Kit principle: This kit contains three highly specific and sensitive D-Dimer monoclonal antibodies, among which D-Dimer monoclonal antibody I is a fluorescently labeled antibody, which is pre-coated on a fluorescent pad, and D-Dimer monoclonal antibody II and III are capture antibodies, which are fixed in the detection area on the membrane, and are coated with rabbit anti-mouse IgG antibody in the quality control area. The antigen-antibody reaction and fluorescence immunochromatography technology are used to quantitatively detect the content of D-Dimer in human blood.
The working principle of the supporting instrument: The measuring system of the instrument automatically scans the binding area of the label and the test substance on the test card after the reaction, and obtains the optical signal. Then the optical signal is measured and analyzed, and the concentration of the measured substance is obtained quantitatively.
D-Dimer Dimer Detection Card (Dry Immunofluorescence Method)
Instructions: 1 copy/box
Note: The components of the D-dimer detection kit (dry immunofluorescence method) of different batches are not interchangeable.
Storage conditions and expiry date
The test card is stored in a sealed state at 4-30C, and the validity period is 18 months.
- For human serum, plasma or whole blood samples, other body fluids and samples may not get accurate results.
- The venous blood should be collected under aseptic conditions. It is recommended to use human serum or plasma for testing.
- Blood and whole blood samples can use heparin, EDTA or sodium citrate anticoagulant.
- After clinical blood samples are collected, the test must be completed within 4 hours at room temperature; serum plasma can be stored at 2-8°C for 5 days; stored below -20°C for 6 months. Whole blood samples should not be frozen, stored at 2~8°C, and can be stored for 3 days. Avoid heating and inactivating samples, and hemolyzed samples should be discarded.
- The sample must be returned to room temperature before testing. The frozen samples must be completely thawed, rewarmed, and evenly mixed before use.
Avoid repeated freezing and thawing. It is recommended that the sample be frozen and thawed no more than once.
Before using this reagent, you must read the instructions of the reagents carefully, and perform the shut-off operation strictly in accordance with the instructions of the reagents, otherwise reliable results cannot be guaranteed.
Return the test card, sample, and buffer to room temperature (15~30 °C) before testing. It is recommended to unpack the test card after returning to room temperature
, And use it as soon as possible within the validity period to prevent the test card from getting wet.
Confirm that the batch number of the SD card matches the test card, perform SD card calibration, and calibrate the instrument parameters (see the instrument manual for details).
- Sample addition method and detection
①According to the type of sample, select the sample mode on the analyzer: “serum/plasma” mode or “whole blood” mode.
- Serum and plasma: draw 100ul of serum or plasma sample, drop it vertically to the sample point of the test card, and start timing.
- Whole blood: draw a 100 ul whole blood sample, drop it vertically to the sample point of the test card, and immediately add a drop of whole blood buffer
(20ul-30ul) Start timing at the sample point.
②After 10 minutes, insert the test card into the carrier of the fluorescence immunoassay analyzer, press the “measure” button, the instrument will automatically detect and print the results.
Positive judgment value or reference interval
The statistical analysis of the results of plasma samples from 500 healthy people showed that the upper limit of the D-Dimer reference interval is 0.25 mg/L at the 90th percentile and 0.50 mg/L at the 95th percentile.
The reference interval for whole blood samples is consistent with the reference interval for plasma samples.
The reference interval may be different for different laboratory techniques. During pregnancy, oral anticoagulant treatment, aging, strenuous exercise, stress, and various clinical diseases, D-Dimcr will increase physiologically. Considering various influencing factors, it is recommended that each laboratory establish its own reference interval and clinical decision level for the group it serves.
Interpretation of test results
Use a fluorescence immunoquantitative analyzer to analyze the test card and issue a quantitative stack test result. The detection range of this kit is 0.10 mg/L-10.00 mg/L. When the sample concentration exceeds the upper limit of detection, the sample should be diluted with a negative sample or detection buffer, and the maximum dilution factor is 2 times.
The hemoglobin, triglycerides and bilirubin in the sample will interfere with the test results, and the maximum allowable concentrations are 5 g/L, 10 g/L and 0.2 g/L.
- The lowest detection limit: not higher than 0.10mg/L.
- Linear range: within the interval of 0.10-10.00] mg/L, the linear correlation coefficient r>0.990.
- Precision: Repeatability: CV<10%. Difference between batches: CV≤15%.
- Accuracy: The relative deviation between the test result of the internal accuracy reference product and the target value is ≤20%.
Limitations of the test method
- This kit is limited to in vitro diagnostic use.
- The test results of this kit are for clinical reference only, and cannot be used alone as a basis for confirming or excluding cases. In order to achieve diagnostic purposes, the test results should be combined with clinical examination, medical history and other examination results.
- The straws cannot be mixed to avoid cross-contamination.
- After the test card is unpacked, the test should be carried out as soon as possible to avoid leaving it in the air for too long, which may cause moisture.
- The test card can be sealed and stored at room temperature. Beware of moisture. The test card stored at low temperature should be equilibrated to room temperature before use.
- This product contains sodium azide as a preservative. Sodium azide can react with copper or lead pipes in drainage pipes and produce explosives. Please dispose of them properly in accordance with local regulations.
- For those substances that contain the source of infection or suspected of containing the source of infection, there should be appropriate biosafety assurance procedures. The following are relevant precautions:
☆Wear gloves to handle samples or disinfect reagents.
☆ Use disinfectant to disinfect the spilled samples or reagents.
☆Disinfect and dispose of all specimens, reagents and potential contaminants in accordance with relevant local regulations.