CN105572384A - High-cost-performance human blood immune globulin G detection reagent kit - Google Patents
High-cost-performance human blood immune globulin G detection reagent kit Download PDFInfo
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Abstract
The invention discloses a high-cost-performance human blood immune globulin G detection reagent knit and a preparation method thereof. The reagent kit comprises a reagent 2. The reagent 2 is the latex particle solution marked with a rabbit antihuman immune globulin G polyclonal antibody, wherein the latex particle size range is 40-120 nm, and the consumption of the antibody in per liter of the reagent 2 is 20-30 ml. The high-cost-performance human blood immune globulin G detection reagent knit can replace an imported reagent, disease cost is saved, and meanwhile the detection efficiency can be improved.
Description
Technical field
What the present invention relates to is biological technical field, and what be specifically related to is a kind of latex immunoturbidimetry human blood immunoglobulin G detection reagent box.
Background technology
Immunoglobulin G (being called for short IGG) is Immunoglobulin in Serum major component, and account for 75% of Immunoglobulin in Serum total content, normal value is 9.5 ~ 12.5g/L.Molecular weight is about 150000 dalton.
When trouble allergic disease, autoimmune disease, various infection and Huppert's disease etc., immunoglobulin (Ig) can increase extremely.When suffering from the immunodeficiency diseases such as acquired immunodeficiency syndrome, immunoglobulin (Ig) can reduce extremely.
The immunoglobulin G detection reagent box (immunoturbidimetry) of modal Beckman Ku Erte (hereinafter referred BC) in the market, state's food medicine prison No. 2401557th, tool (entering) word 2012, antibody is IGG antibody (treated lowlenthal serum), its properties of product are as follows: the range of linearity 2.0 ~ 36.0g/L, and antigen excess scope reaches 216.0g/L.BC is the absolute main flow in occuping market in this project detects, and super half Grade A hospital adopts its product.Although most domestic reagent low price, because the many reasons reagent performances such as technical merit all cannot be contended with BC, most reagent instructions does not mark antigen excess scope, can surmount 100g/L at present without domestic reagent antigen excess scope.Although the immunoglobulin G detection reagent of BC is very expensive, hospital, in order to ensure clinical reliability, has to adopt its reagent.The outstanding substitute products of cost performance are badly in need of in market.
Summary of the invention
In order to improve above-mentioned existing problems, the invention provides a kind of human blood immunoglobulin G detection reagent box of high performance-price ratio.
To achieve these goals, the technical solution used in the present invention is as follows:
A human blood immunoglobulin G detection reagent box for high performance-price ratio, comprises reagent 2, and described reagent 2 is for being marked with the latex particle solution of rabbit human immunoglobulins G polyclonal antibody.Wherein, reagent 1 can select conventional phosphate buffer, Good ' s damping fluid or glycine buffer etc.
What deserves to be explained is, the reagent 2 that the present invention be directed in kit improves, but common agents on the market selected by reagent 1.
Due to too low antibody use amount, when meeting sample antibody ratios and being constant, need Sample Dilution ratio to improve, cause too low sample size, reagent sensitivity cannot meet Clinical practice.Antibody amount is excessive, in labeling process, easily cause emulsion condensation, and reagent differences between batches are difficult to control, and reagent cost is too high, cannot accept.Latex particle size is too small, and reagent sensitivity cannot ensure, latex particle size is excessive, and latex microsphere particle suspends and is affected, and easy sedimentation, so latex particle particle size range of the present invention is 40nm ~ 120nm, in often liter of reagent 2, the consumption of antibody is 20ml ~ 30ml.
Particularly, the present invention adopts chemical conjugation methods to be marked on latex particle by rabbit human immunoglobulins G polyclonal antibody.
Preferred as one, when described kit detects sample, the weight ratio of sample and antibody is 1:48 ~ 1:32.By above-mentioned restriction, can avoid sample and antibody ratios too high or too low because sample and antibody ratios too high, antigen excess in reaction system will be caused, reduce the antigen excess scope even range of linearity of reagent; Time too low, very little, reagent sensitivity cannot meet Clinical practice will to cause antigen amount in reaction system.
Described kit detects human blood immunoglobulin G based on latex immunoturbidimetry, and its range of linearity is 2g/L ~ 60g/L, and antigen excess scope reaches 400g/L.
Particularly, described rabbit human immunoglobulins G polyclonal antibody is the rabbit human immunoglobulins G polyclonal antibody that Dako company produces, or is the rabbit human immunoglobulins G polyclonal antibody of the luxuriant and rich with fragrance roc biological production in Shenzhen.
In addition, described kit is applicable to the automatical analysis instrument with automated sample dilution function, as auspicious in enlightening, the multiple automatic clinical chemistry analyzer such as Mai Rui, Roche, Hitachi, Olympus, and multiple specific protein analyser, as state's Saite determines protein analyzer, Beckman Immage800 specific protein analytic system etc.
The present invention has the following advantages and beneficial effect:
1, kit of the present invention is used to measure the immunoglobulin G in human blood, because of the range of linearity comparatively import reagent raising 67%, the sample size needing manual dilution's repetition measurement is drastically reduce the area during use, manpower and reagent are significantly saved, drastically increase detection efficiency, and save cost.
2, the superfluous scope of kit antigen of the present invention is wide, compare BC reagent and improve 85%, the BC reagent of the most main flow in market can be surmounted in this performance, compare BC reagent and more can effectively avoid clinical effectiveness to be underestimated the appearance of even false negative result, meet the demand of Clinical practice.
3, kit of the present invention adopts ripe chemical coupling latex labeling method, can large-scale production, and can use by supporting most automated analysis instrument on the market, is convenient to promote the use of.
4, adopt kit of the present invention to carry out detection human blood immunoglobulin G, alternative import reagent, save sufferer spending.
Accompanying drawing explanation
Fig. 1 is the linear dilution figure of the present invention-embodiment 1.
Fig. 2 is the linear dilution figure of the present invention-embodiment 2.
Fig. 3 is the linear dilution figure of the present invention-embodiment 3.
Fig. 4 is the linear dilution figure of the present invention-embodiment 4.
Fig. 5 is the linear dilution figure of the present invention-embodiment 5.
Fig. 6 is the linear dilution figure of the present invention-embodiment 6.
Fig. 7 is the linear dilution figure of the present invention-embodiment 7.
Fig. 8 is the linear dilution figure of the present invention-embodiment 8.
Fig. 9 is the linear dilution figure of the present invention-embodiment 9.
Figure 10 is the linear dilution figure of the present invention-embodiment 10.
Figure 11 is the linear dilution figure of the present invention-embodiment 11.
Embodiment
Below in conjunction with embodiment, the invention will be further described, but embodiments of the present invention are not limited to the following example.
Immune detection (comprising immunoturbidimetry and latex immunoturbidimetry) needs to follow Heiden and wins lattice principle, visible Baidupedia antigen-antibody reaction principle, the ratio of antigen-antibody is particularly important in testing process, antibody concentration one timing in reaction system, along with the increase of antigen concentration, antigen antibody complex precipitation increases, reach balance gradually, when antigen concentration is too high, to occur that precipitation depolymerization does not even produce the situation of precipitation, i.e. HOOK effect or antigen excess phenomenon (Antigenexcess), in immune detection system, this phenomenon will cause measured object concentration to be underestimated even false negative result occurring.All immune detection, comprise immunoturbidimetry and latex immunoturbidimetry, and high concentration sample all must be avoided to occur HOOK effect.Such as detect immunoglobulin G with regard to needing to avoid allergic disease, autoimmune disease, the sufferer of various infection and Huppert's disease occurs that measured value is underestimated even false negative result.When sample and reagent 2 ratio certain, in reagent 2 antibody use amount and tire most important for the ability (i.e. antigen excess scope) of reagent opposing HOOK effect.In immune diagnostic technique field, rabbit polyclonal antibody is in immunodiagnosis especially in immunoturbidimetry and latex immunoturbidimetry, because it has very high tire (titre) not available for other kind antibody, be improve to detect the selection that reagent is linear and antigen excess scope is ideal.
When immunoturbidimetry measures IGG, IGG in sample and anti-IGG antibody response, form antigen antibody complex, when the range of linearity and antigen excess scope that detect reagent are certain, because of antigen-antibody proportionality relation, add sample number directly determine the use amount detecting anti-IGG antibody in reagent.Although reduce the use amount that minimizing that sample addition can be proportional detects anti-IGG antibody in reagent, thus reduce and detect reagent cost, reduce the sensitivity that simultaneously proportional reduction is detected reagent by sample size.
Latex immunoturbidimetry can increase substantially detection reagent sensitivity, the limit detection sensitivity of immunoturbidimetry is risen to 5 μ g/L from 5 ㎎/L, inventor is in human blood IGG detects, and employing latex immunoturbidimetry effectively can offset the detection reagent sensitivity reduction impact reducing sample size and bring; And most automatical analysis instrument has the automatic pre-dilution function of sample on the market, as auspicious in enlightening, automatic clinical chemistry analyzer and the multiple specific protein analyser such as Mai Rui, Roche, Hitachi, Olympus, as state's Saite determines protein analyzer, Beckman Immage800 specific protein analytic systems etc., can be joined in reaction system by instrument beforehand dilution sample again.Inventor studies discovery, by regulating sample automatic dilution ratio, can while significantly reducing IGG antibody use amount, and the linear and antigen excess scope of guarantee reagent, meets or exceeds the reagent performance of BC.So the present inventor investigated following kit.
Embodiment 1
The latex particle particle diameter of the present embodiment is 90nm, often liter of reagent 2 marks the rabbit human immunoglobulins G polyclonal antibody (article No.: Q0331) of Dako company of 25ml Denmark production, use phosphate buffer the most conventional in latex immunoturbidimetry as reagent 1, adopt the most common parameters reagent 1 of automatic analyzer: reagent 2 ratio 180 μ l:60 μ l, adds the diluted sample of 3 μ l to (namely sample and antibody ratios are 1:40) in reaction system after sample beforehand dilution 80 times.
Use Hitachi7170 automatic clinical chemistry analyzer, wavelength is 600nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows:
Table 1 calibration data
| Calibration object Nong Du ㎎/L | 0 | 5 | 10 | 20 | 40 | 60 |
| Absorbance changing value | 10 | 992 | 1917 | 3897 | 7344 | 10332 |
Table 2 linearly dilutes
| Dilution ratio | 5% | 10% | 25% | 50% | 75% | 100% |
| Gu Ji Zhi ㎎/L | 3.06385 | 6.077 | 15.11645 | 30.1822 | 45.24795 | 60.3137 |
| Shi Ce Zhi ㎎/L | 3.1 | 6 | 15.2 | 30.1 | 45.3 | 60.3 |
| Deviation | 1.18% | -1.27% | 0.55% | -0.27% | 0.12% | -0.02% |
Specifically as shown in Figure 1, in figure, equation is equation of linear regression, R
2for linear coefficient, estimated value brings regression equation calculation into according to dilution ratio, R > 0.99, estimated value and measured value deviation < 10%, then it is linearly qualified to illustrate.
Table 3 Monitoring lower-cut
| Nong Du ㎎/L | 1 | 2 | 3 | 4 |
| Precision CV | 5.77% | 4.32% | 3.12% | 2.78% |
| Acceptability limit | ＜20% | ＜20% | ＜20% | ＜20% |
Table 4 antigen excess is verified
| Theoretical Zhi ㎎/L | Shi Ce Zhi ㎎/L | Remarks |
| 6 | 5.9 | In the range of linearity |
| 12 | 11.9 | In the range of linearity |
| 24 | 23.8 | In the range of linearity |
| 48 | 48.1 | In the range of linearity |
| 72 | 66.3 | Ultralinear |
| 96 | 79.4 | Ultralinear |
| 120 | 85.2 | Ultralinear |
| 168 | 80.3 | Ultralinear |
| 216 | 75.2 | Ultralinear |
| 288 | 69.1 | Ultralinear |
| 360 | 63.6 | Ultralinear |
| 408 | 62.3 | Ultralinear |
| 456 | 61.2 | Ultralinear |
| 504 | 59.3 | Antigen excess |
As can be seen from table 1 ~ 4, the IGG reagent of embodiment 1, linear dilution measured value and estimated value deviation < 10% is met in 2g/L ~ 60g/L, and Monitoring lower-cut also can reach 2 ㎎/L(precision CV < 20%), meet national relevant laws and regulations requirement, prove that the range of linearity reaches 2g/L ~ 60g/L; In addition, as can be seen from antigen excess checking, actual antigen excess scope reaches 456g/L, meets the requirement that antigen excess scope reaches 400g/L.
Embodiment 2
The latex particle particle diameter of the present embodiment is 40nm, often liter of reagent 2 marks the rabbit human immunoglobulins G polyclonal antibody (article No.: Q0331) of Dako company of 20ml Denmark production, use phosphate buffer the most conventional in latex immunoturbidimetry as reagent 1, adopt the most common parameters reagent 1 of automatic analyzer: reagent 2 ratio 180 μ l:60 μ l, adds the diluted sample of 3 μ l to (namely sample and antibody ratios are 1:32) in reaction system after sample beforehand dilution 80 times.
Use Hitachi7170 automatic clinical chemistry analyzer, wavelength is 600nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 5 calibration data
| Calibration object Nong Du ㎎/L | 0 | 5 | 10 | 20 | 40 | 60 |
| Absorbance changing value | 8 | 284 | 589 | 1239 | 2345 | 3121 |
Table 6 linearly dilutes
| Dilution ratio | 5% | 10% | 25% | 50% | 75% | 100% |
| Gu Ji Zhi ㎎/L | 3.25285 | 6.2674 | 15.31105 | 30.3838 | 45.45655 | 60.5293 |
| Shi Ce Zhi ㎎/L | 3.2 | 6.2 | 15.5 | 30.5 | 45.1 | 60.7 |
| Deviation | -1.62% | -1.08% | 1.23% | 0.38% | -0.78% | 0.28% |
Specifically as shown in Figure 2, in figure, equation is equation of linear regression, R
2for linear coefficient, estimated value brings regression equation calculation into according to dilution ratio, R > 0.99, estimated value and measured value deviation < 10%, then it is linearly qualified to illustrate.
Table 7 Monitoring lower-cut
| Nong Du ㎎/L | 1 | 2 | 3 | 4 |
| Precision CV | 27.21% | 18.30% | 13.28% | 8.34% |
| Acceptability limit | ＜20% | ＜20% | ＜20% | ＜20% |
Table 8 antigen excess is verified
| Theoretical Zhi ㎎/L | Shi Ce Zhi ㎎/L | Remarks |
| 6 | 6.1 | In the range of linearity |
| 12 | 12.1 | In the range of linearity |
| 24 | 24.3 | In the range of linearity |
| 48 | 47.9 | In the range of linearity |
| 72 | 64.2 | Ultralinear |
| 96 | 77.3 | Ultralinear |
| 120 | 81.2 | Ultralinear |
| 168 | 78.7 | Ultralinear |
| 216 | 75.3 | Ultralinear |
| 288 | 69.5 | Ultralinear |
| 360 | 64.2 | Ultralinear |
| 408 | 61.3 | Ultralinear |
| 456 | 59.3 | Antigen excess |
| 504 | 57.2 | Antigen excess |
As can be seen from table 5 ~ 8, the IGG reagent of embodiment 2, linear dilution measured value and estimated value deviation < 10% is met in 2g/L ~ 60g/L, and Monitoring lower-cut also can reach 2g/L(precision CV < 20%), meet national relevant laws and regulations requirement, prove that the range of linearity reaches 2g/L ~ 60g/L; In addition, as can be seen from antigen excess checking, actual antigen excess scope reaches 408g/L, meets the requirement that antigen excess scope reaches 400g/L.But reagent sensitivity is also close to the limit.Reduce latex particle size again and cannot meet Monitoring lower-cut demand.And antigen excess is also close to the limit, then reduces antibody and can not ensure that linear and antigen excess scope satisfies the demands.
Embodiment 3
The latex particle particle diameter of the present embodiment is 90nm, often liter of reagent 2 marks the rabbit human immunoglobulins G polyclonal antibody (article No.: Q0331) of Dako company of 20ml Denmark production, use phosphate buffer the most conventional in latex immunoturbidimetry as reagent 1, adopt the most common parameters reagent 1 of automatic analyzer: reagent 2 ratio 180 μ l:60 μ l, adds the diluted sample of 3 μ l to (namely sample and antibody ratios are 1:32) in reaction system after sample beforehand dilution 80 times.
Use Hitachi7170 automatic clinical chemistry analyzer, wavelength is 600nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 9 calibration data
| Calibration object Nong Du ㎎/L | 0 | 5 | 10 | 20 | 40 | 60 |
| Absorbance changing value | 10 | 699 | 1311 | 2511 | 4577 | 6123 |
Table 10 linearly dilutes
| Dilution ratio | 5% | 10% | 25% | 50% | 75% | 100% |
| Gu Ji Zhi ㎎/L | 2.9902 | 6.0106 | 15.0718 | 30.1738 | 45.2758 | 60.3778 |
| Shi Ce Zhi ㎎/L | 3 | 5.9 | 15.1 | 30.3 | 45.3 | 60.3 |
| Deviation | 0.33% | -1.84% | 0.19% | 0.42% | 0.05% | -0.13% |
Specifically as shown in Figure 3, in figure, equation is equation of linear regression, R
2for linear coefficient, estimated value brings regression equation calculation into according to dilution ratio, R > 0.99, estimated value and measured value deviation < 10%, then it is linearly qualified to illustrate.
Table 11 Monitoring lower-cut
| Nong Du ㎎/L | 1 | 2 | 3 | 4 |
| Precision CV | 21.34% | 16.34% | 11.34% | 6.18% |
| Acceptability limit | ＜20% | ＜20% | ＜20% | ＜20% |
Table 12 antigen excess is verified
| Theoretical Zhi ㎎/L | Shi Ce Zhi ㎎/L | Remarks |
| 6 | 6 | In the range of linearity |
| 12 | 12.2 | In the range of linearity |
| 24 | 24.1 | In the range of linearity |
| 48 | 48.2 | In the range of linearity |
| 72 | 63.1 | Ultralinear |
| 96 | 76.3 | Ultralinear |
| 120 | 80.3 | Ultralinear |
| 168 | 77.9 | Ultralinear |
| 216 | 74.7 | Ultralinear |
| 288 | 68.9 | Ultralinear |
| 360 | 63.9 | Ultralinear |
| 408 | 61.6 | Ultralinear |
| 456 | 59.4 | Antigen excess |
| 504 | 58.3 | Antigen excess |
As can be seen from table 9 ~ 12, the IGG reagent of embodiment 3, linear dilution measured value and estimated value deviation < 10% is met in 2g/L ~ 60g/L, and Monitoring lower-cut also can reach 2g/L(precision CV < 20%), meet national relevant laws and regulations requirement, prove that the range of linearity reaches 2g/L ~ 60g/L; In addition, as can be seen from antigen excess checking, actual antigen excess scope reaches 408g/L, meets the requirement that antigen excess scope reaches 400g/L.But antigen excess is also close to the limit, then reduces antibody and can not ensure that linear and antigen excess scope satisfies the demands.
Embodiment 4
The latex particle particle diameter of the present embodiment is 120nm, often liter of reagent 2 marks the rabbit human immunoglobulins G polyclonal antibody (article No.: Q0331) of Dako company of 20ml Denmark production, use phosphate buffer the most conventional in latex immunoturbidimetry as reagent 1, adopt the most common parameters reagent 1 of automatic analyzer: reagent 2 ratio 180 μ l:60 μ l, adds the diluted sample of 3 μ l to (namely sample and antibody ratios are 1:32) in reaction system after sample beforehand dilution 80 times.
Use Hitachi7170 automatic clinical chemistry analyzer, wavelength is 600nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 13 calibration data
| Calibration object Nong Du ㎎/L | 0 | 5 | 10 | 20 | 40 | 60 |
| Absorbance changing value | 10 | 1501 | 2917 | 5688 | 10133 | 12335 |
Table 14 linearly dilutes
| Dilution ratio | 5% | 10% | 25% | 50% | 75% | 100% |
| Gu Ji Zhi ㎎/L | 3.24025 | 6.2436 | 15.25365 | 30.2704 | 45.28715 | 60.3039 |
| Shi Ce Zhi ㎎/L | 3.2 | 6.2 | 15.3 | 30.2 | 45.6 | 60.1 |
| Deviation | -1.24% | -0.70% | 0.30% | -0.25% | 0.69% | -0.34% |
Specifically as shown in Figure 4, in figure, equation is equation of linear regression, R
2for linear coefficient, estimated value brings regression equation calculation into according to dilution ratio, R > 0.99, estimated value and measured value deviation < 10%, then it is linearly qualified to illustrate.
Table 15 Monitoring lower-cut
| Nong Du ㎎/L | 1 | 2 | 3 | 4 |
| Precision CV | 4.47% | 4.12% | 3.82% | 3.02% |
| Acceptability limit | ＜20% | ＜20% | ＜20% | ＜20% |
Table 16 antigen excess is verified
| Theoretical Zhi ㎎/L | Shi Ce Zhi ㎎/L | Remarks |
| 6 | 5.9 | In the range of linearity |
| 12 | 12.1 | In the range of linearity |
| 24 | 24.1 | In the range of linearity |
| 48 | 48.2 | In the range of linearity |
| 72 | 64.1 | Ultralinear |
| 96 | 73.2 | Ultralinear |
| 120 | 77.3 | Ultralinear |
| 168 | 73.2 | Ultralinear |
| 216 | 70.1 | Ultralinear |
| 288 | 65.2 | Ultralinear |
| 360 | 62.1 | Ultralinear |
| 408 | 60.4 | Ultralinear |
| 456 | 58.3 | Antigen excess |
| 504 | 56.1 | Antigen excess |
As can be seen from table 13 ~ 16, the IGG reagent of embodiment 4, linear dilution measured value and estimated value deviation < 10% is met in 2g/L ~ 60g/L, and Monitoring lower-cut also can reach 2g/L(precision CV < 20%), meet national relevant laws and regulations requirement, prove that the range of linearity reaches 2g/L ~ 60g/L; In addition, as can be seen from antigen excess checking, actual antigen excess scope reaches 408g/L, meets the requirement that antigen excess scope reaches 400g/L.But reagent sensitivity is also close to the limit.Reduce latex particle size again and cannot meet Monitoring lower-cut demand.And antigen excess is also close to the limit, then reduces antibody and can not ensure that linear and antigen excess scope satisfies the demands.
Embodiment 5
The latex particle particle diameter of the present embodiment is 40nm, often liter of reagent 2 marks the rabbit human immunoglobulins G polyclonal antibody (article No.: Q0331) of Dako company of 30ml Denmark production, use phosphate buffer the most conventional in latex immunoturbidimetry as reagent 1, adopt the most common parameters reagent 1 of automatic analyzer: reagent 2 ratio 180 μ l:60 μ l, adds the diluted sample of 3 μ l to (namely sample and antibody ratios are 1:32) in reaction system after sample beforehand dilution 53.3 times.
Use Hitachi7170 automatic clinical chemistry analyzer, wavelength is 600nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 17 calibration data
| Calibration object Nong Du ㎎/L | 0 | 5 | 10 | 20 | 40 | 60 |
| Absorbance changing value | 8 | 376 | 745 | 1498 | 2919 | 4011 |
Table 18 linearly dilutes
| Dilution ratio | 5% | 10% | 25% | 50% | 75% | 100% |
| Gu Ji Zhi ㎎/L | 2.8575 | 5.8821 | 14.9559 | 30.0789 | 45.2019 | 60.3249 |
| Shi Ce Zhi ㎎/L | 2.9 | 5.9 | 14.9 | 30.2 | 44.9 | 60.5 |
| Deviation | 1.49% | 0.30% | -0.37% | 0.40% | -0.67% | 0.29% |
Specifically as shown in Figure 5, in figure, equation is equation of linear regression, R
2for linear coefficient, estimated value brings regression equation calculation into according to dilution ratio, R > 0.99, estimated value and measured value deviation < 10%, then it is linearly qualified to illustrate.
Table 19 Monitoring lower-cut
| Nong Du ㎎/L | 1 | 2 | 3 | 4 |
| Precision CV | 24.33% | 17.32% | 12.15% | 7.99% |
| Acceptability limit | ＜20% | ＜20% | ＜20% | ＜20% |
Table 20 antigen excess is verified
| Theoretical Zhi ㎎/L | Shi Ce Zhi ㎎/L | Remarks |
| 6 | 6 | In the range of linearity |
| 12 | 12 | In the range of linearity |
| 24 | 24.1 | In the range of linearity |
| 48 | 48.2 | In the range of linearity |
| 72 | 63.7 | Ultralinear |
| 96 | 76.8 | Ultralinear |
| 120 | 80.3 | Ultralinear |
| 168 | 77.5 | Ultralinear |
| 216 | 74.8 | Ultralinear |
| 288 | 68.9 | Ultralinear |
| 360 | 64.3 | Ultralinear |
| 408 | 61 | Ultralinear |
| 456 | 59.2 | Antigen excess |
| 504 | 57.2 | Antigen excess |
As can be seen from table 17 ~ 20, the IGG reagent of embodiment 5, linear dilution measured value and estimated value deviation < 10% is met in 2g/L ~ 60g/L, and Monitoring lower-cut also can reach 2g/L(precision CV < 20%), meet national relevant laws and regulations requirement, prove that the range of linearity reaches 2g/L ~ 60g/L; In addition, as can be seen from antigen excess checking, actual antigen excess scope reaches 408g/L, meets the requirement that antigen excess scope reaches 400g/L.But reagent sensitivity is also close to the limit.Reduce latex particle size again and cannot meet Monitoring lower-cut demand.And antigen excess is also close to the limit, then increases sample and antigen ratio and can not ensure that linear and antigen excess scope meets the demands, improving antibody use amount cost cannot accept, and antibody is too much, and production technology is difficult to ensure difference between batch.
Embodiment 6
The latex particle particle diameter of the present embodiment is 120nm, often liter of reagent 2 marks the rabbit human immunoglobulins G polyclonal antibody (article No.: Q0331) of Dako company of 30ml Denmark production, use phosphate buffer the most conventional in latex immunoturbidimetry as reagent 1, adopt the most common parameters reagent 1 of automatic analyzer: reagent 2 ratio 180 μ l:60 μ l, adds the diluted sample of 3 μ l to (namely sample and antibody ratios are 1:32) in reaction system after sample beforehand dilution 53.3 times.
Use Hitachi7170 automatic clinical chemistry analyzer, wavelength is 600nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 21 calibration data
| Calibration object Nong Du ㎎/L | 0 | 5 | 10 | 20 | 40 | 60 |
| Absorbance changing value | 7 | 1598 | 3015 | 5799 | 10423 | 12735 |
Table 22 linearly dilutes
| Dilution ratio | 5% | 10% | 25% | 50% | 75% | 100% |
| Gu Ji Zhi ㎎/L | 2.8527 | 5.8694 | 14.9195 | 30.003 | 45.0865 | 60.17 |
| Shi Ce Zhi ㎎/L | 2.9 | 6 | 14.8 | 29.9 | 45 | 60.3 |
| Deviation | 1.66% | 2.23% | -0.80% | -0.34% | -0.19% | 0.22% |
Specifically as shown in Figure 6, in figure, equation is equation of linear regression, R
2for linear coefficient, estimated value brings regression equation calculation into according to dilution ratio, R > 0.99, estimated value and measured value deviation < 10%, then it is linearly qualified to illustrate.
Table 23 Monitoring lower-cut
| Nong Du ㎎/L | 1 | 2 | 3 | 4 |
| Precision CV | 4.22% | 3.85% | 3.67% | 2.99% |
| Acceptability limit | ＜20% | ＜20% | ＜20% | ＜20% |
Table 24 antigen excess is verified
| Theoretical Zhi ㎎/L | Shi Ce Zhi ㎎/L | Remarks |
| 6 | 5.8 | In the range of linearity |
| 12 | 11.9 | In the range of linearity |
| 24 | 23.9 | In the range of linearity |
| 48 | 48.1 | In the range of linearity |
| 72 | 64.3 | Ultralinear |
| 96 | 73.5 | Ultralinear |
| 120 | 75.3 | Ultralinear |
| 168 | 72.8 | Ultralinear |
| 216 | 69.8 | Ultralinear |
| 288 | 65.2 | Ultralinear |
| 360 | 62.2 | Ultralinear |
| 408 | 60.5 | Ultralinear |
| 456 | 58.5 | Antigen excess |
| 504 | 56.3 | Antigen excess |
As can be seen from table 21 ~ 24, the IGG reagent of embodiment 6, linear dilution measured value and estimated value deviation < 10% is met in 2g/L ~ 60g/L, and Monitoring lower-cut also can reach 2g/L(precision CV < 20%), meet national relevant laws and regulations requirement, prove that the range of linearity reaches 2g/L ~ 60g/L; In addition, as can be seen from antigen excess checking, actual antigen excess scope reaches 408g/L, meets the requirement that antigen excess scope reaches 400g/L.Antigen excess also close to the limit, then increases sample and antigen ratio and can not ensure that linear and antigen excess scope meets the demands, and improving antibody use amount cost cannot accept, and antibody is too much, and production technology is difficult to ensure difference between batch.
Embodiment 7
The latex particle particle diameter of the present embodiment is 120nm, often liter of reagent 2 marks the rabbit human immunoglobulins G polyclonal antibody (article No.: Q0331) of Dako company of 30ml Denmark production, use phosphate buffer the most conventional in latex immunoturbidimetry as reagent 1, adopt the most common parameters reagent 1 of automatic analyzer: reagent 2 ratio 180 μ l:60 μ l, adds the diluted sample of 3 μ l to (namely sample and antibody ratios are 1:48) in reaction system after sample beforehand dilution 80 times.
Use Hitachi7170 automatic clinical chemistry analyzer, wavelength is 600nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 25 calibration data
| Calibration object Nong Du ㎎/L | 0 | 5 | 10 | 20 | 40 | 60 |
| Absorbance changing value | 7 | 803 | 1537 | 2999 | 5633 | 7533 |
Table 26 linearly dilutes
| Dilution ratio | 5% | 10% | 25% | 50% | 75% | 100% |
| Gu Ji Zhi ㎎/L | 2.99265 | 6.017 | 15.09005 | 30.2118 | 45.33355 | 60.4553 |
| Shi Ce Zhi ㎎/L | 3 | 6.1 | 15.1 | 30.1 | 45.2 | 60.6 |
| Deviation | 0.25% | 1.38% | 0.07% | -0.37% | -0.29% | 0.24% |
Specifically as shown in Figure 7, in figure, equation is equation of linear regression, R
2for linear coefficient, estimated value brings regression equation calculation into according to dilution ratio, R > 0.99, estimated value and measured value deviation < 10%, then it is linearly qualified to illustrate.
Table 27 Monitoring lower-cut
| Nong Du ㎎/L | 1 | 2 | 3 | 4 |
| Precision CV | 10.35% | 8.22% | 4.78% | 4.32% |
| Acceptability limit | ＜20% | ＜20% | ＜20% | ＜20% |
Table 28 antigen excess is verified
| Theoretical Zhi ㎎/L | Shi Ce Zhi ㎎/L | Remarks |
| 6 | 6 | In the range of linearity |
| 12 | 12.1 | In the range of linearity |
| 24 | 24.1 | In the range of linearity |
| 48 | 48 | In the range of linearity |
| 72 | 66.3 | Ultralinear |
| 96 | 78.2 | Ultralinear |
| 120 | 83.2 | Ultralinear |
| 168 | 85.3 | Ultralinear |
| 216 | 82.1 | Ultralinear |
| 288 | 76.8 | Ultralinear |
| 360 | 71.3 | Ultralinear |
| 408 | 67.2 | Ultralinear |
| 456 | 64.3 | Ultralinear |
| 504 | 60.2 | Ultralinear |
As can be seen from table 25 ~ 28, the IGG reagent of embodiment 7, linear dilution measured value and estimated value deviation < 10% is met in 2g/L ~ 60g/L, and Monitoring lower-cut also can reach 2g/L(precision CV < 20%), meet national relevant laws and regulations requirement, prove that the range of linearity reaches 2g/L ~ 60g/L; In addition, as can be seen from antigen excess checking, actual antigen excess scope reaches 504g/L, meets the requirement that antigen excess scope reaches 400g/L.But antibody consumption is too large, is in the Limiting Level of marking process, and high cost.
Embodiment 8
The latex particle particle diameter of the present embodiment is 120nm, often liter of reagent 2 marks the rabbit human immunoglobulins G polyclonal antibody (article No.: Q0331) of Dako company of 30ml Denmark production, use phosphate buffer the most conventional in latex immunoturbidimetry as reagent 1, adopt the most common parameters reagent 1 of automatic analyzer: reagent 2 ratio 180 μ l:60 μ l, adds the diluted sample of 3 μ l to (namely sample and antibody ratios are 1:40) in reaction system after sample beforehand dilution 66.7 times.
Use Hitachi7170 automatic clinical chemistry analyzer, wavelength is 600nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 29 calibration data
| Calibration object Nong Du ㎎/L | 0 | 5 | 10 | 20 | 40 | 60 |
| Absorbance changing value | 6 | 999 | 1933 | 3687 | 6834 | 9322 |
Table 30 linearly dilutes
| Dilution ratio | 5% | 10% | 25% | 50% | 75% | 100% |
| Gu Ji Zhi ㎎/L | 3.008 | 6.0091 | 15.0124 | 30.0179 | 45.0234 | 60.0289 |
| Shi Ce Zhi ㎎/L | 3 | 6.1 | 14.9 | 30.1 | 44.9 | 60.1 |
| Deviation | -0.27% | 1.51% | -0.75% | 0.27% | -0.27% | 0.12% |
Specifically as shown in Figure 8, in figure, equation is equation of linear regression, R
2for linear coefficient, estimated value brings regression equation calculation into according to dilution ratio, R > 0.99, estimated value and measured value deviation < 10%, then it is linearly qualified to illustrate.
Table 31 Monitoring lower-cut
| Nong Du ㎎/L | 1 | 2 | 3 | 4 |
| Precision CV | 8.33% | 6.52% | 4.53% | 4.06% |
| Acceptability limit | ＜20% | ＜20% | ＜20% | ＜20% |
Table 32 antigen excess is verified
| Theoretical Zhi ㎎/L | Shi Ce Zhi ㎎/L | Remarks |
| 6 | 6 | In the range of linearity |
| 12 | 12.1 | In the range of linearity |
| 24 | 23.9 | In the range of linearity |
| 48 | 47.8 | In the range of linearity |
| 72 | 64.5 | Ultralinear |
| 96 | 76.3 | Ultralinear |
| 120 | 80.2 | Ultralinear |
| 168 | 82.1 | Ultralinear |
| 216 | 78.3 | Ultralinear |
| 288 | 73.2 | Ultralinear |
| 360 | 67.3 | Ultralinear |
| 408 | 63.2 | Ultralinear |
| 456 | 60.2 | Ultralinear |
| 504 | 58.1 | Antigen excess |
As can be seen from table 29 ~ 32, the IGG reagent of embodiment 8, linear dilution measured value and estimated value deviation < 10% is met in 2g/L ~ 60g/L, and Monitoring lower-cut also can reach 2g/L(precision CV < 20%), meet national relevant laws and regulations requirement, prove that the range of linearity reaches 2g/L ~ 60g/L; In addition, as can be seen from antigen excess checking, actual antigen excess scope reaches 456g/L, meets the requirement that antigen excess scope reaches 400g/L.But antibody consumption is too large, is in the Limiting Level of marking process, and high cost.
Can be found out by embodiment 2 ~ 4 contrast, when antibody consumption and antigen-antibody ratio certain, improve latex particle particle diameter and be conducive to reagent sensitivity, but because the restriction of instrument maximum detection range, unrestrictedly can not improve latex particle size, preferred latex particle size scope is 40nm ~ 120nm.
By embodiment 2 comparative example 5, embodiment 4 comparative example 6 can find out, when latex particle particle diameter and antigen-antibody ratio certain, improve antibody consumption, be conducive to improving sensitivity, but be subject to marking process and cost restriction, can not unrestrictedly improve antibody amount, preferred antibody uses volume range often to rise reagent 2 for 20ml ~ 30ml/.
By comparative example 7 and embodiment 8, when latex particle size and antibody use amount certain, can find out that antigen and antibody ratios are when increasing, sensitivity improves, but antigen excess scope declines, otherwise sensitivity declines, antigen excess scope improves, so, control antigen-antibody ratio can effectively to guarantee within the specific limits the linear and antigen excess of reagent, preferred as one, antigen-antibody proportional range is 1:48 ~ 1:32.
Embodiment 9
The latex particle particle diameter of the present embodiment is 90nm, often liter of reagent 2 marks the rabbit human immunoglobulins G polyclonal antibody (article No.: Q0331) of Dako company of 25ml Denmark production, use Good ' s damping fluid the most conventional in latex immunoturbidimetry as reagent 1, adopt the most common parameters reagent 1 of automatic analyzer: reagent 2 ratio 180 μ l:60 μ l, adds the diluted sample of 3 μ l to (namely sample and antibody ratios are 1:40) in reaction system after sample beforehand dilution 80 times.
Use Hitachi7170 automatic clinical chemistry analyzer, wavelength is 600nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows:
Table 33 calibration data
| Calibration object Nong Du ㎎/L | 0 | 5 | 10 | 20 | 40 | 60 |
| Absorbance changing value | 7 | 983 | 1892 | 3811 | 7283 | 10151 |
Table 34 linearly dilutes
| Dilution ratio | 5% | 10% | 25% | 50% | 75% | 100% |
| Gu Ji Zhi ㎎/L | 3.08345 | 6.0877 | 15.10045 | 30.1217 | 45.14295 | 60.1642 |
| Shi Ce Zhi ㎎/L | 3.2 | 6.1 | 15.1 | 30 | 44.9 | 60.4 |
| Deviation | 3.78% | 0.20% | 0.00% | -0.40% | -0.54% | 0.39% |
Specifically as shown in Figure 9, in figure, equation is equation of linear regression, R
2for linear coefficient, estimated value brings regression equation calculation into according to dilution ratio, R > 0.99, estimated value and measured value deviation < 10%, then it is linearly qualified to illustrate.
Table 35 Monitoring lower-cut
| Nong Du ㎎/L | 1 | 2 | 3 | 4 |
| Precision CV | 6.12% | 5.01% | 3.72% | 3.04% |
| Acceptability limit | ＜20% | ＜20% | ＜20% | ＜20% |
Table 36 antigen excess is verified
| Theoretical Zhi ㎎/L | Shi Ce Zhi ㎎/L | Remarks |
| 6 | 6 | In the range of linearity |
| 12 | 12.1 | In the range of linearity |
| 24 | 24.1 | In the range of linearity |
| 48 | 48 | In the range of linearity |
| 72 | 66.4 | Ultralinear |
| 96 | 79.5 | Ultralinear |
| 120 | 85.4 | Ultralinear |
| 168 | 80.2 | Ultralinear |
| 216 | 75.6 | Ultralinear |
| 288 | 69.9 | Ultralinear |
| 360 | 64.9 | Ultralinear |
| 408 | 62.8 | Ultralinear |
| 456 | 61.7 | Ultralinear |
| 504 | 59.8 | Antigen excess |
As can be seen from table 33 ~ 36, the IGG reagent of embodiment 9, linear dilution measured value and estimated value deviation < 10% is met in 2g/L ~ 60g/L, and Monitoring lower-cut also can reach 2 ㎎/L(precision CV < 20%), meet national relevant laws and regulations requirement, prove that the range of linearity reaches 2g/L ~ 60g/L; In addition, as can be seen from antigen excess checking, actual antigen excess scope reaches 456g/L, meets the requirement that antigen excess scope reaches 400g/L.
Embodiment 10
The latex particle particle diameter of the present embodiment is 90nm, often liter of reagent 2 marks the rabbit human immunoglobulins G polyclonal antibody (article No.: Q0331) of Dako company of 25ml Denmark production, use glycine buffer the most conventional in latex immunoturbidimetry as reagent 1, adopt the most common parameters reagent 1 of automatic analyzer: reagent 2 ratio 180 μ l:60 μ l, adds the diluted sample of 3 μ l to (namely sample and antibody ratios are 1:40) in reaction system after sample beforehand dilution 80 times.
Use Hitachi7170 automatic clinical chemistry analyzer, wavelength is 600nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows:
Table 37 calibration data
| Calibration object Nong Du ㎎/L | 0 | 5 | 10 | 20 | 40 | 60 |
| Absorbance changing value | 12 | 1011 | 2009 | 3972 | 7418 | 10532 |
Table 38 linearly dilutes
| Dilution ratio | 5% | 10% | 25% | 50% | 75% | 100% |
| Gu Ji Zhi ㎎/L | 3.0607 | 6.0785 | 15.1319 | 30.2209 | 45.3099 | 60.3989 |
| Shi Ce Zhi ㎎/L | 3 | 6.1 | 15.3 | 30.1 | 45.2 | 60.5 |
| Deviation | -1.98% | 0.35% | 1.11% | -0.40% | -0.24% | 0.17% |
Specifically as shown in Figure 10, in figure, equation is equation of linear regression, R
2for linear coefficient, estimated value brings regression equation calculation into according to dilution ratio, R > 0.99, estimated value and measured value deviation < 10%, then it is linearly qualified to illustrate.
Table 39 Monitoring lower-cut
| Nong Du ㎎/L | 1 | 2 | 3 | 4 |
| Precision CV | 5.38% | 4.02% | 2.99% | 2.53% |
| Acceptability limit | ＜20% | ＜20% | ＜20% | ＜20% |
Table 40 antigen excess is verified
| Theoretical Zhi ㎎/L | Shi Ce Zhi ㎎/L | Remarks |
| 6 | 6 | In the range of linearity |
| 12 | 12.1 | In the range of linearity |
| 24 | 24.2 | In the range of linearity |
| 48 | 48.3 | In the range of linearity |
| 72 | 65.8 | Ultralinear |
| 96 | 78.7 | Ultralinear |
| 120 | 84.1 | Ultralinear |
| 168 | 79.6 | Ultralinear |
| 216 | 74.6 | Ultralinear |
| 288 | 68.5 | Ultralinear |
| 360 | 64.1 | Ultralinear |
| 408 | 61.7 | Ultralinear |
| 456 | 61.2 | Ultralinear |
| 504 | 59.4 | Antigen excess |
As can be seen from table 37 ~ 40, the IGG reagent of embodiment 10, linear dilution measured value and estimated value deviation < 10% is met in 2g/L ~ 60g/L, and Monitoring lower-cut also can reach 2 ㎎/L(precision CV < 20%), meet national relevant laws and regulations requirement, prove that the range of linearity reaches 2g/L ~ 60g/L; In addition, as can be seen from antigen excess checking, actual antigen excess scope reaches 456g/L, meets the requirement that antigen excess scope reaches 400g/L.
Embodiment 11
The latex particle particle diameter of the present embodiment is 90nm, often liter of reagent 2 marks the rabbit human immunoglobulins G polyclonal antibody of 25ml Shenzhen Fei Peng company production, use phosphate buffer the most conventional in latex immunoturbidimetry as reagent 1, adopt the most common parameters reagent 1 of automatic analyzer: reagent 2 ratio 180 μ l:60 μ l, adds the diluted sample of 3 μ l to (namely sample and antibody ratios are 1:40) in reaction system after sample beforehand dilution 80 times.
Use Hitachi7170 automatic clinical chemistry analyzer, wavelength is 600nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows:
Table 41 calibration data
| Calibration object Nong Du ㎎/L | 0 | 5 | 10 | 20 | 40 | 60 |
| Absorbance changing value | 25 | 732 | 1466 | 2768 | 5120 | 7133 |
Table 42 linearly dilutes
| Dilution ratio | 5% | 10% | 25% | 50% | 75% | 100% |
| Gu Ji Zhi ㎎/L | 2.8585 | 5.8702 | 14.9053 | 29.9638 | 45.0223 | 60.0808 |
| Shi Ce Zhi ㎎/L | 2.9 | 5.9 | 14.9 | 29.9 | 44.9 | 60.2 |
| Deviation | 1.45% | 0.51% | -0.04% | -0.21% | -0.27% | 0.20% |
Specifically as shown in figure 11, in figure, equation is equation of linear regression, R
2for linear coefficient, estimated value brings regression equation calculation into according to dilution ratio, R > 0.99, estimated value and measured value deviation < 10%, then it is linearly qualified to illustrate.
Table 43 Monitoring lower-cut
| Nong Du ㎎/L | 1 | 2 | 3 | 4 |
| Precision CV | 10.32% | 7.47% | 5.88% | 4.32% |
| Acceptability limit | ＜20% | ＜20% | ＜20% | ＜20% |
Table 44 antigen excess is verified
| Theoretical Zhi ㎎/L | Shi Ce Zhi ㎎/L | Remarks |
| 6 | 6 | In the range of linearity |
| 12 | 12 | In the range of linearity |
| 24 | 23.9 | In the range of linearity |
| 48 | 47.9 | In the range of linearity |
| 72 | 63.2 | Ultralinear |
| 96 | 73.1 | Ultralinear |
| 120 | 78.2 | Ultralinear |
| 168 | 76.3 | Ultralinear |
| 216 | 71.2 | Ultralinear |
| 288 | 66.3 | Ultralinear |
| 360 | 61.9 | Ultralinear |
| 408 | 60.5 | Ultralinear |
| 456 | 58 | Antigen excess |
| 504 | 55.7 | Antigen excess |
As can be seen from table 41 ~ 44, the IGG reagent of embodiment 11, linear dilution measured value and estimated value deviation < 10% is met in 2g/L ~ 60g/L, linear coefficient R > 0.99, and Monitoring lower-cut also can reach 2 ㎎/L(precision CV < 20%), meet national relevant laws and regulations requirement, prove that the range of linearity reaches 2g/L ~ 60g/L; In addition, as can be seen from antigen excess checking, actual antigen excess scope reaches 408g/L, meets the requirement that antigen excess scope reaches 400g/L.
According to above-described embodiment, just the present invention can be realized well.
Claims (7)
1. a human blood immunoglobulin G detection reagent box for high performance-price ratio, comprises reagent 2, it is characterized in that: described reagent 2 is for being marked with the latex particle solution of rabbit human immunoglobulins G polyclonal antibody;
Wherein, described latex particle particle size range is 40nm ~ 120nm, and in often liter of reagent 2, the consumption of antibody is 20ml ~ 30ml.
2. the human blood immunoglobulin G detection reagent box of a kind of high performance-price ratio according to claim 1, is characterized in that, when described kit detects sample, the volume ratio of sample and antibody is 1:48 ~ 1:32.
3. the human blood immunoglobulin G detection reagent box of a kind of high performance-price ratio according to claim 1 and 2, is characterized in that, adopts chemical conjugation methods to be marked on latex particle by rabbit human immunoglobulins G polyclonal antibody.
4. the human blood immunoglobulin G detection reagent box of a kind of high performance-price ratio according to claim 1 and 2, it is characterized in that, described kit detects human blood immunoglobulin G based on latex immunoturbidimetry, and its range of linearity is 2g/L ~ 60g/L, and antigen excess scope reaches 400g/L.
5. the human blood immunoglobulin G detection reagent box of a kind of high performance-price ratio according to claim 1 and 2, it is characterized in that, described rabbit human immunoglobulins G polyclonal antibody is the rabbit human immunoglobulins G polyclonal antibody that Dako company of Denmark produces, or is the rabbit human immunoglobulins G polyclonal antibody of the luxuriant and rich with fragrance roc biological production in Shenzhen.
6. the human blood immunoglobulin G detection reagent box of a kind of high performance-price ratio according to claim 1 and 2, is characterized in that, described kit is applicable to the automatical analysis instrument with automated sample dilution function.
7. the human blood immunoglobulin G detection reagent box of a kind of high performance-price ratio according to claim 1 and 2, is characterized in that, also comprise reagent 1, and described reagent 1 is phosphate buffer, Good ' s damping fluid or glycine buffer.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107102153A (en) * | 2017-05-18 | 2017-08-29 | 天津市宝坻区人民医院 | LP(a) priority double reagent assay method in serum |
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| JP2001174461A (en) * | 1999-12-21 | 2001-06-29 | Dai Ichi Pure Chem Co Ltd | Immunological measurement method and measurement reagent used for it |
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