Hypersensitivity: After theorganism initial response to certain antigens, the immune response is enhanced when re-exposure tothe same antigen. When high antigen intake or organismimmune response is in a high level, due to the immune response is too strong, it will cause specific immune response (mainly tissue injury). In1966, Ishizaka found and proved that IgE antibody is the major antibody mediated type Ihypersensitivity. Since then, Screen the allergen through detection of the specific IgE in the serum is an important diagnosis method of allergic diseases.
This test kit is used to qualitatively detect specific IgE antibody and mainly used for the diagnosis of allergen screen.
Principles of the Tests
#Pannel1 (pollen+home allergy): 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.
#Pannel 2 (food allergy): 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 polyclonal antibody is the color substances immobilized on conjugate 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 sIgE’and develop color. And the rest free complexes are captured by the goat anti-mouse IgG antibody on the control line and coloration. C line 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.
The main components of kit:
#Test card 1: PVC case, glass fiber pad, nitrocellulose membrane strip, Goat anti mouse IgG antibody, Artemisia&ambrosia artemisiifoliapollen allergen, dermatophagoides pteronyssinus &dermatophagoides farinae allergen, cat hair allergen and dog hair allergen.
#Test card 2: PVC case, glass fiber pad, nitrocellulose membrane strip, Goat anti mouse IgG antibody, soybean allergen, chicken egg allergen, cow milk allergen and peanut allergen
Unseal the aluminum foil bag and put the test cards on a dry horizontal work surface.
Add 100?L of serum or plasma sample into the sample well of test card.
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), the chicken egg allergen(3.0 IU/ml), cow milk allergen (3.0 IU/ml), peanut allergen(3.0 IU/ml).
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 than the minimum detection limit.
Positive: Appearing one purple stripe on the c line and one or more amaranthstripes 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 line. In this case, re-detection should be done. Stop using the batch of products and contact with local suppliers if still invalid.