Milk Allergy Rapid Test (1 pc/box)

• The price includes 5% VAT.

• The product can be ordered for professional use.

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 the test and other clinical findings, it is possible to identify an allergy caused by type I hypersensitivity mediated by milk-specific class E immunoglobulin (IgE).

Allergy is an increasingly widespread condition today. It is estimated to affect one in three people worldwide during their lifetime, and in Hungary approximately 2 million people seek treatment for allergic diseases every year. It is important to emphasize that milk allergy and lactose sensitivity, or lactose intolerance, are not the same condition. Milk allergy occurs when the body perceives the milk protein (casein) in consumed milk as an allergen and develops an abnormal immune reaction against it. Of children with milk allergy, 90% outgrow it by the age of three. Milk allergy persisting at an older age is characteristic in only 10% of cases. The possible symptoms of milk allergy immediately after consuming milk can be very varied: various skin symptoms (eczema, red patches, hives, itching), nausea, vomiting, diarrhea, bloody stools, swelling of the larynx, difficulty breathing, and persistent hoarseness.

A rapidly developing, intense allergic reaction can be an anaphylactic attack, which may even progress to circulatory failure and result in a life-threatening condition. It therefore requires immediate emergency care! The product can be ordered for professional use.

Milk Allergy Rapid Test Specification

Product name: Milk Allergy Rapid Test
Sample: whole blood/serum/plasma
Package size: 1 pc/box
Format: Cassette test
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
Expiry date: 30/09/2027

Contents of the Milk Allergy Rapid Test Kit

• 1 test cassette
• 1 disposable pipette
• 1 buffer solution
• 1 fingertip lancet
• 1 alcohol wipe
• 1 instructions for use in Hungarian

How to Use the Fingertip Lancet

1. Remove the yellow single-use fingertip lancet from the packaging. Remove the transparent cap.
   
2. Press it against your fingertip. The needle will be released automatically.
   
3. After use, dispose of the lancet in the trash.
   

This visual aid is intended exclusively for healthcare professionals. The product is not intended for self-testing.

Test Procedure

Read the Instructions for Use carefully before performing the test! Collect the sample as described in the instructions for use.

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

After sample collection:

1. Remove the test from the sealed pouch and place it on a clean, level surface. Label the test with the patient or control identifier. For best results, the assay should be performed 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 (approx. 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 (approx. 75 μL) into the sample well (S) of the test, then add 1 drop of buffer (approx. 40 μL) and start the timer. Avoid trapping air bubbles in the sample well (S), and do not allow any solution onto the result area.

3. During the process, the color migrates across the membrane.

4. Wait for the colored bands to appear. The result must be read at 10 minutes. After 15 minutes, the result is invalid.

Interpretation of Results

Positive

Two distinct red lines appear. One line appears in the control region (C) and the other in the test region (T). A line between pink and red in color (T) – however faint – indicates a positive result.

Negative

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

Invalid

Only one red line appears in the test region (T) and no red line appears in the control region (C). / No red line appears at all. The most likely causes: insufficient sample volume or incorrect use of the device.

Performance of the Milk Allergy Rapid Test

• Relative sensitivity: 96.4%
• Relative specificity: 98.5%
• Overall agreement: 97.5%

The test may only be used by qualified professionals and healthcare workers! Carbon Web Kft. accepts no liability for use for self-testing purposes.

ATTENTION!
Pursuant to Hungarian Government Decree 45/2014 (II. 26.), for health protection or hygiene reasons the product cannot be returned after delivery; therefore the 14-day right of return does not apply to this product. Section 29 (1) The consumer may not exercise the right under Section 20 (the consumer's right of withdrawal) in respect of (e) a product in sealed packaging which, for health protection or hygiene reasons, cannot be returned after it has been opened following delivery.

Carbon Web Kft. is not responsible for fulfilling the legal obligations related to the Buyer's procurement procedure, as this falls within the Buyer's competence; its liability is limited exclusively to information on intended use and to the goods delivered.