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D-Dimer Rapid test Kit
● Instrumentation:
MKF-101 fluorescent immunoanalyzer
MKF-201 Portable dry fluorescence immunoassay analyzer
MKF-202 fluorescent immunoanalyzer
● Detection time: 5 minutes
● Storage: Room temperature (4-30°C)
● Shelf life: 24 months
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INTENDED USE
For quantitative detection of D-dimer in human plasma or whole blood samples. They are for professional use only.
D-dimer is a specific degradation product of fibrin monomer which is cross-linked by activated factor XIII and then hydrolyzed by plasmin. It is a specific fibrinolytic process marker. The D-dimer is derived from a plasmin-dissolved cross-linked fibrin clot. The most important clinical value of D-dimer detection is used for excluding venous thrombotic diseases, and also for the diagnosis of disseminated intravascular coagulation, and for the monitoring of thrombolytic therapy.
For in vitro diagnostic use only. For professional use only.
PRINCIPLE
Take the sample to the strip, The DD in the specimen binds to the antibody coated with the fluorescent particles coated on the glass fiber to form a fluorescent particle-antibody-antigen complex. The immune complex is further chromatographed along the nitrocellulose membrane to the detection zone (T), and combined with the pre-coated mouse anti-DD monoclonal antibody, the fluorescence intensity is proportional to the DD content in the sample, and the remaining Fluorescent antibody particles were chromatographed into the control region (C) and bound to pre-coated goat anti-mouse IgG.
MAIN COMPONENTS
The kit contains the corresponding number of test cassettes for each package specification: the test cassette consists of a test strip shell and a test strip, which consists of a binding pad (containing fluorescent microsphere-labelled anti-serum amyloid A monoclonal antibody, anti-C-reactive protein monoclonal antibody, and chicken IgY), a nitrocellulose membrane (C-wire wrapped with the quality control antibody, anti-serum amyloid A antibody, and anti-C-reactive protein antibody), a sample pad, an absorbent paper and PVC plates.
Diluent solution: composed of phosphate, preservative, etc., pH=7.4.
APPLICABLE INSTUMENT
1.MKF-101 fluorescent immunoanalyzer
2.MKF-201 Portable dry fluorescence immunoassay analyzer
3.MKF-202 fluorescent immunoanalyzer
SAMPLE REQUIREMENTS
The Sample types with test cassette include human plasma or whole blood samples Whole blood collection: Blood is collected using sodium heparin, EDTA-K2 or sodium citrate anticoagulation tubes, and the collected blood sample is added and shaken well and set aside.
Samples should not be frozen and should be tested as soon as possible after collection. If the test cannot be completed within 12 hours, it should be stored at 2°C to 8°C for no more than 2 days.
Plasma collection: Plasma should be separated as soon as possible after blood collection to avoid haemolysis. The separated plasma should be tested as soon as possible and, if the test cannot be completed within 12 hours, stored at 2°C-8°C for no more than 7 days. Long-term storage should be frozen at -20°C for no more than 6 months. Samples should not be frozen and thawed more than 2 times.
Samples must be returned to room temperature prior to testing. Frozen samples must be completely thawed, mixed and brought back to room temperature before use, and must not be repeatedly frozen and thawed.
关键词:
ivd
test kit
D-Dimer
rapid test kit
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