A CLIA test kit for the quantitative determination of D-Dimer in human whole blood and plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The D-Dimer Test Kit (CLIA) is intended for quantitative determination of D-Dimer in human whole blood and plasma. It is mainly used to exclude venous thrombosis, as an aid in the diagnosis of diffuse intravascular coagulation and monitoring of thrombolytic therapy.
For professional in vitro diagnostic use only.
【SUMMARY】
Fibrin in the blood is activated and hydrolyzed to produce specific degradation products called “fibrin degradation products”.1,2 D-Dimer is the simplest fibrin degradation product. Elevated D-Dimer levels indicate the presence of hypercoagulable state and secondary fibrinolysis in the body.
Therefore, the mass concentration of D-Dimer is of great significance for the diagnosis, efficacy evaluation and prognosis of thrombotic diseases. In addition, myocardial infarction, cerebral infarction, pulmonary embolism, venous thrombosis, surgery, tumors, diffuse intravascular coagulation, infection and tissue necrosis can also lead to increased D-Dimer.
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the D-Dimer antibody labeled with alkaline phosphatase, and the magnetic particles coated with the D-Dimer antibody are mixed. After incubation, the D-Dimer in the sample forms an immune complex with the corresponding antibody. In the second step, magnetic separation and cleaning are performed to remove free enzyme-labeled antibodies. The third step is to add the chemiluminescent substrate solution to the immune complex.
Luminescence signal generated by the enzyme reaction is detected by Automatic Chemiluminescence Immunoassay Analyzer and the detected luminescence intensity is related to the concentration of D-Dimer in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of D-Dimer in the sample.
【REAGENTS】
The reagent strip includes D-Dimer antibody coated with magnetic particles, alkaline phosphatase labeled D-Dimer antibody, wash buffer and substrate solution.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Read the entire package insert carefully prior to testing.
3. Do not use after the expiration date indicated on the package.
4. The single reagent strip has been assembled into a ready-to-use unit that cannot be separated.
5. Do not interchange or mix reagents from different batches.
6. Used test materials should be disposed of in accordance with local regulations.
7. Test kits and samples need to be equilibrated to room temperature before testing.
8. It is recommended to use fresh blood. Samples with high-fat chylo, jaundice, and high rheumatoid factor are not recommended and hemolyzed samples are also not recommended.
9. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
10.The test results of this kit are for clinical reference only, clinical diagnosis and treatment of patients should be comprehensively considered in conjunction with their symptoms/signs, medical history, other laboratory tests and treatment responses.
11.Due to methodological or antibody specificity and other reasons, test the same sample with reagent strips from different manufacturers may result in different test results. The results obtained from testing with different reagent strips should not be directly compared with each other, which may cause erroneous medical interpretations.
12.Store and test reasonably in strict accordance with the instructions of the package insert. Keep the reagents away from light, do not turn it over.
13.The D-Dimer Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals.
【SPECIMEN COLLECTION AND PREPARATION】
Collect and handle the specimen strictly as below:
1. Collect the specimen according to standard procedures.
2. Human whole blood and plasma collected using EDTA or Heparin sodium.
3. Human specimens should be tested immediately after collection. If the test cannot be detected within 2 hours after blood collection, the plasma should be separated for storage. Grossly hemolytic, lipidic or turbid samples should not be used. Specimen with extensive particulate should be clarified by centrifugation prior to use. Do not use specimens with fibrin particles or contaminated with microbial growth.
4. Do not leave specimens at room temperature for prolonged periods.Serum and Plasma specimens may be stored at 2-8 °C for up to 4 days, below -20 °C stable for 3 months. Whole blood collected by venipuncture should be stored at 2-8 °C if the test is to be used within 1 day of collection. Do not freeze whole blood specimens.
5. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
6. If the patients had been treated by high dose of biotin (5 mg/day), blood collection must be done after at least 8 hours.
7. If specimens are to be shipped, pack them in compliance with local regulations covering the transportation of etiologic agents.
