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Mar 04, 2014

Dual measurement of HbA1c & glucose in just 70 seconds
One instrument to test all required diabetes parameters

ARKRAY, Inc. will release the ADAMS Hybrid AH-8290, a dual glycated-hemoglobin and glucose analyzer on Monday 10 March. This system allows for the measurement of key diabetes parameters, HbA1c (hemoglobin A1c)*1 and blood glucose in just 70 seconds, contributing to the increased efficiency in work performed at diabetes testing facilities.

There are approximately 9.5 million*2 people in Japan who are strongly suspected to be suffering from diabetes and this number is rising. Testing is very important to identify these people quickly so that they can begin treatment.

HbA1c is a diabetes test marker that reflects the average blood glucose over the past 1-2 months. In terms of diabetes diagnosis and treatment, it has grown in importance since the 2010 revision of the diabetes diagnostic standard and the 2012 changes associated with HbA1c value standardization*3. Accordingly, needs associated with rapid HbA1c measurement (together with the measurement of blood glucose) are increasing.

ARKRAY, Inc. (herein 'ARKRAY') will release the ADAMS Hybrid AH-8290 an analyzer for the simultaneous measurement of HbA1c and glucose with a measurement time of just 70 seconds, 10 seconds faster than its predecessor (the AH-8280). It has a compact design, taking up just half of the space you would need with separate instruments. This makes it installable at small hospitals and specialist diabetes clinics.

This is the only diabetes analyzer capable of simultaneous measurement of both HbA1c and glucose in single instrument using the HPLC method*4. ARKRAY, as a pioneer in diabetes testing, has traditionally been involved in the development of high precision analyzers, and has concentrated its technology here to create this product. ARKRAY will continue to provide products that meet the wide-ranging needs of diabetes testing and contribute to it.

Main features

•Dual measurement of HbA1c & glucose
Measurement of both HbA1c and glucose (both important diabetes analytes) in a single instrument. A measurement time of just 70 seconds per sample (10 seconds shorter than the previous model)

•Measurement with whole blood
Measurement with whole blood and requiring no centrifugation or other pretreatment and cutting hassle and time (with hematocrit correction function)

•High performance measurement
High performance: HbA1c usesHPLC while glucose measurement uses the GOD/ hydrogen peroxide electrode method*5

•A compact design
A small size, taking up just half the space of the two instruments you would have needed

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ADAMS Hybrid AH-8290

*Joint development with Sekisui Medical


Explanation of terminology

*1 HbA1c (hemoglobin A1c)
This is formed when hemoglobin within red blood cells binds with glucose. It is proportional to the average blood glucose over the previous 1-2 months. It is a key marker used widely from diabetes diagnosis to treatment and for the control of blood glucose.

*2 Estimate of number of diabetics
Source: 'National Health & Nutrition Survey 2012' (Ministry of Health Labor and Welfare 2012)

*3 Diagnostic criteria for diabetes
Under previous criteria used for the diagnosis of diabetes, if blood glucose exceeded the predefined value during fasting blood glucose, casual blood glucose or oral glucose tolerance testing (2 hour), the patient was determined to be diabetic-type. If these values are exceeded again on another day of testing, then the patient is determined to be diabetic and an HbA1c measurement value was obtained for additional reference purposes.
However under new diabetes diagnosis criteria revised on 1 July 2010, HbA1c values have become the main test parameter and are now also used to determine if the patient is diabetes-type. This marks an increase in their importance. Under the new criteria, if either the predefined HbA1c value or the previous blood glucose values are exceeded, a diabetes diagnosis can be made.
In addition, international standardization of HbA1c in April 2012 resulted in the switch from JDS values (values unique to Japan) to NGSP values (those used in the US and all over the world). This enables the smooth exchange of information relating to treatment and drugs between Japan and the rest of the world.

*4 HPLC method (High Performance Liquid Chromatography)
HPLC is a method to separate the individual constituents from a matrix and to calculate their proportion of the total. It is also a high precision method for detecting HbA1c. ARKRAY developed the world's first dedicated HbA1c method using HPLC back in 1981 which is still used widely in medical facilities today.

*5 GOD/ Hydrogen peroxide electrode method
When glucose reacts with the enzyme GOD (Glucose Oxidase), hydrogen peroxide is produced.
When this is then detected by an electrode, we can measure the glucose concentration.


Overview of ADAMS Hybrid AH-8290

Name ADAMSTM Hybrid AH-8290
Release date Monday 10 March 2014
Specifications  
   Processing speed 70sec/ sample
   Power source 300VA
   Outer dimensions 530 (width) x 530 (depth) x 530 (height) mm
   Weight Main unit: approx. 42kg, sampler unit: approx. 4kg
Sale price JPY9,600,000 (tax not included)
Notification number 25B1X00001000042
Classification Class I (General medical device)/ special maintenance control medical device)

HbA1c measurement specifications
   Sample type Whole blood, hemolysate
   Meas. Item(s) HbA1c (stable HbA1c) , HbF
   Meas. principle Reverse phase cation exchange chromatography
   Meas. range HbA1c: NGSP values 3-20%
(IFCC values: 14-191mmol/mol)
HbF: 0.0-5%
   Sample consumption Approx. 35µL (whole blood), approx. 400µL (hemolysate)
   Reagents used Eluent 80A, Eluent 80B, Hemolysis/ Washing Solution 80H, Column 80, buffer

Glucose measurement specifications
   Sample type Whole blood, serum, plasma (if left to stand)* WB uses hematocrit correction
   Meas. Item(s) Glucose
   Meas. principle Amperometric method with immobilized GOD enzyme membrane/ H2O2 electrode
   Meas. range 0-500mg/dL (Whole blood)
0-1000mg/dL (Serum, plasma)
   Sample consumption Approx. 35uL (Whole blood, plasma, serum)
   Reagents used GOD cartridge, Interna reference solution, Hemolysis/ Washing Solution 80H, buffer

*Manufacturer of Eluent 80A, Eluent 80B, Hemolysis/Washing Solution 80H & Column 80: Sekisui Medical.

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.