CDIA™ Allergen Specific IgE Antibody Rapid Test - Creative Diagnostics

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CDIATM Allergen Specific IgE Antibody Rapid Test (DTS1459)

Intended Use

The Allergen Specific IgE Antibody Rapid Test is intended to detect of allergen specific IgE in serum.

Characteristics of The Test

  • No cross reaction between test lines. Common confounding factors do not affect the results.
  • Serum
  • Strip
  • 3.0IU/ml or lower

Product Introduction

Principles

Pannel1: Artemisia&ambrosia artemisiifolia pollen allergen, dermatophagoides pteronyssinus&dermatophagoides farinae allergen, cat hair allergen and dog hair allergen are coated on the T lines separately and polyclonal goat anti-mouse IgG antibodies on C line of the nitrocellulose membrane strip.

Pannel2: Soybean allergen, chicken egg allergen, cow milk allergen, peanut allergen are coated on the T lines separately and polyclonal goat anti-mouse IgG antibodies on C line of the nitrocellulose membrane strip.

Colloidal gold labeled goat anti-human IgE polyclona antibody is the color substances immobilized on conjugated pad. The sIgE antibodies in serum sample combine with the gold labeled antibody to form colorful immune complex and move alone the membrane strip by the action of chromatography. The allergens pre-coated on the T lines can bind the complex to form allergen-sIgE antibody-colloidal gold labeled mouse anti human IgE and develop color. And the rest free complexes are captured by the goat anti-mouse IgG antibody on the control line and coloration. C lines without coloration means the result is invalid.

Negative results: Coloration on C line only.

Positive results: Coloration on C line and one or more T lines.

Test Procedure

1. Unseal the aluminum foil bag and put the test cards on a dry horizontal work surface.

2. Add 100 uL of serum or plasma sample into the sample well of test card.

3. The test result must be observed in 25-30 minutes. The observation is invalid after 30 minutes. Judge the result according to the reference card

Reference range and results and determine grade

Minimum detection limit:

Artemisia pollen allergen (1.0 IU/ml), ambrosia artemisiifolia allergen (3.0 IU/ml), dermatophagoides pteronyssinus allergen (2.5 IU/ml), dermatophagoides farinae allergen (2.5 IU/ml), cat hair allergen (2.0 IU/ml), dog hair allergen (2.0 IU/ml), soybean allergen (2.5 IU/ml), chicken egg allergen (3.0 IU/ml), cow milk allergen (3.0 IU/ml), peanut allergen (3.0 IU/ml).

The results determine whether chart1:

Negative: The test card appear one amaranth stripe on the C line, which means the sample do not have the relative sIgE antibodies to T lines or it is lower that the minimum detection limit.

Positive: Appearing one purple stripe on the C line and one or more amaranth stripes on the T lines. Judge the result according to the reference card.

Invalid: Develops color on T lines only, or no coloration on both T lines and C lines. In this case, re-detectation should be done. Stop using the batch of products and contact with local suppliers if still invalid.

Related Products

  • Method: Immunoblot
  • Sample:  Serum
  • Target: immunoglobulin E (total IgE)
  • Method: Colloidal gold
  • Sample:  Serum, Plasma
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