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Dade Behring ltd.

Nakano Sakaue Sunbright Twin, 11F
2-46-1 Honcho, Nakano-Ku, Tokyo 164-8603, Japan
Tel:+81-3-5352-6244, Fax:+81-3-5352-6330
Contact: Mr. Mitsunori Hirose, Marketing Division
E-mail: Mitsunori_Hirose@dadebehring.com

1. Cardiac Markers Analyzer (Stratus CS)

1. Product: Stratus CS
   
2. Concept: True STAT assay system for the diagnosis of cardiac disorders
   
3. Principle
   • Solid-state immunoassay using dendrimer
   • All the reagent required for a single test is packaged in the test pack
   • Instrument automatically centrifuges the whole blood sample and dispense plasma into the test pack
   • Whole process results in 13 minutes
   • 3 markers ( Troponin I, Myoglobin, massCKMB ) are now available
     
4. Features / Benefits
   • Results in 13 minutes enable early triage
   • Simple 3-step operation is fitted for all skill levels
   • Both an early marker ( myoglobin ) and a specific marker ( Troponin I ) are available
   • Long calibration stability ( 60 days ) and random access function minimize the waste of reagents
   • Whole blood, closed container sampling minimizes the risk of biohazard
   • Combined with hs CRP ( see below ), can be used to assess the convalescence of AMI
     
5. References
   (1) Ahmed EL Ghamry Sabe et al, Improving emergency cardiac care with a STAT, near-patient blood analyzer. American Clinical Laboratory March 2000
   (2) Myocardial Infarction Refined - A Consensus Document of the Joint European Society of Cardiology / American College for the Redefinition of Myocardial Infarction. J Am Col Cardiol; 36:959-969, 2000

2. High Sensitivity CRP Assay on BN Analyzers as The Marker of Coronary Heart Disease

1. Product: N-Latex CRP II
   
2. Concept: High sensitivity and superior precision to detect slight change at low concentration
   
3. Principle: Latex nepherometry run on BN analyzers
   
4. Features / Benefits
   • The only CRP method which satisfies FDA requirements of the atherosclerosis marker
   • Run on any type of BN analyzers
   • High precision: CVs < 3% down to 0.1mg/dl
   • Low detection limit, wide measuring range: 0.02 - 100 mg/dl
   • Use of serum and plasma ( EDTA, heparin )
   • Standardized against the international reference preparation CRM 470
   • Combined with Total:HDL cholesterol ratio, can be used to assess the risk of first MI
   • Combined with Troponin I ( see above ), can be used to assess the convalescence of MI
   • Attracting notice in the field of the medical checkup
     
5. Reference
   (1) Ridker P.M., High-sensitivity C-reactive protein: potential adjunct for global risk assessment in the primary prevention of cardiovascular disease. Circulation; 103:1813-1818, 2001
   (2) De Winter RJ et al, Independent prognostic value of C-reactive protein and Troponin I in patients with unstable angina or non-Q-wave myocardial infarction. Cardiovase Res; 42:240-245,1999.

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