Total IgE Rapid Test (1 pc/box)

• The price includes 5% VAT.

• This product can be ordered for professional use.

Total IgE Rapid Test

The Total IgE Rapid Test is a simple and effective method for the rapid determination of immunoglobulin E (IgE) levels in the body. IgE is a type of antibody that plays a role in the development of allergic reactions and in type I hypersensitivity, which manifests in various allergic diseases such as allergic asthma, most cases of sinusitis, allergic rhinitis, food allergy, as well as some forms of chronic urticaria and atopic dermatitis.

IgE also plays a key role in allergic conditions such as anaphylactic reactions to certain medicines, pollen and antigen preparations used in specific desensitizing immunotherapy. The test kit measures the concentration of IgE in the body. The test can be ordered for professional use.

Total IgE Rapid Test Specification

Product name: Total IgE Rapid Test Kit
Sample: whole blood/serum/plasma
Pack 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: 31/03/2028

Contents of the Total IgE 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. Take the yellow single-use fingertip 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 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. Before testing, allow the test, the sample and/or the controls to reach room temperature (15-30°C).

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 of opening the pouch.

2.A For serum or 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 apply any solution to the result area. As the test begins to work, the color migrates across the membrane.

3. Wait for the colored lines to appear. The result must be read after 10 minutes. After 15 minutes the result is invalid.

Performance of the Total IgE Rapid Test

• Relative sensitivity: 97.9% (92.7%-99.4%)
• Relative specificity: 98.9% (93.8%-99.8%)
• Overall agreement: 98.4% (95.3%-99.4%)

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!
Under Hungarian Government Decree No. 45/2014 (II. 26.), for health protection or hygiene reasons the product cannot be returned after handover; 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 once it has been opened after handover.

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