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Early pregnancy detection kit using urine as detection sample, and production method and use thereof

A detection kit and production method technology, applied in the field of medical care, can solve the problems of low detection accuracy and inability to detect abnormal pregnancy, etc., and achieve the effects of high industrial value, rapid and large-scale acquisition, high sensitivity and specificity

Inactive Publication Date: 2018-12-04
重庆早柒天生物科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these methods and products generally still have problems such as low detection accuracy and inability to detect abnormal pregnancy.

Method used

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  • Early pregnancy detection kit using urine as detection sample, and production method and use thereof
  • Early pregnancy detection kit using urine as detection sample, and production method and use thereof

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Embodiment Construction

[0030] The present invention will be further explained below in conjunction with specific examples.

[0031] The units of numerical values ​​in the present invention follow the common understanding in the art, and the comparative units of the percentages in the present invention also follow the common understanding in the industry.

[0032] see figure 1 As shown in the flow chart, this embodiment provides a method for producing an early pregnancy detection kit using urine as a detection sample, and the steps are as follows:

[0033] (1) Preparation of NC film

[0034] Step 1. Preparation of NC film: Paste the NC film with a size of 25*300mm on the PVC base plate with a size of 75*300mm.

[0035] Step 2. Preparation of coating solution: Prepare anti-β-HCG core fragment monoclonal antibody with a concentration of 1.2 mg / ml and anti-α-HCG monoclonal antibody with a concentration of 1.0 mg / ml in phosphate buffer solution, and a concentration of 1.0 mg / ml ml of goat anti-mouse I...

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PUM

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Abstract

The invention belongs to the technical field of medical care, and particularly provides a production method of an early pregnancy detection kit using urine as a detection sample. The production methodadopts the principle of a colloidal gold immunochromatography technology and uses a double-antibody sandwich method technology, a T1 detection line of a nitrocellulose membrane is coated with an anti-beta-HCG core fragment monoclonal antibody, a T2 detection line of the nitrocellulose membrane is coated with an anti-alpha-HCG monoclonal antibody, and a quality control line of the nitrocellulose membrane is coated with a goat anti-mouse IgG polyclonal antibody. The kit having a high sensitivity, a high specificity and a good stability and being able to rapidly detect the pregnancy or not and the ectopic pregnancy or not is obtained by controlling a series of production process steps and process parameters. The invention further provides the product obtained through the production method, and a use of the product.

Description

technical field [0001] The invention belongs to the technical field of medical care, and in particular relates to an early pregnancy detection kit using urine as a detection sample, its preparation method and application. Background technique [0002] Most women's early pregnancy reactions such as fatigue, dizziness, nausea, and vomiting begin in the 6th to 8th week, and most of them disappear around the 12th week of pregnancy. And some women who are pregnant by accident have no obvious early pregnancy reaction before 6-8 weeks. In recent years, modern women have neglected medical care and performed artificial abortion without restraint, which has led to a substantial increase in the incidence of ectopic pregnancy in China. In addition to the ectopic pregnancy problem easily caused by abortion, chronic salpingitis, pelvic endometriosis, blocked fallopian tube canalization, and fallopian tube dysplasia or deformity are all important reasons why women are prone to ectopic pre...

Claims

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Application Information

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IPC IPC(8): G01N33/68G01N33/76
CPCG01N33/689G01N33/76
Inventor 杨轶轩李果
Owner 重庆早柒天生物科技股份有限公司
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