Peanut Allergy Rapid Test (1 pc/box)

Peanut Allergy Rapid Test

The Peanut Allergy Rapid Test is designed for the qualitative detection of peanut-specific Immunoglobulin E (sIgE) in human serum, plasma, or whole blood. Combined with other clinical observations, this test allows identification of peanut-specific IgE-mediated type I hypersensitivity allergy.

Allergy is a common health problem affecting approximately 20-25% of people and is characterized by immediate hypersensitivity reactions such as hay fever, urticaria, eczema, gastrointestinal disorders, wheezing, and rarely anaphylactic shock. The term allergy often refers to type I hypersensitivity reactions (immediate reactions) which typically occur within 30-60 minutes after allergen exposure. The allergens causing type I hypersensitivity are mainly proteins from natural sources, e.g., plant pollens, animal dander, foods, mites, and insect venom. A hallmark of type I allergy is the involvement of allergen-specific Immunoglobulin E antibodies (sIgE). Thus, detection of sIgE is an important tool in modern allergy diagnostics.

Peanut allergy is a form of food allergy distinct from other nut allergies. It triggers a type I hypersensitivity reaction and causes an overreaction of the immune system. Due to its prevalence, persistence, and potential severity, it is considered one of the most serious food allergies. In the United States, peanut allergy affects about 0.6% of the population. In Western countries, peanut allergy is the leading cause of food-related anaphylactic shock and fatalities. The product is available for professional use only.

Peanut Allergy Rapid Test Specifications

Product name: Peanut Allergy Rapid Test

Sample: whole blood/serum/plasma

Packaging: 1 piece/box

Format: Cassette

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

Expiration date: 2026.11.

Contents of the Peanut Allergy Rapid Test Kit

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

How to use the lancet

1. Remove the yellow single-use lancet from the packaging.
2. Remove the transparent cap.
3. Press it against your fingertip. The needle will automatically eject.
4. Dispose of the lancet after use.

Test procedure

Before performing the test, carefully read the Instruction Manual! Collect the sample as described in the manual.

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

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 ID. For best results, perform the test within one hour of opening the pouch.

2.A For serum/plasma samples:

Hold the pipette vertically and dispense 2 drops of serum or plasma (about 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 (about 75 μL) into the sample well (S), then add 1 drop of buffer solution (about 40 μL) and start the timer. Avoid trapping air bubbles in the sample well (S) and do not add solution to the result window.

3. The color will migrate across the membrane during the process.

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

Interpretation of results

Positive

Two distinct red lines appear. One line in the control area (C), and the other in the test area (T). Any pink to red colored line in the test area (T), no matter how faint, indicates a positive result.

Negative

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

Invalid

Only one red line appears in the test area (T), and no line in the control area (C), or no red line appears at all. The most likely reasons are insufficient sample volume or incorrect test procedure.

Performance of the Peanut Allergy Rapid Test

• Relative Sensitivity: 97.8%
• Relative Specificity: 98.6%
• Overall Agreement: 98.3%

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