1.3.5 Principles of Measurement
1.3.5.1 Biological Activation Method
(1) Coagulation Reaction Detection Method (Scattered Light Measuring Method):
Red light (660 nm) is irradiated onto the mixture of plasma and reagent and the change of the scattered
light is detected, corresponding to the turbidity change when the fibrinogen is converted to fibrin.
(2) Coagulation End-Point Detection Method (Percent Detection Method):
Let the scattered light intensity at the time when the coagulation reagent is added to be 0% and that when
the coagulation reaction is completed to 100. The coagulation time is obtained from the time to reach the
presumed percent of the coagulation curve.
1.3.5.2 Chromogenic Substrate Method
(1) Calorimetric Method
Rate Method
1.4 PERFORMANCE, INTENDED USE AND EFFECTIVENESS
1.4.1 Intended Use
This unit measures the coagulation of the plasma or serum component of anti-coagulant (sodium citrate) added
human blood.
1.4.2 Performance
(1) Measurement Parameters and Display Parameters (Default Unit is shown in [ ]).
1) Prothrombin Time (PT) [second]
Calculated Parameters:
(a) Prothrombin Activation Percent [%]
(b) Prothrombin Ratio [ – ]
(c) International Normalized Ratio (INR) [ INR ]
(d) Derived Fbg (for export specification only) [mg/dL]
2) Activated Partial Thromboplastin Time (APTT) [second]
Calculated Parameters:
(a) APTT Ratio [ – ]
(b) Activation Percent (for European and UK specifications only) [% ]
3) Fibrinogen (Fbg) [second]
Calculated Parameters:
(a) Fibrinogen Concentration [mg/dL]
4) Thrombo Test (Plasma Method) [second]
Calculated Parameters:
(a) Activation Percent [%]
(b) INR (for European and UK specification only) [ – ]
CA-500 Series S/M 1-3 Revised December 2001 8
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