NewScen Coast Bio-Pharmaceutical Co., Ltd

INTENDED USE
This D-Dimer Quantitative Test Cassette is intended for use in the detection of D- Dimer in human plasma or whole blood, at a cutoff concentration of 1mg/L. It is for health care professional use only.

PRINCIPLE
The D-Dimer Quantitative Test is a chromatographic immunoassay (CIA) for the detection of antigens to D-Dimer in human plasma or whole blood. D-Dimer specific antibody are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidalgold particles, which have been labeled with D-Dimer specific antibodies. Antigen to D-Dimer, if present, a red colored band will develop on the membrane in proportion to the amount of D-Dimer antigens presented in the specimen. Absence of this red coloredband in the test region suggests a negative result.To serve as a procedural control, red colored band in the control region will always appear regardless the presence of antigens to D-Dimer.

PROCEDURE
1.Collect blood/plasma specimen with a clean dry container either plastic or class.
2.Remove the test cassette from pouch by tearing.
3.Get the dilution.
4.Carefully apply 10 ml of (plasma) sample or 20ml (whole blood) sample into the dilution, and mix them.
5.Carefully apply 100 ml the sample after mixing in the S well.
6.Read the result in to 15 -20 minutes following the reader.

INTERPRETATION OF RESULTS

 
Result: If the test result shows ≤0.5mg/L, that means no venous thrombus, pulmonary embolism, Disseminated Intravascular Coagulation (DIC); If the test result > 0.5mg/L, that means it may have Persistent fibrinolytic, but not be identified to be Deep vein thrombosis (DVT), pulmonary embolism,Disseminated Intravascular Coagulation (DIC). When the result shows “>10mg/L”, that means the concentrate of D-Dimer in the sample is higher than the test range limit.
Invalid:If no band appears in the control region(C), regardless of the presence or absence of band in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.