Crab Allergy Rapid Test (1 pc/box)

• The price includes 5% VAT.

• This product can be ordered for professional use only.

Crustacean Allergy Rapid Test

The crustacean allergy rapid test is suitable for the qualitative detection of crustacean-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 to crustaceans caused by type I hypersensitivity mediated by crustacean-specific immunoglobulin class E (IgE).

Allergy is a common health problem affecting approximately 20-25% of people. It involves immediate hypersensitivity reactions that 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 hair, 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.

Crustacean allergy causes an excessive reaction of the immune system, which causes physical symptoms in millions of people worldwide. Crustacean allergy occurs mainly, but not exclusively, in adults. The symptoms of crustacean and shellfish allergy range widely, from mild discomfort to life-threatening conditions. These symptoms may differ significantly not only from person to person but also from occasion to occasion, often appearing within a few minutes after eating the food. The most common signs include itching of the mouth and lips, heartburn, nausea, vomiting, abdominal pain and cramps, diarrhea, difficulty breathing, shortness of breath, coughing and throat irritation. In some cases, skin discoloration, hives, swelling of the lips or throat may be observed, and even confusion and loss of consciousness may occur.

The test kit can be ordered for professional use only.

Crustacean Allergy Rapid Test Specification

Product name: Crustacean 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 Crustacean Allergy Rapid Test Kit

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

How to use the 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 be released automatically.
3. After use, discard 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 identification. For best results, the assay should be performed within one hour after opening the pouch.

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, the color migrates across the membrane.

3. Wait for the colored bands to appear. The result should be read at 10 minutes. After 15 minutes the result is invalid.

Performance of the Crustacean Allergy Rapid Test

• Positive agreement: 97.0% (84.7%-99.5%)
• Negative agreement: 100.0% (89.8%-100.0%)
• Overall agreement: 98.5% (92.0%-99.7%)

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

ATTENTION!
Under Government Decree 45/2014 (II. 26.), for health protection or hygiene reasons the 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 set out in 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 once opened after 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 competence; its responsibility is limited solely to information on intended use and to the goods delivered.