CN103472240A - Human blood fat (serum/plasma) quality management reference kit and preparation method - Google Patents
Human blood fat (serum/plasma) quality management reference kit and preparation method Download PDFInfo
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Abstract
The invention provides a human blood fat (serum/plasma) quality management reference kit. The kit takes human serum (plasma) as a matrix; a human blood fat component (human apolipoprotein A1 antigen, apolipoprotein B antigen, high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL) and the like), a stable system and an anticorrosion system are added to the matrix; the stable system is any combination of a surfactant of Triton series, Tween series, EDTA (ethylene diamine tetraacetic acid) series and the like, a polymer of polyvinyl alcohol series, polyvinylpyrrolidone series, polyethylene glycol series and the like, and a phosphate buffer solution; and the anticorrosion system is any combination of sodium azide, gentamicin, amphomycin and ProClin series. The invention further provides a preparation method of the kit. The kit is free from medium effect interference, is used for quality control and evaluation between the detection systems, and more really reflects actual quality conditions of human serum (plasma) samples, which are detected by detection systems.
Description
Technical field
The invention belongs to biological technical field, relate in particular to a kind of kit and preparation method thereof, is a kind of people's blood fat (serum/plasma) quality management reference kit and preparation method specifically.
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 check, the screening that is hyperlipemia reaches the routine inspection for Analysis on Cardiovascular Risk Factors, has important clinical detection and is worth.Therefore, the consistance of the quality control in testing process and different experiments chamber testing result is quite important.
According to quality control requirement, the composition of the quality-control product used (investigation product) its composition and matrix effect and tested sample and matrix approach unreasonablely to be thought, that is " medium effect " is the smaller the better.It would be desirable the similar sample of direct use tested sample---be human serum (blood plasma).Yet human serum (blood plasma) is difficult for preserving, transportation.Directly 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 domestic goods there is no and emerges at present, 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 use some different detection system and measure kit, its detected value carries out CV calculating, and the CV obtained is larger.Especially the mensuration kit of HDL-C (HDL), LDL-C (LDL) is because the Method And Principle that the various brands manufacturer adopts is different.Therefore, the detection system of different brands and mensuration kit are 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 detection system and the mensuration kit of different brands, and produces different value data and scope.Therefore can not and measure mass ratio between kit to investigation and quality control for the detection system of different brands.
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, contain reference reagent in described kit, described reference reagent is that to take human serum (blood plasma) be matrix, is added with therein the lipid composition containing the humanized, 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 the Triton series of surfactants, the Tween series of surfactants, the EDTA series of surfactants, polyvinyl alcohol (PVA) series polymkeric substance, the 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 the 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).
The present invention also provides the preparation method of above-mentioned people's blood fat (serum/plasma) quality management reference kit, the process that comprises the screening of a human serum (blood plasma) matrix, a process of selecting containing humanized's lipid composition, the process of a preparation systems stabilisation, a process for preparing corrosion protection system, the process that then will mix containing humanized's lipid composition, systems stabilisation and corrosion protection system.
Further, comprise quality-control product, investigation product and correction product in described kit.
Further, described lipid composition all be take human serum (blood plasma) as matrix and is derived from the humanized's lipid composition in human serum (blood plasma), without adding any non-humanized or synthetic lipid composition.
Further, described lipid composition concentration (content) covers the sensing range (range of linearity) of commercialization lipids detection system and mensuration kit.
Further, described lipid composition and matrix are disturbed without medium effect substantially, and during definite value, without the detection system by different brands and measure the kit definite value of being classified, the gained value data is applicable to the detection system of different brands and measures kit.Definite value can be by being used International or National legal or specified standard detection method and generally acknowledged detection method, also can confirm that acceptable detection system carries out definite value to the lipids composition by the user.
Principle of work of the present invention is: adopting human serum (blood plasma) is matrix, add in right amount as required humanized's lipid composition (Apolipoprotein A1 antigen (APOA1), apolipoprotein B antigen (APOB), HDL-C (HDL), LDL-C (LDL), LP(a) (La), cholesterol (CHOL) and triglyceride (TG) etc.), then add the systems stabilisation of appropriate combination and proportioning, above-mentioned human serum (blood plasma) matrix and each lipid composition are tended towards stability, and add appropriate antiseptic, corruption with blocking-up human serum (blood plasma) matrix and lipid composition.
Further, purposes of the present invention is: but definite value or non-definite value are for quality control between the indoor and chamber of clinical labororatory, as detection system and the reference substance of the quality control between the mensuration kit and Evaluation and the consistance investigation use of testing result of different brands.This invention, as Application standard method definite value (assignment), also can be used as blood fat standard items (correction product) and uses.
According to quality control requirement, the composition of the quality-control product used (investigation product) its composition and matrix and tested sample and matrix approach unreasonablely to be thought, that is medium effect is the smaller the better.The all preparations of the lipid composition in human serum (blood plasma) of this quality-control product, matrix is also human serum (blood plasma).The systems stabilisation adopted to the detection of lipid composition also without any interference.Product of the present invention, with respect to other commercial quality-control product, this Quality Control terpinyl this without medium effect.
The present invention compares with prior art, and its technical progress is significant.The main characteristics of the present invention are:
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, without medium effect, disturbs.Alternative human serum (blood plasma), be applied to the detection system of different brands and measure kit, and it detects the CV value and substantially is equal to nature person's serum (blood plasma) average detected CV value (being the intrinsic CV of different detection systems).
3, during product definite value of the present invention without the detection system of distinguishing different brands and measure kit, value data is applicable to the detection system of different brands and measures kit.On the contrary, external similar products can only and be measured the kit definite value with different detection systems, and produce different value data and scope.
4, product of the present invention has solved the medium effect interference that existing commercial blood fat quality control substance exists, as detection system and the quality control between the mensuration kit and the reference substance of Evaluation of different brands, its result will reflect more really the detection system of different brands 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 larger, can not be for the detection system of different brands and quality control and the Evaluation between the mensuration kit.
5, product of the present invention is as the quality evaluation reference sample of lipids detection system (reagent), can be used for quality between the indoor and chamber of clinical labororatory (clinical laboratory) and controls and assessment.Also can be used for investigation 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 obviously is better than external blood fat quality-control product by the quality condition of the actual detection of respondent human serum (blood plasma) sample more really.
6, product of the present invention, as Application standard method definite value (assignment), also can be used as blood fat standard items (correction product) and uses, and can make provincialism lipids detection result 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 card commercialization lipids detection system being arranged and measuring kit of different brands that at present each laboratory (clinical laboratory) is used both at home and abroad, 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 is not disturbed current commercial lipid determination kit.
The sharpest edges of product of the present invention are " disturbing without medium effect ", are applied to the detection system of different brands and measure kit, and it detects (being the intrinsic CV of different detection systems) CV value and nature person's serum (blood plasma) detection CV value.During definite value, without the detection system of distinguishing different brands and mensuration kit, the 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 that the quality condition of actual detection human serum (blood plasma) sample of each detection system, the authenticity of result obviously are better than external blood fat quality-control product more really.As Application standard method definite value (assignment), also can be used as blood fat standard items (correction product) and use, to reaching unifying and recognizing each other of the interior lipids detection result in area.
Product of the present invention is applicable to the domestic and international manufacturer that each laboratory (clinical laboratory) is used at present and adopts Apolipoprotein A1 antigen (APOA1), apolipoprotein B antigen (APOB), HDL-C (HDL), LDL-C (LDL), LP(a) (La), cholesterol (CHOL) and the triglyceride (TG) etc. that the whole bag of tricks is learned and various formula is manufactured to measure kit.
Embodiment
Embodiment 1:
A kind of people's blood fat of the present invention (serum/plasma) quality management reference kit, contain reference reagent in described kit, described reference reagent is that to take human serum (blood plasma) be matrix, be added with therein the lipid composition containing the humanized, 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 the Triton series of surfactants, the Tween series of surfactants, the EDTA series of surfactants, polyvinyl alcohol (PVA) series polymkeric substance, the 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 comprised 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 that uses 5 manufacturers to produce detects HDL, LDL, APOA1, the 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 3 of imports (code name: W, Y, L).
In form, HDL-B means: the project that HDL(detects)-B(measures manufacturer's code name of kit).
Embodiment 2:
A kind of people's blood fat of the present invention (serum/plasma) quality management reference kit, contain reference reagent in described kit, described reference reagent is that to take human serum (blood plasma) be matrix, be added with therein the lipid composition containing the humanized, 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 the Triton series of surfactants, the Tween series of surfactants, the EDTA series of surfactants, polyvinyl alcohol (PVA) series polymkeric substance, the polyvinylpyrrolidone series polymer, any one or any one above combination of polyglycol series polymer and phosphate buffer.
Further, described stabilizing agent is comprised of TritonX100, Tween40, polyvinylpyrrolidone, during use, the whole mass percent concentration that the whole mass percent concentration that the whole mass percent concentration of described TritonX100 is 0.005%---0.3%, described Tween40 is 0.05%---1.0%, described polyvinylpyrrolidone is 0.05%---1.0%.
Further, described antiseptic is comprised of Sodium azide, gentamicin, anphotericin, during use, the whole mass percent concentration of described Sodium azide is the 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 that uses 5 manufacturers to produce detects HDL, LDL, APOA1, the 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 3 of imports (code name: W, Y, L).
Annotate: in form, HDL-B means: the project that HDL(detects)-B(measures manufacturer's code name of kit).
Embodiment 3:
A kind of people's blood fat of the present invention (serum/plasma) quality management reference kit, contain reference reagent in described kit, described reference reagent is that to take human serum (blood plasma) be matrix, be added with therein the lipid composition containing the humanized, 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 the Triton series of surfactants, the Tween series of surfactants, the EDTA series of surfactants, polyvinyl alcohol (PVA) series polymkeric substance, the polyvinylpyrrolidone series polymer, any one or any one above combination of polyglycol series polymer and phosphate buffer.
Further, described stabilizing agent is comprised of Tween80, EDTA-Na4, polyvinyl alcohol (PVA), Macrogol 600, during use, the whole mass percent concentration that the final concentration that the whole mass percent concentration of described Tween80 is 0.005%---0.5%, described EDTA-Na4 is 10umol/l---200umol/l, 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 comprised of Sodium azide, gentamicin, ProClin, during use, the whole mass percent concentration of described Sodium azide is the 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 that uses 5 manufacturers to produce detects HDL, LDL, APOA1, the 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 3 of imports (code name: W, Y, L).
Annotate: in form, HDL-B means: the project that HDL(detects)-B(measures manufacturer's code name of kit).
Embodiment 4:
A kind of people's blood fat of the present invention (serum/plasma) quality management reference kit, contain reference reagent in described kit, described reference reagent is that to take human serum (blood plasma) be matrix, be added with therein the lipid composition containing the humanized, 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 the Triton series of surfactants, the Tween series of surfactants, the EDTA series of surfactants, polyvinyl alcohol (PVA) series polymkeric substance, the polyvinylpyrrolidone series polymer, any one or any one above combination of polyglycol series polymer and phosphate buffer.
Further, described stabilizing agent is comprised of Tween20, EDTA-Na2, polyvinylpyrrolidone, PEG 20000, during use, the whole mass percent concentration that the final concentration that the whole mass percent concentration of described Tween20 is 0.05%---1.0%, described EDTA-Na2 is 0.1mmol/l---10mmol/l, 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 comprised of Sodium azide, gentamicin, ProClin, during use, the whole mass percent concentration of described Sodium azide is the 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 that uses 5 manufacturers to produce detects HDL, LDL, APOA1, the 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 3 of imports (code name: W, Y, L).
Annotate: in form, HDL-B means: the project that HDL(detects)-B(measures manufacturer's code name of kit).
Embodiment 5:
That uses domestic and international 18 different brands manufacturers has card commercialization detection system and a 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.Compare the 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 (%):
The detection coefficient of variation (CV%) of embodiment 5 explanation product of the present invention and the distribution trend that extreme difference (%) is pressed close to human serum (blood plasma) sample natural variation coefficient (CV%) and extreme difference (%).Product of the present invention is compared with nature person's serum (blood plasma) sample, substantially without medium effect, disturbs.
Embodiment 6:
Use 5 external famous brand names and 6 home brands manufacturers' lipid determination kit to detect commercialization blood fat quality-control product (2 batches) and the product of the present invention (3 batches) of external certain famous brand name simultaneously, and calculate average, standard deviation (SD), the coefficient of variation (CV), the extreme difference of 11 testing results.
Table 2: product of the present invention and the average coefficient of variation (CV%) of external commercialization blood fat quality-control product and the comparison of extreme difference (%):
Embodiment 6 sufficient proof the present invention have clear superiority than the commercialization blood fat quality-control product of external famous brand name at medium effect aspect the disturbing effect of measuring kit.
Embodiment 7:
When outside comparator, commercialization blood fat quality-control product and product of the present invention are applied to HDL-C (HDL) that different brands, distinct methods learn and measure the mensuration kit of kit and LDL-C (LDL) issuable " medium effect interference ".
Experimentation:
Use 3 external famous brand names and 1 home brands manufacturer's lipid determination kit (using the distinct methods principle to produce) to detect the commercialization blood fat quality-control product (2 batches) of external 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 different brands manufacturer's mensuration kit, measure " the medium effect interference " of kit with the external commercialization blood fat of observation and comparison quality-control product (2 batches) and product of the present invention to the different brands manufacturer
Table 3-1: the commercialization blood fat quality-control product of product of the present invention and external certain famous brand name for different brands,
The LDL-C (HDL) that distinct methods is learned is measured " 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% |
Annotate: in form, HDL-B means: the project that 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 external certain famous brand name for different brands,
The LDL-C (LDL) that distinct methods is learned is measured " 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% |
Annotate: in form, LDL-B means: the project that LDL(detects)-B(measures manufacturer's code name of kit).
In the 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, very responsive for the medium effect of tested sample.Example explanation 3 shows that product of the present invention is significantly less than the commercialization blood fat quality-control product of external famous brand name to the HDL-C (HDL) prepared by the distinct methods principle, " the medium effect interference " of LDL-C (LDL) mensuration kit.
Embodiment 8:
Using product of the present invention as unified correction product, proofread and correct different brands manufacturer's lipid determination kit, can observation improve the comparability of provincialism lipids detection result.
Experimentation:
Use 11 domestic and international different brands manufacturers' lipid determination kit, use respectively blood fat correction product and the product of the present invention of the configuration of former factory to detect front correction to corresponding mensuration kit.Then detect clinical human serum (blood plasma) sample 19 examples.
Table 4: use the unified standard product to proofread and correct front and back relatively:
After embodiment 8 absolutely proves and uses product of the present invention to carry out standardized assignment, be applied to the different brands detection system and measure kit as standard items, reagent is unified to proofread and correct, can greatly be improved repeatability and the comparability of the testing result of different manufacturers' product and different experiments chamber.Detect 19 routine human serum (blood plasma) samples, average coefficient of variation (CV%) is dwindled 30--50%.
Claims (9)
1. people's blood fat (serum/plasma) quality management reference kit is characterized in that: contain reference reagent in described kit, described reference reagent is that to take human serum (blood plasma) be matrix, is added with therein the lipid composition containing the humanized, 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 the Triton series of surfactants, the Tween series of surfactants, the EDTA series of surfactants, polyvinyl alcohol (PVA) series polymkeric substance, the polyvinylpyrrolidone series polymer, any one or any one above combination in polyglycol series polymer and phosphate buffer, described corrosion protection system is Sodium azide, gentamicin, anphotericin, any one or any one above combination in ProClin series.
2. a kind of people's blood fat as claimed in claim 1 (serum/plasma) quality management reference kit, it is characterized in that: described Triton series of surfactants is the 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, perhaps 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) is mass percent concentration 0.001% to 10%, the whole working concentration of described polyvinylpyrrolidone 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 phosphate buffer is 1mmol/l to 1mol/l.
3. a kind of people's blood fat as claimed in claim 1 (serum/plasma) quality management reference kit, it is characterized in that: 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, and the whole working concentration of described ProClin series is mass percent concentration 0.1% to 1%.
4. a kind of people's blood fat as claimed in claim 1 (serum/plasma) quality management reference kit, it is characterized in that: described humanized's lipid composition all derives from the humanized's lipid composition in human serum (blood plasma), without adding any non-humanized or synthetic lipid composition.
5. a kind of people's blood fat as claimed in claim 1 (serum/plasma) quality management reference kit, it is characterized in that: described lipid composition and matrix are disturbed without " medium effect " substantially, during definite value, without the detection system by different brands and measure the kit definite value of being classified, the gained value data is applicable to the detection system of different brands and measures kit.
6. a kind of people's blood fat as claimed in claim 1 (serum/plasma) quality management reference kit, it is characterized in that: also comprise quality-control product, investigation product and correction product (standard items) in described kit, described investigation product refer to the quality controling product that is used to examination and survey objective.
7. a kind of people's blood fat as claimed in claim 6 (serum/plasma) quality management reference kit, it is characterized in that: but described quality-control product, investigation product underrange are used, also can be by International or National legal or specified standard detection method and generally acknowledged detection method, or the user confirms that acceptable detection system carries out the definite value use to the lipids composition.
8. a kind of people's blood fat as claimed in claim 6 (serum/plasma) quality management reference kit, it is characterized in that: described correction product (standard items) are to use International or National standard detecting method or generally acknowledged detection method to carry out assignment, correction product (standard items) have value accurately, and its value has traceability.
9. the preparation method of people's blood fat claimed in claim 1 (serum/plasma) quality management reference kit, it is characterized in that: the process that comprises the screening of a human serum (blood plasma) matrix, a process of selecting containing humanized's lipid composition, the process of a preparation systems stabilisation, a process for preparing corrosion protection system, the process that then will mix containing humanized's lipid composition, systems stabilisation and corrosion protection system.
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| CN105572208A (en) * | 2015-12-18 | 2016-05-11 | 华北制药金坦生物技术股份有限公司 | Method of identifying neonatal calf serum quality |
| CN107843469A (en) * | 2017-09-15 | 2018-03-27 | 中生北控生物科技股份有限公司 | A kind of biochemical class compound calibration object of stabilization and preparation method thereof |
| CN107923909A (en) * | 2015-08-26 | 2018-04-17 | 国立大学法人大阪大学 | The householder method that type III hyperlipidemia judges |
| CN108139400A (en) * | 2015-08-07 | 2018-06-08 | 乌尔里希·帕什曼 | The method for determining epithelial cell concentration in blood sample or aspiration sample |
| CN108169467A (en) * | 2017-11-27 | 2018-06-15 | 中国科学院苏州生物医学工程技术研究所 | A kind of thrombelastogram instrument quality-control product and its preparation method and application |
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| CN104356227A (en) * | 2014-11-11 | 2015-02-18 | 浙江蓝怡医药有限公司 | Efficient method for concentration and extraction of lipids, lipoprotein and apolipoprotein in serum |
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| CN108169467A (en) * | 2017-11-27 | 2018-06-15 | 中国科学院苏州生物医学工程技术研究所 | A kind of thrombelastogram instrument quality-control product and its preparation method and application |
| 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 |
| 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 |
| 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 |
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| 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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