CN107941791A - A kind of cancer base antigen calibration object method of inspection - Google Patents
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- 206010028980 Neoplasm Diseases 0.000 title claims abstract description 24
- 239000000427 antigen Substances 0.000 title claims abstract description 24
- 102000036639 antigens Human genes 0.000 title claims abstract description 24
- 108091007433 antigens Proteins 0.000 title claims abstract description 24
- 238000007689 inspection Methods 0.000 title claims abstract description 23
- 238000000034 method Methods 0.000 title claims abstract description 20
- 201000011510 cancer Diseases 0.000 title claims abstract description 19
- 238000003908 quality control method Methods 0.000 claims abstract description 20
- 238000012360 testing method Methods 0.000 claims abstract description 6
- 238000002360 preparation method Methods 0.000 claims abstract description 4
- 238000005259 measurement Methods 0.000 claims description 7
- 230000010076 replication Effects 0.000 claims description 6
- 238000003556 assay Methods 0.000 claims description 5
- 239000012925 reference material Substances 0.000 claims 1
- 230000009286 beneficial effect Effects 0.000 abstract description 3
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 206010009944 Colon cancer Diseases 0.000 description 5
- 210000002966 serum Anatomy 0.000 description 5
- 238000001514 detection method Methods 0.000 description 4
- 210000003754 fetus Anatomy 0.000 description 4
- 206010058467 Lung neoplasm malignant Diseases 0.000 description 3
- 206010027457 Metastases to liver Diseases 0.000 description 3
- 210000001072 colon Anatomy 0.000 description 3
- 238000003745 diagnosis Methods 0.000 description 3
- 201000005202 lung cancer Diseases 0.000 description 3
- 208000020816 lung neoplasm Diseases 0.000 description 3
- 108090000623 proteins and genes Proteins 0.000 description 3
- 238000011160 research Methods 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- 208000005718 Stomach Neoplasms Diseases 0.000 description 2
- 208000029742 colonic neoplasm Diseases 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 206010017758 gastric cancer Diseases 0.000 description 2
- 210000000936 intestine Anatomy 0.000 description 2
- 201000007270 liver cancer Diseases 0.000 description 2
- 208000014018 liver neoplasm Diseases 0.000 description 2
- 210000000056 organ Anatomy 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 208000020615 rectal carcinoma Diseases 0.000 description 2
- 230000000391 smoking effect Effects 0.000 description 2
- 238000010561 standard procedure Methods 0.000 description 2
- 210000002784 stomach Anatomy 0.000 description 2
- 201000011549 stomach cancer Diseases 0.000 description 2
- 206010003445 Ascites Diseases 0.000 description 1
- 206010006187 Breast cancer Diseases 0.000 description 1
- 208000026310 Breast neoplasm Diseases 0.000 description 1
- 102000012406 Carcinoembryonic Antigen Human genes 0.000 description 1
- 108010022366 Carcinoembryonic Antigen Proteins 0.000 description 1
- 201000009030 Carcinoma Diseases 0.000 description 1
- 208000001333 Colorectal Neoplasms Diseases 0.000 description 1
- 102000002322 Egg Proteins Human genes 0.000 description 1
- 108010000912 Egg Proteins Proteins 0.000 description 1
- 206010073069 Hepatic cancer Diseases 0.000 description 1
- 208000015634 Rectal Neoplasms Diseases 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 201000001531 bladder carcinoma Diseases 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000000481 breast Anatomy 0.000 description 1
- 230000000739 chaotic effect Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 210000000038 chest Anatomy 0.000 description 1
- 210000000349 chromosome Anatomy 0.000 description 1
- 201000010989 colorectal carcinoma Diseases 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000001079 digestive effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 210000002257 embryonic structure Anatomy 0.000 description 1
- 210000000981 epithelium Anatomy 0.000 description 1
- 235000011389 fruit/vegetable juice Nutrition 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 150000004676 glycans Chemical class 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 206010073071 hepatocellular carcinoma Diseases 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 210000004347 intestinal mucosa Anatomy 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 210000005229 liver cell Anatomy 0.000 description 1
- 208000019423 liver disease Diseases 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 230000001926 lymphatic effect Effects 0.000 description 1
- 208000011645 metastatic carcinoma Diseases 0.000 description 1
- 206010061289 metastatic neoplasm Diseases 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 210000004681 ovum Anatomy 0.000 description 1
- 210000000496 pancreas Anatomy 0.000 description 1
- 230000000649 photocoagulation Effects 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 230000035935 pregnancy Effects 0.000 description 1
- 206010038038 rectal cancer Diseases 0.000 description 1
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- 201000001275 rectum cancer Diseases 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 230000003248 secreting effect Effects 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 210000004881 tumor cell Anatomy 0.000 description 1
- 239000000439 tumor marker Substances 0.000 description 1
- 208000010570 urinary bladder carcinoma Diseases 0.000 description 1
- 210000001635 urinary tract Anatomy 0.000 description 1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/76—Chemiluminescence; Bioluminescence
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/57473—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving carcinoembryonic antigen, i.e. CEA
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Abstract
A kind of cancer base antigen calibration object method of inspection of the present invention, including following preparation process:1) calibration object to be measured, is divided into two groups, measures the luminous value of calibration object to be checked, operating reference product and quality-control product respectively；2), with operating reference product curve matching calibration object to be checked and quality-control product, the value of calibration object and quality-control product to be checked is calculated；3), using calibration object to be checked as curve matching quality-control product, the value of calibration object to be checked is calculated；4) assignment：The calibration object progress assignment completed will be dispensed；5) verify：Homogeneity in homogeneity and bottle is measured between bottle respectively.The inspection method of inspection of the present invention can accurately verify cancer base antigen (CEA) calibration object, and measured value is accurate, can effectively monitor the test value of sample in clinical examination；And relative to the method for inspection used in the past, have the advantages that cost is low, efficient, assignment is accurate, beneficial to mass production.
Description
Technical field
The invention belongs to in-vitro diagnosis inspection technology field, is specially a kind of cancer base antigen calibration object method of inspection.
Background technology
Carcinomebryonic antigen (carcinoembryonic antigen, CEA) is a kind of with the decision of human embryos antigen-specific
The sugar antigen of cluster, is important tumor associated antigen, is derived in early stage fetus by entoderm, by Gastrointestinal Tract of Fetus epithelium
Synthesized by tissue, pancreas and liver cell.Nineteen sixty-five, Gold and Freedman have found from fetus and colon cancer tissue first, therefore incite somebody to action
It is known as carcinomebryonic antigen.Its encoding gene is located at No. 19 chromosomes, is the polysaccharide protein complex that a kind of molecular weight is 22KD,
45% is protein.
CEA belongs to non-organ specificity tumor associated antigen, is primarily present in Rectum and colon cancer tissue and fetus intestinal mucosa
Interior, the tumour for secreting CEA is located at hollow organ, such as intestines and stomach, respiratory tract, the urinary tract mostly.CEA is through stomach and intestine under normal circumstances
Road is metabolized, and the CEA produced by tumor cell secretion enters in local humor and blood and Lymphatic Circulation, therefore in above-mentioned cancer
Serum and chest, ascites, may occur in which that the exception of CEA increases in digestive juice, research find some benign illness especially hepatopathy when,
CEA is also often raised in circulation, but generally less than 20 μ g/L.
CEA is a kind of broad-spectrum tumor marker, is often combined detection with other tumor markerses.Clinically, when CEA is more than
During 60 μ g/L, it is seen that in colon and rectum carcinoma, stomach cancer and lung cancer.Primary colorectal carcinoma when not shifting in early days, CEA sun
Property rate be 45%~80% or so, the concentration and positive rate of patient its CEA shifted raise.The measure of CEA can be made
To observe one of foundation of curative effect.CEA values raise, and show there is lesion remaining or progress.Such as lung cancer, breast cancer, carcinoma of urinary bladder and ovum
Nest cancer patients serum CEA amounts can be significantly raised, is shown as tumor-infiltrated mostly, wherein about 70% is metastatic carcinoma.
Change of serum C EA is often raised during primary carcinoma of liver；During various primary carcinoma (particularly colon, lung and breast) hepatic metastases, CEA
Level is height compared with no hepatic metastases person, and research in recent years is found in the hepatic metastases interstitial laser photocoagulation in various sources with the presence of a large amount of CEA.
Thus also exist in hepatocarcinoma, can be as the index of diagnosing cancer of liver.
CEA contents increase in 6 months usually before gestation, and content is very low in serum after birth.Research finds smoking people
Group CEA has a part rise, and CEA concentration is less than 2.5 μ g/L, a large amount of smokers in the non-smoking healthy adult human serums of 96%-97%
There is the people CEA of 20%-40%>2.5 μ g/L, a small number of CEA>5.0μg/L.
Carcinomebryonic antigen contributes to liver cancer, colon and rectum carcinoma, stomach cancer and lung cancer with other tumor markers joint-detections
Diagnosis, the dynamic monitoring of chemicotherapy effect, with auxiliary judgment disease process or therapeutic effect, it is impossible to as diagnosing early malignant tumor
Or the foundation made a definite diagnosis.The detection of carcinomebryonic antigen is quantitative approach detection currently on the market, therefore calibration object is indispensable
Reagent components, at present, calibration object definite value market is without the unified and standard method of inspection.
The content of the invention
To solve in the prior art, calibration object definite value market without the unified and standard method of inspection, it is more chaotic the defects of, this
Invention provides a kind of cancer base antigen calibration object method of inspection.
A kind of cancer base antigen calibration object method of inspection, including following preparation process:
1) calibration object to be measured, is divided into two groups, calibration to be checked is measured respectively in the case where requiring different time or different instruments
The luminous value of product, operating reference product and quality-control product；Preferably, the luminous value of calibration object, operating reference product and quality-control product repeats
Measure is averaged three times.Pool can preferably be used into the CIA1200 type Full-automatic chemiluminescences of Bioisystech Co., Ltd
Analyzer is measured luminous value；
2), with operating reference product curve matching calibration object to be checked and quality-control product, the value of calibration object and quality-control product to be checked is calculated,
It is required that the value of product fitting concentration to be calibrated and the deviation of theoretical concentration are in the range of ± 10%；
3), using calibration object to be checked as curve matching quality-control product, the value of calibration object to be checked is calculated, it is desirable to calibration object fitting to be checked
Value and operating reference product fitting value deviation in the range of ± 10%；
4) assignment：The calibration object progress assignment completed will be dispensed；
5) verify：Homogeneity in homogeneity and bottle is measured between bottle respectively.
Further, the value of the calibration object and quality-control product to be checked that measure every time is calculated in the step 2) respectively, is taken three times
Average value.The value of the calibration object to be checked measured every time is calculated in the step 3) respectively, takes average value three times.
Further, calibration object to be measured is divided into 5 groups in the step 4), every group of replication 3 times, finally calculates 15 times
Average value be the calibration object point actual value.
Further, in step 5), the assay method of homogeneity is 10 bottles of calibration object for taking the batch between bottle, test one
It is secondary, calculate the CV of the measurement result of 10 times, it is desirable in the range of ± 10%；Further, in step 5), the survey of homogeneity in bottle
The method of determining is that will take 1 bottle of the calibration object of the batch, replication 10 times, calculates the CV of the measurement result of 10 times, it is desirable to ±
In the range of 10%.
Beneficial effect：The inspection method of inspection of the present invention can accurately verify cancer base antigen (CEA) calibration object, and measured value is accurate
Really, the test value of sample in clinical examination can effectively be monitored；And relative to the method for inspection used in the past, have cost it is low,
The advantages of efficient, assignment is accurate, beneficial to producing in enormous quantities.
Embodiment
Embodiment
A kind of cancer base antigen calibration object method of inspection, including following preparation process:
1) calibration object to be measured, is divided into two groups, is requiring different time using damp into Bioisystech Co., Ltd
CIA1200 type Full-automatic chemiluminescences analyzer measures the luminous value of calibration object to be checked, operating reference product and quality-control product, each
Point, is repeated three times and is averaged；
2), with operating reference product curve matching calibration object to be checked and quality-control product, it is every that calibration object and quality-control product to be checked are calculated
The average value of a point, it is desirable to which the value of product fitting concentration to be calibrated and the deviation of theoretical concentration are in the range of ± 10%；
3), using calibration object to be checked as curve matching quality-control product, the average value for each putting calibration object to be checked is calculated, it is desirable to be checked
The value of calibration object fitting and the value deviation of operating reference product fitting are in the range of ± 10%；
4) assignment：Calibration object to be measured is divided into 5 groups, and every group of replication 3 times, the average value for finally calculating 15 times is the school
The actual value of quasi- product point.
5) verify：Homogeneity in homogeneity and bottle is measured between bottle respectively.The assay method of homogeneity is to take the batch between bottle
10 bottles of calibration object, test once, calculate 10 times measurement result CV, it is desirable in the range of ± 10%；Homogeneity in bottle
Assay method is that will take 1 bottle of the calibration object of the batch, replication 10 times, calculates the CV of the measurement result of 10 times, it is desirable to ±
In the range of 10%.
Specific measurement result is as shown in table 1 to table 4.
Product examine is tested among table 1CEA
| Theoretical concentration | RLU1 | RLU2 | RLU3 | AVG | It is fitted concentration |
| 0 | 11084 | 11899 | 10972 | 11318 | 0.00 |
| 10 | 536544 | 507976 | 520256 | 521592 | 9.88 |
| 25 | 951480 | 945782 | 1008425 | 968562 | 25.94 |
| 100 | 2688252 | 2734285 | 2638094 | 2686877 | 97.84 |
| 300 | 6356662 | 6566388 | 6331505 | 6418185 | 290.75 |
| 1000 | 15395787 | 16197244 | 16289749 | 15960927 | 1021.65 |
| 25 | 970680 | 963530 | 960989 | 965066 | 25.81 |
| 300 | 6420171 | 6317881 | 6406101 | 6381384 | 288.62 |
| Theoretical concentration | RLU1 | RLU2 | RLU3 | AVG | It is fitted concentration |
| 0 | 11252 | 11275 | 11420 | 11316 | 0.00 |
| 10 | 537803 | 535717 | 531807 | 535109 | 10.34 |
| 25 | 970149 | 978475 | 978534 | 975719 | 26.21 |
| 100 | 2720094 | 2698558 | 2709233 | 2709295 | 98.86 |
| 300 | 6389739 | 6411631 | 6322416 | 6374595 | 288.23 |
| 1000 | 15679197 | 15611531 | 15548044 | 15612924 | 987.55 |
| 25 | 970680 | 963530 | 960989 | 965066 | 25.6048 |
| 300 | 6420171 | 6317881 | 6406101 | 6381384 | 291.2079 |
2 first groups of CEA calibration object assignment of table
3 second groups of CEA calibration object assignment of table
The testing result of the calibration object to be checked to be detected of table 4
Claims (7)
1. a kind of cancer base antigen calibration object method of inspection, it is characterised in that including following preparation process:
1) calibration object to be measured, is divided into two groups, calibration object to be checked, work are measured respectively in the case where requiring different time or different instruments
Make the luminous value of reference material and quality-control product；
2), with operating reference product curve matching calibration object to be checked and quality-control product, the value of calibration object and quality-control product to be checked is calculated, it is desirable to
The value of product fitting concentration to be calibrated and the deviation of theoretical concentration are in the range of ± 10%；
3), using calibration object to be checked as curve matching quality-control product, the value of calibration object to be checked is calculated, it is desirable to the value of calibration object fitting to be checked
And the value deviation of operating reference product fitting is in the range of ± 10%；
4) assignment：The calibration object progress assignment completed will be dispensed；
5) verify：Homogeneity in homogeneity and bottle is measured between bottle respectively.
2. the cancer base antigen calibration object method of inspection as claimed in claim 1, it is characterised in that step 1) the alignment product,
The luminous value of operating reference product and quality-control product, which is repeated three times, to be averaged.
3. the cancer base antigen calibration object method of inspection as claimed in claim 2, it is characterised in that calculated respectively in the step 2)
The value of the calibration object and quality-control product to be checked that measure every time, takes average value three times.
4. the cancer base antigen calibration object method of inspection as claimed in claim 3, it is characterised in that calculated respectively in the step 3)
The value of the calibration object to be checked measured every time, takes average value three times.
5. the cancer base antigen calibration object method of inspection as claimed in claim 1, it is characterised in that by school to be measured in the step 4)
Quasi- product are divided into 5 groups, and every group of replication 3 times, the average value for finally calculating 15 times is the actual value of the calibration object point.
6. the cancer base antigen calibration object method of inspection as claimed in claim 1, it is characterised in that in the step 5), between bottle
The assay method of one property is 10 bottles of calibration object for taking the batch, and every bottle of test once, calculates the CV of the measurement result of 10 times, it is desirable to
In the range of ± 10%.
7. the cancer base antigen calibration object method of inspection as claimed in claim 1, it is characterised in that in the step 5), in bottle
The assay method of one property is that will take 1 bottle of the calibration object of the batch, replication 10 times, calculates the CV of the measurement result of 10 times,
Ask in the range of ± 10%.
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| CN201711394517.3A CN107941791B (en) | 2017-12-21 | 2017-12-21 | Method for detecting cancer blank antigen calibrator |
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