News & Topics

Jan 05, 2010

Addition of test items for cedar pollen and egg allergy and others. Meeting pediatric needs through rapid testing.

ARKRAY, Inc. the manufacturer of clinical test devices and in vitro diagnostic medicines (head office: Nakagyo Ward, Kyoto City) is announcing the 9 January release of two types of reagent, with a total of 8 items, for use with the rapid test device, SPOTCHEM IL SL-4720 in pediatric clinics:

Allergy (specific IgE)test reagent, SPOTCHEM i-Line IgE Series
Group A streptococcus test reagent, SPOTCHEM i-Line StrepA

Superb rapid test reagents for improving the quality of pediatric clinic care These products are currently only available for sale within the Japanese domestic market.

◆Allergy (specific IgE) test reagent SPOTCHEM i-Line IgE series
One in ten children in Japan*1  are said to have a food allergy. The ingestion of certain foods may result in itchiness, coughing, blocked noses, vomiting or many other symptoms. Some of these symptoms are serious, such as breathing difficulties or loss of consciousness so early treatment comprising early diagnosis and the appropriate diet are important.

In addition, the total infant population with asthma has now reached 73,000 patients *2 and in most of these a reaction can be triggered by pet hair or pollen. So for these inhalant allergens too, early diagnosis, and sound treatment is important in prevent the deterioration of patient condition.

Yet approximately 90 percent of allergy testing in pediatric clinics is outsourced which means there are extended periods between testing and the diagnosis/ commencement of treatment. The little testing that has traditionally been performed at clinics has been of the visual-read variety with associated person-to-person differences in result interpretation and problems associated with hand-writing results onto medical charts.

With the SPOTCHEM i-Line IgE series the measurement of a single item takes approximately 20 minutes.
• Food allergies: egg white, egg yolk, ovomucoid (heat resistant protein) 2),
  milk & wheat

• Inhalant allergies: cat dander, cedar *a reagent for house dust mite allergies is   scheduled for the near future
With 20μL of blood (the size of a grain of rice) you can measure a maximum of 5 items at one time with results ranked according to 6 levels.
Compared with outsourced testing, the burden on the patient from blood sampling is reduced and the risk of differing individual result interpretation is prevented though device determination.

◆Group A streptococcus infection reagent, SPOTCHEM i-Line StrepA
Group A streptococcus is one of the bacterial causes of acute sore throat and tonsillitis. Together with fever and sore throat, the surface of the tongue may become red and lumpy resulting in what is called ‘strawberry tongue.’ In rare cases, acute kidney inflammation and rheumatic fever may result, in which case early diagnosis and treatment with antibiotics is critical. Children from age 5 to 15 are especially susceptible to infection and Strep A is the most in-demand infectious disease item for pediatric clinics, second only to influenza.

The SPOTCHEM i-Line StrepA reagent allows measurement of Group A streptococcus (Group A beta hemolytic streptococcal antigen) in 10 minutes, using throat swabs. This is the first measurement of its kind in Japan to use a small rapid test device.

Previously released reagents for the SPOTCHEM IL SL-4720 include those for influenza, the SPOTCHEM i-Line FluAB and CRP test reagent, SPOTCHEM i-Line CRP. Both these reagents allow for simple and rapid results which, in turn allows for speedy application of appropriate treatment. ARKRAY shall continue to build its product line so that it can continue to answer the needs of the medical field.

*1Ebisawa M. Sugizaki C: Allergy Clin. Immunol. 2008:121:912
*2Japanese Ministry for Education, Culture, Sports, Science and Technology Research Committee for the investigation  concerning allergy patients, 2007 report

Explanation of terminology

1) SPOTCHEM IL SL-4720
An automatic rapid testing device employing the immuno-chromatographic method, the SPOTCHEM IL SL-4720 was developed with the aim of simplifying, accelerating and improving the quality of immuno-chromatographic testing which is traditionally conducted via the visual-read
method in clinics.
With a less-than A4 size footprint, the device takes up
very little space.  You can write the patient name on the
cartridge and see it printed together with the results,
thus reducing the risk of mix-ups. (Patent pending)

100105_01.jpg

2) Ovomucoid
A heat resistant protein and one of the allergens in egg. Even if your egg white IgE test is positive, if your ovomucoid test is negative, you may be able to eat cooked eggs. Egg, together with milk is one of the main food allergens

Product outline

 1. Name

 SPOTCHEM i-Line IgE Series

 2. Specifications

 

   Measurement device

 SPOTCHEM IL SL-4720

   Measurement sample

 Blood serum, blood plasma, whole blood

   Measurement items

 Foods: Egg white, egg yolk, ovomucoid, milk, wheat
 Inhalants: cat dander, cedar

   Reaction principle

 Immuno-chromatographic method

   Storage method

 2-30 C

   Insurance points

 110 points

 1. Name

 SPOTCHEM i-Line IgE Series

 2. Specifications

 

   Measurement device

 SPOTCHEM IL SL-4720

   Measurement sample

 Throat swab

   Measurement items

 Group A beta-hemolytic streptococcal antigen

   Reaction principle

 Immuno-chromatographic method.

   Storage method

 2-30 C

   Insurance points

 140 points

These products will go on sale via ARKRAY’s Japanese domestic sales company, ARKRAY Marketing, Inc.