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May 10, 2011

New in vitro diagnostic reagents and analyzer for various allergens
Launch announcement for Allerport® HRT and its dedicated analyzer, the Allerport HRT System

Tokyo, Japan, May 10 2011 --- Kyowa Medex Co., Ltd. ("Kyowa Medex") announced today the release of two products on May 16 2011. The first, developed by Shionogi & Co., Ltd. (Head office: Osaka) is Allerport® HRT, in vitro diagnostic reagent for measuring the histamine released due to allergens (histamine release test, or HRT); the test kit assists in the diagnosis of the antigens that cause type I allergies. The second product, an analyzer developed by Kyowa Medex specifically for Allerport® HRT, is an enzyme immunoassay system called the Allerport HRT System.

Allerport® HRT is a histamine release test kit that uses a cell response assay to measure the amount of histamine released from blood cells (basophils) triggered by allergens.
The Allerport HRT System is a fully automated device for measuring histamine release. Previously, the cell separation, histamine release reaction, immune competitive reaction, and color absorbance measurement process have been performed manually, but Allerport HRT System can now fully automate the entire assay process.

A histamine release test (HRT) helps to diagnose the allergens that cause diseases characterized by allergic reactions such as food allergies, allergic rhinitis, atopic asthma, some atopic dermatitis, and hives. This test is highly specific and therefore will contribute to accurate diagnosis.

The test results from Allerport® HRT are measured using the dedicated the enzyme immunoassay device, Allerport HRT System, which simplifies daily test procedures and enables quick measurements of the necessary allergens among 32 choices.

Kyowa Medex has been focusing on developing, manufacturing and marketing of in vitro diagnostic reagents and analyzers, and we endeavor to help to improve people's quality of life by responding to their medical needs.

Allerport® HRT product overview
Product name: Allerport® HRT
Intended use: Measurement of blood cell releasing histamine ( triggered by allergens*) (To assist in the diagnosis of antigens that cause type I allergies) (*Egg whites, milk, Dermatophagoides pteronyssinus, ragweed; wheat, rice, buckwheat, peanuts, soy, crab, shrimp, pork, beef, tuna, salmon, egg yolk, chicken, ovalbumin, ovomucoid, Dermatophagoides farinae, cat epithelium, dog epithelium, dog dander, orchard grass, house dust, lysozyme, candida, Alternaria, Japanese cedar, Japanese cypress, mugwort, human sweat)
Measurement method: Enzyme immunoassay
Measurement sample size: 1.2 mL of blood to measure 1 allergen
(Add 0.2 mL for each additional allergen)
Measurement reaction time: 60 min.
Storage conditions and shelf life: 18 months, stored at 2 to 8°C and protected from light (for soy and human sweat: 12 months)
Manufacturer: Shionogi & Co., Ltd.
Distributor: Kyowa Medex Co., Ltd.

Allerport HRT System overview
Product: Allerport HRT System
Measurement principle: Enzyme immunoassay
Detector: Spectrophotometric measurement
Number of simultaneous measurements: Maximum of 30 items
Sample capacity: 20
Reagent capacity: 7 reagents (chilled), 40 reagents other than allergens (chilled), 1 reagent (room temperature)
Throughput: 120 tests/hour
Measurement time: 60.5 min. (31.5 and 29 min.)
Temperature setting: 30 to 45 ± 0.1°C
Dimensions and weight: 1000 x 750 x 800 (WDH in mm), 165 kg
Manufacturer and distributor: Kyowa Medex Co., Ltd.

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