Crab Allergy Rapid Test

The Crab Allergy Rapid Test Kit is designed for the qualitative detection of crab-specific Immunoglobulin E (sIgE) in human serum, plasma, or whole blood. When used alongside other clinical observations, this test can help identify cancer-specific IgE-mediated Type I hypersensitivity allergy.

Allergy is a widespread health problem affecting approximately 20-25% of the population, characterized by immediate hypersensitivity reactions such as hay fever, urticaria, eczema, gastrointestinal disorders, wheezing, and rarely anaphylactic shock. Type I hypersensitivity reactions usually manifest within 30 to 60 minutes after allergen exposure and involve allergen-specific IgE antibodies (sIgE).

Crab allergy triggers an excessive immune response affecting millions worldwide, primarily adults. Symptoms vary widely from mild discomfort to life-threatening conditions, appearing often within minutes after consuming allergenic substances. Common signs include itching of the mouth and lips, heartburn, nausea, vomiting, abdominal pain and cramps, diarrhea, difficulty breathing, cough, throat irritation, skin discoloration, hives, swelling of lips or throat, and in severe cases, confusion or loss of consciousness.

This test kit is intended for professional use only and should be operated by qualified healthcare personnel.

Specifications

Product Name: Crab Allergy Rapid Test Kit

Sample Type: Whole blood / Serum / Plasma

Packaging: 1 test per 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 Crab 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

• Positive Agreement: 97.0% (84.7% - 99.5%)

• Negative Agreement: 100.0% (89.8% - 100.0%)

• Overall Agreement: 98.5% (92.0% - 99.7%)

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