Whole blood hemoglobin measurement device, calibration method therefor, and measurement method

Abstract

The invention discloses a whole blood hemoglobin measuring device, and a correction method, a measuring method, equipment and a medium thereof, which are used for realizing self-check drift compensation for the measuring device. The correction method comprises the following steps: respectively adjusting a first amplification factor of the measuring device for a first wavelength signal and a second amplification factor of the measuring device for a second wavelength signal; respectively obtaining a first preset relation model corresponding to the first magnification factor and a second preset relation model corresponding to the second magnification factor; respectively resolving to obtain a first relation model corresponding to the first wavelength test signal and a second relation model corresponding to the second wavelength test signal; and determining a first signal compensation amount of the measuring device for the first wavelength signal and the first amplification factor according to the first preset relation model and the first relation model. The hemoglobin concentration can be conveniently, rapidly, simply and accurately obtained, the influence of environmental factors on the measurement precision is eliminated, and the method has industrial popularization significance.

Description

Technical Field

[0001] The present invention belongs to the field of medical detection technology, and in particular relates to a whole blood hemoglobin determination device and a calibration method, a determination method, equipment and a medium thereof. Background Art

[0002] Human red blood cells contain large amounts of hemoglobin, a protein responsible for oxygen transport in higher organisms and a key indicator of human health. Hemoglobin levels are currently commonly measured using blood analyzers. While accurate and reliable, blood analyzers are expensive, bulky, require numerous liquid reagents, and require frequent maintenance, making them unsuitable for mobile use. Portable hemoglobin analyzers, on the other hand, utilize dry chemistry and electrochemical methods and require test strips. These test strips have low precision, large batch-to-batch variability, and are susceptible to storage and deterioration, resulting in inaccurate hemoglobin measurements. For whole blood hemoglobin concentration measurement, two methods rely on the reaction between hemoglobin and certain reagents to produce a stable chromogenic substance, which is then calculated based on its absorption characteristics at a specific wavelength. Another method uses electrochemical principles to measure hemoglobin concentration by measuring peak current. Dual-wavelength spectrophotometry eliminates the need for chemical reagents but cannot avoid the effects of light scattering, resulting in low hemoglobin measurement accuracy. Furthermore, it is subject to issues such as scattering, a small optical pathlength of the cuvette, limited equipment, and high cost. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to overcome the above-mentioned defects in the prior art and provide a whole blood hemoglobin determination device and its calibration method, determination method, equipment and medium.

[0004] The present invention solves the above technical problems through the following technical solutions:

[0005] The present invention provides a calibration method for a whole blood hemoglobin measuring device, wherein the measuring device is used to measure the whole blood hemoglobin concentration by dual-wavelength spectrophotometry, and the calibration method is used to achieve self-checking drift compensation for the measuring device; the calibration method comprises the following steps:

[0006] respectively adjusting a first amplification factor of the measuring device for the first wavelength signal and a second amplification factor of the measuring device for the second wavelength signal;

[0007] Obtaining a first preset relationship model corresponding to the first magnification and a second preset relationship model corresponding to the second magnification respectively; wherein the first preset relationship model is a preset relationship model characterizing the relationship between the intensity of the first wavelength signal and the first magnification; and the second preset relationship model is a preset relationship model characterizing the relationship between the intensity of the second wavelength signal and the second magnification;

[0008] Respectively solving and obtaining a first relationship model corresponding to a first wavelength test signal and a second relationship model corresponding to a second wavelength test signal; wherein the first wavelength test signal and the second wavelength test signal are test signals having first and second wavelengths, respectively, emitted by the measuring device in an idle state; the first relationship model represents a relationship between the intensity of the first wavelength test signal and the first amplification factor, and the second relationship model represents a relationship between the intensity of the second wavelength test signal and the second amplification factor;

[0009] The first signal compensation amount of the measuring device for the first wavelength signal and the first amplification factor is determined according to the first preset relationship model and the first relationship model respectively; and the second signal compensation amount of the measuring device for the second wavelength signal and the second amplification factor is determined according to the second preset relationship model and the second relationship model; wherein the first signal compensation amount and the second signal compensation amount are respectively used to compensate for the signals with the first wavelength and the second wavelength obtained by the measuring device in a non-idle state.

[0010] Preferably, the first wavelength is 420nm to 445nm; the second wavelength is 750nm to 435nm.

[0011] Preferably, the first wavelength is 435 nm; and the second wavelength is 680 nm.

[0012] The present invention also provides a calibration system for a whole blood hemoglobin measuring device, wherein the measuring device is used to measure the whole blood hemoglobin concentration by dual-wavelength spectrophotometry, and the calibration system is used to implement self-detection drift compensation for the measuring device; the calibration system comprises:

[0013] A magnification module, used to adjust the first magnification of the measuring device for the first wavelength signal and the second magnification of the measuring device for the second wavelength signal respectively;

[0014] An acquisition module, configured to respectively acquire a first preset relationship model corresponding to the first magnification and a second preset relationship model corresponding to the second magnification; wherein the first preset relationship model is a preset relationship model characterizing the relationship between the intensity of the first wavelength signal and the first magnification; and the second preset relationship model is a preset relationship model characterizing the relationship between the intensity of the second wavelength signal and the second magnification;

[0015] A solution module, configured to respectively solve and obtain a first relationship model corresponding to a first wavelength test signal and a second relationship model corresponding to a second wavelength test signal; wherein the first wavelength test signal and the second wavelength test signal are test signals having first and second wavelengths, respectively, emitted by the measuring device in an idle state; the first relationship model represents a relationship between the intensity of the first wavelength test signal and the first amplification factor, and the second relationship model represents a relationship between the intensity of the second wavelength test signal and the second amplification factor;

[0016] A compensation module is used to determine the first signal compensation amount of the measuring device for the first wavelength signal and the first amplification factor based on the first preset relationship model and the first relationship model respectively; and to determine the second signal compensation amount of the measuring device for the second wavelength signal and the second amplification factor based on the second preset relationship model and the second relationship model; wherein the first signal compensation amount and the second signal compensation amount are respectively used to compensate for the signals with the first wavelength and the second wavelength acquired by the measuring device in a non-idle state.

[0017] The present invention also provides a method for determining whole blood hemoglobin, which is applied to a device for determining the whole blood hemoglobin concentration by dual-wavelength spectrophotometry; the method comprises the following steps:

[0018] Acquire a first light feature vector; the first light feature vector includes a first wavelength light absorbance feature and a second wavelength light absorbance feature based on the first sample data;

[0019] determining a first-level regression model based on the first light feature vector and the sample concentration corresponding to the first sample data;

[0020] Determining a second-level regression model based on the first calculated value and the sample concentration corresponding to the second sample data; the first calculated value is obtained by substituting the second sample data into the first-level regression model;

[0021] The whole blood hemoglobin concentration was determined according to the second-level regression model.

[0022] Preferably, the measuring device is used to measure the hemoglobin concentration of whole blood after the measuring device has been calibrated by the above-mentioned method.

[0023] The present invention also provides a whole blood hemoglobin measurement system, which is used in a measurement device for measuring whole blood hemoglobin concentration by dual-wavelength spectrophotometry; the measurement system comprises:

[0024] A first vector acquisition module is configured to acquire a first light feature vector; the first light feature vector includes a first wavelength light absorbance feature and a second wavelength light absorbance feature based on the first sample data;

[0025] a first model determination module, configured to determine a first-level regression model based on the first light feature vector and the sample concentration corresponding to the first sample data;

[0026] A second model determination module is configured to determine a second-level regression model based on the first calculated value and the sample concentration corresponding to the second sample data; wherein the first calculated value is obtained by substituting the second sample data into the first-level regression model;

[0027] A determination module is used to determine the whole blood hemoglobin concentration according to the second-level regression model.

[0028] The present invention also provides an electronic device comprising a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor implements the above-mentioned method for determining whole blood hemoglobin when executing the computer program.

[0029] The present invention also provides a computer-readable storage medium having a computer program stored thereon, wherein the computer program implements the above-mentioned method for determining whole blood hemoglobin when executed by a processor.

[0030] The present invention also provides a whole blood hemoglobin determination device, comprising the above electronic device.

[0031] The positive progressive effects of the present invention are as follows: the present invention provides a whole blood hemoglobin measurement device and its correction method, measurement method, equipment and medium, applies dual-wavelength spectrophotometry to the measurement device to detect the whole blood hemoglobin concentration, achieves precise control of the detection and significantly improves the hemoglobin measurement accuracy in each concentration range through matching drift compensation, multi-level regression calculation model and cuvette chip based on optimal optical path, compensates for the light loss caused by particle scattering and signal drift under different environments in the existing technology, thereby being able to more conveniently, quickly and concisely obtain the hemoglobin concentration accurately, eliminate the influence of environmental factors on the measurement accuracy, provide a measurement basis for medical and home recovery monitoring of abnormal hemoglobin content, and has industry promotion significance. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 This is a flow chart of the calibration method of the whole blood hemoglobin measuring device according to Example 1 of the present invention.

[0033] Figure 2 Schematic diagram of the modules of the calibration system of the whole blood hemoglobin measuring device in Example 2 of the present invention.

[0034] Figure 3 This is a flow chart of the method for measuring whole blood hemoglobin according to Example 3 of the present invention.

[0035] Figure 4 This is a module schematic diagram of the whole blood hemoglobin measurement system of Example 4 of the present invention.

[0036] Figure 5 This is a structural block diagram of an electronic product according to embodiment 5 of the present invention.

[0037] Figure 6 Schematic diagram of a whole blood hemoglobin measurement device according to Example 7 of the present invention.

[0038] Figure 7 Schematic diagram of the microfluidic chip in the whole blood hemoglobin measurement device of Example 7 of the present invention.

[0039] Figure 8 This is an analysis flow chart of the whole blood hemoglobin measurement device according to Example 7 of the present invention.

[0040] Figure 9 Schematic diagram of the correlation curve comparison between the whole blood hemoglobin determination device of Example 7 of the present invention and the measurement results of the biochemical analyzer. DETAILED DESCRIPTION

[0041] To more clearly illustrate the technical solutions of the embodiments of this specification, the following briefly describes the drawings required for describing the embodiments. Obviously, the drawings described below are merely examples or embodiments of this specification. Those skilled in the art can apply this specification to other similar scenarios based on these drawings without inventive effort. Unless otherwise apparent from the context or otherwise noted, the same reference numerals in the figures represent the same structure or operation.

[0042] The calibration method of the whole blood hemoglobin measuring device and / or the whole blood hemoglobin measuring method provided in this embodiment can be executed in an intelligent terminal, a computer terminal, a network device, a chip, a chip module or a similar computing device. Mentioning "embodiment" in this application means that the specific features, structures or characteristics described in conjunction with the embodiment may be included in at least one embodiment of the present application. The appearance of this phrase in various places in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described in this application can be combined with other embodiments.

[0043] It should be understood that the terms "system," "device," "unit," and / or "module" used herein are a method for distinguishing different components, elements, parts, portions, or assemblies at different levels. However, if other terms can achieve the same purpose, the terms may be replaced by other expressions.

[0044] As used in this specification, unless the context clearly indicates otherwise, the words "a," "an," "an," and / or "the" are not intended to refer to the singular but may include the plural. Generally speaking, the terms "comprise" and "include" only indicate the inclusion of the steps and elements specifically identified, and these steps and elements do not constitute an exclusive list. A method or apparatus may also include other steps or elements.

[0045] Example 1

[0046] See also Figure 1 As shown, this embodiment specifically provides a calibration method for a whole blood hemoglobin measuring device, the measuring device being used to measure the whole blood hemoglobin concentration by dual-wavelength spectrophotometry, and the calibration method being used to implement self-detection drift compensation for the measuring device; the calibration method comprises the following steps:

[0047] S1. respectively adjust the measuring device for the first wavelength signal and the second amplification factor for the second wavelength signal;

[0048] S2. respectively obtain a first preset relationship model corresponding to the first magnification and a second preset relationship model corresponding to the second magnification; wherein the first preset relationship model is a preset relationship model representing the relationship between the intensity of the first wavelength signal and the first magnification; the second preset relationship model is a preset relationship model representing the relationship between the intensity of the second wavelength signal and the second magnification;

[0049] S3. Solve and obtain the first relationship model corresponding to the first wavelength test signal and the second relationship model corresponding to the second wavelength test signal respectively; wherein the first wavelength test signal and the second wavelength test signal are test signals of the first wavelength and the second wavelength, respectively, emitted by the measuring device in an idle state; the first relationship model represents the relationship between the intensity of the first wavelength test signal and the first magnification factor, and the second relationship model represents the relationship between the intensity of the second wavelength test signal and the second magnification factor; the hemoglobin absorption peak in human blood appears at a wavelength of 520nm-545nm, and 600nm-750nm is the matrix wavelength. As a preferred embodiment, the first wavelength collected is 520nm-545nm, preferably 535nm, the second wavelength is 600nm-750nm, preferably 680nm, the light signal of the secondary transmission of the blood sample, and the scattered signals at 8°-40° and -8°--40°.

[0050] S4. Determine the first signal compensation amount of the measuring device for the first wavelength signal and the first amplification factor according to the first preset relationship model and the first relationship model respectively; and determine the second signal compensation amount of the measuring device for the second wavelength signal and the second amplification factor according to the second preset relationship model and the second relationship model; wherein the first signal compensation amount and the second signal compensation amount are respectively used to compensate for the signals with the first wavelength and the second wavelength obtained by the measuring device in a non-idle state.

[0051] Specifically, for light detection instruments, systematic and random errors between instruments are the main causes of inaccurate measurements. Currently, a commonly used method to reduce systematic and random errors between instruments is to replace the sensor device with a more precise one. However, this also leads to increased equipment costs or insufficient equipment streamlining. To address the measurement value drift and cost issues caused by systematic and random errors between instruments, while improving measurement accuracy, reducing measurement errors between instruments, and reducing instrument costs, the present invention designs a model-matched self-checking drift compensation algorithm that automatically corrects for systematic and random errors caused by the instrument structure and measurement environment.

[0052] Step S1: Under stable environmental conditions and instrument structure, adjust the amplification factors of the first wavelength signal and the second wavelength signal of the instrument to obtain the initial relationship model between the intensity of the first wavelength signal and the second wavelength signal and the amplification factor, that is, the first preset relationship model f(x) and the second preset relationship model f(y);

[0053] Step S2: After the instrument is turned on, the measuring device successively emits two beams of light waves in the range of 420nm to 445nm, preferably at a wavelength of 435nm, and in the range of 600nm to 750nm, preferably at a wavelength of 680nm;

[0054] Step S3 obtains the relationship curves between signal intensity and amplification at the two wavelengths, i.e., the first relationship model g(x) and the second relationship model g(y). Using the f(x) and f(y) models as the standard, a matching equation is calculated to obtain a compensation amount that matches the model and is applicable to the current signal:

[0055] Assume f(x) = a f ×x+b f ;

[0056] Signal strength and amplification factor curve g(x)=a in the empty state g ×x+b g ;

[0057] Since the signal amplification factor of instruments with the same configuration system is the same, we have:

[0058]

[0059] The first signal compensation amount Dx:

[0060] Among them, a f 、b f 、a g 、b g is the curve equation coefficient, which can be obtained by analyzing the relationship between the measured signal value and the amplification factor; x is the device signal amplification factor. Similarly, the second signal compensation value D can be obtained y Therefore, the wavelength signal in actual measurement is amplified and compensated based on the above compensation parameters.

[0061] The calibration method of the measuring device of this embodiment achieves precise control of detection and significantly improves the measurement accuracy of hemoglobin in each concentration range through matching drift compensation and a cuvette chip based on the optimal optical path, compensating for the signal drift under different environments in the existing technology, and can more conveniently, quickly, and concisely obtain hemoglobin concentration accurately, eliminating the influence of environmental factors on measurement accuracy, providing a measurement basis for medical and home recovery monitoring of abnormal hemoglobin content, and has industry promotion significance.

[0062] Example 2

[0063] See also Figure 2 As shown, this embodiment specifically provides a calibration system for a whole blood hemoglobin measuring device. The measuring device is used to measure the whole blood hemoglobin concentration by dual-wavelength spectrophotometry. The calibration system is used to implement self-detection drift compensation for the measuring device. The calibration system includes:

[0064] A magnification module 51 is used to adjust the first magnification of the measuring device for the first wavelength signal and the second magnification of the measuring device for the second wavelength signal respectively;

[0065] An acquisition module 52 is configured to respectively acquire a first preset relationship model corresponding to the first magnification and a second preset relationship model corresponding to the second magnification; wherein the first preset relationship model is a preset relationship model representing the relationship between the intensity of the first wavelength signal and the first magnification; and the second preset relationship model is a preset relationship model representing the relationship between the intensity of the second wavelength signal and the second magnification;

[0066] A solution module S3 is configured to solve and obtain a first relationship model corresponding to a first wavelength test signal and a second relationship model corresponding to a second wavelength test signal, respectively; wherein the first wavelength test signal and the second wavelength test signal are test signals having first and second wavelengths, respectively, emitted by the measuring device in an idle state; the first relationship model represents a relationship between the intensity of the first wavelength test signal and a first amplification factor, and the second relationship model represents a relationship between the intensity of the second wavelength test signal and a second amplification factor;

[0067] The compensation module S4 is used to determine the first signal compensation amount of the measuring device for the first wavelength signal and the first amplification factor according to the first preset relationship model and the first relationship model respectively; and to determine the second signal compensation amount of the measuring device for the second wavelength signal and the second amplification factor according to the second preset relationship model and the second relationship model; wherein the first signal compensation amount and the second signal compensation amount are respectively used to compensate for the signals with the first wavelength and the second wavelength obtained by the measuring device in a non-idle state.

[0068] Under stable environmental conditions and instrument structure, the magnification module 51 adjusts the amplification factors of the first wavelength signal and the second wavelength signal of the instrument, and obtains the initial relationship model between the intensity of the first wavelength signal and the second wavelength signal and the amplification factor, i.e., the first preset relationship model f(x) and the second preset relationship model f(y);

[0069] Acquisition module 52 When the instrument is turned on, the measuring device successively emits two beams of light waves in the range of 420nm to 445nm, preferably at a wavelength of 435nm, and in the range of 600nm to 750nm, preferably at a wavelength of 680nm;

[0070] The solution module S3 obtains the relationship curves between the signal intensity and the amplification factor at the two wavelengths, namely the first relationship model g(x) and the second relationship model g(y), and calculates the matching equation based on the f(x) and f(y) models to obtain the compensation amount that matches the model and is applicable to the current signal:

[0071] Assume f(x) = a f ×x+b f ;

[0072] Signal strength and amplification factor curve g(x)=a in the empty state g ×x+b g ;

[0073] Since the signal amplification factor of instruments with the same configuration system is the same, we have:

[0074]

[0075] The first signal compensation amount Dx:

[0076] Among them, a f 、b f 、a g 、b g is the curve equation coefficient, which can be obtained by analyzing the relationship between the measured signal value and the amplification factor; x is the device signal amplification factor. Similarly, the second signal compensation value D can be obtained y Therefore, the wavelength signal in actual measurement is amplified and compensated based on the above compensation parameters.

[0077] The calibration system of the measuring device of this embodiment achieves precise control of detection and significantly improves the measurement accuracy of hemoglobin in each concentration range through matching drift compensation and a cuvette chip based on the optimal optical path, compensating for the signal drift under different environments in the prior art, and can more conveniently, quickly, and concisely obtain hemoglobin concentration accurately, eliminating the influence of environmental factors on measurement accuracy, providing a measurement basis for medical and home use recovery monitoring of abnormal hemoglobin content, and has industry promotion significance.

[0078] Example 3

[0079] Corresponding to the calibration method of the measuring device described above, this embodiment also provides a method for measuring whole blood hemoglobin. It can be understood that it is applied to the same measuring device, which measures the whole blood hemoglobin concentration by dual-wavelength spectrophotometry. Figure 3 As shown, the determination method includes:

[0080] S101. Obtaining a first light feature vector; the first light feature vector includes a first wavelength light absorbance feature and a second wavelength light absorbance feature based on the first sample data;

[0081] S102. Determine a first-level regression model based on the first light feature vector and the sample concentration corresponding to the first sample data;

[0082] S103. Determine a second-level regression model based on the first calculated value and the sample concentration corresponding to the second sample data; the first calculated value is obtained by substituting the second sample data into the first-level regression model;

[0083] S104. Determine the whole blood hemoglobin concentration based on the second-level regression model.

[0084] As a preferred embodiment, the above-mentioned measurement method is used together with the calibration method in Example 1. The whole blood hemoglobin concentration can be measured after the drift of the measurement device is compensated by the calibration method.

[0085] Step S101 constructs a first light feature vector corresponding to the first sample data based on the Lambert-Beers law, including light absorbance feature quantities of the first wavelength light absorbance feature Abs1 and the second wavelength light absorbance feature Abs2, which can be obtained by the following formula:

[0086]

[0087] Among them, I0 1 , I out 1 , I0 2 , I out 2are the first and second incident and transmitted light signals received by the measuring device, respectively, I α 1 , I α 2 are the first and second scattered light signals received by the measurement device, respectively. α is the scattered light reception angle, α∈(8° to 40°, -8° to -40°). The scattered signal reception angle is obtained based on the Mie particle scattering principle and can also be obtained using other particle scattering field methods. Abs1 is the light absorbance characteristic of the first wavelength, and Abs2 is the light absorbance characteristic of the second wavelength.

[0088] Step S102 obtains the first-level regression model based on the relationship between the first eigenvector and the sample concentration:

[0089]

[0090] Among them, HGB0 is the calculated value of the first-level model, and k0~k5 are the model regression coefficients.

[0091] Due to the limitations of component characteristics, each concentration signal is not linearly amplified equally. Signals are often larger at high light intensities and smaller at low light intensities. This results in the hemoglobin value obtained by the first-level regression model for high-concentration blood samples being lower than the sample's actual concentration, while the calculated value for low-concentration samples is higher. To obtain a more accurate hemoglobin value, the present invention selects a second sample set of data, uses the calculated value of the first-level regression model for the second sample set of data as the second eigenvector, and constructs a scatter plot of the second eigenvector and sample concentration. Step S103 constructs a second-level regression model, i.e., the final hemoglobin concentration model:

[0092]

[0093] Wherein, HGB0 is the first-order model calculation value, and m0-m3 are model regression coefficients. Based on this, step S104 completes the hemoglobin concentration calculation and displays the result.

[0094] The whole blood hemoglobin determination method of this embodiment achieves precise control of detection and significantly improves the measurement accuracy of hemoglobin in each concentration range, compensating for the signal drift under different environments in the existing technology, and can more conveniently, quickly, and concisely obtain hemoglobin concentration accurately, providing a measurement basis for medical and home rehabilitation monitoring of abnormal hemoglobin content, and has industry promotion significance.

[0095] Example 3

[0096] This embodiment specifically provides a whole blood hemoglobin determination system. Figure 4 As shown, the measurement system includes:

[0097] S101. Obtaining a first light feature vector; the first light feature vector includes a first wavelength light absorbance feature and a second wavelength light absorbance feature based on the first sample data;

[0098] S102. Determine a first-level regression model based on the first light feature vector and the sample concentration corresponding to the first sample data;

[0099] S103. Determine a second-level regression model based on the first calculated value and the sample concentration corresponding to the second sample data; the first calculated value is obtained by substituting the second sample data into the first-level regression model;

[0100] S104. Determine the whole blood hemoglobin concentration based on the second-level regression model.

[0101] As a preferred embodiment, the above-mentioned measurement method is used together with the calibration method in Example 1. The whole blood hemoglobin concentration can be measured after the drift of the measurement device is compensated by the calibration method.

[0102] Step S101 constructs a first light feature vector corresponding to the first sample data based on the Lambert-Beers law, including light absorbance feature quantities of the first wavelength light absorbance feature Abs1 and the second wavelength light absorbance feature Abs2, which can be obtained by the following formula:

[0103]

[0104] Among them, I0 1 , I out 1 , I0 2 , I out 2 are the first and second incident and transmitted light signals received by the measuring device, respectively, I α 1 , I α 2 are the first and second scattered light signals received by the measurement device, respectively. α is the scattered light reception angle, α∈(8° to 40°, -8° to -40°). The scattered signal reception angle is obtained based on the Mie particle scattering principle and can also be obtained using other particle scattering field methods. Abs1 is the light absorbance characteristic of the first wavelength, and Abs2 is the light absorbance characteristic of the second wavelength.

[0105] Step S102 obtains the first-level regression model based on the relationship between the first eigenvector and the sample concentration:

[0106]

[0107] Among them, HGB0 is the calculated value of the first-level model, and k0~k5 are the model regression coefficients.

[0108] Due to the limitations of component characteristics, each concentration signal is not linearly amplified equally. Signals are often larger at high light intensities and smaller at low light intensities. This results in the hemoglobin value obtained by the first-level regression model for high-concentration blood samples being lower than the sample's actual concentration, while the calculated value for low-concentration samples is higher. To obtain a more accurate hemoglobin value, the present invention selects a second sample set of data, uses the calculated value of the first-level regression model for the second sample set of data as the second eigenvector, and constructs a scatter plot of the second eigenvector and sample concentration. Step S103 constructs a second-level regression model, i.e., the final hemoglobin concentration model:

[0109]

[0110] Wherein, HGB0 is the first-order model calculation value, and m0-m3 are model regression coefficients. Based on this, step S104 completes the hemoglobin concentration calculation and displays the result.

[0111] The whole blood hemoglobin determination method of this embodiment achieves precise control of detection and significantly improves the measurement accuracy of hemoglobin in each concentration range, compensating for the signal drift under different environments in the existing technology, and can more conveniently, quickly, and concisely obtain hemoglobin concentration accurately, providing a measurement basis for medical and home rehabilitation monitoring of abnormal hemoglobin content, and has industry promotion significance.

[0112] Example 4

[0113] See also Figure 4 As shown, this embodiment specifically provides a whole blood hemoglobin measurement system, which is used in a measurement device for measuring the whole blood hemoglobin concentration by dual-wavelength spectrophotometry; the measurement system includes:

[0114] A first vector acquisition module 501 is configured to acquire a first light feature vector; the first light feature vector includes a first wavelength light absorbance feature and a second wavelength light absorbance feature based on first sample data;

[0115] A first model determination module 502 is configured to determine a first-level regression model based on the first light feature vector and the sample concentration corresponding to the first sample data;

[0116] A second model determination module 503 is configured to determine a second-level regression model based on the first calculated value and the sample concentration corresponding to the second sample data; the first calculated value is obtained by substituting the second sample data into the first-level regression model;

[0117] The determination module 504 is configured to determine the hemoglobin concentration of whole blood according to the second-level regression model.

[0118] The first vector acquisition module 501 constructs a first light feature vector corresponding to the first sample data based on the Lambert-Beers law, including light absorbance feature quantities of the first wavelength light absorbance feature Abs1 and the second wavelength light absorbance feature Abs2, which can be obtained by the following formula:

[0119]

[0120] Among them, I0 1 , I out 1 , I0 2 , I out 2 are the first and second incident and transmitted light signals received by the measuring device, respectively, I α 1 , I α 2 are the first and second scattered light signals received by the measurement device, respectively. α is the scattered light reception angle, α∈(8° to 40°, -8° to -40°). The scattered signal reception angle is obtained based on the Mie particle scattering principle and can also be obtained using other particle scattering field methods. Abs1 is the light absorbance characteristic of the first wavelength, and Abs2 is the light absorbance characteristic of the second wavelength.

[0121] The first model determination module 502 obtains a first-level regression model based on the relationship between the first eigenvector and the sample concentration:

[0122]

[0123] Among them, HGB0 is the calculated value of the first-level model, and k0~k5 are the model regression coefficients.

[0124] Due to the limitations of component characteristics, each concentration signal is not linearly amplified equally. Signals are often larger at high light intensities and smaller at low light intensities. This results in the hemoglobin value obtained by the first-level regression model for high-concentration blood samples being lower than the sample's own concentration, while the calculated value for low-concentration samples is higher than the sample's own concentration. To obtain a more accurate hemoglobin value, the present invention selects a second sample set of data, uses the first-level regression model's calculated value for the second sample set of data as the second eigenvector, constructs a scatter plot of the second eigenvector and sample concentration, and the second model determination module 503 constructs a second-level regression model, i.e., the final hemoglobin concentration model:

[0125]

[0126] Wherein, HGB0 is the first-order model calculation value, m0-m3 are the model regression coefficients, and the measurement module 504 completes the hemoglobin concentration calculation based on this and can display the result.

[0127] The whole blood hemoglobin measurement system of this embodiment achieves precise control of detection and significantly improves the measurement accuracy of hemoglobin in each concentration range, compensating for the signal drift under different environments in the existing technology, and can more conveniently, quickly, and concisely obtain hemoglobin concentration accurately, providing a measurement basis for medical and home rehabilitation monitoring of abnormal hemoglobin content, which has industry promotion significance.

[0128] Example 5

[0129] Figure 5 This is a schematic diagram of the structure of an electronic device provided in this embodiment. The electronic device includes a memory, a processor, and a computer program stored in the memory and executable on the processor. When the processor executes the program, it implements the whole blood hemoglobin measurement device calibration method and / or whole blood hemoglobin measurement method described in the above-mentioned embodiment. Figure 5 The electronic device 30 shown is only an example and should not limit the functionality and scope of use of the embodiments of the present invention.

[0130] like Figure 5 As shown, the electronic device 30 may be a general-purpose computing device, such as a server device. Components of the electronic device 30 may include, but are not limited to, the at least one processor 31, the at least one memory 32, and a bus 33 connecting different system components (including the memory 32 and the processor 31).

[0131] The bus 33 includes a data bus, an address bus, and a control bus.

[0132] The memory 32 may include a volatile memory, such as a random access memory (RAM) 321 and / or a cache memory 322 , and may further include a read-only memory (ROM) 323 .

[0133] The memory 32 may also include a program / utility 325 having a set (at least one) of program modules 324, such program modules 324 including but not limited to: an operating system, one or more application programs, other program modules, and program data, each of which or some combination may include an implementation of a network environment.

[0134] The processor 31 executes various functional applications and data processing by running the computer programs stored in the memory 32, such as the calibration method of the whole blood hemoglobin measurement device and / or the whole blood hemoglobin measurement method of the present invention as described above.

[0135] The electronic device 30 may also communicate with one or more external devices 34 (e.g., a keyboard, a pointing device, etc.). Such communication may be performed via an input / output (I / O) interface 35. Furthermore, the model generating device 30 may also communicate with one or more networks (e.g., a local area network (LAN), a wide area network (WAN), and / or a public network, such as the Internet) via a network adapter 36. Figure 5 As shown, the network adapter 36 communicates with the other modules of the model-generated device 30 via the bus 33. It should be understood that, although not shown in the figures, other hardware and / or software modules may be used in conjunction with the model-generated device 30, including but not limited to microcode, device drivers, redundant processors, external disk drive arrays, RAID (RAID) systems, tape drives, and data backup storage systems.

[0136] It should be noted that although several units / modules or sub-units / modules of the electronic device are mentioned in the detailed description above, this division is merely exemplary and not mandatory. In fact, according to embodiments of the present invention, the features and functions of two or more units / modules described above may be embodied in a single unit / module. Conversely, the features and functions of a single unit / module described above may be further divided and embodied by multiple units / modules.

[0137] Example 6

[0138] This embodiment also provides a computer-readable storage medium storing a computer program. When executed by a processor, the program implements the steps of the calibration method for a whole blood hemoglobin measurement device and / or the whole blood hemoglobin measurement method described in the above-described embodiments. The computer-readable storage medium may include, but is not limited to, a portable disk, a hard disk, a random access memory, a read-only memory, an erasable programmable read-only memory, an optical storage device, a magnetic storage device, or any suitable combination thereof.

[0139] In a possible embodiment, the present invention may also be implemented in the form of a program product comprising program code. When the program product is executed on a terminal device, the program code is configured to cause the terminal device to execute the steps of the method for calibrating a whole blood hemoglobin measurement device and / or the method for measuring whole blood hemoglobin. The program code for implementing the present invention may be written in any combination of one or more programming languages ​​and may be executed entirely on the user device, partially on the user device, as a standalone software package, partially on the user device and partially on a remote device, or entirely on the remote device.

[0140] Example 7

[0141] Based on the calibration method and whole blood hemoglobin measurement method of the above-mentioned embodiment, as well as the electronic device capable of executing the above-mentioned method, this embodiment further provides a whole blood hemoglobin measurement device. By configuring the above-mentioned electronic device to achieve precise control and measurement, the device can be used as an analysis device. Figure 6 The measuring device shown includes a sample injection device, a signal collection device, an analysis device and a display device.

[0142] Specifically, the sampling device is a semi-automatic device used to deliver an undiluted blood sample into the detection device and initiate the optical measurement process. The measurement device contains an illumination module and a signal acquisition module. The analysis device obtains the filtered and amplified optical signal and incorporates a high-precision drift compensation model and a multi-level regression calculation model to ultimately measure the hemoglobin content in the undiluted blood sample and transmit the measurement results to a display device equipped with an LED screen to display the hemoglobin concentration of the measured blood sample.

[0143] The sample introduction device is used to deliver the microfluidic chip containing the blood sample into the measuring device in a specific manner and start the measuring program. The sample introduction device is composed of a warehouse entry and exit device and a limiting device. The warehouse entry and exit device is composed of a rotating frame, a moving frame, a sinking platform and a strong magnet. The rotating frame is used to deliver the sample into the measuring device; the moving frame is connected to the rotating frame, and the moving frame is provided with a sinking platform for placing a specific microfluidic chip containing the blood sample to be tested. The limiting device is used to sense the moving frame and trigger the detection device to detect the microfluidic chip during the warehouse entry process. The microfluidic chip adopts a one-time thermoforming technology based on a mold, such as Figure 7 As shown. It includes a chip sampling port 61 for adding blood samples; a cavity 62 for accommodating the sample, which is used to hold the blood sample to be tested; and a chip fixing groove 63, which is used to fix the chip in the storage device to ensure the stability of the entire measurement. The sample analyzed by the present invention is undiluted whole blood. The whole blood sample is filled into a disposable microfluidic chip through the sampling port 61 and is sent to the measuring device for measurement through the sampling device. The microfluidic chip includes at least one cavity 61 with an optical window. The height between the two planes of the cavity 61 meets the requirement that the optical path length is greater than 200μm and less than 500μm. A dry hydrophilic reagent is placed on the inner wall of the cavity, which is conducive to the rapid entry of blood into the chip and uniform distribution in the chip.

[0144] After the sample introduction device enters the chamber, the signal collection device is started. The irradiation unit (specific wavelength lamp) 1 irradiates the microfluidic chip 3 containing the sample through the light guide 2. The signal collection device collects the first and second transmission signals through the blood sample transmission position 5 and the first and second scattered signals at the incident position 4. After signal collection, filtering, and A / D conversion, a quantitative transmission and scattered signal group is obtained and sent to the analysis device to obtain the final hemoglobin concentration. Among them, the light guide 2 sends light of different wavelengths to the designated detection area to irradiate the sample to ensure that light of different wavelengths does not interfere with each other. The light guide 2 can be made of a non-toxic and environmentally friendly material, polymethyl methacrylate PMMA, which has good chemical stability and high light transmittance, to ensure that the light emitted by the light source can be incident on the measuring surface of the microfluidic chip as vertically and parallel as possible, and the transmitted light should also be incident on the receiving surface of the receiving end photoelectric sensor as vertically and parallel as possible to ensure the application of the Lambert-Beers law for the requirements of the incident light characteristics and detection sensitivity.

[0145] The measuring device calculates the first and second light absorbances of the blood sample according to the method in the above embodiment based on the obtained transmitted light and scattered light intensities, and finally obtains the final hemoglobin concentration of the blood based on the absorbance. Figure 8 As shown in the figure, after startup, the system initializes and waits for instructions. The system has a built-in instrument drift compensation program that automatically detects and compensates for drift after power-up. After the instrument self-test is complete, it sends instructions to the control system to complete the subsequent blood sample concentration calculation. The specific process will not be repeated here.

[0146] It is understood that the whole blood hemoglobin measurement device of this embodiment can be a specialized device for home or medical use. Furthermore, by modifying the first and second absorption wavelength ranges and constructing model curves corresponding to the wavelengths, it is possible to measure the concentrations of other components in blood or urine at corresponding wavelengths. This involves obtaining the maximum absorption wavelength of the component to be detected and the isosbestic wavelength of the interfering component, performing Mie simulation to obtain the optimal scattering compensation angle for the component to be detected. Furthermore, according to the present invention, by quantifying dual-wavelength optical signal characteristics, particle light scattering characteristics, instrument drift compensation, and constructing a multi-level regression model (not limited to two-level regression, and also applicable to combinations of regression models at different levels within a specified concentration range), it is also possible to measure the concentrations of other components to be detected.

[0147] In order to verify the feasibility and effectiveness of the present invention, simulation and measurement experiments were conducted (the experimental blood samples were from the physical examination department of the hospital). The LED light source wavelength was 520nm~545nm. The hemoglobin concentration calculation results obtained by the measuring device were compared with the measurement results of the hospital biochemical analyzer. The correlation coefficient R2=0.9942 was obtained. The correlation curve is shown in Figure 2. Figure 9 The experimental results show that the device has good performance and can be used to measure the hemoglobin concentration of human whole blood. In summary, the whole blood hemoglobin determination device of this embodiment has the following technical advantages:

[0148] (1) Instrument Self-Test Drift Compensation Method and System Based on Model Matching: Currently, the commonly used method to reduce the systematic and random errors between instruments is to replace the sensor device with a more precise one, which often leads to increased equipment costs. The present invention designs a model-matching self-test drift compensation algorithm, constructs a standard signal model, monitors the instrument idle signal model in real time under various environmental conditions, and finally obtains the drift compensation amount by matching it with the standard model. This not only improves the instrument measurement accuracy, but also effectively controls the equipment cost.

[0149] (2) A multi-level regression calculation model for hemoglobin based on the characteristics of incident light intensity, transmitted light intensity and scattered light intensity: In view of the signal amplification characteristics of existing components, a multi-level regression calculation model for hemoglobin based on the quantitative characteristics of incident light intensity, transmitted light intensity and scattered light intensity was designed. The signal characteristics were modeled step by step and layer by layer to further improve the measurement accuracy of hemoglobin values.

[0150] (3) Whole blood hemoglobin measurement system and device based on microfluidic chip, model matching instrument self-test drift compensation algorithm, multi-level regression model, sampling device, measuring device, analysis device, result display device and control system: This project optimizes and simplifies the equipment structure of hemoglobin detection equipment, improves measurement accuracy and reduces equipment cost.

[0151] Although specific embodiments of the present invention have been described above, those skilled in the art will appreciate that these are merely illustrative and that the scope of the present invention is defined by the appended claims. Those skilled in the art may make various changes or modifications to these embodiments without departing from the principles and essence of the present invention, and such changes and modifications are intended to fall within the scope of the present invention.

Claims

1. A whole blood hemoglobin measurement system, used for measuring the whole blood hemoglobin concentration by dual-wavelength spectrophotometry; characterized in that: The measuring system comprises: A first vector acquisition module is configured to acquire a first light feature vector; the first light feature vector includes a first wavelength light absorbance feature and a second wavelength light absorbance feature based on the first sample data; a first model determination module, configured to determine a first-level regression model based on the first light feature vector and the sample concentration corresponding to the first sample data; A second model determination module is configured to determine a second-level regression model based on the first calculated value and the sample concentration corresponding to the second sample data; wherein the first calculated value is obtained by substituting the second sample data into the first-level regression model; A determination module is used to determine the whole blood hemoglobin concentration according to the second-level regression model.

2. The whole blood hemoglobin measurement system according to claim 1, wherein: The first wavelength is 420nm to 445nm; the second wavelength is 750nm to 435nm.

3. The whole blood hemoglobin measurement system according to claim 2, wherein: The first wavelength is 435 nm; the second wavelength is 680 nm.

4. The whole blood hemoglobin measurement system according to claim 3, which is used to measure the hemoglobin concentration in whole blood.

5. An electronic device comprising a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein: When the processor executes the computer program, the whole blood hemoglobin measurement system according to any one of claims 1 to 4 is implemented.

6. A computer-readable storage medium having a computer program stored thereon, characterized in that: When the computer program is executed by a processor, the whole blood hemoglobin measurement system according to any one of claims 1 to 4 is implemented.

7. A whole blood hemoglobin measurement device, characterized in that: Comprising the electronic device as claimed in claim 5.

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