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Hyperglycosylated-human chorionic gonadotrophin (H-HCG) rapid immune diagnosis chromatography test paper and preparation method thereof

A chromatographic test strip and rapid immunization technology, applied in the field of medical testing, can solve the problems of limited test results and high false positive rate, and achieve the effects of great application value and clinical significance, high sensitivity, and easy storage

Inactive Publication Date: 2016-12-21
武汉百美生物科技有限公司
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  • Claims
  • Application Information

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Problems solved by technology

However, this method has its shortcomings. First, pregnant women need to see a doctor twice. Second, they need to draw blood twice to detect HCG levels more than twice. Third, the test results are limited. A large number of different literatures report that the sensitivity of the test is 62- 78%, false positive rate as high as 26-40%

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  • Hyperglycosylated-human chorionic gonadotrophin (H-HCG) rapid immune diagnosis chromatography test paper and preparation method thereof
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  • Hyperglycosylated-human chorionic gonadotrophin (H-HCG) rapid immune diagnosis chromatography test paper and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] The preparation method of described a kind of H-HCG rapid immunodiagnosis chromatography test paper comprises the steps:

[0080] The main raw materials are as follows:

[0081] Reagents: chloroauric acid, trisodium citrate, anti-α-HCG or β-HCG antibody, H-HCG specific antibody B207 or B152;, BSA, trehalose, NaCl, Na2HPO4·12H2O, NaH2PO4·2H2O, boric acid, Borax, Tween-20, TritonX-100, sucrose, ultrapure water;

[0082] Consumables: nitrocellulose membrane (NC membrane), 8975 glass fiber, GF-06 glass fiber, absorbent pad, bottom plate, volumetric flask, Erlenmeyer flask, EP tube, pipette tip.

[0083] 1. Preparation before preparation:

[0084] 1.1 Preparation of 2% trisodium citrate solution

[0085] Weigh 0.105g of trisodium citrate into a 15ml EP tube, add 5ml of pure water, and mix until completely dissolved to obtain a 2% trisodium citrate solution.

[0086] Take 40ml of pure water in a 50ml volumetric flask, add 0.5ml of 1% chloroauric acid solution to the volum...

Embodiment 2

[0131] Sensitivity detection of H-HCG rapid immunodiagnostic chromatography test paper

[0132] 1. Preparation of 12.5mIU / ml, 25mIU / ml, 50mIU / ml HCG solution: redissolve HCG standard in PBS solution containing 0.5% BSA, and then prepare 12.5mIU / ml, 25mIU / ml, 50mIU / ml HCG solution.

[0133] 2. Preparation of 110mIU / ml H-HCG solution: redissolve the H-HCG standard in PBS solution containing 0.5% BSA, and then prepare a 110mIU / ml solution.

[0134] 3. Single channel: Put the test strips of the same batch number into 12.5mIU / ml, 25mIU / ml, 50mIU / ml HCG solution and 110mIU / ml H-HCG solution for about 5 seconds, take them out and place them on the table for about 5 seconds. 15 minutes, observe the results, and the test results are valid within 30 minutes. Each test concentration was repeated 3 times, and the test results of each solution were all positive for 3 times before the result of the secondary concentration was judged as positive;

[0135] Dual channel: Put the test strips...

Embodiment 3

[0142] Specific detection of H-HCG rapid immunodiagnostic chromatography test paper

[0143] 1. Solution preparation: 0mIU / ml HCG solution: Weigh 0.5gBSA into a beaker, add 70ml PBS buffer solution to dissolve to 100ml, filter through a 0.22μm filter membrane and set aside.

[0144] 2. 500mIU / ml human luteinizing hormone (hLH) solution: redissolve the hLH standard product with PBS solution containing 0.5% BSA, and prepare it with 0mIU / ml HCG solution to a concentration of 500mIU / ml, which is hLH A solution; use 25mIU / ml HCG solution to prepare it to a concentration of 500mIU / ml, which is hLH B solution; use 110mIU / ml H-HCG solution to prepare it to a concentration of 500mIU / ml, which is hLH C solution.

[0145] 3. 1000mIU / ml human follicle stimulating hormone (hFSH) solution: redissolve the hFSH standard with PBS solution containing 0.5% BSA, and prepare it with 0mIU / ml HCG solution to a concentration of 1000mIU / ml, which is hFSH A solution ; Use 25mIU / ml HCG solution to prepar...

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Abstract

The invention relates to hyperglycosylated-human chorionic gonadotrophin (H-HCG) rapid immune diagnosis chromatography test paper, characterized by comprising a sample pad, a nitrocellulose membrane enveloped with a detection line T and a quality control line C, and a sample absorption pad which are sequentially connected, wherein the sample pad, the nitrocellulose membrane and the sample absorption pad are stuck on a support plate. The H-HCG rapid immune diagnosis chromatography test paper has the advantages that (1) due to the design that a conjugate pad and the nitrocellulose membrane are separately enveloped with an H-HCG specific antibody B207 or B152, an antibody for resisting alpha-HCG or beta-HCG, or an antibody for resisting intact HCG, by detecting the embodiments such as blood, urine, saliva and other samples, of H-HCG content of a human body, whether a person to be tested is pregnant or not and whether the placental function of a pregnant woman is good or not can be known, abortion can be predicted, and the like; (2) the instant diagnostic reagent use an immune chromatography test paper method for rapid detectiong, which is suitable for diagnosis and differential diagnosis of normal first trimester pregnancy and abnormal first trimester pregnancy, and has the advantages of being high in specificity, high in sensibility, safe, easy to store, good in stability, convenient in application, and the like.

Description

technical field [0001] The invention relates to the technical field of medical detection, in particular to a H-HCG rapid immunodiagnostic chromatography test paper and a preparation method thereof. Background technique [0002] Human chorionic gonadotrophin (HCG for short) is a glycoprotein hormone with a molecular weight of 36700 secreted by placental trophoblast cells, which is composed of α and β subunits. HCG is the most commonly used marker in the clinical examination of pregnancy and pregnancy-related diseases. Its biological and immunological characteristics are mainly determined by the β subunit. HCG is the most common form found during pregnancy, but HCG exists in different forms in blood and urine, and other subtypes or fragments of HCG are also present in the blood, urine and saliva of pregnant women. These subtypes or Fragments include hyperglycosylated human chorionic gonadotropin (H-HCG), free HCG-α units, free HCG-β units, HCG-β core fragments and gapped HCG,...

Claims

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Application Information

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IPC IPC(8): G01N33/76
CPCG01N33/76
Inventor 马北峰马北阳徐晓峰谢从平李娟娟
Owner 武汉百美生物科技有限公司
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