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Carcinoembryonic antigen detection kit and preparation method thereof

A detection kit and carcinoembryonic antigen technology, applied in the field of immune detection, can solve the problems of long detection time and narrow linear range, and achieve the effects of excellent accuracy, wide linear range and high sensitivity

Inactive Publication Date: 2018-11-23
山东康华生物医疗科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The detection methods of carcinoembryonic antigen in the prior art mainly include enzyme-linked immunoassay, time-resolved fluorescent immunoassay, chemiluminescence, etc. However, these methods have shortcomings such as narrow linear range and long detection time, which cannot meet the clinical needs. A more effective detection method has become the key to clinical application

Method used

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  • Carcinoembryonic antigen detection kit and preparation method thereof
  • Carcinoembryonic antigen detection kit and preparation method thereof
  • Carcinoembryonic antigen detection kit and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] A carcinoembryonic antigen detection kit, characterized in that: the detection kit includes magnetic microsphere suspension coated with CEA antibody, CEA calibrator, CEA quality control product, CEA tracer working solution, concentrated washing solution, substrate solution and sample diluent.

[0048] The concentration of the magnetic microsphere suspension coated with CEA antibody is prepared according to the ratio of 1:1000; The proportion of preparation; CEA calibrator and quality control substance are prepared from CEA calibrator diluent, the concentration of CEA calibrator is 0ng / mL, 5ng / mL, 20ng / mL, 100ng / mL, 400ng / mL, 1000ng / mL; the concentration of CEA quality control substance is 20ng / mL, 400ng / mL.

[0049] The calibrator diluent is PB buffer at pH 7.4, and every 1L of buffer also contains 5g casein, 20gNa 2 HPO 4 12H 2 O, 2g Na 2 h 2 PO 4 2H 2 O, 5 mL of calf serum and 0.3 mL of Proclin-300.

[0050] The concentrated washing solution is 0.04mol, pH7....

Embodiment 2

[0075] A carcinoembryonic antigen detection kit, characterized in that: the detection kit includes magnetic microsphere suspension coated with CEA antibody, CEA calibrator, CEA quality control product, CEA tracer working solution, concentrated washing solution, substrate solution and sample diluent.

[0076] Wherein the concentration of the magnetic microsphere suspension coated with CEA antibody is prepared according to the ratio of 1:3000; The proportion of preparation; CEA calibrator and quality control substance are prepared from CEA calibrator diluent, the concentration of CEA calibrator is 0ng / mL, 5ng / mL, 20ng / mL, 100ng / mL, 400ng / mL, 1000ng / mL; the concentration of CEA quality control substance is 20ng / mL, 400ng / mL.

[0077] The calibrator diluent is PB buffer at pH 7.5, and every 1L of buffer also contains 12g of casein, 28g of Na 2 HPO 4 12H 2 O, 2.5g Na 2 h 2 PO 4 2H 2 O, 10 mL of calf serum and 0.4 mL of Proclin-300.

[0078] The concentrated washing soluti...

Embodiment 3

[0103] A carcinoembryonic antigen detection kit, characterized in that: the detection kit includes magnetic microsphere suspension coated with CEA antibody, CEA calibrator, CEA quality control product, CEA tracer working solution, concentrated washing solution, substrate solution and sample diluent.

[0104] The concentration of the magnetic microsphere suspension coated with CEA antibody is prepared according to the ratio of 1:5500; the CEA tracer working solution is the acridinium ester-labeled CEA monoclonal antibody solution according to its dilution ratio of 1:4000 The proportion of preparation; CEA calibrator and quality control substance are prepared from CEA calibrator diluent, the concentration of CEA calibrator is 0ng / mL, 5ng / mL, 20ng / mL, 100ng / mL, 400ng / mL, 1000ng / mL; the concentration of CEA quality control substance is 20ng / mL, 400ng / mL.

[0105] The calibrator diluent is PB buffer at pH 7.6, and every 1L of buffer also contains 15g of casein, 35g of Na 2 HPO ...

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Abstract

The invention relates to the technical field of immunodetection and in particular relates to a carcinoembryonic antigen (CEA) detection kit and a preparation method thereof. The detection kit comprises a magnetic microsphere suspension solution coated with a CEA antibody, a CEA calibration product, a CEA quality control product, a CEA tracer working solution, a concentrated washing solution, a substrate solution and a specimen dilution solution. The kit has the advantages of accurate detection result, good stability, strong specificity, high sensitivity, wide linear range, short detection timeand convenience for utilization and is suitable for being popularized and applied.

Description

technical field [0001] The invention relates to the technical field of immune detection, in particular to a carcinoembryonic antigen detection kit and a preparation method thereof. Background technique [0002] Carcinoembryonic antigen (CEA) is a broad-spectrum tumor marker, which was first isolated by Gold and Freedman in 1965 from the extracts of colon cancer and normal fetal digestive tract. of acidic glycoproteins. CEA is considered to be an antigen related to human tumors, with a molecular weight of 175,100-200,000 Daltons, and its sugar content varies between 50% and 60%. [0003] Elevated CEA is common in colon cancer, colorectal cancer, pancreatic cancer, gastric cancer, small cell lung cancer, breast cancer, and medullary thyroid cancer. The increase of serum CEA concentration is not only seen in malignant diseases but also in various benign diseases, such as liver cirrhosis, heavy smokers, bronchitis, pancreatitis, gastritis, infectious enteritis and kidney disea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/543
CPCG01N33/54326G01N33/6854
Inventor 杨致亭魏红李贞孙树凯杨锋斌
Owner 山东康华生物医疗科技股份有限公司
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