Peanut Allergy Rapid Test (1 pc/box)

• The price includes 5% VAT.

• This product can be ordered for professional use.

Peanut Allergy Rapid Test

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

Allergy is a common health problem that affects approximately 20-25% of people and involves 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 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 of modern allergy diagnostics.

Peanut allergy is a type of food allergy. It differs from other tree nut allergies. Peanuts trigger a type I hypersensitivity reaction and cause an excessive reaction of the immune system. Because of its prevalence, frequency, persistence and the potential severity of the allergic reaction, it is considered one of the most serious food allergies. In the United States, peanut allergy occurs in 0.6% of the population. In Western cultures, peanut allergy is the most common cause of food-related anaphylactic shock and death. This product can be ordered for professional use.

Peanut Allergy Rapid Test Specification

Product name: Peanut Allergy Rapid Test
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: 30/11/2026

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

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

Test procedure

Read the Instructions for Use carefully before performing the test! Collect the sample as described in the instructions for use.

Before use, allow the devices, reagents, samples and/or controls to reach room temperature (15°C–30°C).

After sample collection:

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 of opening.

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 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 allow any solution onto the result area.

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

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

Interpretation of results

Positive

Two distinct red lines appear. One line appears in the control region (C) and the other in the test region (T). A line with a color between pink and red in the test region (T), however faint, 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 region (T) and no red line appears in the control region (C). / No red line appears at all. The most likely causes: insufficient sample volume or incorrect use of the device.

Performance of the Peanut Allergy Rapid Test

• Relative sensitivity: 97.8%
• Relative specificity: 98.6%
• Overall agreement: 98.3%

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 No. 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 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 once opened after delivery.

Carbon Web Kft. is not responsible for the fulfillment of the legal obligations related to the Buyer's procurement procedure, as this falls within the Buyer's competence; its liability is limited exclusively to information on the intended use and to the goods delivered.