Products Glycated hemoglobin (HbA1c)

rapid test

Glycated hemoglobin (HbA1c) diabetes rapid test

Item Number : HbA1c

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Product Overview Table

Feature Description
Product Name Anti-h HbA1c
Description Monoclonal mouse antibody, cultured in vitro under conditions free from animal-derived components.
Application FIA (Fluorescence Immunoassay)
Form/Appearance Liquid, may turn slightly opaque during storage
Concentration 5.0 mg/ml (+/- 10 %)
Isotype IgG1
Clonality Monoclonal
Epitope N-terminal end of the beta chain
Purity ≥ 95 %
Affinity constant N/D
Buffer 50 mM Na-citrate, pH 6.0, 0.9 % NaCl, 0.095 % NaN3 as a preservative
IEF Profile 6.7–7.7
Cross Reactivity Does not recognize non-glycated hemoglobin A1.
Specificity Antibody recognizes human glycated hemoglobin A1

Storage and Transportation Conditions Table

Condition Specification
Storage +2-8°C
Shipping Cold packs
Shelf Life 18 months

Finished Product Performance Indicator Table

Indicator Specification
Package Product outer packaging box, aluminum foil packaging bag should be complete and undamaged.
Traceability According to GB/T21415-2008, provide the assignment process, source, measurement uncertainty, etc. of the calibrators used.
Detection Buffer Appearance The buffer should be clear and transparent, without suspended matter. The bottle should be tight and leak-proof.
Detection Buffer Volume Buffer volume is 1mL, and the net content should be within the range of 1.0g±0.05g.
Detection Buffer pH The pH of the buffer should be within the range of 7.2±0.2.
Test Strip Appearance The appearance should be neat and flat, without burrs, damage, or pollution; the material should be firmly attached.
Test Strip Width The width should not exceed ±0.20mm of the nominal value, and the nominal value is 4.00mm.
Migration Speed The liquid migration speed should not be less than 10mm/min.
Limit of Detection The limit of detection should not be higher than 2.0%.
Linearity Range Within the range of 2.0%~14.0%, the linear correlation coefficient r≥0.990.
Accuracy (Comparison Test) Correlation coefficient r≥0.975, relative deviation not greater than ±20%.
Accuracy (Relative Deviation) Relative deviation not greater than ±20%.
Repeatability Repeatability should not be greater than 10%.
Batch-to-batch Precision (Inter-batch difference) Inter-batch difference should not be greater than 15%.
Stability When stored at 4~30℃ in a sealed aluminum foil bag, take the product within 1 month of the expiration date for testing, and the test results should meet the requirements in items 2.3~2.8.

Glycated Hemoglobin (HbA1c)

Target Introduction:

Glycated hemoglobin (HbA1c), also known as hemoglobin A1c, is formed when glucose in the blood binds to hemoglobin, the oxygen-carrying protein inside red blood cells. The amount of HbA1c reflects the average blood glucose levels over the preceding 2-3 months, which is the lifespan of red blood cells. The higher a person's average blood sugar levels, the more glycated hemoglobin they will have.

Relationship with Related Diseases:

HbA1c is a crucial marker for assessing long-term glycemic control in individuals with diabetes. It provides a retrospective measure of blood glucose levels, helping to determine how effectively a person's diabetes is being managed.

Application:

  • Diagnostic Testing: HbA1c is measured via blood test to determine the average blood glucose level over the past 2-3 months.
  • Diabetes Management: HbA1c testing is widely used to monitor the effectiveness of diabetes treatment plans and guide adjustments to medication, diet, and exercise.
  • FIA (Fluorescence Immunoassay): Anti-h HbA1c monoclonal antibodies can be used in fluorescence immunoassays for HbA1c detection.

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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