D-Dimer test rapid test assay
For D-Dimer
Methodology
Fluorescence Immunoassay
Product Show
Package
Test card: Aluminum foil pouch 1pc/bag, desiccant
Package size: 25pcs/box
Size in detailed:15.5CMx16.5CMx8.1CM
25PCSx30BOXES/CARTON
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):
Timer
Centrifuge tube
Pipette
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.
Specimen Collection And Preparation
1.The blood plasma specimen is suggested to use 1: 9 Na-Citrate blood collection tube for
collecting and the specimen is suggested to be tested within 4hours.
2.The specimens must be returned to room temperature before testing.
Interpretation Of Test Results
1.The analysis of test results are accomplished by immune-fluorescence quantitative
analyzer of our company's NORMAN series.
2.The concentration of D-Dimer in the unknown samples can be read directly in the
corresponding batch of ID card standard curve by fluorescence signal value we
measured. The default results use mg/L as a unit.
Expected values/Reference range
The reference range study was conducted based on D-Dimer content of 95% of the
distribution range of statistical analysis in 120 healthy people, the result was as follows:
Normal reference values: ≤ 0.5 mg/L
It is recommended that each laboratory established its own reference range, which may be
unique to the population it serves depending upon geographical, patient, dietary, or
environmental factors.
D-Dimer
Negative exclusion indicator of venous thromboembolism.
High sensitivity, VTE negative predictive value ≥99%.
D-Dimer plasma specs
Methodology | Fluorescence Immunoassay |
Specimen | 30ul plasma |
Measuring range | 0.1-10mg/L |
Cut-off value | 0.1mg/L |
Reaction time | 15 minutes |
Shelf life | 12months |
Clinical Significance
1.Deep vein thrombosis (DVI) and exclusion diagnosis of pulmonary embolism(PE).
2.Diagnosis of disseminated intravascular coagulation(DIC).
3.Effective detection and evaluation indicator of thrombolytic effect.
4.Condition evaluation of cardiovascular disease.
5.Identification and treatment detection of cerebral infarction.
Performance Analysis
Correlation analysis between Norman D-Dimer and Siemens D-Dimer.
European society of Cardiology
Guidelines for the diagnosis and treatment of acute pulmonary embolism
Recommend to use D-Dimer test as the screening indicator of pulmonary embolism
diagnosis in emergency department
Clinical and laboratory standards institute
H59-P guideline: In low and middle clinical risk peak, D-Dimer quantitative test is used
for exclusion diagnosis of venous thrombus embolism(VET).
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About us
Nanjing Norman Biological Technology Co., Ltd is dedicated to R&D and manufacturing of
automated chemiluminescence system. Founded in 2008, Norman biological has been
upholding the idea that R&D shapes future ,and concentration determines success. Ever
since the beginning, Norman has been focusing on developing and manufacturing
chemiluminescence instruments and reagents.
Norman's manufacture center is located in the Yuhua District and owns an over 2,000m2
GMP-approved clean workshop. The R&D base, which is over 2,000m2 , is located in state-
level new Jiangbei district. Now there are over 100 R&D engineers, 40% of which hold a
PhD or master's degree.
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If you are interested in working with us, please feel free to contact.
