CN108508201A - A kind of carcinomebryonic antigen latex enhancing immune is than turbid kit - Google Patents

A kind of carcinomebryonic antigen latex enhancing immune is than turbid kit Download PDF

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Publication number
CN108508201A
CN108508201A CN201810255959.8A CN201810255959A CN108508201A CN 108508201 A CN108508201 A CN 108508201A CN 201810255959 A CN201810255959 A CN 201810255959A CN 108508201 A CN108508201 A CN 108508201A
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China
Prior art keywords
latex particles
polystyrene latex
grain size
reagent
small particle
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Inventor
李晓舟
果玮
刘瑶
刘希
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Beijing Strong Biotechnologies Inc
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Beijing Strong Biotechnologies Inc
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Priority to CN201810255959.8A priority Critical patent/CN108508201A/en
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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
    • 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
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54313—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
    • 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
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/544—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being organic

Abstract

This application involves a kind of carcinomebryonic antigen latex enhancing immunes than turbid kit.Specifically, this application involves a kind of latex enhancing immunes of carcinomebryonic antigen content in detection human serum than turbid kit, which includes the first reagent, the second reagent and optional calibration object.First reagent includes buffer solution, and the second reagent includes polystyrene latex particles, carcinomebryonic antigen antibody and buffer solution.The kit of the application can be detected accurately<Carcinomebryonic antigen within the scope of 100ng/mL is horizontal, and linear good, accuracy is reliable, still greater than the linear upper limit when clinical extremely high value, can be applied to clinical carcinomebryonic antigen detection.

Description

A kind of carcinomebryonic antigen latex enhancing immune is than turbid kit
Technical field
This application involves clinical examination fields.Specifically, this application involves a kind of latex of detection carcinomebryonic antigen content Enhance Immunoturbidimetric kit.
Background technology
Carcinomebryonic antigen (CEA) is originally found in colon cancer and fetal gut tissue, in tumor tissues (including the embryo of adult Property the tumor tissues such as tumour, stomach, intestines, mammary gland) in express, and secrete in body fluid.
CEA is a kind of important tumor associated antigen, colon cancer, gastric cancer, cancer of pancreas, lung cancer, intestinal adenocarcinoma, liver cancer, There is higher positive rate in the nausea tumour such as breast cancer.Many other diseases (such as：Hepatic sclerosis, pulmonary emphysema, intestines and stomach inflammation Deng) and smoking population in, CEA concentration can also increase.Therefore, CEA cannot function as tumoral character marker.But CEA can be with Auxiliary provides the information such as tumor recurrence and therapeutic effect after patient's prognosis, operation excision.
Currently, the detection method of CEA is more, including enzyme-linked immunization (ELISA) and chemiluminescence (CLIA) immunoassay Method etc..Enzyme-linked immunization and chemoluminescence method are all made of double antibody sandwich method, and the main distinction is the marker type difference used.
For example, disclosing a kind of carcinomebryonic antigen latex enhancing immune in CN105181694A than turbid kit, it includes R1 Reagent, R2 reagents and calibration object.The R1 reagents include following ingredient：MOPS buffer solutions, BSA, surfactant, anti-corrosion Agent；The R2 reagents include following ingredient：PBS buffer solution, the coated latex particle of CEA antibody, BSA, surfactant, Trehalose and preservative.The precision of kit is up to 5.27% and 3.21% in CN105181694A；It is tried with chemoluminescence method The correlation of agent box is good.
CN103472229A discloses a kind of carcinomebryonic antigen magnetic microparticle chemiluminescence immune assay detection kit comprising Monoclonal antibody, substrate and the thickening and washing of the coated magnetic bead of carcinomebryonic antigen calibration object, anti-carcinoembryonic-antigen (CEA) antibody, enzyme label Liquid.
CN106093405A discloses a kind of kit measuring carcinomebryonic antigen.The kit is made of reagent R1 and R2, Wherein R1 reagents include 15 to 185mmol/L MOPS buffer solutions, sodium chloride 150 to 400mmol/L, polyethylene glycol 5 to 25g/L, Bovine serum albumin(BSA) 18 is to 42g/L, Sodium azide 0.3 to 0.9g/L；R2 reagents include MOPS buffer solutions 50 to 150mmol/L, chlorine Change sodium 100 to 300mmol/L, bovine serum albumin(BSA) 4 to 18g/L, trehalose 5 to 35g/L, Sodium azide 0.3 to 0.9g/L, latex It is coated with anti-human Cea Monoclonal Antibodies 0.1 to 2.0%.
The major defect that carcinomebryonic antigen is detected using enzyme-linked immunization is to need to be manually operated in detection process, and time-consuming, As a result reproducibility is poor.It is all preferable using chemical Luminous Method on Carcinoembryonic Antigen accuracy and repeatability, but reagent cost phase To higher.
Invention content
A kind of carcino-embryonic antigen assay kit is provided according to some embodiments of the application in view of the demand, Including the first reagent, the second reagent and optionally calibration object.
In some embodiments, first reagent includes：
In some embodiments, the second reagent includes：
In some embodiments, the calibration object includes：
In some embodiments, the buffer solution in the first reagent, the second reagent and calibration object can be identical or not Together.
In some embodiments, buffer solution is selected from：Hepes buffer solutions, glycine buffer, PBS buffer solution, boric acid are slow Fliud flushing, acetate buffer solution.
In some embodiments, the average grain diameter of polystyrene latex particles is 100nm to 500nm.
In some embodiments, relative to the quality of polystyrene latex particles, carboxyl-content is 20 μm of ol/g to 200 μm ol/g, preferably 30 μm of ol/g to 180 μm of ol/g.
In some embodiments, the carcinomebryonic antigen antibody is originated from：Mouse, rabbit, goat, sheep, fowl, camel.
In some embodiments, the carcinomebryonic antigen antibody is monoclonal antibody or polyclonal antibody.
In specific embodiments, the carcinomebryonic antigen antibody is mouse monoclonal antibody.
In some embodiments, a concentration of 6.25ng/mL, 12.5ng/mL of carcinomebryonic antigen in the calibration object, 25ng/mL、50ng/mL、100ng/mL。
In some embodiments, the stabilizer is selected from：Bovine serum albumin(BSA), egg white powder.
In specific embodiments, the stabilizer is BSA.
In some embodiments, the polystyrene latex particles include big grain size polystyrene latex particles and granule Diameter polystyrene latex particles.In specific embodiments, big grain size refers to the average grain diameter of 350nm to 500nm.Specific Embodiment in, the small particle refers to the average grain diameter of 150nm to 220nm.In specific embodiments, the big grain Diameter polystyrene latex particles：The mass ratio of small particle polystyrene latex particles is 2：3.In specific embodiments, institute State on big grain size polystyrene latex particles coated antibody difference on coated antibody and small particle polystyrene latex particles Identify different carcinomebryonic antigen epitopes.
It is not limited to specific theory, inventors have surprisingly discovered that, distinguish when the apparent two kinds of particles of grain size gap When being combined with different mouse monoclonal antibodies, sensitivity is not only improved, but also improves the preceding band performance of reagent simultaneously.Detect superelevation value Ensure that false negative does not occur in testing result when clinical sample.
In specific embodiments, a kind of carcino-embryonic antigen assay kit is provided, wherein：
First reagent includes：
Second reagent includes：
The calibration object includes：
Wherein：The carcinomebryonic antigen antibody is mouse monoclonal antibody；The polystyrene latex particles include big grain size Polystyrene latex particles and small particle polystyrene latex particles；The big grain size refers to the average grain of 350nm to 500nm Diameter, the small particle refer to the average grain diameter of 150nm to 220nm；It is coated anti-on the big grain size polystyrene latex particles Coated antibody identifies different carcinomebryonic antigen epitopes respectively on body and small particle polystyrene latex particles；And the big grain size Polystyrene latex particles：The mass ratio of small particle polystyrene latex particles is 2：3.
In specific embodiments, in calibration object carcinomebryonic antigen a concentration of 6.25ng/mL, 12.5ng/mL, 25ng/ mL、50ng/mL、100ng/mL。
According to some embodiments, a kind of method with effect before improvement latex enhancing immune turbidimetry is provided, including Step：The combination of big grain size polystyrene latex particles and small particle polystyrene latex particles is introduced into detection reagent.
In specific embodiments, the big grain size refers to the average grain diameter of 350nm to 500nm, and the small particle is Refer to the average grain diameter of 150nm to 220nm.Coated antibody and small particle polyphenyl second on the big grain size polystyrene latex particles Coated antibody identifies different epitopes respectively on alkene latex particle.In specific embodiments, the big grain size is poly- Styrene latex particle：The mass ratio of small particle polystyrene latex particles is 2：3.
In specific embodiments, the detection reagent refers to for detecting the latex enhancing immune of carcinomebryonic antigen than turbid Reagent.
Description of the drawings
Fig. 1：The range of linearity experimental result of the application kit.
Fig. 2：The application kit and commercially available chemical luminescence reagent kit correlation results.
Specific implementation mode
Embodiment
The preparation of 1. first reagent of embodiment
1. preparing the first reagent (1) according to consisting of：
2. alternatively, preparing the first reagent (2) according to consisting of：
The preparation of 2. latex particle of embodiment
One, first method：
1. providing polystyrene latex particles：
The latex particle for taking average grain size 300nm is added in 125mL Hepes pH6.5 buffer solutions, obtains latex A concentration of based on w/v 1.6% particle suspension of grain；
2. providing crosslinking agent：
With 8mL deionized water dissolving 25mg carbodiimides, it is spare that preparation obtains carbodiimides aqueous solution；
3. activated polystyrene latex particle：
Particle suspension is added in carbodiimides solution, activation 0.5h, the particle activated are reacted at 37 DEG C；
4. providing antibody：
It takes the CEA antibody of 125mg to be added in 100mL Hepes pH8.0 buffer solutions, makes the final concentration of 1.25mg/ of antibody mL；
5. cross-linking reaction：
The particle of activation and CEA antibody-solutions are mixed, 37 DEG C of shaking table mixing 2h；
6. closing：
100mL confining liquids (polysorbas20 containing 2%w/v, 2%w/v BSA, glycine buffer, pH7.4) room temperature (20- is added 25 DEG C) reaction 3h；
7. terminating：
In 4 DEG C of centrifugations, 14000rpm continues 30 minutes；
8. cleaning：
With 1000mL Hepes pH7.5 buffer solution resuspended particles, eccentric cleaning.
Two, second method：
According to first method, the final concentration of 3.75mg/mL of antibody of step 4 is differed only in.
The preparation of 3. second reagent of embodiment
1. solution, which is added, in particle prepared by 2 first method of embodiment (contains 0.5%w/v BSA, 0.5%w/v NaN3、 150mM glycine buffer pH7.5), ultrasound obtains the second reagent (1) after being resuspended.Wherein：The latex particle for being combined with antibody is dense Degree is equivalent to 0.2%w/v；The concentration of antibody is equivalent to 125 μ g/mL.
2. solution, which is added, in particle prepared by 2 second method of embodiment (contains 2.5%w/v BSA, 2.5%w/v NaN3、 The glycine buffer pH8.0 of 750mM), ultrasound obtains the second reagent (2) after being resuspended.Wherein：It is combined with the latex particle of antibody Concentration is equivalent to 0.2%w/v；The concentration of antibody is equivalent to 375 μ g/mL.
The preparation of 4. calibration object of embodiment
1. preparing calibration object (1) according to consisting of：
2. alternatively, preparing calibration object (2) according to consisting of：
The preparation of 5. the application kit of embodiment
Calibration object (1) prepared by 1 first reagent (1) of embodiment, 3 second reagent (1) of embodiment and embodiment 4 is assembled into Kit A.
Calibration object (2) prepared by 1 first reagent (2) of embodiment, 3 second reagent (2) of embodiment and embodiment 4 is assembled into Kit B.
Embodiment 6. prepares little particle kit
With reference to the preparation method reagent preparation box C of kit A, the average grain diameter for differing only in particle be 150nm extremely 220nm。
Embodiment 7. prepares bulky grain kit
With reference to the preparation method reagent preparation box D of kit A, the average grain diameter for differing only in particle be 350nm extremely 500nm。
Kit of the embodiment 8. containing large and small particle
Preparation method obtains kit E according to kit A, difference lies in：
150nm is used simultaneously to 220nm little particles and 350nm to 500nm bulky grains；And little particle：Bulky grain Mass ratio is 3：2；
Monoclonal antibody of the coating for CEA different epitopes on large and small particle.
Test case
1. kit application method of test case
1. detection instrument：Biochemical Analyzer (such as, but not limited to, 7180 type of Hitachi)
2. analysis method：
Two point end assay；Wavelength：660nm；Sample size：25μL；R1：200μL；R2：50μL；
Calibrating mode：Logit 4p, 6 points of calibrations；The Direction of Reaction：Rise.
The evaluation of 2. range of linearity of test case
With deionized water according to 1/40,1/20,1/10,2/10,3/10 ... 10/10 dilution proportion portion high level serum sample This, each concentration replication twice, is investigated linear (being shown in Table 1, Fig. 1) by calculating related coefficient.
As a result it shows：Regression equation is：Y=98.699x+1.1309, R2=0.9996.
Table 1：The detection range of kit E
Measured value Theoretical value Deviation
0.025 3.88 3.60 7.83%
0.05 6.60 6.07 8.81%
0.1 12.03 11.00 9.36%
0.2 19.61 20.87 - 6.04%
0.3 30.13 30.74 - 1.99%
0.4 41.16 40.61 1.35%
0.5 49.56 50.48 - 1.82%
0.6 59.73 60.35 - 1.03%
0.7 70.35 70.22 0.18%
0.8 80.35 80.09 0.32%
0.9 90.12 89.96 0.18%
1.0 100.30 99.83 0.47%
3. kits of test case are tested with commercially available luminescence reagent box correlation
20 or more sample (exceptional samples are detected using this kit E and the control luminescence reagent box listed simultaneously No less than 5), record the testing result (being shown in Table 2, Fig. 2) of two kits.
Experimental result linear regression method is calculated into related coefficient.
Dependent equation is y=0.9799x+0.4472, R2=0.9772.
As a result show that this kit measured value is accurate, it is good with luminescence reagent correlation, it can be used for clinical carcinomebryonic antigen inspection It surveys.
2. correlation of table
Luminescence reagent Kit E
1 3.63 4.95
2 1.02 1.96
3 6.01 7.05
4 8.03 12.3
5 12.79 13.71
6 15.07 18.13
7 20.01 22.72
8 28.15 27.69
9 31.68 34.08
10 35.59 32.08
11 42.58 48.84
12 44.83 50.04
13 69.9 67.61
14 76.94 72.03
15 85.11 71.59
16 96.17 104.47
17 1.65 1.4
18 2.42 3.38
19 1.90 1.61
20 2.50 1.66
21 1.53 0.8
22 1.11 1.87
23 3.05 2.89
24 3.76 2.52
25 2.04 3.08
26 5.17 2.4
27 6.42 5.18
28 9.67 8.97
29 13.84 7.41
30 24.58 25.18
31 26.98 26.14
32 37.23 31.9
33 46.99 48.56
34 54.27 62.61
35 55.79 54.34
36 60.55 62.09
37 71.57 63.54
4. precision of test case is evaluated
With this kit E test low values and high level test sample reagent, retest 20 times calculates mean value and the coefficient of variation (being shown in Table 3).Result of calculation CV is respectively 8.16% and 2.83%.
Experimental result shows that the application kit has preferable precision.
Table 3：The evaluation result of kit E precision
Sample ng/mL Low value sample High level sample
Measure number 20 20
Mean value 5.39 12.35
SD 0.44 0.35
CV 8.16% 2.83%
Band evaluation before test case 5.
Clinical extremely high value sample (about 10000ng/mL, shine definite value) is taken, with deionized water according to different proportion diluted sample This, record test result is simultaneously and the theoretical concentration of sample compares (being shown in Table 4).The results show that working as clinical sample CEA actual concentrations pole Gao Shi, sample results are not in the result of false negative still greater than 100ng/mL.
Table 4：The preceding band experimental result of kit E
Number Actual concentrations Calculate concentration
1 52.64 52.95
2 105.28 110.08
3 211.80 160.57
4 317.70 174.20
5 423.60 161.10
6 529.50 154.07
7 2000 111.16
8 4000 102.95
9 8000 96.59
6. grain diameter of test case is to the preceding influence with effect
There may be the situations that content is high in cancer patient, thus have higher requirements to reagent performance.It is used alone The reagent (embodiment 6) of small grain size latex particle, when detection 10000ng/mL or so sample before band better performances；But low value is smart Density is poor.However, the reagent (embodiment 7) of large grain size latex particle is used alone, detection knot when concentration of specimens 500ng/mL Fruit is already close to 100ng/mL.It is aobvious when detecting the sample of 4000ng/mL while ensure that sensitivity in embodiment 8 Show result still greater than the range of linearity (100ng/mL), ensures that false negative does not occur in testing result when detecting superelevation value clinical sample (referring to table 5 to 10).The kit C of 5. embodiment 6 of table
Sample ng/mL Low value sample High level sample
Measure number 20 20
Mean value 5.20 12.41
SD 0.91 1.03
CV 17.51% 8.30%
The kit C of 6. embodiment 6 of table
Number Actual concentrations Detectable concentration
1 60.02 61.13
2 120.04 117.13
3 180.06 160.76
4 240.08 188.67
5 300.10 210.84
6 360.12 201.56
7 420.14 217.16
8 480.16 205.05
9 540.18 198.77
10 600.20 201.18
11 3667.80 150.10
12 9780.80 136.89
The kit D of 7. embodiment 7 of table
Sample ng/mL Low value sample High level sample
Measure number 20 20
Mean value 5.01 12.12
SD 0.36 0.32
CV 7.19% 2.65%
The kit D of 8. embodiment 7 of table
Number Actual concentrations Detectable concentration
1 53.50 53.50
2 107.00 102.27
3 160.50 130.68
4 214.00 135.19
5 267.50 139.00
6 321.00 127.48
7 374.50 122.72
8 428.00 117.69
9 481.50 111.51
10 535.00 106.78
11 2000 78.81
12 4000 74.88
13 8000 70.75
The kit E of 9. embodiment 8 of table
Sample ng/mL Low value sample High level sample
Measure number 20 20
Mean value 5.39 12.35
SD 0.44 0.35
CV 8.16% 2.83%
The kit E of 10. embodiment 8 of table
Number Actual concentrations Detectable concentration
1 52.64 52.95
2 105.28 110.08
3 211.80 160.57
4 317.70 174.20
5 423.60 161.10
6 529.50 154.07
7 2000 111.16
8 4000 102.95
9 8000 96.59
The kit E of the application can be used for accurately detecting carcinomebryonic antigen spirit of the concentration range less than 100ng/mL in human serum Sensitivity is up to 1.5ng/mL, CV<10%；When clinical extremely high value, as a result still greater than 100ng/mL, meet clinical needs.

Claims (8)

1. a kind of carcino-embryonic antigen assay kit, it includes：
First reagent, the second reagent and optionally calibration object；
Wherein, first reagent includes：
Second reagent includes：
The calibration object includes：
Wherein：
The buffer solution is selected from：Hepes buffer solutions, glycine buffer, PBS buffer solution, borate buffer, acetate buffer solution；
The average grain diameter of the polystyrene latex particles is 100nm to 500nm；
Relative to the quality of polystyrene latex particles, carboxyl-content is 20 μm of ol/g to 200 μm of ol/g, and preferably 30 μm of ol/g are extremely 180μmol/g；
The carcinomebryonic antigen antibody is originated from：Mouse, rabbit, goat, sheep, fowl, camel；
The carcinomebryonic antigen antibody is monoclonal antibody or polyclonal antibody；
It is preferred that a concentration of 6.25ng/mL, 12.5ng/mL of carcinomebryonic antigen in the calibration object, 25ng/mL, 50ng/mL, 100ng/mL；
The stabilizer is selected from：Bovine serum albumin(BSA), egg white powder.
2. carcino-embryonic antigen assay kit according to claim 1, wherein the polystyrene latex particles include：
Big grain size polystyrene latex particles and
Small particle polystyrene latex particles；
The big grain size refers to the average grain diameter of 350nm to 500nm,
The small particle refers to the average grain diameter of 150nm to 220nm.
3. carcino-embryonic antigen assay kit according to claim 2, wherein：
The big grain size polystyrene latex particles：The mass ratio of small particle polystyrene latex particles is 2：3.
4. carcino-embryonic antigen assay kit according to claim 2, wherein：
It is coated anti-on coated antibody and small particle polystyrene latex particles on the big grain size polystyrene latex particles Body identifies different carcinomebryonic antigen epitopes respectively.
5. carcino-embryonic antigen assay kit according to claim 1, wherein：
First reagent includes：
Second reagent includes：
Optionally, the calibration object includes：
Wherein：
The carcinomebryonic antigen antibody is originated from：Mouse, rabbit, goat, sheep, fowl, camel；
The carcinomebryonic antigen antibody is monoclonal antibody；
The polystyrene latex particles include big grain size polystyrene latex particles and small particle polystyrene latex particles；Institute The average grain diameter that big grain size refers to 350nm to 500nm is stated, the small particle refers to the average grain diameter of 150nm to 220nm；
Relative to the quality of polystyrene latex particles, carboxyl-content is 30 μm of ol/g to 180 μm of ol/g；
It is coated anti-on coated antibody and small particle polystyrene latex particles on the big grain size polystyrene latex particles Body identifies different carcinomebryonic antigen epitopes respectively；
The big grain size polystyrene latex particles：The mass ratio of small particle polystyrene latex particles is 2：3.
6. carcino-embryonic antigen assay kit according to claim 5, wherein in the calibration object carcinomebryonic antigen it is a concentration of 6.25ng/mL、12.5ng/mL、25ng/mL、50ng/mL、100ng/mL。
7. a kind of method with effect before improvement latex enhancing immune turbidimetry, including step：
The combination of big grain size polystyrene latex particles and small particle polystyrene latex particles is introduced into detection reagent；
Wherein, the big grain size refers to the average grain diameter of 350nm to 500nm, and the small particle refers to the flat of 150nm to 220nm Equal grain size；
It is coated anti-on coated antibody and small particle polystyrene latex particles on the big grain size polystyrene latex particles Body identifies different epitopes respectively；
The big grain size polystyrene latex particles：The mass ratio of small particle polystyrene latex particles is 2：3.
8. according to the method described in claim 7, wherein：
The detection reagent refers to for detecting the latex enhancing immune of carcinomebryonic antigen than turbid reagent.
CN201810255959.8A 2018-03-27 2018-03-27 A kind of carcinomebryonic antigen latex enhancing immune is than turbid kit Pending CN108508201A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110658336A (en) * 2019-11-19 2020-01-07 北京赛科希德科技股份有限公司 D-dimer latex immunoturbidimetry detection reagent
CN110736839A (en) * 2019-09-17 2020-01-31 北京九强生物技术股份有限公司 Latex-enhanced immunoturbidimetric assay kit for cytokeratin 19 fragments
CN112698034A (en) * 2020-12-16 2021-04-23 北京安图生物工程有限公司 Carcinoembryonic antigen CEA detection kit

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102395885A (en) * 2009-04-15 2012-03-28 贝克曼考尔特生物医学有限公司 Homogeneous agglutination immunoassay method and kit for such method
CN102628867A (en) * 2011-12-30 2012-08-08 北京九强生物技术股份有限公司 Double antibody latex enhanced retinol binding protein detection kit
CN102809654A (en) * 2012-08-23 2012-12-05 上海睿康生物科技有限公司 Double-particle compounded C-reactive protein detection kit
CN104215770A (en) * 2014-08-14 2014-12-17 上海睿康生物科技有限公司 Two-particle-based retinol binding protein detection kit
CN104237525A (en) * 2013-06-24 2014-12-24 北京美康生物技术研究中心有限责任公司 Latex enhanced immuno-nephelometry kit for determining procalcitonin and preparation method and application of latex enhanced immuno-nephelometry kit for determining procalcitonin
CN105158476A (en) * 2015-06-03 2015-12-16 南京闻智生物科技有限公司 Full-scale range C-reactive protein latex-enhanced immunoturbidimetry detection kit
CN105510604A (en) * 2016-02-01 2016-04-20 浙江夸克生物科技有限公司 Method for improving sensitivity and linearity of latex reagent
CN106093405A (en) * 2016-05-27 2016-11-09 安徽伊普诺康生物技术股份有限公司 A kind of test kit measuring carcinoembryonic antigen
CN106501505A (en) * 2016-10-03 2017-03-15 王贤俊 A kind of latex orientation coupling technology detection lipoprotein（a）Method
CN107340395A (en) * 2017-07-05 2017-11-10 深圳开立生物医疗科技股份有限公司 A kind of Immunoturbidimetric kit for detecting Procalcitonin
CN107656069A (en) * 2017-09-28 2018-02-02 宁波普瑞柏生物技术股份有限公司 Full-range C reactive protein quantitative detecting reagent and method in whole blood

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102395885A (en) * 2009-04-15 2012-03-28 贝克曼考尔特生物医学有限公司 Homogeneous agglutination immunoassay method and kit for such method
CN102628867A (en) * 2011-12-30 2012-08-08 北京九强生物技术股份有限公司 Double antibody latex enhanced retinol binding protein detection kit
CN102809654A (en) * 2012-08-23 2012-12-05 上海睿康生物科技有限公司 Double-particle compounded C-reactive protein detection kit
CN104237525A (en) * 2013-06-24 2014-12-24 北京美康生物技术研究中心有限责任公司 Latex enhanced immuno-nephelometry kit for determining procalcitonin and preparation method and application of latex enhanced immuno-nephelometry kit for determining procalcitonin
CN104215770A (en) * 2014-08-14 2014-12-17 上海睿康生物科技有限公司 Two-particle-based retinol binding protein detection kit
CN105158476A (en) * 2015-06-03 2015-12-16 南京闻智生物科技有限公司 Full-scale range C-reactive protein latex-enhanced immunoturbidimetry detection kit
CN105510604A (en) * 2016-02-01 2016-04-20 浙江夸克生物科技有限公司 Method for improving sensitivity and linearity of latex reagent
CN106093405A (en) * 2016-05-27 2016-11-09 安徽伊普诺康生物技术股份有限公司 A kind of test kit measuring carcinoembryonic antigen
CN106501505A (en) * 2016-10-03 2017-03-15 王贤俊 A kind of latex orientation coupling technology detection lipoprotein（a）Method
CN107340395A (en) * 2017-07-05 2017-11-10 深圳开立生物医疗科技股份有限公司 A kind of Immunoturbidimetric kit for detecting Procalcitonin
CN107656069A (en) * 2017-09-28 2018-02-02 宁波普瑞柏生物技术股份有限公司 Full-range C reactive protein quantitative detecting reagent and method in whole blood

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110736839A (en) * 2019-09-17 2020-01-31 北京九强生物技术股份有限公司 Latex-enhanced immunoturbidimetric assay kit for cytokeratin 19 fragments
CN110658336A (en) * 2019-11-19 2020-01-07 北京赛科希德科技股份有限公司 D-dimer latex immunoturbidimetry detection reagent
CN112698034A (en) * 2020-12-16 2021-04-23 北京安图生物工程有限公司 Carcinoembryonic antigen CEA detection kit

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