Products creatine phosphokinase-MB (CK-MB)

rapid test

creatine phosphokinase-MB (CK-MB) heart disease rapid test

Item Number : CK-MB

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Product Overview Table

Feature Description
Product Name Anti-h CK-MB
Description Monoclonal mouse antibody, cultured in vitro under conditions free from animal-derived components.
Application FIA, Diagnosis of acute myocardial infarction, myocardial ischemia, or myocarditis
Form/Appearance Liquid, may turn slightly opaque during storage
Concentration 5.0 mg/ml (+/- 10 %)
Isotype IgG1
Clonality Monoclonal
Epitope N/D
Purity ≥ 95 %
Affinity Constant KA= 2 x 109 1/M
Buffer 37 mM citrate, 125 mM phosphate, pH 6.0, 0.9 % NaCl, 0.095 % NaN3 as a preservative
IEF Profile 6.7–8.0
Cross Reactivity CK-BB isoenzyme 182 %, CK-MM isoenzyme 7.3 %
Specificity Antibody recognizes human creatine kinase MB isoenzyme

Storage and Transportation Conditions Table

Condition Description
Storage +2-8°C
Shipping Cold packs
Shelf Life 24 months

Finished Product Performance Indicator Table

Indicator Specification
Package Appearance Product outer packaging box and aluminum foil packaging bag should be complete and undamaged.
Test Strip Width Should not exceed the nominal value ±0.20mm. (Nominal value: 4.00mm)
Migration Speed Liquid migration speed should be no less than 8.0 mm/min.
Minimum Detection Limit (CK-MB) ≤2.5 ng/ml
Linear Range (CK-MB) 5.0 ng/ml~80.0 ng/ml, linear correlation coefficient r≥0.990
Accuracy When testing BIORAD myocardial marker quality control products, the relative deviation between the mean of the test values and the target value should be no greater than 20%.
Repeatability Should be no greater than 10%.
Batch-to-Batch Precision (Inter-batch difference) Should be no greater than 15%.
Stability When stored at 4-30°C in a sealed aluminum foil bag, and tested within 1 month of the expiration date, the test results should meet the requirements for Test Strip Width, Migration Speed, Minimum Detection Limit, Linear Range, and Accuracy.

Creatine Phosphokinase-MB (CK-MB)

Target Introduction:

Creatine phosphokinase-MB (CK-MB) is a cardiac marker, a bound dimer composed of two isoenzymes, CKM and CKB, which are variants of the enzyme phosphocreatine kinase. It's found primarily in heart muscle. Measurement of CK-MB levels in the blood is used to aid in the diagnosis of acute myocardial infarction, myocardial ischemia, and myocarditis. Monoclonal antibodies against CK-MB are produced in vitro under conditions free from animal-derived components.

Associated Diseases and Conditions:

  • Acute Myocardial Infarction (AMI): Elevated CK-MB levels are indicative of heart muscle damage, such as that caused by a heart attack.
  • Myocardial Ischemia: Reduced blood flow to the heart muscle, leading to damage.
  • Myocarditis: Inflammation of the heart muscle.
  • Ventricular Septal Defects (VSD): In newborns with cardiac malformations like VSDs, CK-MB levels exceeding the blood level of total CK have been reported.
  • Pulmonary Emboli or Vasculitis: Increased CK-MB levels may also be associated with pulmonary emboli or vasculitis.

Application:

  • Diagnosis of Cardiac Events: Primarily used as a cardiac marker to assist in the diagnosis of acute myocardial infarction, myocardial ischemia and myocarditis.
  • Point-of-care Testing: Can be used in FIA (Fluorescence Immunoassay).
  • Monitoring Cardiac Damage: Evaluating the extent of heart muscle damage after a cardiac event.

Antibody Specificity and Cross-Reactivity:

  • The antibody recognizes the human creatine kinase MB isoenzyme.
  • Cross-reactivity has been observed with CK-BB isoenzyme (182%) and CK-MM isoenzyme (7.3%).

Considerations:

  • In some locations, the troponin test has largely superseded the CK-MB test. However, improvements involving measurement of CK-MB1 and CK-MB2 isoforms are being implemented.
  • In rare cases, elevated CK-MB levels can be caused by autoimmune reactions creating a complex molecule of CK and IgG.

Technology Transfer

Technology transfer and customization

For research institutions and growing enterprises, especially those in the early stages of development, we offer a comprehensive suite of mature and stable production process technology transfer, along with relevant process documentation. 

Additionally, we can tailor transformation production processes to align with diverse customer requirements and market needs. 

This approach not only expedites the R&D and production process optimization timeline but also significantly reduces time and capital investment for our clients.

Expert lectures

The course will be led by seasoned industry experts, covering a range of topics including immunochromatography knowledge, theoretical explanations of process flows, and hands-on experimental operations. It will systematically address and analyze technical challenges faced by customers in their R&D and production processes, offering practical solutions. 

Additionally, the course will feature demonstrations and practical operation sessions focused on immunochromatography equipment that is of particular interest to participants.

Process

The process unfolds as follows: 

The customer outlines their requirements -> we collaborate to explore feasible solutions -> the customer settles the fee -> based on the provided solution, the customer either attends on-site training or receives remote guidance -> should production issues arise, we dispatch experts to the customer's site to offer on-site guidance and resolve the problems.

Research Outsourcing

We provide a variety of scientific and technical services, including laboratory equipment, experimental materials, data analysis and report writing, etc.

  • ‌Experimental Consumables and Chemical Reagents: We provide a comprehensive range of consumables and chemical reagents required for various experiments to meet the diverse needs of scientific research.
  • ‌Data Analysis: We are responsible for collecting and conducting in-depth analysis of experimental data, generating detailed reports to lay a solid foundation for the presentation of research findings.
  • Technical Support: We offer comprehensive technical support to ensure the smooth progress of experiments, facilitating the successful conduct of research work.
  • ‌Customized Services: We possess the capability to tailor scientific and technological services to meet the specific needs and expectations of our clients, ensuring a high level of alignment and effectiveness in our offerings.
  • ‌One-Stop Services: We provide comprehensive one-stop scientific research services, including equipment rental and experimental material procurement, aiming to deliver a convenient and efficient user experience while streamlining the research process.

Process:

  • Customer Submits Requirements: The customer clearly outlines their research or production needs, laying the foundation for subsequent services.
  • Exploring Feasible Solutions: We engage in in-depth communication with the customer to jointly explore and formulate practical solutions, ensuring the forward-looking and operational nature of the service.
  • Customer Pays Fees: Upon reaching a mutual agreement, the customer settles the relevant fees, providing assurance for the formal initiation of the service.
  • Conducting Experiments or Data Characterization Analysis for the Customer: Based on the agreed-upon plan, we perform experimental operations or data characterization analysis for the customer, ensuring the process is professional and precise.
  • Providing the Customer with a Detailed Experimental Report: Upon completion of the experiments or analysis, we deliver a comprehensive experimental report to the customer, offering robust support for their research or production decisions.

Semi-finished Products (large Packaging)

We can provide semi-finished (bulk packaged) reagents for quick assembly and application in your own country.

Advantages of Semi-Finished Reagents for Local Assembly:

  • Rapid Market Entry: Quick assembly allows for swift deployment and faster market penetration.
  • Compliance: Meets government self-production mandates and local regulatory requirements.
  • Cost Efficiency: Reduces logistics and capital investment costs.
  • Scalability: Flexible production adapts to market demand.
  • Quality Assurance: Ensures consistent quality with local oversight.
  • Competitive Edge: Combines global expertise with local production for a strategic advantage.

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