CN106596962A - CODE constant value correction method based on blood glucose test strip test value attenuation - Google Patents
CODE constant value correction method based on blood glucose test strip test value attenuation Download PDFInfo
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- CN106596962A CN106596962A CN201610935727.8A CN201610935727A CN106596962A CN 106596962 A CN106596962 A CN 106596962A CN 201610935727 A CN201610935727 A CN 201610935727A CN 106596962 A CN106596962 A CN 106596962A
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- 238000012360 testing method Methods 0.000 title claims abstract description 148
- 239000008280 blood Substances 0.000 title claims abstract description 105
- 210000004369 blood Anatomy 0.000 title claims abstract description 105
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 title claims abstract description 69
- 239000008103 glucose Substances 0.000 title claims abstract description 69
- 238000000034 method Methods 0.000 title abstract description 15
- 235000000346 sugar Nutrition 0.000 claims description 48
- 238000004519 manufacturing process Methods 0.000 claims description 22
- 238000005516 engineering process Methods 0.000 claims description 11
- 230000004071 biological effect Effects 0.000 claims description 8
- 239000002994 raw material Substances 0.000 claims description 8
- 238000002715 modification method Methods 0.000 claims description 6
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 4
- 230000007423 decrease Effects 0.000 abstract description 4
- 230000002035 prolonged effect Effects 0.000 abstract description 2
- 238000001514 detection method Methods 0.000 description 15
- 235000001727 glucose Nutrition 0.000 description 14
- 230000000694 effects Effects 0.000 description 9
- 239000003153 chemical reaction reagent Substances 0.000 description 7
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 description 4
- 238000006243 chemical reaction Methods 0.000 description 4
- 238000003487 electrochemical reaction Methods 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- 108090000790 Enzymes Proteins 0.000 description 3
- 102000004190 Enzymes Human genes 0.000 description 3
- 238000004587 chromatography analysis Methods 0.000 description 3
- 238000013499 data model Methods 0.000 description 3
- 235000013399 edible fruits Nutrition 0.000 description 3
- 229940088598 enzyme Drugs 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 238000003908 quality control method Methods 0.000 description 3
- LRFVTYWOQMYALW-UHFFFAOYSA-N 9H-xanthine Chemical compound O=C1NC(=O)NC2=C1NC=N2 LRFVTYWOQMYALW-UHFFFAOYSA-N 0.000 description 2
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 108010015776 Glucose oxidase Proteins 0.000 description 2
- 239000004366 Glucose oxidase Substances 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 229940116332 glucose oxidase Drugs 0.000 description 2
- 235000019420 glucose oxidase Nutrition 0.000 description 2
- ZBKIUFWVEIBQRT-UHFFFAOYSA-N gold(1+) Chemical compound [Au+] ZBKIUFWVEIBQRT-UHFFFAOYSA-N 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 239000004816 latex Substances 0.000 description 2
- 229920000126 latex Polymers 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 230000007246 mechanism Effects 0.000 description 2
- 239000012429 reaction media Substances 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 238000012827 research and development Methods 0.000 description 2
- QSHQKIURKJITMZ-OBUPQJQESA-N 5β-cholane Chemical compound C([C@H]1CC2)CCC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@H](C)CCC)[C@@]2(C)CC1 QSHQKIURKJITMZ-OBUPQJQESA-N 0.000 description 1
- 241000208340 Araliaceae Species 0.000 description 1
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 description 1
- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 description 1
- 235000003140 Panax quinquefolius Nutrition 0.000 description 1
- 229910021529 ammonia Inorganic materials 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 238000006555 catalytic reaction Methods 0.000 description 1
- 235000012000 cholesterol Nutrition 0.000 description 1
- 238000011982 device technology Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000005611 electricity Effects 0.000 description 1
- 238000000835 electrochemical detection Methods 0.000 description 1
- 238000002848 electrochemical method Methods 0.000 description 1
- 230000005518 electrochemistry Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 235000008434 ginseng Nutrition 0.000 description 1
- 150000002304 glucoses Chemical class 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 230000033116 oxidation-reduction process Effects 0.000 description 1
- 238000012123 point-of-care testing Methods 0.000 description 1
- 238000007639 printing Methods 0.000 description 1
- 238000012372 quality testing Methods 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000027756 respiratory electron transport chain Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 229940075420 xanthine Drugs 0.000 description 1
Classifications
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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
- G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
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- Biomedical Technology (AREA)
- Chemical & Material Sciences (AREA)
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- Food Science & Technology (AREA)
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Abstract
The invention relates to a CODE constant value correction method based on blood glucose test strip test value attenuation. The CODE constant value correction method includes that linear fitting is conducted to obtain a numerical value a and a numerical value b according to a linear relation of test values and blood glucose concentration values, wherein the linear relation satisfies the equation that Y=a*X+b, in which X refers to the blood glucose concentration value, Y refers to the test value, and a and b refer to liner relation parameters of the blood glucose concentration value and the test value respectively; a stability fluctuation rule of the test values of blood glucose test strips is that a linear relation of test value decrease amplitude and time satisfies the equation of p=1-c*t, and linear fitting is conducted to obtain a numerical value c, wherein p refers to the test value decrease amplitude, t refers to the time, unit refers to month, and c refers to the parameter; after CODE correction, the relations between the blood glucose test value Y and the concentration value X as well as the test time and ex-factory date month interval t satisfy the equation that Y=(a*X+b)*(1-c*t), and accordingly CODE original values of the blood glucose test strips are (ex-factory date, a, b and c). The CODE constant value correction method based on blood glucose test strip test value attenuation is capable of effectively avoiding the practical problem of a short effective period of quantitative determination blood glucose test strip products due to stability fluctuation, the effective period of the quantitative products is effectively prolonged, and test accuracy of the quantitative products is effectively improved.
Description
Technical field
The invention belongs to enzymatic-electrochemical reaction technology, microelectrode surface Electroanalytical Chemistry technology, photoelectric type bio-sensing
Device technology and POCT field of fast detection, are specifically related to a kind of CODE definite values amendment side decayed based on blood sugar test paper test value
Method.
Background technology
Electroanalytical Chemistry (Electroanalytical Chemistry) is an important branch of Instrumental Analysis, it
It is the alanysis method set up based on the electroresponse for measuring a certain chemical system or sample.It is the object for determining
The ingredient of a chemical cell is constituted, by some physical quantitys for measuring battery, such as current potential, electric current, conductance or electricity,
Try to achieve the content of material or determine some electrochemical properties.
Blood sugar test paper in existing system for detecting blood sugar, its ultimate principle is glucose oxidase electrode method, and it is to pass
A kind of method that the glucose enzyme chemical detection of system combines with electrochemical detection method.Using the product of oxydasises glucose
, by reacting with special reaction medium, there is the electrochemical reaction of electron transfer in electrode surface in the oxidisability of hydrogen peroxide.
Due to the gain and loss of electronics, so as to produce electric current on electrode.Due to the difference of glucose content, the amount of produced hydrogen peroxide
Also different, reaction medium is also different in the electron amount that electrode surface participates in the gain and loss of electrochemical reaction institute, is macroscopically showing as
Produce the of different sizes of electric current.Therefore we can design a kind of response system, by the size of detecting electrode kinetic current come
Judge the content of glucose in solutions.Reactive Mechanism of Electrode is illustrated as shown in Figure 1.
For potentiostatic method, by applying certain current potential, the current potential should be situated between to the electrochemical method that detection electric current is adopted
Oxidation-reduction potential of the matter in reaction system solution.Kinetic current is larger when initial is then gradually reduced, increasing over time
When length, electrochemistry and chemical reaction reach stable state, electric current is held essentially constant.Control regular hour collection current value, the ginseng
Number reflects to a certain extent the content of the glucose for participating in reaction.One can be made according to the concentration of size of current and glucose
Fixed relation curve, on the contrary according to the curve, we are obtained the glucose content in solution to be measured.
Based on design, the system for detecting blood sugar that gets up of research and development on the basis of enzyme electrode, for detecting blood sample in
Glucose content.In addition to glucose, the method can also be used to detecting other important biomolecule media, such as cholesterol, lactate,
The materials with electro-chemical activity such as xanthine, cholane, flesh ammonia enzyme and ethanol.
Due to blood sugar test paper prepared by production technology horizontal factor, difference batch, in terms of detection by quantitative, there is certain criticizing
Between it is poor, so as to cause the deviation of test result, so on the market existing like product in terms of production technology, using batch default
Value CODE method, defines the detection by quantitative result reduction formula of every batch of reagent paper product.So as to the test for ensureing every batch products is tied
The accuracy of fruit.
However, because blood sugar test paper is designed into biological activity raw material, and it is known that the activity of biological activity raw material with
Time can progressively decay.So with a collection of blood sugar test paper, require that placing environment places according to description, its test result also with
Time and progressively reduce, after its test result reduces amplitude to be reached to a certain degree, that is, cause its test result deviation excessive from
And test result fails, i.e., the blood sugar test paper for detection by quantitative exceedes effect duration and fails.Typically refer to according to correlations such as regulations
Lead, test value deviation reaches and be set to failure after 10%, is instructed with this, cause the effective of blood sugar test paper for detection by quantitative
Phase is limited and shorter.
The content of the invention
The purpose of the present invention based on quantitative testing test paper such as blood sugar test paper stability experiment research, analyze its test value with
Time fluctuation rule, it is proposed that a kind of CODE definite value modification methods decayed based on blood sugar test paper test value；The present invention is based on
Blood sugar test paper test value fluctuation pattern and a kind of definite value modification method for setting up over time, on the basis of existing definite value CODE
On, test value stability fluctuation pattern is brought in CODE formulating methods, worked out by CODE, effectively the test of amendment blood sugar test paper
As a result, it is to avoid test value influence of fluctuations over time, so as to effectively improve accuracy in detection；Simultaneously because CODE establishments are introduced and surveyed
Examination value fluctuation pattern over time, so as to effectively break through amendment before test value deviation 10% restriction, can effectively increase amendment
Front test value deviation amplitude, so as to the effect duration for extending detection by quantitative product of actual high degree.
The technical scheme is that：
A kind of CODE definite value modification methods decayed based on blood sugar test paper test value, it is characterised in that enter according to the following steps
OK：Test value and blood glucose concentration value first according to blood sugar test paper is linear relationship Y=a*X+b, therefore derives X=(Y-b)/a,
Wherein X is blood glucose concentration value, and Y is test value, and a, b are respectively blood glucose concentration value, the linear relationship parameter of test value, using blood glucose
Reagent paper tests the test value of more than three groups known blood glucose concentration values, after linear fit, obtains the numerical value of a, b, according to stable
Journal of Sex Research result, it is made under existing manufacturing condition on the premise of biological activity raw material and production technology are not altered
The test value stability fluctuation pattern of standby blood sugar test paper is：Test value fall and time are linear relationship, p=1-c*t,
Wherein p is test value fall, and t is the time, and unit is the moon, and c is test value fall, the parameter of linearly relation,
After again by linear fit, the numerical value of c is obtained；Through revised blood sugar test values Y of this CODE and blood glucose concentration value X, survey
Between examination time and the date of production every other month count t between relation be：Y=(a*X+b) * (1-c*t), so the CODE of batch blood sugar test paper
Original value is (date of production, a, b, c).
Blood glucose meter can either be manually entered code by code bar or network-side remote input code means arrange inspection
Blood glucose instrument CODE before surveying.Blood glucose meter has self-clocking and date calibration function.Blood sugar test paper in blood glucose meter is based on silk
The enzymatic-electrochemical biosensor that the electrochemical reaction technology of the glucoseoxidase catalysis on wire mark brush electrode surface is developed.
The quick and precisely detection of the glucose content of denier sample can be realized.
In the CODE values using front elder generation according to printing above blood sugar test paper outer package through present invention amendment, blood glucose meter is set
CODE, amendment CODE input blood glucose meter after, by machine plug-in, can be converted into automatically system for detecting blood sugar detection
As a result conversion formula, and while also introduce test value stability fluctuation pattern formula, so as to effectively tie follow-up test
Fruit is converted to instrument and reports the concentration value of result, and corrects product use time with the interval at the production time of making the product to test result
Impact, improve testing result accuracy.
It is existing that the test value stability fluctuation pattern of blood sugar test paper involved in the present invention is not limited to only our company
The data model drawn under manufacturing condition, can also be the data model of other type function, these data models
Purpose is to preferably be fitted the stability fluctuation of description test value, being easy to Mathematical treatment.
CODE valued methods involved in the present invention and its detecting system, are suitable for but are not limited to blood sugar test paper, gold colloidal and exempt from
Epidemic disease chromatographic test paper, latex immune chromatography test paper, fluorescence immune chromatography test paper etc. are related to the quantitative inspection of biological activity raw material stability
Examining system.It is such to be related to the stepping quantitative detection system of caused detected value because of biological activity raw material stability,
Using CODE valued methods of the present invention, to effectively improve accuracy in detection and its effect duration.
The present invention adopts the blood sugar test system based on the CODE of blood sugar test paper test value stability fluctuation pattern definite value, can
The test value occurred over time during effectively to correct blood sugar test paper use declines phenomenon, it is to avoid the decline of test value
The phenomenon for causing test result grade less than normal inaccurate, improves test accuracy, while extremely significantly extend test paper making
It is enterprise's production and user using bringing significant economic benefit with effect duration.
Description of the drawings
Fig. 1 is the Reactive Mechanism of Electrode schematic diagram of the blood sugar test paper in existing system for detecting blood sugar.
Specific embodiment
A preferred embodiment example of the invention, is illustrated, its invention by taking blood sugar test paper and blood glucose meter as an example
The immune chromatography test paper quantitative detection systems such as applicable and gold colloidal, latex.
Embodiment 1：By taking blood glucose meter as an example
A kind of CODE definite value modification methods decayed based on blood sugar test paper test value, it is characterised in that enter according to the following steps
OK：Test value and blood glucose concentration value first according to blood sugar test paper is linear relationship Y=a*X+b, therefore derives X=(Y-b)/a,
Wherein X is blood glucose concentration value, and Y is test value, and a, b are respectively blood glucose concentration value, the linear relationship parameter of test value, using blood glucose
Reagent paper tests the test value of more than three groups known blood glucose concentration values, after linear fit, obtains the numerical value 200 of a, the numerical value of b
For 300, therefore Y=200*X+300, according to results of stability, before biological activity raw material and production technology are not altered
Put, under existing manufacturing condition, the test value stability fluctuation pattern of prepared blood sugar test paper is：Test value declines
Amplitude is linear relationship with the time, and p=1-c*t, wherein p are test value fall, and t is the time, and unit is the moon, and c is test
Value fall, the parameter of linearly relation, again by linear fit after, obtain c numerical value be 0.0034；Therefore p=1-
0.0034*t, through revised blood sugar test values Y of this CODE and between blood glucose concentration value X, testing time and the date of production every other month
Number t between relation be：Y=(a*X+b) * (1-c*t), so the CODE original values of batch blood sugar test paper for (20160606,200,
300,0.0034).By the built-in CODE tables of blood glucose meter it is known that (20160606,200,300,0.0034) simplify,
2478. event CODE definite values are 2478.Test first manually adjusts blood glucose meter CODE for 2478 using front, then blood glucose meter inside is automatically
The corresponding parameter of selection (20160606,200,300,0.0034), date when blood glucose meter is then used according to tester, automatically
To t values；Blood glucose meter obtains test value after tester's test, then according to according to revised test value concentration value relation y=
(200*X+300) * (1-0.0034*t), calculates the blood sugar concentration of test sample automatically, is then reported out institute's test sample
Concentration value and early warning.
Embodiment 2：By taking blood glucose meter as an example
In the case where biological activity raw material and production technology are not changed, according under the existing manufacturing condition of our company
Research and development technology and creation data, it is p=1-0.0034*t to count blood sugar test paper test value stability fluctuation pattern, and wherein p is
Test value fall, t is the time, and unit is the moon；By taking a collection of blood sugar test paper that our company develops in the recent period as an example, its finished product production
Date be on 06 07th, 2014, test value linear fit curve be Y=215X+210, linear fit coefficient R2=
0.9968, thus the amendment CODE definite values that adopted of this batch blood sugar test paper for (20140607,215,210,0.0034), Ran Houtong
Cross the built-in CODE tables of blood glucose meter it is known that (20140607,215,210,1,328 0.0034) can be reduced to, wherein first
Position 1 represents the date 20140607, and second 3 represents 215, and the 3rd 2 represents 210, and the 4th 8 represents 0.0034；So batch examination
The CODE definite values of paper are 1328.
The blood glucose meter of the CODE definite value compilation facilities for being built-in with present invention amendment is taken, this blood glucose meter has clocking capability simultaneously
And date calibration function.The code bar for being built-in with CODE values 1328 is inserted into blood glucose meter read port, blood glucose meter reads CODE values,
Then reagent paper is inserted into blood glucose meter, takes the quality-control product that definite value is 5.5mmol/l glucoses and test, instrument report result is
5.4mmol/l。
The blood glucose meter of the CODE definite value compilation facilities without built-in present invention amendment is taken, according to company's blood glucose meter production note
Record, it is Y=215X+210 that the CODE for consulting the supporting original blood glucose meter of this batch of reagent paper is 32, i.e. built-in linear fitting formula, according to
Quality testing department is recorded, the supporting original blood glucose meter of this batch of reagent paper, and test result preparation meets GB and company standard when dispatching from the factory.But
Reagent paper effect duration is 2 years, through the phase.According to description test concentration of glucose is directly operated for the Quality Control of 5.5mmol/l
Liquid, is as a result shown as 3.2mmol/l, hence it is evident that excessive with definite value quality-control product concentration deviation and fail.Therefore adopt after present invention amendment
CODE blood glucose meter, keeping life is obviously prolonged.
The a collection of blood sugar test paper of the production on the 15th of September in 2015 is taken, the CODE of supporting original blood glucose meter is 37, according to Ben Faxiu
Positive CODE definite values are 3378, take the control liquid that concentration of glucose is 11.5mmol/l and detect respectively, original blood glucose meter test knot
Fruit is 11.0mmol/l, and deviation close 5% takes the blood glucose of the blood glucose meter definite value function of being built-in with the CODE according to present invention amendment
Instrument is tested, and code CODE is 3378, tests control liquid of the concentration of glucose for 11.5mmol/l, is as a result shown as 11.3mmol/
L, deviation is significantly less than 5%, therefore test accuracy is obviously improved.
The present invention adopts the blood sugar test based on the CODE of blood sugar test paper test value stability fluctuation pattern definite value, Ke Yiyou
The test value occurred over time during effect amendment blood sugar test paper use declines phenomenon, it is to avoid the decline of test value causes
The inaccurate phenomenon of test result grade less than normal, effectively realizes accurate and stable detection by quantitative.Extremely significantly extend simultaneously
Test paper uses effect duration, effectively improves the feasibility that manufacturer's yield is amplified, and is that enterprise's production and user use band
Significant economic benefit is carried out.
It should be noted last that, above specific embodiment only to illustrate technical scheme and unrestricted,
Although being described in detail to the present invention with reference to preferred embodiment, it will be understood by those within the art that, can be right
Technical scheme is modified or equivalent, and without deviating from the spirit and scope of technical solution of the present invention, its is equal
Should cover in the middle of scope of the presently claimed invention.
Claims (1)
1. it is a kind of based on blood sugar test paper test value decay CODE definite value modification methods, it is characterised in that carry out according to the following steps：
Test value and blood glucose concentration value first according to blood sugar test paper is linear relationship Y=a*X+b, therefore derives X=(Y-b)/a, its
Middle X is blood glucose concentration value, and Y is test value, and a, b are respectively blood glucose concentration value, the linear relationship parameter of test value, is tried using blood glucose
Paper tests the test value of more than three groups known blood glucose concentration values, after linear fit, the numerical value of a, b is obtained, according to stability
Result of study, it is prepared under existing manufacturing condition on the premise of biological activity raw material and production technology are not altered
The test value stability fluctuation pattern of blood sugar test paper be：Test value fall is linear relationship p=1-c*t with the time, its
Middle p is test value fall, and t is the time, and unit is the moon, and c is test value fall, the parameter of linearly relation, together
Sample obtains the numerical value of c after linear fit；Through revised blood sugar test values Y of this CODE and concentration value X, testing time
With between the date of production every other month count t between relation be：Y=(a*X+b) * (1-c*t), so the CODE original values of batch blood sugar test paper
For (date of production, a, b, c).
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| CN106028932A (en) * | 2013-12-16 | 2016-10-12 | 美敦力迷你迈德公司 | Methods and systems for improving the reliability of orthogonally redundant glucose sensors |
| CN103901079A (en) * | 2013-12-20 | 2014-07-02 | 杭州世佳电子有限公司 | Test paper with code information and manufacturing method thereof |
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