CN108562754A - Hepatitis B e antigen individual event quality-control product and its preparation process - Google Patents
Hepatitis B e antigen individual event quality-control product and its preparation process Download PDFInfo
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- CN108562754A CN108562754A CN201810045266.6A CN201810045266A CN108562754A CN 108562754 A CN108562754 A CN 108562754A CN 201810045266 A CN201810045266 A CN 201810045266A CN 108562754 A CN108562754 A CN 108562754A
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- Prior art keywords
- hepatitis
- antigen
- quality
- control product
- stabilizer
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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
- G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
-
- 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
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56983—Viruses
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/005—Assays involving biological materials from specific organisms or of a specific nature from viruses
- G01N2333/01—DNA viruses
- G01N2333/02—Hepadnaviridae, e.g. hepatitis B virus
Abstract
The present invention relates to medical test field of quality control, particularly relate to the preparation of hepatitis B e antigen individual event Quality Control object, Hepatitis B virus e antigen is diluted to the numerical value of needs using specific stabilizer, quality-control product is made.Preparation process is simple, and production cost is low, and the substance and content of addition are controllable, belong to liquid-type, without redissolving, stable components.By biological traceability chain program and its reference method assignment, it can be used as third party medical laboratory quality-control product before the deadline, meet clinical infection's disease and examine demand.
Description
Technical field
The present invention relates to medical test field of quality control, the specially preparation of hepatitis B e antigen individual event Quality Control object.
Background technology
Hepatitis type B virus（HBV）It is the pathogen for causing human hepatitis B, belongs to Hepadna Virus section, positive Hepadna Virus
Belong to.HBV is the main reason for causing chronic hepatitis, hepatic sclerosis and liver cancer, to be widely current in the whole world.Hepatitis B virus e antigen
（HBeAg）It is a kind of major structural protein of hepatitis B kernel, is the core of hepatitis B, therefore is generally acknowledged that HBeAg
The positive is that have communicable mark.In incubation period or even the entire course of disease, HBeAg can be detected.HBeAg is five indexes of hepatitis b inspection
Section 3 in looking into, it is not the ingredient of composition virus, is the byproduct in HBcAg building-up processes, and HBeAg is multiple as virus
The index of system.Virus replicates actively, infectiousness is strong HBeAg positives explanation in massive duplication in vivo；HBeAg feminine genders explanation is internal
Hepatitis B content is few or does not have hepatitis B, and virus replication is inactive or does not replicate, and infectiousness is small or does not have infectiousness.Due to
HBeAg has bioactivity, therefore has higher requirement for storage transport, and HBeAg antigenic structures itself are very unstable
It is fixed, the difficulty of storage transport is just more increased, medicine is produced, scientific research and medical quality control are affected.
With clinical labororatory by past centered on sample, the patient-centered health care for the purpose of data till now,
Transformation for the purpose of the diagnoses and treatment of disease, importance of the quality control in clinical examination increasingly highlight.It is clinical
Laboratory will obtain reliable measurement result, need to establish a comprehensive quality management system.Third party medical laboratory matter
Control product do not aim at certain ad hoc approach or instrument setting make optimization, its performance and reagent or kit lot number it is completely irrelevant,
The control product without bias evaluation can be provided to detecting system.So more can be objective using third party medical laboratory quality-control product
Ground reflects the error level in laboratory, more can provide objectivity for the reliability of inspection result.Third party in clinical immunization detection
Medical laboratory's quality-control product as Internal Quality Control be ensure inspection quality important means, but with biochemistry, haemocyte, urine
Equal Internal Quality Controls are mainly reflected in quality-control product less varieties compared to there is also gaps, expensive, and supply unstable etc., have become
For the obstruction that Internal Quality Control is normally carried out is immunized.
Invention content
For problems of the prior art, the application be intended to provide a kind of Hepatitis B virus e antigen individual event quality-control product and
Its preparation process.
In order to solve the above-mentioned technical problem, technical solution used by the application is：A kind of Hepatitis B virus e antigen individual event matter
Control product are mixed by quality-control product stabilizer and hepatitis B e antigen dilution；The quality-control product stabilizer is 10- containing carbohydrate
50 g/L, buffer salt 10-500mmol/L, calf serum 20-100 g/L, surfactant 5-80 g/L, preservative 10-100
g/L；The hepatitis B e antigen dilution is the hepatitis B e antigen that salt 10-500mmol/L dilutes 500-2000 times；Institute
It is 1 to state quality-control product stabilizer and hepatitis B e antigen dilution mixed volume ratio：100~10：1.
Hepatitis B virus e antigen described herein is anti-from the high level serum of hepatitis B patient or the hepatitis B e of recombination
It is former.
Buffer solution described herein is potassium dihydrogen phosphate or magnesium chloride solution.
Glucide described herein is in maltose, glucose, fructose, lactose, trehalose, sucrose and galactolipin
One or two, based on fructose or trehalose.
Albumen described herein is one or both of bovine serum albumin(BSA), oralbumin, human albumin.
Preservative described herein is one kind in Sodium azide, merthiolate and proclin300.
Stabilizer described herein includes one kind that antigen stabilizer is PPCD, CCD, SHe-50, AeP-HBC and DPD
Or two kinds.
Surfactant described herein includes one kind in polysorbate40, Tween 80 and SDS.
This application provides the preparation processes of hepatitis B e antigen individual event quality-control product, include the following steps：
（1）, prepare quality-control product stabilizer：Carbohydrate, calf serum, surfactant, preservative are dissolved in buffer salt, mixing is equal
It is even, prepare the quality-control product stabilizer of above-mentioned each component percentage；
（2）, with buffer salt hepatitis B e antigen is diluted to aimed concn；
（3）, with quality-control product stabilizer by hepatitis B e antigen diluted to ultimate density, vibrate mixing.
（4）, packing and freezen protective：Hepatitis B e antigen quality-control product is dispensed by specification using vial, sealing, -20
DEG C freezen protective.
The advantages of the present invention：
The raw material of the hepatitis B e antigen of selection, source is sufficient, easily obtains.
Stabilizer can be that albumen improves efficiency.
Liquid-type quality-control product, without redissolving.
Preparation process is simple, and production cost is low, and the substance and content of addition are controllable, stable components.
The quality-control product prepared before the deadline can be with by biological traceability chain program and its reference method assignment
As third party medical laboratory quality-control product, meets clinical infection's disease and examine demand.
Specific implementation mode
It is in order to preferably further understand the present invention, and never to present disclosure and protection to provide following embodiments
Range constitutes any restrictions.
The materials, reagents and the like used in the following examples is commercially available unless otherwise specified.
1 hepatitis B e antigen individual event quality-control product of embodiment
（1）Hepatitis B e recombinant antigen dilutions：By the 2000 times of dilutions of hepatitis B e recombinant antigens
（2）Quality-control product stabilizer：
Bovine serum albumin(BSA) 30g/L
20 g/L of fructose
Dipotassium hydrogen phosphate 20mmol/L
25 g/L of calf serum
5 g/L of merthiolate
10 g/L of antigen stabilizer PPCD
15 g/L of surfactant SDS.
2 stability of embodiment
- 20 DEG C of this quality-control product is taken to freeze, continuous detection 24 months, Long-term Cryopreservation has good stability, and the results are shown in table below.
| 0 day | 6 months | 12 months | 18 months | 24 months | |
| Testing result（COI） | 15. 37 | 15. 46 | 15. 28 | 15.79 | 15.43。 |
2 ~ 8 DEG C of refrigerations of this quality-control product are taken, continuous detection 60 days, Long-term Cold Storage has good stability, and the results are shown in table below.
| 0 day | 10 days | 20 days | 40 days | 60 days | |
| Testing result（COI） | 15. 72 | 15. 65 | 15. 82 | 15.69 | 15.75 |
For above-described embodiment, those skilled in the art can make various modifications and changes to the present invention, these modification and
It changes all within protection scope of the present invention.In addition to the implementation, the present invention can also have other embodiment.All uses
The technical solution that equivalent substitution or equivalent transformation is formed, falls within the scope of protection required by the present invention.
Claims (10)
1. a kind of hepatitis B e antigen quality-control product, which is characterized in that diluted by quality-control product stabilizer and hepatitis B e antigen
Liquid mixes；
The quality-control product stabilizer be 10-50 containing carbohydrate g/L, buffer salt 10-500mmol/L, calf serum 20-100 g/L,
- 50 g/L of protein 10, surfactant 5-80 g/L, preservative 1-100 g/L, 10-50 g/L of stabilizer；
The hepatitis B e antigen dilution is the hepatitis B e antigen that salt 10-500mmol/L dilutes 500-2000 times；
The hepatitis B e antigen dilution and quality-control product stabilizer mixed volume ratio are 1：10~1：1000.
2. hepatitis B e antigen quality-control product according to claim 1, which is characterized in that the hepatitis B e antigen comes
Derived from the high level serum of hepatitis B patient or the hepatitis B e antigen of recombination.
3. hepatitis B e antigen quality-control product according to claim 1, which is characterized in that the carbohydrate is maltose, grape
One or both of sugar, fructose, lactose, trehalose, sucrose and galactolipin.
4. hepatitis B e antigen quality-control product according to claim 1, which is characterized in that the buffer salt is di(2-ethylhexyl)phosphate
Hydrogen potassium solution or magnesium chloride solution.
5. hepatitis B e antigen quality-control product according to claim 1, which is characterized in that the preservative be Sodium azide,
One kind in merthiolate and proclin300.
6. hepatitis B e antigen quality-control product according to claim 1, which is characterized in that the stabilizer includes antigen
Stabilizer is the one or two of PPCD, CCD, SHe-50, AeP-HBC and DPD.
7. hepatitis B e antigen quality-control product according to claim 1, which is characterized in that the surfactant includes
One kind in polysorbate40, Tween 80 and SDS.
8. hepatitis B e antigen quality-control product according to claim 1, which is characterized in that the albumen is that ox blood is pure
One or both of albumen, oralbumin, human albumin.
9. hepatitis B e antigen quality-control product according to claim 1, which is characterized in that the quality-control product stabilizer is
Trehalose 50g/L, dipotassium hydrogen phosphate buffer salt 10mmol/L, calf serum 20g/L, oralbumin 20g/L, surface-active
Agent SDS is 5 g/L, and preservative proclin300 is 1g/L, and stabilizer SHe-50 is 15g/L.
10. a kind of preparation process of hepatitis B e antigen quality-control product, which is characterized in that include the following steps：
（1）, prepare quality-control product stabilizer：Carbohydrate, calf serum, surfactant, preservative are dissolved in buffer salt, mixed
Uniformly, the quality-control product stabilizer of above-mentioned each component percentage is prepared；
（2）, with buffer salt hepatitis B e antigen is diluted to aimed concn；
（3）, with quality-control product stabilizer by hepatitis B e antigen diluted to ultimate density, vibrate mixing；
（4）, packing and freezen protective：Using vial by hepatitis B e antigen quality-control product by specification packing, sealing, -20 DEG C cold
Freeze and preserves.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810045266.6A CN108562754A (en) | 2018-01-17 | 2018-01-17 | Hepatitis B e antigen individual event quality-control product and its preparation process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810045266.6A CN108562754A (en) | 2018-01-17 | 2018-01-17 | Hepatitis B e antigen individual event quality-control product and its preparation process |
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Family
ID=63530918
Family Applications (1)
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| CN201810045266.6A Pending CN108562754A (en) | 2018-01-17 | 2018-01-17 | Hepatitis B e antigen individual event quality-control product and its preparation process |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111024964A (en) * | 2019-12-20 | 2020-04-17 | 深圳市蔚景生物科技有限公司 | Composite quality control product for detecting stomach function and detection kit |
| CN111721945A (en) * | 2020-06-22 | 2020-09-29 | 中山市滔略生物科技有限公司 | Quality control product for endocrine mesenchyme assessment |
| CN112067810A (en) * | 2020-09-17 | 2020-12-11 | 郑州标源生物科技有限公司 | Composite quality control product, detection reagent and detection kit for infectious disease markers |
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|---|---|---|---|---|
| CN111024964A (en) * | 2019-12-20 | 2020-04-17 | 深圳市蔚景生物科技有限公司 | Composite quality control product for detecting stomach function and detection kit |
| CN111721945A (en) * | 2020-06-22 | 2020-09-29 | 中山市滔略生物科技有限公司 | Quality control product for endocrine mesenchyme assessment |
| CN112067810A (en) * | 2020-09-17 | 2020-12-11 | 郑州标源生物科技有限公司 | Composite quality control product, detection reagent and detection kit for infectious disease markers |
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