Cat Allergy Rapid Test (1 pc/box)

• This product can be ordered for professional use only.

Cat Allergy Rapid Test

The Cat Allergy Rapid Test is suitable for the qualitative detection of cat dander-specific immunoglobulin E (sIgE) in human serum, plasma or whole blood. Together with this test and other clinical observations, it is possible to identify an allergy caused by type I hypersensitivity mediated by cat dander-specific immunoglobulin E (IgE).

Allergy is a common health problem affecting approximately 20-25% of people. It involves immediate hypersensitivity reactions, which present in the form of hay fever, urticaria, eczema, gastrointestinal disorders, wheezing and, rarely, anaphylactic shock. The term allergy is often used for type I hypersensitivity reactions (immediate reactions), the symptoms of which usually appear within 30-60 minutes after contact with the allergen. The allergens that trigger type I hypersensitivity reactions are primarily proteins from the natural environment, e.g. plant pollens, animal hair, foods, mites and insect venom.

Type I allergy is characterised by the involvement of allergen-specific immunoglobulin E (antibodies) (sIgE). Therefore, the detection of sIgE is an important tool of modern allergy diagnostics. Cat dander is produced in the skin of the pet and is shed through its fur. Some people may be allergic to a specific protein in cat dander. The same protein is also present in cat saliva. These allergens are airborne and, when inhaled, can trigger allergic reactions in sensitive individuals.

Cat hair can easily adhere to clothes, carpets or sofas, and can remain present in a household for up to 6 months, even after the cat has gone. The most common allergic symptoms caused by cat dander are: skin rashes, sneezing, itchy eyes, itchy skin and a runny nose. In certain cases, cat dander can cause asthma attacks and even chronic asthma. This product can be ordered for professional use only.

Cat Allergy Rapid Test Specification

Product name: Cat Allergy Rapid Test
Sample: whole blood/serum/plasma
Packaging: 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: 2027.02.28.

Contents of the Cat 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 lancet

1. Take the yellow single-use lancet out of the packaging. Remove the transparent cap.
2. Press it against your fingertip. The needle will be ejected automatically.
3. After use, dispose of the lancet in the waste bin.

The visual aid is intended for healthcare professionals only. 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 identification. For best results, the assay should be performed within one hour after opening.

2.A For serum/plasma samples:

Hold the pipette vertically and dispense 2 drops of serum or plasma (approx. 50μ L) 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. 75μ L) into the sample well (S) of the test, then add 1 drop of buffer (approx. 40μ L) and start the timer. Avoid trapping air bubbles in the sample well (S), and do not apply any solution to the result area.

3. As the test begins to work, color migrates across the membrane.

4. Wait for the colored bands to appear. The result should 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 line appears in the test region (T). A line in the (T) region with a color between pink and red, 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 are: insufficient sample volume or incorrect use of the device.

Performance of the Cat Allergy Rapid Test

• Relative sensitivity: 96.2%
• Relative specificity: 98.4%
• Overall agreement: 97.7%

The test may only be used by competent professional staff and healthcare professionals. 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 this 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 (consumer's right of withdrawal) in respect of e) a product supplied in sealed packaging which, for health protection or hygiene reasons, cannot be returned once opened after delivery.

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