Milk Allergy Rapid Test (1 pc/box)

Milk Allergy Rapid Test

The Milk Allergy Rapid Test is suitable for the qualitative detection of milk-specific Immunoglobulin E (sIgE) in human serum, plasma, or whole blood. Together with other clinical observations, this test helps to identify milk-specific Immunoglobulin E (IgE)-mediated type I hypersensitivity allergies.

Allergy is becoming an increasingly widespread chronic disease. It is estimated that one in three people worldwide will be affected by allergic conditions at some point in their lives. In Hungary, approximately 2 million people seek treatment related to allergic diseases every year. It is important to highlight that milk allergy and lactose intolerance or milk sugar sensitivity are not the same condition. Milk allergy occurs when the body recognizes the milk protein (casein) as an allergen and mounts an abnormal immune response against it. About 90% of children outgrow milk allergy by the age of three. Persistence of milk allergy beyond this age occurs in only 10% of cases. Symptoms immediately following milk consumption can vary widely and include skin manifestations (eczema, redness, hives, itching), nausea, vomiting, diarrhea, bloody stools, swelling of the larynx, difficulty breathing, or persistent hoarseness.

A rapid and severe allergic reaction known as anaphylaxis can occur, potentially progressing to circulatory failure and a life-threatening situation, which requires immediate emergency treatment! This product is available for professional use only.

Milk Allergy Rapid Test Specifications

Product name: Milk Allergy Rapid Test

Sample type: Whole blood / serum / plasma

Packaging: 1 test/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 Representative: Lotus NL B.V., Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands, peter@lotusnl.com

Expiration date: 2026.09

Contents of the Milk Allergy Rapid Test Kit

• 1 test cassette

• 1 disposable pipette

• 1 buffer solution

• 1 lancet for fingertip blood collection

• 1 alcohol wipe

• 1 user manual in English

Instructions for Using the Lancet

1. Remove the yellow single-use lancet from its packaging.

2. Remove the transparent cap.

3. Press it firmly against the fingertip. The lancet will automatically release.

4. After use, dispose of the lancet in a sharps container or trash.

Test Procedure

Please read the user manual carefully before performing the test. Collect the sample according to the instructions. Before use, ensure that all devices, reagents, samples, and/or controls have reached room temperature (15°C-30°C).

After sample collection:

1. Remove the test cassette from the sealed pouch and place it on a clean, flat surface. Label the test with the patient or control ID. For best results, conduct the test within one hour of opening the pouch.

2A. For serum/plasma samples:

Hold the pipette vertically and apply 2 drops of serum or plasma (approx. 50 μL) into the sample well (S), then start the timer.

2B. For whole blood samples:

Hold the pipette vertically and apply 3 drops of blood (approx. 75 μL) into the sample well (S), then add 1 drop of buffer solution (approx. 40 μL) and start the timer. Avoid trapping air bubbles in the sample well (S) and do not allow the buffer solution to enter the result window.

The color will migrate along the membrane.

3. 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 in the control region (C) and one in the test region (T). Any visible pink or red line in the test region (T), regardless of thickness, indicates a positive result.

• Negative: A single red line appears in the control region (C). No line appears in the test region (T).

• Invalid: Only a red line appears in the test region (T) without a red line in the control region (C), or no lines appear at all. This is usually due to insufficient sample volume or incorrect test procedure.

Performance of the Milk Allergy Rapid Test

• Relative sensitivity: 96.4%

• Relative specificity: 98.5%

• Overall agreement: 97.5%

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