Products Thyroid peroxidase antibodies (TPO-Ab)

rapid test

Thyroid peroxidase antibodies (TPO-Ab) thyroid conditions rapid test

Item Number : TPO-Ab

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Product Overview Table

Feature Description
Product Name Anti-Thyroid Peroxidase (anti-TPO) positive human plasma;
Host Species Human
Application IVD reagent for detection of TPO-Ab; Diagnosis of autoimmune thyroid disease; Assessing risk factor for atherosclerosis
Dosage Form/Appearance Liquid, Yellow to orange liquid;
Source Single Human Donor
Biological Activity anti-TPO: > 1,000 U/mL (Immunoassay)

Storage and Transportation Conditions Table

Condition Description
Storage -20 ºC; 2~8℃ Store in unopened state away from light
Shipping Dry Ice
Shelf Life N/A (for plasma); See instructions for the kit

Finished Product Performance Indicator Table

Indicator Specification
Accuracy Correlation coefficient (r) ≥ 0.975; Relative deviation within ±10%
Limit of Detection ≤ 5 IU/mL
Linearity Linear range: 5 IU/mL ~ 600 IU/mL; Correlation coefficient (r) ≥ 0.990 within the linear range
Repeatability Coefficient of Variation (CV) ≤ 8%
Inter-batch Variation Inter-batch Coefficient of Variation (CV) ≤ 15%
Stability When stored at 2-8°C in the dark and unopened, the appearance, quantity, accuracy, minimum detection limit, linearity, and repeatability of the test reagent within one month after the expiry date should meet the requirements of 2.1-2.5.
Calibrator Uniformity ≤ 10%
Calibrator Accuracy Relative deviation within ±10%
Calibrator Stability When stored at 2-8°C in the dark and unopened, the uniformity and accuracy of the test product within 1 month after the expiry date should meet the requirements.

Thyroid Peroxidase Antibodies (TPO-Ab)

Introduction:

Thyroid peroxidase antibodies (TPO-Ab) are antibodies that target thyroid peroxidase (TPO), an enzyme crucial for thyroid hormone production. The presence of TPO-Ab is a key indicator of autoimmune thyroid disease.

Biological Activity:

  • TPO-Ab levels are typically measured in U/mL or IU/mL using immunoassay techniques.
  • Elevated TPO-Ab levels (e.g., >1,000 U/mL) are indicative of autoimmune activity against the thyroid.

Relationship with Related Diseases:

  • Autoimmune Thyroid Disease: TPO-Ab is a known cause of autoimmune thyroid diseases.
  • Atherosclerosis: Research suggests a potential link between TPO-Ab levels and atherosclerosis. A normal TPO-Ab range (TPO-Ab negative) might be positively associated with atherosclerosis in individuals with normal thyroid function, potentially due to the role of low-grade inflammation.

Application in IVD:

TPO-Ab testing is crucial for:

  • Diagnosis of autoimmune thyroid diseases.
  • Risk stratification

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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