Soybean Allergy Rapid Test

• The price includes 5% VAT.

• This product can be ordered for professional use.

Soybean Allergy Rapid Test

The Soybean Allergy Rapid Test is intended for the qualitative detection of soybean-specific immunoglobulin E (sIgE) in human serum, plasma or whole blood. Together with the test and other clinical findings, it is possible to identify allergy caused by type I hypersensitivity mediated by soybean-specific immunoglobulin E (IgE).

Allergy is a common health problem that affects approximately 20-25% of people and is associated with immediate hypersensitivity reactions, which appear in the form of hay fever, urticaria, eczema, gastrointestinal disorders, wheezing and, rarely, anaphylactic shock. The term allergy is often used for type I hypersensitivity reactions (immediate reactions), the symptoms of which usually appear within 30-60 minutes after contact with the allergen.

The allergens that trigger type I hypersensitivity reactions are primarily proteins originating from the natural environment, e.g. plant pollens, animal dander, foods, mites and insect venom. Type I allergy is characterized by the involvement of allergen-specific immunoglobulins of class E (antibodies) (sIgE). Therefore, the detection of sIgE is an important tool in modern allergy diagnostics.

Soy allergy is one of the most common food allergies in the world, especially among infants and children. About 0.4 percent of children are allergic to soy. Studies show that soy allergy usually appears in early childhood, but children often outgrow it by the age of three, and at the latest by the age of ten. The test kit can be ordered for professional use.

Soybean Allergy Rapid Test Specification

Product name: Soybean Allergy Rapid Test Kit
Sample: whole blood/serum/plasma
Packaging: 1 pc/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: 30/09/2027

Contents of the Soybean Allergy Rapid Test Kit

• 1 test cassette
• 1 disposable pipette
• 1 buffer solution
• 1 fingertip lancet
• 1 alcohol wipe
• 1 Hungarian-language instructions for use

How to use the lancet

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

The visual aid is intended for healthcare professionals only. The product is not intended for self-testing.

Test procedure

Read the Instructions for Use carefully before performing the test. Before testing, allow the test, the sample and/or the controls to reach room temperature (15-30°C).

1. Remove the test from the sealed pouch and place it on a clean, level surface. Label the test with the patient or control ID. For best results, the assay should be performed within one hour after opening.

2.A For serum or 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 blood (approx. 75 μL) into the sample well (S) of the test, then add 1 drop of buffer (approx. 40 μL) and start the timer.

Avoid trapping air bubbles in the sample well (S), and do not apply any solution to the result area. As the test begins to work, color will migrate across the membrane.

3. Wait for the colored bands to appear. The result should be read at 10 minutes. Do not interpret the result after 15 minutes.

Performance of the Soybean Allergy Rapid Test

• Relative sensitivity: 97.7% (88.2%-99.6%)
• Relative specificity: 97.6% (91.8%-99.4%)
• Overall agreement: 97.7% (93.4%-99.2%)

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

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

Carbon Web Kft. is not responsible for fulfilling the legal obligations related to the Buyer's procurement procedure, as this falls within the Buyer's remit; its responsibility is limited solely to information on the intended use and to the goods delivered.