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Cardiovascular Panel: hs-cTnI OEM kit Adopting Chemiluminescence assay platforms
hs-cTnI kit is applied for early diagnosis and monitoring of myocardial injury and acute myocardial infarction.
hs-cTnI OEM kit utilizes a three-antibody sandwich immunoassay and is applicable to chemiluminescence platforms. Specific antibodies target different cTnI epitopes to capture trace plasma hs-cTnI, delivering high sensitivity and specificity. Calibrated with high-purity recombinant cTnI, the assay provides accurate and stable quantitative results. Serving as the gold standard for acute myocardial infarction diagnosis, it supports early identification and dynamic monitoring of myocardial injury for clinical auxiliary diagnosis.
Ischemia and hypoxia induce myocardial degeneration and necrosis, enabling cTnI leakage into circulation. Plasma cTnI surges 3–12 hours after injury and remains elevated for over one week. In MI patients, cTnI rises early, peaks at 18 h, and stays abnormal for 6–8 days. As a universally accepted biomarker, cTnI detects myocardial injury and is the gold standard for AMI diagnosis.
★Bulk reagents are available with matching raw materials.
Marca :
QYM,SURFTECHArtículo n.° :
hs-cTnI-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 requesths-cTnI OEM reagent
Product Specifications
| Product Name | hs-cTnI OEM reagent (chemiluminescence platforms) |
| Application: | It is applied for early diagnosis and monitoring of myocardial injury and acute myocardial infarction. |
|
Assay Principle: |
Three-antibody sandwich immunoassay |
|
Sample Type: |
Serum / Plasma |
|
Calibrator Component: |
Recombinant cTnI |
| Analytical Sensitivity: |
0.01 μg/L |
|
Linear Range: |
0.02–50 μg/L |
|
Reference Interval: |
<0.04 μg/L |
|
Traceability Reference Material: |
Beckman |
|
Precision: |
Intra-assay ≤5%; Inter-assay ≤8% |
|
Cross-Reactivity: |
Interference from 1000 ng/mL cTnC, cTnT, sTnI ≤0.1% |
|
Interfering Substances:
|
Bilirubin <0.4 mg/mL, Hemoglobin <500 mg/dL, Triglycerides <10 mg/mL |
| Hook Effect Concentration: |
2000 μg/L |
| 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.Measured sensitivity: 0.001 μg/L, surpassing industry standards and satisfying ultra/high-sensitivity requirements
2.Linear range R²＞0.99, deviation ＜5%
3.Precision repeatability CV: 1%~3% (measured)
4.Good correlation with Beckman, R²＞0.975
Sensitivity&Troponin Linear Range Validation Ultra-Sensitive & High-Sensitivity Standard Verification
High-Sensitivity Cardiac Troponin Clinical Comparison (Beckman, N=514)
Precision CV at Different Concerntrations
Application Scenarios
hs-cTnI kit provides accurate and stable quantitative results. Serving as the gold standard for acute myocardial infarction diagnosis, it supports early identification and dynamic monitoring of myocardial injury for clinical auxiliary diagnosis.
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FAQ
Is it a true high-sensitivity assay meeting IFCC criteria?
Yes.
How well does it correlate with global benchmark platforms ?
Highly correlated (Beckman, R2 > 0.975) across clinical panels, ensuring consistent AMI Rule-in/Rule-out decisions and supporting sex-specific 99th percentile cutoffs.
What are the shelf-life specs and lot-to-lot variations?
Real-time stability is 12–18 months (2–8℃), with 14–28 days on-board stability. Lot-to-lot variation is strictly controlled within CV＜8%.
Are the core raw materials (antibodies) self-owned and supply-secured?
Core monoclonal antibody pairs are self-developed or long-term locked, guaranteeing zero clone-change risk and consistent multi-year supply for OEM partners.
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