CN111912974A - Immune reagent calibration method - Google Patents
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Abstract
The application discloses an immunoreagent calibration method, which comprises the following steps: the target drone tests to obtain a plurality of test concentration values corresponding to first calibration solutions with different actual concentration values; and storing a plurality of actual concentration values of the first calibration solution and the corresponding test concentration values into a physical card so that the test instrument completes calibration by using the physical card. By means of the mode, the calibration solution is not required to be tested when the test instrument is calibrated again.
Description
Technical Field
The application relates to the technical field of medical treatment, in particular to an immune reagent calibration method.
Background
In order to ensure the accuracy of the detection result of the biochemical analyzer, the reagent must be calibrated before clinical detection. When different batches of reagents are measured in the same biochemical analyzer, the applicable calibration curves are different. Therefore, when a new reagent is replaced, recalibration is required, and if the calibration curve of the original reagent is not used, the measurement result is inaccurate.
The inventor of the application finds that in the existing recalibration process, calibration can be completed only after a plurality of calibration liquids with different actual concentration values are measured on a test instrument in the prior recalibration process; the calibration method is long in time consumption, needs manual operation and is relatively complex.
Disclosure of Invention
The technical problem that this application mainly solved provides an immunity reagent calibration method, can make the test instrument need not to test the calibration solution when the calibration again.
In order to solve the technical problem, the application adopts a technical scheme that: providing an immunoreagent scaling method, the scaling method comprising: the target drone tests to obtain a plurality of test concentration values corresponding to first calibration solutions with different actual concentration values; and storing a plurality of actual concentration values of the first calibration solution and the corresponding test concentration values into a physical card so that the test instrument completes calibration by using the physical card.
The target drone test obtains a plurality of test concentration values corresponding to first calibration solutions with different actual concentration values, and comprises the following steps: an optical measurement component in the target drone measures and obtains a plurality of reactivity values corresponding to the first calibration solutions with different actual concentration values; and the target drone calculates and obtains the test concentration value according to the reactivity value and a pre-stored first calibration curve.
Wherein the pre-stored first calibration curve satisfies the following formula:
wherein R is a reactivity value, C is the test concentration value, A11、A21、A(x-1)1、Ax1Is a first constant term, A15、A25、A(x-1)5、Ax5Is a coefficient of the third power, A16、A26、A(x-1)6、Ax6Is a quadratic coefficient, A17、A27、A(x-1)7、Ax7Is a first order coefficient, A18、A28、A(x-1)8、Ax8Is a second constant term, and x is a positive integer.
In order to solve the above technical problem, the present application adopts another technical solution: providing an immunoreagent scaling method, the scaling method comprising: the testing instrument obtains a plurality of testing concentration values of first calibration liquid with different actual concentration values in the target drone from the entity card; calling a second calibration curve prestored in the test instrument to calculate and obtain a reactivity value corresponding to the first calibration solution of each test concentration value; fitting the reaction values corresponding to the first calibration liquids and the actual concentration values to obtain a third calibration curve; and updating the calibration curve in the test instrument into the third calibration curve.
Wherein the second and third calibration curves satisfy the following formula:
wherein R is a reactivity value, C is the test concentration value, A11、A21、A(x-1)1、Ax1Is a first constant term, A15、A25、A(x-1)5、Ax5Is a coefficient of the third power, A16、A26、A(x-1)6、Ax6Is a quadratic coefficient, A17、A27、A(x-1)7、Ax7Is a first order coefficient, A18、A28、A(x-1)8、Ax8Is a second constant term, and x is a positive integer.
Calling a second calibration curve prestored in the test instrument to calculate and obtain a reactivity value corresponding to the first calibration solution of each test concentration value, wherein the calculating comprises: obtaining a corresponding first constant term A in the second calibration curve11、A21、A(x-1)1、Ax1Coefficient of cubic equation A15、A25、A(x-1)5、Ax5Quadratic coefficient A16、A26、A(x-1)6、Ax6First power coefficient A17、A27、A(x-1)7、Ax7A second constant term A18、A28、A(x-1)8、Ax8(ii) a Substituting the test concentration value C corresponding to each first calibration solution into the formula to obtain a plurality of corresponding reactivity values R.
Wherein the reaction value and the actual concentration corresponding to the plurality of first calibration liquids are usedAnd fitting the values to obtain a third calibration curve, which comprises: fitting the plurality of reactivity values and the actual concentration value to obtain a third calibration curve with an abscissa as the actual concentration value and an ordinate as the reactivity value; analyzing the third calibration curve to obtain a cubic coefficient A corresponding to the third calibration curve15、A25、A(x-1)5、Ax5Quadratic coefficient A16、A26、A(x-1)6、Ax6First power coefficient A17、A27、A(x-1)7、Ax7A second constant term A18、A28、A(x-1)8、Ax8。
Wherein the actual concentration values of the plurality of first calibration solutions are not 0, and a third calibration curve is obtained by fitting the reactivity values and the actual concentration values corresponding to the plurality of first calibration solutions, before the method further includes: and the testing instrument obtains a corresponding reactivity value when the actual concentration value of the first calibration solution is 0.
Wherein, the first calibration solution has the same formula as the second calibration solution corresponding to the second calibration curve, and the obtaining, by the testing instrument, the corresponding reactivity value when the actual concentration value of the first calibration solution is 0 includes: and taking the reaction value of the second calibration solution corresponding to the second calibration curve when the actual concentration value of the second calibration solution is 0 as the reaction value of the first calibration solution when the actual concentration value of the first calibration solution is 0.
Wherein, the first calibration liquid and the second calibration liquid corresponding to the second calibration curve have different formulas, and the obtaining, by the testing instrument, a corresponding reactivity value when the actual concentration value of the first calibration liquid is 0 includes: and obtaining the reaction value measured when the testing instrument runs empty.
The beneficial effect of this application is: different from the situation of the prior art, in the immune reagent calibration method provided by the application, a target machine is tested firstly to obtain a plurality of test concentration values corresponding to first calibration solutions with different actual concentration values; then storing a plurality of actual concentration values of the first calibration solution and corresponding test concentration values into an entity card; when the test instrument (non-target) needs to be calibrated again, the test instrument can obtain a plurality of actual concentration values and test concentration values of the first calibration solution stored in the test instrument from the entity card, and then deduces and obtains a new calibration curve in a calculation mode. The calibration method provided by the application can calibrate the newly replaced reagent on one hand, and on the other hand, the test instrument does not need to measure a plurality of first calibration liquids during calibration, and can realize recalibration by adopting a card swiping calculation mode, wherein the mode is simple and convenient.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the description of the embodiments are briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts. Wherein:
FIG. 1 is a schematic flow chart of one embodiment of a method for the targeting of immunoreagents according to the present application;
FIG. 2 is a schematic flow chart of another embodiment of the immunoassay reagent targeting method of the present application.
Detailed Description
The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
Referring to fig. 1, fig. 1 is a schematic flow chart of an embodiment of the present invention of an immunoreagent scaling method, which includes:
s101: the target drone test obtains a plurality of test concentration values corresponding to first calibration solutions with different actual concentration values.
Specifically, in this embodiment, the first calibrator is an immunoreagent calibrator, such as a C-reactive protein CRP calibrator, a thyroglobulin antibody calibrator, or the like. The number of the first calibration solutions with different actual concentration values is at least 5, for example, 5, 6, 7, etc., and when the actual concentration values of the plurality of first calibration solutions are arranged from small to large, the concentration gradients of the actual concentration values of the plurality of first calibration solutions can be set by the manufacturer, for example, the ratios or the differences of the actual concentration values of the adjacent first calibration solutions can be set to be the same.
The selection mode of the target drone can be as follows: selecting one of the biochemical analysis instruments which can normally use normal calibration as a target machine; the specific implementation manner in step S101 is as follows:
A. an optical measurement component in the target drone measures and obtains a plurality of reactivity values corresponding to first calibration solutions with different actual concentration values. In this embodiment, a plurality of first calibration solutions with different actual concentration values may be simultaneously or sequentially placed in the target drone, and an optical signal measured by an optical measurement component in the target drone is converted to obtain an electrical signal parameter (e.g., a voltage variation, etc.), where the electrical signal parameter is a reaction value.
B. And calculating by the target drone according to the reactivity value and a pre-stored first calibration curve to obtain a test concentration value. In this embodiment, the first calibration curve is a calibration curve corresponding to a previous batch of reagent in the target drone, and the first calibration curve satisfies the following formula:
wherein R is reactivity value, C is test concentration value, A11、A21、A(x-1)1、Ax1Is a first constant term, A15、A25、A(x-1)5、Ax5Is a coefficient of the third power, A16、A26、A(x-1)6、Ax6Is a quadratic coefficient, A17、A27、A(x-1)7、Ax7Is a first order coefficient, A18、A28、A(x-1)8、Ax8Is a second constant term, x is a positive integer; wherein in this step the first constant term A11、A21、A(x-1)1、Ax1The actual concentration value of the calibration solution corresponding to the previous batch of reagents in the target drone. At this time, substituting different reactivity values into the above formula can solve and obtain corresponding test concentration values.
S102: and storing a plurality of actual concentration values of the first calibration solution and corresponding test concentration values into the entity card so that the test instrument completes calibration by using the entity card.
Specifically, in the present embodiment, the physical card may be a magnetic card, a usb disk, or the like having a function of storing information and obtaining the information by an external instrument. The actual concentration values and the corresponding test concentration values can be stored in the entity card by adopting a mapping table and other modes; of course, in other embodiments, a plurality of actual concentration values and corresponding test concentration values of the first calibration solution may also be stored in a network virtual storage device, for example, a cloud platform, a network disk, and the like.
Referring to FIG. 2, FIG. 2 is a schematic flow chart of another embodiment of the present disclosure, the method for scaling immunoreagents includes:
s201: the testing instrument obtains a plurality of testing concentration values of first calibration solution with different actual concentration values in the target drone from the entity card.
Specifically, in this embodiment, the testing apparatus is not the same as the target drone in the above embodiment, and the step S201 may be performed before the testing apparatus replaces the second batch of reagent corresponding to the first calibration solution as the testing reagent. When the entity card is a magnetic card, the magnetic card is contacted with a magnetic card induction area on the test instrument so that the test instrument can identify and obtain the data information stored in the entity. When the entity card is a U disk, the USB disk is contacted with a USB interface on the test instrument, so that the test instrument can identify and obtain the data information stored in the entity card. Of course, the manner of obtaining the data information in the entity card by the test instrument may be other, and the present application does not limit this.
S202: and calling a second calibration curve prestored in the test instrument to calculate and obtain the corresponding reactivity value of the first calibration liquid of each test concentration value.
Specifically, in one application scenario, the second scaling curve satisfies the following formula:
wherein R is a reactivity value, C is the test concentration value, A11、A21、A(x-1)1、Ax1Is a first constant term, A15、A25、A(x-1)5、Ax5Is a coefficient of the third power, A16、A26、A(x-1)6、Ax6Is a quadratic coefficient, A17、A27、A(x-1)7、Ax7Is a first order coefficient, A18、A28、A(x-1)8、Ax8Is a second constant term, x is a positive integer; wherein in this step the first constant term A11、A21、A(x-1)1、Ax1The actual concentration value of the second calibration solution corresponding to the second calibration curve in the test instrument.
The step S202 specifically includes: obtaining a corresponding first constant term A in the second calibration curve11、A21、A(x-1)1、Ax1Coefficient of cubic equation A15、A25、A(x-1)5、Ax5Quadratic coefficient A16、A26、A(x-1)6、Ax6First power coefficient A17、A27、A(x-1)7、Ax7A second constant term A18、A28、A(x-1)8、Ax8(ii) a And substituting the test concentration value C corresponding to each first calibration solution into a formula to obtain a plurality of corresponding reactivity values R.
For example, in an application scenario, assuming that the number of the first calibration solutions with different actual concentration values at this time is m, the corresponding test concentration values are C1、C2、…、CmAnd C is1≤C2≤…≤Cm(ii) a The step S202 specifically includes:
A. calling a pre-stored second calibration curve to construct a formula, wherein the second calibration curve is the second calibration curve in the formulaThe actual concentration value of the second calibration liquid corresponding to the calibration curve is A11、A21、…、Am1And A is11≤A21≤…≤Am1;
B. Different test concentration values C1、C2、…、CmSubstituting the above formula to calculate and obtain the corresponding reactivity value R1、R2、···、Rm。
S203: and fitting the reaction values corresponding to the plurality of first calibration solutions and the actual concentration value to obtain a third calibration curve.
Specifically, in an application scenario, the third scaling curve satisfies the following formula:
wherein R is a reactivity value, C is the test concentration value, A11、A21、A(x-1)1、Ax1Is a first constant term, A15、A25、A(x-1)5、Ax5Is a coefficient of the third power, A16、A26、A(x-1)6、Ax6Is a quadratic coefficient, A17、A27、A(x-1)7、Ax7Is a first order coefficient, A18、A28、A(x-1)8、Ax8Is a second constant term, and x is a positive integer.
In an application scenario, the step S203 specifically includes: fitting the plurality of reactivity values and the actual concentration value to obtain a third calibration curve with the abscissa as the actual concentration value and the ordinate as the reactivity value; analyzing the third calibration curve to obtain a cubic coefficient A corresponding to the third calibration curve15、A25、A(x-1)5、Ax5Quadratic coefficient A16、A26、A(x-1)6、Ax6First power coefficient A17、A27、A(x-1)7、Ax7Constant term A18、A28、A(x-1)8、Ax8And the instrument is tested through the process to finish the calibration process of the first calibration liquid.
In another embodiment, the actual concentration values of the plurality of first calibration solutions in step S201 are not 0, and before step S203, the calibration method provided by the present application further includes: and obtaining a corresponding reactivity value when the actual concentration value of the first calibration solution is 0. The step S203 specifically includes: and fitting the reaction values corresponding to the plurality of first calibration solutions and the actual concentration value to obtain a third calibration curve, wherein the actual concentration value contains 0.
In one application scenario, the first calibration solution has the same formula as a second calibration solution corresponding to a second calibration curve (e.g., the first calibration solution and the second calibration solution from the same manufacturer), and obtaining a reactivity value corresponding to an actual concentration value of 0 of the first calibration solution includes: and taking the reaction value when the actual concentration value of the second calibration solution corresponding to the second calibration curve is 0 as the reaction value when the actual concentration value of the first calibration solution is 0.
In yet another application scenario, the first calibration solution and the second calibration solution corresponding to the second calibration curve have different formulations (e.g., the first calibration solution and the second calibration solution from different manufacturers), and obtaining the corresponding reactivity value when the actual concentration value is 0 includes: obtaining a reaction value measured when the test instrument runs empty, namely the reaction value obtained when the test instrument does not contain the calibration solution; for example, in order to reduce the probability of the occurrence of air bubbles in the test instrument, a diluent (the concentration of the immunological substance in the diluent is 0) may be placed in the test instrument, and then the test instrument tests to obtain a reaction value at that time, which is the reaction value when the test instrument runs empty.
S204: the calibration curve in the test instrument is updated to a third calibration curve.
Specifically, this step S204 includes updating the data of the second calibration curve originally stored in the test instrument to the data of the third calibration curve.
In summary, in the immunoassay reagent calibration method provided by the present application, a target machine is first tested to obtain a plurality of test concentration values corresponding to first calibration solutions with different actual concentration values; then storing a plurality of actual concentration values of the first calibration solution and corresponding test concentration values into an entity card; when the test instrument needs to be calibrated again, the test instrument can obtain a plurality of actual concentration values and test concentration values of the first calibration solution stored in the test instrument from the entity card, and then deduces and obtains a new calibration curve in a calculation mode. The calibration method provided by the application can calibrate the newly replaced reagent on one hand, and on the other hand, the test instrument does not need to measure a plurality of first calibration liquids during calibration, and can realize recalibration by adopting a card swiping calculation mode, wherein the mode is simple and convenient.
The immunoassay reagent calibration method provided herein is further illustrated by the following specific examples.
A. One of the instruments which can be normally used and normally calibrated is selected as the target drone.
B. Providing a plurality of first calibration liquids with different actual concentration values; in this embodiment, the number of the first standard solutions is 5, and assuming that the actual concentration values of the first standard solutions are [10,20,40,80,120], the first standard solutions can be directly provided by the manufacturer.
C. The multiple first calibration liquids are changed into the target drone, the target drone tests to obtain the reactivity values of the multiple first calibration liquids, and the test concentration values of the multiple first calibration liquids on the target drone are respectively [ B ] through calculation according to the first calibration curves stored in the target drone10,B20,B40,B80,B120]。
D. Storing a plurality of actual concentration values of the first calibration solution and the test concentration value on the drone in a physical card.
E. Before a test instrument (non-target drone) uses a new reagent and a calibration solution corresponding to the new reagent is a first calibration solution, the test instrument obtains a plurality of test concentration values of the first calibration solution in the target drone, wherein the test concentration values of the first calibration solution are different in actual concentration value, from a physical card in a card swiping mode.
F. Obtaining a configuration file corresponding to a second calibration curve stored in the test instrument before swiping the card, wherein the configuration file is as follows:
0,34.53,10,144.3,0.03632004219,0,7.344995781,34.53;
10,144.3,20,415.23,-0.02044021097,1.089601266,18.24100844,144.3;
20,415.23,40,1210.57,-0.009154672996,0.4763949367,33.90097046,415.23;
40,1210.57,80,2688.4,-0.001318745385,-0.07288544304,41.97116034,1210.57;
80,2688.4,120,3634.27,0.001926124077,-0.2311348892,29.81034705,2688.4;
each line in the configuration file has 8 parameters, which can be respectively recorded as: a. thex1,Ax2,Ax3,Ax4,Ax5,Ax6,Ax7,Ax8Wherein A isx1The actual concentration value of the second calibration liquid corresponding to the second calibration curve, Ax2Is Ax1Corresponding reaction value, Ax2Is a and Ax1Adjacent next actual concentration value, Ax3Is Ax2Corresponding reaction value, Ax5Is a coefficient of the third power, Ax6Coefficient of quadratic form, Ax7Is a coefficient of the first power, Ax8Is a constant term.
G. Calling each parameter of the second calibration curve obtained in the step F to construct a formula, and testing concentration values [ B ] of the plurality of first calibration liquids obtained in the step E10,B20,B40,B80,B120]Substituting into the following formula to obtain corresponding reactivity value [ R10,R20,R40,R80,R120]。
H. Obtaining a corresponding reactivity value R when the actual concentration value of the first calibration solution is 00The method specifically comprises the following steps: judgment ofIf the first calibration liquid and the second calibration liquid corresponding to the second calibration curve have the same formula, if so, setting the corresponding reactivity value A when the actual concentration value of the second calibration liquid corresponding to the second calibration curve in the step F is 012Direct assignment as R0I.e. R0=A12(ii) a Otherwise, obtaining the response value R of the test instrument during idle running0;
I. The actual concentration value [0,10,20,40,80,120 ] of the first calibration solution is measured]And [ R ]0,R10,R20,R40,R80,R120]And generating a third calibration curve, and storing each parameter corresponding to the third calibration curve.
The above description is only for the purpose of illustrating embodiments of the present application and is not intended to limit the scope of the present application, and all modifications of equivalent structures and equivalent processes, which are made by the contents of the specification and the drawings of the present application or are directly or indirectly applied to other related technical fields, are also included in the scope of the present application.
Claims (10)
1. A method for scaling an immunoreagent, the method comprising:
the target drone tests to obtain a plurality of test concentration values corresponding to first calibration solutions with different actual concentration values;
and storing a plurality of actual concentration values of the first calibration solution and the corresponding test concentration values into a physical card so that the test instrument completes calibration by using the physical card.
2. The calibration method according to claim 1, wherein the target drone test obtains a plurality of test concentration values corresponding to first calibration solutions different in actual concentration value, and comprises:
an optical measurement component in the target drone measures and obtains a plurality of reactivity values corresponding to the first calibration solutions with different actual concentration values;
and the target drone calculates and obtains the test concentration value according to the reactivity value and a pre-stored first calibration curve.
3. The scaling method according to claim 2, wherein the pre-stored first scaling curve satisfies the following formula:
wherein R is a reactivity value, C is the test concentration value, A11、A21、A(x-1)1、Ax1Is a first constant term, A15、A25、A(x-1)5、Ax5Is a coefficient of the third power, A16、A26、A(x-1)6、Ax6Is a quadratic coefficient, A17、A27、A(x-1)7、Ax7Is a first order coefficient, A18、A28、A(x-1)8、Ax8Is a second constant term, and x is a positive integer.
4. A method for scaling an immunoreagent, the method comprising:
the testing instrument obtains a plurality of testing concentration values of first calibration liquid with different actual concentration values in the target drone from the entity card;
calling a second calibration curve prestored in the test instrument to calculate and obtain a reactivity value corresponding to the first calibration solution of each test concentration value;
fitting the reaction values corresponding to the first calibration liquids and the actual concentration values to obtain a third calibration curve;
and updating the calibration curve in the test instrument into the third calibration curve.
5. The scaling method according to claim 4,
the second and third calibration curves satisfy the following formulas:
wherein R is a reactivity value, C is the test concentration value, A11、A21、A(x-1)1、Ax1Is a first constant term, A15、A25、A(x-1)5、Ax5Is a coefficient of the third power, A16、A26、A(x-1)6、Ax6Is a quadratic coefficient, A17、A27、A(x-1)7、Ax7Is a first order coefficient, A18、A28、A(x-1)8、Ax8Is a second constant term, and x is a positive integer.
6. The calibration method according to claim 5, wherein said invoking a second calibration curve pre-stored in the test instrument to calculate a reactivity value corresponding to the first calibration solution for each of the test concentration values comprises:
obtaining a corresponding first constant term A in the second calibration curve11、A21、A(x-1)1、Ax1Coefficient of cubic equation A15、A25、A(x-1)5、Ax5Quadratic coefficient A16、A26、A(x-1)6、Ax6First power coefficient A17、A27、A(x-1)7、Ax7A second constant term A18、A28、A(x-1)8、Ax8;
Substituting the test concentration value C corresponding to each first calibration solution into the formula to obtain a plurality of corresponding reactivity values R.
7. The calibration method according to claim 5, wherein said fitting with said reactivity values and said actual concentration values corresponding to a plurality of said first calibration solutions to obtain a third calibration curve comprises:
fitting the plurality of reactivity values and the actual concentration value to obtain a third calibration curve with an abscissa as the actual concentration value and an ordinate as the reactivity value;
analyzing the third calibration curve to obtain a cubic coefficient A corresponding to the third calibration curve15、A25、A(x-1)5、Ax5Quadratic coefficient A16、A26、A(x-1)6、Ax6First power coefficient A17、A27、A(x-1)7、Ax7A second constant term A18、A28、A(x-1)8、Ax8。
8. The scaling method according to claim 4,
the actual concentration values of the plurality of first calibration solutions are not 0, and a third calibration curve is obtained by fitting the reactivity values and the actual concentration values corresponding to the plurality of first calibration solutions, before the method further includes: and the testing instrument obtains a corresponding reactivity value when the actual concentration value of the first calibration solution is 0.
9. The calibration method according to claim 8, wherein the first calibration solution has the same formula as a second calibration solution corresponding to the second calibration curve, and the obtaining, by the testing apparatus, a corresponding reactivity value when the actual concentration value of the first calibration solution is 0 comprises:
and taking the reaction value of the second calibration solution corresponding to the second calibration curve when the actual concentration value of the second calibration solution is 0 as the reaction value of the first calibration solution when the actual concentration value of the first calibration solution is 0.
10. The calibration method according to claim 8, wherein the first calibration solution has a different formula from a second calibration solution corresponding to the second calibration curve, and the obtaining, by the testing apparatus, a corresponding reactivity value when the actual concentration value of the first calibration solution is 0 comprises:
and obtaining the reaction value measured when the testing instrument runs empty.
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