations are the most typical. Asthma-like attacks are very rare. Symptoms usually appear in childhood but can also develop in adults. Egg allergy is mostly triggered by two types of egg proteins. One is ovalbumin, a very stable allergen that does not degrade with heat, meaning it remains allergenic even in cooked eggs. The other problematic protein is ovomucoid, which breaks down with heat and thus causes issues only if eggs are consumed raw.

Our immune system protects the body from unwanted intruders such as bacteria and viruses that cause infections and diseases. In individuals with allergic diseases, the immune system mistakenly perceives harmless substances (allergens) as intruders. To defend itself, the body produces specific antibodies (IgE) against these allergens, which cause other immune cells to release substances triggering allergic symptoms. Together, these cause the allergic reaction. This product is intended for professional use only.

Egg White Allergy Rapid Test Specifications

Product name: Egg White Allergy Rapid Test

Sample: Whole blood / Serum / Plasma

Packaging: 1 test/box

Format: Cassette test

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

Expiry date: 2026.05

Contents of the Egg White Allergy Rapid Test Kit

• 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 disposable lancet from the packaging.
2. Remove the transparent cap.
3. Press it firmly against the fingertip. The needle will automatically deploy.
4. Dispose of the lancet in the trash after use.

Testing Procedure

Before performing the test, carefully read the Instruction Manual! Collect samples according to the instructions. Before use, allow devices, reagents, samples, and/or controls to reach room temperature (15°C-30°C).

After sample collection:

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

2.A For serum/plasma samples:

Hold the pipette vertically and dispense 2 drops of serum or plasma (approx. 50 μL) into the sample well (S) of the test, then start the timer!

2.B For whole blood samples:

Hold the pipette vertically and dispense 3 drops of whole blood (approx. 75 μL) into the sample well (S), then add 1 drop of buffer (approx. 40 μL) and start the timer. Avoid air bubbles in the sample well (S), and do not apply liquid to the result window.

The color will migrate along the membrane.

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

Interpretation of Results

Positive: Two distinct red lines appear: one at the control region (C) and one at the test region (T). Any pink or red line at (T), even very thin, indicates a positive result.

Negative: Only one red line appears in the control region (C). No line appears at the test region (T).

Invalid: Only a red line appears in the test region (T) without a control line (C), or no red lines appear at all. The most likely causes are insufficient sample volume or incorrect use of the device.

Performance of the Egg White Allergy Rapid Test

• Relative sensitivity: 98.1% (90.2%–99.7%)

• Relative specificity: 98.4% (91.5%–99.7%)

• Overall agreement: 98.3% (94.0%–99.5%) / 99.4% (98.0%–99.8%)

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