Products specifications
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Species
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Mouse
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Format
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96T
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Sample Type
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Plasma
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Assay Length
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2.5 h
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Detection Range
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19.53-5000ng/mL The standard curve concentrations used for the CLIA’s were 5000ng/mL, 1250ng/mL, 312.5ng/mL, 78.13ng/mL, 19.53ng/mL
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Sensitivity
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9ng/mL
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Specificity
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This assay has high sensitivity and excellent specificity for detection of D-Dimer (D2D).
No significant cross-reactivity or interference between D-Dimer (D2D) and analogues was observed.
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Intra-Assay Precision
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<10%
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Inter-Assay Precision
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<12%
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Storage Temperature
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-20 °C
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Shipping Conditions
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2-8 °C
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Handling Instruction
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The activity loss rate (stability) of this kit is less than 5% within the expiration date under appropriate storage conditions. To minimize extra influence on the stability, operation procedures and lab conditions, especially room temperature, air humidity, incubator temperature should be strictly controlled. When not in use, kit components should be refrigerated. All reagents should be brought to room temperature before use. It is recommended that all standards, controls, and samples be run in duplicate. Do not mix or interchange different reagent lots from various kit lots.
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Test Principle
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The microtiter plate provided in this kit has been pre-coated with a monoclonal antigen. A competitive inhibition reaction is launched between biotin labeled D-Dimer (D2D) and unlabeled D-Dimer (D2D) (Standards or samples) with the pre-coated secondary antibody. After incubation the unbound conjugate is washed off. Next, avidin conjugated to Horseradish Peroxidase (HRP) is added to each microplate well and incubated. The amount of bound HRP conjugate is reverse proportional to the concentration of D-Dimer (D2D) in the sample. Then the mixture of substrate A and B is added to generate glow light emission kinetics. Upon plate development, the intensity of the emitted light is reverse proportional to the D-Dimer (D2D) level in the sample or standard.
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Notes
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All kits are custom made on-demand. Please allow 10-15 working days for production and 2-3 days for shipment.
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Legal Information
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Marketed under license from USCN Life Science Inc.
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| Reagents | Quantity |
| Pre-coated, ready to use 96-well strip plate | 1 |
| Standard | 2 |
| Detection Reagent A | 1×120µL |
| Detection Reagent B | 1×120µL |
| Substrate A | 1×10mL |
| Wash Buffer (30 × concentrate) | 1×20mL |
| Plate sealer for 96 wells | 4 |
| Standard Diluent | 1×20mL |
| Assay Diluent A | 1×12mL |
| Assay Diluent B | 1×12mL |
| Substrate B | 1×2mL |
| Instruction manual | 1 |
The linearity of the kit was assayed by testing samples spiked with appropriate concentration of D-Dimer (D2D) and their serial dilutions. The results were demonstrated by the percentage of calculated concentration to the expected.
| Sample | 1:2 | 1:4 | 1:8 | 1:16 |
| serum(n=5) | 89-99% | 96-103% | 96-105% | 96-105% |
| EDTA plasma(n=5) | 83-101% | 80-105% | 90-98% | 80-93% |
| heparin plasma(n=5) | 81-94% | 85-101% | 88-95% | 97-105% |
Matrices listed below were spiked with certain level of recombinant D-Dimer (D2D) and the recovery rates were calculated by comparing the measured value to the expected amount of D-Dimer (D2D) in samples.
| Matrix | Recovery range (%) | Average(%) |
| serum(n=5) | 80-92 | 88 |
| EDTA plasma(n=5) | 95-102 | 98 |
| heparin plasma(n=5) | 84-105 | 101 |