Announcing the Release of Banalyst®Ace, a Safe, Rapid and Easy Microvolume Blood Testing System
- Employing the world’s first μTAS measurement chip based on liquid reagent -
Ushio Inc. (head office: Chiyoda-ku, Tokyo; president and CEO: Shiro Sugata; hereinafter, Ushio), ROHM Co., Ltd. (head office: Kyoto-shi, Kyoto; president & CEO: Ken Sato; hereinafter, ROHM) and Sanwa Kagaku Kenkyusho Co., Ltd. (head office: Nagoya-shi, Aichi; president & CEO: Kazuo Yamamoto; a member of the Suzuken Group; hereinafter,SKK) have just completed the joint development of Banalyst ®Ace, a microvolume blood testing system using the world’s first μTAS (micro tas)*1 measurement chip based on liquid reagent. The three parties have reached a decision to launch the product throughout Japan on October 30, 2008.
1.Summary of Banalyst® Ace, a Microvolume Blood Testing System
Banalyst® Ace is a microvolume blood testing system that permits quick, high-precision determination with trace whole blood.*2 It consists of a small analyzer and a measurement chip and enables the determination of two types of CRP (for normal and low concentrations) as an inflammation marker and hemoglobin A1c as a marker for blood glucose control in diabetes by replacing measurement chips. The product represents the outcome of six years of development based on a combination of the technologies and know-how of Ushio, a light source and optical device manufacturer, ROHM, a semiconductor manufacturer, and SKK, a pharmaceuticals company.
Plans are in place for the launch of Banalyst Ace CRP, with an analyzer and a CRP measurement chip for normal concentrations, on October 30, 2008. The launch of Banalyst Ace hsCRP with a CRP measurement chip for low concentrations is planned for December 2008 and the launch of Banalyst Ace Hb A1c with a hemoglobin A1c measurement chip, a marker for blood glucose control in diabetes mellitus, is planned for around spring 2009.
For the initial fiscal year (from October 2008 to March 2009), the companies set the target sales at 80 analyzers and 40,000 measurement chips for the two types (representing the consolidated sales of Banalyst Ace CRP and Banalyst Ace hsCRP).
2. Uses and Characteristics of Banalyst ®Ace, a Microvolume Blood Testing System
Uses
| Items measured | Clinical significance | Department |
|---|---|---|
| CRP (for normal concentrations) | Inflammation marker (identifying the degree of inflammation in infections, rheumatism, pneumonia and others) |
Pediatrics internal medicine |
| CRP (for low concentrations) | Inflammation marker (identifying the degree of slight inflammation in arteriosclerosis, colon cancer and others) |
Internal medicine |
| Hemoglobin A1c | Blood glucose control marker in diabetes | Internal medicine |
Characteristics
1) Permits examinations with a small quantity of whole blood – Drastically reduces the burden on patients
Conventional large analyzers require the collection of 1 ml of venous blood for adults and 0.5 ml for newborns as the plasma and blood cells had to be separated from whole blood before examination. For newborns, in particular, frequent examinations were not permitted because of the need for a large quantity of blood compared to the body weight. By enabling examinations with such a small amount of blood as 4 μl, Banalyst Ace CRP enables blood collection from fingertips and earlobes, drastically alleviating burden on patients. (One microliter, 1 μl, equals 1/1000 ml; the quantity corresponds to 1/250 of the quantity for adults and 1/125 of the quantity for newborns compared to the old analyzers.)
2) Full infection prevention with non-contact operation
Specimens that may be contaminated with infectious substances will not leak from the measurement chip. The user can discard the measurement chips without touching the specimen after measurement.
3) Easy operation
Banalyst®Ace allows the user to perform the measurement simply by attaching a measurement chip with the specimen injected in the analyzer and pressing the Start button. The product can be used even if a clinic has no clinical laboratory technologist.
4)Speedy examination results in feedback through quick measurement
Unlike measurements done by external laboratories, the product immediately displays the results of its high-precision examinations. This allows institutes to give diagnosis, instructions about lifestyle and medication, thereby allowing the product to be used in the new health check system for metabolic syndromes,*3 diabetes tests and the area of inflammatory diseases.
5) Favorable correlation with large analyzers
Unlike conventional POCT devices,*4 the product is equipped with a centrifugal blood cell separation function. In addition, it utilizes the same liquid reagents as those used by large analyzers, an exhibits favorable correlation with large analyzers and examination results despite its compact size.
6) Great extensibility for test items
While currently permitting three test items (two types of CRP and hemoglobin A1c), the product will enable up to ten test items after employing measurement chips to be developed in the future.
3.Banalyst®Ace – the Product of Three Companies’ Technologies and Know-How
Ushio Group’s light source and precision alignment technologies
The product employs a special LED as the light source for measurement that was developed specially by Epitex Incorporation, a member of the Ushio Group that specializes in the manufacture of LEDs. In addition, Ushio’s optical technologies have enabled the irradiation of highly stable, high-intensity beams to a 0.6-mm light path. The precision alignment technology for optical devices has made it possible to create a device that enables alignment to within tens of micrometers, even after centrifuging the sample at 3000 rotations per minute.
ROHM’s state-of-the-art micro-fabrication technologies
The measurement chip was developed thanks to the application of ROHM’s microfabrication technologies cultivated through the development of semiconductors and LSIs. The design and processing technologies for minute fluid circuits having a minimum width of 100 μm have enabled the integration of all processes, from blood cell separation, measurement and test agent mixing to drainage, into a chip that is several centimeters square. This makes it possible to conduct the tests with a greatly reduced quantity of blood.
SKK’s expertise in the diagnostic products and POCT fields
SKK is the sole distributor in Japan of qualitative reagents that permit the quick examinations of CRP with whole blood specimens. The company's familiarity with the clinical significance of CRP measurement has permitted the ef