CE Certification PGII Factory – D-Dimer – Aehealth

Performance Characteristics

Detection Limit: 0.1mg/L (µg/mL) ;

Linear Range: 0.1～10 mg/L(µg/mL);

Linear correlation coefficient R ≥ 0.990;

Precision: within batch C.V. is ≤ 15%; between batches C.V. is ≤ 20%;

Accuracy: the relative deviation of the measurement results shall not exceed ± 15% when the standardized accuracy calibrator is tested.

1. Store the detector buffer at 2～30℃. The buffer is stable up to 18 months.

2. Store Aehealth Ferritin Rapid Quantitative test cassette at 2～30℃, shelf life is up to 18 months.

3. Test cassette should be used within 1 hour after opening the pack.

D-Dimer is a specific degradation product of fibrin monomer after cross-linking with activation factor XIII, which is produced by fibrinolytic enzyme hydrolysis. It can reflect the coagulation function and fibrinolytic activity in vivo, and it is an indicator of hypercoagulability, thrombosis and secondary hyperfibrinolysis. The level of D-dimer increased in deep vein thrombosis, pulmonary embolism, disseminated intravascular coagulation, severe hepatitis and other diseases, as well as after thrombolytic therapy, which can be used as an effective observation index of thrombolytic therapy. Because of its high sensitivity and negative predictive value, D-dimer negative has been used as an important basis to exclude the formation of pulmonary embolism (PE) and deep venous thrombosis (DVT).