CFDA Approval No.:CE Mark:20142400842
D-dimer is a cross-linked fibrin degradation product. The concentration of D-dimer arises when there is activated thrombus (significant blood clot) formation or fibrinolysis in blood vessels found in conditions such as deep vein thrombosis, pulmonary embolism, disseminated intravascular coagulation (DIC), acute aortic dissection, myocardial infarction,malignant diseases, recentsurgery, cancer, infection and tissue necrosis. D-dimer test, in conjunction with clinical assessment, can be used to rule out deep vein thrombosis (DVT), pulmonary embolism (PE) and stroke.
►TestingTime: 20 minutes.
►Testing principle: A quantitative immunochromatographic test. Anti-human D-dimer antibodies conjugated with colloidal gold binding to D-dimer when present in the sample.
►Testing format: Single use test cartridge with barcode defines lot specific calibration.
►Sample Material: Serum/plasma/whole blood.
►Performance:A clinical trial showed the concordance rate between the PROPRIUM D-dimer assay and another commercial assay for positives and negatives 89.01% and 93.25% respectively.
►Measuring Range: 500ng/ml -10, 000 ng/ml.
►Precision:CV<15%.
The product is CFDA approved for clinical use in China and CE marked for IVD use in CE-marking countries (e.g. European countries).
1 servings / bag, 20 / box, 20 boxes / carton
【Storage conditions and period】
Original packaging stored in 2-30 ℃, cool dark dry place, avoid freezing.
Under the storage conditions of the original packaging is valid for 12 months, a specific expiration date stamped on.
Products that have been opened shall, within one hour use, otherwise the product easy to damp, may lead to invalid test results.
【Applicable Instruments】
Hangzhou Proprium Biotechnology Limited production of HPJ-1 type colloidal gold immunoassay analyzer (registration number: Zhejiang FDA (prospective) 2014 No. 2400659)
【Sample Requirements】
1. This kit is only suitable for serum samples.
2. Serum samples should not be placed for a long time at room temperature. Such as the use of serum samples prior to testing, to be separated as soon as possible to avoid hemolysis. Has hemolytic samples can not be used.
3. The blood samples at 2-8 ℃ conditions can save three days, as long-term storage needs freezing -20 ℃. Avoid repeated freezing and thawing.
4. sample before use rewarming to room temperature and refrigerated samples must be mixed thoroughly before use.
5. Do not detect serious hemolysis and jaundice and severe lipemic samples.
Also, a blood sample if required transport, should strictly abide by state laws and regulations on the transport of blood products.
【Precautions】
1. This product is suitable for in vitro diagnostic professionals only.
2. This product is only semi-quantitative determination of creatine kinase, creatine kinase MB To diagnose abnormalities associated with the disease, response of samples for further laboratory testing.
3. Before using this product to keep the packaging intact, do not use damaged packaging products. Do not use expired products.
4. operate in strict accordance with the instructions, can not detect the start midway termination, if she can no longer detect the termination of the recovery. To re-tested, must be replaced with new reagents.
5. This reagent is a disposable product, please use caution to prevent microbiological hazards and infections.
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