Package size

100 Tests, 50 Tests, 25 Tests, 10 Tests, 5 Tests, 100 Tests (N-QC), 50 Tests (N-QC), 25 Tests (N-QC), 10 Tests (N-QC), 5 Tests (N-QC).

Intended use

This device is intended to be used for the in vitro quantitative determination of D-dimer in human whole blood or plasma. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing.

Summary

D-dimer is a specific degradation product produced by plasmin hydrolysis after fibrin monomer is cross-linked by activating factor XIII, which can reflect the coagulation function and fibrinolytic activity in the body. It is an indicator of the body's hypercoagulable state, thrombosis, and secondary hyperfibrinolysis. The level of D-dimer is increased during deep vein thrombosis, pulmonary embolism, disseminated intravascular coagulation, severe hepatitis and other diseases, and after thrombolytic therapy, which can be used as an effective observation indicator for thrombolytic therapy. Due to its extremely high sensitivity and negative predictive value, D-dimer negativity has been clinically used as an important basis for excluding pulmonary embolism (PE) and deep venous thrombosis (DVT). A variety of clinical diseases can cause increased D-dimer concentration. Non-disease states such as long-distance travel or sedentary conditions can also increase the concentration of D-dimer in the body. This product has not carried out research related to the auxiliary diagnosis and exclusion diagnosis of VTE (Venous Thromboembolism).

The current clinical methods for detecting D-dimer include chemiluminescence, colloidal gold method, immunochromatography and so on.

PRODUCT PARAMETER

Method	Microfluidic Fluorescent Immunoassay	Test	LYOFIA® D-dimer
Format	Cassette	Reaction Time	10min
Linearity	0.1～4.4mg/L FEU	Reference Interval	≤0.55mg/L FEU
Sample	P	Certificate	CE / NMPA

ORDERING
Cat. No.	LMCMDD25	Applicable analyzer	LYOFIA-I, LYOFIA 8,	Kit Size	25T
Cat. No.	LACMDD25	Applicable analyzer	LYOFIA 100 (Full-Automatic)	Kit Size	25T