News & Topics

Aug 22, 2017

Responding to various samples with single instrument

New Diabetes Testing Instrument to be Released

-High speed testing at 24 sec. per sample achieved/Variant hemoglobin detection function implemented as standard feature-

ARKRAY, Inc. will release the new glycohemoglobin analyzer ADAMS A1c HA-8190V for medical facilities across the country on Monday 28th August 2017. This new instrument is equipped with functions for high-precision measurement of hemoglobin A1c (HbA1c)^*1 using the HPLC method^*2 and high-frequency variant hemoglobin^*3 separation (detection) to measure various samples more accurately, easily and conveniently. For HbA1c testing, high speed measurement at 24 sec. per sample has been achieved, responding to an increasing demand for HbA1c measurement in diabetes testing.

In Japan, the number of diabetes patients has risen to around 7.2 million people (ranking 9th worldwide)^*4 and in this situation the early detection and treatment of diabetes is absolutely essential. Within the field of diabetes testing, hemoglobin A1c (HbA1c) is used as a marker which reflects the average blood glucose value over the past 1 to 2 months. This value is recognized as an important indicator for the diagnosis and treatment of diabetes. Following recent advances in globalization, more patients with variant hemoglobin that affects the HbA1c measurement value are also visiting medical facilities in Japan. In these circumstances, for the purpose of performing more accurate diagnosis, there is a greater need for detecting variant hemoglobin within hospitals.

As a testing instrument responding to variant hemoglobin, ARKRAY has sold the large ADAMS A1c HA-8180V and ADAMS A1c HA-8180T since 2014, and the compact ADAMS A1c Lite HA-8380V since 2016 in Japan. The new product ADAMS A1c HA-8190V is a successor of ADAMS A1c HA-8180V. This model is equipped with two modes comprising HbA1c measurement and variant hemoglobin separation (detection) as a standard feature. The HbA1c measurement time (the fast mode) is approximately halved from 48 sec. to 24 sec. and the measurement time of variant hemoglobin (the variant mode) is also cut from 90 sec. to 58 sec., responding to an increase in HbA1c testing frequency in diabetes testing. Usability has also been improved by adding an automatic alignment function for sample tubes and a touchscreen.

ARKRAY will continue to expand the portfolio of related products as a pioneer of diabetes testing, endeavor to spread awareness of significance of new testing such as variant hemoglobin measurement and contribute to diagnosis and treatment in the more diversified front lines of diabetes medical facilities.

Product Features

• High precision and quick measurements

・With the HPLC method, high-precision HbA1c measurement and variant hemoglobin detection are possible.

・Two measurement modes are available; HbA1c can be measured at 24 sec. per sample with the fast mode, and variant hemoglobin (HbS, HbC, HbE and HbD) can be separated (detected) at 58 sec. per sample. By means of system connection, automatic switching of the measurement modes per sample is possible. Data can be rapidly fed back before medical consultation or to the clinical team.

・As measurement results, fractioned hemoglobin analysis results are output in the form of information on each peak or chromatogram, assisting in assessing results. Output of IFCC data is possible in addition to NGSP values.

・When any HbF values are high, which affects HbA1c calculation, correction will automatically be performed^*5.

• Improved usability

・During the barcode reading process, sample tubes are automatically rotated. Therefore the bothersome processing of aligning sample tubes is no longer necessary.

・ A 7 inch color touchscreen-mounted LCD is adopted for the operator panel. The pressure-sensitive touchscreen enables users to operate the instrument even with rubber gloves on.

・The column and pre-filter are incorporated into a single design so there is no need to replace the pre-filter separately.

・As for daily maintenance, consumables can be replaced easily without any need for tools.

• Equipped with management functions

・By reading the barcode marked on the reagent, it is possible to manage the record of lot numbers and expiry dates.

・ It is possible to print and record the name of the operator on the measurement result by registering the operator ID in advance.

• Connection with glucose measurement instrument is possible

・Connection with the glucose analyzer ADAMS Glucose GA-1172 provides simultaneous measurement of HbA1c and glucose levels which are crucial for diabetes testing and contributes to more rapid testing and higher operation efficiency.

Terminology

*1 HbA1c (hemoglobin A1c)
HbA1c is formed when hemoglobin within red blood cells combines with glucose and is a marker to identify the average blood glucose concentration in the last one to two months. With the 2010 revision of the diagnostic criteria for diabetes in Japan and the global standardization of HbA1c levels in 2012, this marker is now positioned as a key testing item for controlling blood sugar levels in treating and diagnosing diabetes. In turn, there is a greater need at the front lines of diabetes testing for immediate measurement of HbA1c in addition to blood sugar (blood glucose) measurements.

*2 HPLC method (High-performance Liquid Chromatography method)
HPLC method is a method to separate various components in a mixture and calculate the ratio of each material. It can also measure HbA1c with a high degree of accuracy. ARKRAY developed the world's first dedicated HbA1c analyzer using HPLC back in 1981, which is still widely used in medical facilities today.

*3 Variant hemoglobin
Genetic mutations result in the replacement of constituent amino acids within the hemoglobin inside red blood cells. This affects the 3D structure of the hemoglobin. There are a number of different types of variant hemoglobin. Among those, HbS, HbC, HbE and HbD are well known. Although many of the people with variant hemoglobin are said to be Southeast Asian and African people, it is also said that one out of every 2,000 to 3,000 Japanese people has variant hemoglobin. As the number of foreign patients increases in the future, a greater need for variant hemoglobin detection, mainly in urban areas, is anticipated.

*4 Estimated number of diabetic patients
Source: International Diabetes Federation. IDF Diabetes Atlas, 7th edn.　Brussels, Belgium: International Diabetes Federation, 2015

*5 Automatic correction for elevated HbF (hemoglobin F)
HbF is one type of normal hemoglobin, similar to HbA (hemoglobin A), and it makes up the majority of hemoglobin in the embryonic stage. After birth, the composition of HbF falls accordingly with an increase of HbA and, after approximately 6 months to 1 year after birth the HbF level makes up approximately 1% of total hemoglobin in the body.
In samples that have elevated levels of HbF, there is a trend in which the HbA1c measurement is adversely affected by the HbF, resulting in a lower measurement result than the actual HbA1c value. Through the application of an automatic correction to measurements, it is possible to obtain measurement results that are closer to the actual HbA1c value. (Results are calculated as reference values)

Summary of ADAMS A1c HA-8190V

Name	ADAMS A1c HA-8190V
Release date	Monday, August 28, 2017
Specifications
Meas. target	Whole blood or hemolysates
Test item	HbA1c (Stable HbA1c), HbF (In the variant mode, HbS and HbC separated, and HbE and HbD detected.)
Measurement principle	Reversed-phase partition cation exchange chromatography
Sample size	Sample tube: 10mm or higher from bottom of sample tube Sample cup: 400μL or more
Processing speed	Fast mode: 24 sec. per sample Variant mode: 58 sec. per sample
Power consumption	300VA
Dimensions	530mm (W) X 530mm (D) X 530mm (H) *excluding protruding parts, eluent packs and hemolysis wash solution bottle.
Weight	Main unit: approx. 41kg Sampler unit: approx. 4kg

※ Jointly developed with SEKISUI MEDICAL Co., Ltd.

This product will be sold through ARKRAY Marketing, Inc.
ARKRAY Marketing, Inc. is ARKRAY, Inc.'s distributor in Japan.