Place of Origin:
ISO 13485, CE
【Product name】 D-Dimer.pdf
D-Dimer Rapid Quantitative Test(Fluorescence immunoassay)
This kit is used for quantitative determination of D-dimer in human whole blood and plasma.
The principle of immunofluorescence chromatography was applied to the kit. The D-dimer antigen in the sample was first bound with the conjugated compound of fluorescent labeled D-dimer monoclonal antibody, then moved and combined with another D-dimer monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.
|Test card||25||It is composed of fluorescent pad (coated with fluorescent labeled D-dimer monoclonal mouse antibody), nitrocellulose membrane (coated with D-dimer monoclonal mouse antibody and Goat anti mouse IgG antibody), absorbent paper and backing|
|Sample buffer||25(300μL/tube)||Phosphate buffer|
|ID card||1||Record the standard curve information of this kit|
By measuring 268 healthy people aged between 19 and 79, statistical analysis shows that the reference interval is less than 500 ng/ml. According to the characteristics of the local population, the reference intervals of the laboratories were established.
【Interpretation of results】
【Limitations of methods】
1. Analysis sensitivity
No more than 40ng/ml.
The relative deviation from the target value is within ±15%.
The within and between assay coefficient of variations are within 15%.
4. Linear range
Within the linear range (40 ~ 10000ng/ml), the linear correlation coefficient R≥0.990.
1. This kit is only used for in vitro diagnosis.
2. The test card and sample diluent are disposable and cannot be reused.
3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃~30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.
4. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.
5. The used kits should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.
|WWHS Assay list|
|cat#.||Product item||Specimen||Reaction Time||Measure Range||Clinical Range||Itended Use|
|1||cTnI||WB/Serum/Plasma||12min.||0.1-40ng/ml||<0.3ng/ml||several heart diseases including myocardial infarction and heart failure.|
|2||Myo||WB/Serum/Plasma||12min.||5-400ng/ml||<58ng/ml||acute myocardial infarction (AMI) in early stage.|
|3||CK-MB||WB/Serum/Plasma||12min.||1-200ng/ml||<5ng/ml||acute myocardial infarction (AMI) in early stage.|
|heart failure .|
|5||D-Dimer||WB/Plasma||10min.||40-10000ng/ml||<500ng/ml||disseminated intravascular coagulation (DIC),deep vein thrombosis (DVT),pulmonary embolism (PE), myocardial infarction, cerebral infarction, etc.|
|6||cTnI+Myo+CKMB||WB/Serum/Plasma||12min.||same with single item||same with single item||Triple marker of myocardial infarction.|
|7||ST2||WB/Serum/Plasma||10min.||10-400ng/ml||<35ng/ml||heart failure .|
|8||Lp-PLA2||WB/Serum/Plasma||10min.||10-900ng/ml||<175ng/ml||Risk evaluation of ACS and atherosclerotic ischemic stroke patients.|
|9||S100-β||WB/Serum/Plasma||10min.||0.05-10ng/ml||<0.2ng/ml||Cerebral infarction, cerebral injury.|
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