OPTIGEN AP3600 & CLA-1 Allergen Specific Assays

OPTIGEN allergen-specific IgE assay panels for AP3600 and CLA-1

The OPTIGEN® Allergen-Specific IgE Assay provides semiquantitative measurement of allergen-specific IgE antibodies in human serum. Preconfigured environmental, food, inhalant and mixed panels support multiplex testing of up to 36 allergens, depending on the selected panel and instrument. Compatible panel menus vary between the AP3600™ and CLA-1™ systems; contact Jant Pharmacal to confirm the correct configuration.

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Product Overview

The OPTIGEN® Allergen-Specific IgE Assay is a preconfigured, multiplex in vitro diagnostic test designed for the semiquantitative measurement of circulating allergen-specific IgE antibodies in human serum. The assay is intended to aid in the clinical diagnosis of IgE-mediated allergic disorders when used together with other clinical findings.

OPTIGEN panel testing allows multiple environmental or food allergens to be evaluated from one serum sample. Depending on the selected panel and compatible testing platform, a laboratory can obtain as many as 36 allergen-specific IgE results from a single pette.

Panel compatibility is instrument-specific. The OPTIGEN AP3600 uses the US Environmental 36 and US Food 30 panels. The CLA-1 Luminometer is used with its designated OPTIGEN panel configurations. Always confirm the correct panel, package size and current labeling for the instrument being used.

Up to 36 Allergens

Multiplex panel testing provides multiple allergen-specific IgE results from one patient sample.

Preconfigured Panels

Environmental, food, inhalant and mixed panel configurations are available by instrument.

Human Serum Testing

Designed for professional laboratory measurement of allergen-specific IgE in human serum.

Choose the Correct Panel for Your Instrument

For the OPTIGEN AP3600

  • OPTIGEN US Environmental 36
  • OPTIGEN US Food 30

The AP3600 fully automates the OPTIGEN assay from sample tube through result and processes up to 50 pettes per run.

For the CLA-1 Luminometer

  • OPTIGEN Inhalant US 36
  • OPTIGEN Food US 20
  • OPTIGEN Mix US 36
  • OPTIGEN Environmental 36
  • OPTIGEN Food 29

The CLA-1 reads processed OPTIGEN pettes from the manual assay workflow. Contact Jant to confirm currently available CLA-1 panels and configurations.

Panel names and availability are based on current manufacturer information. Do not substitute panels between instruments without confirming compatibility in the current instructions for use.

Assay Information

Assay OPTIGEN® Allergen-Specific IgE Assay
Intended Use Semiquantitative determination of circulating allergen-specific IgE concentrations in human serum; intended to aid in the clinical diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings
Method Solid-phase chemiluminescent immunoassay
Specimen Human serum
Format Preconfigured multiplex pette containing multiple allergens and assay controls
Maximum Panel Size Up to 36 allergens, depending on the selected panel
Compatible Systems OPTIGEN AP3600 and CLA-1 Luminometer, using the panels designated for each instrument
Use Environment Professional clinical laboratory; prescription use
Result Interpretation Semiquantitative result classes; interpret according to the current platform- and panel-specific instructions for use

OPTIGEN US Environmental 36 Allergen Menu

For use with the OPTIGEN AP3600. This preconfigured panel includes 36 environmental allergens.

Trees

Acacia, American Sycamore, Ash, Black Alder, Black Walnut, Boxelder Maple, Eastern Cottonwood, Mesquite, Mountain Cedar, Olive, White Birch, White Elm, White Mulberry and White Oak.

Grasses

Bahia, Bermuda and Timothy.

Weeds

Cocklebur, English Plantain, Lamb’s Quarters, Mugwort, Nettle, Pigweed, Ragweed Mix I, Rough Marshelder, Russian Thistle and Sheep Sorrel.

Molds

Alternaria, Aspergillus, Cladosporium and Penicillium.

Danders

Cat and Dog.

Dust Mites

Mite Farinae and Mite Pteronyssinus.

Insect

Cockroach Mix.

OPTIGEN US Food 30 Allergen Menu

For use with the OPTIGEN AP3600. This preconfigured panel includes 30 food allergens.

Fish and Seafood

Clam, Codfish, Crab, Salmon, Shrimp and Tuna.

Grains

Corn, Wheat and White Rice.

Fruit

Banana, Orange and Strawberry.

Vegetables

Carrot, Garlic, Onion and Potato.

Legumes

Pea, Peanut and Soybean.

Nuts and Seeds

Almond, Cashew, Hazelnut, Sesame Seed and Walnut.

Dairy

Cheddar Cheese and Milk.

Meat

Chicken and Pork.

Egg

Egg White.

Other

Baker’s Yeast.

How the OPTIGEN Assay Works

The OPTIGEN pette contains a solid phase coated with multiple allergens or allergen mixes. During processing, allergen-specific IgE in the patient serum binds to the corresponding allergen. After washing, an enzyme-labeled anti-human IgE antibody and photoreagents are used to produce a chemiluminescent signal.

The amount of emitted light corresponds to the allergen-specific IgE response and is measured by the compatible instrument. The system reports semiquantitative result classes according to the applicable instrument and assay labeling.

Results must be interpreted by qualified healthcare professionals together with the patient’s clinical history and other relevant findings.

Compatible Allergy-Testing Systems

Review the compatible instrument pages before selecting an OPTIGEN panel. Jant Pharmacal can help confirm the appropriate instrument, panel configuration, controls and consumables for the laboratory’s testing needs.

View the OPTIGEN AP3600 View the CLA-1 Luminometer Browse Allergy Diagnostics Request an ROI Proposal

Important Product Information

  • The OPTIGEN assay is an in vitro diagnostic test for prescription use in professional clinical laboratories.
  • Results are intended to aid in the diagnosis of IgE-mediated allergic disorders and must be considered together with clinical history and other findings.
  • AP3600 and CLA-1 panel menus are not identical. Confirm that each panel is designated for the instrument being used.
  • Follow the current instructions for use for specimen requirements, reagent preparation, quality control, storage, processing and result interpretation.
  • Billing and coding information is provided for reference only. Providers are responsible for determining medical necessity, coverage and appropriate coding.
  • Panel availability, part numbers, package sizes and specifications may change. Confirm current information with Jant Pharmacal before ordering.

Documentation and Resources

Review the current OPTIGEN panel brochure and related system information. Contact Jant Pharmacal for the current instructions for use, safety documentation and ordering information applicable to the selected panel and instrument.

OPTIGEN Environmental 36 and Food 30 Brochure OPTIGEN AP3600 System Brochure Manufacturer OPTIGEN Assay Page

Frequently Asked Questions

The OPTIGEN assay provides a semiquantitative measurement of circulating allergen-specific IgE antibodies in human serum. It is intended to aid in the clinical diagnosis of IgE-mediated allergic disorders when considered with other clinical findings.

The assay uses human serum. Follow the current instructions for use for specimen collection, preparation, storage and handling requirements.

Depending on the selected panel, a single OPTIGEN pette can test as many as 36 allergens simultaneously.

The manufacturer currently lists OPTIGEN US Environmental 36 and OPTIGEN US Food 30 for the AP3600. Confirm the current panel and package configuration before ordering.

The manufacturer lists OPTIGEN Inhalant US 36, Food US 20, Mix US 36, Environmental 36 and Food 29 panel configurations for the CLA-1. Contact Jant to confirm current availability and ordering information.

Do not assume that panels are interchangeable. The AP3600 and CLA-1 have different listed panel menus. Use only the panel and package configuration identified as compatible in the current manufacturer instructions.

The Environmental 36 panel includes selected trees, weeds, grasses, molds, cat and dog dander, dust mites and cockroach mix. The complete list is provided on this page and in the current OPTIGEN brochure.

The US Food 30 panel includes selected fish and seafood, grains, fruits, vegetables, legumes, nuts and seeds, dairy, meat, egg white and baker’s yeast. The complete list is provided on this page and in the current OPTIGEN brochure.

No. OPTIGEN results are intended to aid in the clinical diagnosis of IgE-mediated allergic disorders. Results must be evaluated by qualified healthcare professionals together with the patient’s clinical history and other relevant findings.

Yes. Jant Pharmacal can help the laboratory review the AP3600 and CLA-1 system options, compatible panels, controls, consumables and available ROI-assessment resources.

Ordering Information

To confirm panel compatibility, availability or pricing, call Jant Pharmacal at 800.676.5565

Catalog/Part Number Description Package
85268 OPTIGEN® US Environmental 36 for AP3600™ 100 tests
85267 OPTIGEN® US Food 30 for AP3600™ 100 tests
80109 OPTIGEN® Control Reagent Positive and negative controls; 4 tests
95409 AP3600™ Sample Cups 1,000 cups
71312 AP3600™ Sample Transfer Tips 500 tips/bag
95418 AP3600™ Pette Tips 500 tips/bag

Contact Jant Pharmacal for current CLA-1 compatible panel numbers, package configurations and availability. Please confirm all catalog numbers and package sizes at the time of quotation.