News & Topics

Jul 27, 2015

Providing Total Support for Diabetes Testing
- New Release of Quality Control Product for Diabetes Testing -

ARKRAY, Inc. will release B-analyst HbA1c control, a new quality control product for HbA1c (hemoglobin A1c)*1 tests, an indispensable testing item for diabetes, on Monday, July 27th, 2015. With the release of this quality control product,*2 that monitors the accuracy of diabetes testing, ARKRAY shall provide total support for diabetes testing.

B-analyst HbA1c control released from ARKRAY, Inc.(ARKRAY hereafter), is a dedicated control product for use with HbA1c measurement using the SPOTCHEM BANALYST series of instruments.

Since diabetes treatment requires long term observation, a high level of accuracy is required for test instruments and reagents and, in recent years, the quality control aspects have also become very important. Operational guidelines for measurements in sample measurement rooms*3 at pharmacies and drugstores also now recommend quality control (in-house or external).*4
With the release of this dedicated control product, not only does ARKRAY provide enhanced support for daily in-house quality control, ARKRAY has also established systems to support highly accurate measurements at clinics, drugstores and pharmacies by conducting an original survey on external quality control (target: SPOTCHEM BANALYST HbA1c).

As a pioneering company in diabetes testing, ARKRAY continues to strive for the development of products and services that can serve beneficial use within various medical settings to realize total support for diabetes testing.

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B-analyst HbA1c control

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In the 1st Nippon Pharmacy Fair 2015, to be held at PACIFICO Yokohama from Friday, July 31st, ARKRAY will exhibit products and services that can benefit operations at testing labs, including this product as well as blood glucose meters and test data management systems.
We will also install a mock testing lab at our booth to simulate actual sample measurements so that we can advise on operational aspects of the products.

☐ Overview of Our Exhibit at 1st Nippon Pharmacy Fair 2015 ☐
Date and time: Friday, July 31st 2015 to Sunday, August 2nd 2015. 10:00 - 18:00 (until 17:00 on Sunday)
Location: MB-06, Exhibit Hall C&D, PACIFICO Yokohama


*1 HbA1c (hemoglobin A1c)
HbA1c is formed when hemoglobin within red blood cells combines with glucose and is a marker to identify the average plasma glucose concentration in the last one to two months.
HbA1c has become established as an important examination marker for glucose control in the diagnosis and treatment of diabetes. Thus, there is a greater need in medical settings for the immediate measurement of HbA1c in addition to glucose (blood glucose level) measurements.

*2 Quality Control Product
This is a reagent used in quality control to confirm the reliability of measurement values.
Reference values are set for reagents, and the accuracy of measurement instruments and reagents can be checked by measuring this reagent.

*3 Sample Measurement Rooms
The partial amendment of the Clinical Laboratory Technologist Law in April, 2014 paved the way for "sample measurement rooms" to be set up in pharmacies, in accordance with guidelines outlined by the Ministry of Health, Labor and Welfare. As a result, it is now possible to conduct simple blood testing in pharmacies. This may contribute to early discovery and treatment recommendations at medical facilities for those suspected of having diabetes, and demand for in-store testing is expected to rise even further.

*4 Quality Control (in-house / external)
Quality control refers to carrying out control to ensure measurement results are correct (to enhance accuracy of measurement results) by setting various control conditions for handling samples to improve maintenance and measurement methods for measurement instruments.
In-house quality control is conducted by each facility, and the accuracy of measurement instruments and reagents are checked by measuring reagents with set reference values. Meanwhile, external quality control is engaged mainly to enhance accuracy of measurement values by comparing measurement values between one's own facility and other facilities.

Product Overview: B-analyst HbA1c control

Name Glycated hemoglobin A1c control "B-analyst HbA1c control"
Release date July 27, 2015
Specifications Glycated hemoglobin A1c control Level 1, frozen product x 1 vial
Glycated hemoglobin A1c control Level 2, frozen product x 1 vial

This product is manufactured by ROHM Co., Ltd.
This product will be sold through ARKRAY Marketing, Inc. (ARKRAY, Inc.'s distributor in Japan).
This product is only available in Japan and is not sold in other countries.