Human chorionic gonadotropin (hCG) cycle detection test kit and preparation method thereof

A cycle detection and kit technology, which is applied in biological testing, measuring devices, material inspection products, etc., can solve problems such as complicated operations, and achieve the effects of simple detection steps, estimation of pregnancy time, and accurate detection results.

Inactive Publication Date: 2017-07-07
NANTONG EGENS BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] At present, the number of days of pregnancy is detected by blood test, ultrasonic detection, HCG detection and ultrasonic detection, but t

Method used

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  • Human chorionic gonadotropin (hCG) cycle detection test kit and preparation method thereof
  • Human chorionic gonadotropin (hCG) cycle detection test kit and preparation method thereof
  • Human chorionic gonadotropin (hCG) cycle detection test kit and preparation method thereof

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preparation example Construction

[0044] A preparation method of HCG cycle detection kit, comprising the following steps:

[0045] A. Preparation of nitrocellulose membrane:

[0046] 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 requirements;

[0047] b. Use 0.1M phosphate buffer to prepare the anti-α-HCG monoclonal antibody 1.3 mg / ml for the test line coating and use 0.85% sodium chloride buffer to prepare the quality control line coating. Anti-mouse IgG polyclonal antibody 2.0mg / ml;

[0048] c. Select the antibody-coated surface of the nitrocellulose membrane and mark it. Coat the detection line and the quality control line to be coated on the membrane in parallel and evenly, and the distance between the detection line and the quality control line is controlled at a distance of 0.5 cm, the nitrocellulose membrane was dried at a constant temperature of 4°C to 35°C fo...

Embodiment 1

[0075] Randomly sample from the same batch, the minimum sampling amount shall not be less than 3 times of the testing amount.

[0076] 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.

[0077] 1. The required reagents are as follows: 0mIU / ml sample solution: protein-containing phosphate buffered saline (PBS) is 0mIU / ml HCG sample solution. 50mIU / ml, 25mIU / ml, 12.5mIU / ml human chorionic gonadotropin (HCG) sample solution: Dilute human chorionic gonadotropin (HCG) standard with protein-containing phosphate buffered saline (0.01M PBS) Prepare ...

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Abstract

The invention discloses a human chorionic gonadotropin (hCG) cycle detection test kit, which comprises an upper cap and a cassette, wherein two parallel grooves are arranged in the cassette, a piece of T1 detection test paper is arranged in one of the grooves, and a piece of T2 detection test paper is arranged in the other groove. The preparation method of the test kit comprises the following steps: preparing a nitrocellulose membrane; labeling a colloidal gold pad and drying; and assembling and cutting. The test kit disclosed by the invention adopts the principle of double antibody sandwich and immunochromatographic assay to qualitatively detect hCG in urine of pregnant women, the detection procedure is simple, the result can be observed within 5 min, a user can self-detect, and the detection result is accurate. Based on the color of a first test line and a second test line, a user can estimate gestational age and pregnancy time.

Description

technical field [0001] The invention belongs to the field of medical testing reagents, and relates to a preparation method of a HCG cycle detection kit. Background technique [0002] During early pregnancy, the number of days of pregnancy is calculated from the first day after the end of the last menstrual period. This calculation method is relatively inaccurate; the general early pregnancy test paper is detected by a double-antibody sandwich one-step method, with colloidal gold as an indicator Marking, detecting the concentration of HCG in urine can only be used to judge whether you are pregnant, but not the time of pregnancy. Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by placental trophoblast cells during pregnancy. It consists of two different subunits, α and β, connected by non-covalent bonds. In the process of hormone production, secretion, metabolism, etc., hCG molecules will find various changes such as fragmentation and dissociation, and t...

Claims

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Application Information

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IPC IPC(8): G01N33/76G01N33/558G01N33/532
CPCG01N33/76G01N33/532G01N33/558G01N33/54386G01N2333/59G01N33/54387
Inventor 欧卫军孙一品邵志燕徐秋楠
Owner NANTONG EGENS BIOTECH
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