CN105785045A - High-performance detection reagent kit for human blood immunoglobulin M - Google Patents
High-performance detection reagent kit for human blood immunoglobulin M Download PDFInfo
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- CN105785045A CN105785045A CN201610227864.6A CN201610227864A CN105785045A CN 105785045 A CN105785045 A CN 105785045A CN 201610227864 A CN201610227864 A CN 201610227864A CN 105785045 A CN105785045 A CN 105785045A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6854—Immunoglobulins
Abstract
The invention relates to a high-performance detection reagent kit for human blood immunoglobulin M.The reagent kit comprises a reagent 2 which is a latex particle solution marked with a rabbit anti-human immunoglobulin M polyclonal antibody, wherein the particle size of latex particles ranges from 80 nm to 200 nm, and the dosage of the antibody in each liter of the reagent 2 ranges from 14 ml to 26 ml.The high-performance detection reagent kit can replace an imported reagent, and thus the expense of patients can be saved; meanwhile, the detection efficiency can be improved.
Description
Technical field
The present invention relates to biological technical field, particularly relate to a kind of high performance human blood immune globulin M detection reagent box.
Background technology
IgM accounts for the 5%-10% of serum immune globulin total amount, and serum-concentration is about 1mg/ml.Monomer IgM is expressed in cell surface with film conjunction type (mIgM), constitutes B cell antigen receptor (BCR).Secreting type IgM is pentamer, is the maximum Ig of molecular weight, and sedimentation coefficient is 19S, is called macroglobulin, generally can not pass through blood vessel wall, be primarily present in blood.Pentamer IgM, containing 10 Fab section, has very strong antigen binding capacity；Containing 5 Fc sections, it is more easy to activating complement than IgG.Natural blood group antibody is IgM, and the blood transfusion that blood group is not inconsistent can cause significant hemolysis reaction.IgM is the antibody of synthesis and secretion the earliest in ontogenetic process, and the fetus in fetal development late period can produce IgM, therefore Cord blood IgM raises prompting fetus and has intrauterine infection (as rubella virus or cytomegalovirus etc. infect).IgM is also the antibody occurred the earliest in Primary humoral immune response, is body anti-infective " vanguard "；Serum detects IgM prompting recently infect, can be used for the early diagnosis infected.Surface Ig M is the main component of B cell antigen receptor.Only express the mark that mIgM is immature B cells.
In course of infection, first IgM occurs, but the persistent period is not long, is the mark of recent infection.The normal reference value of IgM is 0.40～2.60g/L.
Clinical meaning
Increase: macroglobulinemia, viral hepatitis acute stage, connective tissue disease, malignant tumor, infectious monocytosis, typhoid fever, syphilis, kala azar, malaria, filaricide, mycoplasma pneumonia, rubella etc..
Lower: immunodeficiency, the multiple myeloma of IgA, IgG type, Hodgkin, chronic lymphocytic leukemia, mongolism, Protein-losing gastropathy, reticuloendothelial cell hyperplasia disease, uremia.
Detecting at present the test kit of haematogenic immunity globulin M on the market, common to there is the range of linearity relatively low, the phenomenon that antigen excess is inadequate.
Summary of the invention
In order to improve above-mentioned existing problems, the invention provides a kind of high performance human blood immune globulin M detection reagent box.
To achieve these goals, the technical solution used in the present invention is as follows:
A kind of high performance human blood immune globulin M detection reagent box, including reagent 2, described reagent 2 is the latex particle solution being marked with rabbit human immunoglobulins's M polyclonal antibody.Wherein, reagent 1 selects the phosphate buffer of routine, Good ' s buffer or glycine buffer.
What deserves to be explained is, the reagent 2 that the present invention be directed in test kit improves, but common agents on the market selected by reagent 1.
Owing to too low antibody makes consumption, when meeting sample antibody ratios and being constant, it is necessary to Sample Dilution ratio improves, and causes too low sample size, and reagent sensitivity cannot meet Clinical practice.Amount of antibody is excessive, is easily caused emulsion condensation in labeling process, and reagent differences between batches are difficult to control to, and reagent cost is too high, it is impossible to accept.Latex particle size is too small, and reagent sensitivity cannot ensure, latex particle size is excessive, and latex microsphere granule suspends and is affected, it is easy to sedimentation, so, the latex particle particle size range of the present invention is 80nm～200nm, and in every liter of reagent 2, the consumption of antibody is 14ml～26ml.
Specifically, the present invention adopts chemical conjugation methods to be marked on latex particle by rabbit human immunoglobulins's M polyclonal antibody.
Preferred as one, when sample is detected by described test kit, the volume ratio of sample and antibody is 1:6.3～1:11.7.By above-mentioned restriction, it is possible to avoid sample and antibody ratios too high or too low, because sample is too high with antibody ratios, antigen excess in reaction system will be caused, reduce the antigen excess scope even range of linearity of reagent；Time too low, causing that in reaction system, amount of antigen is very little, reagent sensitivity cannot meet Clinical practice.
Described test kit is based on latex immunoturbidimetry detection human blood IgM, and its range of linearity is 0.10g/L～12.00g/L, and antigen excess ranges up to 180g/L.
Specifically, described rabbit human immunoglobulins's M polyclonal antibody is rabbit human immunoglobulins's M polyclonal antibody that Dako company produces, or the rabbit human immunoglobulins's M polyclonal antibody for the production of GeneTex company.
It addition, described test 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.
The present invention has the following advantages and beneficial effect:
1, use the test kit of the present invention that the haematogenic immunity globulin M in human urine is measured, because the range of linearity relatively import reagent improves 2 times, the sample size needing manual dilution's repetition measurement is drastically reduce the area during use, manpower and reagent are greatly saved, drastically increase detection efficiency, and save cost.
2, the kit antigen surplus scope of the present invention is wide, effectively prevent clinical effectiveness and is underestimated the appearance of even false negative result, and it is higher that measurement result reliability compares import reagent.
3, the present invention adopts the chemical coupling latex labeling method of maturation, it is possible to large-scale production, and can use by supporting most automated analysis instruments on the market, it is simple to promote the use of.
4, the test kit of the present invention is adopted to detect, 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.
Detailed description of the invention
Below in conjunction with embodiment, the invention will be further described, but embodiments of the present invention are not limited to the following example.
The reagent major part measuring haematogenic immunity globulin M on the market is common immunoturbidimetry reagent, the major part range of linearity is narrower, this means that substantial amounts of specimen exceedes replication after reagent detection range of linearity needs dilute by hand, the specimen of waste of manpower and reagent.The present invention adopts latex immunoturbidimetry, but the while that simple latex immunoturbidimetry reagent carrying highly sensitive, reduces the reagent detection range of linearity.Most automatic clinical chemistry analyzers and specific protein analyser all have sample automatic dilution function, subsequent reactions can be participated in again with regard to first automatic dilution sample when first mensuration, namely human error is avoided, improve again efficiency, inventor finds to use appropriate ratio by studying, by the automatic pre-dilution sample of instrument, it is possible to ensureing significantly to widen while detection sensitivity meets detection demand the detection range of linearity of test kit.
Additionally, immune detection (includes latex immunoturbidimetry) to be needed to follow the rich lattice principle of tiopropamine, visible Baidupedia antigen antibody reaction principle, the ratio of antigen-antibody is particularly important in detection process, antibody concentration one timing in reaction system, increase along with antigen concentration, antigen antibody complex precipitation capacity increases, progressively reach balance, when antigen concentration is too high, will appear from the precipitation even non-setting situation of depolymerization, i.e. HOOK effect or antigen excess phenomenon (Antigenexcess), in immune detection system, this phenomenon will cause that measured object concentration is underestimated even false negative result and occurred.All of immune detection, including latex immunoturbidimetry, it is necessary to avoid high concentration sample HOOK effect occur.Such as detection haematogenic immunity globulin M is accomplished by avoiding serious systemic lupus erythematosus (sle), and malignant tumor, macroglobulinemia patient occur that measured value is underestimated even false negative result.When sample and reagent 2 ratio are certain, in reagent 2, antibody makes the ability (i.e. antigen excess scope) that consumption and titer resist HOOK effect for reagent most important.Inventor compares discovery, and rabbit human immunoglobulins's M polyclonal antibody of Dako company has very high titer (titre), and namely potent antibodies concentration is high, is the comparatively ideal selection of haematogenic immunity globulin M detection.
The haematogenic immunity globulin M reagent of Diasys company only reaches 80g/L in the range of linearity (0～8g/L) and antigen excess scope, namely the concentration sample more than 80g/L is it is possible that underestimated that (measurement result is lower than 8g/L, cannot remind doctor is the high level sample needing dilution repetition measurement) even false negative (lower than negative reference value 2.6g/L), when antigen-antibody ratio is certain, antigen excess scope and the range of linearity are inversely proportional to, particularly at area with high mercury, the range of linearity improves 1%, and antigen excess scope often decreases beyond 10%.Result: linear and antigen excess exists open defect；Macroglobulinemia is the most common person during unicellular strain IgM increases clinically, also known as Waldenstrom disease, and IgM in blood > 20g/L, namely use Diasys reagent repetition measurement after Clinical practice, the sufferer needs dilution of 80%, it is possible to false negative occurs.So the present inventor investigated following test kit, solve the problems referred to above.
Embodiment 1
The latex particle particle diameter of the present embodiment is 130nm, rabbit human immunoglobulins's M polyclonal antibody (article No.: Q0333) that every liter of reagent 2 labelling 20mlDako company produces, 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 240 μ l:60 μ l, after sample beforehand dilution 30 times, add 4 samples (namely sample and antibody ratios are 1:9) in reaction system diluted for μ l.
Using Hitachi7170 automatic clinical chemistry analyzer, wavelength is 570nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows:
Table 1 calibration data
| Calibration object concentration g/L | 0.00 | 0.30 | 1.50 | 3.00 | 6.00 | 12.00 |
| Absorbance changing value | -10 | 208 | 1010 | 2036 | 4008 | 10328 |
Table 2 linearly dilutes
| Dilution ratio | Estimated value | Measured value | Deviation |
| 1/128 | 0.07 | 0.09 | 0.02 |
| 1/64 | 0.17 | 0.16 | -0.01 |
| 1/32 | 0.36 | 0.34 | -4.27% |
| 1/16 | 0.73 | 0.74 | 1.51% |
| 1/8 | 1.48 | 1.48 | 0.24% |
| 1/4 | 2.97 | 2.96 | -0.39% |
| 1/2 | 5.96 | 5.97 | 0.14% |
| 3/4 | 8.95 | 8.95 | -0.02% |
| 1 | 11.94 | 12.03 | 0.73% |
Specifically as shown in Fig. 1 and table 2, a) linearly dependent coefficient r >=0.990；B) within the scope of 0.10-0.30g/L, linear absolute deviation is less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is less than ± 15.0%, and it is linearly qualified to illustrate.
Table 3 Monitoring lower-cut
Table 4 antigen excess is verified
| Theoretical value | Measured value | Remarks |
| 2.91 | 2.90 | In the range of linearity |
| 5.81 | 5.83 | In the range of linearity |
| 11.63 | 11.61 | In the range of linearity |
| 23.25 | 19.22 | Superlinearity |
| 46.50 | 24.33 | Superlinearity |
| 93.00 | 19.33 | Superlinearity |
| 186.00 | 13.12 | Superlinearity |
From table 1～4 it can be seen that the haematogenic immunity globulin M reagent of the present embodiment, within the scope of 0.10-0.30g/L, linear absolute deviation is not less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is not less than ± 15.0%.And Monitoring lower-cut also can reach 0.10g/L (precision CV < 20%), meet country's relevant laws and regulations requirement, it was demonstrated that the range of linearity reaches 0.10g/L～12.00g/L；It addition, verify it can be seen that actual antigen excess ranges up to 186g/L from antigen excess, meet antigen excess and range up to the requirement of 180g/L.
Embodiment 2
The latex particle particle diameter of the present embodiment is 80nm, rabbit human immunoglobulins's M polyclonal antibody (article No.: Q0333) that every liter of reagent 2 labelling 14mlDako company produces, 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 240 μ l:60 μ l, after sample beforehand dilution 30 times, add 4 samples (namely sample and antibody ratios are 1:6.3) in reaction system diluted for μ l.
Using Hitachi7170 automatic clinical chemistry analyzer, wavelength is 570nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 5 calibration data
| Calibration object concentration g/L | 0.00 | 0.30 | 1.50 | 3.00 | 6.00 | 12.00 |
| Absorbance changing value | -8 | 188 | 778 | 1606 | 3218 | 8328 |
Table 6 linearly dilutes
| Dilution ratio | Estimated value | Measured value | Deviation |
| 1/128 | 0.07 | 0.08 | 0.01 |
| 1/64 | 0.17 | 0.17 | 0.00 |
| 1/32 | 0.36 | 0.35 | -1.71% |
| 1/16 | 0.74 | 0.72 | -2.07% |
| 1/8 | 1.49 | 1.50 | 0.44% |
| 1/4 | 3.01 | 3.05 | 1.34% |
| 1/2 | 6.04 | 5.97 | -1.20% |
| 3/4 | 9.08 | 9.11 | 0.38% |
| 1 | 12.11 | 12.13 | 0.18% |
Specifically as shown in Fig. 2 and table 6, a) linearly dependent coefficient r >=0.990；B) within the scope of 0.10-0.30g/L, linear absolute deviation is less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is less than ± 15.0%, and it is linearly qualified to illustrate.
Table 7 Monitoring lower-cut
| Concentration | Precision CV | Acceptability limit |
| 0.10 | 19.33% | < 20% |
| 0.30 | 10.18% | < 20% |
| 0.60 | 5.89% | < 20% |
| 1.20 | 3.33% | < 20% |
Table 8 antigen excess is verified
| Theoretical value | Measured value | Remarks |
| 2.91 | 2.9 | In the range of linearity |
| 5.81 | 5.77 | In the range of linearity |
| 11.63 | 11.56 | In the range of linearity |
| 23.25 | 18.21 | Superlinearity 5--> |
| 46.50 | 24.38 | Superlinearity |
| 93.00 | 20.82 | Superlinearity |
| 186.00 | 12.21 | Superlinearity |
From table 5～8 it can be seen that the haematogenic immunity globulin M reagent of embodiment 2, within the scope of 0.10-0.30g/L, linear absolute deviation is not less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is not less than ± 15.0%.And Monitoring lower-cut also can reach 0.10g/L (precision CV < 20%), meet country's relevant laws and regulations requirement, it was demonstrated that the range of linearity reaches 0.10g/L～12.00g/L；It addition, verify it can be seen that actual antigen excess ranges up to 186g/L from antigen excess, meet antigen excess and range up to the requirement of 180g/L.But antigen excess has been in borderline state, sensitivity is also already at borderline state.Reduce antibody again and make consumption or latex particle size, it is difficult to ensure that reagent performance meets requirement.
Embodiment 3
The latex particle particle diameter of the present embodiment is 150nm, rabbit human immunoglobulins's M polyclonal antibody (article No.: Q0333) that every liter of reagent 2 labelling 14mlDako company produces, 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 240 μ l:60 μ l, after sample beforehand dilution 30 times, add 4 samples (namely sample and antibody ratios are 1:6.3) in reaction system diluted for μ l.
Using Hitachi7170 automatic clinical chemistry analyzer, wavelength is 570nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 9 calibration data
| Calibration object concentration g/L | 0.00 | 0.50 | 1.00 | 4.00 | 8.00 | 16.00 |
| Absorbance changing value | 12 | 258 | 513 | 1836 | 3708 | 9728 |
Table 10 linearly dilutes
| Dilution ratio | Estimated value | Measured value | Deviation |
| 1/128 | 0.07 | 0.08 | 0.01 |
| 1/64 | 0.17 | 0.15 | -0.02 |
| 1/32 | 0.36 | 0.35 | -1.46% |
| 1/16 | 0.73 | 0.75 | 2.89% |
| 1/8 | 1.48 | 1.52 | 2.94% |
| 1/4 | 2.97 | 3.08 | 3.65% |
| 1/2 | 5.96 | 6.09 | 2.15% |
| 3/4 | 8.95 | 9.11 | 1.76% |
| 1 | 11.94 | 11.98 | 0.31% |
Specifically as shown in Fig. 3 and table 10, a) linearly dependent coefficient r >=0.990；B) within the scope of 0.10-0.30g/L, linear absolute deviation is less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is less than ± 15.0%, and it is linearly qualified to illustrate.
Table 11 Monitoring lower-cut
| Concentration | Precision CV | Acceptability limit |
| 0.10 | 18.01% | <20% 6--> |
| 0.30 | 9.32% | < 20% |
| 0.60 | 5.33% | < 20% |
| 1.20 | 3.20% | < 20% |
Table 12 antigen excess is verified
From table 9～12 it can be seen that the haematogenic immunity globulin M reagent of embodiment 3, within the scope of 0.10-0.30g/L, linear absolute deviation is not less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is not less than ± 15.0%.And Monitoring lower-cut also can reach 0.10g/L (precision CV < 20%), meet country's relevant laws and regulations requirement, it was demonstrated that the range of linearity reaches 0.10g/L～12.00g/L；It addition, verify it can be seen that actual antigen excess ranges up to 186g/L from antigen excess, meet antigen excess and range up to the requirement of 180g/L.But antigen excess has been in borderline state, sensitivity is also already at borderline state.Reduce antibody again and make consumption, it is difficult to ensure that reagent performance meets requirement.
Embodiment 4
The latex particle particle diameter of the present embodiment is 200nm, rabbit human immunoglobulins's M polyclonal antibody (article No.: Q0333) that every liter of reagent 2 labelling 14mlDako company produces, 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 240 μ l:60 μ l, after sample beforehand dilution 30 times, add 4 samples (namely sample and antibody ratios are 1:6.3) in reaction system diluted for μ l.
Using Hitachi7170 automatic clinical chemistry analyzer, wavelength is 570nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 13 calibration data
| Calibration object concentration g/L | 0.00 | 0.50 | 1.00 | 4.00 | 8.00 | 16.00 |
| Absorbance changing value | 10 | 266 | 532 | 2113 | 4110 | 10238 |
Table 14 linearly dilutes
| Dilution ratio | Estimated value | Measured value | Deviation |
| 1/128 | 0.10 | 0.08 | -0.02 |
| 1/64 | 0.20 | 0.18 | -0.02 7 --> |
| 1/32 | 0.38 | 0.33 | -13.98% |
| 1/16 | 0.76 | 0.75 | -0.98% |
| 1/8 | 1.51 | 1.53 | 1.66% |
| 1/4 | 3.00 | 3.15 | 4.99% |
| 1/2 | 5.99 | 5.97 | -0.35% |
| 3/4 | 8.98 | 8.88 | -1.13% |
| 1 | 11.97 | 12.02 | 0.40% |
Specifically as shown in Fig. 4 and table 14, a) linearly dependent coefficient r >=0.990；B) within the scope of 0.10-0.30g/L, linear absolute deviation is less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is less than ± 15.0%, and it is linearly qualified to illustrate.
Table 15 Monitoring lower-cut
| Concentration | Precision CV | Acceptability limit |
| 0.10 | 18.34% | < 20% |
| 0.30 | 9.56% | < 20% |
| 0.60 | 5.11% | < 20% |
| 1.20 | 3.25% | < 20% |
Table 16 antigen excess is verified
From table 13～16 it can be seen that the haematogenic immunity globulin M reagent of embodiment 4, within the scope of 0.10-0.30g/L, linear absolute deviation is not less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is not less than ± 15.0%.And Monitoring lower-cut also can reach 0.10g/L (precision CV < 20%), meet country's relevant laws and regulations requirement, it was demonstrated that the range of linearity reaches 0.10g/L～12.00g/L；It addition, verify it can be seen that actual antigen excess ranges up to 186g/L from antigen excess, meet antigen excess and range up to the requirement of 180g/L.But antigen excess has been in borderline state, sensitivity is also already at borderline state.Reduce antibody again and make consumption, it is difficult to ensure that reagent performance meets requirement.
Embodiment 5
The latex particle particle diameter of the present embodiment is 80nm, rabbit human immunoglobulins's M polyclonal antibody (article No.: Q0333) that every liter of reagent 2 labelling 26mlDako company produces, 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 240 μ l:60 μ l, after sample beforehand dilution 16 times, add 4 samples (namely sample and antibody ratios are 1:6.3) in reaction system diluted for μ l.
Using Hitachi7170 automatic clinical chemistry analyzer, wavelength is 570nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 17 calibration data
| Calibration object concentration g/L | 0.00 | 0.50 | 1.00 | 4.00 | 8.00 | 16.00 |
| Absorbance changing value | 10 | 238 | 499 | 1986 | 3856 | 10234 |
Table 18 linearly dilutes
Specifically as shown in Fig. 5 and table 18, a) linearly dependent coefficient r >=0.990；B) within the scope of 0.10-0.30g/L, linear absolute deviation is less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is less than ± 15.0%.
It is linearly qualified to illustrate.
Table 19 Monitoring lower-cut
| Concentration | Precision CV | Acceptability limit |
| 0.10 | 19.13% | < 20% |
| 0.30 | 9.88% | < 20% |
| 0.60 | 4.56% | < 20% |
| 1.20 | 2.95% | < 20% |
Table 20 antigen excess is verified
From table 17～20 it can be seen that the haematogenic immunity globulin M reagent of embodiment 5, within the scope of 0.10-0.30g/L, linear absolute deviation is not less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is not less than ± 15.0%.And Monitoring lower-cut also can reach 0.10g/L (precision CV < 20%), meet country's relevant laws and regulations requirement, it was demonstrated that the range of linearity reaches 0.10g/L～12.00g/L；It addition, verify it can be seen that actual antigen excess ranges up to 186g/L from antigen excess, meet antigen excess and range up to the requirement of 180g/L.But antibody consumption is too big, is in the Limiting Level of marking process and high cost.
Embodiment 6
The latex particle particle diameter of the present embodiment is 200nm, rabbit human immunoglobulins's M polyclonal antibody (article No.: Q0333) that every liter of reagent 2 labelling 26mlDako company produces, 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 240 μ l:60 μ l, after sample beforehand dilution 16 times, add 4 samples (namely sample and antibody ratios are 1:6.3) in reaction system diluted for μ l.
Using Hitachi7170 automatic clinical chemistry analyzer, wavelength is 570nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 21 calibration data
| Calibration object concentration g/L | 0.00 | 0.50 | 1.00 | 4.00 | 8.00 | 16.00 |
| Absorbance changing value | 10 | 278 | 520 | 2136 | 4233 | 11456 |
Table 22 linearly dilutes
Specifically as shown in Fig. 6 and table 22, a) linearly dependent coefficient r >=0.990；B) within the scope of 0.10-0.30g/L, linear absolute deviation is less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is less than ± 15.0%, and it is linearly qualified to illustrate.
Table 23 Monitoring lower-cut
| Concentration | Precision CV | Acceptability limit |
| 0.10 | 17.31% | < 20% |
| 0.30 | 9.88% | < 20% |
| 0.60 | 5.68% | < 20% |
| 1.20 | 3.21% | < 20% |
Table 24 antigen excess is verified
| Theoretical value | Measured value | Remarks |
| 2.91 | 2.89 | In the range of linearity |
| 5.81 | 5.78 | In the range of linearity |
| 11.63 | 11.52 | In the range of linearity |
| 23.25 | 17.66 | Superlinearity |
| 46.50 | 24.25 | Superlinearity |
| 93.00 | 17.22 | Superlinearity |
| 186.00 | 14.12 | Superlinearity |
From table 21～24 it can be seen that the haematogenic immunity globulin M reagent of embodiment 6, within the scope of 0.10-0.30g/L, linear absolute deviation is not less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is not less than ± 15.0%.And Monitoring lower-cut also can reach 0.10g/L (precision CV < 20%), meet country's relevant laws and regulations requirement, it was demonstrated that the range of linearity reaches 0.10g/L～12.00g/L；It addition, verify it can be seen that actual antigen excess ranges up to 186.00g/L from antigen excess, meet antigen excess and range up to the requirement of 180g/L.But antibody consumption is too big, is in the Limiting Level of marking process and high cost.
Embodiment 7
The latex particle particle diameter of the present embodiment is 200nm, rabbit human immunoglobulins's M polyclonal antibody (article No.: Q0333) that every liter of reagent 2 labelling 26mlDako company produces, 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 240 μ l:60 μ l, after sample beforehand dilution 30 times, add 4 samples (namely sample and antibody ratios are 1:11.7) in reaction system diluted for μ l.
Using Hitachi7170 automatic clinical chemistry analyzer, wavelength is 570nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 25 calibration data
| Calibration object concentration g/L | 0.00 | 0.50 | 1.00 | 4.00 | 8.00 | 16.00 |
| Absorbance changing value | 15 | 303 | 615 | 2448 | 4256 | 11875 |
Table 26 linearly dilutes
Specifically as shown in Fig. 7 and table 26, a) linearly dependent coefficient r >=0.990；B) within the scope of 0.10-0.30g/L, linear absolute deviation is less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is less than ± 15.0%, and it is linearly qualified to illustrate.
Table 27 Monitoring lower-cut
| Concentration | Precision CV | Acceptability limit |
| 0.10 | 18.88% | < 20% |
| 0.30 | 9.68% | < 20% |
| 0.60 | 5.21% | < 20% |
| 1.20 | 2.34% | < 20% |
Table 28 antigen excess is verified
| Theoretical value | Measured value | Remarks 12--> |
| 2.91 | 2.90 | In the range of linearity |
| 5.81 | 5.83 | In the range of linearity |
| 11.63 | 11.61 | In the range of linearity |
| 23.25 | 19.22 | Superlinearity |
| 46.50 | 24.33 | Superlinearity |
| 93.00 | 19.33 | Superlinearity |
| 186.00 | 13.12 | Superlinearity |
From table 24～28 it can be seen that the haematogenic immunity globulin M reagent of embodiment 7, within the scope of 0.10-0.30g/L, linear absolute deviation is not less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is not less than ± 15.0%.And Monitoring lower-cut also can reach 0.10g/L (precision CV < 20%), meet country's relevant laws and regulations requirement, it was demonstrated that the range of linearity reaches 0.10g/L～12.00g/L；It addition, verify it can be seen that actual antigen excess ranges up to 186g/L from antigen excess, meet antigen excess and range up to the requirement of 180g/L.But antibody consumption is too big, is in the Limiting Level of marking process and high cost.
Embodiment 8
The latex particle particle diameter of the present embodiment is 200nm, rabbit human immunoglobulins's M polyclonal antibody (article No.: Q0333) that every liter of reagent 2 labelling 26mlDako company produces, 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 240 μ l:60 μ l, after sample beforehand dilution 25 times, add 4 samples (namely sample and antibody ratios are 1:9.75) in reaction system diluted for μ l.
Using Hitachi7170 automatic clinical chemistry analyzer, wavelength is 570nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 29 calibration data
| Calibration object concentration g/L | 0.00 | 0.50 | 1.00 | 4.00 | 8.00 | 16.00 |
| Absorbance changing value | 12 | 286 | 586 | 2338 | 4977 | 10256 |
Table 30 linearly dilutes
Specifically as shown in Fig. 8 and table 30, a) linearly dependent coefficient r >=0.990；B) within the scope of 0.10-0.30g/L, linear absolute deviation is less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is less than ± 15.0%, and it is linearly qualified to illustrate.
Table 31 Monitoring lower-cut
| Concentration | Precision CV | Acceptability limit |
| 0.10 | 17.89% | < 20% |
| 0.30 | 7.91% | < 20% |
| 0.60 | 4.82% | < 20% |
| 1.20 | 2.31% | < 20% |
Table 32 antigen excess is verified
| Theoretical value | Measured value | Remarks |
| 2.91 | 2.88 | In the range of linearity |
| 5.81 | 5.80 | In the range of linearity |
| 11.63 | 11.14 | In the range of linearity |
| 23.25 | 24.38 | Superlinearity |
| 46.50 | 26.08 | Superlinearity |
| 93.00 | 23.12 | Superlinearity |
| 186.00 | 18.04 | Superlinearity |
From table 29～32 it can be seen that the haematogenic immunity globulin M reagent of embodiment 8, within the scope of (0.10-0.30) g/L, linear absolute deviation is not less than ± 0.10g/L；Within the scope of (0.30-12.00) g/L, linear relative deviation is not less than ± 15.0%.And Monitoring lower-cut also can reach 0.10g/L (precision CV < 20%), meet country's relevant laws and regulations requirement, it was demonstrated that the range of linearity reaches 0.10g/L～12.00g/L；It addition, verify it can be seen that actual antigen excess ranges up to 186g/L from antigen excess, meet antigen excess and range up to the requirement of 180g/L.But antibody consumption is too big, is in the Limiting Level of marking process and high cost.
Be can be seen that by embodiment 2～4 contrast, when antibody consumption and antigen-antibody ratio are certain, improve latex particle particle diameter and be conducive to reagent sensitivity, but because emulsion reagent stability limits, can not unrestrictedly improve latex particle size, it is preferred that latex particle size ranges for 80nm～200nm.
By embodiment 2 comparative example 5, embodiment 4 comparative example 6 can be seen that, when latex particle particle diameter and antigen-antibody ratio are certain, improve antibody consumption, be conducive to improving sensitivity, but it is subject to marking process and cost restriction, it is impossible to unrestrictedly improve amount of antibody, it is preferable that antibody uses volume range to be 14ml～26ml/L reagent 2.
By comparative example 7 and embodiment 8, when latex particle size and antibody make consumption certain, can be seen that antigen and antibody ratios are when increasing, sensitivity improves, but antigen excess scope declines, otherwise sensitivity declines, antigen excess scope improves, so, antigen-antibody ratio controlling can effectively to guarantee within the specific limits, reagent is linear and antigen excess, preferred as one, antigen-antibody proportion is 1:6.3～1:11.7.
Embodiment 9
The latex particle particle diameter of the present embodiment is 130nm, rabbit human immunoglobulins's M polyclonal antibody (article No.: Q0333) that every liter of reagent 2 labelling 20mlDako company produces, use Good ' s buffer the most conventional in latex immunoturbidimetry as reagent 1, adopt the most common parameters reagent 1 of automatic analyzer: reagent 2 ratio 240 μ l:60 μ l, after sample beforehand dilution 30 times, add 4 samples (namely sample and antibody ratios are 1:9) in reaction system diluted for μ l.
Using Hitachi7170 automatic clinical chemistry analyzer, wavelength is 570nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 33 calibration data
| Calibration object concentration g/L | 0.00 | 0.50 | 1.00 | 4.00 | 8.00 | 16.00 |
| Absorbance changing value | 8 | 253 | 509 | 1998 | 3998 | 10589 |
Table 34 linearly dilutes
| Dilution ratio | Estimated value | Measured value | Deviation |
| 1/128 | 0.07 | 0.09 | 0.02 |
| 1/64 | 0.17 | 0.16 | -0.05 |
| 1/32 | 0.36 | 0.34 | -4.27% |
| 1/16 | 0.73 | 0.74 | 1.51% |
| 1/8 | 1.48 | 1.48 | 0.24% |
| 1/4 | 2.97 | 2.96 | -0.39% |
| 1/2 | 5.96 | 5.97 | 0.14% |
| 3/4 | 8.95 | 8.95 | -0.02% |
| 1 | 11.94 | 12.03 | 0.73% |
Specifically as shown in Fig. 9 and table 34, a) linearly dependent coefficient r >=0.990；B) within the scope of 0.10-0.30g/L, linear absolute deviation is less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is less than ± 15.0%, and it is linearly qualified to illustrate.
Table 35 Monitoring lower-cut
| Concentration | Precision CV | Acceptability limit |
| 0.10 | 18.75% | < 20% |
| 0.30 | 12.13% | < 20% |
| 0.60 | 8.32% | < 20% |
| 1.20 | 5.41% | < 20% |
Table 36 antigen excess is verified
From table 33～36 it can be seen that the haematogenic immunity globulin M reagent of embodiment 9, within the scope of 0.10-0.30g/L, linear absolute deviation is not less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is not less than ± 15.0%.And Monitoring lower-cut also can reach 0.10g/L (precision CV < 20%), meet country's relevant laws and regulations requirement, it was demonstrated that the range of linearity reaches 0.10g/L～12.00g/L；It addition, verify it can be seen that actual antigen excess ranges up to 186g/L from antigen excess, meet antigen excess and range up to the requirement of 180g/L.
Implement 10
The latex particle particle diameter of the present embodiment is 130nm, rabbit human immunoglobulins's M polyclonal antibody (article No.: Q0333) that every liter of reagent 2 labelling 20mlDako company produces, 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 240 μ l:60 μ l, after sample beforehand dilution 30 times, add 4 samples (namely sample and antibody ratios are 1:9) in reaction system diluted for μ l.
Using Hitachi7170 automatic clinical chemistry analyzer, wavelength is 570nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 37 calibration data
| Calibration object concentration g/L | 0.00 | 0.50 | 1.00 | 4.00 | 8.00 | 16.00 |
| Absorbance changing value | 12 | 265 | 523 | 2123 | 4121 | 10989 |
Table 38 linearly dilutes
Specifically as shown in Figure 10 and table 38, a) linearly dependent coefficient r >=0.990；B is within the scope of 0.10-0.30g/L, and linear absolute deviation is less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is less than ± 15.0%, and it is linearly qualified to illustrate.
Table 39 Monitoring lower-cut
| Concentration | Precision CV | Acceptability limit |
| 0.10 | 18.15% | < 20% |
| 0.30 | 12.30% | < 20% |
| 0.60 | 8.56% | < 20% |
| 1.20 | 6.23% | < 20% |
Table 40 antigen excess is verified
From table 37～40 it can be seen that the haematogenic immunity globulin M reagent of embodiment 10, within the scope of 0.10-0.30g/L, linear absolute deviation is not less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is not less than ± 15.0%.And Monitoring lower-cut also can reach 0.10g/L (precision CV < 20%), meet country's relevant laws and regulations requirement, it was demonstrated that the range of linearity reaches 0.10g/L～12.00g/L；It addition, verify it can be seen that actual antigen excess ranges up to 186g/L from antigen excess, meet antigen excess and range up to the requirement of 180g/L.
Implement 11
The latex particle particle diameter of the present embodiment is 130nm, rabbit human immunoglobulins's M polyclonal antibody that every liter of reagent 2 labelling 20mlGeneTex produces, 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 240 μ l:60 μ l, after sample beforehand dilution 30 times, add 4 samples (namely sample and antibody ratios are 1:9) in reaction system diluted for μ l.
Using Hitachi7170 automatic clinical chemistry analyzer, wavelength is 570nm Single wavelength, and Two point end assay 18-34 read point calculates, and data are as follows.
Table 41 calibration data
| Calibration object concentration g/L | 0.00 | 0.50 | 1.00 | 4.00 | 8.00 | 16.00 |
| Absorbance changing value | 15 | 263 | 523 | 2133 | 4118 | 11025 |
Table 42 linearly dilutes
Specifically as shown in Figure 11 and table 42, a) linearly dependent coefficient r >=0.990；B) within the scope of 0.10-0.30g/L, linear absolute deviation is less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is less than ± 15.0%.
It is linearly qualified to illustrate.
Table 43 Monitoring lower-cut
| Concentration | Precision CV | Acceptability limit |
| 0.10 | 18.21% | < 20% |
| 0.30 | 8.77% | <20% 18--> |
| 0.60 | 5.21% | < 20% |
| 1.20 | 3.65% | < 20% |
Table 44 antigen excess is verified
| Theoretical value | Measured value | Remarks |
| 2.91 | 2.88 | In the range of linearity |
| 5.81 | 5.76 | In the range of linearity |
| 11.63 | 11.56 | In the range of linearity |
| 23.25 | 18.35 | Superlinearity |
| 46.50 | 24.56 | Superlinearity |
| 93.00 | 18.76 | Superlinearity |
| 186.00 | 15.23 | Superlinearity |
From table 41～44 it can be seen that the haematogenic immunity globulin M reagent of embodiment 11, within the scope of 0.10-0.30g/L, linear absolute deviation is not less than ± 0.10g/L；Within the scope of 0.31-12.00g/L, linear relative deviation is not less than ± 15.0%.And Monitoring lower-cut also can reach 0.10g/L (precision CV < 20%), meet country's relevant laws and regulations requirement, it was demonstrated that the range of linearity reaches 0.10g/L～12.00g/L；It addition, verify it can be seen that actual antigen excess ranges up to 186g/L from antigen excess, meet antigen excess and range up to the requirement of 180g/L.
According to above-described embodiment, the present invention just can be realized well.
Claims (7)
1. a high performance human blood immune globulin M detection reagent box, including reagent 2, it is characterised in that: described reagent 2 is the latex particle solution being marked with rabbit human immunoglobulins's M polyclonal antibody；
Wherein, described latex particle particle size range is 80nm～200nm, and in every liter of reagent 2, the consumption of antibody is 14ml～26ml.
2. the volume ratio of the high performance human blood immune globulin M detection reagent box of one according to claim 1, it is characterised in that when sample is detected by described test kit, sample and antibody is 1:6.3～1:11.7.
3. the high performance human blood immune globulin M detection reagent box of one according to claim 1 and 2, it is characterised in that adopt chemical conjugation methods to be marked on latex particle by rabbit human immunoglobulins's M polyclonal antibody.
4. the high performance human blood immune globulin M detection reagent box of one according to claim 1 and 2, it is characterized in that, described test kit is based on latex immunoturbidimetry detection human blood IgM, and its range of linearity is 0.10g/L～12.00g/L, and antigen excess ranges up to 180g/L.
5. the high performance human blood immune globulin M detection reagent box of one according to claim 1 and 2, it is characterized in that, described rabbit human immunoglobulins's M polyclonal antibody is rabbit human immunoglobulins's M polyclonal antibody that Dako company produces, or the rabbit human immunoglobulins's M polyclonal antibody for the production of GeneTex company.
6. the high performance human blood immune globulin M detection reagent box of one according to claim 1 and 2, it is characterised in that described test kit is applicable to the automatical analysis instrument with automated sample dilution function.
7. the high performance human blood immune globulin M detection reagent box of one according to claim 1 and 2, it is characterised in that also include reagent 1, described reagent 1 is phosphate buffer, Good ' s buffer or glycine buffer.
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