CN103869059A - Sample applying method of diagnostic kit - Google Patents
Sample applying method of diagnostic kit Download PDFInfo
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- CN103869059A CN103869059A CN201410120353.5A CN201410120353A CN103869059A CN 103869059 A CN103869059 A CN 103869059A CN 201410120353 A CN201410120353 A CN 201410120353A CN 103869059 A CN103869059 A CN 103869059A
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Abstract
The invention discloses a sample applying method of a diagnostic kit, belongs to the field of diagnostic reagents, and particularly to application of a color indicator to preparation of a diagnostic reagent. The sample applying method comprises the following step: spraying a sample applying buffer solution containing a biological raw material on a substrate or coating the substrate with the solution, wherein the sample applying buffer solution further contains a color indicator. By applying the sample applying method, whether an intermediate product during production and operation is subjected to sample application can be remarkably distinguished, the intermediate product which does not accord with the product standard in a sample applying process is favorably removed, the abnormal condition is favorably and immediately found and processed in the sample applying process, the production efficiency is increased, and the error rate in the production process is reduced.
Description
Technical field
The invention belongs to diagnostic reagent field, be specially colored indicator for the preparation of diagnostic reagent.
Background technology
External diagnosis reagent is mainly used in the judgement of diagnosis, prevention, curative effect and the prognosis of disease, monitoring, the evaluation of health status and the prediction of genetic disease of medicine.
The applied methodology of external diagnosis reagent mainly contains enzyme linked immunosorbent assay, colloidal gold method, immunofluorescence technique, external nucleic acid amplification (PCR), biochip etc., wherein colloidal gold method, immunofluorescence technique, in many methodologies such as biochip, all comprise this committed step of point sample, comprise various native antigens by biological raw material, recombinant antigen, monoclonal antibody, polyclonal antibody and polypeptide class biological raw material etc., be fixed on (for example nitrocellulose filter in special matrix, nylon membrane etc.), afterwards by series reaction such as application of samples, realize the qualitative or quantitative detection to sample.
In diagnostic reagent production run, affect a lot of because have of technological process, wherein the quality control of point sample has very large impact to the stability of end product quality.In general, the liquid that most of biological raw material is clear, containing foreign matter, muddiness or deposit seed etc., does not also contain the impurity of other colors, and visual inspection outward appearance should meet the quality control standard of supplementary material.
Whole point sample process mainly comprises point sample and dries two key steps.Biological raw material, after the dilution of point sample damping fluid, through mechanical deposition or artificial point sample, is fixed in special matrix.
Learn from diagnostic reagent knowhow for many years, the spot size shape of point sample, the even thickness degree of lines etc. all affects the testing result of final sample.Same product, if the differences such as the speckle displacement of point sample, size shape, line weight are large, between product is criticized, batch in CV value can raise, affect accuracy of detection; If the point sample position of biological raw material is positioned in the middle of matrix, the shape of point sample is when more regular, accuracy of detection is better.
And the liquid point sample of clear dry after, naked eyes cannot be observed the net shape of point sample, some shapes exist the point sample spot of notable difference, lines also cannot distinguish, thereby cause product criticize between, batch in CV raise.
Therefore, need to be improved to overcome the problems referred to above to prior art.
Summary of the invention
The present invention aims to provide a kind of point sample damping fluid, contains colored indicator, can be used for immune external diagnosis reagent case envelope antigen antibody.
Technical solution of the present invention is that the point sample damping fluid by colored indicator for the preparation of immune response detection kit, prepares reaction plate or test strips that immune response detects.
The present invention adds a kind of colored indicator that does not react and do not affect whole test reaction with this biological raw material in point sample damping fluid, after drying, point sample can clearly distinguish shape, size, the uniformity coefficient of point sample, thereby carry out Quality Control, reject that point sample position skew is large, out-of-shape or inhomogeneous reaction plate or testing bar.
Colored indicator is preferably methyl orange, bromophenol blue, thymol blue (bromothymol blue), alizarin red S, bromcresol green, methyl red, dibromophenolphthalein, bromcresol purple, bromthymol blue, phenol red, cresol red, thymolphthalein.
These colored indicators are mixed with the point sample damping fluid containing with biological raw material (as native antigen, recombinant antigen, monoclonal antibody, polyclonal antibody and polypeptide class etc.), spray in matrix.
The content of colored indicator in point sample damping fluid is 0.0005wt%～0.1wt%, is preferably 0.001wt%～0.05wt%.
Described biological raw material is antigen or antibody, preferred, is antigen, recombinant antibodies, monoclonal antibody or polyclonal antibody.Preferred, described antibody is C reactive protein (CRP) antibody, DDi protein antibodies, microdose urine protein antibody, hCG antibodies, serum amyloid A protein antibody, troponin antibodies, plasma pro-brain natriuretic peptide levels antibody, myoglobins antibody, and antigen is Mycobacterium tuberculosis antigen.
The detection method of kit, reaction plate or test strips application can be the methods such as colloid gold immune reaction (colloidal gold immunity percolation reaction or colloidal gold immunochromatographimethod reaction), Immunofluorescence Reactions (as fluorescence immune chromatography reaction).
The present invention has added the colored indicator that does not react and do not affect whole test reaction with this biological raw material in point sample damping fluid, and by concentration, obtains best colour developing concentration, and point sample can clearly be distinguished the shape, size, uniformity coefficient of point sample etc. after drying.The method may be used on, in all diagnostic reagents productions that comprise point sample operation, not being subject to methodological restriction.When use, add confining liquid to wash out colored indicator afterwards, the point sample location restore of reaction plate and test strips is colourless, then adds testing sample to react.
Use this point sample method, whether the middle product that can obviously distinguish in production operation carry out point sample operation, be conducive to remove the middle product that do not meet product standard in point sample process, also be conducive to the timely discovery processing to abnormal conditions in point sample process, enhance productivity, reduce error rate in production run.If the method is applied in colloidal gold method, immunofluorescence technique, in product use procedure, can obviously distinguish and use and untapped reaction plate, test strips, reduce experimental error.
Brief description of the drawings
Fig. 1 is that embodiment 1 adds colored indicator or do not add the detection comparison of the colloidal gold method CRP reaction plate of colored indicator
Fig. 2 is that embodiment 1 adds colored indicator or do not add the detection comparison of the fluorescent immune method CRP test strips of colored indicator
Fig. 3 is that embodiment 3 adds colored indicator or do not add the detection comparison of the colloidal gold method DDi reaction plate of colored indicator
Fig. 4 is that embodiment 4 adds colored indicator or do not add the detection comparison of the colloidal gold method microdose urine protein reaction plate of colored indicator
Fig. 5 is that embodiment 5 adds colored indicator or do not add the detection comparison of the colloidal gold method human chorionic gonadotrophin reaction plate of colored indicator
Fig. 6 is that embodiment 6 adds colored indicator or do not add the detection comparison of the colloidal gold method serum amyloid A protein reaction plate of colored indicator
Embodiment
(1) preparation of super quick C reactive protein (hs-CRP) fast quantification kit (colloidal gold method)
This kit is mainly made up of anti-CRP immune colloid gold conjugate and the various damping fluid of reaction plate, freeze-drying.The principle that this kit adopts is percolation.The critical process of preparation feedback plate is the CRP antibody of point sample dilution on nitrocellulose filter.In point sample damping fluid (pH=3～6), add bromophenol blue (0.002wt%), all the other techniques are constant, and contrast adds the reaction plate of indicator and the reaction plate that does not add indicator, investigates kit performance.
First bromophenol blue is dissolved in 20wt%～98wt% alcoholic solution, is mixed with the solution of 1g/L, then use point sample damping fluid stepwise dilution, until contain 0.002wt% bromophenol blue in point sample damping fluid.
Add the reaction plate of colored indicator, after point sample is dry, be shown as yellow or blueness, shape, position, size and the uniformity coefficient of clear demonstration CRP antibody spot sample.Also can obviously distinguish point sample and the reaction plate of point sample not.
When use, first on reaction plate, add confining liquid, flushable removal bromophenol blue colored indicator, then adds testing sample chromogenic reaction.Can distinguish significantly and use and untapped reaction plate like this, reduce experimental error, avoid maloperation.
(2) performance such as repeatability and the range of linearity of two kinds of reaction plates of comparison (add indicator and do not add indicator)
1. test respectively 10mg/L CRP standard items (cutoff value) with two kinds of reaction plates, result is as table 1.
Table 1
, detect method described in sample by above-mentioned two kinds of reaction plates according to kit and measure as sample with the standard items of the cutoff value 10mg/L of CRP, respectively measure 10 times, respectively calculating mean value and coefficient of variation CV.Wherein, calculate CV and carry out repeatability investigation, result shows that it adds indicator and does not add indicator CV and is respectively 12.31% and 11.83%; Calculate relative deviation with (1-mean value/sign value) * 100% and carry out accuracy investigation, be respectively 1.68% and-3.49%.P>0.05, does not have significant difference.
2. investigate two kinds of reaction plate stability
Will add the reaction plate of indicator be placed on respectively 2-8 DEG C and 37 DEG C with the reaction plate that does not add indicator, with CRP standard items 10mg/L test, each replication 3 times, test average differs with initial average≤20% be qualified stability, investigation stability.Result, as table 2, adds developer rear stability unaffected.
Table 2
3. investigate two kinds of reaction plate ranges of linearity
By the CRP standard items of two kinds of reaction plate test variable concentrations, every kind of each test of standard items is averaged for 3 times.Two kinds of reaction plates are compared, and comparison equation is Y=1.0765X+0.2383, and coefficient R=0.999 illustrates this two kinds of reaction plate there was no significant differences.Result is as Fig. 1 and table 3.
Table 3
By thymol blue (bromothymol blue), bromthymol blue, bromcresol green, methyl orange, methyl red or methyl orange replacement bromophenol blue, effect is similar to bromophenol blue, the minimum 0.0005wt% that reaches of content in point sample damping fluid.
While using phenolphthalein, Congo red replacement bromophenol blue, the effect not obvious or that confining liquid rinses that develops the color is bad.
(3) can precision improvement and deviation with the reaction plate of colored indicator Quality Control
Prepare super quick C reactive protein (hs-CRP) fast quantification kit according to the method point sample of (), and according to the shape of point sample, size, uniformity coefficient, thereby carry out Quality Control, reject that point sample position skew is large, out-of-shape or inhomogeneous reaction plate or testing bar.
Table 4
, detect method described in sample by above-mentioned three special quality control and control reaction plate according to kit and measure as sample with the standard items of the cutoff value 10mg/L of CRP, respectively measure 10 times, respectively calculating mean value and coefficient of variation CV.Wherein, calculate CV and carry out repeatability and investigate, result shows reaction plate after Quality Control screening, contrast unscreened reaction plate and be entirely inhomogeneous or irregular reaction plate test CV be respectively 8.18%%, 12.74% and 16.09%, CV obviously improve.As can be seen here, by said method, can carry out Quality Control to the result of point sample, reduce detection error, improve precision.
(1) preparation of C reactive protein (CRP) quantitative test kit (immunofluorescence technique)
Kit is made up of chromatograph test strip, sample-loading buffer.Chromatograph test strip mainly comprises the compositions such as sample pad, coated film, thieving paper.The critical process of this test strips is that the sampling liquid that contains CRP antibody (pH=3～6) is sprayed onto on coated film (coated film is nylon membrane or nitrocellulose filter).
Bromthymol blue, methyl orange or 20wt%～98wt% alcoholic solution dissolving for methyl red, be mixed with the solution of 1g/L, then use sampling liquid stepwise dilution, until content is the minimum 0.0005wt% that reaches of 0.001wt%(in sampling liquid).Again the sampling liquid that contains CRP antibody and colored indicator is sprayed onto on coated film, obtains test strips.
With the sampling liquid spraying coated film that does not contain colored indicator, other techniques are constant, obtain control stripes bar again.
Add the test strips of colored indicator, colour developing after point sample is dry, shape, position, size and the uniformity coefficient of clear demonstration CRP antibody spot sample.Also can obviously distinguish point sample and the reaction plate of point sample not.
When use, first on reaction plate, add confining liquid, flushable removal bromophenol blue colored indicator, then adds testing sample chromogenic reaction.Can distinguish significantly and use and untapped reaction plate like this, reduce experimental error, avoid maloperation.
(2) performance such as repeatability and the range of linearity of two kinds of test strips of contrast (add indicator and do not add indicator).
1. test respectively 10mg/LCRP standard items (cutoff value) by two kinds of test strips of step () (colored indicator methyl orange or do not add colored indicator), result is as table 5.
Table 5
, detect method described in sample by above-mentioned two kinds of test strips according to kit and measure as sample with the standard items of the cutoff value 10mg/L of CRP, respectively measure 10 times, respectively calculating mean value and coefficient of variation CV.Wherein, calculate CV and carry out repeatability investigation, result shows that it adds indicator and does not add indicator CV and is respectively 12.22% and 11.69%; Calculate relative deviation with (1-mean value/sign value) * 100% and carry out accuracy investigation, be respectively 0.36% and 2.00%, P>0.05, there is no significant difference.
2. investigate two kinds of test strips stability
Will add the test strips of indicator be placed on respectively 2-8 DEG C and 37 DEG C with the test strips that does not add indicator, with CRP standard items 10mg/L test, each replication 3 times, test average differs with initial average≤15% be qualified stability, investigation stability.Result, as table 6, adds developer rear stability unaffected.
Table 6
3. investigate two kinds of test strips ranges of linearity
By the CRP standard items of two kinds of test strips test variable concentrations, every kind of each test of standard items is averaged for 3 times.Two kinds of test strips are compared, and comparison equation is Y=1.0025X+0.9069, and coefficient R=0.999 illustrates this two kinds of test strips there was no significant differences.Result is as Fig. 2 and table 7.
Table 7
While using the phenolphthalein of same concentration, Congo red, dimethyl diaminophenazine chloride to replace bromophenol blue, the effect not obvious or that confining liquid rinses that develops the color is bad.
Above comparative descriptions, the colored indicator adding and antibody, reagent and testing sample do not react, and immune response is not occurred not affect.
(3) can precision improvement and deviation with the reaction plate of colored indicator Quality Control
Prepare immunofluorescence technique C reactive protein quantification kit according to the method point sample of (), and according to the shape of point sample, size, uniformity coefficient, thereby carry out Quality Control, reject that the skew of point sample position is large, out-of-shape or inhomogeneous testing bar.
Table 8
, detect method described in sample by above-mentioned three special quality control and control reaction plate according to kit and measure as sample with the standard items of the cutoff value 10mg/L of CRP, respectively measure 10 times, respectively calculating mean value and coefficient of variation CV.Wherein, calculate CV and carry out repeatability and investigate, result shows reaction plate after Quality Control screening, contrast unscreened reaction plate and be entirely inhomogeneous or irregular reaction plate test CV be respectively 8.64%, 11.18% and 14.75%, CV obviously improve.As can be seen here, by said method, can carry out Quality Control to the result of point sample, reduce detection error, improve precision.
(1) preparation of DDi detection kit (colloidal gold method)
This kit is mainly made up of anti-DDi immune colloid gold conjugate and the various damping fluid of reaction plate, freeze-drying.The principle that this kit adopts is percolation.The critical process of preparation feedback plate is the DDi antibody of point sample dilution on nitrocellulose filter.In point sample damping fluid (pH=3～6), add bromophenol blue (0.002wt%), all the other techniques are constant, and contrast adds the reaction plate of indicator and the reaction plate that does not add indicator, investigates kit performance.
First bromophenol blue is dissolved in 20wt%～98wt% alcoholic solution, is mixed with the solution of 1g/L, then use point sample damping fluid stepwise dilution, until contain 0.002wt% bromophenol blue in point sample damping fluid.
Add the reaction plate of colored indicator, after point sample is dry, be shown as yellow or blueness, shape, position, size and the uniformity coefficient of clear demonstration DDi antibody spot sample.Also can obviously distinguish point sample and the reaction plate of point sample not.
When use, first on reaction plate, add confining liquid, flushable removal bromophenol blue colored indicator, then adds testing sample chromogenic reaction.Can distinguish significantly and use and untapped reaction plate like this, reduce experimental error, avoid maloperation.
(2) performance such as repeatability and the range of linearity of two kinds of reaction plates of comparison (add indicator and do not add indicator)
1. test respectively 0.3mg/L DDi standard items (cutoff value) with two kinds of reaction plates, result is as table 9.
Table 9
, detect method described in sample by above-mentioned two kinds of reaction plates according to kit and measure as sample with the standard items of the cutoff value 0.3mg/L of DDi, respectively measure 10 times, respectively calculating mean value and coefficient of variation CV.Wherein, calculate CV and carry out repeatability investigation, result shows that it adds indicator and does not add indicator CV and is respectively 11.97% and 12.57%; Calculate relative deviation with (1-mean value/sign value) * 100% and carry out accuracy investigation, be respectively-0.33% and 2.33%.P>0.05, does not have significant difference.
2. investigate two kinds of reaction plate stability
To add the reaction plate of indicator and the reaction plate that does not add indicator to be placed on respectively 2-8 DEG C and 37 DEG C, test with DDi standard items 0.3mg/L, each replication 3 times, test average and initial average differ≤and 20% be qualified stability, investigate stability, result, as table 10, adds developer rear stability unaffected.
Table 10
3. investigate two kinds of reaction plate ranges of linearity
By the DDi standard items of two kinds of reaction plate test variable concentrations, every kind of each test of standard items is averaged for 3 times.Two kinds of reaction plates are compared, and comparison equation is y=1.008x+0.031, and coefficient R=0.999 illustrates this two kinds of reaction plate there was no significant differences.Result is as Fig. 3 and table 11.
Table 11
By thymol blue (bromothymol blue), bromthymol blue, bromcresol green, methyl orange, methyl red or methyl orange replacement bromophenol blue, effect is similar to bromophenol blue, the minimum 0.0005wt% that reaches of content in point sample damping fluid.
While using phenolphthalein, Congo red replacement bromophenol blue, the effect not obvious or that confining liquid rinses that develops the color is bad.
(3) can precision improvement and deviation with the reaction plate of colored indicator Quality Control
Method point sample according to (one) is prepared DDi detection kit, and according to the shape of point sample, size, uniformity coefficient, thereby carries out Quality Control, rejects that the skew of point sample position is large, out-of-shape or inhomogeneous reaction plate or testing bar.
Table 12
, detect method described in sample by above-mentioned three special quality control and control reaction plate according to kit and measure as sample with the standard items of the cutoff value 0.3mg/L of DDi, respectively measure 10 times, respectively calculating mean value and coefficient of variation CV.Wherein, calculate CV and carry out repeatability and investigate, result shows reaction plate after Quality Control screening, contrast unscreened reaction plate and be entirely inhomogeneous or irregular reaction plate test CV be respectively 7.27%, 11.66% and 16.29%, CV obviously improve.As can be seen here, by said method, can carry out Quality Control to the result of point sample, reduce detection error, improve precision.
(1) preparation of microdose urine protein fast quantification kit (colloidal gold method)
This kit is mainly made up of anti-microdose urine protein immune colloid gold conjugate and the various damping fluid of reaction plate, freeze-drying.The principle that this kit adopts is percolation.The critical process of preparation feedback plate is the microdose urine protein antibody of point sample dilution on nitrocellulose filter.In point sample damping fluid (pH=3～6), add bromophenol blue (0.002wt%), all the other techniques are constant, and contrast adds the reaction plate of indicator and the reaction plate that does not add indicator, investigates kit performance.
First bromophenol blue is dissolved in 20wt%～98wt% alcoholic solution, is mixed with the solution of 1g/L, then use point sample damping fluid stepwise dilution, until contain 0.002wt% bromophenol blue in point sample damping fluid.
Add the reaction plate of colored indicator, after point sample is dry, be shown as yellow or blueness, shape, position, size and the uniformity coefficient of clear demonstration microdose urine protein antibody spot sample.Also can obviously distinguish point sample and the reaction plate of point sample not.
When use, first on reaction plate, add confining liquid, flushable removal bromophenol blue colored indicator, then adds testing sample chromogenic reaction.Can distinguish significantly and use and untapped reaction plate like this, reduce experimental error, avoid maloperation.
(2) performance such as repeatability and the range of linearity of two kinds of reaction plates of comparison (add indicator and do not add indicator)
1. test respectively 30mg/L microdose urine protein standard items (cutoff value) with two kinds of reaction plates, result is as table 13.
Table 13
, detect method described in sample by above-mentioned two kinds of reaction plates according to kit and measure as sample with the standard items of the cutoff value 30mg/L of microdose urine protein, respectively measure 10 times, respectively calculating mean value and coefficient of variation CV.Wherein, calculate CV and carry out repeatability investigation, result shows that it adds indicator and does not add indicator CV and is respectively 12.08% and 11.96%; Calculate relative deviation with (1-mean value/sign value) * 100% and carry out accuracy investigation, be respectively-1.66% and-3.81%.P>0.05, does not have significant difference
2. investigate two kinds of reaction plate stability
To add the reaction plate of indicator and the reaction plate that does not add indicator to be placed on respectively 2-8 DEG C and 37 DEG C, test with microdose urine protein standard items 30mg/L, each replication 3 times, test average and initial average differ≤and 20% be qualified stability, investigate stability, result, as table 14, adds developer rear stability unaffected.
Table 14
3. investigate two kinds of reaction plate ranges of linearity
By the microdose urine protein standard items of two kinds of reaction plate test variable concentrations, every kind of each test of standard items is averaged for 3 times.Two kinds of reaction plates are compared, and comparison equation is y=0.978x+2.403, and coefficient R=0.999 illustrates this two kinds of reaction plate there was no significant differences.Result is as Fig. 4 and table 15.
Table 15
By thymol blue (bromothymol blue), bromthymol blue, bromcresol green, methyl orange, methyl red or methyl orange replacement bromophenol blue, effect is similar to bromophenol blue, the minimum 0.0005wt% that reaches of content in point sample damping fluid.
While using phenolphthalein, Congo red replacement bromophenol blue, the effect not obvious or that confining liquid rinses that develops the color is bad.
(3) can precision improvement and deviation with the reaction plate of colored indicator Quality Control
Method point sample according to (one) is prepared microdose urine protein detection kit, and according to the shape of point sample, size, uniformity coefficient, thereby carries out Quality Control, rejects that the skew of point sample position is large, out-of-shape or inhomogeneous reaction plate or testing bar.
Table 16
, detect method described in sample by above-mentioned three special quality control and control reaction plate according to kit and measure as sample with the standard items of the cutoff value 30mg/L of microdose urine protein, respectively measure 10 times, respectively calculating mean value and coefficient of variation CV.Wherein, calculate CV and carry out repeatability and investigate, result shows reaction plate after Quality Control screening, contrast unscreened reaction plate and be entirely inhomogeneous or irregular reaction plate test CV be respectively 7.98%, 11.52% and 15.40%, CV obviously improve.As can be seen here, by said method, can carry out Quality Control to the result of point sample, reduce detection error, improve precision.
(1) preparation of human chorionic gonadotrophin fast quantification kit (colloidal gold method)
This kit is mainly made up of anti-hCG immune colloid gold conjugate and the various damping fluid of reaction plate, freeze-drying.The principle that this kit adopts is percolation.The critical process of preparation feedback plate is the hCG antibodies of point sample dilution on nitrocellulose filter.In point sample damping fluid (pH=3～6), add bromophenol blue (0.002wt%), all the other techniques are constant, and contrast adds the reaction plate of indicator and the reaction plate that does not add indicator, investigates kit performance.
First bromophenol blue is dissolved in 20wt%～98wt% alcoholic solution, is mixed with the solution of 1g/L, then use point sample damping fluid stepwise dilution, until contain 0.002wt% bromophenol blue in point sample damping fluid.
Add the reaction plate of colored indicator, after point sample is dry, be shown as yellow or blueness, shape, position, size and the uniformity coefficient of clear demonstration microdose urine protein antibody spot sample.Also can obviously distinguish point sample and the reaction plate of point sample not.
When use, first on reaction plate, add confining liquid, flushable removal bromophenol blue colored indicator, then adds testing sample chromogenic reaction.Can distinguish significantly and use and untapped reaction plate like this, reduce experimental error, avoid maloperation.
(2) performance such as repeatability and the range of linearity of two kinds of reaction plates of comparison (add indicator and do not add indicator)
1. test respectively 25mIU human chorionic gonadotrophin standard items (cutoff value) with two kinds of reaction plates, result is as table 17.
Table 17
, detect method described in sample by above-mentioned two kinds of reaction plates according to kit and measure as sample with the standard items of the cutoff value 25mg/L of human chorionic gonadotrophin, respectively measure 10 times, respectively calculating mean value and coefficient of variation CV.Wherein, calculate CV and carry out repeatability investigation, result shows that it adds indicator and does not add indicator CV and is respectively 11.95% and 12.43%; Calculate relative deviation with (1-mean value/sign value) * 100% and carry out accuracy investigation, be respectively-2.02% and-1.18%.P>0.05, does not have significant difference.
2. investigate two kinds of reaction plate stability
To add the reaction plate of indicator and the reaction plate that does not add indicator to be placed on respectively 2-8 DEG C and 37 DEG C, test with human chorionic gonadotrophin standard items 25mg/L, each replication 3 times, test average and initial average differ≤and 20% be qualified stability, investigation stability.Result is as table 18,
Table 18
3. investigate two kinds of reaction plate ranges of linearity
By the human chorionic gonadotrophin standard items of two kinds of reaction plate test variable concentrations, every kind of each test of standard items is averaged for 3 times.Two kinds of reaction plates are compared, and comparison equation is y=1.031x+11.71, and coefficient R=0.999 illustrates this two kinds of reaction plate there was no significant differences.Result is as Fig. 5 and table 19.
Table 19
By thymol blue (bromothymol blue), bromthymol blue, bromcresol green, methyl orange, methyl red or methyl orange replacement bromophenol blue, effect is similar to bromophenol blue, the minimum 0.0005wt% that reaches of content in point sample damping fluid.
While using phenolphthalein, Congo red replacement bromophenol blue, the effect not obvious or that confining liquid rinses that develops the color is bad.
(3) can precision improvement and deviation with the reaction plate of colored indicator Quality Control
Method point sample according to (one) is prepared human chorionic gonadotrophin detection kit, and according to the shape of point sample, size, uniformity coefficient, thereby carries out Quality Control, rejects that the skew of point sample position is large, out-of-shape or inhomogeneous reaction plate or testing bar.
Table 20
, detect method described in sample by above-mentioned three special quality control and control reaction plate according to kit and measure as sample with the standard items of the cutoff value 25mg/L of human chorionic gonadotrophin, respectively measure 10 times, respectively calculating mean value and coefficient of variation CV.Wherein, calculate CV and carry out repeatability and investigate, result shows reaction plate after Quality Control screening, contrast unscreened reaction plate and be entirely inhomogeneous or irregular reaction plate test CV be respectively 8.12%, 11.65% and 14.94%, CV obviously improve.As can be seen here, by said method, can carry out Quality Control to the result of point sample, reduce detection error, improve precision.
Embodiment 6 colloidal gold method point samples (serum amyloid A protein)
(1) preparation of serum amyloid A protein (SAA) quantification kit (colloidal gold method)
This kit is mainly made up of antiserum amyloid A immune colloid gold conjugate and the various damping fluid of reaction plate, freeze-drying.The principle that this kit adopts is percolation.The critical process of preparation feedback plate is the serum amyloid A protein antibody of point sample dilution on nitrocellulose filter.In point sample damping fluid (pH=3～6), add bromophenol blue (0.002wt%), all the other techniques are constant, and contrast adds the reaction plate of indicator and the reaction plate that does not add indicator, investigates kit performance.
First bromophenol blue is dissolved in 20wt%～98wt% alcoholic solution, is mixed with the solution of 1g/L, then use point sample damping fluid stepwise dilution, until contain 0.002wt% bromophenol blue in point sample damping fluid.
Add the reaction plate of colored indicator, after point sample is dry, be shown as yellow or blueness, shape, position, size and the uniformity coefficient of clear demonstration microdose urine protein antibody spot sample.Also can obviously distinguish point sample and the reaction plate of point sample not.
When use, first on reaction plate, add confining liquid, flushable removal bromophenol blue colored indicator, then adds testing sample chromogenic reaction.Can distinguish significantly and use and untapped reaction plate like this, reduce experimental error, avoid maloperation.
(2) performance such as repeatability and the range of linearity of two kinds of reaction plates of comparison (add indicator and do not add indicator)
1. test respectively 10mg/L serum amyloid A protein standard items (cutoff value) with two kinds of reaction plates, result is as table 21.
Table 21
, detect method described in sample by above-mentioned two kinds of reaction plates according to kit and measure as sample with the standard items of the cutoff value 10mg/L of serum amyloid A protein, respectively measure 10 times, respectively calculating mean value and coefficient of variation CV.Wherein, calculate CV and carry out repeatability investigation, result shows that it adds indicator and does not add indicator CV and is respectively 11.89% and 12.04%; Calculate relative deviation with (1-mean value/sign value) * 100% and carry out accuracy investigation, be respectively 1.35% and 1.50%.
2. investigate two kinds of reaction plate stability
To add the reaction plate of indicator and the reaction plate that does not add indicator to be placed on respectively 2-8 DEG C and 37 DEG C, test with serum amyloid A protein standard items 10mg/L, each replication 3 times, test average and initial average differ≤and 20% be qualified stability, investigation stability.
Table 22
3. investigate two kinds of reaction plate ranges of linearity
By the serum amyloid A protein standard items of two kinds of reaction plate test variable concentrations, every kind of each test of standard items is averaged for 3 times.Two kinds of reaction plates are compared, and comparison equation is y=1.041x-0.749, and coefficient R=0.999 illustrates this two kinds of reaction plate there was no significant differences.Result is as Fig. 6 and table 23.
Table 23
By thymol blue (bromothymol blue), bromthymol blue, bromcresol green, methyl orange, methyl red or methyl orange replacement bromophenol blue, effect is similar to bromophenol blue, the minimum 0.0005wt% that reaches of content in point sample damping fluid.
While using phenolphthalein, Congo red replacement bromophenol blue, the effect not obvious or that confining liquid rinses that develops the color is bad.
(3) can precision improvement and deviation with the reaction plate of colored indicator Quality Control
Prepare serum amyloid A protein (SAA) detection kit according to the method point sample of (), and according to the shape of point sample, size, uniformity coefficient, thereby carry out Quality Control, reject that the skew of point sample position is large, out-of-shape or inhomogeneous reaction plate or testing bar.
Table 24
, detect method described in sample by above-mentioned three special quality control and control reaction plate according to kit and measure as sample with the standard items of the cutoff value 10mg/L of serum amyloid A protein, respectively measure 10 times, respectively calculating mean value and coefficient of variation CV.Wherein, calculate CV and carry out repeatability and investigate, result shows reaction plate after Quality Control screening, contrast unscreened reaction plate and be entirely inhomogeneous or irregular reaction plate test CV be respectively 8.27%, 11.25% and 14.57%, CV obviously improve.As can be seen here, by said method, can carry out Quality Control to the result of point sample, reduce detection error, improve precision.
Can also use troponin antibodies, plasma pro-brain natriuretic peptide levels antibody, myoglobins antibody or Mycobacterium tuberculosis antigen replace antibody or the antigen in embodiment 1～6, testing result shows, in point sample damping fluid, add bromophenol blue, thymol blue (bromothymol blue), bromthymol blue, bromcresol green, methyl orange, methyl red or methyl orange, do not affect the repeatability of detection kit, stability and the range of linearity, but carry out Quality Control screening, reject the skew of point sample position large, after out-of-shape or inhomogeneous reaction plate or testing bar, CV value is down to 8% left and right from 12% left and right, have clear improvement.
Claims (9)
1. the point sample method of a diagnostic kit, comprise the point sample damping fluid spraying that contains biological raw material or be coated in matrix, it is characterized in that, in point sample damping fluid, also contain colored indicator, described colored indicator is selected from methyl orange, bromophenol blue, thymol blue, alizarin red S, bromcresol green, methyl red, dibromophenolphthalein, bromcresol purple, bromthymol blue, phenol red, cresol red, thymolphthalein.
2. the point sample method of diagnostic kit described in claim 1, is characterized in that, described colored indicator is selected from methyl orange, bromophenol blue, thymol blue, methyl red, dibromophenolphthalein, bromcresol purple or bromthymol blue.
3. the point sample method of diagnostic kit described in claim 1, is characterized in that, described biological raw material is antigen, recombinant antibodies, monoclonal antibody or polyclonal antibody.
4. the point sample method of diagnostic kit described in claim 1, it is characterized in that, described biological raw material is c reactive protein antibody, DDi protein antibodies, microdose urine protein antibody, hCG antibodies, serum amyloid A protein antibody, troponin antibodies, plasma pro-brain natriuretic peptide levels antibody, myoglobins antibody or Mycobacterium tuberculosis antigen.
5. the point sample method of diagnostic kit described in claim 1, is characterized in that, described diagnostic kit is immune response reagent box.
6. the point sample method of diagnostic kit described in claim 1, is characterized in that, described diagnostic kit is colloid gold immune reaction kit or fluorescence immune reaction kit.
7. the point sample method of diagnostic kit described in claim 1, is characterized in that, in point sample damping fluid, the content of colored indicator is 0.0005wt%～0.1wt%.
8. the point sample method of diagnostic kit described in claim 1, is characterized in that, in point sample damping fluid, the content of colored indicator is 0.001wt%～0.05wt%.
9. developer is for the preparation of immune response diagnostic kit, reaction plate or test strips, it is characterized in that, described colored indicator is selected from methyl orange, bromophenol blue, thymol blue, alizarin red S, bromcresol green, methyl red, dibromophenolphthalein, bromcresol purple, bromthymol blue, phenol red, cresol red or thymolphthalein.
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