CN110441516A - Diabetes early stage non-invasive detection system and method based on urinary biomarkers object - Google Patents
Diabetes early stage non-invasive detection system and method based on urinary biomarkers object Download PDFInfo
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- CN110441516A CN110441516A CN201810422960.5A CN201810422960A CN110441516A CN 110441516 A CN110441516 A CN 110441516A CN 201810422960 A CN201810422960 A CN 201810422960A CN 110441516 A CN110441516 A CN 110441516A
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Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/27—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration
-
- 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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54366—Apparatus specially adapted for solid-phase testing
- G01N33/54386—Analytical elements
- G01N33/54387—Immunochromatographic test strips
-
- 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
- G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
-
- 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
- G01N33/70—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving creatine or creatinine
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/04—Endocrine or metabolic disorders
- G01N2800/042—Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Hematology (AREA)
- Chemical & Material Sciences (AREA)
- Urology & Nephrology (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Pathology (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Cell Biology (AREA)
- Microbiology (AREA)
- Medicinal Chemistry (AREA)
- Biotechnology (AREA)
- Food Science & Technology (AREA)
- Diabetes (AREA)
- Mathematical Physics (AREA)
- Theoretical Computer Science (AREA)
- Spectroscopy & Molecular Physics (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention discloses a kind of diabetes early stage non-invasive detection systems and method based on urinary biomarkers object, which includes: transmitting module, for emitting the incident light spectrum of predetermined wavelength；Detection module, for being reacted by test strips with glucose in urine, urine creatinine and/or the urine cysteine proteinase inhibitor C in urine sample and receiving incident light spectrum；Spectrum acquisition module for receiving spectrum or fluorescence signal after passing through test strips and decaying, and is converted to analog electrical signal；Signal conversion module, connect with spectrum acquisition module, and analog electrical signal is converted into digital signal；Data processing module is connect with signal conversion module, and the magnitude of the biomarker in urine sample is calculated according to digital signal；Output module is connect with data processing module, for exporting magnitude.The systematic quantification detects the multiple markers of diabetes and its complication, improves detection accuracy and sensitivity, reduces interference, really reflects urine sugar concentrations, Simultaneous Monitoring diabetes and its complication.
Description
Technical field
The present invention relates to the field of medical instrument technology more particularly to a kind of diabetes early stages based on urinary biomarkers object
Non-invasive detection system and method.
Background technique
With the rapid development of the national economy, the raising of living standards of the people, the obese people in China is also stepped up；It removes
Population of being obese quicklys increase, and the growth of the aged also promotes the growth of people with diabetes.According to statistics, China at present
Diabetic is up to 1.2 hundred million people, and diabetic's number in China will break through 200,000,000 in coming 10 years.Meanwhile if diabetes
Patient blood glucose controls shakiness, will lead to various complication, such as diabetes and cardiovascular disease, diabetic eye diseases, diabetic nephropathy, sugar
Urinate sick neurogenic disease etc..Wherein, diabetic nephropathy is one of diabetes most serious and most important chronic microvascular complication.
According to statistics, 30%~40% diabetes B people would develop into diabetic nephropathy, and 20%~40% type 1 diabetes patient exists
It also would develop into diabetic nephropathy after 15~30 years, more and more societies and financial burden can be brought to China.
Currently, diabetes mainly carry out Newly diagnosed by monitoring empty stomach or postprandial blood sugar.However, it is current medical and
Home-use blood glucose measurement is mainly based upon invasive mode and carries out, and is unfavorable for carrying out screening for diabetes to a wide range of crowd, cause mostly
Number people has suffered from diabetes and has not still known completely, and various complication has occurred until discovery.Meanwhile diabetic in order to avoid
Diabetic complication needs continually to measure and control blood sugar concentration.Frequent blood sampling carries out the measurement of blood glucose concentration,
On the one hand huge financial burden and medical expense are brought to diabetic, is on the other hand also brought to diabetic
Huge body and mental anguish and the risk for increasing infectious disease.And the noninvasive Tes-Tape generallyd use in the market, due to
Measurement accuracy is limited, false negative, false positive usually occurs, is unable to large-scale promotion.In order to cope with above-mentioned situation, there is an urgent need to one
Kind diabetes and its complication (diabetic nephropathy) non-invasive detection system.
Summary of the invention
The present invention provides a kind of diabetes early stage non-invasive detection system and method based on urinary biomarkers object, Neng Gouding
The multiple markers of diabetes and its complication in amount detection urine, improve detection accuracy and sensitivity, it is dense to reduce glucose in urine
Degree is really reflected urine sugar concentrations, Simultaneous Monitoring diabetes and its complication by the interference of extraneous factor.
The present invention provides a kind of diabetes early stage non-invasive detection system based on urinary biomarkers object, comprising:
Transmitting module, for emitting the incident light spectrum of predetermined wavelength；
Detection module, for passing through glucose in urine, urine creatinine and/or the urine cysteine proteinase in test strips and urine sample
Inhibitor C reacts and receives the incident light spectrum, and the test strips of the detection glucose in urine are dry chemical test strips, including from up to
Under the urine diffusion layer, filter layer, hydrophilic layer and the reagent layer that set gradually, wherein have on the reagent layer glucose oxidase,
The test strips of peroxidase, potassium iodide and polyethylene pyrrole network alkanone, the detection urine creatinine are dry chemical test strips, including
Urine diffusion layer, filter layer, hydrophilic layer and the reagent layer set gradually from top to bottom, wherein have on the reagent layer copper sulphate,
Sodium citrate, orange, polyvinylpyrrolidone and tetramethyl benzidine, the detection urine cysteine proteinase inhibitor C
Test strips are dry chemical test strips, including successively overlapped sample pad, nitrocellulose filter and water absorption pad, wherein the nitric acid
There are detection line and nature controlling line on cellulose membrane, the antibody of anti-cysteine proteinase inhibitor C, institute are coated in the detection line
It states and is coated with IgG antibody on nature controlling line；
Spectrum acquisition module for receiving spectrum or fluorescence signal after passing through test strips and decaying, and is converted to simulation
Electric signal；
Signal conversion module, connect with spectrum acquisition module, and analog electrical signal is converted into digital signal；
Data processing module is connect with signal conversion module, and glucose in urine, urine in urine sample are calculated according to digital signal
Creatinine, the concentration value for urinating cysteine proteinase inhibitor C and glucose in urine/urine creatinine ratio and/or urine cysteine proteinase
Inhibitor C/urine creatinine ratio；
Output module is connect with data processing module, for exporting concentration value and/or ratio.
Preferably, urine sample is taken from subject in postprandial 0.5~2.5h drained of urine, and in postprandial 2~4.5h
Urine.
Preferably, transmitting module includes spectral emissions circuit and emission power circuit；Spectrum acquisition module includes that spectrum connects
It receives circuit and receives power circuit.
Preferably, data processing module includes microprocessor (MCU) and its peripheral circuit.
Preferably, output module includes human-computer interaction module and data communication module；Human-computer interaction module, for realizing people
Machine interaction, shows the concentration value and/or ratio of output；Data communication module, for realizing remote information communication function, by concentration
Value and/or ratio are transmitted to remote data storage, analysis platform.
The present invention also provides the non-invasive detection methods of a kind of nondiagnostic diabetes and its complication, comprising:
Urine is added dropwise to test strips reacting hole in detection module, glucose in urine, urine creatinine and half Guang ammonia of urine in test strips and urine
The reaction of pepsin inhibitor C；
Incident light spectrum of the transmitting module to the test strips transmitting predetermined wavelength after reaction；
Spectrum acquisition module receives the spectrum or fluorescence signal after passing through test strips and decaying, and is converted to analog telecommunications
Number；
Analog electrical signal is converted into digital signal by signal conversion module；
Data processing module calculates glucose in urine, urine creatinine, urine cysteine protein in urine sample according to digital signal
Concentration value and glucose in urine/the urine creatinine ratio and/or urine cysteine proteinase inhibitor C/urine creatinine ratio of enzyme inhibitor C；
Output module exports concentration value and/or ratio.
Preferably, before urine is added dropwise to test strips reacting hole in detection module further include: obtain subject postprandial 0.5~
2.5h drained of urine and the urine taken in postprandial 2~4.5h.
The present invention, which has the following technical effect that, introduces urine creatinine as reference, is accurately reflected by glucose in urine/urine creatinine ratio
The concentration of random glucose in urine, can exclude influence of the external interference factor to urine sugar concentrations in urine；Introduce renal functional evaluation index urine
Cysteine proteinase inhibitor C causes glucose in urine test result false positive or false yin occur for excluding due to kidney injury
Property, and renal function is evaluated by urine cysteine proteinase inhibitor C, diabetic nephropathy complication can be monitored in early stage,
Realize the Simultaneous Monitoring of diabetes and its complication, therefore quantitative measurment may be implemented in the present invention, accuracy and sensitivity are compared
Existing Tes-Tape is higher.
Detailed description of the invention
Fig. 1 is the diabetes early stage non-invasive detection system based on urinary biomarkers object in another embodiment of the present invention
Tactic pattern figure；
Fig. 2 is the flow chart of the diabetes early stage non-invasive detection methods in one embodiment of the invention；
Fig. 3 is in the diabetes early stage non-invasive detection system based on urinary biomarkers object in one embodiment of the invention
The test strip structural schematic diagram of glucose in urine and urine creatinine；
Fig. 4 is in the diabetes early stage non-invasive detection system based on urinary biomarkers object in one embodiment of the invention
Urinate the test strip structural schematic diagram of cysteine proteinase inhibitor C.
Specific embodiment
Below by specific embodiment combination attached drawing, invention is further described in detail.
Referring to FIG. 1, the diabetes early stage Non-invasive detection based on urinary biomarkers object in one embodiment of the invention
System includes: transmitting module 10, for emitting the incident light spectrum of predetermined wavelength；Detection module 20, for passing through test strips and urine
Glucose in urine, urine creatinine and/or urine cysteine proteinase inhibitor C in liquid sample react and receive incident light spectrum；Spectrum acquisition
Module 30 for receiving spectrum or fluorescence signal after passing through test strips and decaying, and is converted to analog electrical signal；Signal conversion
Module 40 connect with spectrum acquisition module 30, converts the electrical signal to digital signal；Data processing module 50 is converted with signal
Module 40 connects, and glucose in urine, urine creatinine, urine cysteine proteinase inhibitor C in urine sample are calculated according to digital signal
Concentration value and glucose in urine/urine creatinine ratio and/or urine cysteine proteinase inhibitor C/urine creatinine ratio；Output module
60, it is connect with data processing module 50, for exporting concentration value and/or ratio.
The diabetes early stage non-invasive detection system based on urinary biomarkers object of the present embodiment introduces urine creatinine as ginseng
Than.Its foundation is described as follows: for kidney in filtering blood impurity, glucose can pass freely through glomerulus, that is to say, that crude urine
Middle concentration of glucose is consistent with the concentration of glucose in blood, and during reabsorption, glucose is thin by renal tubular epithelial
Born of the same parents' reabsorption.When blood sugar concentration is more than renal glucose threshold (8.96mmol/L-10.08mmol/L), renal cells are to glucose
Absorption reach capacity, glucose glycosuria cannot just occur by complete reabsorption blood back liquid.However, urine sugar concentrations are vulnerable to urine
The influence for measuring variation causes random glucose in urine concentration determination inaccurate.Everyone contains in urine creatinine of the unit time endocrine into urine
Amount be it is certain, the concentration variation of urine creatinine is directly influenced (such as moisture absorbs excessive) by external environment in urine, works as row
Washiness out, concentration of urinary creatinine reduce；When the moisture of discharge is less, concentration of urinary creatinine is increased.Pass through glucose in urine/urine creatinine ratio
Value can exclude because the interference of the factors to urine solution concentration such as moisture intake is excessive, accurate response urinate one of solution's solute-urine
The relative level of sugar.Wherein, glucose in urine/urine creatinine=(unit time glucose in urine content/amount of urine)/(unit time urine creatinine content/
Amount of urine) because in the unit time individual urine creatinine content be it is constant, urine can be excluded by glucose in urine/urine creatinine
The influence to glucose in urine is measured, the real-time glucose in urine content of urine is accurately reflected.
The diabetes early stage non-invasive detection system based on urinary biomarkers object of the present embodiment introduces renal functional evaluation and refers to
(specifically renal tubular function index) urine cysteine proteinase inhibitor C (Cystatin C) is marked, for excluding due to kidney
Damage, causes glucose in urine test result false positive or false negative occur.Meanwhile the kidney function of user is evaluated by Cystatin C
Can, it can be used for the generation of early detection diabetic nephropathy complication.Its foundation is described as follows: Cystatin C inorganization is special
Property, it is generated in human body cell with constant speed.Cystatin C level can reflect glomerular filtration rate in blood.In blood
Cystatin C can be with constant speed by glomerular basement membrane, into the Cystatin C in crude urine in Healthy People renal tubule
Place is by complete reabsorption.When renal tubule damages, Cystatin C presence is just had in urine.Largely research is pointed out, when
Kidney damages, and renal tubule can be also damaged simultaneously, influences reabsorption function.These researchs simultaneously are pointed out in urine
Cystatin C can be used as nephrosis (including diabetic nephropathy) early stage biomarker.
In more detail, transmitting module 10 includes spectral emissions circuit 11 and emission power circuit 12, in real time to generation
The light wave of test strips transmitting specific wavelength after reaction；Detection module 20, is detected by test strip, test strip
It is made of the thin slice of sensitive chemical ingredient, specifically anti-can be occurred with glucose in urine, urine creatinine and urine Cystatin C by containing on thin slice
Enzyme, substrate or antibody are answered, for reacting simultaneously with glucose in urine, urine creatinine and the urine cysteine proteinase inhibitor C in urine sample
Spectrum or fluorescence signal after decaying are issued after the irradiation of incident light spectrum；Spectrum acquisition module 30, including spectrum acquisition circuit
31 and power circuit 32 is received, for receiving the spectral signal of a wavelength range, when the examination that reacts of spectral signal irradiation
After paper slip, illumination spectra can occur to decay or issue fluorescence to a certain degree, calculate light loss rate or fluorescence intensity, and by reflected light
Spectrum or fluorescence signal are converted to electric signal；Signal conversion module 40 is connect with spectrum acquisition module 30, by glucose in urine, urine in urine
Creatinine, the urine concentration dependent electric signal of Cystatin C is converted into microprocessor can identify and received digital signal；Data
Processing module 50 is connect with signal conversion module 40, including microprocessor (MCU) 51 and its peripheral circuit 52, by what is received
Glucose in urine, urine creatinine, urine Cystatin C information analyzed, calculated, finally obtain glucose in urine in surveyed urine specimen, urine creatinine,
Urinate the concentration value and glucose in urine/urine creatinine, urine Cystatin C/ urine creatinine ratio of Cystatin C；Output module 60, with data
Processing module 50 connects, including human-computer interaction module 61 and data communication module 62, wherein human-computer interaction module 61 further may be used
To include that MCU, LCM display circuit and keyboard input circuit for realizing human-computer interaction show the concentration value and ratio of output
Value, i.e., glucose in urine, urine creatinine, the concentration value for urinating Cystatin C and glucose in urine/urine creatinine, urine Cystatin C/ urinate flesh in urine
Acid anhydride ratio measurement data result；Data communication module 62 can further include MCU and data communicating circuit, for realizing long-range
Concentration value and ratio are transmitted to remote data storage, analysis platform by information communication function.
It should be noted that the module or circuit in the present invention are not limited to particular electrical circuit figure construction, because for real
Now the module or circuit of respective function, those skilled in the art can select according to current technology.
The present invention is based on the diabetes early stage non-invasive detection system of urinary biomarkers object detection urinary biomarkers objects
Method flow diagram is as shown in Figure 2, comprising the following steps: urine, test strips and urine is added dropwise to test strips reacting hole in S1. detection module
Glucose in urine, urine creatinine and urine cysteine proteinase inhibitor C reaction in liquid；S2. transmitting module is sent out to the test strips after reaction
Penetrate the incident light spectrum of predetermined wavelength；S3. spectrum acquisition module receives the spectrum after passing through the test strips and decaying or fluorescence is believed
Number, and be converted to analog electrical signal；S4. the analog electrical signal is converted into digital signal by signal conversion module；S5. at data
Reason module calculates glucose in urine, urine creatinine, urine cysteine proteinase in the urine sample according to the digital signal and inhibits
Concentration value and glucose in urine/the urine creatinine ratio and/or urine cysteine proteinase inhibitor C/urine creatinine ratio of agent C；S6. defeated
Module exports the concentration value and/or the ratio out.
It should be understood that the application range of the non-invasive detection methods of diabetes and its complication of the invention is not limited to
The system of specific configuration in the present invention.
Dry-type biochemical test strips in diabetes early stage non-invasive detection system based on urinary biomarkers object of the invention
As shown in Figure 3 and Figure 4.
1) detect glucose in urine and urine creatinine dry chemical test strips successively include from top to bottom upper layer baffle (not shown), in
Interbed and bottom bracket (not shown).Middle layer is successively arranged urine diffusion layer, filter layer, hydrophilic layer and reagent from top to bottom
Layer, wherein reagent layer can merge on hydrophilic layer.When the difference into two, upper layer baffle mutually independent holes (A and B in Fig. 3)
After urine specimen is added, urine specimen is uniformly spread in the urine diffusion layer of porous polyester fibrous material, passes through filter layer (glass
Glass tunica fibrosa) impurity is filtered, it reacts with the reagent in reagent layer, light absorption value variation, inspection is generated by test paper color change
Light loss is surveyed, the content of respective objects substance in urine is obtained.
Urine creatinine Test paper detection method: copper sulphate, sodium citrate, orange, polyvinylpyrrolidone and tetramethyl are utilized
Base benzidine prepares the reagent layer of urine creatinine Test paper, specifically the preparation method is as follows: reagent layer is first sufficiently submerged in A liquid
(buffer of Tris containing 2mol/L in 1000ml solution, copper sulphate 0.4g-2g, sodium citrate 2-5g, orange 2mg0-200mg are used
Pure water constant volume) after, then the reagent layer after drying is immersed B liquid (polyethylene by taking-up and the dry 15-30min at 70-100 DEG C
Pyrrolidones 10-20g, tetramethyl benzidine 3-5g, with chloroform constant volume), the dry 5-15min under the conditions of 70-100 DEG C.As general
After urine is added in test paper reacting hole, creatinine and copper sulphate generate complex compound, which can and tetramethyl orange with colour developing object
Base benzidine reacts colour developing.Creatine concentration existsIn range, test paper present from it is pale yellow to
The obvious color range of dark green level Four is that is, yellowish-light green-grass green-dark green.Spectrum analysis is carried out to reflected light by sensor (to use
Wave-length coverage 580-650nm), light loss is detected, the concentration of creatinine in urine is obtained.Specifically, the concentration of urine creatinine with react
Afterwards the shade of test strips be in correlation, i.e., with by test strips and decay after spectral intensity be in correlation, and then with turn
Analog electrical signal and digital signal after changing are in correlation, pass through the standard items urine creatinines of gradient concentrations a series of and corresponding number
Word signal strength can establish the standard curve relationship of concentration of urinary creatinine and digital signal, can calculate survey according to standard curve
The concentration of urine creatinine in the sample of examination.The understanding of those skilled in the art through the embodiment of the present invention, can pass through the prior art
Concentration of urinary creatinine value is calculated, this will not be repeated here.
Glucose in urine Test paper detection method: glucose oxidase (GOD), peroxidase, potassium iodide, polyethylene pyrrole are utilized
Network alkanone matches antidiuresis glucose sugar test paper.Specifically, peroxidase 1200U, glucose oxidase 1200U, potassium iodide are weighed
100mg, polyethylene pyrrole network alkanone 100mg, is settled to 100ml, reagent layer is impregnated in the solution, dry 30min.When by urine
After being added in test paper reacting hole, glucose in urine reacts with the glucose oxidase on test paper, remaining years gluconic acid and hydrogen peroxide；It is double
Oxygen water under the catalysis of catalase, releases oxygen radical [O :] again, and chromogenic reaction occurs for oxygen radical and substrate potassium iodide,
The free-iodine and polyethylene pyrrole network alkanone of generation form brown complex compound.Spectrum analysis is carried out to reflected light by sensor (to adopt
With wave-length coverage 550-750nm), light loss is detected, urine sugar concentrations in urine are obtained.Specifically, the concentration of glucose in urine with react after
The shade of test strips be in correlation, i.e., with by test strips and decay after spectral intensity be in correlation, and then with conversion
Analog electrical signal and digital signal afterwards is in correlation, is believed by a series of standard items glucose in urine of gradient concentrations with corresponding number
Number intensity can establish the standard curve relationship of urine sugar concentrations and digital signal, and the sample of test can be calculated according to standard curve
The concentration of glucose in urine in this.The understanding of those skilled in the art through the embodiment of the present invention can calculate urine by the prior art
Sugared concentration value, this will not be repeated here.
2) the dry type Immunofluorescence test paper strip of detection urine Cystatin C includes upper layer baffle (not shown), middle layer and bottom
Layer bracket (not shown).Wherein, middle layer is from left to right successively stained with sample pad (C in Fig. 4), nitrocellulose filter, water absorption pad
Three layers, as shown in figure 4, nitrocellulose filter is equipped with detection line (C1) and nature controlling line (C2), the coated specific antibody of detection line
For the monoclonal antibody of anti-Cystatin C, the coated specific antibody of nature controlling line is rabbit igg antibody.The platinum porphyrins mark individually packed
Remember that antibody is anti-microalbumin monoclonal antibody and anti-rabbit IgG antibody.Pass through detection line and matter on detection nitrocellulose filter
Line platinum porphyrins fluorescence intensity is controlled, the concentration of Cystatin C in urine specimen is calculated.
Urine Cystatin C Test paper detection method: the nitrocellulose filter of urine Cystatin C test strip is leaning on
The detection zone of nearly loading wells has detection line and nature controlling line respectively.The antibody of anti-Cystatin C, Quality Control are coated in detection line
Rabbit igg antibody is coated on line.Meanwhile anti-Cystatain C antibody and platinum porphin are marked comprising platinum porphyrins in platinum porphyrins marking fluid
Quinoline marks anti-rabbit IgG antibody.When detection, urine specimen and platinum porphyrins marking fluid are mixed in a certain proportion uniformly, platinum porphyrins are made
Target protein (Cystatin C) sufficiently combines in labelled antibody and urine, and loading wells then is added in mixed liquor, after 3 minutes,
By dry type Immunofluorescence test paper strip inserting instrument, sensor issues light wave (range is 400-420nm), reads detection line and Quality Control
The fluorescence intensity of line obtains the concentration of Cystatin C in urine according to fluorescence intensity.Specifically, the concentration of Cystatin C is urinated
With after reaction in test strips detection line fluorescence intensity be in correlation, and then with after conversion analog electrical signal and digital signal be in
Correlation, urinating Cystatin C by a series of standard items of gradient concentrations can establish urine with corresponding digital signal strength
The standard curve relationship of Cystatin C concentration and digital signal, can calculate in the sample of test according to standard curve and urinate
The concentration of Cystatin C.The understanding of those skilled in the art through the embodiment of the present invention, can be calculated by the prior art
Cystatin C concentration value is urinated, this will not be repeated here.
According to glucose in urine, urine creatinine, urine Cystatin C, glucose in urine/urine creatinine and the measured value for urinating Cystatin C/ urine creatinine
Judge: if 1) in urine urine sugar value or glucose in urine/urine creatinine value beyond normal range (NR) (normal range (NR) of glucose in urine is 0-20mg/
dL；Glucose in urine/urine creatinine normal range (NR) upper limit value is between 50-100mg/g), but be not detected urine Cystatin C, then judge by
Examination person has suffered from diabetes, but does not have complication appearance.Such application can be used for carrying out extensive primary dcreening operation patient of diabetes in crowd
Person because renal glucose threshold be it is certain, when measured using this method urine in have a certain amount of glucose when, illustrate that subject person exists
There is or will have the danger for suffering from diabetes to a certain extent；2) for having suffered from diabetic, if urine Cystatin C value exceeds
Normal range (NR) (< 0.15mg/dL), then illustrate that patient is susceptible to suffer from diabetic nephropathy；3) diabetic normal for renal function,
Reaction test paper (A, B in such as Fig. 3) measurement comprising detection glucose in urine, urine creatinine can be used, glucose in urine, glucose in urine/urine creatinine parameter can be with
Reflect blood glucose level in patients to a certain extent, the difficult to handle pain referred to of patient can be reduced to a certain extent.
The monitoring recommended method of diabetes early stage non-invasive detection system based on urinary biomarkers object of the invention is, right
In the extensive screening diabetic of crowd, it is preferable that subject takes in postprandial 0.5h-2.5h drained of urine, postprandial 2h-4.5h
Secondary urine measurement glucose in urine, urine creatinine, urine Cystatin C.For example, postprandial 3h acquires urine in postprandial 1.5h drained of urine, adopted
Urine sugar concentrations in the urine of collection have reacted the mean concentration of urine in postprandial 1.5h-3h, can more reflect that post-prandial blood blood glucose is (real
When) concentration；Complication (diabetic nephropathy), which occurs, to be predicted for diabetic, it is preferable that subject takes urina sanguinis mud-stream urine,
Measure glucose in urine, urine inosine, urine Cystatin C；For having suffered from diabetes, but do not occur the patient of complication, subject can be
In the metastable situation of blood glucose, urina sanguinis, postprandial urine, random urine detection glucose in urine, urine creatinine are taken, to a certain extent instead of measurement
Blood glucose.
Table 1 shows the case where 10 samples detected using system and method for the invention.
Table 1
Note: No. 1-8 is diabetic (glycosylated hemoglobin and postprandial blood sugar) in table, and 9 and No. 10 are normal control.Its
In, No. 6 patients have mild diabetes nephrosis (eGFR 87).It is detected by this method, it is found that No. 6 testers urinate Cystatin
C value is greater than normal range (NR), implies and suffers from diabetic nephropathy, is not suitable for glucose in urine/urine creatinine value prediction blood sugar concentration；Remaining is suffered from
Person is without kidney trouble；It is seen by glucose in urine/urine creatinine value, 1-5 and 7, No. 8 subject's glucose in urine/urine creatinines are higher than normal range (NR), imply
There are different degrees of diabetes.
The above content is specific embodiment is combined, further detailed description of the invention, and it cannot be said that this hair
Bright specific implementation is only limited to these instructions.For those of ordinary skill in the art to which the present invention belongs, it is not taking off
Under the premise of from present inventive concept, a number of simple deductions or replacements can also be made.
Claims (7)
1. a kind of diabetes early stage non-invasive detection system based on urinary biomarkers object, which is characterized in that the system comprises:
Transmitting module, for emitting the incident light spectrum of predetermined wavelength；
Detection module, for being inhibited by glucose in urine, urine creatinine and/or the urine cysteine proteinase in test strips and urine sample
Agent C reacts and receives the incident light spectrum, and the test strips of the detection glucose in urine are dry chemical test strips, including from top to bottom according to
Urine diffusion layer, filter layer, hydrophilic layer and the reagent layer of secondary setting, wherein having glucose oxidase, peroxide on the reagent layer
The test strips of compound enzyme, potassium iodide and polyethylene pyrrole network alkanone, the detection urine creatinine are dry chemical test strips, including from upper
Urine diffusion layer, filter layer, hydrophilic layer and the reagent layer set gradually under, wherein having copper sulphate, lemon on the reagent layer
Sour sodium, orange, polyvinylpyrrolidone and tetramethyl benzidine, the test paper of the detection urine cysteine proteinase inhibitor C
Item is dry chemical test strips, including successively overlapped sample pad, nitrocellulose filter and water absorption pad, wherein the cellulose nitrate
There are detection line and nature controlling line on plain film, the antibody of anti-cysteine proteinase inhibitor C, the matter are coated in the detection line
IgG antibody is coated on control line；
Spectrum acquisition module for receiving spectrum or fluorescence signal after passing through the test strips and decaying, and is converted to simulation
Electric signal；
Signal conversion module, connect with the spectrum acquisition module, and the analog electrical signal is converted into digital signal；
Data processing module, connect with the signal conversion module, is calculated in the urine sample according to the digital signal
Glucose in urine, urine creatinine, urinate cysteine proteinase inhibitor C concentration value and glucose in urine/urine creatinine ratio and/or urine half Guang
Serine protease inhibitor C/urine creatinine ratio；
Output module is connect with the data processing module, for exporting the concentration value and/or the ratio.
2. system according to claim 1, which is characterized in that the urine sample from subject postprandial 0.5~
2.5h drained of urine, and the urine taken in postprandial 2~4.5h.
3. system according to claim 1, which is characterized in that the transmitting module includes spectral emissions circuit and transmitting electricity
Source circuit；The spectrum acquisition module includes spectrum acquisition circuit and reception power circuit.
4. system according to claim 1, which is characterized in that the data processing module includes MCU and its peripheral circuit.
5. system according to claim 1, which is characterized in that the output module includes that human-computer interaction module and data are logical
Interrogate module；The human-computer interaction module shows the concentration value and/or the ratio of output for realizing human-computer interaction；Institute
Data communication module is stated, for realizing remote information communication function, the concentration value and/or the ratio are transmitted to long-range number
According to storage, analysis platform.
6. a kind of diabetes early stage non-invasive detection methods, which is characterized in that the described method includes:
Urine is added dropwise to test strips reacting hole in detection module, glucose in urine, urine creatinine and urine cysteine egg in test strips and urine
White enzyme inhibitor C reaction；
Incident light spectrum of the transmitting module to the test strips transmitting predetermined wavelength after reaction；
Spectrum acquisition module receives the spectrum or fluorescence signal after passing through the test strips and decaying, and is converted to analog telecommunications
Number；
The analog electrical signal is converted into digital signal by signal conversion module；
Data processing module calculates glucose in urine, urine creatinine, urine cysteine in the urine sample according to the digital signal
Concentration value and glucose in urine/the urine creatinine ratio and/or urine cysteine proteinase inhibitor C/urine creatinine of proteinase inhibitor C
Ratio；
Output module exports the concentration value and/or the ratio.
7. according to the method described in claim 6, it is characterized in that, urine is added dropwise to test strips reacting hole in the detection module
Before further include:
Subject is obtained in postprandial 0.5~2.5h drained of urine and the urine that is taken in postprandial 2~4.5h.
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| PCT/CN2019/085080 WO2019214494A1 (en) | 2018-05-05 | 2019-04-30 | Urine biomarker-based early non-invasive detection system and method for diabetes |
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| CN114527265A (en) * | 2021-12-31 | 2022-05-24 | 攸太科技(台州)有限公司 | Spectral detection method for urine components |
| CN117031029A (en) * | 2023-08-17 | 2023-11-10 | 中国人民解放军总医院第二医学中心 | Urine collection monitoring device for family care of elderly patients |
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| CN114152737B (en) * | 2021-12-08 | 2024-06-07 | 广东阳光生物科技有限公司 | Urine galactose detection kit |
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| US20030207441A1 (en) * | 2002-05-01 | 2003-11-06 | Eyster Curt R. | Devices and methods for analyte concentration determination |
| EP1522254A1 (en) * | 2003-10-08 | 2005-04-13 | Hitachi, Ltd. | Blood sugar level measuring method and apparatus |
| CN201233368Y (en) * | 2008-07-31 | 2009-05-06 | 孙英信 | Miniature non-invasive urine glucose and spittle glucose detecting instrument |
| CN201837460U (en) * | 2009-11-25 | 2011-05-18 | 全友电脑股份有限公司 | Detection device |
| WO2012033443A1 (en) * | 2010-09-06 | 2012-03-15 | Chromalytica Ab | Combination of spectrograph barrier gas, carrier gas and cooling of ccd |
| CN104390918A (en) * | 2014-11-11 | 2015-03-04 | 深圳市前海安测信息技术有限公司 | Noninvasive detection system and method of diabetes and complications of diabetes |
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| CN114527265A (en) * | 2021-12-31 | 2022-05-24 | 攸太科技(台州)有限公司 | Spectral detection method for urine components |
| CN117031029A (en) * | 2023-08-17 | 2023-11-10 | 中国人民解放军总医院第二医学中心 | Urine collection monitoring device for family care of elderly patients |
| CN117031029B (en) * | 2023-08-17 | 2024-01-09 | 中国人民解放军总医院第二医学中心 | Urine collection monitoring device for family care of elderly patients |
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Application publication date: 20191112 |