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This document outlines the safety and effectiveness of the IMMULITE® 2000 3gAllergyTM Specific IgE assay, including device details, clinical performance, and regulatory information for measuring
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How to fill out immulite 2000 3gallergytm specific
How to fill out IMMULITE® 2000 3gAllergyTM Specific IgE Assay
01
Gather all necessary materials including the IMMULITE® 2000 instrument, sample tubes, and reagents.
02
Prepare the sample by collecting the patient's serum in a designated tube.
03
Ensure the serum sample is properly labeled with patient information.
04
Set up the IMMULITE® 2000 instrument according to the manufacturer's instructions.
05
Calibrate the instrument as required using control samples.
06
Load the patient samples onto the instrument and select the appropriate assay parameters.
07
Start the assay and monitor the system for any errors or alerts.
08
Once the assay is complete, retrieve the results and analyze them according to clinical guidelines.
09
Document the results in the patient's medical record.
Who needs IMMULITE® 2000 3gAllergyTM Specific IgE Assay?
01
Individuals experiencing allergy symptoms such as sneezing, itching, or rashes.
02
Patients with a history of allergic reactions or suspected allergies.
03
Healthcare providers looking to diagnose specific allergies in patients.
04
Researchers studying the prevalence of allergies in various populations.
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People Also Ask about
What is immulite used for?
Intended Use: IMMULITE Anti-HBc is a solid-phase chemiluminescent enzyme immunoassay designed for use on the IMMULITE automated immunoassay analyzer for the qualitative detection of total antibodies against hepatitis B core antigen (anti-HBc) in human serum or plasma (EDTA, heparinized, citrate).
What is considered a very high IgE level?
A very elevated IgE level (1000 ≥ IgE < 10,000 kU/L) is not uncommon in patients with active eczema but is suggestive of a monogenic atopy disorder or one of the hyper-IgE immunodeficiency syndromes in which extremely high total serum IgE levels (IgE ≥ 10,000 kU/L) may be found.
What is the IgE range for allergies?
The total IgE reference range depends on the age of the individual (it ranges from 0 to 4 kU/L in a newborn and 0 to ~148 kU/L in an older child or adult). The result of a specific IgE test is reported for a grouped allergen mix or an individual allergen.
What is Immulite 2000?
Assays. The IMMULITE 2000 XPi system offers an extensive IA testing menu, with approximately 100 assays covering 16 disease states, including anemia, diabetes, growth, metabolic, reproductive endocrinology, thyroid, TORCH, and infectious disease, as well as approximately 320 specific allergens.
What level of IgE indicates allergy?
An elevated IgE level (100 ≥ IgE < 1000 kU/L) indicates allergy, eczema, or chronic skin infection.
How do I read my IgE allergy test results?
How To Interpret Results Values under 0.35 mean unlikely sensitization to the allergen. Values between 0.35-0.69 mean doubtful significance. Values between 0.70-3.49 mean there is a possibility. Values between 3.50-17.49 mean a greater possibility. Values between 17.50-49.99 mean very likely.
What is the normal range for specific IgE?
Allergen Specific IgE levels can be reported in grades (0 to 6) or in units (KUA/L). Normal value is <0.35 KUA/L or grade 0.
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What is IMMULITE® 2000 3gAllergyTM Specific IgE Assay?
The IMMULITE® 2000 3gAllergyTM Specific IgE Assay is a diagnostic test designed to measure specific immunoglobulin E (IgE) antibodies in response to various allergens. It is used to help diagnose allergic conditions.
Who is required to file IMMULITE® 2000 3gAllergyTM Specific IgE Assay?
Clinical laboratories and healthcare providers who perform allergy testing on patients are required to file the IMMULITE® 2000 3gAllergyTM Specific IgE Assay as part of their diagnostic services.
How to fill out IMMULITE® 2000 3gAllergyTM Specific IgE Assay?
To fill out the IMMULITE® 2000 3gAllergyTM Specific IgE Assay, healthcare professionals must collect blood samples, process them according to the manufacturer's instructions, and enter the necessary patient and test information into the laboratory information system.
What is the purpose of IMMULITE® 2000 3gAllergyTM Specific IgE Assay?
The purpose of the IMMULITE® 2000 3gAllergyTM Specific IgE Assay is to identify specific allergens that may be causing allergic reactions in patients, thereby aiding in effective management and treatment of allergies.
What information must be reported on IMMULITE® 2000 3gAllergyTM Specific IgE Assay?
The information that must be reported includes the patient’s identification details, the tested allergens, IgE levels for each allergen, and any relevant clinical interpretation or recommendations based on the results.
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