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Chemiluminescence quantitative detection kit for carbohydrate antigen 19-9

A technology for quantitative detection of sugar chain antigens, applied in chemiluminescence/bioluminescence, analysis through chemical reactions of materials, measurement devices, etc., can solve the problems of weak and elevated organ specificity, and achieve specificity retention , Accurate detection results, and the effect of improving sensitivity

Inactive Publication Date: 2011-06-15
上海裕隆生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CA19-9 organ specificity is not strong, it can be increased in various adenocarcinomas, such as 99% of pancreatic cancer, 67% of liver and bile duct cancer, 40% to 50% of liver cancer, 30% of colorectal cancer and 15% of breast cancer, it has been reported that 10% to 20% of benign pancreatitis and gastrointestinal diseases can increase CA19-9, but its value rarely exceeds 120kU / L

Method used

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  • Chemiluminescence quantitative detection kit for carbohydrate antigen 19-9
  • Chemiluminescence quantitative detection kit for carbohydrate antigen 19-9
  • Chemiluminescence quantitative detection kit for carbohydrate antigen 19-9

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Preparation of CA19-9 Quantitative Detection Kit

[0020] The steps are mainly: (1) preparation of anti-CA19-9 antibody-coated plate (preparation of CA19-9 detection reaction plate); (2) preparation of enzyme-labeled antibody; (3) preparation of CA19-9 calibrator; ( 4) Preparation of CA19-9 quality control products; (5) Preparation of chemiluminescent substrate solution; (6) Preparation of washing solution; (7) Composition of semi-finished products and finished products

[0021] (1) Preparation of anti-CA19-9 antibody-coated plates

[0022] a. Coating: Take 1mol / L Na 2 HPO 4 77.4ml and 1mol / L NaH 2 PO 4 22.6ml, mix evenly, add deionized water to 1000ml to form a 10-fold coating solution, dilute ten-fold before use, add an appropriate amount of anti-CA19-9 monoclonal antibody (purchased from Kangnaig, Sweden) and mix evenly, and then add to In microplate wells, 100 μl / well, 4°C for 16 hours;

[0023] b. Sealing: discard the coating solution, pat dry on absorbent ...

Embodiment 2

[0039] How to use the CA19-9 quantitative detection kit

[0040]1. Reagent and Sample Preparation

[0041] (1) Reagent preparation

[0042] a. Put the kit at room temperature (18-26°C) to equilibrate for 20 minutes.

[0043] b. Take out the concentrated washing solution from the kit, dilute it 1:20 with fresh purified water and add it to the washing solution bottle of the plate washer.

[0044] (2) Sample preparation

[0045] The qualified serum or plasma to be tested should be equilibrated at room temperature (18-26°C) for 20 minutes before use.

[0046] 2. Operation steps

[0047] a. Take out the required CA19-9 antibody-coated microwell plate and place it on the microwell rack

[0048] b. Add calibrators 1-6, quality control products 1-2 and samples to be tested, 50 μl per well, mix thoroughly, and incubate in a 37°C incubator for 90 minutes.

[0049] c. Manual washing: Discard the liquid in the wells, fill each well with the washing liquid, let it stand for 5 seconds...

Embodiment 3

[0058] Methodological Identification of CA19-9 Quantitative Detection Kit

[0059] According to the conventional manufacturing and identification procedures in the art, the test kit prepared in Example 1 is tested and the results are as follows:

[0060] 1. Accuracy

[0061] The known content sample is detected with the kit prepared in Example 1 of the present invention, and the recovery rate is calculated (recovery rate=recovery amount / addition amount×100%), the sample size is not less than 10, and the results are as follows:

[0062] Amount added (U / ml)

[0063] 2. Specificity

[0064] The known content analogue is detected with the kit prepared in the embodiment of the present invention, and the cross-reaction rate is calculated (cross-reaction rate=detection value / addition amount×100%), and the results are as follows:

[0065] name

[0066] 3. Precision

[0067] Make 10 parallel wells of quality control product 1 and quality control product 2 respect...

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Abstract

The invention discloses a chemiluminescence quantitative detection kit for a carbohydrate antigen 19-9 (CA19-9). The kit comprises a CA19-9 detection reaction plate, an enzyme conjugate, a luminescent substrate, a calibrator, a quality control material and washing concentrate, wherein the reaction plate is coated with a CA19-9 antibody. The kit can specifically and quantitatively detect the content of the CA19-9 in patient serum, determines prognosis level and identities benign and malignant pancreatic tumors. Compared with the conventional enzyme linked immunosorbent assay (ELISA) technology, the chemiluminescence immunoassay keeps high specificity of the ELISA technology, stability and reliability of a detection result, and convenience of operation, and can improve detection sensitivity simultaneously.

Description

technical field [0001] The invention belongs to the technical field of in vitro clinical testing and chemiluminescence immunoassay, and in particular relates to a reaction plate and a kit for detecting related indicators of colon, rectal cancer and pancreatic cancer. Background technique [0002] For nearly half a century, the morbidity and mortality of tumors have been increasing year by year, becoming a hot spot in the medical field. In the 1970s, the "March into Tumor" proposed by the United States reflected the social anxiety about the high mortality rate of tumors. At the same time, in the past few decades, tumor markers have made breakthroughs in technology and definition. These have promoted the rapid development of tumor marker research. [0003] Carbohydrate Antigen 19-9 (Carbohydrate Antigen 19-9, CA19-9) is a 116NS19-9 monoclonal antibody obtained by Koprowski et al. in 1979 by immunizing mice with colon cancer cells and hybridizing with myeloma. It is a mixture...

Claims

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Application Information

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IPC IPC(8): G01N33/543G01N33/545G01N33/574G01N21/76
Inventor 穆海东汪宁梅穆宇豪李胡丹
Owner 上海裕隆生物科技有限公司
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