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tsh immunochromatography kit and preparation method thereof

An immunochromatography and immunochromatographic detection technology, applied in the field of TSH immunochromatography kits and their preparation, can solve the problems of antibody or protein detachment, kit stability and sensitivity cannot be guaranteed, colloidal gold instability, etc. Fast response, simple operation, high sensitivity effect

Active Publication Date: 2016-08-17
杭州睿丽科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the strong charge of colloidal gold, through electrostatic adsorption of antibodies or proteins, it is easy to cause the detachment of antibodies or proteins under the change of pH and the colloidal gold after adsorbing antibodies or proteins is unstable, which leads to the failure of the kit. Stability and sensitivity cannot be guaranteed

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] TSHα, β subunit-specific paired antibodies were purchased from abcam, USA; other reagents were purchased from sigma.

[0019] The coating process of NC membrane antibody is as follows: TSHα subunit antibody is prepared into a 2mg / ml solution with 0.1M pH8.0 phosphate buffer (PBS), and anti-mouse IgG is prepared into a 1.5mg / ml solution. The film instrument draws lines on the upper and lower parts of the NC film at a parameter of 1.5 μl / cm, and coats the C and T lines. After marking, place the NC film in a drying room at a temperature of 20-25°C and a humidity of less than 30%. Dry for 4 Hour.

[0020] The preparation process of the colloidal gold pad is as follows: a colloidal gold solution with a diameter of 20nm is prepared by the chloroauric acid-trisodium citrate reduction method (Frens method). 2 CO 3 Adjust to pH 7.5, add 2.0mg TSHβ subunit antibody to 100ml colloidal gold solution, then slowly add 0.2M K 2 CO 3 Adjust the colloidal gold solution to pH 9.0, ad...

Embodiment 2

[0023] Embodiment 2 Sensitivity test

[0024]TSH standard products of 0, 0.1, 0.5, 1.0, 2.0, 4.0, and 8.0 μIU / mL were used to measure the test paper card, and each concentration was tested five times in parallel. Detection method: 1) Equilibrate the detection reagent and sample to room temperature, take out the test paper card, and lay it flat; 2) Accurately draw 10 μl of serum or plasma sample, when the sample is whole blood, draw 20ul of sample, add it to the sample hole, and immediately put it in the lower part Add 100 μL sample diluent (PBS) to the buffer well, and within 10-15 minutes, interpret the immunochromatographic results by naked eyes and BiodotTSR3000 reading system. The visual judgment results are judged by the color difference between different concentrations of TSH standard test paper and negative test paper (TSH is 0 μIU / mL), and the instrument judgment results are judged by the OD590 value of different concentrations of TSH standard test paper and negative t...

Embodiment 3

[0028] Embodiment 3 stability test

[0029] After the test paper card prepared in Example 1 was placed at 40°C for 1 month and 3 months respectively, the sensitivity of the test paper was measured according to the method of Example 2.

[0030] The comparative examples of this embodiment are as follows:

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Abstract

The invention belongs to the field of biology, and particularly relates to a TSH immunochromatography kit and a manufacturing method thereof. The TSH immunochromatography reagent box is composed of a test paper card, a colorimetric card and an immunochromatography result interpretation recorder. The test paper card is structurally characterized in that a sample loading pad is pasted at one end of a plastic baseplate, one end of the sample loading pad is closely connected with a colloidal gold pad containing a marked TSHbeta sub-unit special antibody in a pressed manner, one end of the collaurum pad is closely connected with a nitrocellulose NC film in a pressed manner, a detection line T and a quality control line C which are separated mutually are coated on the NC film, the line T is a TSHalpha sub-unit antibody, the line C is an anti-mouse IgG antibody, the other end of the NC film is connected with a sample sucking pad to form test paper, and the test paper is mounted in a plastic card to form the test paper card.

Description

technical field [0001] The invention belongs to the field of biology, and in particular relates to a TSH immunochromatography kit and a preparation method thereof. Background technique [0002] TSH is the index of choice for the examination of congenital hypothyroidism. About one in every 4,000 newborns has a severe defect in thyroid function, and many more have mild or varying degrees of defect. Almost all developed countries including my country implement newborn screening in order to detect and treat congenital hypothyroidism. The reference value of TSH in neonates with hypothyroidism is generally less than 10 μIU / mL. [0003] Thyroid-stimulating hormone (TSH) is a hormone secreted by the pituitary gland that promotes the growth and function of the thyroid gland. Human TSH is a glycoprotein containing 211 amino acids, and sugars account for about 15% of the entire molecule. The entire molecule consists of α-subunit and β-subunit 2 conditional peptide chains. TSH comp...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N21/25G01N33/74
Inventor 陈立国胡申刚
Owner 杭州睿丽科技有限公司