CN117664921A - IVD instrument calibration device and method based on immune scattering turbidimetry - Google Patents
IVD instrument calibration device and method based on immune scattering turbidimetry Download PDFInfo
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- G—PHYSICS
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/47—Scattering, i.e. diffuse reflection
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- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/5302—Apparatus specially adapted for immunological test procedures
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2201/00—Features of devices classified in G01N21/00
- G01N2201/12—Circuits of general importance; Signal processing
- G01N2201/124—Sensitivity
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Abstract
The invention discloses a calibrating device of an IVD instrument based on an immune scattering nephelometry, which comprises a light path part and a photoelectric conversion part, wherein the light path part comprises a laser light source for providing incident light, a cuvette, a condensing lens and a photoelectric sensor, the photoelectric conversion part comprises an amplifier for amplifying an electric signal, an A/D conversion circuit for converting the electric signal into a digital signal and a processor, the processor processes the digital signal and outputs a calibration value, and the size of the calibration value is equal to the concentration of a calibrator. After the communication parameters, the gain adjustment range, the stepping and the target output value are set by the user, the calibration device provided by the invention can automatically produce the gain adjustment instruction to control the main board or the test board to finish gain adjustment of the amplifier, so that the output detection value is equal to the concentration of the calibration product, thereby finishing automatic calibration.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a calibration device and method of an IVD instrument based on an immune scattering nephelometry.
Background
The immune scattering turbidimetry is a traditional clinical detection method, and the principle is that when light with a certain wavelength passes through a solution containing antigen-antibody complexes, scattering occurs, the intensity of the scattered light is closely related to the particle size of the antigen-antibody complexes, the intensity and the wavelength of incident light, and the concentration of the antigen-antibody complexes in the solution is quantitatively determined by measuring the intensity of the scattered light.
The sensitivity and the precision of the immune scattering nephelometry are high, and the immune scattering nephelometry is commonly used in IVD (In Vitro Diagnostic, in vitro diagnosis) instruments such as various semi-automatic and full-automatic specific protein analyzers, CRP analyzers and the like. These instruments are composed of elements such as light sources and photoelectric converters. When the instrument needs to be shipped, different measured values can appear due to the fact that the calibration products or samples with the same concentration are used for measurement on different instruments due to the fact that the installation positions of elements in the instrument are physically deviated, namely, inter-platform differences can appear; or providing a reference to a linear range for a user detected using the instrument; or after the instrument is started and used for a period of time, the concentration of the calibrator or the sample measured before is different from the concentration measured after the light source is aged due to the aging of the light source. To eliminate the case of inter-stage differences or degradation in accuracy and to provide a linear range of reference for a user using the instrument to detect, the instrument is calibrated by detecting the same concentration of calibrator using the instrument to obtain the same detection value as the concentration of calibrator. Therefore, when each instrument detects a calibrator at the same concentration, the detection value (i.e., the output value or the target value) of the instrument needs to be adjusted. In the prior art, such adjustment is achieved by manually moving the position of the light source or adjusting the power of the light source, which is inefficient and not accurate.
Disclosure of Invention
The invention provides a calibration device and a method for an IVD instrument based on an immune scattering turbidimetry, and aims to solve the technical problems.
The invention provides a calibrating device of an IVD instrument based on an immune scattering nephelometry, which comprises an optical path part and a photoelectric conversion part, wherein the optical path part comprises a laser light source for providing incident light, a cuvette for containing a calibrator or a sample to be measured, a condensing lens for condensing scattered light emitted from the cuvette in different directions, and a photoelectric sensor for receiving the light emitted by the condensing lens and converting the light into an electric signal, the photoelectric conversion part comprises an amplifier for amplifying the electric signal, an A/D conversion circuit for converting the electric signal into a digital signal, and a processor for processing the digital signal to output a calibration value, and the size of the calibration value is equal to the concentration of the calibrator.
Further, the processor includes:
a setting module for setting at least one set of communication parameters, a gain adjustment range, a step, and a target output value, the target output value being equal to a calibration value;
the instruction module is used for obtaining a plurality of gain adjustment values from the gain adjustment range according to preset steps, generating at least one corresponding gain adjustment instruction by the gain adjustment values according to the communication parameters, and respectively sending the at least one gain adjustment instruction to a circuit capable of debugging the amplifier, so that the circuit respectively adjusts the gain of the amplifier according to each gain adjustment value and respectively obtains actual detection values;
the data acquisition module is used for acquiring each actual detection value detected by the circuit and a corresponding gain adjustment value;
and the adjusting module is used for comparing the actual detection value with the target output value, selecting the actual detection value which is equal to or close to the target output value (the deviation of the actual detection value and the target output value is within +/-5 percent), and using a gain adjusting value corresponding to the actual detection value to adjust the gain of the amplifier.
Further, the setting module is further configured to set a gain reading duration, and the instruction module is further configured to generate at least one corresponding gain adjustment instruction according to the communication parameters by using a plurality of gain adjustment values, so that the circuit delays the gain reading duration to be detected again after adjusting the gain of the amplifier according to each gain adjustment value, and an actual detection value is obtained.
Further, the communication parameters further include a communication protocol type, and the instruction module is further configured to, after generating the corresponding at least one gain adjustment instruction according to the communication parameters by using the plurality of gain adjustment values and the gain reading duration, enable the gain adjustment instruction to be received and processed by a circuit that satisfies the communication protocol type.
Further, the device also comprises a nonvolatile memory, which is used for storing an actual detection value equal to or close to the target output value and a gain adjustment value corresponding to the actual detection value, so that the device can acquire the self-availability after being restarted.
Further, the calibrator is a latex solution with a set concentration.
The invention also provides a calibration method of the IVD instrument based on the immune scattering nephelometry, which comprises the following steps:
s1, turning on a laser light source, placing a calibrator in a cuvette, and then placing the cuvette on a station for instrument testing;
s2, correspondingly setting a target output value according to the concentration of the calibrator, wherein the target output value is equal to the concentration of the calibrator, and setting communication parameters, a gain adjustment range and stepping;
s3, the incident light provided by the laser light source is scattered after being emitted to the cuvette, the scattered light is converged by the converging lens and then is converted into an electric signal by the photoelectric sensor, the electric signal is amplified by the amplifier and is converted into a digital signal by the A/D conversion circuit, and the processor processes the digital signal to output an actual detection value equal to a target output value, so that calibration is completed.
Further, the processor processes the signal comprising the steps of:
a. acquiring at least one group of communication parameters, a gain adjustment range, a step and a target output value set by a user, wherein the target output value is equal to a calibration value;
b. for each set of communication parameters, gain adjustment range, step, and target output values: obtaining a plurality of gain adjustment values from the gain adjustment range according to preset steps, generating at least one corresponding gain adjustment instruction by the gain adjustment values according to the communication parameters, and respectively sending the at least one gain adjustment instruction to a circuit capable of debugging the amplifier, so that the circuit respectively adjusts the gain of the amplifier according to each gain adjustment value and respectively obtains actual detection values;
c. acquiring each actual detection value and a corresponding gain adjustment value detected by the circuit;
d. and comparing the actual detection value with the target output value, selecting the actual detection value which is equal to or similar to the target output value, and using a gain adjustment value corresponding to the actual detection value for adjusting the gain of the amplifier.
Further, the step a further includes the step that the user sets a gain reading duration, and the method further includes: generating at least one corresponding gain adjustment instruction according to the communication parameters by using the gain adjustment values and the gain reading time length, so that the circuit respectively adjusts the gain of the amplifier according to each gain adjustment value, and then delays the gain reading time length for re-detection to obtain an actual detection value;
and/or the communication parameters further comprise a communication protocol type, and after the gain adjustment values and the gain reading time length are generated into at least one corresponding gain adjustment instruction according to the communication parameters, the gain adjustment instruction can be received and processed by a circuit meeting the communication protocol type.
Further, the method further comprises a nonvolatile memory, and further comprises the step d: the nonvolatile memory stores an actual detection value equal to or similar to the target output value and a gain adjustment value corresponding to the actual detection value, so that the instrument can be acquired automatically after being restarted and shut down.
Compared with the prior art, the invention has the beneficial effects that:
after the communication parameters, the gain adjustment range, the stepping and the target output value are set by the user, the calibration device and the calibration method can automatically produce the gain adjustment instruction to control the main board or the test board to finish gain adjustment of the amplifier, so that the output detection value is equal to the concentration of the calibration product, thereby finishing automatic calibration.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the description of the embodiments of the present invention will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a light path portion of a calibration device of an IVD instrument;
fig. 2 is a photoelectric conversion portion of a calibration device of an IVD instrument.
1, a laser light source; 2. a cuvette; 3. a condensing lens; 4. a photoelectric sensor.
Detailed Description
In order to make the technical problems, technical schemes and beneficial effects to be solved more clear, the invention is further described in detail below with reference to the embodiments and the accompanying drawings. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention. The present invention will be specifically described with reference to the following specific examples.
The embodiment of the invention provides a calibrating device of an IVD instrument based on an immune scattering turbidimetry, referring to fig. 1 and 2, the calibrating device comprises a light path part and a photoelectric conversion part, the light path part comprises a laser light source 1 for providing incident light, a cuvette 2 for containing a calibrator or a sample to be measured, a condensing lens 3 for condensing scattered light emitted from the cuvette 2 in different directions, and a photoelectric sensor 4 (light entering after passing through the condensing lens 3 and exciting the light to generate corresponding ions through light energy) for generating charges in a certain direction, forming tiny electricity for conversion, wherein the photoelectric conversion part comprises an amplifier (or a digital potentiometer) for amplifying the electric signals, an A/D conversion circuit for converting the electric signals into digital signals, and a processor (such as an MCU processor) for processing the digital signals to output calibration values, and the size of the calibration values is equal to the concentration of the calibrator.
Specifically, the processor includes:
a setting module for setting at least one set of communication parameters, a gain adjustment range, a step, and a target output value, the target output value being equal to a calibration value. Wherein the gain adjustment range represents a range of gain adjustment values input to the amplifier, so that the amplifier can be adjusted according to the respective gain adjustment values in the gain adjustment range.
The instruction module is used for obtaining a plurality of gain adjustment values from the gain adjustment range according to preset steps, generating at least one corresponding gain adjustment instruction by the gain adjustment values according to the communication parameters, and respectively sending the at least one gain adjustment instruction to a circuit capable of debugging the amplifier, so that the circuit respectively adjusts the gain of the amplifier according to each gain adjustment value and respectively obtains actual detection values. Under the same gain adjustment range, if the preset step is smaller, the number of gain adjustment values is larger, and the adjustment of the amplifier is more accurate, so that the preset step can be correspondingly adjusted according to the requirement of a user. In the embodiment of the invention, the gain adjustment value is obtained from the gain adjustment range according to the preset step, so that the efficiency is higher than that of manually inputting the gain adjustment value, and the accuracy can be adjusted according to the requirement. The circuit capable of debugging the amplifier can be realized by controlling the main board or the test board, the main board or the test board is controlled to input a digital signal for gain adjustment to the amplifier so as to adjust the gain of the amplifier, the amplifier is enabled to correspondingly amplify the electric signal, and then the main board or the test board is controlled to detect, so that a detection value is obtained. The upper computer is in communication connection with the control main board or the test board, so that a corresponding gain adjustment instruction is sent to the control main board or the test board, and after the control main board or the test board receives the gain adjustment instruction, the gain of the amplifier is adjusted according to a gain adjustment value corresponding to the gain adjustment instruction.
And the data acquisition module is used for acquiring each actual detection value detected by the circuit and the corresponding gain adjustment value. When the control main board or the test board adjusts the gain of the amplifier according to the gain adjusting value corresponding to the gain adjusting instruction, detects the actual gain value corresponding to the amplifier, controls the main board or the test board to package the actual gain value and the corresponding gain adjusting value into gain feedback data according to a communication protocol between the main board or the test board and the upper computer, and transmits the gain feedback data to the upper computer.
And the adjusting module is used for comparing the actual detection value with the target output value, selecting the actual detection value which is equal to or similar to the target output value, and using the gain adjusting value corresponding to the actual detection value to adjust the gain of the amplifier.
Specifically, the setting module is further configured to set a gain reading duration, and the instruction module is further configured to generate at least one corresponding gain adjustment instruction according to the communication parameters by using a plurality of gain adjustment values and the gain reading duration, so that the circuit delays the gain reading duration to be detected again after adjusting the gain of the amplifier according to each gain adjustment value, and an actual detection value is obtained.
The gain reading time period indicates a time period from when the amplifier finishes adjusting to when the actual detection value is read, and after the control main board or the test board inputs a digital signal for gain adjustment to the amplifier, if the actual detection value of the amplifier is measured immediately, errors may exist in the measurement of the actual detection value due to unstable output of the amplifier. Therefore, when the delay is delayed for a certain time, for example, the gain reading time is prolonged, the actual detection value tends to be stable, and the measurement is performed at the moment, so that the accuracy of the actual detection value can be improved.
Specifically, the communication parameters further include a communication protocol type, and the instruction module is further configured to, after generating the plurality of gain adjustment values and the gain reading duration according to the communication parameters, generate at least one corresponding gain adjustment instruction, so that the gain adjustment instruction may be received by a circuit that satisfies the communication protocol type. The communication protocol type is used for determining a communication protocol and a corresponding communication mode between the upper computer and the control main board or the test board, for example, when the communication protocol type determined by the user is obtained to be a USB communication protocol, communication connection can be established between the upper computer and the control main board or the test board through a USB interface, and data transmission is performed through the USB interface.
Specifically, the device also comprises a nonvolatile memory, which is used for storing an actual detection value equal to or close to the target output value and a gain adjustment value corresponding to the actual detection value, so that the instrument can be acquired automatically after being restarted and shut down, and the calibration process is not required to be repeated before each detection.
Specifically, the calibrator is a latex solution with a set concentration, and compared with an immune transmission turbidimetry, the immune scattering turbidimetry needs to adopt a latex solution with a certain concentration as a reference background, so that the difference of scattered light entering the condensing lens 3 can be conveniently regulated, and the electric signal is conveniently amplified. And the sample to be detected is quantitatively detected by using an immune scattering turbidimetry after leaving a factory or using a period of time for calibration, a standard curve can be prepared first, and the concentration of the standard substance selected by the standard curve can be set by taking the concentration of the calibrator as the center concentration.
The embodiment of the invention also provides a calibration method of the IVD instrument based on the immune scattering turbidimetry, which comprises the following steps:
s1, turning on a laser light source 1, placing a calibration product in a cuvette 2, and then placing the cuvette 2 on a station for instrument testing;
s2, correspondingly setting a target output value according to the concentration of the calibrator, wherein the target output value is equal to the concentration of the calibrator, and setting communication parameters, a gain adjustment range and stepping;
s3, the incident light provided by the laser light source 1 is scattered after being converged by the condenser lens 3, the scattered light is converted into an electric signal through the photoelectric sensor 4, the electric signal is amplified by the amplifier, the electric signal is converted into a digital signal through the A/D conversion circuit, the digital signal is processed by the processor to output an actual detection value equal to or similar to a target output value, namely the concentration C=kA of the calibrator, wherein k is a concentration coefficient of the calibrator, the k takes a specific value as 1, the numerical value transmission and the processing are convenient, A is absorbance, A=AD and AD are photoelectric values obtained by converting the incident light through the photoelectric sensor after the incident light passes through a standard solution contained in the cuvette, and the calibration is completed.
Specifically, the signal processing by the processor includes the following steps:
a. acquiring at least one group of communication parameters, gain adjustment range, step and target output value set by a user;
b. for each set of communication parameters, gain adjustment range, step, and target output values: obtaining a plurality of gain adjustment values from the gain adjustment range according to preset steps, generating at least one corresponding gain adjustment instruction by the gain adjustment values according to the communication parameters, and respectively sending the at least one gain adjustment instruction to a circuit capable of debugging the amplifier, so that the circuit respectively adjusts the gain of the amplifier according to each gain adjustment value and respectively obtains actual detection values;
c. acquiring each actual detection value and a corresponding gain adjustment value detected by the circuit;
d. and comparing the actual detection value with the target output value, selecting the actual detection value which is equal to or similar to the target output value, and using a gain adjustment value corresponding to the actual detection value for adjusting the gain of the amplifier.
Specifically, the step a further includes the steps that the user sets a gain reading duration, and the method further includes: and generating at least one corresponding gain adjustment instruction according to the communication parameters by using the gain adjustment values and the gain reading time length, so that the circuit delays the gain reading time length to detect again after respectively adjusting the gain of the amplifier according to each gain adjustment value to obtain an actual detection value.
Specifically, the communication parameters further include a communication protocol type, and after the gain adjustment values and the gain reading time periods are generated according to the communication parameters, at least one corresponding gain adjustment instruction is generated, so that the gain adjustment instruction can be received and processed by a circuit meeting the communication protocol type.
Specifically, the method further comprises a nonvolatile memory, and further comprises a step d: the nonvolatile memory stores an actual detection value equal to or similar to the target output value and a gain adjustment value corresponding to the actual detection value, so that the instrument can be acquired automatically after being restarted and shut down, and the calibration process is not required to be repeated before each detection.
According to the calibration device and the calibration method provided by the embodiment of the invention, after the communication parameters, the gain adjustment range, the stepping and the target output value are set by a user, the gain adjustment instruction can be automatically produced to control the control main board or the test board to finish gain adjustment of the amplifier, so that the output detection value is equal to the concentration of the calibration product, and the automatic calibration is finished.
The above description is only of the preferred embodiments of the present invention and is not intended to limit the invention, but any modifications, equivalents, improvements, etc. within the principles of the present invention should be included in the scope of the present invention.
Claims (10)
1. An IVD instrument calibration device based on an immune scattering turbidimetry method is characterized by comprising an optical path part and a photoelectric conversion part, wherein the optical path part comprises a laser light source for providing incident light, a cuvette for containing a calibrator or a sample to be tested, a condensing lens for condensing scattered light emitted from the cuvette in different directions and a photoelectric sensor for receiving the light emitted by the condensing lens and converting the light into an electric signal, the photoelectric conversion part comprises an amplifier for amplifying the electric signal, an A/D conversion circuit for converting the electric signal into a digital signal and a processor, and the processor processes the digital signal to output a calibration value, wherein the size of the calibration value is equal to the concentration of the calibrator.
2. The calibration device of claim 1, wherein the processor comprises:
a setting module for setting at least one set of communication parameters, a gain adjustment range, a step, and a target output value, the target output value being equal to a calibration value;
the instruction module is used for obtaining a plurality of gain adjustment values from the gain adjustment range according to preset steps, generating at least one corresponding gain adjustment instruction by the gain adjustment values according to the communication parameters, and respectively sending the at least one gain adjustment instruction to a circuit capable of debugging the amplifier, so that the circuit respectively adjusts the gain of the amplifier according to each gain adjustment value and respectively obtains actual detection values;
the data acquisition module is used for acquiring each actual detection value detected by the circuit and a corresponding gain adjustment value;
and the adjusting module is used for comparing the actual detection value with the target output value, selecting the actual detection value equal to the target output value, and using a gain adjusting value corresponding to the actual detection value to adjust the gain of the amplifier.
3. The calibration device of claim 2, wherein the setting module is further configured to set a gain reading time period, and the instruction module is further configured to generate at least one corresponding gain adjustment instruction from the plurality of gain adjustment values according to the communication parameter, so that the circuit delays the gain reading time period for re-detection after adjusting the gain of the amplifier according to each gain adjustment value, and obtains an actual detection value.
4. The calibration device of claim 3, wherein the communication parameters further comprise a communication protocol type, and the instruction module is further configured to, after generating the corresponding at least one gain adjustment instruction from the communication parameters based on the plurality of gain adjustment values and the gain read duration, enable the gain adjustment instruction to be received by circuitry that satisfies the communication protocol type.
5. The calibration device of claim 2, further comprising a nonvolatile memory for storing an actual detection value equal to the target output value, and a gain adjustment value corresponding to the actual detection value, so that the instrument can be acquired automatically after being powered on and off again.
6. The calibration device of claim 1, wherein the calibrator is a latex solution of a set concentration.
7. A method for calibrating an IVD instrument based on immunoscattering turbidimetry, comprising the steps of:
s1, turning on a laser light source, placing a calibrator in a cuvette, and then placing the cuvette on a station for instrument testing;
s2, correspondingly setting a target output value according to the concentration of the calibrator, wherein the target output value is equal to the concentration of the calibrator, and setting communication parameters, a gain adjustment range and stepping;
s3, the incident light provided by the laser light source is scattered after being emitted to the cuvette, the scattered light is converged by the converging lens and then is converted into an electric signal by the photoelectric sensor, the electric signal is amplified by the amplifier and is converted into a digital signal by the A/D conversion circuit, and the processor processes the digital signal to output an actual detection value equal to a target output value, so that calibration is completed.
8. The calibration method of claim 7, wherein the processor processing the signal comprises the steps of:
a. acquiring at least one group of communication parameters, a gain adjustment range, a step and a target output value set by a user, wherein the target output value is equal to a calibration value;
b. for each set of communication parameters, gain adjustment range, step, and target output values: obtaining a plurality of gain adjustment values from the gain adjustment range according to preset steps, generating at least one corresponding gain adjustment instruction by the gain adjustment values according to the communication parameters, and respectively sending the at least one gain adjustment instruction to a circuit capable of debugging the amplifier, so that the circuit respectively adjusts the gain of the amplifier according to each gain adjustment value and respectively obtains actual detection values;
c. acquiring each actual detection value and a corresponding gain adjustment value detected by the circuit;
d. and comparing the actual detection value with the target output value, selecting an actual detection value equal to the target output value, and using a gain adjustment value corresponding to the actual detection value to adjust the gain of the amplifier.
9. The method of calibrating according to claim 8, wherein the step a user further sets a gain reading duration, further comprising: generating at least one corresponding gain adjustment instruction according to the communication parameters by using the gain adjustment values and the gain reading time length, so that the circuit respectively adjusts the gain of the amplifier according to each gain adjustment value, and then delays the gain reading time length for re-detection to obtain an actual detection value;
and/or the communication parameters further comprise a communication protocol type, and after the gain adjustment values and the gain reading time length are generated into at least one corresponding gain adjustment instruction according to the communication parameters, the gain adjustment instruction can be received and processed by a circuit meeting the communication protocol type.
10. The method of calibrating according to claim 8, further comprising a non-volatile memory, further comprising step d: the nonvolatile memory stores an actual detection value equal to the target output value and a gain adjustment value corresponding to the actual detection value, so that the instrument can be acquired automatically after being restarted.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311682629.4A CN117664921A (en) | 2023-12-07 | 2023-12-07 | IVD instrument calibration device and method based on immune scattering turbidimetry |
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| CN202311682629.4A CN117664921A (en) | 2023-12-07 | 2023-12-07 | IVD instrument calibration device and method based on immune scattering turbidimetry |
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