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Jun 15, 2015
ARKRAY, Inc. (hereinafter called ARKRAY) will release "SPOTCHEM BANALYST SI-3620", an instrument capable of providing immediate measurements of the inflammatory markers, CRP, hsCRP and a marker of chronic renal diseases and early stage renal function disorder, CysC (cystatin C), in addition to HbA1c measurements for 'Point of Care' diagnosis.
Whilst maintaining the high level of measurement accuracy of the previous analyzer (SPOTCHEM BANALYST SI-3610), a color touch panel has been incorporated and usability has been enhanced. Also a QC mode has been added to allow for daily internal quality control to be carried out with ease. Furthermore, ARKRAY will conduct an independent external quality control survey for SPOTCHEM BANALYST in order to provide support for measurements of higher accuracy at healthcare providers.
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 to guidelines outlined by the Ministry of Health, Labour and Welfare. As a result, it is now possible to conduct simple blood testing in pharmacies and an increasing demand has emerged for storefront testing. "SPOTCHEM BANALYST SI-3620" shows its strength in HbA1c measurement not only in clinics but also in "sample measurement rooms" with ease of operation and its satisfying system to support quality control as well as providing measurement with high accuracy. It can contribute to early detection of diabetes in individuals suspected of having developed the disease and can be used to provide recommendations for such individuals to consult a doctor.
ARKRAY continues to strive for the development of products and services that can serve beneficial use within various medical settings.
•High Accuracy Measurement
Using a measurement chip exploiting μ-TAS technology*2 enables high accuracy measurement with 4 to 9.5 μL microsample. HbA1c measurements correlate highly with those obtained through the HPLC method *3
•Ease of Operation
Incorporated a color touch panel that is easy to operate and supports simple measurement.
•Accuracy Control
Added QC mode to perform internal quality control (the dedicated control reagent will be released in July).
Only four step measurement.
*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. With the revision of the diagnostic criteria for diabetes in 2010 and the international standardization of HbA1c levels, HbA1c has been 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 μ-TAS technology
It is an abbreviation for Micro Total Analysis System technology. By embedding microfabrications such as flow lines and reflection rooms on the chip, μ-TAS allows for a series of operations, including blood cell separation and mixture with the reagent , to be carried out in a short period of time.
*3 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.
| Name | Mobile Centrifugal Clinical Chemical Analyser "SPOTCHEM BANALYST SI-3620" |
|---|---|
| Release Date | June 22nd, 2015 |
| Specifications | |
| Meas. target | HbA1c：whole blood CRP, hsCRP：whole blood, serum, plasma CysC：whole blood, serum |
| Meas. item | HbA1c, CRP, hsCRP, CysC, eGFRcys (calculation items) |
| Meas. principle | Latex Agglutination Immunization Turbidimetry |
| Meas. range | HbA1c：3.3 to 12.6% CRP: 0.1 to 20.0 mg/dL hsCRP：0.01 to 4.00 mg/dL CysC：0.20 to 8.00 mg/L |
| Processing Speed | HbA1c, CRP, hsCRP：approximately 7'30"/sample CysC：approximately 7'57"/sample |
| Required sample | HbA1c, CRP：4μL, hsCRP：9.5 μL, CysC：6μL |
| Reagent to be used | SPOTCHEM BANALYST Series |
| Meas. time | Approx. 4 minutes per specimen |
| External dimensions | 240(width) x 388(length) x 212 (height) mm |
| Weight | Approximately 8.3 kg |
| Power consumption | 220VA |
| Medical Device Applic. No. | 26B2X10014000004 |
| Classification | Class I (general medical devices）/Specific Maintenance Medical Device |
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.
