Beef Allergy Rapid Test (1 pc/box)

Beef Allergy Rapid Test Kit

The Beef Allergy Rapid Test Kit is designed for the qualitative detection of beef-specific immunoglobulin E (sIgE) in human serum, plasma, or whole blood. Used in conjunction with clinical observations, this test can help identify Type I hypersensitivity reactions caused by beef-specific IgE antibodies.

Allergies are a common health concern, affecting around 20–25% of the global population. They are immediate hypersensitivity reactions that can manifest as hay fever, urticaria, eczema, gastrointestinal symptoms, wheezing, and in rare cases, anaphylactic shock. The term “allergy” often refers to Type I hypersensitivity reactions, with symptoms typically appearing within 30–60 minutes of exposure to the allergen.

Allergens triggering Type I hypersensitivity are typically environmental proteins such as pollen, animal dander, food, dust mites, or insect venom. These reactions involve allergen-specific IgE antibodies (sIgE), which are crucial biomarkers in modern allergy diagnostics.

Beef allergy is a condition where the immune system reacts abnormally to beef proteins, leading to physical symptoms in millions of individuals worldwide. It occurs primarily in adults, though not exclusively. Symptoms may include skin rashes, gastrointestinal issues, and in more severe cases, anaphylactic reactions. This test kit is available for professional use only.

Specifications

Product Name: Beef Allergy Rapid Test Kit

Sample Type: Whole blood / Serum / Plasma

Format: Cassette

Packaging: 1 pc/box

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:

Kit Contents

• 1 test cassette

• 1 disposable pipette

• 1 buffer solution

• 1 lancet

• 1 alcohol pad

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

2.A For serum or plasma samples:
Hold the pipette vertically and dispense 2 drops of serum or plasma (approx. 50μL) into the sample well (S) on the test cassette, then start the timer.

2.B For whole blood samples:
Hold the pipette vertically and dispense 3 drops of blood (approx. 75μL) into the sample well (S), then add 1 drop of buffer solution (approx. 40μL) and start the timer.

Avoid air bubbles entering the sample well (S), and do not apply any solution onto the result area. During the process, 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.

Performance of the Beef Allergy Rapid Test

• Positive Agreement: 96.2% (81.1%–99.3%)

• Negative Agreement: 97.4% (86.8%–99.5%)

• Overall Agreement: 96.9% (89.5%–99.2%)

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