CN103472240B - People's blood fat (serum/plasma) quality management reference kit and preparation method - Google Patents
People's blood fat (serum/plasma) quality management reference kit and preparation method Download PDFInfo
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Abstract
A kind of people's blood fat (serum/plasma) quality management reference kit, with human serum (blood plasma) for matrix, be added with containing humanized's lipid composition (humanized's Apolipoprotein A1 antigen, apolipoprotein B antigen, HDL-C (HDL), LDL-C (LDL) etc.) and systems stabilisation and corrosion protection system.The combination in any of the polymkeric substance such as systems stabilisation is Triton series, Tween is serial, EDTA is serial etc. surfactant and polyvinyl alcohol (PVA) series, polyvinylpyrrolidone is serial, polyglycol is serial and phosphate buffer.Corrosion protection system is Sodium azide, gentamicin, anphotericin, ProClin series combination in any.Present invention also offers the preparation method of mentioned reagent box.Product of the present invention, without " medium effect " interference, as the quality control between each detection system and assessment, will reflect that each detection system detects the actual mass situation of human serum (blood plasma) sample more really.
Description
Technical field
The invention belongs to biological technical field, particularly relate to a kind of kit and preparation method thereof, specifically a kind of people's blood fat (serum/plasma) quality management reference kit and preparation method.
Background technology
Apolipoprotein A1 antigen, apolipoprotein B antigen, HDL-C, LDL-C, LP(a), cholesterol and triglyceride are the most frequently used Interventions Requested of clinical biochemical lipid-metabolism inspection, be the screening of hyperlipemia and the routine inspection for Analysis on Cardiovascular Risk Factors, there is important clinical detection and be worth.Therefore, the consistance of the quality control in testing process and different experiments room testing result is quite important.
According to quality control requirement, composition and the matrix of the quality-control product used (investigation product) its composition and matrix effect and tested sample are more thought close to unreasonable, that is " medium effect " is the smaller the better.It would be desirable similar sample---the i.e. human serum (blood plasma) directly using tested sample.But human serum (blood plasma) is not easily preserved, is transported.Direct end user's serum (blood plasma) can not meet the durability requirements of quality-control product (investigation product).
The blood fat quality-control product of current domestic goods there is no and emerges, and external commercial blood fat quality-control product has " medium effect interference " in various degree.Be applied to different detection systems and measure kit, its detected value has larger skew.As used some different detection system and measuring kit, its detected value carries out CV calculating, and the CV obtained is larger.Especially the Method And Principle that adopts due to various brands manufacturer of the mensuration kit of HDL-C (HDL), LDL-C (LDL) is different.Therefore, different brands detection system and measure kit very responsive for the medium effect of existing commercial quality control substance.The definite value of external similar products can only be carried out respectively by the detection system of different brands and mensuration kit, and produces different value data and scope.The detection system that therefore can not be used for different brands and the mass ratio that measures between kit are to investigation and quality control.
Summary of the invention
For the defect existed in above-mentioned prior art, the invention provides a kind of people's blood fat (serum/plasma) quality management reference kit and preparation method,
The object of the present invention is to provide a kind of people's blood fat (serum/plasma) quality management reference kit, containing reference reagent in described kit, described reference reagent be with human serum (blood plasma) for matrix, be added with containing humanized's lipid composition wherein, systems stabilisation and corrosion protection system, described is humanized's Apolipoprotein A1 antigen (APOA1) containing humanized's lipid composition, apolipoprotein B antigen (APOB), HDL-C (HDL), LDL-C (LDL), LP(a) (La), any one or more than one combination in cholesterol (CHOL) and triglyceride (TG), described systems stabilisation is Triton series of surfactants, Tween series of surfactants, EDTA series of surfactants, polyvinyl alcohol (PVA) series polymkeric substance, polyvinylpyrrolidone series polymer, any one or any one above combination of polyglycol series polymer and phosphate buffer, described corrosion protection system is Sodium azide, gentamicin, anphotericin, any one or any one above combination of ProClin series.
Further, described Triton series of surfactants is TritonX100 surfactant, in described human serum (blood plasma) matrix, the whole working concentration of described TritonX100 surfactant is 0.005% to 10% (mass percent concentration).
Further, described Tween series of surfactants is Tween20 to 80, and in described human serum (blood plasma) matrix, the whole working concentration of described Tween series of surfactants is 0.005% to 10% (mass percent concentration).
Further, described EDTA series of surfactants is EDTA, EDTA-Na2, EDTA-Na4, and in described human serum (blood plasma) matrix, the whole working concentration of described EDTA series of surfactants is 1umol/l to 1mol/l.。
Further, in described human serum (blood plasma) matrix, the whole working concentration of described polyvinyl alcohol (PVA) is 0.001% to 10% (mass percent concentration).
Further, in described human serum (blood plasma) matrix, the whole working concentration of described polyvinylpyrrolidone is 0.001% to 10% (mass percent concentration).
Further, described polyglycol series polymer is PEG400 to PEG20000, and in described human serum (blood plasma) matrix, the whole working concentration of described polyglycol series polymer is 0.005% to 20% (mass percent concentration).
Further, in described human serum (blood plasma) matrix, the whole working concentration of described phosphate buffer is 1mmol/l to 1mol/l.
Further, in described human serum (blood plasma) matrix, the whole working concentration of described Sodium azide is 0.005% to 1%.
Further, in described human serum (blood plasma) matrix, the whole working concentration of described gentamicin is 0.6mg/l to 20mg/l.
Further, in described human serum (blood plasma) matrix, the whole working concentration of described anphotericin is 0.06mg/l to 6mg/l.
Further, described ProClin series is ProClin100, ProClin300, and in described human serum (blood plasma) matrix, the whole working concentration of described ProClin series is 0.1% to 1% (mass percent concentration).
Present invention also offers the preparation method of above-mentioned people's blood fat (serum/plasma) quality management reference kit, comprise the process of the screening of human serum (blood plasma) matrix, a process selected containing humanized's lipid composition, the process of a preparation systems stabilisation, a process preparing corrosion protection system, then will containing the process of humanized's lipid composition, systems stabilisation and corrosion protection system mixing.
Further, quality-control product, investigation product and correction product are comprised in described kit.
Further, described lipid composition all with human serum (blood plasma) for matrix and humanized's lipid composition of deriving from human serum (blood plasma), without the lipid composition adding any non-human or synthesis.
Further, described lipid composition concentration (content) covers commercialization lipids detection system and measures the sensing range (range of linearity) of kit.
Further, described lipid composition and matrix are substantially without medium effect interference, and without the need to the detection system of different brands and mensuration kit are carried out classification definite value during definite value, gained value data is applicable to the detection system of different brands and measures kit.By user, definite value, by using International or National legal or specified standard detection method and generally acknowledged detection method, also confirms that acceptable detection system carries out definite value to lipids composition.
Principle of work of the present invention is: adopt human serum (blood plasma) to be matrix, add humanized's lipid composition (Apolipoprotein A1 antigen (APOA1) in right amount as required, apolipoprotein B antigen (APOB), HDL-C (HDL), LDL-C (LDL), LP(a) (La), cholesterol (CHOL) and triglyceride (TG) etc.), then the systems stabilisation of appropriate combination and proportioning is added, above-mentioned human serum (blood plasma) matrix and each lipid composition are tended towards stability, and add appropriate antiseptic, to block the corruption of human serum (blood plasma) matrix and lipid composition.
Further, purposes of the present invention is: definite value or non-definite value can be used for indoor and the between ward quality monitoring of clinical labororatory, the consistance investigation as the detection system of different brands and the reference substance of the quality control measured between kit and Evaluation and testing result uses.This invention, as used standardized method definite value (assignment), also can be used as blood fat standard items (correction product) and uses.
According to quality control requirement, composition and the matrix of the quality-control product used (investigation product) its composition and matrix and tested sample are more thought close to unreasonable, that is medium effect is the smaller the better.This quality-control product is all prepared by the lipid composition in human serum (blood plasma), and matrix is also human serum (blood plasma).Adopt systems stabilisation to the detection of lipid composition also without any interference.Product of the present invention, relative to other commercial quality-control product, this quality-control product is substantially without medium effect.
The present invention compares with prior art, and its technical progress is significant.The main feature of the present invention is:
1, human serum (blood plasma) matrix and humanized's lipid composition, more approach clinic tested person serum (blood plasma) sample completely.
2, product of the present invention is compared with clinical tested human serum (blood plasma) sample, disturbs without medium effect.Alternative human serum (blood plasma), is applied to the detection system of different brands and measures kit, and it detects CV value and is substantially equal to nature person's serum (blood plasma) average detected CV value (CV that namely different detection system is intrinsic).
3, during product definite value of the present invention without the need to distinguish different brands detection system and measure kit, value data be applicable to different brands detection system and measure kit.On the contrary, external similar products with different detection systems and can only measure kit definite value, and produce different value data and scope.
4, product of the present invention solves the medium effect interference that existing commercial blood fat quality control substance exists, as the detection system of different brands and the reference substance of the quality control measured between kit and Evaluation, its result will reflect the detection system of different brands more really and measure the quality condition of actual detection human serum (blood plasma) sample of kit.On the contrary, external similar products are because of " medium effect interference ", be applied to the detection system of different brands and measure kit, its detected value has larger skew, its detected value carries out CV calculating, the CV obtained is comparatively large, can not be used for the detection system of different brands and the quality control measured between kit and Evaluation.
5, product of the present invention is as the quality evaluation reference sample of lipids detection system (reagent), can be used for the indoor of clinical labororatory (clinical laboratory) and between ward quality monitoring and assessment.Also can be used for investigation that is extensive, provincialism lipids detection quality control level.Because its issuable medium effect is similar to human serum (blood plasma), investigation result will reflect that the authenticity of investigation result is obviously better than external blood fat quality-control product by the quality condition of respondent's actual detection human serum (blood plasma) sample more really.
6, product of the present invention is as used standardized method definite value (assignment), also can be used as blood fat standard items (correction product) and uses, provincialism lipids detection result can be made to be tending towards unified, to reaching unifying and recognizing each other of the interior lipids detection result in area.
7, product of the present invention is applicable to there is card commercialization lipids detection system both at home and abroad and measures kit of the different brands that current each laboratory (clinical laboratory) uses, the testing result coefficient of variation (CV%): Apolipoprotein A1 antigen (APOA1)≤10%, apolipoprotein B antigen (APOB)≤10%, HDL-C (HDL)≤15%, LDL-C (LDL)≤25%, LP(a) (La)≤25%, cholesterol (CHOL)≤5%, triglyceride (TG)≤5%.
8, the systems stabilisation that the present invention adopts is formed by the various combination proportioning of multiple, multi-series surfactant (Triton is serial, Tween is serial, EDTA is serial) and multiple polymers (polyvinyl alcohol (PVA) is serial, polyvinylpyrrolidone is serial, polyglycol is serial).Systems stabilisation does not disturb current commercial lipid determination kit.
The sharpest edges of product of the present invention are " without medium effect interference ", are applied to the detection system of different brands and measure kit, its detect CV value detect CV value from nature person's serum (blood plasma) (CV that namely different detection system is intrinsic).Without the need to distinguishing the detection system of different brands and measuring kit during definite value, gained value data can be applicable to the detection system of different brands and measures kit.Therefore, apply product of the present invention as the detection system of different brands and measure the quality control of kit and the reference substance of assessment, its result will reflect the quality condition of actual detection human serum (blood plasma) sample of each detection system more really, and the authenticity of result is obviously better than external blood fat quality-control product.As used standardized method definite value (assignment), also can be used as blood fat standard items (correction product) and using, to reaching unifying and recognizing each other of the interior lipids detection result in area.
Product of the present invention is applicable to Apolipoprotein A1 antigen (APOA1), apolipoprotein B antigen (APOB), HDL-C (HDL), LDL-C (LDL), LP(a) (La), cholesterol (CHOL) and triglyceride (TG) etc. that domestic and international manufacturer that current each laboratory (clinical laboratory) uses adopts various methodology and various formula to manufacture and measures kit.
Embodiment
Embodiment 1:
A kind of people's blood fat (serum/plasma) quality management of the present invention reference kit, containing reference reagent in described kit, described reference reagent is for matrix with human serum (blood plasma), be added with containing humanized's lipid composition wherein, systems stabilisation and corrosion protection system, described is humanized's Apolipoprotein A1 antigen (APOA1) containing humanized's lipid composition, apolipoprotein B antigen (APOB), HDL-C (HDL), LDL-C (LDL), LP(a) (La), any one or more than one combination in cholesterol (CHOL) and triglyceride (TG), described systems stabilisation is Triton series of surfactants, Tween series of surfactants, EDTA series of surfactants, polyvinyl alcohol (PVA) series polymkeric substance, polyvinylpyrrolidone series polymer, polyglycol series polymer and phosphate buffer,
Described stabilizing agent is by TritonX100, Tween20, EDTA, polyvinyl alcohol (PVA), polyvinylpyrrolidone, Macrogol 6000 forms, during use, the whole mass percent concentration of described TritonX100 is 0.01%---0.1%, the whole mass percent concentration of described Tween20 is 0.005%---0.05%, the final concentration of described EDTA is 5umol/l---50umol/l, the whole mass percent concentration of described polyvinyl alcohol (PVA) is 0.01%---0.1%, the whole mass percent concentration of described polyvinylpyrrolidone is 0.05%---0.5%, the whole mass percent concentration of described Macrogol 6000 is 0.005%---0.05%.
Further, described antiseptic is made up of Sodium azide, gentamicin, anphotericin and ProClin, during use, the whole mass percent concentration of described Sodium azide is 0.02%--0.1%, the final concentration of described gentamicin is 0.3-1.2mg/l, the final concentration of described anphotericin is 0.3-1.2mg/l, and the whole mass percent concentration of described ProClin is 0.1%--1%.
Experimentation:
The commercially available lipid determination kit of card that has using 5 manufacturers to produce detects HDL, LDL, APOA1, APOB blood fat project of the product of the present invention (3 batches) of 3 variable concentrations simultaneously, and calculates average, standard deviation (SD), the coefficient of variation (CV) of testing result.5 manufacturers are respectively: domestic 2 (code name: B, K), external import 3 (code name: W, Y, L).
In form, HDL-B represents: the project that HDL(detects)-B(measures manufacturer's code name of kit).
Embodiment 2:
A kind of people's blood fat (serum/plasma) quality management of the present invention reference kit, containing reference reagent in described kit, described reference reagent is for matrix with human serum (blood plasma), be added with containing humanized's lipid composition wherein, systems stabilisation and corrosion protection system, described is humanized's Apolipoprotein A1 antigen (APOA1) containing humanized's lipid composition, apolipoprotein B antigen (APOB), HDL-C (HDL), LDL-C (LDL), LP(a) (La), any one or more than one combination in cholesterol (CHOL) and triglyceride (TG), described systems stabilisation is Triton series of surfactants, Tween series of surfactants, EDTA series of surfactants, polyvinyl alcohol (PVA) series polymkeric substance, polyvinylpyrrolidone series polymer, any one or any one above combination of polyglycol series polymer and phosphate buffer.
Further, described stabilizing agent is made up of TritonX100, Tween40, polyvinylpyrrolidone, during use, the whole mass percent concentration of described TritonX100 is 0.005%---0.3%, the whole mass percent concentration of described Tween40 is 0.05%---1.0%, the whole mass percent concentration of described polyvinylpyrrolidone is 0.05%---1.0%.
Further, described antiseptic is made up of Sodium azide, gentamicin, anphotericin, during use, the whole mass percent concentration of described Sodium azide is 0.02%--0.1% Sodium azide, the final concentration of described gentamicin is 0.3-1.2mg/l, and the final concentration of described anphotericin is 0.3-1.2mg/l.
Experimentation:
The commercially available lipid determination kit of card that has using 5 manufacturers to produce detects HDL, LDL, APOA1, APOB blood fat project of the product of the present invention (3 batches) of 3 variable concentrations simultaneously, and calculates average, standard deviation (SD), the coefficient of variation (CV) of testing result.5 manufacturers are respectively: domestic 2 (code name: B, K), external import 3 (code name: W, Y, L).
The project that note: in form, HDL-B represents: HDL(detects)-B(measures manufacturer's code name of kit).
Embodiment 3:
A kind of people's blood fat (serum/plasma) quality management of the present invention reference kit, containing reference reagent in described kit, described reference reagent is for matrix with human serum (blood plasma), be added with containing humanized's lipid composition wherein, systems stabilisation and corrosion protection system, described is humanized's Apolipoprotein A1 antigen (APOA1) containing humanized's lipid composition, apolipoprotein B antigen (APOB), HDL-C (HDL), LDL-C (LDL), LP(a) (La), any one or more than one combination in cholesterol (CHOL) and triglyceride (TG), described systems stabilisation is Triton series of surfactants, Tween series of surfactants, EDTA series of surfactants, polyvinyl alcohol (PVA) series polymkeric substance, polyvinylpyrrolidone series polymer, any one or any one above combination of polyglycol series polymer and phosphate buffer.
Further, described stabilizing agent is made up of Tween80, EDTA-Na4, polyvinyl alcohol (PVA), Macrogol 600, during use, the whole mass percent concentration of described Tween80 is 0.005%---0.5%, the final concentration of described EDTA-Na4 is 10umol/l---200umol/l, the whole mass percent concentration of described polyvinyl alcohol (PVA) is 0.01%---1.0%, and the whole mass percent concentration of described Macrogol 600 is 0.01%---1.0%.
Further, described antiseptic is made up of Sodium azide, gentamicin, ProClin, during use, the whole mass percent concentration of described Sodium azide is 0.02%--0.1% Sodium azide, the final concentration of described gentamicin is 0.3-1.2mg/l, and the whole mass percent concentration of described ProClin is 0.1%--1%.
Experimentation:
The commercially available lipid determination kit of card that has using 5 manufacturers to produce detects HDL, LDL, APOA1, APOB blood fat project of the product of the present invention (3 batches) of 3 variable concentrations simultaneously, and calculates average, standard deviation (SD), the coefficient of variation (CV) of testing result.5 manufacturers are respectively: domestic 2 (code name: B, K), external import 3 (code name: W, Y, L).
The project that note: in form, HDL-B represents: HDL(detects)-B(measures manufacturer's code name of kit).
Embodiment 4:
A kind of people's blood fat (serum/plasma) quality management of the present invention reference kit, containing reference reagent in described kit, described reference reagent is for matrix with human serum (blood plasma), be added with containing humanized's lipid composition wherein, systems stabilisation and corrosion protection system, described is humanized's Apolipoprotein A1 antigen (APOA1) containing humanized's lipid composition, apolipoprotein B antigen (APOB), HDL-C (HDL), LDL-C (LDL), LP(a) (La), any one or more than one combination in cholesterol (CHOL) and triglyceride (TG), described systems stabilisation is Triton series of surfactants, Tween series of surfactants, EDTA series of surfactants, polyvinyl alcohol (PVA) series polymkeric substance, polyvinylpyrrolidone series polymer, any one or any one above combination of polyglycol series polymer and phosphate buffer.
Further, described stabilizing agent is made up of Tween20, EDTA-Na2, polyvinylpyrrolidone, PEG 20000, during use, the whole mass percent concentration of described Tween20 is 0.05%---1.0%, the final concentration of described EDTA-Na2 is 0.1mmol/l---10mmol/l, the whole mass percent concentration of described polyvinylpyrrolidone is 0.01%---0.05%, and the whole mass percent concentration of described PEG 20000 is 0.05-0.5%.
Further, described antiseptic is made up of Sodium azide, gentamicin, ProClin, during use, the whole mass percent concentration of described Sodium azide is 0.02%--0.1% Sodium azide, the final concentration of described gentamicin is 0.3-1.2mg/l, and the whole mass percent concentration of described ProClin is 0.1%--1%.
Experimentation:
The commercially available lipid determination kit of card that has using 5 manufacturers to produce detects HDL, LDL, APOA1, APOB blood fat project of the product of the present invention (3 batches) of 3 variable concentrations simultaneously, and calculates average, standard deviation (SD), the coefficient of variation (CV) of testing result.5 manufacturers are respectively: domestic 2 (code name: B, K), external import 3 (code name: W, Y, L).
The project that note: in form, HDL-B represents: HDL(detects)-B(measures manufacturer's code name of kit).
Embodiment 5:
What use domestic and international 18 different brands manufacturers has card commercialization detection system and lipid determination kit, detect the lipid composition of product of the present invention (3 batches) and 20 parts of random human serum samples simultaneously, and calculate average, standard deviation (SD), the coefficient of variation (CV), the extreme difference of 18 testing results.The relatively coefficient of variation (CV%) and extreme difference, to observe " medium effect " of product of the present invention and nature person's serum sample.
Table 1: the average coefficient of variation (CV%) of product of the present invention and human serum sample and the comparison of extreme difference (%):
Embodiment 5 illustrates that the detection coefficient of variation (CV%) of product of the present invention and extreme difference (%) press close to the distribution trend of human serum (blood plasma) sample natural variation coefficient (CV%) and extreme difference (%).Product of the present invention, compared with nature person's serum (blood plasma) sample, disturbs without medium effect substantially.
Embodiment 6:
Use the lipid determination kit of 5 famous foreign brands and 6 home brands manufacturers to detect commercialization blood fat quality-control product (2 batches) and the product of the present invention (3 batches) of certain famous brand name external simultaneously, and calculate average, standard deviation (SD), the coefficient of variation (CV), the extreme difference of 11 testing results.
Table 2: the average coefficient of variation (CV%) of product of the present invention and external commercialization blood fat quality-control product and the comparison of extreme difference (%):
The present invention of embodiment 6 sufficient proof has clear superiority in the disturbing effect of mensuration kit than the commercialization blood fat quality-control product of famous foreign brand at medium effect.
Embodiment 7:
Outside comparator, commercialization blood fat quality-control product and products application of the present invention are when the HDL-C (HDL) of different brands, distinct methods measures the mensuration kit of kit and LDL-C (LDL) issuable " medium effect interference ".
Experimentation:
Use the lipid determination kit of 3 famous foreign brands and 1 home brands manufacturer (differently principle is produced) to detect the external commercialization blood fat quality-control product (2 batches) of certain famous brand name and HDL-C (HDL), the LDL-C (LDL) of product of the present invention (3 batches) simultaneously.Relatively the CV of the testing result of the mensuration kit of different brands manufacturer, measures " the medium effect interference " of kit with observation and comparison external commercialization blood fat quality-control product (2 batches) and product of the present invention to different brands manufacturer
Table 3-1: the commercialization blood fat quality-control product of product of the present invention and certain famous brand name external for different brands,
The LDL-C (HDL) of distinct methods measures " the medium effect interference " of kit.
| HDL-B | HDL-W | HDL-Y | HDL-L | Average | SD | CV | |
| The present invention 1 | 1.78 | 1.61 | 1.83 | 1.76 | 1.75 | 0.095 | 5.43% |
| The present invention 2 | 1.29 | 1.25 | 1.43 | 1.34 | 1.33 | 0.078 | 5.85% |
| The present invention 3 | 0.72 | 0.75 | 0.86 | 0.804 | 0.78 | 0.061 | 7.78% |
| External product 1 | 1.16 | 0.82 | 0.96 | 0.80 | 0.94 | 0.166 | 17.76% |
| External product 2 | 2.09 | 1.70 | 2.00 | 1.68 | 1.87 | 0.208 | 11.16% |
The project that note: in form, HDL-B represents: HDL(detects)-B(measures manufacturer's code name of kit).
Table 3-2: the commercialization blood fat quality-control product of product of the present invention and certain famous brand name external for different brands,
The LDL-C (LDL) of distinct methods measures " the medium effect interference " of kit.
| LDL-B | LDL-W | LDL-Y | LDL-L | Average | SD | CV | |
| The present invention 1 | 4.61 | 6.37 | 4.51 | 4.73 | 5.06 | 0.881 | 17.43% |
| The present invention 2 | 3.13 | 3.91 | 2.82 | 2.75 | 3.15 | 0.531 | 16.85% |
| The present invention 3 | 1.79 | 2.35 | 1.61 | 1.75 | 1.87 | 0.324 | 17.29% |
| External product 1 | 2.99 | 4.94 | 2.52 | 2.98 | 3.36 | 1.078 | 32.09% |
| External product 2 | 5.31 | 8.29 | 4.74 | 4.52 | 5.72 | 1.749 | 30.60% |
The project that note: in form, LDL-B represents: LDL(detects)-B(measures manufacturer's code name of kit).
In lipid determination project, the Method And Principle that the kit of HDL-C (HDL), LDL-C (LDL) adopts due to each manufacturer and fill a prescription different.Therefore, the medium effect for tested sample is very responsive.Example illustrates that 3 show that product of the present invention is significantly less than the commercialization blood fat quality-control product of famous foreign brand to " medium effect interference " that the HDL-C prepared by distinct methods principle (HDL), LDL-C (LDL) measure kit.
Embodiment 8:
Using product of the present invention as unified correction product, correct the lipid determination kit of different brands manufacturer, observe the comparability that can improve provincialism lipids detection result.
Experimentation:
Use the lipid determination kit of 11 domestic and international different brands manufacturers, the correction before using the blood fat correction product of genuine configuration and product of the present invention to detect corresponding mensuration kit respectively.Then clinical human serum (blood plasma) sample 19 example is detected.
Table 4: use unified standard product to carry out comparing before and after correction:
After embodiment 8 absolutely proves and uses product of the present invention to carry out standardized assignment, be applied to different brands detection system as standard items and measure kit, unify to correct to reagent, greatly can improve repeatability and the comparability of the product of different manufacturer and the testing result of different experiments room.Detect 19 routine human serum (blood plasma) samples, average coefficient of variation (CV%) reduces 30--50%.
Claims (7)
1. people's Lipid buret reason reference kit, it is characterized in that: containing reference reagent in described kit, described reference reagent is for matrix with human serum or blood plasma, be added with humanized's lipid composition wherein, systems stabilisation and corrosion protection system, described humanized's lipid composition is humanized's Apolipoprotein A1 antigen, apolipoprotein B antigen, HDL-C, LDL-C, LP(a), in cholesterol and triglyceride any one or more than a kind of combination, described systems stabilisation is Triton series of surfactants, Tween series of surfactants, EDTA series of surfactants, polyvinyl alcohol (PVA) series polymkeric substance, polyvinylpyrrolidone series polymer, in polyglycol series polymer any one or more than a kind of combination, described corrosion protection system is Sodium azide, gentamicin, anphotericin, in ProClin series any one or more than a kind of combination, described Triton series of surfactants is TritonX100 surfactant, the whole working concentration of described TritonX100 surfactant is mass percent concentration 0.005% to 10%, described Tween series of surfactants is Tween20 to 80, the whole working concentration of described Tween series of surfactants is mass percent concentration 0.005% to 10%, described EDTA series of surfactants is EDTA, EDTA-Na2, or EDTA-Na4, the whole working concentration of described EDTA series of surfactants is 1umol/l to 1mol/l, the whole working concentration of described polyvinyl alcohol (PVA) series polymkeric substance is mass percent concentration 0.001% to 10%, the whole working concentration of described polyvinylpyrrolidone series polymer is mass percent concentration 0.001% to 10%, described polyglycol series polymer is PEG400 to PEG20000, the whole working concentration of described polyglycol series polymer is mass percent concentration 0.005% to 20%, the whole working concentration of described Sodium azide is mass percent concentration 0.005% to 1%, the whole working concentration of described gentamicin is 0.6mg/l to 20mg/l, the whole working concentration of described anphotericin is 0.06mg/l to 6mg/l, described ProClin series is ProClin100, ProClin300, the whole working concentration of described ProClin series is mass percent concentration 0.1% to 1%.
2. a kind of people's Lipid buret reason reference kit as claimed in claim 1, is characterized in that: described humanized's lipid composition all derives from the humanized's lipid composition in human serum or blood plasma, without the lipid composition adding any non-human or synthesis.
3. a kind of people's Lipid buret reason reference kit as claimed in claim 1, it is characterized in that: described lipid composition and matrix are disturbed without " medium effect " substantially, without the need to the detection system of different brands and mensuration kit are carried out classification definite value during definite value, gained value data is applicable to the detection system of different brands and measures kit.
4. a kind of people's Lipid buret reason reference kit as claimed in claim 1, is characterized in that: described reference reagent can be used as quality-control product or standard items.
5. a kind of people's Lipid buret reason reference kit as claimed in claim 4, it is characterized in that: described quality-control product can underrange use, also by International or National legal or specified standard detection method and generally acknowledged detection method, or user confirms that acceptable detection system carries out definite value use to lipids composition.
6. a kind of people's Lipid buret reason reference kit as claimed in claim 4, it is characterized in that: described standard items use International or National standard detecting method or generally acknowledged detection method to carry out assignment, standard items have value accurately, and its value has traceability.
7. the preparation method of people's Lipid buret reason reference kit according to claim 1, it is characterized in that: the process comprising the screening of a human serum or plasma matrix, the process that humanized's lipid composition is selected, the process of a preparation systems stabilisation, a process preparing corrosion protection system, then by process that humanized's lipid composition, systems stabilisation and corrosion protection system mix.
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| CN104020301B (en) * | 2014-01-06 | 2015-11-18 | 宁波博泰生物技术有限公司 | For calibrating the preparation method of the caliberator of Apolipoprotein A1 and apolipoprotein B |
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| DK3128325T3 (en) * | 2015-08-07 | 2019-04-15 | Ulrich Pachmann | PROCEDURE FOR DETERMINING A CONCENTRATION OF EPITHELIAL CELLS IN A BLOOD OR ASPIRATE SAMPLE |
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| CN109298192A (en) * | 2018-09-17 | 2019-02-01 | 山东博科生物产业有限公司 | A kind of compound quality-control product of liquid biochemistry blood-lipoids that stability is strong |
| CN110057641A (en) * | 2019-04-30 | 2019-07-26 | 山东博科生物产业有限公司 | The compound calibration object and preparation method thereof containing 6 indexs of strong antijamming capability |
| CN111041066A (en) * | 2019-12-10 | 2020-04-21 | 郑州标源生物科技有限公司 | Lipid quality control product and preparation method thereof |
| CN113234792A (en) * | 2021-04-06 | 2021-08-10 | 北京九强生物技术股份有限公司 | Quality control composition for blood coagulation detection |
| CN114544926A (en) * | 2021-12-02 | 2022-05-27 | 浙江鑫科医疗科技有限公司 | Serum protein stabilizer |
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