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Thyroglobulin antibody detection kit and use method thereof

A technology for detection of thyroglobulin and antibodies, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of uncomfortable emergency and timely diagnosis of clinical patients, cumbersome steps of radioimmunoassay, and expensive reagents, etc., to achieve easy mixing and Separation, improved sensitivity and specificity performance, effect of small variation

Pending Publication Date: 2020-05-19
JIANGSU ZECEN BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The steps of radioimmunoassay are cumbersome, the reagents are expensive, and supporting equipment is required and there is radioactive contamination
Enzyme-linked immunosorbent assay has long detection time, complicated operation, poor repeatability, and is not suitable for emergency and clinical patients in time for diagnosis.
Latex-enhanced immunoturbidimetric method is simple and fast to operate, but has low sensitivity and poor reproducibility at low values

Method used

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  • Thyroglobulin antibody detection kit and use method thereof
  • Thyroglobulin antibody detection kit and use method thereof
  • Thyroglobulin antibody detection kit and use method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] A detection kit for thyroglobulin antibody, comprising independently packaged calibration products, quality control products, anti-reagents, magnetic particle reagents, luminescent substrates and cleaning solutions;

[0061] The calibrators and controls have the same components and are prepared by dissolving the thyroglobulin antibody in a protein-containing buffer and diluting it into a buffer containing neonatal bovine serum: where the protein-containing buffer The solution can be replaced by a buffer containing newborn bovine serum, which includes preservatives tetracycline 0.01% and neomycin sulfate 0.1%, and the buffer containing newborn bovine serum is filtered through a 0.22 μm membrane;

[0062] The anti-reagent is prepared by an operation comprising the following steps:

[0063] SA: Preparation of fluorescein isothiocyanate-labeled thyroglobulin-coated antigen:

[0064] Sa1: Use anti-reagent buffer to prepare FITC solution with a concentration of 1.0 mg / mL; wh...

Embodiment 2

[0081] A detection kit for thyroglobulin antibody, comprising independently packaged calibration products, quality control products, anti-reagents, magnetic particle reagents, luminescent substrates and cleaning solutions;

[0082] The calibrators and controls have the same components and are prepared by dissolving the thyroglobulin antibody in a protein-containing buffer and diluting it into a buffer containing neonatal bovine serum: where the protein-containing buffer The solution can be replaced by a buffer solution containing neonatal bovine serum, which includes preservatives tetracycline 0.03% and neomycin sulfate 0.3%, and the buffer solution containing neonatal bovine serum is filtered through a 0.22 μm membrane;

[0083] The anti-reagent is prepared by an operation comprising the following steps:

[0084] SA: Preparation of fluorescein isothiocyanate-labeled thyroglobulin-coated antigen:

[0085] Sa1: Use anti-reagent buffer to prepare fluorescein isothiocyanate solu...

Embodiment 3

[0103] A detection kit for thyroglobulin antibody, comprising independently packaged calibration products, quality control products, anti-reagents, magnetic particle reagents, luminescent substrates and cleaning solutions;

[0104] The calibrators and controls have the same components and are prepared by dissolving the thyroglobulin antibody in a protein-containing buffer and diluting it into a buffer containing neonatal bovine serum: where the protein-containing buffer The solution can be replaced by a buffer containing newborn bovine serum, which includes preservatives tetracycline 0.05% and neomycin sulfate 0.5%, and the buffer containing newborn bovine serum is filtered through a 0.22 μm filter membrane;

[0105] The anti-reagent is prepared by an operation comprising the following steps:

[0106] SA: Preparation of fluorescein isothiocyanate-labeled thyroglobulin-coated antigen:

[0107] Sa1: Use anti-reagent buffer to prepare FITC solution with a concentration of 5.0 mg...

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Abstract

The invention discloses the technical field related to biological immune in-vitro diagnosis of medical instruments, and particularly relates to a thyroglobulin antibody detection kit and a use methodthereof. The kit comprises a calibration product, a quality control product, an anti-reagent, a magnetic particle reagent, a luminous substrate and a cleaning solution which are independently packaged, wherein the anti-reagents comprise a fluorescein isothiocyanate labeled thyroglobulin coating antigen and an alkaline phosphatase labeled anti-thyroglobulin labeled antibody; the magnetic particle reagent is prepared by coupling magnetic particles and a goat anti-fluorescein isothiocyanate antibody; a chemiluminescence technology is combined with immunomagnetic particles, so that the detection sensitivity and precision are greatly improved, the detection range is expanded, and the reaction time is short; a plurality of samples can be simultaneously determined on a full-automatic chemiluminiscence instrument, high-throughput quick determination of the thyroglobulin antibody is realized, the performance is reliable, the sensitivity is high, the linear range is wide, and the kit can be matched with semi-automatic and full-automatic instruments for use.

Description

technical field [0001] The invention relates to the related technical field of biological immune in vitro diagnosis of medical devices, in particular to a thyroglobulin antibody detection kit and a use method thereof. Background technique [0002] Thyroglobulin (TG) is a glycoprotein in thyroid follicular columnar cells with a molecular weight of 660KD and plays an important role in the synthesis and storage of thyroid hormones. In the body, thyroglobulin contains T3 and T4 in the form of colloid, which is stored in the follicle cavity. Under the action of enzymes, T3 and T4 are released into the cytoplasm and enter the blood circulation. At the same time, a small amount of TG is also released into the blood, and normal people can also detect TG, with a concentration of 3-40ug / L. However, when the thyroid gland is damaged due to pathological reasons, a large amount of TG is released into the blood, and TG acts as an autoantigen to induce the production of anti-TG antibodies...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/543G01N33/533G01N33/535G01N33/577
CPCG01N33/54326G01N33/533G01N33/535G01N33/577
Inventor 张小玉刘振世夏振伟
Owner JIANGSU ZECEN BIOTECH CO LTD
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