D-Dimer test Rapid Test poct Kits
Methodology
Fluorescence Immunoassay
Product Name
General Name:D-Dimer Test Kit(Immunofluorescence)
Package
Test card: Aluminum foil pouch 1pc/bag, desiccant
Package size: 25pcs/box
Size in detailed:15.5CM x 16.5CM x7.5CM
Intended use
The test kit is primarily for the in vitro quantitative determination of D-Dimer content in
human blood plasma.
D-Dimer is a good index for diagnosing activity fibrinolysis. It has significant diagnosis
value for thrombosis diseases such as DIC, deep venous thrombosis, cerebrovascular
disease, pulmonary embolism, hepatic disease, after surgery, AMI, gynecology and
pediatrics diseases, meanwhile it can be used in detecting the thrombolytic therapy.
Principle of the Procedure
The reagent is based on immunefluorescence sandwich assay to detect D-Dimer
concentrations quantitatively. Using the pipette provided, drop diluted sample into the
sample well. During testing, specimen reacts with the particles coated with anti-D-Dimer
monoclonal antibody I which has conjugated with fluorescent latex. The mixture migrates
upward on the nitrocellulose membrane by capillary action to react with anti-D-Dimer
monoclonal antibody II on the test line. The intensity of fluorescent antibody signal reflects
the amount of captured D-Dimer. Immunefluorescence quantitative analyzer produced by
our company can detect the concentration of D-Dimer in the sample.
Main components
1. Test kit contains: 25 test cards and an IC card
The test card is composed of plastic shell and test strip.
The main components of test strip: Sample pad, bonding pad, nitrocellulose membrane,
Anti-MIgG, absorbent paper, PVC base plate.
2. Diluents (3ml×1 bottle): composed of phosphat , etc. PH=7.4±0.2.
Materials required (but not provided):
1.Timer
2.Centrifuge tube
3.Pipette
4.Disposable tips
Storage And Stability
The reagent box must be stored from 4 to 30℃, and the period of validity is 12 months.
The reagent strip must be used within 1 hour once its foil pouch has been opened. Do not
use the strip beyond the expiration date printed on the outside of the box.
Warnings And Precautions
This in vitro diagnostic reagents is disposable product, please do not re-use, do not use
expired products.
1.In the collection, processing, storage, mixing and sample testing process should take
appropriate protective measures.
2.Please do not use the product which has been opened, do not use obvious damaged test
kit or detection card.
3.Different batches of reagents can not be mixed, IC card and the detection card are the
same.
4.The detection card and its components are only applicable to the series of
immunofluorescent analyzer in NORMAN.
5.The test must follow the steps indicated by the operation, improper operation will lead
to erroneous results.
6.Do not insert detection card which has wetted the surface by liquid into the analyzer, in
order to prevent damaging to the instrument. Please properly dispose the used
detection card, do not throw it away.
7.Suitable ambient temperature was good for the test, do not keep the temperature too
high or too low. Cryopreserved detection card needs to be restored to room temperature
before opening, in order to avoid moisture absorption.
8.The detection card and quantitative immunofluorescence analyzer should keep away
flutter and electromagnetic environment when be used. The instrument itself fibrillation
is normal, did not pull out the IC card when it was detected.
9.Fresh samples were recommended, if the samples which have significant hemolysis or
blood clots should be abandoned, all patient samples should be treated as a potential
source of infection.
10.The date of manufacture and expiry date were on the label.
Clinical Significance
Deep vein thrombosis (DVI) and exclusion diagnosis of pulmonary embolism(PE).
Diagnosis of disseminated intravascular coagulation(DIC).
Effective detection and evaluation indicator of thrombolytic effect.
Condition evaluation of cardiovascular disease.
Identification and treatment detection of cerebral infarction.
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