CN104195221A - Composite stabilizer for glucose assay kit - Google Patents
Composite stabilizer for glucose assay kit Download PDFInfo
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- CN104195221A CN104195221A CN201410404619.9A CN201410404619A CN104195221A CN 104195221 A CN104195221 A CN 104195221A CN 201410404619 A CN201410404619 A CN 201410404619A CN 104195221 A CN104195221 A CN 104195221A
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- package stabilizer
- test kit
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Abstract
The invention discloses a composite stabilizer for a glucose assay kit. The composite stabilizer comprises the ingredients by content: 5-15g/L of bovine serum albumin, 5-15g/L of trehalose, 10-20g/L of glycerol, 0.5-2g/L of surfactant Brij35 and 0.5-2g/L of liquid biological preservative Proclin300. Through the manner, by applying the composite stabilizer disclosed by the invention to the glucose assay kit, the accuracy of kit assay results is guaranteed, the kit assay results can be more stable, and the shelf time of the kit can be effectively prolonged. In addition, the composite stabilizer is low in cost and simple in preparation, thereby being worthy of further popularization.
Description
Technical field
The present invention relates to in-vitro diagnosis field, particularly relate to a kind of one package stabilizer for glucose assays test kit.
Background technology
Glucose in blood is human life activity's necessary material, its oxidizing reaction liberated heat is the important sources of human life activity institute energy requirement, it is important physical signs in human body, so blood sugar must keep certain level just can maintain the needs of each Organ and tissue in body, its assay is significant to clinical detection.The main detection method of blood sugar has glucose oxidase method and hexokinase method at present.Because the latter's detection kit cost is higher, price is more expensive, most of medical institutions first-selection is usingd glucose oxidase method as the glucose assays test kit that detects principle, but because this test kit comprises glucose oxidase and peroxidase, and enzymic activity is vulnerable to the interference of the various factorss such as pH, temperature, ultraviolet ray, heavy metallic salt, inhibitor, activator, cause glucose assays test kit deficient in stability, the shelf time is short, directly has influence on clinical use.
At present very limited about the report of glucose assays reagent and stability thereof.Patent CN101571485A provides a kind of glucose detection test kit, but does not add any stablizer, the stability of test kit is not described; Patent CN200510111883.4 provides a kind of enzyme combining stabilizer, independent superoxide enzyme solution is had to satisfactory stability effect, but and not mentionedly for the more complicated test kit of composition, also can play similar stabilization, and this stablizer moiety is more complicated, comprise bovine serum albumin, ethylene glycol diethyl ether ethylenediamine tetraacetic acid (EDTA) (EGTA), 1,2-dithiothreitol dithio, Potassium Gluconate, sodium-chlor, Proclin 300, magnesium acetate etc., easily produce and disturb detected result.Therefore study a kind of simple, with low cost, glucose assays test kit to be had to good stabilising effect one package stabilizer of preparing, be very important.
Summary of the invention
The technical problem that the present invention mainly solves is to provide a kind of one package stabilizer for glucose assays test kit, and this one package stabilizer will be prepared simple, with low cost and glucose assays test kit is had to satisfactory stability effect.
For solving the problems of the technologies described above, the technical scheme that the present invention adopts is: a kind of one package stabilizer for glucose assays test kit is provided, described one package stabilizer comprises bovine serum albumin, trehalose, glycerol, surfactant B rij 35 and liquid bio sanitas Proclin 300, and the content of each component is: bovine serum albumin 5 ~ 15 g/L, trehalose 5 ~ 15 g/L, glycerol 10 ~ 20 g/L, Brij 35 0.5 ~ 2.0 g/L, Proclin 300 0.5 ~ 2.0 g/L.
In a preferred embodiment of the present invention, the content of described one package stabilizer component is: bovine serum albumin 10 g/L, trehalose 10 g/L, glycerol 15 g/L, surfactant B rij 35 1 g/L and Proclin 300 1 g/L.
In a preferred embodiment of the present invention, described one package stabilizer is applied in glucose assays test kit, described glucose assays test kit comprises the first reagent and the second reagent, the component of described the first reagent is: disodium hydrogen phosphate 21.488 g/L, potassium primary phosphate 1.371 g/L, magnesium chloride 0.609 g/L, 4-AA 0.508 g/L, the component of described the second reagent is: disodium hydrogen phosphate 21.488 g/L, potassium primary phosphate 1.371 g/L, ESPAS 1.476 g/L, glucose oxidase 20000 U/L, peroxidase 1500 U/L.
In a preferred embodiment of the present invention, the volume fraction that the usage quantity of described one package stabilizer is measured in test kit at total cholesterol is 1%.
The invention has the beneficial effects as follows: one package stabilizer of the present invention, for glucose assays test kit, has not only guaranteed the accuracy of test kit detected result, can also make this kit measurement result more stable, can effectively extend the shelf time of test kit.In addition, this one package stabilizer is with low cost, and preparation is simple, is therefore worth further promoting the use of.
Embodiment
Below the technical scheme in the embodiment of the present invention is clearly and completely described, obviously, described embodiment is only a part of embodiment of the present invention, rather than whole embodiment.Embodiment based in the present invention, those of ordinary skills, not making all other embodiment that obtain under creative work prerequisite, belong to the scope of protection of the invention.
The instrument relating in following examples of the present invention has: 1 of UV Blue Star ultraviolet spectrophotometer (Beijing Labtech Instruments Co., Ltd, also or other brand); 1 of constant temperature digital display water-bath (Shanghai Mei Xiang Instrument Ltd., also or other brand).
Embodiment 1:
A kind of one package stabilizer for glucose assays test kit is provided, the content of described one package stabilizer component is: bovine serum albumin 10 g/L, trehalose 10 g/L, glycerol 15 g/L, surfactant B rij 35 1 g/L and Proclin 300 1 g/L, after above-mentioned each component is fully dissolved, mixed, can make a kind of liquid composite stabilizing agent finished product.
Embodiment 1 is applied to glucose assays test kit, and from stablizing the effect phase and usage quantity two aspects are evaluated.
(1) stablize the test of effect phase
1, material is prepared: one package stabilizer described in preparation embodiment 1;
Preparation glucose assays test kit, is comprised of reagent 1 and reagent 2, and component is as follows:
Reagent 1: disodium hydrogen phosphate 21.488 g/L, potassium primary phosphate 1.371 g/L, magnesium chloride 0.609 g/L, 4-AA 0.508 g/L;
Reagent 2: disodium hydrogen phosphate 21.488 g/L, potassium primary phosphate 1.371 g/L, ESPAS 1.476 g/L, glucose oxidase 20000 U/L, peroxidase 1500 U/L.
2, measuring method
Press embodiment 1 preparation one package stabilizer, by 1%(v/v) amount add (reagent 1 and reagent 2 are all measured interpolation by this) in glucose assays test kit, measure respectively glucose content in sample with the glucose assays test kit that does not add one package stabilizer.The horizontal 2(Quality Control 2 of Britain's Landau quality controlled serum is take in this test) and the horizontal 3(Quality Control 3 of quality controlled serum) be sample, standard substance are separately purchased, adopt ultraviolet-visible pectrophotometer to detect, establish a skip test, standard testing, two test samples (skip test replaces sample with distilled water).The ratio of sample and reagent 1 and reagent 2 is: 15 μ L ︰ 1000 μ L ︰ 500 μ L, the predominant wavelength of setting is that 505nm, commplementary wave length are 660nm, after sample and reagent 1 mix, hatch 3.5min for 37 ℃, read and respectively manage absorbance A 1, add reagent 2 to mix rear reaction 5min, read absorbance A 2, the absorbancy of every pipe changes △ A=A2-A1, calculates the absorbancy changing value △ A of sample, standard substance after deduction reagent blank
sample, △ A
standard, then according to formula glucose (mg/dL)=△ A
sample/ △ A
standard* C
standardcalculate glucose content (C in sample
standardfor standard substance concentration).The target value of Quality Control 2 glucose is 111mg/dL, and the target value of Quality Control 3 glucose is 281mg/dL, and permissible variation scope is ± 10%.
According to above measuring method, using with batch with bottled quality controlled serum 2, quality controlled serum 3 as detection sample, respectively with adding 1%(v/v) the glucose assays test kit of one package stabilizer and the glucose assays test kit that do not add one package stabilizer detect, within every 7 days, detect once, sense cycle 50 days, the standard deviation (SD) and the validity period number of days that calculate measurement result, this can reflect the stability of measurement result standard deviation.
3, measurement result
Stablize effect phase test-results data and refer to following table.
From upper table data, the glucose assays test kit that does not add one package stabilizer, its detected result standard deviation is obviously larger, be about 4 times of test kit detected result standard deviation that add 1% one package stabilizer, illustrate that not add the glucose assays test kit of one package stabilizer very unstable, validity period number of days can only maintain about 20 days, relatively, add the glucose assays test kit of 1% one package stabilizer in whole test period, accuracy all, within the scope of permissible variation, illustrates at 50 days these mensuration test kits of left and right and still can keep good test performance.As can be seen here, the glucose assays test kit that has added 1% one package stabilizer shows more excellent aspect measuring stability, and one package stabilizer has obvious stabilising effect to it, can effectively extend the storage life of glucose assays test kit.
(2) usage quantity simultaneous test
1, material is prepared: one package stabilizer described in employing embodiment 1.Adopt glucose detection test kit, compound method is with stablizing the test of effect phase.
2, detection method
By one package stabilizer according to 0.5%(v/v), 2%(v/v) ratio add respectively in glucose assays test kit (reagent 1 and reagent 2 all add by same amount), carry out the mensuration of glucose content in sample.By the present invention, stablize the measuring method of effect phase test and measure, calculate standard deviation and the validity period number of days of measurement result.This can reflect the stability of measurement result standard deviation.
3, measurement result
Usage quantity test-results data refer to following table.
From upper table data, three kinds of different add-ons of one package stabilizer are all improved the stability of glucose assays test kit, and can make the test kit uncork effect phase extend to about 50 days from 29 days.Wherein, add the standard deviation of kit measurement result of 1% one package stabilizer less than the standard deviation of other two add-ons, the glucose assays test kit repeatability the best that adds 1% one package stabilizer is described, this test kit is more stable, after test kit uncork, about 50 days, also can keep good test performance.Therefore, 1% can be decided to be the optimum quantum of utilization of one package stabilizer in glucose assays test kit.
From above data and analytical results, can obtain, glucose assays test kit adds after one package stabilizer of the present invention, can extend the shelf time of test kit, and measurement result stability is better, and the suitableeest volume ratio that adds is approximately 1%.In addition, this one package stabilizer is with low cost, and preparation is simple, is therefore worth further promoting the use of.
The foregoing is only embodiments of the invention; not thereby limit the scope of the claims of the present invention; every equivalent structure or conversion of equivalent flow process that utilizes description of the present invention to do; or be directly or indirectly used in other relevant technical field, be all in like manner included in scope of patent protection of the present invention.
Claims (4)
1. the one package stabilizer for glucose assays test kit, it is characterized in that, described one package stabilizer comprises bovine serum albumin, trehalose, glycerol, surfactant B rij 35 and liquid bio sanitas Proclin 300, and the content of each component is: bovine serum albumin 5 ~ 15 g/L, trehalose 5 ~ 15 g/L, glycerol 10 ~ 20 g/L, Brij 35 0.5 ~ 2.0 g/L, Proclin 300 0.5 ~ 2.0 g/L.
2. one package stabilizer according to claim 1, it is characterized in that, the content of described one package stabilizer component is: bovine serum albumin 10 g/L, trehalose 10 g/L, glycerol 15 g/L, surfactant B rij 35 1 g/L and Proclin 300 1 g/L.
3. one package stabilizer according to claim 1, it is characterized in that, described one package stabilizer is applied in glucose assays test kit, described glucose assays test kit comprises the first reagent and the second reagent, the component of described the first reagent is: disodium hydrogen phosphate 21.488 g/L, potassium primary phosphate 1.371 g/L, magnesium chloride 0.609 g/L, 4-AA 0.508 g/L, the component of described the second reagent is: disodium hydrogen phosphate 21.488 g/L, potassium primary phosphate 1.371 g/L, N-ethyl-N-(3-sulfopropyl)-3-anisidine sodium salt (ESPAS) 1.476 g/L, glucose oxidase 20000 U/L, peroxidase 1500 U/L.
4. one package stabilizer according to claim 1, is characterized in that, the volume fraction that the usage quantity of described one package stabilizer is measured in test kit at total cholesterol is 1%.
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| CN201410404619.9A CN104195221B (en) | 2014-08-18 | 2014-08-18 | A kind of compound stabilizer for Glucose estimation kit |
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| CN201410404619.9A CN104195221B (en) | 2014-08-18 | 2014-08-18 | A kind of compound stabilizer for Glucose estimation kit |
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| CN104195221B CN104195221B (en) | 2017-07-28 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106282308A (en) * | 2016-08-29 | 2017-01-04 | 湖南海源医疗科技有限公司 | A kind of in-vitro diagnosis biochemical reagents stabilizer |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102823579A (en) * | 2012-08-27 | 2012-12-19 | 杭州博拓生物技术有限公司 | Blood protective agent, preparation method thereof and application |
| CN103266166A (en) * | 2013-05-24 | 2013-08-28 | 宁波美康生物科技股份有限公司 | Glucose detecting reagent |
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2014
- 2014-08-18 CN CN201410404619.9A patent/CN104195221B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102823579A (en) * | 2012-08-27 | 2012-12-19 | 杭州博拓生物技术有限公司 | Blood protective agent, preparation method thereof and application |
| CN103266166A (en) * | 2013-05-24 | 2013-08-28 | 宁波美康生物科技股份有限公司 | Glucose detecting reagent |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106282308A (en) * | 2016-08-29 | 2017-01-04 | 湖南海源医疗科技有限公司 | A kind of in-vitro diagnosis biochemical reagents stabilizer |
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