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This document outlines the safety and effectiveness of the IMMULITE 2000 3gAllergy Specific IgE Assay, a diagnostic tool for measuring allergen-specific IgE levels in human serum, intended for use

How to fill out immulite 2000 3gallergy specific

How to fill out IMMULITE 2000 3gAllergy Specific IgE Assay Kit Summary

1. Step 1: Gather all necessary materials including the IMMULITE 2000 3gAllergy Specific IgE Assay Kit and required equipment.
2. Step 2: Read the manufacturer's instructions and ensure you understand the assay procedure.
3. Step 3: Prepare the samples as outlined in the kit's guidelines, ensuring proper handling and storage.
4. Step 4: Calibrate the IMMULITE 2000 instrument according to the instructions to ensure accurate measurement.
5. Step 5: Add the samples to the appropriate wells on the assay plate as specified.
6. Step 6: Incubate the plate for the recommended time at the specified temperature.
7. Step 7: Perform any necessary washes to remove unbound substances as described in the kit instructions.
8. Step 8: Add the detection reagents and incubate as directed.
9. Step 9: Measure the optical density using the IMMULITE 2000 analyzer.
10. Step 10: Record the results and interpret according to the provided reference values.

Who needs IMMULITE 2000 3gAllergy Specific IgE Assay Kit Summary?

1. Healthcare professionals who diagnose allergies.
2. Laboratories that require detailed allergy testing.
3. Clinics that specialize in allergy management.
4. Researchers conducting studies on allergic responses.
5. Patients requiring allergy assessments by their healthcare providers.

People Also Ask about

What is the principle of ImmunoCAP?

Singleplex ImmunoCAP assays are based on binding of allergen-specific IgE antibodies in serum or other body fluids to allergen (extract or allergen molecule) coupled in excess to a solid phase.

How do you interpret an IgE test?

What do the results mean? A total IgE test result that is high means that you may have some kind of allergy. But the results of a total IgE test don't show what you're allergic to or how serious your allergy may be. A specific IgE test result that is high means that you may be allergic to the allergen that was tested.

What is the principle of the assay?

An assay usually aims to measure an analyte's intensive property and express it in the relevant measurement unit (e.g. molarity, density, functional activity in enzyme international units, degree of effect in comparison to a standard, etc.).

What is the principle of ImmunoCAP assay?

ImmunoCAP™ blood tests are sandwich assays, which means that the solid phase ensures binding of all relevant antibodies. This is achieved through an optimized amount of cellulose material with a very large surface area providing a uniquely high binding capacity in each ImmunoCAP test.

What is the best method for detection of allergen specific IgE?

Skin Test (SPT): This represents the first level of approach for the diagnosis of type I, immediate, IgE-mediated allergy. It is safe, has high sensitivity and good specificity when performed and interpreted correctly; a specific variant of type I skin tests is -to- testing (PPT) with native allergens.

How does an ImmunoCAP test work?

ImmunoCAP Immuno-Solid phase Allergy Chip IgE antibodies from the patient's blood sample bind to the immobilised allergen components on the slide, and allergen-bound IgE antibodies are then detected using fluorescence-labelled anti-IgE antibodies.

What is the principle of immunological assay?

Mixing a sample with labelled antibodies, the targeted analyte is bound by labelled antibodies. The unbound, labelled antibodies are washed away, and the bound, labelled antibodies are measured. The intensity of the signal is directly proportional to the amount of analyte in the sample.

What is an immunoassay test for allergies?

Enzyme-Linked Immunosorbent Assay (ELISA): ELISA is a widely used and versatile immunoassay technique in allergen testing. It involves the use of an enzyme-labeled antibody that binds to the allergen-specific antibodies in the patient's serum.

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What is IMMULITE 2000 3gAllergy Specific IgE Assay Kit Summary?

The IMMULITE 2000 3gAllergy Specific IgE Assay Kit is designed for the quantitative measurement of allergen-specific IgE in human serum or plasma, aiding in the diagnosis of allergic conditions.

Who is required to file IMMULITE 2000 3gAllergy Specific IgE Assay Kit Summary?

Laboratories and healthcare providers utilizing the IMMULITE 2000 system for allergy testing are required to file the summary to ensure proper tracking and regulatory compliance.

How to fill out IMMULITE 2000 3gAllergy Specific IgE Assay Kit Summary?

To fill out the summary, gather all relevant testing data, including patient information, assay results, and date of testing, and enter it into the specified format indicating test-specific details as required by laboratory protocols.

What is the purpose of IMMULITE 2000 3gAllergy Specific IgE Assay Kit Summary?

The purpose of the summary is to provide a comprehensive record of the IgE testing performed, enabling tracking of results and ensuring compliance with regulations and quality standards in allergy diagnostics.

What information must be reported on IMMULITE 2000 3gAllergy Specific IgE Assay Kit Summary?

The information that must be reported includes patient identification details, date and time of sample collection, allergen specifics, assay results, and laboratory personnel involved in the testing process.