Allergen Specific IgE Blood Test Colloidal Gold Rapid Test 20 Strips

Allergen Specific IgE Rapid Tests

Intended Use
Hypersensitivity: After the organism, initial response to certain antigens, the immune response is enhanced when re-exposure to the same antigen. When high antigen intake or organism immune 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 I hypersensitivity. Since then, Screen the allergen through detection of the specific IgE in the serum is an important diagnosis method of allergic diseases.
This kit is used to qualitatively detect specific IgE antibody and mainly used for the diagnosis of allergen screen.

Principles of the Tests
Panel 1: 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.
Panel 2 : Soybean allergen,chicken egg allergen,cow milk allergen,cottonwood &willow & elm 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 antibodycolloidal 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.

Main Constituent
The main components of kit:
Test card:
Test card 1: PVC case, glass fiber pad, nitrocellulose membrane strip, Goat anti mouse IgG antibody, Artemisia&ambrosia artemisiifolia pollen 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 cottonwood & willow & elm allergen
Each box contains:
1. Test card:25 tests / box
1 test contains isolated two test cards (Panel 1, Panel 2) and one desiccating agent.
The test card of Panel 1 and Panel 2 is each containing 1 control lines and 4
detection lines. It can detect 4 or more allergens. (Some Test lines for mixed allergen)
2. Reference card: 1

3. Product instruction: 1
Storage conditions and the period of validity
Store at 2～30℃, dry places for 36 months.
Sample Request
1. To collect the venous blood by conventional method and separated the serum or plasma as soon as possible to avoid hemolysis. Hemolysis is not suitable for the test kit.
2. Samples can be stored at 4 ℃ if tests will be done within 7 days, otherwise stored at -20 ℃. No more than 3 times of freeze-thaw with test sample.
3. The common heparin or sodium citrate anticoagulant does not influence the
test results.
Test Procedure
1. Unseal the aluminum foil bag and put the test cards on a dry horizontal work surface.
2. Add 100μL 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), the chicken egg allergen (3.0 IU/ml), cow milk allergen (3.0 IU/ml), cottonwood allergen (2.5 IU/ml), willow allergen (2.5 IU/ml), elm allergen (2.5 IU/ml).
The results determine whether chart1:

Negative: The test card appears one amaranth stripe on the c line, which means the sample do not have the relative slgE 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 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 line. In this case, re-detection should be done. Stop using the batch of products and contact with local suppliers if still invalid.

Test results explain
1. Appearing purple strip on the C line is internal control standard of test card.
2. Four T lines on 1 test card may appear color in different degree because of the different concentration of relative sIgE antibodies in one sample. A very weak coloration should also be considered as positive results.

Limitation
The kit is an assistant clinical diagnosis product. Its positive results cover the allergen items designed in the card only. It does not mean the patient is not allergic to other allergens out of the test kit．

Product performance indicators
1. 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), cottonwood allergen (2.5 IU/ml), willow allergen (2.5 IU/ml), elm allergen (2.5 IU/ml).
2. Sensitivity: Test 4 internal references serum (two positive, one weak positive and one negative). The test of positive serum references show purple strip on T lines clearly, light red stripe for the weak positive serum and blank for the negative.
3. Positive coincidence rate: to internal positive reference (+/+) =10/10.
4. The negative coincidence rate: to internal negative reference (- / -) =10/10
5. Precision (n=10): positive for all tests, and develop color equably;
6. Cross Reactions: There is not cross reaction between allergens of pannel1&2.
7. Interference factor: hemoglobin(≤10mg/ml), triglyceride (≤40.0mg /ml), bilirubin(≤0.4mg/ml), and high concentration IgM or IgG do not affect the test results.

Precautions
1. This kit is applicable to the detection in vitro only. Do not use the expired products.
2. Do operate according to the instructions strictly.
3. To avoid the test card exposing in the air long time since it can absorb moisture and affect the test results. Use test card within 1 hour once open to atmosphere when the humidity is below 60%, or use it immediately if the humidity is higher.
4. Be attention to the potential biological risks. Wearing necessary protective equipments, and dealing with waste as infectious material.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world