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GBR-3112 |
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IgE Test (Cassette) GBR-3112
“Export use Only”
Total-IgE Rapid Test is a one-step qualitative immunoassay for the detection of elevated levels of immunoglobulin E (total IgE) in human serum or plasma. This human IgE rapid test is an aid for diagnosis of allergic reactions and autoimmune disorders.
Materials provided with the Total-IgE Rapid Test Kits:
1. Testing Device
2. Sample Dropper
3. Test Instructions
Materials required, not provided:
1. Specimen collection container
2. Clock or timer
3. Centrifuge
IgE Rapid Test Background Information
An elevated concentration of IgE in serum is a common symptom associated with allergic pathologies; it may also becaused by autoimmune diseases and some infections. Rapid detection of elevated levels of IgE using the Diagnostic Automation Total- IgE Test will help in the diagnosis and treatment of IgE-mediated allergic and autoimmune disorders.
IgE Rapid Test Principle
The test utilizes the sandwich immunodetection principle. Dye conjugated polyclonal antibody against human IgE and immobilized mouse monoclonal anti-human IgE antibody bind to IgE in the sample specimen to produce a distinctive visual pattern registering IgE concentrations of 80 IU/ml and higher. In the test procedure, patient serum or plasma is added to the sample well “S” of the test device with the aid of a sample dropper. Labeled antibodydye conjugate binds to the human IgE molecules present in the specimen forming an antigen- antibody-dye complex. When the total IgE concentration is at or above the sensitivity level of the test, a visual test band forms in the test zone “T”. For additional details please refer to the instructions for use.
For a complete list of Rapid Tests, ELISA tests, IFA Kits, Serology Tests, and available testing Instrumentation, please visit our website home page or contact our Customer Service Representatives at 818-591-3030.
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Directions for use:
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- Remove the test device from its foil wrapper by tearing along the slice.
- Using the specimen dropper, withdraw urine sample from the specimen cup and slowly dispense three drops (approx 120 UI) into the circular sample well.
- Be careful not to overfill the absorbent pad.
- Read results after 5 minutes.
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- For medical and other professional in vitro diagnostic use only.
- Do not use after expiration date.
- The test device should remain in the sealed pouch until use.
- The test is for single use only. Do not reuse.
- Wearing gloves is recommended.
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- Store as packaged in the sealed pouch at anywhere between 2-30° (36-46°F).
- The test is stable through to the expiration date printed on the sealed pouch.
- The test must remain in the pouch until use.
- Do not freeze.
- Do not use beyond the expiration date.
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- Positive: One colour line appears in the control region. No line appears in the test region.
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- Invalid: Control line fails to appear.
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