Egg White Allergy Rapid Test (1 pc/box)

• The product is available for professional use only.

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 the test and other clinical observations, it is possible to identify an allergy caused by type I hypersensitivity to egg white-specific class E immunoglobulin (IgE).

Allergies are an increasingly common condition nowadays. It is estimated that one in three people worldwide is affected at some point in their lives, while in our country approximately 2 million people seek treatment for allergic diseases every year. In healthy adults, the digestion of egg proteins is a problem-free process. In people with egg allergy, however, certain egg proteins trigger an allergic reaction that primarily causes eczema-like skin symptoms. Gastrointestinal complaints may also occur, but skin symptoms are the most characteristic. Asthma-like attacks may occur very rarely. In most affected individuals, symptoms appear as early as childhood, but the condition can also develop in adults. In most cases, egg allergy is triggered by two types of egg protein. One is ovalbumin, which is a very stable allergen and is not broken down by heat. This means that this substance remains allergenic even in cooked eggs. Another problematic protein is ovomucin, which is broken down by heat. This type therefore only causes problems when the egg is consumed raw.

Our immune system protects our body from unwanted invaders, such as bacteria and viruses that cause infections and diseases. In individuals suffering from allergic diseases, the immune system also recognizes harmless substances (allergens) as invaders. In order to protect itself, the body produces specific antibodies (IgE) against them, which cause other immune cells to release substances that trigger allergic symptoms. Together, these cause the symptoms of an allergic reaction. The product is available for professional use only.

Egg White Allergy Rapid Test Specification

Product name: Egg White Allergy Rapid Test
Sample: whole blood/serum/plasma
Pack size: 1 pc/box
Format: Cassette test
Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - ,MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA
EC REP: Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA,The Hague,Netherlands
Expiry date: 31/08/2028

Contents of the Egg White Allergy Rapid Test Kit

• 1 test cassette
• 1 disposable pipette
• 1 buffer solution
• 1 lancet
• 1 alcohol wipe
• 1 instruction manual in Hungarian

Procedure for using the finger-prick lancet

1. Take the yellow single-use lancet out of the packaging. Remove the transparent cap.
2. Press it against your fingertip. The needle will automatically be released.
3. After use, dispose of the lancet in the waste bin.

Testing procedure

Read the Instructions for Use carefully before performing the test! Collect the sample according to the instructions provided in the Instructions for Use.

Before use, wait until the devices, reagents and 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, horizontal surface! Label the test with the patient or control identifier! For best results, the test should be performed 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 (approximately 50μ L) into the test sample well (S), then start the timer!

2.B For whole blood samples:

Hold the pipette vertically and dispense 3 drops of blood (approximately 75μ L) into the test sample well (S), then add 1 drop of buffer (approximately 40μ L) and start the timer. Avoid trapping air bubbles in the sample well (S), and do not apply solution to the result area.

3. During the process, the colour migrates across the membrane.

4. Wait for the coloured lines to appear! The result must be read after 10 minutes. After 15 minutes, the
result is invalid.

Interpretation of results

Positive

Two separate red lines appear. One line appears in the control area (C), and the other line appears in the test area (T). A line with a colour ranging from pink to red (T) – regardless of how thin – indicates a positive result.

Negative

One red line appears in the control region (C). No line appears in the test region (T).

Invalid

Only one red line appears in the test area (T) and no red line appears in the control area (C). / No red line appears 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%)

The test may only be used by qualified professional personnel and healthcare professionals! Carbon Web Kft. accepts no liability for use for self-testing purposes.

ATTENTION!
In accordance with Government Decree 45/2014 (II. 26.), the product may not be returned after delivery for health protection or hygiene reasons; therefore, the 14-day right of return does not apply to this product. Section 29 (1) e) The consumer may not exercise the right under Section 20 (the consumer's right of withdrawal) in respect of a sealed packaged product which, for reasons of health protection or hygiene, cannot be returned after opening following delivery.

Carbon Web Kft. is not responsible for compliance with the legal obligations related to the Buyer's procurement procedure, as this falls within the Buyer's responsibility; its liability is limited exclusively to information concerning proper use and to the goods delivered.