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Cardiovascular Panel: hs-cTnI OEM kit Adopting Chemiluminescence assay platforms

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.

  • Brand :

    QYM,SURFTECH
  • Item No :

    hs-cTnI-1
  • Order(MOQ) :

    On request
  • Payment :

    T/T
  • Product Origin :

    China
  • Color :

    R1 should be a colorless to pale yellow transparent liquid; R2 should be a milky white suspension.
  • Shipping Port :

    Hefei or other ports
  • Lead Time :

    On request
  • Weight :

    On request

hs-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

 

--------------占位---------------

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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