Fibrin Degradation Product
INTENDED USE
For in vitro quantitative determination of fibrin degradation product (FDP) in human plasma.
CLINICAL SIGNIFICANCE
It is mainly used to Diagnosis of primary and secondary hyperfibrinolytic diseases
REPEATABILITY
The coefficient of variation (CV) obtained by repeated measurements in low-value and high-value controlled plasma should not exceed 10%
BATCH DIFFERENCE
The coefficient of variation (CV) of the low-value quality controlled plasma tested with three different batches of reagents was should be less than 14%
ACCURACY
For the comparison test, linear regression was performed between the kit to be tested and the comparison kit, with a linear correlation coefficient of r > 0.98, and the following conditions were met :(2.5, 10] ug/ml concentration range absolute deviation is no more than ±1ug/ml, [10, 120] ug/ml concentration range relative deviation is less than ±10%
LINEARITY
The reagent was determined in the range of (2.5, 120) ug/ml with a linear correlation coefficient of r > 0.98