WO2024082992A1 - Apparatus for body fluid based detection of chronic diseases - Google Patents
Apparatus for body fluid based detection of chronic diseases Download PDFInfo
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- WO2024082992A1 WO2024082992A1 PCT/CN2023/123667 CN2023123667W WO2024082992A1 WO 2024082992 A1 WO2024082992 A1 WO 2024082992A1 CN 2023123667 W CN2023123667 W CN 2023123667W WO 2024082992 A1 WO2024082992 A1 WO 2024082992A1
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Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/48707—Physical analysis of biological material of liquid biological material by electrical means
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N11/00—Investigating flow properties of materials, e.g. viscosity, plasticity; Analysing materials by determining flow properties
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N13/00—Investigating surface or boundary effects, e.g. wetting power; Investigating diffusion effects; Analysing materials by determining surface, boundary, or diffusion effects
- G01N13/04—Investigating osmotic effects
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/49—Blood
- G01N33/4905—Determining clotting time of blood
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
- Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
Definitions
- the invention relates to a device for detecting chronic diseases based on body fluids, belonging to the technical field of medical devices.
- the purpose of the present invention is to solve the technical problem of how to perform early diagnosis of chronic diseases based on body fluid detection.
- the technical solution adopted by the present invention is to provide a device for detecting chronic diseases based on body fluids, including a body fluid detection fluid channel, a detection probe, a data processing module and a data display module; a detection probe is provided in the body fluid detection fluid channel, the detection probe is connected to the data processing module, and the data processing module is connected to the data display module; the body fluid detection fluid channel includes a channel for detecting body fluid ions, cytokines, nucleic acids, proteins and their derivatives or trace elements, a channel for detecting body fluid oxygen and other soluble gases, a channel for detecting body fluid pH, a channel for detecting body fluid viscosity and other fluid mechanics properties, a channel for detecting physical properties of white blood cells and tumor cells including osmotic pressure, a channel for detecting electrical characterization of white blood cells and tumor cells including electrical impedance and charge, a channel for detecting physical properties of red blood cells including osmotic pressure,
- the device is provided with a body fluid inlet, and channels for detecting body fluid ions, cytokines, nucleic acids, proteins and their derivatives or trace elements, a channel for detecting body fluid pH, a channel for detecting oxygen and other soluble gases, a channel for detecting fluid mechanics properties such as body fluid viscosity, and a body fluid cell separation channel are respectively provided in communication with the body fluid inlet.
- a body fluid inlet and channels for detecting body fluid ions, cytokines, nucleic acids, proteins and their derivatives or trace elements, a channel for detecting body fluid pH, a channel for detecting oxygen and other soluble gases, a channel for detecting fluid mechanics properties such as body fluid viscosity, and a body fluid cell separation channel are respectively provided in communication with the body fluid inlet.
- the device is provided with a cell separation microfluidic channel, one end of the cell separation microfluidic channel is connected to the body fluid cell separation channel, and the other end of the cell separation microfluidic channel is provided with a separated white blood cell and tumor cell channel, a separated red blood cell channel and a separated body fluid channel.
- the separated leukocyte and tumor cell channels are respectively connected to a physical property detection channel for detecting leukocytes and tumor cells including osmotic pressure and an electrical characterization channel for detecting leukocytes and tumor cells including electrical impedance and charge.
- the separated red blood cell channel is respectively connected to a channel for detecting the physical properties of red blood cells including osmotic pressure and a channel for detecting the electrical characterization of red blood cells including electrical impedance and charge.
- the separated body fluid channel is respectively connected to a coagulation, anticoagulation and fibrinolysis function detection channel including coagulation factors, fibrinogen, D-dimer, platelets, etc. and an electrical characterization channel including electrical impedance and charge for detecting the separated body fluid; the coagulation, anticoagulation and fibrinolysis function detection channel is also provided with a coagulation factor channel for adding coagulation factors.
- a coagulation, anticoagulation and fibrinolysis function detection channel including coagulation factors, fibrinogen, D-dimer, platelets, etc.
- an electrical characterization channel including electrical impedance and charge for detecting the separated body fluid
- the coagulation, anticoagulation and fibrinolysis function detection channel is also provided with a coagulation factor channel for adding coagulation factors.
- a method for detecting chronic diseases using detection data obtained by a device for detecting chronic diseases based on body fluids comprising the following steps:
- v is the body fluid ion concentration
- SpO2 is the oxygen content
- ph is the body fluid pH value
- ⁇ is the body fluid viscosity value
- ⁇ 1 is the osmotic pressure value of white blood cells and tumor cells
- ⁇ 2 is the osmotic pressure value of red blood cells
- Ze1 is the electrical impedance value of white blood cells and tumor cells
- Ze2 is the electrical impedance value of red blood cells
- Ze3 is the electrical impedance value of body fluid after separation
- t is the coagulation time
- v1 is the D-dimer concentration in the body fluid after separation
- v2 is the fibrinogen degradation product concentration in the body fluid after separation
- Step 2 Assess the risk of chronic diseases based on the n1 value. If the n1 value is below 105, it is low risk; if the n1 value is between 105-135, it is medium risk; if the n1 value is above 135, it belongs to the high-risk group. The higher the value, the greater the risk.
- the chronic disease includes a tumor.
- the cytokine is hypoxia-inducible factor-1 ⁇ and/or hypoxia-inducible factor-1 ⁇ .
- the present invention also provides a method for processing detection data obtained by a device for detecting chronic diseases based on body fluids for detecting chronic diseases, comprising the following steps:
- H1 is the concentration of hypoxia-inducible factor 1 ⁇
- H2 is the concentration of hypoxia-inducible factor 1 ⁇
- v is the body fluid ion concentration
- SpO 2 is the oxygen content
- ph is the body fluid pH value
- ⁇ is the body fluid viscosity value
- ⁇ 1 is the osmotic pressure value of white blood cells and tumor cells
- ⁇ 2 is the osmotic pressure value of red blood cells
- Ze1 is the electrical impedance value of white blood cells and tumor cells
- Ze2 is the electrical impedance value of red blood cells
- Ze3 is the electrical impedance value of body fluid after separation
- t is the coagulation time
- v1 is the D-dimer concentration in the body fluid after separation
- v2 is the concentration of fibrinogen degradation products in the body fluid after separation
- Step 2 Assess the risk of chronic diseases based on the n2 value. If the n2 value is below 120, it is low risk; if the n2 value is 120-150, it is medium risk; if the n2 value is above 150, it belongs to the high-risk group. The higher the value, the greater the risk.
- the body fluid pH detection channel is further provided with a detection probe for detecting physical properties including electrical impedance and charge of the body fluid in the channel.
- the present invention provides a method for processing detection data obtained by a device for detecting chronic diseases based on body fluids for detecting chronic diseases, comprising the following steps:
- Step 2 Assess the risk of chronic diseases based on the n3 value. If the n3 value is below 10, it is low risk; if the n3 value is 10-14, it is medium risk; if the n3 value is above 14, it belongs to the high-risk group; the higher the n3 value, the greater the risk; in the subclinical and clinical stages of chronic diseases, the n3 value increases gradually, and the increase in the value indicates that the patient should go to the hospital for further examination based on his or her medical history.
- the detection probes provided in the body fluid pH detection channel for detecting physical properties including electrical impedance and charge of the body fluid in the channel include detection probes for detecting the electrical impedance value Ze5 of the body fluid cell part and detection probes for detecting the overall electrical impedance value Ze4 of the body fluid.
- the present invention provides a method for processing detection data obtained by a device for detecting chronic diseases based on body fluids for detecting chronic diseases, comprising the following steps:
- Step 1 Obtain the body fluid overall electrical impedance value Ze4, the body fluid cell portion electrical impedance value Ze5 and the separated body fluid electrical impedance value Ze3;
- n5 1.79Ze4+1.85Ze3+1.73Ze5
- the n5 value is calculated; used to evaluate the risk of the subject suffering from prostate cancer
- n6 1.64Ze4+1.58Ze3+1.56Ze5
- the n6 value is calculated; it is used to evaluate the risk of the subject suffering from colorectal cancer
- n8 1.85Ze4+1.48Ze3+1.61Ze5, calculate the n8 value; used to evaluate the risk of the subject suffering from liver cancer;
- n9 1.59Ze4+1.86Ze3+1.47Ze5
- n10 1.56Ze4+1.47Ze3+1.41Ze5
- the n10 value is calculated; it is used to evaluate the risk of the subject suffering from pancreatic cancer
- n11 1.37Ze4+1.93Ze3+1.52Ze5
- n12 1.86Ze4+1.82Ze3+1.44Ze5
- the n12 value is calculated; it is used to evaluate the risk of the subject suffering from kidney cancer
- n14 1.35Ze4+1.57Ze3+1.69Ze5, calculate the n14 value; used to evaluate the risk of the subject suffering from oral cancer;
- n16 1.74Ze4+1.69Ze3+1.63Ze5
- n17 1.63Ze4+1.77Ze3+1.78Ze5
- the n17 value is calculated; used to evaluate the risk of the subject suffering from nasal cancer
- n19 1.64Ze4+1.68Ze3+1.71Ze5
- the n19 value is calculated; it is used to evaluate the risk of esophageal cancer in the subject;
- n20 1.56Ze4+1.73Ze3+1.58Ze5
- the n20 value is calculated; it is used to evaluate the risk of the subject suffering from cardiac cancer
- n22 1.55Ze4+1.85Ze3+1.91Ze5
- the n22 value is calculated; used to evaluate the risk of the subject suffering from bladder cancer
- n23 1.88Ze4+1.61Ze3+1.84Ze5, calculate the n23 value; used to evaluate the risk of the subject suffering from lymphoma;
- n24 1.75Ze4+1.82Ze3+1.86Ze5
- n26 1.87Ze4+1.78Ze3+1.72Ze5
- n27 1.53Ze4+1.96Ze3+1.83Ze5
- n28 1.69Ze4+1.83Ze3+1.56Ze5
- Step 3 Based on the values of n4 to n28 in step 2 above, assess the risk of the subject developing the corresponding cancer. If the value of n4 to n28 exceeds 60, it indicates a high risk of developing the cancer corresponding to the value and further clinical examination is required.
- the present invention has the following beneficial effects:
- the present invention can be used to conduct non-invasive examinations without radiation or other factors that are harmful to the human body; it has high sensitivity and can provide a powerful means for early diagnosis of chronic diseases; it requires a small amount of samples; it has no special requirements for the patient's physiological state during sampling, and there is no need to fast or hold urine, etc.; the test is convenient and fast.
- FIG1 is a schematic diagram of the structure of a body fluid detection fluid channel of the main components of the present invention.
- FIG2 is a receiver operating curve obtained by applying Formula 1, comparing the effectiveness of the algorithm of the present invention in distinguishing chronic disease patients from healthy people;
- FIG3 is a receiver operating curve obtained by applying Formula 2, comparing the effectiveness of the algorithm of the present invention in distinguishing chronic disease patients from healthy people;
- FIG4 is a receiver operating curve obtained by applying Formula 3, comparing the effectiveness of the algorithm of the present invention in distinguishing chronic disease patients from healthy people;
- Figure numerals 1. Channel for detecting body fluid ions, cytokines, nucleic acids, proteins and their derivatives or trace elements; 2. Channel for detecting body fluid pH; 3. Channel for detecting body fluid viscosity and fluid dynamics properties; 4. Channel for separating white blood cells and tumor cells; 5. Channel for detecting physical properties of white blood cells and tumor cells including osmotic pressure; 6. Channel for detecting electrical characterization of white blood cells and tumor cells including electrical impedance and charge; 7. Channel for separating red blood cells; 8. Channel for detecting physical properties of red blood cells including osmotic pressure; 9. Channel for detecting electrical characterization of red blood cells including electrical impedance and charge; 10. Channel for body fluid after separation; 11. Coagulation factor channel; 12. Cell separation microfluidic channel; 13.
- Body fluid inlet 14.
- Channel for detecting coagulation, anticoagulation and fibrinolytic functions including coagulation factors, fibrinogen, D-dimer and platelets;
- Body fluid cell separation channel 16.
- Channel for detecting oxygen soluble gas content 17.
- Channel for detecting electrical characterization of body fluid after separation including electrical impedance and charge.
- the present invention provides a device for detecting chronic diseases based on body fluids, including a body fluid detection fluid channel, a detection probe, a data processing module and a data display module; a detection probe is provided in the body fluid detection fluid channel, the detection probe is connected to the data processing module, and the data processing module is connected to the data display module; the body fluid detection fluid channel includes a channel 1 for detecting body fluid ions, cytokines, nucleic acids, proteins and their derivatives or trace elements, a channel 2 for detecting body fluid pH, a channel 3 for detecting fluid mechanics properties such as body fluid viscosity, a channel 16 for detecting the content of soluble gases such as oxygen, a detection channel 5 for detecting the physical properties of white blood cells and tumor cells including osmotic pressure, a channel 6 for detecting electrical characterization of white blood cells and tumor cells including impedance and charge, a detection channel 8 for detecting the physical properties of red blood cells including osmotic pressure, a channel 9 for detecting electrical
- the device is provided with a body fluid inlet 13, and is connected to the body fluid inlet 13 and is respectively provided with a channel 1 for detecting body fluid ions, cytokines, nucleic acids, proteins and their derivatives or trace elements, a channel 2 for detecting body fluid pH, a channel 3 for detecting fluid mechanics properties such as body fluid viscosity, a channel 16 for detecting soluble gas content such as oxygen, and a body fluid cell separation channel 15.
- the device is provided with a cell separation microfluidic channel 12, one end of the cell separation microfluidic channel 12 is connected to the body fluid cell separation channel 15, and the other end of the cell separation microfluidic channel 12 is provided with a channel 4 for separating white blood cells and tumor cells, a channel 7 for separating red blood cells, and a body fluid channel 10 after separation.
- the separated white blood cell and tumor cell channel 4 is respectively connected to a detection channel 5 for detecting physical properties of white blood cells and tumor cells including osmotic pressure and a channel 6 for detecting electrical characterization of white blood cells and tumor cells including electrical impedance and charge.
- the separated red blood cell channel 7 is respectively connected to a detection channel 8 for detecting physical properties of red blood cells including osmotic pressure and a channel 9 for detecting electrical characterization of red blood cells including electrical impedance and charge.
- the separated body fluid channel 10 is respectively connected to the coagulation, anticoagulation and fibrinolysis function detection channel 14 including coagulation factors, fibrinogen, D-dimer, platelets, etc. and the electrical characterization channel 17 including electrical impedance and charge for detecting the separated body fluid; the coagulation, anticoagulation and fibrinolysis function detection channel 14 including coagulation factors, fibrinogen, D-dimer, platelets, etc. is also provided with a coagulation factor channel 11 for adding coagulation factors.
- the detection probe structure in the above channels is the same as that in the prior art.
- the detection data obtained by the device is used for detecting a treatment method for chronic diseases, comprising the following steps:
- Step 2 Assess the risk of the subject suffering from chronic diseases based on the n1 value. If the n1 value is below 105, it is a low risk; if the n1 value is between 105 and 135, it is a medium risk; if the n1 value is above 135, it belongs to the high-risk group. The higher the value, the greater the risk.
- the chronic diseases include tumors.
- hypoxia-inducible factor 1 ⁇ and/or hypoxia-inducible factor 1 ⁇ Another method for processing detection data obtained by a device for detecting chronic diseases based on body fluids for detecting chronic diseases is provided, comprising the following steps:
- Step 2 Assess the risk of chronic diseases based on the n2 value. If the n2 value is below 120, it is low risk; if the n2 value is 120-150, it is medium risk; if the n2 value is above 150, it belongs to the high-risk group. The higher the value, the greater the risk.
- the body fluid pH detection channel is also provided with a detection probe for detecting physical properties including electrical impedance and charge of the body fluid in the channel;
- the present invention also provides a method for processing detection data obtained by a device for detecting chronic diseases based on body fluids for detecting chronic diseases, comprising the following steps:
- Step 2 Assess the risk of chronic diseases based on the n3 value. If the n3 value is below 10, it is low risk; if the n3 value is 10-14, it is medium risk; if the n3 value is above 14, it belongs to the high-risk group; the higher the n3 value, the greater the risk; in the subclinical and clinical stages of chronic diseases, the n3 value increases gradually, and the increase in the value indicates that the patient should go to the hospital for further examination based on his or her medical history.
- the detection probes provided in the body fluid pH channel for detecting the physical properties of the body fluid in the channel, including the electrical impedance and charge include detection probes for detecting the electrical impedance value Ze5 of the body fluid cell part and detection probes for detecting the electrical impedance value Ze4 of the body fluid as a whole;
- the present invention provides a method for processing detection data obtained by a device for detecting chronic diseases based on body fluids for detecting chronic diseases, comprising the following steps:
- Step 1 Obtain the body fluid overall electrical impedance value Ze4, the body fluid cell portion electrical impedance value Ze5 and the separated body fluid electrical impedance value Ze3;
- n5 1.79Ze4+1.85Ze3+1.73Ze5
- the n5 value is calculated; used to evaluate the risk of the subject suffering from prostate cancer
- n6 1.64Ze4+1.58Ze3+1.56Ze5
- the n6 value is calculated; it is used to evaluate the risk of the subject suffering from colorectal cancer
- n8 1.85Ze4+1.48Ze3+1.61Ze5, calculate the n8 value; used to evaluate the risk of the subject suffering from liver cancer;
- n9 1.59Ze4+1.86Ze3+1.47Ze5
- n10 1.56Ze4+1.47Ze3+1.41Ze5
- the n10 value is calculated; it is used to evaluate the risk of the subject suffering from pancreatic cancer
- n11 1.37Ze4+1.93Ze3+1.52Ze5
- n12 1.86Ze4+1.82Ze3+1.44Ze5
- the n12 value is calculated; it is used to evaluate the risk of the subject suffering from kidney cancer
- n14 1.35Ze4+1.57Ze3+1.69Ze5, calculate the n14 value; used to evaluate the risk of the subject suffering from oral cancer;
- n16 1.74Ze4+1.69Ze3+1.63Ze5
- n17 1.63Ze4+1.77Ze3+1.78Ze5
- the n17 value is calculated; used to evaluate the risk of the subject suffering from nasal cancer
- n19 1.64Ze4+1.68Ze3+1.71Ze5
- the n19 value is calculated; it is used to evaluate the risk of esophageal cancer in the subject;
- n20 1.56Ze4+1.73Ze3+1.58Ze5
- the n20 value is calculated; it is used to evaluate the risk of the subject suffering from cardiac cancer
- n22 1.55Ze4+1.85Ze3+1.91Ze5
- the n22 value is calculated; used to evaluate the risk of the subject suffering from bladder cancer
- n23 1.88Ze4+1.61Ze3+1.84Ze5, calculate the n23 value; used to evaluate the risk of the subject suffering from lymphoma;
- n24 1.75Ze4+1.82Ze3+1.86Ze5
- n26 1.87Ze4+1.78Ze3+1.72Ze5
- n27 1.53Ze4+1.96Ze3+1.83Ze5
- n28 1.69Ze4+1.83Ze3+1.56Ze5
- Step 3 Assess the risk of the subject suffering from the corresponding cancer based on the values of n4 to n28 in step 2 above. If the value of n4 to n28 exceeds 60, it means that there is a high risk of suffering from the corresponding cancer and further clinical examination is required.
- the collection tube containing body fluid is placed in the detection machine, the body fluid is sucked by the built-in pump of the detection machine and pumped into the body fluid detection fluid channel provided by the device of the present invention, the probe set in the body fluid detection fluid channel is used to collect relevant signals, and the relevant signal value is transmitted to the data processing module of the computer, and the data processing module calculates a value n through the built-in program. After comparing this value with the reference value, it can be judged that the body fluid provider has a risk of chronic disease. Then the result is transmitted to the data display module and displayed to the medical staff.
- Figure 2 is the application of formula 1 to test the effect of distinguishing between tumor and healthy people.
- the experimental results show that the area under the curve (AUC) of the algorithm provided by the present invention for distinguishing chronic disease patients from healthy people reaches 0.910, with a sensitivity of 84.3% and a specificity of 92.6%. This scheme is significantly better than the distinction effect of CEA and AFP, suggesting that formula 1 can effectively distinguish chronic disease patients from healthy people in case-control studies.
- the experimental conclusion shows that the device of the present invention can effectively detect chronic diseases.
- Figure 3 is the application of formula 2 to test the effect of distinguishing between tumor and healthy people.
- the experimental results show that the area under the curve (AUC) of the algorithm provided by the present invention for distinguishing chronic disease patients from healthy people reached 0.908, with a sensitivity of 84.6% and a specificity of 92.7%; this scheme is significantly better than the distinction effect of CEA and AFP, suggesting that formula 2 can effectively distinguish chronic disease patients from healthy people in case-control studies.
- the experimental conclusion shows that the device of the present invention can effectively detect chronic diseases.
- Figure 4 shows the effect of using formula 3 to test the differentiation between tumor and healthy population.
- the experimental results show that the area under the curve (AUC) of the algorithm provided by the present invention for distinguishing chronic disease patients from healthy people reaches 0.864, with a sensitivity of 82.4% and a specificity of 89.6%. This scheme is better than the distinction effect of CEA and AFP, suggesting that formula 3 can effectively distinguish chronic disease patients from healthy people in case-control studies.
- the experimental conclusion shows that the device of the present invention can effectively detect chronic diseases.
- Blood samples were collected from 4457 cancer patients (including 605 lung cancer patients, 110 prostate cancer patients, 182 breast cancer patients, 206 esophageal cancer patients, 194 colorectal cancer patients, 195 gastric cancer patients, 129 liver cancer patients, 193 thyroid cancer patients, 137 pancreatic cancer patients, 196 leukemia patients, 153 kidney cancer patients, 164 uterine fibroids patients, 128 oral cancer patients, 183 ovarian cancer patients, 159 brain cancer patients, 156 nasal cancer patients, 176 pharyngeal cancer patients, 112 cardia cancer patients, 171 bile duct cancer patients, 189 bladder cancer patients, 122 lymphoma patients, 135 skin cancer patients, 157 bone cancer patients, 179 testicular cancer patients, and 126 gallbladder cancer patients) and 1063 healthy controls from physical examination centers.
- 4457 cancer patients including 605 lung cancer patients, 110 prostate cancer patients, 182 breast cancer patients, 206 esophageal cancer patients, 194 colorectal cancer patients, 195 gastric
- the conventional cancer marker CEA (carcinoembryonic antigen) was detected using the detection technology provided by the present invention and the algorithm of formula 4 to formula 28.
- the receiver operating characteristic (ROC) curve was drawn and the area under the cure (AUC) was calculated to compare the effects of the three methods in distinguishing cancer patients from healthy people.
- the experimental results show that the sensitivity and specificity of the algorithm provided by the present invention: Formula 4-Formula 28 in distinguishing cancer patients from healthy people are shown in Table 1 below; indicating that Formula 4-Formula 28 can effectively distinguish cancer patients from healthy people in case-control studies.
- the experimental conclusion shows that the device of the present invention can effectively detect cancer.
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Abstract
The present invention relates to an apparatus for the body fluid based detection of chronic diseases, and belongs to the technical field of medical instruments. The apparatus comprises a body fluid detection fluid channel, a detection probe, a data processing module, and a data display module; the detection probe is arranged in the body fluid detection fluid channel, the detection probe is connected to the data processing module, and the data processing module is connected to the data display module; the body fluid detection fluid channel comprises: a body fluid ion detection channel, a body fluid pH detection channel, a body fluid fluid mechanics characteristic detection channel, a channel for detecting the content of soluble gases such as oxygen, a detection channel for detecting leukocyte and tumor cell physical characteristics, a leukocyte and tumor cell electrical characterization detection channel, an erythrocyte physical characteristic detection channel, an erythrocyte electrical characterization detection channel, a post-separation body fluid electrical characterization detection channel, and an anticoagulation and fibrinolysis function detection channel. The present invention allows for performing non-invasive examinations with high sensitivity, and provides a powerful means for early diagnosis of chronic diseases.
Description
本发明涉及一种基于体液检测慢性病的装置，属于医疗器械技术领域。The invention relates to a device for detecting chronic diseases based on body fluids, belonging to the technical field of medical devices.
既往对慢性病的诊断监测主要有常规血液生化指标检测、影像学检查、疾病生物标志物检测等，但这些现有技术存在疾病监测效能低的问题。在慢性病早期，常规血液生化指标检测及疾病生物标志物等血液学检测差异并不明显；而影像学检查也难以分辨极小的病灶；这对慢性病早期诊断产生了极大的困难。所以，本技术领域亟需获得一种基于体液检测可以对慢性病进行早期诊断的装置。In the past, the diagnosis and monitoring of chronic diseases mainly included routine blood biochemical index detection, imaging examination, disease biomarker detection, etc., but these existing technologies have the problem of low disease monitoring efficiency. In the early stages of chronic diseases, the differences between routine blood biochemical index detection and hematological tests such as disease biomarkers are not obvious; and imaging examinations are also difficult to distinguish extremely small lesions; this has caused great difficulties in the early diagnosis of chronic diseases. Therefore, this technical field urgently needs to obtain a device that can perform early diagnosis of chronic diseases based on body fluid detection.
本发明的目的是为解决如何基于体液检测对慢性病进行早期诊断的技术问题。The purpose of the present invention is to solve the technical problem of how to perform early diagnosis of chronic diseases based on body fluid detection.
为达到解决上述问题的目的，本发明所采取的技术方案是提供一种基于体液检测慢性病的装置，包括体液检测流体通道、检测探头、数据处理模块和数据显示模块；体液检测流体通道中设有检测探头，检测探头与数据处理模块连接，数据处理模块与数据显示模块连接；所述体液检测流体通道包括检测体液离子，细胞因子，核酸，蛋白及其衍生物或微量元素通道、检测体液氧等可溶性气体通道、检测体液pH通道、检测体液粘滞度等流体力学特性通道、检测白细胞和肿瘤细胞包括渗透压在内的物理特性检测通道、检测白细胞和肿瘤细胞包括电阻抗，电荷在内的电学表征通道、检测红细胞包括渗透压在内的物理特性检测通道、检测红细胞包括电阻抗，电荷在内的电学表征通道、检测分离后的体液包括电阻抗，电荷在内的电学表征通道和检测分离后的体液包括凝血因子、纤维蛋白原、D-二聚体、血小板等在内的凝血、抗凝和纤溶功能检测通道。In order to achieve the purpose of solving the above-mentioned problems, the technical solution adopted by the present invention is to provide a device for detecting chronic diseases based on body fluids, including a body fluid detection fluid channel, a detection probe, a data processing module and a data display module; a detection probe is provided in the body fluid detection fluid channel, the detection probe is connected to the data processing module, and the data processing module is connected to the data display module; the body fluid detection fluid channel includes a channel for detecting body fluid ions, cytokines, nucleic acids, proteins and their derivatives or trace elements, a channel for detecting body fluid oxygen and other soluble gases, a channel for detecting body fluid pH, a channel for detecting body fluid viscosity and other fluid mechanics properties, a channel for detecting physical properties of white blood cells and tumor cells including osmotic pressure, a channel for detecting electrical characterization of white blood cells and tumor cells including electrical impedance and charge, a channel for detecting physical properties of red blood cells including osmotic pressure, a channel for detecting electrical characterization of red blood cells including electrical impedance and charge, a channel for detecting electrical characterization of separated body fluids including electrical impedance and charge, and a channel for detecting coagulation, anticoagulation and fibrinolytic functions of separated body fluids including coagulation factors, fibrinogen, D-dimer, platelets, etc.
优选地，所述装置中设有体液入口，与体液入口连通分别设有检测体液离子，细胞因子，核酸，蛋白及其衍生物或微量元素通道、检测体液pH通道、检测氧等可溶性气体通道、检测体液粘滞度等流体力学特性通道和体液细胞分离通道。Preferably, the device is provided with a body fluid inlet, and channels for detecting body fluid ions, cytokines, nucleic acids, proteins and their derivatives or trace elements, a channel for detecting body fluid pH, a channel for detecting oxygen and other soluble gases, a channel for detecting fluid mechanics properties such as body fluid viscosity, and a body fluid cell separation channel are respectively provided in communication with the body fluid inlet.
优选地，所述装置中设有细胞分离微流控通道，细胞分离微流控通道的一端与体液细胞分离通道连通，细胞分离微流控通道的另一端设有分离的白细胞和肿瘤细胞通道、分离的红细胞通道和分离后的体液通道。Preferably, the device is provided with a cell separation microfluidic channel, one end of the cell separation microfluidic channel is connected to the body fluid cell separation channel, and the other end of the cell separation microfluidic channel is provided with a separated white blood cell and tumor cell channel, a separated red blood cell channel and a separated body fluid channel.
优选地，所述分离的白细胞和肿瘤细胞通道分别与检测白细胞和肿瘤细胞包括渗透压在内的物理特性检测通道和检测白细胞和肿瘤细胞包括电阻抗、电荷在内的电学表征通道连通。Preferably, the separated leukocyte and tumor cell channels are respectively connected to a physical property detection channel for detecting leukocytes and tumor cells including osmotic pressure and an electrical characterization channel for detecting leukocytes and tumor cells including electrical impedance and charge.
优选地，所述分离的红细胞通道分别与检测红细胞包括渗透压在内的物理特性检测通道和检测红细胞包括电阻抗、电荷在内的电学表征通道连通。Preferably, the separated red blood cell channel is respectively connected to a channel for detecting the physical properties of red blood cells including osmotic pressure and a channel for detecting the electrical characterization of red blood cells including electrical impedance and charge.
优选地，所述分离后的体液通道分别与检测包括凝血因子、纤维蛋白原、D-二聚体、血小板等在内的凝血、抗凝和纤溶功能检测通道和检测分离后的体液包括电阻抗、电荷在内的电学表征通道连通；所述的检测凝血、抗凝和纤溶功能检测通道上还设有用于添加凝血因子的凝血因子通道。Preferably, the separated body fluid channel is respectively connected to a coagulation, anticoagulation and fibrinolysis function detection channel including coagulation factors, fibrinogen, D-dimer, platelets, etc. and an electrical characterization channel including electrical impedance and charge for detecting the separated body fluid; the coagulation, anticoagulation and fibrinolysis function detection channel is also provided with a coagulation factor channel for adding coagulation factors.
一种基于体液检测慢性病的装置获得的检测数据用于检测慢性病的处理方法，包括以下步骤：A method for detecting chronic diseases using detection data obtained by a device for detecting chronic diseases based on body fluids, comprising the following steps:
步骤1：根据公式1，n1=3.73v+6.38SpO
2+6.29 ph +6.4η+3.51π1+1.75 Ze1+3.64π2+5.19 Ze2+9.09 t+8.74Ze3+6.58v1+4.95v2，计算n1值；
Step 1: According to formula 1, n1=3.73v+6.38SpO2 + 6.29ph+6.4η+3.51π1+1.75Ze1+3.64π2+5.19Ze2+9.09t+8.74Ze3+6.58v1+4.95v2, calculate the value of n1;
其中，v为体液离子浓度、SpO
2为氧含量、ph为体液pH值、η为体液粘滞度值、π1为白细胞和肿瘤细胞渗透压值、π2为红细胞渗透压值、Ze1为白细胞和肿瘤细胞电阻抗值、Ze2为红细胞电阻抗值、Ze3为分离后的体液电阻抗值、t为凝血时间、v1是分离后的体液中D-二聚体浓度、v2是分离后的体液中纤维蛋白原降解产物浓度；
Wherein, v is the body fluid ion concentration, SpO2 is the oxygen content, ph is the body fluid pH value, η is the body fluid viscosity value, π1 is the osmotic pressure value of white blood cells and tumor cells, π2 is the osmotic pressure value of red blood cells, Ze1 is the electrical impedance value of white blood cells and tumor cells, Ze2 is the electrical impedance value of red blood cells, Ze3 is the electrical impedance value of body fluid after separation, t is the coagulation time, v1 is the D-dimer concentration in the body fluid after separation, and v2 is the fibrinogen degradation product concentration in the body fluid after separation;
步骤2：依据n1值评估被测者患慢性病的风险，如果n1值在105以下，为低风险；如果n1值在105-135为中风险；如果n1值在135以上属于高风险人群，数值越高则风险越大。Step 2: Assess the risk of chronic diseases based on the n1 value. If the n1 value is below 105, it is low risk; if the n1 value is between 105-135, it is medium risk; if the n1 value is above 135, it belongs to the high-risk group. The higher the value, the greater the risk.
优选地，所述慢性病包括肿瘤。Preferably, the chronic disease includes a tumor.
优选地，所述细胞因子为缺氧诱导因子1α和/或缺氧诱导因子1β。Preferably, the cytokine is hypoxia-inducible factor-1α and/or hypoxia-inducible factor-1β.
本发明还提供一种基于体液检测慢性病的装置获得的检测数据用于检测慢性病的处理方法，包括以下步骤：The present invention also provides a method for processing detection data obtained by a device for detecting chronic diseases based on body fluids for detecting chronic diseases, comprising the following steps:
步骤1：根据公式2，n2=5.69H1+7.32H2+3.73v+6.38SpO
2+6.29ph+6.4η+3.51π1+1.75 Ze1+3.64π2+5.19 Ze2+9.09 t+8.55Ze3+4.72v1+6.94v2，计算n2值；
Step 1: According to formula 2, n2=5.69H1+7.32H2+3.73v+6.38SpO2+6.29ph+6.4η+3.51π1+1.75 Ze1+3.64π2+5.19 Ze2+9.09 t +8.55Ze3+4.72v1+6.94v2, calculate the value of n2;
其中H1为缺氧诱导因子1α浓度、H2为缺氧诱导因子1β浓度、v为体液离子浓度、SpO
2为氧含量、ph为体液pH值、η为体液粘滞度值、π1为白细胞和肿瘤细胞渗透压值、π2为红细胞渗透压值、Ze1为白细胞和肿瘤细胞电阻抗值、Ze2为红细胞电阻抗值、Ze3为分离后的体液电阻抗值、t为凝血时间、v1是分离后的体液中D-二聚体浓度、v2是分离后的体液中纤维蛋白原降解产物浓度；
Wherein, H1 is the concentration of hypoxia-inducible factor 1α, H2 is the concentration of hypoxia-inducible factor 1β, v is the body fluid ion concentration, SpO 2 is the oxygen content, ph is the body fluid pH value, η is the body fluid viscosity value, π1 is the osmotic pressure value of white blood cells and tumor cells, π2 is the osmotic pressure value of red blood cells, Ze1 is the electrical impedance value of white blood cells and tumor cells, Ze2 is the electrical impedance value of red blood cells, Ze3 is the electrical impedance value of body fluid after separation, t is the coagulation time, v1 is the D-dimer concentration in the body fluid after separation, and v2 is the concentration of fibrinogen degradation products in the body fluid after separation;
步骤2：依据n2值评估被测者患慢性病的风险，如果n2值在120以下为低风险，n2值在120-150为中风险，n2值在150以上属于高风险人群，数值越高风险越大。Step 2: Assess the risk of chronic diseases based on the n2 value. If the n2 value is below 120, it is low risk; if the n2 value is 120-150, it is medium risk; if the n2 value is above 150, it belongs to the high-risk group. The higher the value, the greater the risk.
优选地，所述检测体液pH通道中还设有用于检测通道内体液的电阻抗、电荷在内的物理性质的检测探头。Preferably, the body fluid pH detection channel is further provided with a detection probe for detecting physical properties including electrical impedance and charge of the body fluid in the channel.
本发明提供一种基于体液检测慢性病的装置获得的检测数据用于检测慢性病的处理方法，包括以下步骤：The present invention provides a method for processing detection data obtained by a device for detecting chronic diseases based on body fluids for detecting chronic diseases, comprising the following steps:
步骤1：根据公式3，n3=Ze4，计算n3值；其中Ze4是体液细胞分离前的体液整体电阻抗值；Ze4值由检测体液pH通道中设有的检测探头获得；Step 1: According to formula 3, n3=Ze4, calculate the n3 value; wherein Ze4 is the overall electrical impedance value of the body fluid before the body fluid cell separation; the Ze4 value is obtained by the detection probe provided in the body fluid pH detection channel;
步骤2：依据n3值评估被测者患慢性病的风险，如果n3值在10以下为低风险，n3值在10-14为中风险，n3值在14以上属于高风险人群；n3值的数值越高风险越大；慢性病亚临床期、临床期，n3值呈现梯度升高，数值升高，提示患者应去医院，结合自身病史，做进一步检查。Step 2: Assess the risk of chronic diseases based on the n3 value. If the n3 value is below 10, it is low risk; if the n3 value is 10-14, it is medium risk; if the n3 value is above 14, it belongs to the high-risk group; the higher the n3 value, the greater the risk; in the subclinical and clinical stages of chronic diseases, the n3 value increases gradually, and the increase in the value indicates that the patient should go to the hospital for further examination based on his or her medical history.
优选地，所述检测体液pH通道中设有的用于检测通道内体液的电阻抗、电荷在内的物理性质的检测探头包括分别检测体液细胞部分电阻抗值Ze5的检测探头和检测体液整体电阻抗值Ze4的检测探头。Preferably, the detection probes provided in the body fluid pH detection channel for detecting physical properties including electrical impedance and charge of the body fluid in the channel include detection probes for detecting the electrical impedance value Ze5 of the body fluid cell part and detection probes for detecting the overall electrical impedance value Ze4 of the body fluid.
本发明提供一种基于体液检测慢性病的装置获得的检测数据用于检测慢性病的处理方法，包括以下步骤：The present invention provides a method for processing detection data obtained by a device for detecting chronic diseases based on body fluids for detecting chronic diseases, comprising the following steps:
步骤1：获得体液整体电阻抗值Ze4、体液细胞部分电阻抗值Ze5和分离后的体液电阻抗值Ze3；Step 1: Obtain the body fluid overall electrical impedance value Ze4, the body fluid cell portion electrical impedance value Ze5 and the separated body fluid electrical impedance value Ze3;
步骤2：根据公式4，n4=1.73Ze4+1.89Ze3+1.36Ze5，计算n4值；用于评价被检测者患有乳腺癌的风险；Step 2: According to formula 4, n4=1.73Ze4+1.89Ze3+1.36Ze5, calculate the n4 value; used to evaluate the risk of breast cancer in the tested person;
或，根据公式5，n5=1.79Ze4+1.85Ze3+1.73Ze5，计算n5值；用于评价被检测者患有前列腺癌的风险；Or, according to formula 5, n5=1.79Ze4+1.85Ze3+1.73Ze5, the n5 value is calculated; used to evaluate the risk of the subject suffering from prostate cancer;
或，根据公式6，n6=1.64Ze4+1.58Ze3+1.56Ze5，计算n6值；用于评价被检测者患有结直肠癌的风险；Or, according to formula 6, n6=1.64Ze4+1.58Ze3+1.56Ze5, the n6 value is calculated; it is used to evaluate the risk of the subject suffering from colorectal cancer;
或，根据公式7，n7=1.67Ze4+1.88Ze3+1.49Ze5，计算n7值；用于评价被检测者患有胃癌的风险；Or, according to formula 7, n7=1.67Ze4+1.88Ze3+1.49Ze5, calculate the n7 value; used to evaluate the risk of gastric cancer in the subject;
或，根据公式8，n8=1.85Ze4+1.48Ze3+1.61Ze5，计算n8值；用于评价被检测者患有肝癌的风险；Or, according to formula 8, n8=1.85Ze4+1.48Ze3+1.61Ze5, calculate the n8 value; used to evaluate the risk of the subject suffering from liver cancer;
或，根据公式9，n9=1.59Ze4+1.86Ze3+1.47Ze5，计算n9值；用于评价被检测者患有甲状腺癌的风险；Or, according to formula 9, n9=1.59Ze4+1.86Ze3+1.47Ze5, calculate the n9 value; used to evaluate the risk of thyroid cancer in the subject;
或，根据公式10，n10=1.56Ze4+1.47Ze3+1.41Ze5，计算n10值；用于评价被检测者患有胰腺癌的风险；Or, according to formula 10, n10=1.56Ze4+1.47Ze3+1.41Ze5, the n10 value is calculated; it is used to evaluate the risk of the subject suffering from pancreatic cancer;
或，根据公式11，n11=1.37Ze4+1.93Ze3+1.52Ze5，计算n11值；用于评价被检测者患有白血病的风险；Or, according to formula 11, n11=1.37Ze4+1.93Ze3+1.52Ze5, calculate the n11 value; used to evaluate the risk of the subject suffering from leukemia;
或，根据公式12，n12=1.86Ze4+1.82Ze3+1.44Ze5，计算n12值；用于评价被检测者患有肾癌的风险；Or, according to formula 12, n12=1.86Ze4+1.82Ze3+1.44Ze5, the n12 value is calculated; it is used to evaluate the risk of the subject suffering from kidney cancer;
或，根据公式13，n13=1.72Ze4+1.52Ze3+1.85Ze5，计算n13值；用于评价被检测者患有子宫肌瘤的风险；Or, according to formula 13, n13=1.72Ze4+1.52Ze3+1.85Ze5, calculate the n13 value; used to evaluate the risk of the subject suffering from uterine fibroids;
或，根据公式14，n14=1.35Ze4+1.57Ze3+1.69Ze5，计算n14值；用于评价被检测者患有口腔癌的风险；Or, according to formula 14, n14=1.35Ze4+1.57Ze3+1.69Ze5, calculate the n14 value; used to evaluate the risk of the subject suffering from oral cancer;
或，根据公式15，n15=1.69Ze4+1.55Ze3+1.42Ze5，计算n15值；用于评价被检测者患有卵巢癌的风险；Or, according to formula 15, n15=1.69Ze4+1.55Ze3+1.42Ze5, calculate the n15 value; used to evaluate the risk of the subject suffering from ovarian cancer;
或，根据公式16，n16=1.74Ze4+1.69Ze3+1.63Ze5，计算n16值；用于评价被检测者患有脑癌的风险；Or, according to formula 16, n16=1.74Ze4+1.69Ze3+1.63Ze5, calculate the n16 value; used to evaluate the risk of the subject suffering from brain cancer;
或，根据公式17，n17=1.63Ze4+1.77Ze3+1.78Ze5，计算n17值；用于评价被检测者患有鼻癌的风险；Or, according to formula 17, n17=1.63Ze4+1.77Ze3+1.78Ze5, the n17 value is calculated; used to evaluate the risk of the subject suffering from nasal cancer;
或，根据公式18，n18=1.62Ze4+1.67Ze3+1.96Ze5，计算n18值；用于评价被检测者患有咽喉癌的风险；Or, according to formula 18, n18=1.62Ze4+1.67Ze3+1.96Ze5, calculate the n18 value; used to evaluate the risk of the subject suffering from laryngeal cancer;
或，根据公式19，n19=1.64Ze4+1.68Ze3+1.71Ze5，计算n19值；用于评价被检测者患有食管癌的风险；Or, according to formula 19, n19=1.64Ze4+1.68Ze3+1.71Ze5, the n19 value is calculated; it is used to evaluate the risk of esophageal cancer in the subject;
或，根据公式20，n20=1.56Ze4+1.73Ze3+1.58Ze5，计算n20值；用于评价被检测者患有贲门癌的风险；Or, according to formula 20, n20=1.56Ze4+1.73Ze3+1.58Ze5, the n20 value is calculated; it is used to evaluate the risk of the subject suffering from cardiac cancer;
或，根据公式21，n21=1.74Ze4+1.98Ze3+1.89Ze5，计算n21值；用于评价被检测者患有胆管癌的风险；Or, according to formula 21, n21=1.74Ze4+1.98Ze3+1.89Ze5, calculate the n21 value; used to evaluate the risk of bile duct cancer in the tested person;
或，根据公式22，n22=1.55Ze4+1.85Ze3+1.91Ze5，计算n22值；用于评价被检测者患有膀胱癌的风险；Or, according to formula 22, n22=1.55Ze4+1.85Ze3+1.91Ze5, the n22 value is calculated; used to evaluate the risk of the subject suffering from bladder cancer;
或，根据公式23，n23=1.88Ze4+1.61Ze3+1.84Ze5，计算n23值；用于评价被检测者患有淋巴癌的风险；Or, according to formula 23, n23=1.88Ze4+1.61Ze3+1.84Ze5, calculate the n23 value; used to evaluate the risk of the subject suffering from lymphoma;
或，根据公式24，n24=1.75Ze4+1.82Ze3+1.86Ze5，计算n24值；用于评价被检测者患有皮肤癌的风险；Or, according to formula 24, n24=1.75Ze4+1.82Ze3+1.86Ze5, calculate the n24 value; used to evaluate the risk of the subject suffering from skin cancer;
或，根据公式25，n25=1.91Ze4+1.66Ze3+1.57Ze5，计算n25值；用于评价被检测者患有骨癌的风险；Or, according to formula 25, n25=1.91Ze4+1.66Ze3+1.57Ze5, calculate the n25 value; used to evaluate the risk of bone cancer in the subject;
或，根据公式26，n26=1.87Ze4+1.78Ze3+1.72Ze5，计算n26值；用于评价被检测者患有睾丸癌的风险；Or, according to formula 26, n26=1.87Ze4+1.78Ze3+1.72Ze5, calculate the n26 value; used to evaluate the risk of the subject suffering from testicular cancer;
或，根据公式27，n27=1.53Ze4+1.96Ze3+1.83Ze5，计算n27值；用于评价被检测者患有胆囊癌的风险；Or, according to formula 27, n27=1.53Ze4+1.96Ze3+1.83Ze5, calculate the n27 value; used to evaluate the risk of the subject suffering from gallbladder cancer;
或，根据公式28，n28=1.69Ze4+1.83Ze3+1.56Ze5，计算n28值；用于评价被检测者患有肺癌的风险；Or, according to formula 28, n28=1.69Ze4+1.83Ze3+1.56Ze5, calculate the n28 value; used to evaluate the risk of lung cancer in the tested person;
步骤3：依据上述步骤2中n4至n28的值评估被测者患相对应的癌症的风险，如果n4至n28的值超过60，则表示有患该值相对应的癌的高风险，需进行进一步的临床检查。Step 3: Based on the values of n4 to n28 in step 2 above, assess the risk of the subject developing the corresponding cancer. If the value of n4 to n28 exceeds 60, it indicates a high risk of developing the cancer corresponding to the value and further clinical examination is required.
相比现有技术，本发明具有如下有益效果：Compared with the prior art, the present invention has the following beneficial effects:
通过检测体液粘滞度变化以及体液内代谢物的电学特征来判定体液的改变，从而达到对慢性病进行风险筛查、诊断、疗效监测、预后判断（简称为疾病监测）的目的。使患者的疾病得以早发现，早治疗，以达到减少疾病死亡率，提高患者生活水平的目的。By detecting changes in body fluid viscosity and the electrical characteristics of metabolites in body fluids, changes in body fluids can be determined, thereby achieving the purpose of risk screening, diagnosis, efficacy monitoring, and prognosis judgment (referred to as disease monitoring) for chronic diseases. This allows patients' diseases to be discovered and treated early, thereby reducing disease mortality and improving patients' living standards.
通过本发明可进行非侵入性的检查，无辐射等对人体有害的因素；灵敏度高，可以为慢性病的早期诊断提供有力手段；样本需求量少；对采样时患者的生理状态无特别要求，无需空腹或者憋尿等；检测便捷，快速。The present invention can be used to conduct non-invasive examinations without radiation or other factors that are harmful to the human body; it has high sensitivity and can provide a powerful means for early diagnosis of chronic diseases; it requires a small amount of samples; it has no special requirements for the patient's physiological state during sampling, and there is no need to fast or hold urine, etc.; the test is convenient and fast.
图1为本发明主要组成部件体液检测流体通道结构示意图；FIG1 is a schematic diagram of the structure of a body fluid detection fluid channel of the main components of the present invention;
图2为应用公式1获得受试者工作曲线，比较本发明算法区分慢性病患者和健康人群的效果；FIG2 is a receiver operating curve obtained by applying Formula 1, comparing the effectiveness of the algorithm of the present invention in distinguishing chronic disease patients from healthy people;
图3为应用公式2获得受试者工作曲线，比较本发明算法区分慢性病患者和健康人群的效果；FIG3 is a receiver operating curve obtained by applying Formula 2, comparing the effectiveness of the algorithm of the present invention in distinguishing chronic disease patients from healthy people;
图4为应用公式3获得受试者工作曲线，比较本发明算法区分慢性病患者和健康人群的效果；FIG4 is a receiver operating curve obtained by applying Formula 3, comparing the effectiveness of the algorithm of the present invention in distinguishing chronic disease patients from healthy people;
附图标记：1.检测体液离子、细胞因子、核酸、蛋白及其衍生物或微量元素通道；2.检测体液pH通道；3.检测体液粘滞度流体力学特性通道；4.分离白细胞和肿瘤细胞通道；5.检测白细胞和肿瘤细胞包括渗透压在内的物理特性检测通道；6.检测白细胞和肿瘤细胞包括电阻抗、电荷在内的电学表征通道；7.分离红细胞通道；8.检测红细胞包括渗透压在内的物理特性检测通道；9.检测红细胞包括电阻抗、电荷在内的电学表征通道；10.分离后的体液通道；11.凝血因子通道；12.细胞分离微流控通道；13.体液入口；14.检测包括凝血因子、纤维蛋白原、D-二聚体、血小板在内的凝血、抗凝和纤溶功能检测通道；15.体液细胞分离通道；16.检测氧可溶性气体含量通道；17.检测分离后的体液包括电阻抗、电荷在内的电学表征通道。Figure numerals: 1. Channel for detecting body fluid ions, cytokines, nucleic acids, proteins and their derivatives or trace elements; 2. Channel for detecting body fluid pH; 3. Channel for detecting body fluid viscosity and fluid dynamics properties; 4. Channel for separating white blood cells and tumor cells; 5. Channel for detecting physical properties of white blood cells and tumor cells including osmotic pressure; 6. Channel for detecting electrical characterization of white blood cells and tumor cells including electrical impedance and charge; 7. Channel for separating red blood cells; 8. Channel for detecting physical properties of red blood cells including osmotic pressure; 9. Channel for detecting electrical characterization of red blood cells including electrical impedance and charge; 10. Channel for body fluid after separation; 11. Coagulation factor channel; 12. Cell separation microfluidic channel; 13. Body fluid inlet; 14. Channel for detecting coagulation, anticoagulation and fibrinolytic functions including coagulation factors, fibrinogen, D-dimer and platelets; 15. Body fluid cell separation channel; 16. Channel for detecting oxygen soluble gas content; 17. Channel for detecting electrical characterization of body fluid after separation including electrical impedance and charge.
为使本发明更明显易懂，兹以优选实施例，并配合附图作详细说明如下：In order to make the present invention more clearly understood, a preferred embodiment is described in detail with reference to the accompanying drawings as follows:
如图1所示，本发明提供一种基于体液检测慢性病的装置，包括体液检测流体通道、检测探头、数据处理模块和数据显示模块；体液检测流体通道中设有检测探头，检测探头与数据处理模块连接，数据处理模块与数据显示模块连接；体液检测流体通道包括检测体液离子，细胞因子，核酸，蛋白及其衍生物或微量元素通道1、检测体液pH通道2、检测体液粘滞度等流体力学特性通道3、检测氧等可溶性气体含量通道16、检测白细胞和肿瘤细胞包括渗透压在内的物理特性检测通道5、检测白细胞和肿瘤细胞包括电阻抗、电荷在内的电学表征通道6、检测红细胞包括渗透压在内的物理特性检测通道8、检测红细胞包括电阻抗、电荷在内的电学表征通道9、检测包括凝血因子，纤维蛋白原，D-二聚体，血小板等在内的凝血，抗凝和纤溶功能检测通道14和检测分离后的体液包括电阻抗、电荷在内的电学表征通道17。装置中设有体液入口13，与体液入口13连通分别设有检测体液离子，细胞因子，核酸，蛋白及其衍生物或微量元素通道1、检测体液pH通道2、检测体液粘滞度等流体力学特性通道3、检测氧等可溶性气体含量通道16和体液细胞分离通道15。装置中设有细胞分离微流控通道12，细胞分离微流控通道12的一端与体液细胞分离通道15连通，细胞分离微流控通道12的另一端设有分离白细胞和肿瘤细胞通道4、分离红细胞通道7和分离后的体液通道10。分离的白细胞和肿瘤细胞通道4分别与检测白细胞和肿瘤细胞包括渗透压在内的物理特性检测通道5和检测白细胞和肿瘤细胞包括电阻抗、电荷在内的电学表征通道6连通。分离的红细胞通道7分别与检测红细胞包括渗透压在内的物理特性检测通道8和检测红细胞包括电阻抗、电荷在内的电学表征通道9连通。分离后的体液通道10分别与检测包括凝血因子、纤维蛋白原、D-二聚体、血小板等在内的凝血、抗凝和纤溶功能检测通道14和检测分离后的体液包括电阻抗、电荷在内的电学表征通道17连通；检测包括凝血因子、纤维蛋白原、D-二聚体、血小板等在内的凝血、抗凝和纤溶功能检测通道14上还设有用于添加凝血因子的凝血因子通道11。上述通道中检测探头结构形式与现有技术中相同。检测体液离子、细胞因子、核酸、蛋白及其衍生物、微量元素、检测体液pH、检测体液粘滞度等流体力学特性、检测氧等可溶性气体含量、检测白细胞和肿瘤细胞包括渗透压在内的物理特性检测、检测白细胞和肿瘤细胞包括电阻抗、电荷在内的电学表征、检测红细胞包括渗透压在内的物理特性检测、检测红细胞包括电阻抗、电荷在内的电学表征、检测分离后的体液包括电阻抗、电荷在内的电学表征、检测包括凝血因子、纤维蛋白原、D-二聚体、血小板等在内的凝血、抗凝和纤溶功能检测的方法是现有技术的公知常识。分离血细胞中白细胞、肿瘤细胞、红细胞和分离后的体液采用类似如已公开的文献NATURE COMMUNICATIONS (2022) 13：3086As shown in Figure 1, the present invention provides a device for detecting chronic diseases based on body fluids, including a body fluid detection fluid channel, a detection probe, a data processing module and a data display module; a detection probe is provided in the body fluid detection fluid channel, the detection probe is connected to the data processing module, and the data processing module is connected to the data display module; the body fluid detection fluid channel includes a channel 1 for detecting body fluid ions, cytokines, nucleic acids, proteins and their derivatives or trace elements, a channel 2 for detecting body fluid pH, a channel 3 for detecting fluid mechanics properties such as body fluid viscosity, a channel 16 for detecting the content of soluble gases such as oxygen, a detection channel 5 for detecting the physical properties of white blood cells and tumor cells including osmotic pressure, a channel 6 for detecting electrical characterization of white blood cells and tumor cells including impedance and charge, a detection channel 8 for detecting the physical properties of red blood cells including osmotic pressure, a channel 9 for detecting electrical characterization of red blood cells including impedance and charge, a detection channel 14 for detecting coagulation, anticoagulation and fibrinolytic functions including coagulation factors, fibrinogen, D-dimer, platelets, etc., and a channel 17 for detecting electrical characterization of separated body fluids including impedance and charge. The device is provided with a body fluid inlet 13, and is connected to the body fluid inlet 13 and is respectively provided with a channel 1 for detecting body fluid ions, cytokines, nucleic acids, proteins and their derivatives or trace elements, a channel 2 for detecting body fluid pH, a channel 3 for detecting fluid mechanics properties such as body fluid viscosity, a channel 16 for detecting soluble gas content such as oxygen, and a body fluid cell separation channel 15. The device is provided with a cell separation microfluidic channel 12, one end of the cell separation microfluidic channel 12 is connected to the body fluid cell separation channel 15, and the other end of the cell separation microfluidic channel 12 is provided with a channel 4 for separating white blood cells and tumor cells, a channel 7 for separating red blood cells, and a body fluid channel 10 after separation. The separated white blood cell and tumor cell channel 4 is respectively connected to a detection channel 5 for detecting physical properties of white blood cells and tumor cells including osmotic pressure and a channel 6 for detecting electrical characterization of white blood cells and tumor cells including electrical impedance and charge. The separated red blood cell channel 7 is respectively connected to a detection channel 8 for detecting physical properties of red blood cells including osmotic pressure and a channel 9 for detecting electrical characterization of red blood cells including electrical impedance and charge. The separated body fluid channel 10 is respectively connected to the coagulation, anticoagulation and fibrinolysis function detection channel 14 including coagulation factors, fibrinogen, D-dimer, platelets, etc. and the electrical characterization channel 17 including electrical impedance and charge for detecting the separated body fluid; the coagulation, anticoagulation and fibrinolysis function detection channel 14 including coagulation factors, fibrinogen, D-dimer, platelets, etc. is also provided with a coagulation factor channel 11 for adding coagulation factors. The detection probe structure in the above channels is the same as that in the prior art. Methods for detecting body fluid ions, cytokines, nucleic acids, proteins and their derivatives, trace elements, body fluid pH, body fluid viscosity and other fluid mechanics, oxygen and other soluble gas content, physical properties of white blood cells and tumor cells including osmotic pressure, electrical characterization of white blood cells and tumor cells including electrical impedance and charge, physical properties of red blood cells including osmotic pressure, electrical characterization of red blood cells including electrical impedance and charge, electrical characterization of separated body fluids including electrical impedance and charge, and coagulation, anticoagulation and fibrinolytic function detection including coagulation factors, fibrinogen, D-dimer, platelets, etc. are common knowledge in the prior art. Separating white blood cells, tumor cells, red blood cells and separated body fluids from blood cells using methods similar to those disclosed in NATURE COMMUNICATIONS (2022) 13:3086
https://doi.org/10.1038/s41467-022-30384-7 ；www.nature.com/naturecommunications中“A role for microfluidic systems in precision medicine”文中所公开的血细胞分离装置。The blood cell separation device disclosed in the article “A role for microfluidic systems in precision medicine” in https://doi.org/10.1038/s41467-022-30384-7 ; www.nature.com/naturecommunications.
本装置获得的检测数据用于检测慢性病的处理方法，包括以下步骤：The detection data obtained by the device is used for detecting a treatment method for chronic diseases, comprising the following steps:
步骤1：根据公式1；n1=3.73v+6.38SpO
2+6.29 ph +6.4η+3.51π1+1.75 Ze1+3.64π2+5.19 Ze2+9.09 t+8.74Ze3+6.58v1+4.95v2，计算n1值；v为体液离子浓度、SpO
2为氧含量、ph为体液pH值、η为体液粘滞度值、π1为白细胞和循环肿瘤细胞渗透压值、π2为红细胞渗透压值、Ze1为白细胞和肿瘤细胞电阻抗值、Ze2为红细胞电阻抗值、Ze3为分离后的体液电阻抗值、t为凝血时间、v1是分离后的体液中D-二聚体浓度、v2是分离后的体液中纤维蛋白原降解产物浓度；
Step 1: According to formula 1; n1=3.73v+ 6.38SpO2+ 6.29ph+6.4η+3.51π1+1.75 Ze1+3.64π2+5.19 Ze2+9.09t+8.74Ze3+6.58v1+4.95v2, calculate the n1 value; v is the body fluid ion concentration, SpO2 is the oxygen content, ph is the body fluid pH value, η is the body fluid viscosity value, π1 is the osmotic pressure value of white blood cells and circulating tumor cells, π2 is the osmotic pressure value of red blood cells, Ze1 is the electrical impedance value of white blood cells and tumor cells, Ze2 is the electrical impedance value of red blood cells, Ze3 is the electrical impedance value of the body fluid after separation, t is the coagulation time, v1 is the D-dimer concentration in the body fluid after separation, and v2 is the fibrinogen degradation product concentration in the body fluid after separation;
步骤2：依据n1值评估被测者患慢性病的风险，如果n1值在105以下，为低风险；如果n1值在105-135为中风险；如果n1值在135以上属于高风险人群，数值越高则风险越大。所述慢性病包括肿瘤。Step 2: Assess the risk of the subject suffering from chronic diseases based on the n1 value. If the n1 value is below 105, it is a low risk; if the n1 value is between 105 and 135, it is a medium risk; if the n1 value is above 135, it belongs to the high-risk group. The higher the value, the greater the risk. The chronic diseases include tumors.
当检测细胞因子为缺氧诱导因子1α和/或缺氧诱导因子1β；提供另一种基于体液检测慢性病的装置获得的检测数据用于检测慢性病的处理方法，包括以下步骤：When the detected cytokine is hypoxia-inducible factor 1α and/or hypoxia-inducible factor 1β; another method for processing detection data obtained by a device for detecting chronic diseases based on body fluids for detecting chronic diseases is provided, comprising the following steps:
步骤1：根据公式2；n2=5.69H1+7.32H2+3.73v+6.38SpO
2+6.29ph+6.4η+3.51π1+1.75 Ze1+3.64π2+5.19 Ze2+9.09 t+8.55Ze3+4.72v1+6.94v2，计算n2值；其中H1为缺氧诱导因子1α浓度、H2为缺氧诱导因子1β浓度、v为体液离子浓度、SpO
2为氧含量、ph为体液pH值、η为体液粘滞度值、π1为白细胞和肿瘤细胞渗透压值、π2为红细胞渗透压值、Ze1为白细胞和肿瘤细胞电阻抗值、Ze2为红细胞电阻抗值、Ze3为分离后的体液电阻抗值、t为凝血时间、v1是分离后的体液中D-二聚体浓度、v2是分离后的体液中纤维蛋白原降解产物浓度；
Step 1: Calculate the n2 value according to formula 2; n2=5.69H1+7.32H2+3.73v+6.38SpO2+6.29ph+6.4η+3.51π1+1.75Ze1+3.64π2+5.19Ze2+ 9.09t +8.55Ze3+4.72v1+6.94v2; where H1 is the concentration of hypoxia-inducible factor 1α, H2 is the concentration of hypoxia-inducible factor 1β, v is the concentration of body fluid ions, and SpO 2 is oxygen content, ph is body fluid pH, η is body fluid viscosity, π1 is leukocyte and tumor cell osmotic pressure, π2 is erythrocyte osmotic pressure, Ze1 is leukocyte and tumor cell electrical impedance, Ze2 is erythrocyte electrical impedance, Ze3 is body fluid electrical impedance after separation, t is coagulation time, v1 is D-dimer concentration in body fluid after separation, v2 is fibrinogen degradation product concentration in body fluid after separation;
步骤2：依据n2值评估被测者患慢性病的风险，如果n2值在120以下为低风险，n2值在120-150为中风险，n2值在150以上属于高风险人群，数值越高风险越大。Step 2: Assess the risk of chronic diseases based on the n2 value. If the n2 value is below 120, it is low risk; if the n2 value is 120-150, it is medium risk; if the n2 value is above 150, it belongs to the high-risk group. The higher the value, the greater the risk.
当检测体液pH通道中还设有用于检测通道内体液的电阻抗、电荷在内的物理性质的检测探头时；When the body fluid pH detection channel is also provided with a detection probe for detecting physical properties including electrical impedance and charge of the body fluid in the channel;
本发明还提供一种基于体液检测慢性病的装置获得的检测数据用于检测慢性病的处理方法，包括以下步骤：The present invention also provides a method for processing detection data obtained by a device for detecting chronic diseases based on body fluids for detecting chronic diseases, comprising the following steps:
步骤1：根据公式3，n3=Ze4，计算n3值；其中Ze4是体液细胞分离前的体液整体电阻抗值；Ze4值由检测体液pH通道中设有的检测探头获得；Step 1: According to formula 3, n3=Ze4, calculate the n3 value; wherein Ze4 is the overall electrical impedance value of the body fluid before the body fluid cell separation; the Ze4 value is obtained by the detection probe provided in the body fluid pH detection channel;
步骤2：依据n3值评估被测者患慢性病的风险，如果n3值在10以下为低风险，n3值在10-14为中风险，n3值在14以上属于高风险人群；n3值的数值越高风险越大；慢性病亚临床期、临床期，n3值呈现梯度升高，数值升高，提示患者应去医院，结合自身病史，做进一步检查。Step 2: Assess the risk of chronic diseases based on the n3 value. If the n3 value is below 10, it is low risk; if the n3 value is 10-14, it is medium risk; if the n3 value is above 14, it belongs to the high-risk group; the higher the n3 value, the greater the risk; in the subclinical and clinical stages of chronic diseases, the n3 value increases gradually, and the increase in the value indicates that the patient should go to the hospital for further examination based on his or her medical history.
当检测体液pH通道中设有的用于检测通道内体液的电阻抗、电荷在内的物理性质的检测探头包括分别检测体液细胞部分电阻抗值Ze5的检测探头和检测体液整体电阻抗值Ze4的检测探头；When the detection probes provided in the body fluid pH channel for detecting the physical properties of the body fluid in the channel, including the electrical impedance and charge, include detection probes for detecting the electrical impedance value Ze5 of the body fluid cell part and detection probes for detecting the electrical impedance value Ze4 of the body fluid as a whole;
本发明提供一种基于体液检测慢性病的装置获得的检测数据用于检测慢性病的处理方法，包括以下步骤：The present invention provides a method for processing detection data obtained by a device for detecting chronic diseases based on body fluids for detecting chronic diseases, comprising the following steps:
步骤1：获得体液整体电阻抗值Ze4、体液细胞部分电阻抗值Ze5和分离后的体液电阻抗值Ze3；Step 1: Obtain the body fluid overall electrical impedance value Ze4, the body fluid cell portion electrical impedance value Ze5 and the separated body fluid electrical impedance value Ze3;
步骤2：根据公式4，n4=1.73Ze4+1.89Ze3+1.36Ze5，计算n4值；用于评价被检测者患有乳腺癌的风险；Step 2: According to formula 4, n4=1.73Ze4+1.89Ze3+1.36Ze5, calculate the n4 value; used to evaluate the risk of breast cancer in the tested person;
或，根据公式5，n5=1.79Ze4+1.85Ze3+1.73Ze5，计算n5值；用于评价被检测者患有前列腺癌的风险；Or, according to formula 5, n5=1.79Ze4+1.85Ze3+1.73Ze5, the n5 value is calculated; used to evaluate the risk of the subject suffering from prostate cancer;
或，根据公式6，n6=1.64Ze4+1.58Ze3+1.56Ze5，计算n6值；用于评价被检测者患有结直肠癌的风险；Or, according to formula 6, n6=1.64Ze4+1.58Ze3+1.56Ze5, the n6 value is calculated; it is used to evaluate the risk of the subject suffering from colorectal cancer;
或，根据公式7，n7=1.67Ze4+1.88Ze3+1.49Ze5，计算n7值；用于评价被检测者患有胃癌的风险；Or, according to formula 7, n7=1.67Ze4+1.88Ze3+1.49Ze5, calculate the n7 value; used to evaluate the risk of gastric cancer in the subject;
或，根据公式8，n8=1.85Ze4+1.48Ze3+1.61Ze5，计算n8值；用于评价被检测者患有肝癌的风险；Or, according to formula 8, n8=1.85Ze4+1.48Ze3+1.61Ze5, calculate the n8 value; used to evaluate the risk of the subject suffering from liver cancer;
或，根据公式9，n9=1.59Ze4+1.86Ze3+1.47Ze5，计算n9值；用于评价被检测者患有甲状腺癌的风险；Or, according to formula 9, n9=1.59Ze4+1.86Ze3+1.47Ze5, calculate the n9 value; used to evaluate the risk of thyroid cancer in the subject;
或，根据公式10，n10=1.56Ze4+1.47Ze3+1.41Ze5，计算n10值；用于评价被检测者患有胰腺癌的风险；Or, according to formula 10, n10=1.56Ze4+1.47Ze3+1.41Ze5, the n10 value is calculated; it is used to evaluate the risk of the subject suffering from pancreatic cancer;
或，根据公式11，n11=1.37Ze4+1.93Ze3+1.52Ze5，计算n11值；用于评价被检测者患有白血病的风险；Or, according to formula 11, n11=1.37Ze4+1.93Ze3+1.52Ze5, calculate the n11 value; used to evaluate the risk of the subject suffering from leukemia;
或，根据公式12，n12=1.86Ze4+1.82Ze3+1.44Ze5，计算n12值；用于评价被检测者患有肾癌的风险；Or, according to formula 12, n12=1.86Ze4+1.82Ze3+1.44Ze5, the n12 value is calculated; it is used to evaluate the risk of the subject suffering from kidney cancer;
或，根据公式13，n13=1.72Ze4+1.52Ze3+1.85Ze5，计算n13值；用于评价被检测者患有子宫肌瘤的风险；Or, according to formula 13, n13=1.72Ze4+1.52Ze3+1.85Ze5, calculate the n13 value; used to evaluate the risk of the subject suffering from uterine fibroids;
或，根据公式14，n14=1.35Ze4+1.57Ze3+1.69Ze5，计算n14值；用于评价被检测者患有口腔癌的风险；Or, according to formula 14, n14=1.35Ze4+1.57Ze3+1.69Ze5, calculate the n14 value; used to evaluate the risk of the subject suffering from oral cancer;
或，根据公式15，n15=1.69Ze4+1.55Ze3+1.42Ze5，计算n15值；用于评价被检测者患有卵巢癌的风险；Or, according to formula 15, n15=1.69Ze4+1.55Ze3+1.42Ze5, calculate the n15 value; used to evaluate the risk of the subject suffering from ovarian cancer;
或，根据公式16，n16=1.74Ze4+1.69Ze3+1.63Ze5，计算n16值；用于评价被检测者患有脑癌的风险；Or, according to formula 16, n16=1.74Ze4+1.69Ze3+1.63Ze5, calculate the n16 value; used to evaluate the risk of the subject suffering from brain cancer;
或，根据公式17，n17=1.63Ze4+1.77Ze3+1.78Ze5，计算n17值；用于评价被检测者患有鼻癌的风险；Or, according to formula 17, n17=1.63Ze4+1.77Ze3+1.78Ze5, the n17 value is calculated; used to evaluate the risk of the subject suffering from nasal cancer;
或，根据公式18，n18=1.62Ze4+1.67Ze3+1.96Ze5，计算n18值；用于评价被检测者患有咽喉癌的风险；Or, according to formula 18, n18=1.62Ze4+1.67Ze3+1.96Ze5, calculate the n18 value; used to evaluate the risk of the subject suffering from laryngeal cancer;
或，根据公式19，n19=1.64Ze4+1.68Ze3+1.71Ze5，计算n19值；用于评价被检测者患有食管癌的风险；Or, according to formula 19, n19=1.64Ze4+1.68Ze3+1.71Ze5, the n19 value is calculated; it is used to evaluate the risk of esophageal cancer in the subject;
或，根据公式20，n20=1.56Ze4+1.73Ze3+1.58Ze5，计算n20值；用于评价被检测者患有贲门癌的风险；Or, according to formula 20, n20=1.56Ze4+1.73Ze3+1.58Ze5, the n20 value is calculated; it is used to evaluate the risk of the subject suffering from cardiac cancer;
或，根据公式21，n21=1.74Ze4+1.98Ze3+1.89Ze5，计算n21值；用于评价被检测者患有胆管癌的风险；Or, according to formula 21, n21=1.74Ze4+1.98Ze3+1.89Ze5, calculate the n21 value; used to evaluate the risk of bile duct cancer in the tested person;
或，根据公式22，n22=1.55Ze4+1.85Ze3+1.91Ze5，计算n22值；用于评价被检测者患有膀胱癌的风险；Or, according to formula 22, n22=1.55Ze4+1.85Ze3+1.91Ze5, the n22 value is calculated; used to evaluate the risk of the subject suffering from bladder cancer;
或，根据公式23，n23=1.88Ze4+1.61Ze3+1.84Ze5，计算n23值；用于评价被检测者患有淋巴癌的风险；Or, according to formula 23, n23=1.88Ze4+1.61Ze3+1.84Ze5, calculate the n23 value; used to evaluate the risk of the subject suffering from lymphoma;
或，根据公式24，n24=1.75Ze4+1.82Ze3+1.86Ze5，计算n24值；用于评价被检测者患有皮肤癌的风险；Or, according to formula 24, n24=1.75Ze4+1.82Ze3+1.86Ze5, calculate the n24 value; used to evaluate the risk of the subject suffering from skin cancer;
或，根据公式25，n25=1.91Ze4+1.66Ze3+1.57Ze5，计算n25值；用于评价被检测者患有骨癌的风险；Or, according to formula 25, n25=1.91Ze4+1.66Ze3+1.57Ze5, calculate the n25 value; used to evaluate the risk of bone cancer in the subject;
或，根据公式26，n26=1.87Ze4+1.78Ze3+1.72Ze5，计算n26值；用于评价被检测者患有睾丸癌的风险；Or, according to formula 26, n26=1.87Ze4+1.78Ze3+1.72Ze5, the n26 value is calculated; it is used to evaluate the risk of the subject suffering from testicular cancer;
或，根据公式27，n27=1.53Ze4+1.96Ze3+1.83Ze5，计算n27值；用于评价被检测者患有胆囊癌的风险；Or, according to formula 27, n27=1.53Ze4+1.96Ze3+1.83Ze5, calculate the n27 value; used to evaluate the risk of the subject suffering from gallbladder cancer;
或，根据公式28，n28=1.69Ze4+1.83Ze3+1.56Ze5，计算n28值；用于评价被检测者患有肺癌的风险；Or, according to formula 28, n28=1.69Ze4+1.83Ze3+1.56Ze5, calculate the n28 value; used to evaluate the risk of lung cancer in the tested person;
步骤3：依据上述步骤2中n4至n28的值评估被测者患相对应的癌症的风险，如果n4至n28的值超过60，则表示有患该值相对应的癌的高风险，需进行进一步的临床检查Step 3: Assess the risk of the subject suffering from the corresponding cancer based on the values of n4 to n28 in step 2 above. If the value of n4 to n28 exceeds 60, it means that there is a high risk of suffering from the corresponding cancer and further clinical examination is required.
本装置的使用过程：The use process of this device:
将装有体液的采集管置于检测机器内，通过检测机器内置的泵吸取体液并泵入本发明装置提供的体液检测流体通道内，使用体液检测流体通道内设置的探头收集相关信号，并将相关信号值传输至计算机的数据处理模块，数据处理模块通过内置的程序计算出一个数值n。将该数值与参考值进行对比后可以判断体液提供者患有慢性病风险。再将结果传输至数据显示模块，显示给医护人员。The collection tube containing body fluid is placed in the detection machine, the body fluid is sucked by the built-in pump of the detection machine and pumped into the body fluid detection fluid channel provided by the device of the present invention, the probe set in the body fluid detection fluid channel is used to collect relevant signals, and the relevant signal value is transmitted to the data processing module of the computer, and the data processing module calculates a value n through the built-in program. After comparing this value with the reference value, it can be judged that the body fluid provider has a risk of chronic disease. Then the result is transmitted to the data display module and displayed to the medical staff.
图2是应用公式1检验肿瘤与健康人群区分效果，Figure 2 is the application of formula 1 to test the effect of distinguishing between tumor and healthy people.
采集1103名癌症患者（包括605名肺癌、110名前列腺癌、182名乳腺癌、206名食管癌）和1063名体检中心健康人群对照的血液样本，使用本发明提供的检测技术和公式1的算法，同时检测常规癌标CEA（癌胚抗原,carcino-embryonic antigen，CEA）和AFP（甲胎蛋白，α-fetoprotein，AFP）。绘制受试者工作特征（receiver operator characteristic curve，ROC）曲线并计算ROC曲线下面积（area under the cure，AUC），比较三者区分癌症患者和健康人群的效果，结果如图2所示：该研究的统计学方法为受试者工作曲线（ROC），实验结果显示本发明提供的算法区分慢性病患者和健康人群的曲线下面积（AUC）达到0.910，灵敏度为84.3%，特异性为92.6%；本方案显著优于CEA和AFP区分效果，提示公式1在病例对照研究中可有效区分慢病患者与健康人群。实验结论说明本发明装置能有效检测出慢性病。Blood samples were collected from 1,103 cancer patients (including 605 lung cancer patients, 110 prostate cancer patients, 182 breast cancer patients, and 206 esophageal cancer patients) and 1,063 healthy controls from physical examination centers. The conventional cancer markers CEA (carcino-embryonic antigen, CEA) and AFP (alpha-fetoprotein, AFP) were detected simultaneously using the detection technology provided by the present invention and the algorithm of formula 1. The receiver operating characteristic (ROC) curve was drawn and the area under the cure (AUC) of the ROC curve was calculated to compare the effects of the three methods in distinguishing cancer patients from healthy people. The results are shown in Figure 2: The statistical method of this study is the receiver operating curve (ROC). The experimental results show that the area under the curve (AUC) of the algorithm provided by the present invention for distinguishing chronic disease patients from healthy people reaches 0.910, with a sensitivity of 84.3% and a specificity of 92.6%. This scheme is significantly better than the distinction effect of CEA and AFP, suggesting that formula 1 can effectively distinguish chronic disease patients from healthy people in case-control studies. The experimental conclusion shows that the device of the present invention can effectively detect chronic diseases.
图3是应用公式2检验肿瘤与健康人群区分效果，Figure 3 is the application of formula 2 to test the effect of distinguishing between tumor and healthy people.
采集1103名癌症患者（包括605名肺癌、110名前列腺癌、182名乳腺癌、206名食管癌）和1063名体检中心健康人群对照的血液样本，使用本发明提供的检测技术和公式2的算法，同时检测常规癌标CEA（癌胚抗原,carcino-embryonic antigen，CEA）和AFP（甲胎蛋白，α-fetoprotein，AFP）。绘制受试者工作特征（receiver operator characteristic curve，ROC）曲线并计算ROC曲线下面积（area under the cure，AUC），比较三者区分癌症患者和健康人群的效果，结果如图3所示：该研究的统计学方法为受试者工作曲线（ROC），实验结果显示本发明提供的算法区分慢性病患者和健康人群的曲线下面积（AUC）达到0.908，灵敏度为84.6%，特异性为92.7%；本方案显著优于CEA和AFP区分效果，提示公式2在病例对照研究中可有效区分慢病患者与健康人群。实验结论说明本发明装置能有效检测出慢性病。Blood samples were collected from 1,103 cancer patients (including 605 lung cancer patients, 110 prostate cancer patients, 182 breast cancer patients, and 206 esophageal cancer patients) and 1,063 healthy controls from physical examination centers. The conventional cancer markers CEA (carcino-embryonic antigen, CEA) and AFP (alpha-fetoprotein, AFP) were detected simultaneously using the detection technology provided by the present invention and the algorithm of formula 2. The receiver operating characteristic (ROC) curve was drawn and the area under the cure (AUC) of the ROC curve was calculated to compare the effects of the three methods in distinguishing cancer patients from healthy people. The results are shown in Figure 3: The statistical method of this study is the receiver operating curve (ROC). The experimental results show that the area under the curve (AUC) of the algorithm provided by the present invention for distinguishing chronic disease patients from healthy people reached 0.908, with a sensitivity of 84.6% and a specificity of 92.7%; this scheme is significantly better than the distinction effect of CEA and AFP, suggesting that formula 2 can effectively distinguish chronic disease patients from healthy people in case-control studies. The experimental conclusion shows that the device of the present invention can effectively detect chronic diseases.
图4是应用公式3检验肿瘤与健康人群区分效果，Figure 4 shows the effect of using formula 3 to test the differentiation between tumor and healthy population.
采集1103名癌症患者（包括605名肺癌、110名前列腺癌、182名乳腺癌、206名食管癌）和1063名体检中心健康人群对照的血液样本，使用本发明提供的检测技术和公式3的算法，同时检测常规癌标CEA（癌胚抗原,carcino-embryonic antigen，CEA）和AFP（甲胎蛋白，α-fetoprotein，AFP）。绘制受试者工作特征（receiver operator characteristic curve，ROC）曲线并计算ROC曲线下面积（area under the cure，AUC），比较三者区分癌症患者和健康人群的效果，结果如图4所示：该研究的统计学方法为受试者工作曲线（ROC），实验结果显示本发明提供的算法区分慢性病患者和健康人群的曲线下面积（AUC）达到0.864，灵敏度为82.4%，特异性为89.6%；本方案优于CEA和AFP区分效果，提示公式3在病例对照研究中可有效区分慢病患者与健康人群。实验结论说明本发明装置能有效检测出慢性病。Blood samples were collected from 1,103 cancer patients (including 605 lung cancer patients, 110 prostate cancer patients, 182 breast cancer patients, and 206 esophageal cancer patients) and 1,063 healthy controls from physical examination centers. The conventional cancer markers CEA (carcino-embryonic antigen, CEA) and AFP (alpha-fetoprotein, AFP) were detected simultaneously using the detection technology provided by the present invention and the algorithm of formula 3. The receiver operator characteristic curve (ROC) curve was drawn and the area under the cure (AUC) of the ROC curve was calculated to compare the effects of the three methods in distinguishing cancer patients from healthy people. The results are shown in Figure 4: The statistical method of this study is the receiver operating curve (ROC). The experimental results show that the area under the curve (AUC) of the algorithm provided by the present invention for distinguishing chronic disease patients from healthy people reaches 0.864, with a sensitivity of 82.4% and a specificity of 89.6%. This scheme is better than the distinction effect of CEA and AFP, suggesting that formula 3 can effectively distinguish chronic disease patients from healthy people in case-control studies. The experimental conclusion shows that the device of the present invention can effectively detect chronic diseases.
采集4457名癌症患者（包括605名肺癌、110名前列腺癌、182名乳腺癌、206名食管癌、194名结直肠癌、195名胃癌、129名肝癌、193名甲状腺癌、137名胰腺癌、196名白血病、153名肾癌、164名子宫肌瘤、128名口腔癌、183名卵巢癌、159名脑癌、156名鼻癌、176名咽喉癌、112名贲门癌、171名胆管癌、189名膀胱癌、122名淋巴癌、135名皮肤癌、157名骨癌、179名睾丸癌、126名胆囊癌）和1063名体检中心健康人群对照的血液样本，使用本发明提供的检测技术和公式4-公式28的算法，同时检测常规癌标CEA（癌胚抗原,carcino-embryonic antigen，CEA）和AFP（甲胎蛋白，α-fetoprotein，AFP）。绘制受试者工作特征（receiver operator characteristic curve，ROC）曲线并计算ROC曲线下面积（area under the cure，AUC），比较三者区分癌症患者和健康人群的效果，实验结果显示本发明提供的算法：公式4-公式28区分癌症患者和健康人群的灵敏度和特异性如下表1；提示公式4-公式28在病例对照研究中可有效区分癌症患者与健康人群。实验结论说明本发明装置能有效检测出癌症。Blood samples were collected from 4457 cancer patients (including 605 lung cancer patients, 110 prostate cancer patients, 182 breast cancer patients, 206 esophageal cancer patients, 194 colorectal cancer patients, 195 gastric cancer patients, 129 liver cancer patients, 193 thyroid cancer patients, 137 pancreatic cancer patients, 196 leukemia patients, 153 kidney cancer patients, 164 uterine fibroids patients, 128 oral cancer patients, 183 ovarian cancer patients, 159 brain cancer patients, 156 nasal cancer patients, 176 pharyngeal cancer patients, 112 cardia cancer patients, 171 bile duct cancer patients, 189 bladder cancer patients, 122 lymphoma patients, 135 skin cancer patients, 157 bone cancer patients, 179 testicular cancer patients, and 126 gallbladder cancer patients) and 1063 healthy controls from physical examination centers. The conventional cancer marker CEA (carcinoembryonic antigen) was detected using the detection technology provided by the present invention and the algorithm of formula 4 to formula 28. The receiver operating characteristic (ROC) curve was drawn and the area under the cure (AUC) was calculated to compare the effects of the three methods in distinguishing cancer patients from healthy people. The experimental results show that the sensitivity and specificity of the algorithm provided by the present invention: Formula 4-Formula 28 in distinguishing cancer patients from healthy people are shown in Table 1 below; indicating that Formula 4-Formula 28 can effectively distinguish cancer patients from healthy people in case-control studies. The experimental conclusion shows that the device of the present invention can effectively detect cancer.
表1
Table 1
| 公式4-公式28 | 灵敏度 | 特异性 |
| n4 | 91.5% | 92.2% |
| n5 | 90.7% | 85.7% |
| n6 | 89.8% | 92.5% |
| n7 | 90.3% | 91.4% |
| n8 | 86.6% | 91.3% |
| n9 | 86.1% | 88.6% |
| n10 | 89.1% | 92.7% |
| n11 | 88.3% | 90.4% |
| n12 | 90.2% | 92.4% |
| n13 | 87.8% | 85.1% |
| n14 | 90.1% | 87.5% |
| n15 | 91.9% | 88.5% |
| n16 | 89.6% | 89.9% |
| n17 | 90.6% | 90.3% |
| n18 | 86.5% | 87.2% |
| n19 | 84.1% | 86.8% |
| n20 | 86.2% | 85.4% |
| n21 | 91.1% | 90.9% |
| n22 | 93.4% | 92.5% |
| n23 | 86.1% | 84.9% |
| n24 | 93.2% | 88.7% |
| n25 | 84.2% | 91.4% |
| n26 | 89.9% | 87.4% |
| n27 | 86.6% | 90.6% |
| n28 | 92.2% | 91.3% |
| Formula 4 - Formula 28 | Sensitivity | Specificity |
| n4 | 91.5% | 92.2% |
| n5 | 90.7% | 85.7% |
| n6 | 89.8% | 92.5% |
| n7 | 90.3% | 91.4% |
| n8 | 86.6% | 91.3% |
| n9 | 86.1% | 88.6% |
| n10 | 89.1% | 92.7% |
| n11 | 88.3% | 90.4% |
| n12 | 90.2% | 92.4% |
| n13 | 87.8% | 85.1% |
| n14 | 90.1% | 87.5% |
| n15 | 91.9% | 88.5% |
| n16 | 89.6% | 89.9% |
| n17 | 90.6% | 90.3% |
| n18 | 86.5% | 87.2% |
| n19 | 84.1% | 86.8% |
| n20 | 86.2% | 85.4% |
| n21 | 91.1% | 90.9% |
| n22 | 93.4% | 92.5% |
| n23 | 86.1% | 84.9% |
| n24 | 93.2% | 88.7% |
| n25 | 84.2% | 91.4% |
| n26 | 89.9% | 87.4% |
| n27 | 86.6% | 90.6% |
| n28 | 92.2% | 91.3% |
以上所述，仅为本发明的较佳实施例，并非对本发明任何形式上和实质上的限制，应当指出，对于本技术领域的普通技术人员，在不脱离本发明的前提下，还将可以做出若干改进和补充，这些改进和补充也应视为本发明的保护范围。凡熟悉本专业的技术人员，在不脱离本发明的精神和范围的情况下，当可利用以上所揭示的技术内容而做出的些许更动、修饰与演变的等同变化，均为本发明的等效实施例；同时，凡依据本发明的实质技术对上述实施例所作的任何等同变化的更动、修饰与演变，均仍属于本发明的技术方案的范围内。The above is only a preferred embodiment of the present invention, and is not any formal or substantial limitation of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the present invention, and these improvements and supplements should also be regarded as the protection scope of the present invention. Any technician familiar with this profession, without departing from the spirit and scope of the present invention, can make some changes, modifications and equivalent changes made by using the technical content disclosed above, which are equivalent embodiments of the present invention; at the same time, any changes, modifications and evolutions of any equivalent changes made to the above embodiments based on the essential technology of the present invention are still within the scope of the technical solution of the present invention.
Claims (14)
- 一种基于体液检测慢性病的装置，其特征在于，包括体液检测流体通道、检测探头、数据处理模块和数据显示模块；体液检测流体通道中设有检测探头，检测探头与数据处理模块连接，数据处理模块与数据显示模块连接；所述体液检测流体通道包括检测体液离子，细胞因子，核酸，蛋白及其衍生物或微量元素通道、检测氧可溶性气体含量通道、检测体液pH通道、检测体液粘滞度流体力学特性通道、检测白细胞和肿瘤细胞包括渗透压在内的物理特性检测通道、检测白细胞和肿瘤细胞包括电阻抗，电荷在内的电学表征通道、检测红细胞包括渗透压在内的物理特性检测通道、检测红细胞包括电阻抗，电荷在内的电学表征通道、检测分离后的体液包括电阻抗、电荷在内的电学表征通道和检测包括凝血因子、纤维蛋白原、D-二聚体、血小板等在内的凝血、抗凝和纤溶功能检测通道。A device for detecting chronic diseases based on body fluids, characterized in that it includes a body fluid detection fluid channel, a detection probe, a data processing module and a data display module; a detection probe is provided in the body fluid detection fluid channel, the detection probe is connected to the data processing module, and the data processing module is connected to the data display module; the body fluid detection fluid channel includes a channel for detecting body fluid ions, cytokines, nucleic acids, proteins and their derivatives or trace elements, a channel for detecting oxygen soluble gas content, a channel for detecting body fluid pH, a channel for detecting body fluid viscosity fluid mechanics properties, a channel for detecting physical properties of white blood cells and tumor cells including osmotic pressure, a channel for detecting electrical characterization of white blood cells and tumor cells including electrical impedance and charge, a channel for detecting physical properties of red blood cells including osmotic pressure, a channel for detecting electrical characterization of red blood cells including electrical impedance and charge, a channel for detecting electrical characterization of separated body fluids including electrical impedance and charge, and a channel for detecting coagulation, anticoagulation and fibrinolytic functions including coagulation factors, fibrinogen, D-dimer, platelets, etc.
- 根据权利要求1所述的一种基于体液检测慢性病的装置，其特征在于，所述装置中设有体液入口，与体液入口连通分别设有检测体液离子，细胞因子，核酸，蛋白及其衍生物或微量元素通道、检测体液pH通道、检测氧可溶性气体含量通道、检测体液粘滞度流体力学特性通道和体液细胞分离通道。According to claim 1, a device for detecting chronic diseases based on body fluids is characterized in that a body fluid inlet is provided in the device, and channels for detecting body fluid ions, cytokines, nucleic acids, proteins and their derivatives or trace elements, a channel for detecting body fluid pH, a channel for detecting oxygen soluble gas content, a channel for detecting body fluid viscosity and fluid mechanics properties, and a body fluid cell separation channel are respectively provided in communication with the body fluid inlet.
- 根据权利要求2所述的一种基于体液检测慢性病的装置，其特征在于，所述装置中设有细胞分离微流控通道，细胞分离微流控通道的一端与体液细胞分离通道连通，细胞分离微流控通道的另一端设有分离的白细胞和肿瘤细胞通道、分离的红细胞通道和分离后的体液通道。According to claim 2, a device for detecting chronic diseases based on body fluids is characterized in that a cell separation microfluidic channel is provided in the device, one end of the cell separation microfluidic channel is connected to the body fluid cell separation channel, and the other end of the cell separation microfluidic channel is provided with a separated white blood cell and tumor cell channel, a separated red blood cell channel and a separated body fluid channel.
- 根据权利要求3所述的一种基于体液检测慢性病的装置，其特征在于，所述分离的白细胞和肿瘤细胞通道分别与检测白细胞和肿瘤细胞包括渗透压在内的物理特性检测通道以及检测白细胞和肿瘤细胞包括电阻抗、电荷在内的电学表征通道连通。According to claim 3, a device for detecting chronic diseases based on body fluids is characterized in that the separated white blood cell and tumor cell channels are respectively connected to a physical property detection channel for detecting white blood cells and tumor cells including osmotic pressure and an electrical characterization channel for detecting white blood cells and tumor cells including electrical impedance and charge.
- 根据权利要求4所述的一种基于体液检测慢性病的装置，其特征在于，所述分离的红细胞通道分别与检测红细胞包括渗透压在内的物理特性检测通道和检测红细胞包括电阻抗、电荷在内的电学表征通道连通。According to the device for detecting chronic diseases based on body fluids according to claim 4, it is characterized in that the separated red blood cell channel is respectively connected to a channel for detecting physical properties of red blood cells including osmotic pressure and a channel for detecting electrical characterization of red blood cells including electrical impedance and charge.
- 根据权利要求5所述的一种基于体液检测慢性病的装置，其特征在于，所述分离后的体液通道分别与检测包括凝血因子、纤维蛋白原、D-二聚体、血小板在内的凝血、抗凝和纤溶功能检测通道以及检测分离后的体液包括电阻抗、电荷在内的电学表征通道连通；所述的检测包括凝血因子、纤维蛋白原、D-二聚体、血小板在内的凝血、抗凝和纤溶功能检测检测通道上还设有用于添加凝血因子的凝血因子通道。According to claim 5, a device for detecting chronic diseases based on body fluids is characterized in that the separated body fluid channel is respectively connected to a detection channel for detecting coagulation, anticoagulation and fibrinolysis functions including coagulation factors, fibrinogen, D-dimer and platelets, and a channel for detecting electrical characterization of the separated body fluid including electrical impedance and charge; the detection channel for detecting coagulation, anticoagulation and fibrinolysis functions including coagulation factors, fibrinogen, D-dimer and platelets is also provided with a coagulation factor channel for adding coagulation factors.
- 根据权利要求1至6中任一项所述的一种基于体液检测慢性病的装置获得的检测数据用于检测慢性病的处理方法，其特征在于，包括以下步骤：A method for detecting chronic diseases using detection data obtained by a device for detecting chronic diseases based on body fluids according to any one of claims 1 to 6, characterized in that it comprises the following steps:步骤1：根据公式1，n1=3.73v+6.38SpO 2+6.29ph+6.4η+3.51π1+1.75Ze1+3.64π2+5.19Ze2+9.09t+8.74Ze3+6.58v1+4.95v2，计算n1值； Step 1: According to formula 1 , n1=3.73v+6.38SpO2+6.29ph+6.4η+3.51π1+1.75Ze1+3.64π2+5.19Ze2+9.09t+8.74Ze3+6.58v1+4.95v2, calculate the value of n1;其中，v为体液离子浓度、SpO 2为氧含量、ph为体液pH值、η为体液粘滞度值、π1为白细胞和循环肿瘤细胞渗透压值、π2为红细胞渗透压值、Ze1为白细胞和肿瘤细胞电阻抗值、Ze2为红细胞电阻抗值、Ze3为分离后的体液电阻抗值、t为凝血时间、v1是分离后的体液中D-二聚体浓度、v2是分离后的体液中纤维蛋白原降解产物浓度； Wherein, v is the body fluid ion concentration, SpO2 is the oxygen content, ph is the body fluid pH value, η is the body fluid viscosity value, π1 is the osmotic pressure value of white blood cells and circulating tumor cells, π2 is the osmotic pressure value of red blood cells, Ze1 is the electrical impedance value of white blood cells and tumor cells, Ze2 is the electrical impedance value of red blood cells, Ze3 is the electrical impedance value of body fluid after separation, t is the coagulation time, v1 is the D-dimer concentration in the body fluid after separation, and v2 is the concentration of fibrinogen degradation products in the body fluid after separation;步骤2：依据n1值评估被测者患慢性病的风险，如果n1值在105以下，为低风险；如果n1值在105-135为中风险；如果n1值在135以上属于高风险人群，数值越高则风险越大。Step 2: Assess the risk of chronic diseases based on the n1 value. If the n1 value is below 105, it is low risk; if the n1 value is between 105-135, it is medium risk; if the n1 value is above 135, it belongs to the high-risk group. The higher the value, the greater the risk.
- 根据权利要求7所述的方法，其特征在于，所述慢性病包括肿瘤。The method according to claim 7, characterized in that the chronic disease includes a tumor.
- 根据权利要求1所述的一种基于体液检测慢性病的装置，其特征在于，所述细胞因子为缺氧诱导因子1α和/或缺氧诱导因子1β。The device for detecting chronic diseases based on body fluids according to claim 1, characterized in that the cytokine is hypoxia-inducible factor 1α and/or hypoxia-inducible factor 1β.
- 根据权利要求9所述的一种基于体液检测慢性病的装置获得的检测数据用于检测慢性病的处理方法，其特征在于，包括以下步骤：The method for detecting chronic diseases using detection data obtained by a device for detecting chronic diseases based on body fluids according to claim 9 is characterized in that it comprises the following steps:步骤1：根据公式2，n2=5.69H1+7.32H2+3.73v+6.38SpO 2+6.29ph+6.4η+3.51π1+1.75 Ze1+3.64π2+5.19 Ze2+9.09 t+8.55Ze3+4.72v1+6.94v2，计算n2值； Step 1: According to formula 2, n2=5.69H1+7.32H2+3.73v+6.38SpO2+6.29ph+6.4η+3.51π1+1.75 Ze1+3.64π2+5.19 Ze2+9.09 t +8.55Ze3+4.72v1+6.94v2, calculate the value of n2;其中H1为缺氧诱导因子1α浓度、H2为缺氧诱导因子1β浓度、v为体液离子浓度、SpO 2为氧含量、ph为体液pH值、η为体液粘滞度值、π1为白细胞和肿瘤细胞渗透压值、π2为红细胞渗透压值、Ze1为白细胞和肿瘤细胞电阻抗值、Ze2为红细胞电阻抗值、Ze3为分离后的体液电阻抗值、t为凝血时间、v1是分离后的体液中D-二聚体浓度、v2是分离后的体液中纤维蛋白原降解产物浓度； Wherein, H1 is the concentration of hypoxia-inducible factor 1α, H2 is the concentration of hypoxia-inducible factor 1β, v is the body fluid ion concentration, SpO 2 is the oxygen content, ph is the body fluid pH value, η is the body fluid viscosity value, π1 is the osmotic pressure value of white blood cells and tumor cells, π2 is the osmotic pressure value of red blood cells, Ze1 is the electrical impedance value of white blood cells and tumor cells, Ze2 is the electrical impedance value of red blood cells, Ze3 is the electrical impedance value of body fluid after separation, t is the coagulation time, v1 is the D-dimer concentration in the body fluid after separation, and v2 is the concentration of fibrinogen degradation products in the body fluid after separation;步骤2：依据n2值评估被测者患慢性病的风险，如果n2值在120以下为低风险，n2值在120-150为中风险，n2值在150以上属于高风险人群，数值越高风险越大。Step 2: Assess the risk of chronic diseases based on the n2 value. If the n2 value is below 120, it is low risk; if the n2 value is 120-150, it is medium risk; if the n2 value is above 150, it belongs to the high-risk group. The higher the value, the greater the risk.
- 根据权利要求1所述的一种基于体液检测慢性病的装置，其特征在于，所述检测体液pH通道中还设有用于检测通道内体液的电阻抗、电荷在内的物理性质的检测探头。According to the device for detecting chronic diseases based on body fluids as described in claim 1, it is characterized in that the body fluid pH detection channel is also provided with a detection probe for detecting physical properties including electrical impedance and charge of the body fluid in the channel.
- 根据权利要求11所述的一种基于体液检测慢性病的装置获得的检测数据用于检测慢性病的处理方法，其特征在于，包括以下步骤：The method for detecting chronic diseases using detection data obtained by a device for detecting chronic diseases based on body fluids according to claim 11 is characterized in that it comprises the following steps:步骤1：根据公式3，n3=Ze4，计算n3值；其中Ze4是体液细胞分离前的体液整体电阻抗值；Ze4值由检测体液pH通道中设有的检测探头获得；Step 1: According to formula 3, n3=Ze4, calculate the n3 value; wherein Ze4 is the overall electrical impedance value of the body fluid before the body fluid cell separation; the Ze4 value is obtained by the detection probe provided in the body fluid pH detection channel;步骤2：依据n3值评估被测者患慢性病的风险，如果n3值在10以下为低风险，n3值在10-14为中风险，n3值在14以上属于高风险人群；n3值的数值越高风险越大；慢性病亚临床期、临床期，n3值呈现梯度升高，数值升高，提示患者应去医院，结合自身病史，做进一步检查。Step 2: Assess the risk of chronic diseases based on the n3 value. If the n3 value is below 10, it is low risk; if the n3 value is 10-14, it is medium risk; if the n3 value is above 14, it belongs to the high-risk group; the higher the n3 value, the greater the risk; in the subclinical and clinical stages of chronic diseases, the n3 value increases gradually, and the increase in the value indicates that the patient should go to the hospital for further examination based on his or her medical history.
- 根据权利要求11所述的一种基于体液检测慢性病的装置，其特征在于，所述检测体液pH通道中设有的用于检测通道内体液的电阻抗、电荷在内的物理性质的检测探头包括分别检测体液细胞部分电阻抗值Ze5的检测探头和检测体液整体电阻抗值Ze4的检测探头。According to a device for detecting chronic diseases based on body fluids as described in claim 11, it is characterized in that the detection probes provided in the body fluid pH channel for detecting the physical properties of the body fluid in the channel, including the electrical impedance and charge, include detection probes for respectively detecting the electrical impedance value Ze5 of the cell part of the body fluid and the detection probes for detecting the overall electrical impedance value Ze4 of the body fluid.
- 根据权利要求13所述的一种基于体液检测慢性病的装置获得的检测数据用于检测慢性病的处理方法，其特征在于，包括以下步骤：The method for detecting chronic diseases using detection data obtained by a device for detecting chronic diseases based on body fluids according to claim 13 is characterized in that it comprises the following steps:步骤1：获得体液整体电阻抗值Ze4、体液细胞部分电阻抗值Ze5和分离后的体液电阻抗值Ze3；Step 1: Obtain the body fluid overall electrical impedance value Ze4, the body fluid cell portion electrical impedance value Ze5 and the separated body fluid electrical impedance value Ze3;步骤2：根据公式4，n4=1.73Ze4+1.89Ze3+1.36Ze5，计算n4值；用于评价被检测者患有乳腺癌的风险；Step 2: According to formula 4, n4=1.73Ze4+1.89Ze3+1.36Ze5, calculate the n4 value; used to evaluate the risk of breast cancer in the tested person;或，根据公式5，n5=1.79Ze4+1.85Ze3+1.73Ze5，计算n5值；用于评价被检测者患有前列腺癌的风险；Or, according to formula 5, n5=1.79Ze4+1.85Ze3+1.73Ze5, calculate the n5 value; used to evaluate the risk of the subject suffering from prostate cancer;或，根据公式6，n6=1.64Ze4+1.58Ze3+1.56Ze5，计算n6值；用于评价被检测者患有结直肠癌的风险；Or, according to formula 6, n6=1.64Ze4+1.58Ze3+1.56Ze5, the n6 value is calculated; it is used to evaluate the risk of the subject suffering from colorectal cancer;或，根据公式7，n7=1.67Ze4+1.88Ze3+1.49Ze5，计算n7值；用于评价被检测者患有胃癌的风险；Or, according to formula 7, n7=1.67Ze4+1.88Ze3+1.49Ze5, calculate the n7 value; used to evaluate the risk of gastric cancer in the subject;或，根据公式8，n8=1.85Ze4+1.48Ze3+1.61Ze5，计算n8值；用于评价被检测者患有肝癌的风险；Or, according to formula 8, n8=1.85Ze4+1.48Ze3+1.61Ze5, calculate the n8 value; used to evaluate the risk of the subject suffering from liver cancer;或，根据公式9，n9=1.59Ze4+1.86Ze3+1.47Ze5，计算n9值；用于评价被检测者患有甲状腺癌的风险；Or, according to formula 9, n9=1.59Ze4+1.86Ze3+1.47Ze5, calculate the n9 value; used to evaluate the risk of thyroid cancer in the subject;或，根据公式10，n10=1.56Ze4+1.47Ze3+1.41Ze5，计算n10值；用于评价被检测者患有胰腺癌的风险；Or, according to formula 10, n10=1.56Ze4+1.47Ze3+1.41Ze5, the n10 value is calculated; it is used to evaluate the risk of the subject suffering from pancreatic cancer;或，根据公式11，n11=1.37Ze4+1.93Ze3+1.52Ze5，计算n11值；用于评价被检测者患有白血病的风险；Or, according to formula 11, n11=1.37Ze4+1.93Ze3+1.52Ze5, calculate the n11 value; used to evaluate the risk of the subject suffering from leukemia;或，根据公式12，n12=1.86Ze4+1.82Ze3+1.44Ze5，计算n12值；用于评价被检测者患有肾癌的风险；Or, according to formula 12, n12=1.86Ze4+1.82Ze3+1.44Ze5, the n12 value is calculated; it is used to evaluate the risk of the subject suffering from kidney cancer;或，根据公式13，n13=1.72Ze4+1.52Ze3+1.85Ze5，计算n13值；用于评价被检测者患有子宫肌瘤的风险；Or, according to formula 13, n13=1.72Ze4+1.52Ze3+1.85Ze5, calculate the n13 value; used to evaluate the risk of the subject suffering from uterine fibroids;或，根据公式14，n14=1.35Ze4+1.57Ze3+1.69Ze5，计算n14值；用于评价被检测者患有口腔癌的风险；Or, according to formula 14, n14=1.35Ze4+1.57Ze3+1.69Ze5, calculate the n14 value; used to evaluate the risk of the subject suffering from oral cancer;或，根据公式15，n15=1.69Ze4+1.55Ze3+1.42Ze5，计算n15值；用于评价被检测者患有卵巢癌的风险；Or, according to formula 15, n15=1.69Ze4+1.55Ze3+1.42Ze5, calculate the n15 value; used to evaluate the risk of the subject suffering from ovarian cancer;或，根据公式16，n16=1.74Ze4+1.69Ze3+1.63Ze5，计算n16值；用于评价被检测者患有脑癌的风险；Or, according to formula 16, n16=1.74Ze4+1.69Ze3+1.63Ze5, calculate the n16 value; used to evaluate the risk of the subject suffering from brain cancer;或，根据公式17，n17=1.63Ze4+1.77Ze3+1.78Ze5，计算n17值；用于评价被检测者患有鼻癌的风险；Or, according to formula 17, n17=1.63Ze4+1.77Ze3+1.78Ze5, the n17 value is calculated; used to evaluate the risk of the subject suffering from nasal cancer;或，根据公式18，n18=1.62Ze4+1.67Ze3+1.96Ze5，计算n18值；用于评价被检测者患有咽喉癌的风险；Or, according to formula 18, n18=1.62Ze4+1.67Ze3+1.96Ze5, calculate the n18 value; used to evaluate the risk of the subject suffering from laryngeal cancer;或，根据公式19，n19=1.64Ze4+1.68Ze3+1.71Ze5，计算n19值；用于评价被检测者患有食管癌的风险；Or, according to formula 19, n19=1.64Ze4+1.68Ze3+1.71Ze5, the n19 value is calculated; it is used to evaluate the risk of esophageal cancer in the subject;或，根据公式20，n20=1.56Ze4+1.73Ze3+1.58Ze5，计算n20值；用于评价被检测者患有贲门癌的风险；Or, according to formula 20, n20=1.56Ze4+1.73Ze3+1.58Ze5, the n20 value is calculated; it is used to evaluate the risk of the subject suffering from cardiac cancer;或，根据公式21，n21=1.74Ze4+1.98Ze3+1.89Ze5，计算n21值；用于评价被检测者患有胆管癌的风险；Or, according to formula 21, n21=1.74Ze4+1.98Ze3+1.89Ze5, calculate the n21 value; used to evaluate the risk of bile duct cancer in the tested person;或，根据公式22，n22=1.55Ze4+1.85Ze3+1.91Ze5，计算n22值；用于评价被检测者患有膀胱癌的风险；Or, according to formula 22, n22=1.55Ze4+1.85Ze3+1.91Ze5, the n22 value is calculated; used to evaluate the risk of the subject suffering from bladder cancer;或，根据公式23，n23=1.88Ze4+1.61Ze3+1.84Ze5，计算n23值；用于评价被检测者患有淋巴癌的风险；Or, according to formula 23, n23=1.88Ze4+1.61Ze3+1.84Ze5, calculate the n23 value; used to evaluate the risk of the subject suffering from lymphoma;或，根据公式24，n24=1.75Ze4+1.82Ze3+1.86Ze5，计算n24值；用于评价被检测者患有皮肤癌的风险；Or, according to formula 24, n24=1.75Ze4+1.82Ze3+1.86Ze5, calculate the n24 value; used to evaluate the risk of the subject suffering from skin cancer;或，根据公式25，n25=1.91Ze4+1.66Ze3+1.57Ze5，计算n25值；用于评价被检测者患有骨癌的风险；Or, according to formula 25, n25=1.91Ze4+1.66Ze3+1.57Ze5, calculate the n25 value; used to evaluate the risk of bone cancer in the subject;或，根据公式26，n26=1.87Ze4+1.78Ze3+1.72Ze5，计算n26值；用于评价被检测者患有睾丸癌的风险；Or, according to formula 26, n26=1.87Ze4+1.78Ze3+1.72Ze5, calculate the n26 value; used to evaluate the risk of the subject suffering from testicular cancer;或，根据公式27，n27=1.53Ze4+1.96Ze3+1.83Ze5，计算n27值；用于评价被检测者患有胆囊癌的风险；Or, according to formula 27, n27=1.53Ze4+1.96Ze3+1.83Ze5, calculate the n27 value; used to evaluate the risk of the subject suffering from gallbladder cancer;或，根据公式28，n28=1.69Ze4+1.83Ze3+1.56Ze5，计算n28值；用于评价被检测者患有肺癌的风险；Or, according to formula 28, n28=1.69Ze4+1.83Ze3+1.56Ze5, calculate the n28 value; used to evaluate the risk of lung cancer in the tested person;步骤3：依据上述步骤2中n4至n28的值评估被测者患相对应的癌症的风险，如果n4至n28的值超过60，则表示有患该值相对应的癌的高风险，需进行进一步的临床检查。Step 3: Based on the values of n4 to n28 in step 2 above, assess the risk of the subject developing the corresponding cancer. If the value of n4 to n28 exceeds 60, it indicates a high risk of developing the cancer corresponding to the value and further clinical examination is required.
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| CN116068156A (en) * | 2022-10-21 | 2023-05-05 | 徐畅 | Device for detecting chronic diseases based on body fluid |
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