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Carcino-embryonic antigen calibrator test method

A test method and technology of calibrator, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that cannot be used as the basis for early diagnosis or diagnosis of malignant tumors, and there is no standardized and unified test method, so as to facilitate mass production and test The effect of accurate value and low cost

Active Publication Date: 2018-04-20
JIANGSU ZECEN BIOTECH CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The combined detection of carcinoembryonic antigen and other tumor markers is helpful for the diagnosis of liver cancer, colon cancer, rectal cancer, gastric cancer and lung cancer, as well as the dynamic monitoring of radiochemical efficacy, to assist in judging the disease process or treatment effect, and cannot be used as an early diagnosis or treatment for malignant tumors. Basis for diagnosis
The detection of carcinoembryonic antigen is currently carried out by quantitative methods in the market, so the calibrator is an indispensable reagent component. At present, there is no standardized and unified inspection method in the calibrator value market

Method used

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Embodiment

[0020] A method for testing a cancer blank antigen calibrator, comprising the following preparation steps:

[0021] 1) Divide the calibration products to be tested into two groups, and use the CIA1200 automatic chemiluminescence analyzer of Zecheng Biotechnology Co., Ltd. to measure the luminescence values ​​of the calibration products to be tested, working reference materials and quality control products at different times , for each point, repeat the measurement three times to get the average value;

[0022] 2) Use the curve of the working reference product to fit the calibration product and the quality control product to be tested, calculate the average value of each point of the calibration product to be tested and the quality control product, and require the deviation between the value of the fitted concentration of the product to be calibrated and the theoretical concentration Within the range of ±10%;

[0023] 3) Use the calibration product to be tested as the curve fi...

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Abstract

A carcino-embryonic antigen calibrator test method is disclosed. The carcino-embryonic antigen calibrator test method includes the following preparation steps: 1) dividing to-be-tested calibrators into two groups, respectively testing the luminescence value of the to-be-tested calibrators, a working reference product and a quality control product; 2) using the working reference product as a curvefor fitting of the to-be-tested calibrators and the quality control product, and calculating the values of the to-be-tested calibrators and the quality control product; 3) using the to-be-tested calibrators as a curve for fitting of the quality control product, and calculating the values of the to-be-tested calibrators; 4) assigning, to be more specific, assigning the sub-packaged calibrators; and5) verifying, to be more specific, respectively determining inter-bottle homogeneity and the in-bottle homogeneity. The carcino-embryonic antigen calibrator test method can accurately detect the calibrator of a carcino-embryonic antigen (CEA), is accurate in measurement value, can effectively monitor a test value of a sample in a clinical test, and has the advantages of low cost, high efficiency,accurate assignment, mass production convenience compared with a test method used in the prior art.

Description

technical field [0001] The invention belongs to the technical field of in vitro diagnostic testing, in particular to a method for testing a cancer blank antigen calibrator. Background technique [0002] Carcinoembryonic antigen (CEA) is a carbohydrate antigen with a specific determinant of human embryonic antigen, which is an important tumor-associated antigen. synthesized by hepatocytes. In 1965, Gold and Freedman first discovered it from fetal and colon cancer tissues, so they called it carcinoembryonic antigen. Its coding gene is located on chromosome 19 and is a polysaccharide-protein complex with a molecular weight of 22KD, 45% of which is protein. [0003] CEA is a non-organ-specific tumor-associated antigen, which mainly exists in rectal and colon cancer tissues and fetal intestinal mucosa. Most of the tumors that secrete CEA are located in hollow organs, such as the gastrointestinal tract, respiratory tract, and urinary tract. Under normal circumstances, CEA is me...

Claims

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Application Information

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IPC IPC(8): G01N21/76G01N33/574
CPCG01N21/76G01N33/57473
Inventor 陈峰刘振世陈玲沈文瑾刘成洋
Owner JIANGSU ZECEN BIOTECH CO LTD
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