CN110333356A - A kind of compound Quality Control object of urine special proteins and preparation method - Google Patents
A kind of compound Quality Control object of urine special proteins and preparation method Download PDFInfo
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- CN110333356A CN110333356A CN201910461018.4A CN201910461018A CN110333356A CN 110333356 A CN110333356 A CN 110333356A CN 201910461018 A CN201910461018 A CN 201910461018A CN 110333356 A CN110333356 A CN 110333356A
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- 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
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- G01N2800/34—Genitourinary disorders
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Abstract
The present invention relates to urine special proteins detection technique fields; more particularly to a kind of compound Quality Control object of urine special proteins and preparation method; the Quality Control object includes low value positive quality control object and high level positive quality control object, buffer, urea, salt, preservative, creatinine, PH, protein protective agent, stabilizer, source of people albumin, transferrins, RBP ELISA, α 1- microglobulin, β2-microglobulin, immunoglobulin G, neutrophil gelatinase-associated lipocalin.The compound Quality Control object of a kind of urine special proteins of the invention and preparation method, easy to operate, corkage is used, and stability is good, and production cost is low, the quality control of urine special proteins detection system easy to accomplish.
Description
Technical field
The present invention relates to urine special proteins detection technique field more particularly to a kind of compound Quality Control objects of urine special proteins
And preparation method.
Background technique
As the disease incidence of renal disease patient constantly increases, kidney trouble has become the publilc health that the whole world faces and asks
Topic.For renal disease patient before there are obvious clinical symptoms, there are the longer asymptomatic stages, do not pass through screening, it is very difficult to send out
Now with respect to the kidney injury of early stage.Renal puncture histopathological examination is the most reliable method for diagnosing kidney injury, but technology
It is required that high, and have traumatic, is not easy to promote.The detection of urine special proteins is one of the hot spot of kidney trouble clinical means, urine
The content detection of special proteins has important diagnostic value to the diagnosis of nephrosis in liquid.
In recent years, it as the detection technique of latex enhancing immune turbidimetry and scattered light urbidmetry graduallys mature, urinates in the market
The detection kit of special proteins is more and more abundant in liquid, special proteins include microalbumin (ALB), transferrins (TF),
RBP ELISA (RBP), α 1- microglobulin (α 1-MG), β2-microglobulin (β 2-MG), immunoglobulin G (IGG) and
Neutrophil gelatinase-associated lipocalin (NGAL) etc..Currently used quality-control product is mostly individual event quality-control product, client
In use, carry out multiple special proteins Quality Control projects, need to open more bottles of Quality Controls, it is cumbersome, it is easy error, and non-
The quality-control product of urine matrix, there are certain matrix effects.
An existing Patent No. " CN201610674109.2 ", patent name are a kind of " the strong biochemical use of stability
The Chinese invention patent of the compound quality-control product of special proteins liquid ", disclosed quality-control product are able to detect streptococcus O, C reaction egg
12 kinds of white, Complement C_3, Complement C4, IgM, IgA, IgG, prealbumin, rheumatoid factor, transferrins, total protein, albumin objects
Matter is that progress quality control, various albumen contain on the basis of protein content corresponding in serum as the quality-control product of this 12 kinds of substances
Amount is higher, and by taking transferrins project as an example, the content range for turning special albumen is 2600-2800mg/L, and the content of albumen is high, with urine
Special proteins content value is compared to differing larger in liquid, and the probability that error occurs in detection is larger, and protein content is high, storage stability
It is relatively easy to realize, and if, since corresponding protein content is low, will lead to corresponding matter on the basis of protein content corresponding in urine
It is poor to control object stability, it is not easy to maintain.
Summary of the invention
In view of this, the object of the present invention is to provide a kind of compound Quality Control object of urine special proteins and preparation method, operation
Simply, corkage is used, and stability is good, and production cost is low, the quality control of urine special proteins detection system easy to accomplish.
The present invention solves above-mentioned technical problem by following technological means:
A kind of compound Quality Control object of urine special proteins, which is characterized in that including low value positive quality control object and high level positive matter
Control object.
Further, the low value positive quality control object includes:
Further, the high level positive quality control object includes:
Further, in the low value positive quality control object and high level positive quality control object, buffer is phosphate buffer, boric acid
Salt buffer, Tris- hydrochloride buffer, Glycine-NaOH buffer, formate buffer, carbonate buffer solution, lemon
One of phthalate buffer, carbonate buffer solution are a variety of.Preferably citrate buffer.
Further, in the low value positive quality control object and high level positive quality control object, salt is potassium chloride, sodium carbonate, carbonic acid
Potassium, magnesium chloride, aluminium chloride, sodium chloride, sodium sulphate, ammonium sulfate, potassium sulfate, magnesium sulfate, sodium nitrate, potassium nitrate, ammonium nitrate, carbonic acid
One of potassium is a variety of.Preferably sodium chloride.
Further, in the low value positive quality control object and high level positive quality control object, preservative is benzoic acid and its esters, mountain
Pears acid and its esters, dehydroactic acid, dehydroactic acid sodium, methyl p-hydroxybenzoate, ethyl-para-hydroxybenzoate, para hydroxybenzene first
Propyl propionate, butyl p-hydroxybenzoate, sodium Diacetate, benzalkonium chloride, cetylpyridinium chloride, cetyl ammonium,
One of sodium azide, Proclin 300 or a variety of.Preferably sodium benzoate.
Further, in the low value positive quality control object and high level positive quality control object, protein protective agent is polyvinylpyrrolidine
One of alkanone, gelatin, bovine serum albumin(BSA), globulin are a variety of.Preferably gelatin.
Further, in the low value positive quality control object and high level positive quality control object, stabilizer is amino acids, carbohydrate, enzyme
One of class is a variety of.
Wherein amino acids can choose phenylalanine, tyrosine, tryptophan, lysine, arginine, one in proline
Kind is a variety of.Preferably lysine.
Carbohydrate can choose one of glucose, fructose, sucrose, D-mannose, trehalose or a variety of, preferably
Trehalose.
Enzyme can choose amylase, succinate dehydrogenase, alkaline phosphatase, hexokinase, and one in lactic dehydrogenase
Kind is a variety of.Preferably hexokinase.
Further, in the low value positive quality control object and high level positive quality control object, source of people albumin, transferrins, view are yellow
Alcohol binding protein, α 1- microglobulin, β2-microglobulin, immunoglobulin G, neutrophil leucocyte gelatinase related lipid deliver egg
It is white to be selected from one of human urine extraction, the separation of people's blood source, genetic recombination or a variety of.Preferably separated for people's blood source.
The invention also discloses a kind of preparation methods of the compound Quality Control object of urine special proteins, comprising the following steps:
The preparation of low value positive quality control object: at normal temperature, formula according to claim 2, respectively successively into water
Buffer, urea, salt, preservative, creatinine, protein protective agent, stabilizer, source of people albumin, transferrins, retinol is added
Binding protein, α 1- microglobulin, β2-microglobulin, immunoglobulin G, neutrophil leucocyte gelatinase related lipid deliver egg
It is white, pH value is adjusted to 5.0-8.0, obtains low value positive quality control object；
The preparation of high level positive quality control object: at normal temperature, formula according to claim 3, respectively successively into water
Buffer, urea, salt, preservative, creatinine, protein protective agent, stabilizer, source of people albumin, transferrins, retinol is added
Binding protein, α 1- microglobulin, β2-microglobulin, immunoglobulin G, neutrophil leucocyte gelatinase related lipid deliver egg
It is white, pH value is adjusted to 5.0-8.0, obtains high level positive quality control object；
Packing: using dispensing apparatus for the low value positive quality control object being prepared and high level positive quality control object, filling respectively,
Sealing.
Compared with the existing technology, the invention has the benefit that
1. the compound Quality Control object of urine special proteins of the invention includes low value positive quality control object and high level positive quality control object,
And content of material each in low value positive quality control object is arranged near practical reference value, each content of material in high level positive quality control object
The middle high section of the range of linearity is set, thus, it is possible to realize that detection system is controlled in the quality of detection range well.
2. a kind of compound Quality Control object of urine special proteins of the present invention be on the basis of protein content corresponding in human urine into
The control of row quality, reduces the influence of matrix effect, is bonded clinical sample, the probability that error occurs in detection is relatively low, and property
It can stablize, long-time stability were at 12 months or more.
3. liquid storage of the invention, corkage is used, and compared with existing dried frozen aquatic products Quality Control object, user is using the present invention
Product is more convenient simple, and non-controllable risk is small.
Specific embodiment
Below with reference to specific embodiment, the present invention is described in detail:
The compound Quality Control object of a kind of urine special proteins of the invention, including low value positive quality control object and high level positive quality control
Object.
Embodiment one
Low value positive quality control object includes: in the present embodiment
High level positive quality control object includes:
Wherein, buffer selects phosphate buffer, salt selective chlorination potassium, and preservative selects potassium sorbate, and albumen is protected
It protects agent and selects gelatin, stabilizer selects lysine, and source of people albumin selects albumin.
The preparation of low value positive quality control object: at normal temperature, according to the formula of low value positive quality control object in the present embodiment, respectively
Xiang Shuizhong is successively added buffer, urea, salt, preservative, creatinine, protein protective agent, stabilizer, source of people albumin, turns iron
Albumen, RBP ELISA, α 1- microglobulin, β2-microglobulin, immunoglobulin G, neutrophil leucocyte gelatinase are related
Lipocalin protein adjusts pH value to 5.0-8.0, obtains low value positive quality control object.
The preparation of high level positive quality control object: at normal temperature, according to the formula of high level positive quality control object in the present embodiment, respectively
Xiang Shuizhong is successively added buffer, urea, salt, preservative, creatinine, protein protective agent, stabilizer, source of people albumin, turns iron
Albumen, RBP ELISA, α 1- microglobulin, β2-microglobulin, immunoglobulin G, neutrophil leucocyte gelatinase are related
Lipocalin protein adjusts pH value to 5.0-8.0, obtains high level positive quality control object.
Packing: using dispensing apparatus for the low value positive quality control object being prepared and high level positive quality control object, filling respectively,
Sealing.
The low value positive quality control object and high level positive quality control object that the present embodiment is prepared are in Guilin Uritest URIT-
Stability observing test is carried out on 8280 automatic clinical chemistry analyzers, matches the corresponding special proteins detection with registration certificate
Kit is tested.Experimental observations are as shown in table 1, table 2:
1 urine special proteins low value positive quality control object stability observing data of table
2 urine special proteins high level positive quality control object stability observing data of table
As can be seen from the above table, low value positive quality control object and high level positive quality control object manufactured in the present embodiment can be right simultaneously
Albumin in urine, transferrins, RBP ELISA, α 1- microglobulin, β2-microglobulin, immunoglobulin G and in
Property the special proteins such as granulocyte gelatinase associated lipocalin carry out quality control, it is compound to have urine special proteins Quality Control
Diversification, easy to operate, the good advantage of stability, and detection architecture can be carried out with mating Biochemical Analyzer and detection kit
Quality control.
Embodiment two
Low value positive quality control object includes: in the present embodiment
High level positive quality control object includes:
Wherein, buffer selects citrate buffer, salt selective chlorination sodium, and preservative selects sodium benzoate, albumen
Protective agent selects polyvinylpyrrolidone, and stabilizer selects trehalose, and source of people albumin selects albumin.
Embodiment three
Low value positive quality control object includes: in the present embodiment
High level positive quality control object includes:
Wherein, buffer selects Glycine-NaOH buffer, and salt selects sodium carbonate, and preservative selects dehydrogenation second
Acid, protein protective agent select globulin, and stabilizer selects hexokinase, and source of people albumin selects albumin.
Obviously, the above embodiment of the present invention be only to clearly illustrate example of the present invention, and not be pair
The restriction of embodiments of the present invention.For those of ordinary skill in the art, may be used also on the basis of the above description
To make other variations or changes in different ways.Here all embodiments can not be exhaustive.It is all to belong to this hair
The obvious changes or variations that bright technical solution is extended out are still in the scope of protection of the present invention.
Claims (10)
1. a kind of compound Quality Control object of urine special proteins, which is characterized in that including low value positive quality control object and high level positive quality control
Object.
2. the compound Quality Control object of a kind of urine special proteins according to claim 1, which is characterized in that the low value positive matter
Controlling object includes:
3. the compound Quality Control object of a kind of urine special proteins according to claim 1, which is characterized in that the high level positive matter
Controlling object includes:
4. the compound Quality Control object of a kind of urine special proteins according to claim 2 or 3, which is characterized in that the low value sun
In property control object and high level positive quality control object, buffer be phosphate buffer, borate buffer solution, Tris- hydrochloride buffer,
Glycine-NaOH buffer, formate buffer, carbonate buffer solution, citrate buffer, in carbonate buffer solution
It is one or more.
5. the compound Quality Control object of a kind of urine special proteins according to claim 2 or 3, which is characterized in that the low value sun
In property control object and high level positive quality control object, salt is potassium chloride, sodium carbonate, potassium carbonate, magnesium chloride, aluminium chloride, sodium chloride, sulphur
One of sour sodium, ammonium sulfate, potassium sulfate, magnesium sulfate, sodium nitrate, potassium nitrate, ammonium nitrate, potassium carbonate are a variety of.
6. the compound Quality Control object of a kind of urine special proteins according to claim 2 or 3, which is characterized in that the low value sun
In property control object and high level positive quality control object, preservative is benzoic acid and its esters, sorbic acid and its esters, dehydroactic acid, takes off
Hydroacetic acid sodium, methyl p-hydroxybenzoate, ethyl-para-hydroxybenzoate, propylparaben, butyl p-hydroxybenzoate,
Sodium Diacetate, benzalkonium chloride, cetylpyridinium chloride, cetyl ammonium, sodium azide, in Proclin 300
It is one or more.
7. the compound Quality Control object of a kind of urine special proteins according to claim 2 or 3, which is characterized in that the low value sun
In property control object and high level positive quality control object, protein protective agent is polyvinylpyrrolidone, gelatin, bovine serum albumin(BSA), ball
One of albumen is a variety of.
8. the compound Quality Control object of a kind of urine special proteins according to claim 2 or 3, which is characterized in that the low value sun
In property control object and high level positive quality control object, stabilizer is one of amino acids, carbohydrate, enzyme or a variety of.
9. the compound Quality Control object of a kind of urine special proteins according to claim 2 or 3, which is characterized in that the low value sun
In property control object and high level positive quality control object, source of people albumin, transferrins, RBP ELISA, α 1- microglobulin, β 2-
Microglobulin, immunoglobulin G, neutrophil gelatinase-associated lipocalin are selected from human urine extraction, people's blood source point
From one of, genetic recombination or a variety of.
10. a kind of preparation method of the compound Quality Control object of urine special proteins according to claim 2 or 3, which is characterized in that
The following steps are included:
The preparation of low value positive quality control object: at normal temperature, formula according to claim 2 is successively added into water respectively
Buffer, urea, salt, preservative, creatinine, protein protective agent, stabilizer, source of people albumin, transferrins, retinol combine
Albumen, α 1- microglobulin, β2-microglobulin, immunoglobulin G, neutrophil gelatinase-associated lipocalin are adjusted
PH value is saved to 5.0-8.0, obtains low value positive quality control object；
The preparation of high level positive quality control object: at normal temperature, formula according to claim 3 is successively added into water respectively
Buffer, urea, salt, preservative, creatinine, protein protective agent, stabilizer, source of people albumin, transferrins, retinol combine
Albumen, α 1- microglobulin, β2-microglobulin, immunoglobulin G, neutrophil gelatinase-associated lipocalin are adjusted
PH value is saved to 5.0-8.0, obtains high level positive quality control object；
Packing: using dispensing apparatus for the low value positive quality control object being prepared and high level positive quality control object, filling respectively, close
Envelope.
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Cited By (4)
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| CN111638106A (en) * | 2020-06-09 | 2020-09-08 | 吉林基蛋生物科技有限公司 | Dry chemical analysis quality control substance for urine |
| CN112067398A (en) * | 2020-09-18 | 2020-12-11 | 郑州安图生物工程股份有限公司 | Urine chemical analysis quality control product |
| CN112067399A (en) * | 2020-09-18 | 2020-12-11 | 郑州安图生物工程股份有限公司 | Preparation method of urine chemical analysis quality control product |
| CN113049839A (en) * | 2019-12-27 | 2021-06-29 | 桂林英美特生物技术研究所 | Stable liver function composite quality control product |
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