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CE 200IU/ML 98.6% Accuracy Total IgE Rapid Test Diagnosis Of Allergy

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CE 200IU/ML 98.6% Accuracy Total IgE Rapid Test Diagnosis Of Allergy

City & Province	hangzhou zhejiang
Categories	Drugs

Product Details

Accurate Total IgE Rapid Test with 98.6% Overall Accuracy CE Approved

Principle	Chromatographic Immunoassay
Format	Cassette
Specimen	WB/S/P
Certificate	CE
Reading Time	5 minutes
Pack	10 T
Storage Temperature	2-30°C
Shelf Life	2 Years
Sensitivity	98.40%
Specificity	98.70%
Accuracy	98.60%
Cut-Off	200 IU/mL

Application:

The IgE Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of human IgE antibody in whole blood, serum or plasma to aid in the diagnosis of allergy.

Description:

The IgE Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, lateral flow immunoassay for the detection of human IgE antibody in whole blood, serum or plasma specimens. In this test, mouse anti-human IgE is coated in the test line region of the test.

During testing, IgE present in whole blood, serum or plasma specimen reacts with mouse anti-human IgE coated particles in the test strip. The mixture then migrates forward on the membrane by capillary action and reacts with the mouse anti-IgE on the membrane in the test line region. The presence of a colored line in the test line region indicates a positive result for IgE, while its absence indicates a negative result for that infection.

To serve as a procedural control, a colored line will always appear in the control line region of the strip indicating that proper volume of specimen has been added and membrane wicking has occurred.

How to use?

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within 1 hour.

2. Place the cassette on a clean and level surface.

For Serum or Plasma specimen:

Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50μL) to the specimen well, and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75μL) to the specimen well, then add 1 drop of buffer (approximately 40μL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

Fill the capillary tube and transfer approximately 75μL of fingerstick whole blood specimen to the specimen well of test cassette, then add 1 drop of buffer (approximately 40μL) and start the timer. See illustration below.

3. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10 minutes.

Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.

【INTERPRETATION OF RESULTS 】

(Please refer to the illustration above)

POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the test line region.

*NOTE: The intensity of the color in the test line region may vary depending on the concentration of human IgE antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

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