Magnetic particle chemiluminescence immune assay detection kit for carcino-embryonic antigen and detection method of detection kit

A chemiluminescence immunoassay, detection kit technology, applied in chemiluminescence/bioluminescence, analysis by chemical reaction of materials, analysis of materials, etc., can solve the problems of low degree of automation, narrow linear range, poor reproducibility, etc. Achieve the effect of overcoming technical defects and ensuring effectiveness and accuracy

Active Publication Date: 2013-12-25
WUHAN LIFE ORIGIN BIOTECH LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The detection kits of these methods have their own advantages and disadvantages, such as: low detection limit of enzyme-linked immunoassay, wide linear range, but the detection kit is cumbersome to operate, long detection time, low degree of automation, and greatly affected by human factors; Radioimmunoassay also has the advantage of low detection limit, but because it needs to use radioactive markers in the detection process, it has adverse effects on the health of operators and also pollutes the environment to a certain extent. This detection method has been gradually adopted by other The colloidal gold immunochromatography method has the advantages of rapid detection and convenient operation, which is conducive to the detection of samples by patients themselves, and is suitable for home detection, but this detection method cannot be quantitatively detected, and the interpretation results have certain errors; chemiluminescence Immunoassay technology is an emerging detection technology in the past few years. It has many excellent characteristics such as easy operation, high degree of automation, wide detection linear range, and low detection limit. It is the general trend of technology development in the field of biochemical detection in the future.
Because chemiluminescence technology is an emerging technology, existing chemiluminescence detection kits have some obvious defects and deficiencies in technology: the linear range detected by the kit in the carcinoembryonic antigen detection process is very narrow, the accuracy is very low, and the Poor reproducibility, which has adverse effects on its application and detection, limiting the popularization and application of this technology

Method used

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  • Magnetic particle chemiluminescence immune assay detection kit for carcino-embryonic antigen and detection method of detection kit
  • Magnetic particle chemiluminescence immune assay detection kit for carcino-embryonic antigen and detection method of detection kit
  • Magnetic particle chemiluminescence immune assay detection kit for carcino-embryonic antigen and detection method of detection kit

Examples

Experimental program
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Effect test

Embodiment 1

[0042] Preparation of detection kit in this embodiment:

[0043] 1. Preparation of carcinoembryonic antigen calibrator

[0044]①Preparation of hormone-free human serum: Take 20mL of normal human serum and put it in a centrifuge tube, then add 8.0g of activated carbon to the serum, put the centrifuge tube on a vortex mixer to mix evenly, oscillate for 5 hours, and centrifuge at 8000rpm for 30 minutes. Filter the supernatant, add sodium azide with a volume percentage concentration of 1 / 1000 to the filtrate, mix well and then freeze and store.

[0045] ② Take a certain amount of carcinoembryonic antigen protein (purchased from Bioss, USA) and use the above-mentioned hormone-free human serum to prepare a calibrator solution with a concentration of 80ng / mL, and dilute this calibrator with hormone-free human serum to obtain concentrations of 40ng / mL, 20ng / mL, 10ng / mL, 5ng / mL calibrator, aliquoted into aliquots with concentrations of 0ng / mL, 5ng / mL, 10ng / mL, 20ng / mL, 40ng / mL and 80n...

Embodiment 2

[0067] The difference between this example and Example 1 is that the magnetic beads used in the preparation process of anti-carcinoembryonic antigen monoclonal antibody-coated magnetic beads have a particle size of 1.0 μm (purchased from Germany Merck Company).

Embodiment 3

[0069] The difference between this example and Example 1 is that the magnetic beads used in the preparation process of the anti-carcinoembryonic antigen monoclonal antibody-coated magnetic beads have a particle size of 0.6 μm (purchased from Germany Merck Company).

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Abstract

The invention discloses a magnetic particle chemiluminescence immune assay detection kit for a carcino-embryonic antigen and a detection method of the detection kit, belonging to the technical field of kits. The magnetic particle chemiluminescence immune assay detection kit for the carcino-embryonic antigen comprises a carcino-embryonic antigen calibration material, a magnetic bead covered by an anti-carcino-embryonic antigen antibody, an enzyme labeled monoclonal antibody, an enzyme acted chemiluminiscence substrate and a concentrated washing solution. The detection kit disclosed by the invention utilizes the advantages of magnetic separation and chemiluminiscence detection methods so that the detection process is simple, the operation is easy and the automation is convenient; meanwhile, the detection kit further has the properties of high sensitivity, good specificity, low detection limit, good stability and the like and the requirements of clinic auxiliary diagnosis or detection of various cancers are met.

Description

technical field [0001] The invention belongs to the technical field of kits, in particular to a carcinoembryonic antigen magnetic particle chemiluminescent immunoassay detection kit and a detection method thereof. Background technique [0002] Carcinoembryonic antigen (CEA) was first discovered by Gold and Freedman from fetal and colon cancer tissues in 1965. It is a polysaccharide-protein complex with a molecular weight of 22ku, 45% of which is protein. Under normal circumstances, CEA is synthesized by fetal gastrointestinal epithelial tissue, pancreas and liver cells. Usually, the CEA content increases within 6 months of pregnancy, and the serum content is already very low after birth. The serum CEA concentration of healthy adults is less than 5μIU / mL. [0003] CEA is a non-organ-specific tumor-associated antigen, and most of the tumors that secrete CEA are located in hollow organs, such as the gastrointestinal tract, respiratory tract, and urinary tract. Under normal c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577G01N33/531G01N21/76
Inventor 不公告发明人
Owner WUHAN LIFE ORIGIN BIOTECH LTD
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