Shrimp Allergy Rapid Test (1 pc/box)

Shrimp Allergy Rapid Test

The allergen (shrimp) rapid test is designed for the qualitative detection of shrimp-specific E immunoglobulin (sIgE) in human serum, plasma, or whole blood. Along with other clinical observations, the test can help identify allergy caused by shrimp-specific E-class immunoglobulin (IgE) due to type I hypersensitivity.

Allergy is a common health problem affecting approximately 20-25% of the population. It causes 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), with symptoms typically appearing within 30-60 minutes after exposure to the allergen.

The allergens triggering type I hypersensitivity are primarily proteins from the natural environment, such as plant pollens, animal hairs, foods, dust mites, and insect venom. Type I allergy is characterized by the involvement of allergen-specific E-class immunoglobulins (antibodies) (sIgE). Therefore, detection of sIgE is an important tool in modern allergy diagnostics.

Shrimp is an aquatic arthropod. Due to its delicate flavor and rich nutritional content, shrimp is a popular food worldwide. However, shrimp can cause anaphylactic reactions in some individuals. Shrimp allergy occurs when a person is sensitive to the proteins found in shrimp meat. Symptoms can vary and include skin rashes, swelling of lips or throat, gastrointestinal problems such as nausea or diarrhea, and respiratory difficulties. This test kit is available for professional use only.

Shrimp Allergy Rapid Test Kit Specifications

Product Name: Shrimp Allergy Rapid Test Kit

Sample: 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 REP: Lotus NL B.V., Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands, peter@lotusnl.com

Expiration date:

Contents of the Shrimp Allergy Rapid Test Kit

• 1 test cassette

• 1 disposable pipette

• 1 buffer solution

• 1 lancet

• 1 alcohol swab
  

• 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 Shrimp Allergy Rapid Test

• Relative Sensitivity: 95.9% (86.3%-98.9%)
• Relative Specificity: 97.4% (91.0%-99.3%)
• Overall Agreement: 96.8% (92.1%-98.8%)

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