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Cardiovascular Panel: D-Dimer OEM kit Adopting Chemiluminescence assay platforms
D-Dimer is applied for the rule-out diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as the auxiliary diagnosis, risk evaluation, and dynamic monitoring of disseminated intravascular coagulation (DIC) and hypercoagulable states.
D-Dimer OEM kit utilizes a two-antibody sandwich immunoassay and is applicable to chemiluminescence platforms. Specific monoclonal antibodies target distinct cross-linked D-Dimer domain epitopes on fibrin degradation products to capture plasma D-Dimer, delivering high sensitivity and exceptional specificity without cross-reactivity to fibrinogen. Calibrated with high-purity recombinant D-Dimer antigen, the assay provides accurate, reliable, and stable quantitative results. Serving as a crucial clinical biomarker for thrombotic disorders, it supports rapid emergency rule-out, risk assessment, and therapeutic response monitoring in thrombolytic therapy.
As a classic thrombosis marker, D-Dimer is widely used clinically to rule out venous thromboembolism (VTE). It also supports diagnosis and therapeutic monitoring of disseminated intravascular coagulation (DIC) and malignant tumors, as well as evaluation of coagulation disorders, making it one of the most commonly ordered coagulation tests by clinicians.
★Bulk reagents are available with matching raw materials.
Marca :
QYM,SURFTECHArtículo n.° :
DDIMER-1Pedido (MOQ) :
On requestPago :
T/TOrigen del producto :
ChinaColor :
R1 should be a colorless to pale yellow transparent liquid; R2 should be a milky white suspension.Puerto de embarque :
Hefei or other portsPlazo de entrega :
On requestPeso :
On requestD-Dimer OEM reagent
Product Specifications
| Product Name | D-Dimer OEM reagent (chemiluminescence platforms) |
| Application: | It is applied for the rule-out diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as the auxiliary diagnosis, risk evaluation, and dynamic monitoring of disseminated intravascular coagulation (DIC) and hypercoagulable states. |
|
Assay Principle: |
Two-antibody sandwich immunoassay |
|
Sample Type: |
Serum / Plasma |
|
Calibrator Component: |
Recombinant D-Dimer |
|
Analyte |
D-Dimer |
|
Accuracy |
Relative bias ≤10% |
|
Limit of blank (LoB) |
≤0.05 μg/mL FEU |
|
Measuring range |
Within 0.1–20 μg/mL FEU, correlation coefficient (r) ≥0.9900 |
|
Reference interval |
Cutoff = 0.5 μg/mL FEU |
|
Cross-reactivity |
No significant cross-reactivity with ANP, BNP, CNP, etc. |
|
Precision |
Within-run ≤5%; Between-run ≤8% |
|
Interfering Substances |
Bilirubin ＜25 mg/dL; Hemoglobin ＜1.0 g/dL; Lipemia ＜1500 mg/dL |
|
Method comparison |
Correlation coefficient (r) ＞0.975 vs Roche assay |
| Package Size |
on request |
| Storage/Shipping | Store sealed and protected from light at 2 °C to 8 °C |
| Shelf Life | 12 months |
Product Advantages
1.World-class sensitivity.
2.Excellent linearity over the full concentration range.
3.Precision complies with quality criteria at all concentrations.
4.Reliable long-term stability under specified storage conditions (heat degradation test).
5.High correlation vs leading China brands in clinical comparison, R²＞0.975.
Sensitivity Analysis Batch precision test Linear Range Validation
Thermal damage test
Application Scenarios
D-Dimer is applied for the rule-out diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as the auxiliary diagnosis, risk evaluation, and dynamic monitoring of disseminated intravascular coagulation (DIC) and hypercoagulable states.
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FAQ
How well does it correlate with clinical reference platforms (e.g., Roche )?
Correlation coefficient (r) ＞0.975 vs Roche assay.
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