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©Hitachi Chemical Diagnostics, Inc. All rights reserved.Doc. No. 0690 Rev. 01OPTIGEN is a registered trademark and CLA-1 is a tademark of Hitachi Chemical Diagnostics, Inc. in the United States and other countries.

Allergies and the OPTIGEN®

ALLERGEN-SPECIFIC IgE ASSAYAlways follow your doctor’s instructions carefully.

1 Sly RM, Changing prevalence of allergic rhinitis and asthma, Annals of Allergy, Asthma & Immunology, Vol 82, March 1999, p233-248.2 Nolte, H, Undiagnosed Asthma & Allergy; Nursing & Patient Care– Allergy Diagnosis, Private Hospital Healthcare Europe; 2001.

What is an Allergy? An allergy is an overreaction of the body’s immune system to an ordinarily harmless substance. Allergies are not just seasonal. They exist throughout the year, indoors and out, and affect people of all ages. Allergies can impair perfor-mance, interfering with sleep, cognitive skills and even physical ability. Occasionally, allergies can cause anaphy-laxis, a potentially life threatening reaction.

Many things in our every day lives can trigger an allergic reaction, including animal dander, housedust and mites, foods, grasses, trees, weeds, and molds.

Animal Dander… Traditionally, fur is believed to cause allergic reaction to animals, but researchers have found the cause to be proteins secreted by oil glands in the animal’s skin. Dander, saliva, and urine, which carry these proteins, eventually dry up and release the proteins into the air.

Housedust and Mites… This allergic reaction results from the airborne waste product of Dust Mites, tiny organisms that live in the dust of things like bedding, upholstered fur-niture, drapes and carpets.

Foods… Many different things can cause an allergic reac-tion to a certain food. In a typical food allergy, the immune system produces antibodies to a specific food. Commonly troublesome food allergens include milk, egg white, peanut, soybean and wheat.

Grasses, Trees and Weeds… In warmer months, tiny particles of pollen are released into the air where they can enter human noses and throats, triggering an allergic reac-tion. Patients suffering from seasonal “hay fever” may also have sensitivities to other, more perennial allergens such as housedust. Sensitivities to such perennial allergens may contribute to the severity of seasonal symptoms.

Molds… Molds, much like pollens, release spores into the air where they can enter human noses and throats, trigger-ing an allergic reaction. Mold allergies can be perennial or seasonal depending on the geographic area and are most noticeable in damp environments or on windy days.

Who Gets Allergies?Over the past decade, allergic sensitization symptoms have been increasing dramatically in western culture. The inci-dence of allergy has been reported as 20 to more than 40 percent of the population and it is generally noted that at least one out of every four children suffers from allergies.1,

2

People who suffer from allergies are often sensitive to more than one thing. Their symptoms may not appear until they are exposed to an intolerable amount of a single allergen or smaller amounts of multiple allergens. This makes it important to identify the specific allergens responsible. With this information, a plan for prevention or treatment can make the difference between a chronic illness and a productive, healthy lifestyle.

With its headquarters in the heart of Silicon Valley and offices around the world, Hitachi Chemical Diagnostics is a global leader of in vitro allergy diagnostics with a legacy of innovation. Hitachi Chemical Diagnostics was the first company to introduce a multiple format diagnostic test reporting individual allergy test results and one of the first to introduce a chemiluminescent assay system for the detection of these specific lgE antibodies.

Hitachi Chemical Diagnostics, an integral member of the Hitachi Group, works with industry leaders, laboratories and distributors around the world to provide the medical community access to the latest in vitro allergy testing technology. Hitachi Chemical Diagnostics is committed to innovation, quality, and the strength of the Hitachi brand. Our products are marketed to over 40 countries worldwide. To learn more about Hitachi Chemical Diagnostics and the OPTIGEN® Allergy Test, please contact us, or your local representative, or visit us on the web at www.hcdiagnostics.com.

T E CHNO LOGY I N A C T I O N

Early Signs of Allergy Proper diagnosis is particularly useful in children where the identification of early sensitivities is important for predicting allergic disease later in life. In the first years of life, eczema, gastrointestinal symptoms and recurrent wheezing are indicators of possible allergy. Food allergy, mainly to egg or cow’s milk, account for a large portion of allergic sensitization and symptoms in this age group. Researchers also believe eczema early in life is a predictor of asthma later in childhood. Some babies simply grow out of the problem while others with recurring symptoms are at risk for allergic disease later in childhood. IgE antibodies in this youngest age group can be predictive of further sensitizations and symptoms. Inhalant aller-gies that provoke seasonal and perennial asthma as well as allergic rhinitis and allergic conjunctivitis more com-monly develop in children as they grow older. Medical intervention at a young age may alter the course of development of this subsequent allergic disease.

Hitachi Chemical Diagnostics proudly supports scientific research into allergic disease. For more information about early allergy diagnosis, please contact Hitachi Chemical Diagnostics for a free copy of the EAACI symposium abstract booklet, “The Importance and Benefit of Early Detection of IgE-Mediated Disease.”

Diagnosing AllergiesGeneral practitioners and pediatricians are responsible for identifying allergic patients. These ‘front-line’ doctors screen suspected individuals to (1) identify the allergen; (2) establish a causal relationship between exposure and the occurrence of symptoms; and (3) identify the immunological mechanism involved. To establish the immunologic mechanism, allergen-specific antibodies called IgE must be identified and measured. This is done by skin prick testing or in vitro allergy testing.

Skin Prick Testing… An allergy specialist usually per-forms skin testing after a referral from a general practi-tioner. There are no age limits for skin testing. Results are usually available within 20 minutes.

Commonly performed on the forearm and sometimes the back, the skin is cleaned with alcohol and an allergen extract is pricked into the skin. If an allergy is present, a small itchy bump and surrounding redness often referred to as a ‘wheal and flare’ will appear in approximately 15–20 minutes. This indicates the presence of IgE anti-bodies capable of recognizing the shape of that specific allergen, like a lock “recognizes” a key.

There are some side effects of skin testing. Medications with anti-histamine-like actions including commonly used anti-depressants and sleep aids must usually be

Once an allergy diagnosis is made, a specific treatment program can begin. Allergy management falls into three main categories: avoidance, medication and immuno-therapy.

Avoidance… Once the source of an allergy is identified, one cure may be to simply remove or control it. This approach is most effective with food and animal allergies. In addition to standard heating and cooling air filters, portable devices can be especially helpful in reducing animal allergens in individual rooms. As for outdoor air-borne allergens such as pollens and mold spores, it is obviously difficult to effectively diminish an individual’s exposure especially during the seasons in which they are abundant.

Allergy avoidance literature is readily available and can serve as a useful tool in coping with allergy and asthma symptoms. It is always recommended that patients comply with their physicians’ recommendations first.

Pharmacotherapy (Medication)… Effective new pre-scription drugs can reduce allergy symptoms. Many are often effective immediately, producing benefits by neu-tralizing the effects of the histamine released in an aller-gic reaction. However, drugs are expensive and may have side effects. They are best used as a part of an overall allergy treatment program.

Immunotherapy (Allergy Shots)… Injections are given frequently in scheduled doses of gradually increasing concentrations using extracts containing allergens to which the patient has specific IgE antibodies. The objective is to gradually desensitize the body to the offending allergens while ultimately diminishing the frequency of the injections and then discontinuing the injection program.

Immunotherapy can be effective and should be consid-ered only when the patient's test results, symptoms and clinical history have been carefully evaluated.

It is important to note that food allergies differ from inhal-ant allergies due to different routes of contact and poten-tially greater exposure volume. Although there are studies currently underway, immunotherapy is not yet an option. Avoidance of the identified food that causes specific allergic symptoms is recommended. A small percentage of individuals develop severe, life threatening sensitivity to a single food and must avoid all contact for their entire life. Most food allergies are not so severe but are generally still best treated by avoidance. A carefully crafted elimination diet is used to confirm a food allergy. If the results are not clear, the best approach is a place-bo controlled food challenge. This should be performed by an allergist in a medical setting since there is a risk of a serious allergic reaction.

Class

0 0 - 26 No antibodies detected. Consider non-

allergic causes.

Consider further testing (infectious diseases, etc.) & treatment options.

1 26 - 65

66 - 142

Low levels of antibodiesdetected. Undeterminedclinical relevance. May

be a risk factor forfuture sensitization.

Consider further specific IgE testing inrelevant category and as suggested by

patient history. Consider treatment options.

Moderate levels ofantibodies detected.Probably contributing

to symptoms.

Consider further specific IgE testing in relevant category and as suggested by

patient history. Consider treatment options.

Lumi Units(LU)

ClinicalCorrelation

ManagementOptions

2

143 - 242 High levels ofantibodies detected.Clinically relevant.

Consider treatment options:Indoor• Environmental control may be effective. • Consider pharmacotherapy. • Consider referral to an allergy specialist. Outdoor• Consider pharmacotherapy. • Consider referral to an allergy specialist.

3

> 242 Very high levels ofantibodies detected.

Highly clinically relevant.

4

avoided for three to thirty or more days before testing so as not to interfere with test results. After testing, swelling and itching typically resolve within an hour. However, for some patients swelling may persist for days. On occassion, a generalized allergic reaction may be provoked by skin testing.

In Vitro Testing… Performed in vitro, or ‘outside the body,’ this laboratory test can measure specific IgE levels in patient serum. Medications need not be discontinued as they do not interfere with the reliability and performance of the test. General practitioners and pediatricians draw a small amount of blood during an office visit, send it to a lab and usually receive the results within 48–72 hours.

Many professional medical societies recommend the use of objective measures like the OPTIGEN® Allergen-Specific IgE Assay to confirm the diagnosis of allergy in symp-tomatic patients.

Hitachi Chemical Diagnostics’ OPTIGEN technology is helping more doctors comfortably diagnose allergic disease. The OPTIGEN Universal Panel 20 is optimized to cover the most prevalent food and inhalant allergens to which a person might be sensitized. Additionally, OPTIGEN requires minimal serum to be drawn, enabling early diagnosis in children.

Interpretation of OPTIGEN® Allergy Test ResultsOPTIGEN allergy test results are assigned a class value ranging from zero (0) to four (4). Class one (1) and increas-ingly positive tests indicate the presence of antibodies to that specific allergen, with a Class four (4) representing the highest degree of response. Class zero (0) represents absent or non-detectable levels of allergen-specific anti-bodies. The following information may be useful in inter-preting positive results and their clinical relevance.