clia / elisa, rapid test
The thyroid-stimulating hormone (TSH) thyroid function clia / elisa rapid test
Item Number : TSH
Price varies based on specs and customizations
- Diseases
- thyroid function
- Application
- clia / elisa , rapid test
Shipping:
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Product Overview Table
Feature | Description |
---|---|
Product Name | Anti-h TSH |
Description | Monoclonal mouse antibody, cultured in vitro under conditions free from animal-derived components. |
Application | LF, CLIA, FIA |
Form/Appearance | Liquid, may turn slightly opaque during storage |
Concentration | 1.0 mg/ml (+/- 10 %) |
Isotype | IgG1 |
Clonality | Monoclonal |
Epitope | Group 1 |
Purity | ≥ 95 % |
Affinity constant | KA= 5.1 x 109 1/M; KD= 2.0 x 10-10 M (= 0.20 nM) |
Associated Products | Native TSH antigen 996-51 |
Buffer | 0.9 % NaCl, 0.095 % NaN3 as a preservative |
IEF Profile | 6.6–7.7 |
Cross Reactivity | hCG 0.1 %, LH 0.8 %, FSH 1.0 % |
Specificity | Antibody recognizes human thyrotropin and its free beta subunit |
Storage and Transportation Conditions Table
Condition | Details |
---|---|
Storage | +2-8°C |
Shipping | Cold packs |
Shelf Life | 12 months |
Finished Product Performance Indicator Table
Indicator | Specification |
---|---|
Packaging Appearance | Product outer packaging box and aluminum foil packaging bag are complete and undamaged. |
Buffer Appearance | The buffer should be clear and transparent, without suspended matter. The bottle should be tight and leak-free.(This applies only to reagent kits for the Getein1100 analyzer.) |
Buffer Volume | The volume of the buffer should be 2.0mL, and its net content should be within the range of 2.0g±0.10g.(This applies only to reagent kits for the Getein1100 analyzer.) |
Buffer pH | The pH of the buffer should be within the range of 7.2±0.2.(This applies only to reagent kits for the Getein1100 analyzer.) |
Test Strip Appearance | Clean and flat appearance, no burrs, no damage, no pollution; material attached firmly. |
Test Strip Width | The width should not exceed ±0.20mm of the nominal value, which is 4.00mm. |
Migration Speed | The liquid migration speed should not be less than 10mm/min. |
Minimum Detection Limit | The minimum detection limit concentration should not be higher than 0.10 μIU/mL. |
Specificity | The detection result of follicle-stimulating hormone (FSH) with a concentration of no less than 200IU/L should not be higher than the minimum detection level. The detection result of luteinizing hormone (LH) with a concentration of no less than 200IU/L should not be higher than the minimum detection level. The detection result of human chorionic gonadotropin (HCG) with a concentration of no less than 1000IU/L should not be higher than the minimum detection level. |
Linear Range | Within the range of 0.10 μIU/mL~50 μIU/mL, the linear correlation coefficient r≥0.990. |
Accuracy | Relative deviation should not be greater than 20%. |
Repeatability | Repeatability should not be greater than 10%. |
Inter-batch Precision | Inter-batch difference should not be greater than 15%. |
Stability | The product is stored at 4~30℃ in a sealed aluminum foil bag, and the product within 1 month after the expiration date is tested, and the test results should meet the requirements of items 2.1~2.8. |
The Thyroid-Stimulating Hormone (TSH)
Introduction
Thyroid-stimulating hormone (TSH), also known as thyrotropin, is widely recognized as the most sensitive and specific test for evaluating thyroid function in the general population. It is a hormone with a molecular weight of approximately 30 kDa. TSH is crucial in screening newborns for underactive thyroid, adults for thyroid diseases and female infertility, and in monitoring thyroid hormone replacement therapy. Close monitoring of TSH levels is essential for diagnosing and treating thyroid disorders.
Relationship with Related Diseases
- Hypothyroidism: TSH is used to screen newborns for underactive thyroid and diagnose hypothyroidism in adults.
- Female Infertility: TSH is used to evaluate thyroid function in women with infertility.
- Subclinical Hypothyroidism (SCH): TSH is crucial for the diagnosis and treatment of SCH, a common condition where TSH levels are elevated, but thyroid hormone levels are normal. Treatment is generally considered for patients with TSH ≥10 μIU/mL or those with symptoms consistent with mild hypothyroidism.
- Autoimmune Thyroid Disease (AITD): The presence of TSH-Ab is often observed in patients with AITD. Studies investigate the epidemiological characteristics and clinical interference of TSH-Abs in patients with mild SCH and autoimmune thyroiditis but normal thyroid function.
Macro-TSH Interference
- Macro-TSH Formation: Macro-TSH is a high-molecular-weight form of TSH (approximately 150 kDa) composed of TSH and immunoglobulins (anti-TSH autoantibody, TSH-Ab). It is biologically inactive but immunoreactive.
- False Elevated TSH: Macro-TSH cannot be filtered by the kidneys due to its size, leading to accumulation in the circulatory system and falsely elevated serum TSH concentrations.
Application
TSH is measured using in vitro diagnostic (IVD) assays, including:
- Lateral Flow (LF)
- Chemiluminescent Immunoassay (CLIA)
- Fluorescence Immunoassay (FIA)
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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