CN107505460A - C reactive protein quality for POCT controls the preparation method of product - Google Patents
C reactive protein quality for POCT controls the preparation method of product Download PDFInfo
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- CN107505460A CN107505460A CN201710665620.0A CN201710665620A CN107505460A CN 107505460 A CN107505460 A CN 107505460A CN 201710665620 A CN201710665620 A CN 201710665620A CN 107505460 A CN107505460 A CN 107505460A
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- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
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Abstract
The invention discloses the preparation method that a kind of c reactive protein quality for POCT controls product.Above-mentioned preparation method comprises the following steps：（1）The preparation of stroma ground substance：Sources of initial raw materials is in the commercially available healthy horse serum after aseptic filtration；After horse serum is added into preservative, as last stroma ground substance after the aseptic filtration of degranulation degreasing；（2）The preparation of quality-control product：Humanized's c reactive protein is added in stroma ground substance to the mg/L of aimed concn 79；Described quality controling product is sub-packed in the cryopreservation tube of cleaned drying, 1 milliliter every bottle, 28 DEG C of fluid storages；Obtain stable homogeneous, concentration level controls product for the c reactive protein quality of 79 mg/L horse serum matrix.C reactive protein quality control product have excellent homogeneity, stability, meet《External diagnosis reagent calibration object, quality-control product investigative technique guideline》Requirement, prepared using horse blood, wide material sources, the features such as preparation method is simple.
Description
Technical field
The present invention relates to a kind of c reactive protein quality to control product preparation method, and in particular to a kind of C for POCT reacts
Albumen quality controls the preparation method of product.
Background technology
The clinical meaning of 1.C reactive proteins
Applications of Cardiac Markers full name is Cardiac injury markers, refers to horizontal rise in blood in 6 hours after myocardial damage
Mark, be the heart diseases such as diagnosing myocardial infarction in clinic, myocardial ischemia, heart failure important Testing index.Super sensitive C-reactive
Albumen (hypersensitive C-reactive protein, hs-CRP) is acute coronary syndrome (acute
Coronary syndrome, ACS) serial marker of inflammation, it is mainly used in the examination of coronary risk factor.
The research background of 2.POCT quality-control products
Real-time test (point of care testing, POCT) refers to be sampled at one's side in patient, analyzed, quickly
Obtain a kind of method of diagnostic result.Applications of Cardiac Markers, energy quick diagnosis miocardial infarction, heart failure, to patient are detected with this mode
Clinical early diagnosis and early treatment it is significant.《External diagnosis reagent calibration object, quality-control product investigative technique instruct former
Then》In mention, quality-control product is the quality control material (definite value and non-definite value) for in-vitro diagnosis, is that one kind is intended to be used for medical science
The material that is used in detecting system, material etc., the purpose is to evaluate or confirmatory measurement precision or due to reagent or analytical instrument
Change caused by analysis deviation etc., for quality control in proficiency testing, laboratory etc..At present, the CRP matter supporting with POCT
Control product famine, it is imperative for POCT CRP quality-control products to develop.
The content of the invention
The present invention is directed to the situation of prior art, there is provided a kind of c reactive protein quality for POCT controls the preparation of product
Method, significantly shorten the re-testing periods of POCT quality controls, solve the defects of POCT instruments are without supporting quality-control product.Due to POCT
Quality-control product is close to patient's sample, so it is effective quality control method that test analysis is carried out to it.
The present invention uses following technical scheme, and the c reactive protein quality for POCT controls the preparation method bag of product
Include following steps：
Step 1：Sources of initial raw materials is in the commercially available horse serum after aseptic filtration, after horse serum is added into preservative,
Under the conditions of 4 DEG C, 9000rpm centrifugation 30min, supernatant is taken, is filtered off with double-deck qualitative fast grade filter paper and removes lipid material, then successively
After 0.45 μm or 0.22 μm of hydrophilic film are sterile filtered, stroma ground substance is formed；
Step 2：According to c reactive protein mother liquid concentration and TIANZHU XINGNAO Capsul, with the liquid-transfering gun by metering in stroma ground substance
The middle c reactive protein that adds is to aimed concn；Described c reactive protein is sub-packed in cleaned drying with the liquid-transfering gun by metering again
Cryopreservation tube in, 1 milliliter every bottle, 2-8 DEG C of fluid storage, obtain stable homogeneous, concentration level as 7-9mg/L horse serum matrix
C reactive protein quality controls product.
According to above-mentioned technical proposal, the aimed concn of the c reactive protein added in stroma ground substance is 7-9mg/L.
According to above-mentioned technical proposal, the c reactive protein is humanized's c reactive protein.
C reactive protein quality disclosed by the invention for POCT controls the preparation method of product, and its advantage is, shows
The re-testing periods for shortening POCT quality controls are write, solve the defects of POCT instruments are without supporting quality-control product.Due to POCT quality-control products
Close to patient's sample, so it is effective quality control method that test analysis is carried out to it.
Embodiment
The invention discloses the preparation method that a kind of c reactive protein quality for POCT controls product, with reference to preferred
Embodiment, the embodiment of the present invention is further described.
A kind of c reactive protein quality for POCT of the present invention controls the preparation method of product, the preparation method bag
Include following steps：
Step 1：Sources of initial raw materials is in the commercially available horse serum after aseptic filtration, after horse serum is added into preservative,
Under the conditions of 4 DEG C, 9000rpm centrifugation 30min, supernatant is taken, is filtered off with double-deck qualitative fast grade filter paper and removes lipid material, then successively
After 0.45 μm or 0.22 μm of hydrophilic film are sterile filtered, stroma ground substance is formed；
Step 2：According to c reactive protein mother liquid concentration and TIANZHU XINGNAO Capsul, with the liquid-transfering gun by metering in stroma ground substance
The middle c reactive protein that adds is to aimed concn；Described c reactive protein is sub-packed in cleaned drying with the liquid-transfering gun by metering again
Cryopreservation tube in, 1 milliliter every bottle, 2-8 DEG C of fluid storage, obtain stable homogeneous, concentration level as 7-9mg/L horse serum matrix
C reactive protein quality controls product.
Wherein, the aimed concn of the c reactive protein added in stroma ground substance is 7-9mg/L.
Wherein, the c reactive protein is humanized's c reactive protein.
According to above preferred embodiment, the present invention possesses for the preparation method of POCT c reactive protein quality control product
Following characteristics：
First, prepared by the good stroma ground substance of interchangeability
The processing of 1.1 stroma ground substances：
C reactive protein Quality Control product stroma ground substance processing method is as follows：The commercially available healthy horse serum after aseptic filtration is selected,
The raw material prepared as stroma ground substance.After preservative being added in horse serum, by it under the conditions of 4 DEG C, 9000rpm centrifugations
30min, supernatant is taken, filtered off with double-deck qualitative fast grade filter paper and remove lipid material.It is hydrophilic by 0.45,0.22 μm etc. successively again
After film is sterile filtered, as last stroma ground substance.
1.2 stroma ground substances are assessed：
1.2.1 c reactive protein initial value is tested in stroma ground substance：After testing, the value of c reactive protein is almost 0, horse serum
Suitable stroma ground substance can be used as.
1.2.2 quality-control product adds recovery test
Initial analysis can be carried out to the matrix effect of base matter by adding recovery experiment (recovery test).The rate of recovery
Close to 100% show analysis method for analyte no matter in the solution or complexity matrix environment in, respond is
Consistent, analysis is not influenceed by matrix substantially.Conversely, deviating considerably from 100%, illustrate the analyte being in different substrates environment
Respond significant difference be present.
Using certain density CRP, stroma ground substance and with the addition of respective concentration CRP stroma ground substance as detection mark
This；Tested with i-CHROMA immunofluorescence analysis instrument.Each sample determines 2 times, and with its mean value calculation rate of recovery, knot
Fruit is shown in Table 1.
The horse serum stroma ground substance of table 1 adds CRP addition recovery test result (unit：mg/L)
It can be drawn from the result of table 1, TIANZHU XINGNAO Capsuls of the CRP in horse serum matrix is close to 100%.It is preliminary selected
Stroma ground substance of the matrix as CRP quality-control products.
2nd, the preparation of c reactive protein Quality Control product
According to CRP mother liquid concentrations and TIANZHU XINGNAO Capsul, addition is accurately calculated.In 100,000 grades of dust proof workshop environmental conditions
Under, with the liquid-transfering gun by metering, in the stroma ground substance prepared, addition humanized's c reactive protein to aimed concn (7-
9mg/L).Quantitative separating is carried out with the liquid-transfering gun by metering again, is sub-packed in the cryopreservation tube of cleaned drying, 1 milliliter every bottle,
Totally 500 bottles, 2-8 DEG C of fluid storage.
3rd, homogeneity determines
After the completion of packing, foundation《External diagnosis reagent calibration object, quality-control product investigative technique guideline》Carry out homogeneity
Examine.Homogeneity Test standard is as follows：
5 bottles are extracted in the quality-control product of same lot number, every bottle is tested 1 time, and being averaged for test result is calculated by following formula
ValueWith standard deviation S1；It is another to take wherein 1 bottle of retest 5 times, calculate the average value of test resultWith standard deviation S2；
By coefficient of variation CV% between following each formula calculating bottle, the requirement of coefficient of variation CV≤5.0% between bottle as a result should be met.
Formula 1
Formula 2
Formula 3
Formula 4
Work as S1<S2When, make CVBetween bottle=0
In formula：
----average value；
S---- standard deviations；
N---- pendulous frequencies；
Xi---- specifies parameter ith measured value.
Foundation《External diagnosis reagent calibration object, quality-control product investigative technique guideline》Carry out Homogeneity Test.With a collection of
Number quality-control product in extract 5 bottles, every bottle is tested 1 time, and the average value of test result is calculated by following formulaAnd standard deviation
S1；It is another to take wherein 1 bottle of retest 5 times, calculate the average value of test resultWith standard deviation S2,2 are the results are shown in Table.
The c reactive protein Quality Control product Homogeneity Test measurement result (unit of table 2：mg/L)
4th, Stability Determination
In order to assess the stability of c reactive protein quality control product, the present invention observes the short-term stability of the quality-control product
And long-time stability.The stability that short-term stability is mainly tested in the case where simulating quality-control product traffic condition, long-time stability are then
Test stability of the quality-control product under long-term storage requirement.
C reactive protein quality controls product stability assessment measurement data result and statistical result to be shown in Table 4~5, from average
It is worth consistency-checking method and carries out stability analysis.Compared with the test result of the test result of different holding times and first time
Compared with analysis.According to formula：
Wherein,S1, n1 are the average value, standard deviation, measurement of first time quality-control product Detection of Stability measurement data
Number.S2, n2 are average value, the standard deviation of second of quality-control product Detection of Stability measurement data after separated in time
Difference, pendulous frequency.
As t and level of significance α, the t when free degree is n1+n2-2 examines the relation between critical value t α (n1+n2-2)
For：During t≤t α (n1+n2-2), it is believed that conspicuousness change does not occur for the characteristic magnitude of the quality-control product, otherwise it is assumed that the quality-control product
Characteristic magnitude occurred conspicuousness change.
4.1 short-term stabilities are assessed
Short-term stability tests the stability for being concerned with the quality-control product under specific traffic condition.According to the fortune in current China
Defeated condition, using express transportation, goods can be transported to China main cities in 2 days.The design of this experiment is as follows：Simulate Quality Control
Product send out sample and the environment of transportation, analyze the change situation of c reactive protein concentration in the process.Specifically include following
Step：It would be stored at quality-control product in 2-8 DEG C of environment first to take out rapidly, the exterior and interior packing before being transported, sample is in 2-8 degree
In ice bag environment.Traffic condition is simulated, preserves have wrapped sample at room temperature, and the vigor of sample is measured, from
And assess influence of the transportation to sample vigor.CRP quality-control products are taken, according to the ice bag and packaging during actual shipment, are being stored
0h, 9h, 24h, 33h, 48h, 57h carries out viability examination to it, as a result as shown in table 3.
The c reactive protein quality of table 3 controls product short-term stability assessment of the measurement result (unit：mg/L)
4.2 long-time stability are assessed
Long-time stability test the stability for being concerned with the quality-control product CRP concentration under specific storage requirement.This reality
It is under 2-8 DEG C of storage requirement to test, and is sampled analysis to the quality-control product of storage, as shown in table 4.
The c reactive protein quality of table 4 controls product long-time stability assessment of the measurement result (unit：mg/L)
For a person skilled in the art, the technical scheme described in foregoing embodiments can still be repaiied
Change, or equivalent substitution is carried out to which part technical characteristic, within the spirit and principles of the invention, that is made any repaiies
Change, equivalent substitution, improvement etc., should be included in protection scope of the present invention.
Claims (3)
1. a kind of c reactive protein quality for POCT controls the preparation method of product, it is characterised in that the preparation method include with
Lower step：
Step 1：Sources of initial raw materials is in the commercially available horse serum after aseptic filtration, after horse serum is added into preservative, at 4 DEG C
Under the conditions of, 9000rpm centrifugation 30min, supernatant is taken, is filtered off with double-deck qualitative fast grade filter paper and removes lipid material, then passed through successively
After crossing 0.45 μm or 0.22 μm of hydrophilic film aseptic filtration, stroma ground substance is formed；
Step 2：According to c reactive protein mother liquid concentration and TIANZHU XINGNAO Capsul, added with the liquid-transfering gun by metering in stroma ground substance
Add c reactive protein to aimed concn；Described c reactive protein is sub-packed in the jelly of cleaned drying with the liquid-transfering gun by metering again
Deposit in pipe, 1 milliliter every bottle, 2-8 DEG C of fluid storage, it is anti-for the C of 7-9mg/L horse serum matrix to obtain stable homogeneous, concentration level
Albumen quality is answered to control product.
2. the c reactive protein quality according to claim 1 for POCT controls the preparation method of product, it is characterised in that
The aimed concn of the c reactive protein added in stroma ground substance is 7-9 mg/L.
3. the c reactive protein quality for POCT according to any claim in claims 1 or 2 controls the system of product
Preparation Method, it is characterised in that the c reactive protein is humanized's c reactive protein.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109342713A (en) * | 2018-08-27 | 2019-02-15 | 北京九强生物技术股份有限公司 | A kind of Quality Control substance for lipids detection |
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| CN109342713B (en) * | 2018-08-27 | 2021-09-28 | 北京九强生物技术股份有限公司 | Quality control substance for blood fat detection |
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Inventor after: Li Hailong Inventor after: Meng Fanguo Inventor after: Jiang Zhe Inventor after: Cheng Bei Inventor before: Li Hailong Inventor before: Meng Fanguo Inventor before: Bao Zhe Inventor before: Cheng Bei |
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Application publication date: 20171222 |