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Thyroid stimulating hormone test paper and preparation method thereof

A technology for detecting thyroid-stimulating hormone and test paper, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of high cost and expensive, and achieve the effect of simple detection steps

Inactive Publication Date: 2017-06-13
NANTONG EGENS BIOTECH
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Problems solved by technology

In view of the important clinical significance of the test results of thyroid stimulating hormone, there are many detection methods, mainly including radioimmunoassay (RIA), enzyme-linked immunosorbent assay (ELISA), time-resolved immunofluorescence assay (TRIFMA), chemiluminescence assay, etc. , and these methods require expensive instruments and professional operations, and the cost is relatively high

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  • Thyroid stimulating hormone test paper and preparation method thereof

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preparation example Construction

[0033] The preparation method of thyroid-stimulating hormone detection test paper comprises the following steps:

[0034] A. Preparation of nitrocellulose membrane:

[0035]a. Choose a nitrocellulose membrane with a pore size of 3um ~ 10um, and cut the membrane into specifications with a width greater than or equal to 2.0cm and a length of 30.5cm according to needs;

[0036] b. Use 0.1M phosphate buffer to prepare TSH-α monoclonal antibody 1.5 mg / ml for testing line coating and use 0.85% by mass sodium chloride buffer to prepare quality control line coating Anti-mouse IgG polyclonal antibody 1.5mg / ml;

[0037] c. Select the antibody-coated surface of the nitrocellulose membrane and mark it. Coat the test line and quality control line to be coated on the membrane in parallel and evenly, and control the distance between the test line and the quality control line at 0.5cm. , and the nitrocellulose membrane was dried at a constant temperature of 4°C to 35°C for later use;

[00...

Embodiment 1

[0055] Randomly sample from the same batch, the minimum sampling amount shall not be less than 3 times of the testing amount.

[0056] After sampling, put the product to be inspected in the yellow waiting area. If it can be inspected on the same day, it can be inspected on the same day. If it cannot be inspected, it must be inspected on the next day. The remaining paper strips that pass the inspection can be used as reserved samples, temporarily placed in the qualified product area, and then a certain amount is taken from production to reserve samples of finished products according to the output and sample requirements.

[0057] 1. The required reagents are as follows: (1) 0μIU / ml sample solution: protein-containing phosphate buffered saline (PBS) is 0μIU / ml TSH sample solution; (2) 1μIU / ml, 2μIU / ml and 5μIU / ml ml of TSH sample solution: prepare thyroid-stimulating hormone (TSH) standard substance with protein-containing phosphate buffer (0.01M PBS) to the corresponding concen...

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Abstract

The invention discloses a thyroid-stimulating hormone detection test paper, which comprises a plastic substrate, a sample pad and a water-absorbing pad are arranged on the plastic substrate, a protective film is arranged on the sample-loading pad and the water-absorbing pad, and the bottom between the sample-loading pad and the water-absorbing pad is A nitrocellulose membrane is provided, and the connection end of the sample pad is provided with solid-phase colloidal gold, and one end of the solid-phase colloidal gold is overlapped with one end of the nitrocellulose membrane, and the nitrocellulose membrane is sequentially coated with detection Line and quality control line; the manufacturing method steps include: preparation of nitrocellulose membrane; marking and solid phase of polyester fiber strip; assembly and cutting. The present invention applies the principle of double-antibody sandwich method and immunochromatography to qualitatively detect human thyroid-stimulating hormone (TSH) in urine. The detection steps are relatively simple, and the results can be observed within 10 minutes. General users can perform the detection by themselves. The present invention judges whether there is a risk of hypothyroidism by comparing the color depth of the detection line with the matched color card.

Description

technical field [0001] The invention belongs to the field of medical testing reagents, and relates to a thyroid stimulating hormone detection test paper and a preparation method thereof. Background technique [0002] Thyroid-stimulating hormone is the main factor that regulates the growth of thyroid cells and the synthesis and secretion of thyroid hormones. It is synthesized and secreted by pituitary thyroid-stimulating hormone cells and is regulated by negative feedback of thyroid hormones. When thyroid function changes, thyroid-stimulating hormone fluctuates more rapidly and significantly than thyroid hormone, and it is a sensitive indicator reflecting the function of the hypothalamus-pituitary-thyroid axis. Therefore, detection of thyroid-stimulating hormone level can reflect the state of thyroid function. The detection of thyroid-stimulating hormone has important clinical significance, such as screening of thyroid diseases, monitoring of treatment effects of thyroid dise...

Claims

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Application Information

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IPC IPC(8): G01N33/558G01N33/543
CPCG01N33/558G01N33/543
Inventor 欧卫军孙一品邵志燕徐秋楠
Owner NANTONG EGENS BIOTECH
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