D-Dimer FIA Test

Foto : CK BIOTEC

CATALOG # F3010

PRODUCT D-Dimer FIA Test

QUANTITY 25/kit

SPECIMEN Serum, Plasma

The D-Dimer Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of D-Dimer in human plasma or whole blood using the RaFIA system. This test is intended for in vitro diagnostic use only.

D-Dimer is the fibrinolysis-specific degradation product found in human blood. D-Dimer is not normally present in human blood, except when the coagulation system has been activated, for instance because of the presence of thrombosis or disseminated intravascular coagulation

. Therefore, D-Dimer is commonly used to exclude thromboembolic disease where the probability is low. While a negative result may rule out thrombosis, a positive result can indicate thrombosis but does not rule out other potential causes. In addition,

D-Dimer can be used in the diagnosis of blood disorders disseminated by intravascular coagulation. Myocardial infarction, cerebral infarction, pulmonary embolism, venous thrombosis, surgery, cancer, disseminated intravascular coagulation, infection and tissue necrosis may lead to elevated concentration of D-Dimer.

Increased concentration of D-Dimer may also be observed in the elderly or hospitalized patients with abnormal coagulation caused by bacteremia.

The D-Dimer FIA Test was developed to detect D-Dimer in human plasma or whole blood within 3 minutes, without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel.

PRODUCT FEATURES

Quantitative, non-subjective results

Increased sensitivity and broader detection range compared to rapid tests

RANGES

Working range: 0.1–10.0 mg/L

PRECISION

Intra-lot Precision

Intra-lot precision was determined by testing of D-Dimer reference materials using 10 test devices from the same lot. CV ≤ 15%.

Inter-lot Precision

Inter-lot precision was determined by testing of D-Dimer reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.

ACCURACY

D-Dimer control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.

LINEARITY

A serial concentration of D-Dimer reference materials at 0.1–10.0 mg/L was tested, and the correlation coefficient (R) is ≥0.9900.

PRODUCT SPECIFICATIONS

REAGENTS AND MATERIALS PROVIDED:

Individually sealed foil pouches containing:

a. One test device

b. One desiccant

Detection buffer tubes

SD card

Instructions for Use