SF-8200 Operation Manual
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Optical
method
chromogenic sub-
strate method
AT-
Ⅲ
（
%
）
≤5.0%
≤10.0%
immunoturbidimetric
method
D-Dimer
（
μg/ml
）
≤10.0%
≤5.0%
Note:
1, the conventional four abnormal samples refers to not less than twice the median value of the normal reference range
of the instrument;
2, AT-
Ⅲ
normal sample concentration of 80% -120%, abnormal sample concentration of 30% -79% and 120% -140%;
3, D-Dimer normal sample content (0.15-
0.5) μg / ml, abnormal samp
le concentration (0.5-
8) μg / ml
6) Accuracy
The relative bias measured by the FIB does not exceed ± 10.0%.
AT-
Ⅲ
measurement results should be consistent with the quality control of the target range.
D-Dimer measurement results should be consistent with the control target range.
7) Linearity
The linearity range of FIB was determined to be 0.7-
7 g / L, r ≥ 0.975.
The linearity range of AT-III was determined: 9% -140%, r> 0.98.
The linearity range of D-Dimer was determined to be 0.15-8 ug / ml, r> 0.98.
4. ANALYSIS PRINCIPLE
4.1 SOLIDIFICATION TEST SYSTEM DESCRIPTION
The test is based on the increasing viscosity of the plasma being tested, and an increase in the
viscosity of the plasma is detected by the curved movement of the test bead at the base of the cuvette.
Independent coils on both sides of the cuvette generate opposite electromagnetic fields that drive the
test bead. The viscosity does not change when the plasma does not coagulate, and the test beads will
swing with a constant amplitude; When the plasma is coagulated, fibrous protein occurs, plasma vis-
cosity will be increased, and the amplitude of test bead will be attenuated. The change of amplitude is
calculated by mathematical algorithm and then get the clotting time.
4.2 OPTICAL METHOD TEST SYSTEM DESCRIPTION
There are two methods of optical method: chromogenic substrate method, immune turbidimetry.
Chromogenic substrate method: artificial synthesis of a cleavage site compounds and chromogenic
substances linked to form a specific substrate for the enzyme, due to the presence or reaction of the
sample was generated during the activity of the enzyme, the substrate was Hydrolysis and release of
chromogenic substances, the reaction system of color change, colorimetric method to detect the extent
of its color change, and the enzyme activity or analyte into a certain relationship.
Immunoturbidimetric method: the use of antigen and antibody specificity between the characteris-