CN111855594B - Electronic display device and method for early pregnancy detection - Google Patents

Electronic display device and method for early pregnancy detection Download PDF

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CN111855594B
CN111855594B CN202010756016.0A CN202010756016A CN111855594B CN 111855594 B CN111855594 B CN 111855594B CN 202010756016 A CN202010756016 A CN 202010756016A CN 111855594 B CN111855594 B CN 111855594B
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difference value
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quality control
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CN111855594A (en
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齐颖颖
李森
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Shijiazhuang Huanzhong Biotechnology Co ltd
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Shijiazhuang Huanzhong Biotechnology Co ltd
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    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
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    • G01—MEASURING; TESTING
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    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
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    • G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • G01N33/76—Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
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    • G01N2333/575—Hormones
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Abstract

The invention discloses an electronic display device and a method for early pregnancy detection, which relate to the field of human chorionic gonadotropin detection and comprise the following steps: the system comprises a photoelectric sensor group, a control center data processing module and a test strip; the test strip comprises a bottom lining, an absorption pad, a nitrocellulose membrane coating a quality control line and a detection line, a gold pad and a sample pad between the nitrocellulose membrane and the sample pad; the sample pad, the gold pad, the nitrocellulose membrane and the absorption pad are adhered to the other side of the bottom lining in sequence; one side of the gold pad overlaps with part of the nitrocellulose membrane, and the other side overlaps with part of the sample pad; the quality control line is positioned at one side close to the absorption pad; the nitrocellulose membrane also overlaps a portion of the absorbent pad; the photoelectric sensor group is used for detecting the optical signal of the test strip; the control center data processing module is used for determining whether the sample in the sample pad is pregnant or not and the pregnancy period according to the optical signals detected by the photoelectric sensor group. The invention can achieve the purpose of conveniently and rapidly detecting whether the sample is pregnant or not and the pregnancy period.

Description

Electronic display device and method for early pregnancy detection
Technical Field
The invention relates to the technical field of human chorionic gonadotropin detection, in particular to an electronic display device and method for early pregnancy detection.
Background
Human Chorionic Gonadotropin (HCG) is a glycoprotein secreted by the trophoblast cells of the placenta chorion, has a molecular weight of 36700, and consists of alpha and beta dimeric glycoproteins. After the fertilized ovum of the mature female moves into the uterine cavity, an embryo is formed by implantation. During the development and growth of the embryo into a fetus, the placental syncytiotrophoblast cells produce large amounts of human chorionic gonadotropin, which can be excreted into the urine through the blood circulation of the pregnant woman. The human chorionic gonadotropin is secreted from 10-14 days after conception, when pregnancy lasts for 1-2.5 weeks, the HCG level in serum and urine can be rapidly increased, the pregnancy reaches the peak in 8 weeks, and is reduced to the medium level from 4 months of the pregnancy and is maintained until the end of pregnancy. At present, the detection of pregnancy weeks requires a long time of detection of a professional to obtain a detection result, and the operation process is complex.
Disclosure of Invention
The invention aims to provide an electronic display device and method for early pregnancy detection, so as to achieve the purpose of conveniently and quickly detecting whether a sample is pregnant or not and a pregnancy period.
In order to achieve the purpose, the invention provides the following scheme:
an electronic display device for early pregnancy detection, comprising: the system comprises a photoelectric sensor group, a control center data processing module and a test strip;
the test strip comprises a bottom lining, an absorption pad, a nitrocellulose membrane, a gold pad and a sample pad; the sample pad, the gold pad, the nitrocellulose membrane and the absorbent pad are adhered to one side of the bottom lining from the other side in sequence; the gold pad is disposed between the nitrocellulose membrane and the sample pad; one side of the gold pad overlaps with part of the nitrocellulose membrane, and the other side of the gold pad overlaps with part of the sample pad; the nitrocellulose membrane coats the quality control line and the detection line; the quality control line is positioned at one side close to the absorption pad; the nitrocellulose membrane also overlaps a portion of the absorbent pad;
the photoelectric sensor group is used for detecting optical signals of the quality control lines, the detection lines and the blank area; wherein the blank region is a region between the quality control line and the detection line;
the control center data processing module is used for determining whether the sample in the sample pad is pregnant or not and the pregnancy period according to the optical signals detected by the photoelectric sensor group.
Optionally, the detection line is coated with a mouse anti-beta-hCG monoclonal antibody; the quality control line coats the goat anti-mouse IgG polyclonal antibody.
Optionally, the gold pad is made of a mixture of colloidal gold β -hCG monoclonal antibodies.
Optionally, the photoelectric sensor group comprises a light emitting diode; the light emitting diodes are used for providing light sources for the quality control lines, the detection lines and the blank area.
Optionally, the photoelectric sensor group further comprises a photoelectric sensor; the photoelectric sensor is used for detecting optical signals of the quality control line, the detection line and the blank area.
Optionally, there are 3 photoelectric sensors; the quality control line, the detection line and the blank area correspond to one photoelectric sensor respectively.
Optionally, the electronic display device for early pregnancy detection further comprises an electronic detection device housing, and the photoelectric sensor group, the control center data processing module and the test strip are all disposed in the electronic detection device housing.
Optionally, the electronic display device for early pregnancy detection further comprises an electronic display screen, the electronic display screen is arranged outside the shell of the electronic detection device, and the electronic display screen is used for displaying whether the sample is pregnant or not and the pregnancy cycle.
An electronic detection method for early pregnancy detection, comprising:
acquiring optical signal values of a quality control line, a detection line and a blank area detected by the photoelectric sensor group;
judging whether the optical signal value of the quality control line is larger than the optical signal value of the blank area or not to obtain a first judgment result;
if the first judgment result shows that the optical signal value of the quality control line is smaller than the optical signal value of the blank area, outputting an invalid detection instruction;
if the first judgment result shows that the optical signal value of the quality control line is greater than or equal to the optical signal value of the blank area, judging whether the optical signal value of the detection line is greater than the optical signal value of the blank area or not to obtain a second judgment result;
if the second judgment result indicates that the optical signal value of the detection line is smaller than or equal to the optical signal value of the blank area, outputting a non-pregnant instruction;
and if the second judgment result indicates that the optical signal value of the detection line is greater than the optical signal value of the blank area, outputting a pregnancy instruction.
Optionally, the electronic detection method for detecting early pregnancy further comprises:
calculating a first difference value, which is a difference value between the optical signal values of the detection lines and the optical signal value of the blank area;
calculating a second difference value, wherein the second difference value is a difference value between the optical signal value of the quality control line and the optical signal value of the blank area;
judging whether the quotient of the first difference value divided by the second difference value is located in a first interval or not to obtain a third judgment result;
if the third judgment result shows that the quotient obtained by dividing the first difference value by the second difference value is positioned in a first interval, outputting an instruction that the pregnancy period is 1-2 weeks;
if the third judgment result shows that the quotient of the first difference value divided by the second difference value is not located in the first interval, judging whether the quotient of the first difference value divided by the second difference value is located in the second interval or not to obtain a fourth judgment result;
if the fourth judgment result shows that the quotient of the first difference value divided by the second difference value is in a second interval, outputting an instruction that the pregnancy period is 2-3 weeks;
if the fourth judgment result indicates that the quotient of the first difference value divided by the second difference value is not located in the second interval, judging whether the quotient of the first difference value divided by the second difference value is located in a third interval or not to obtain a fifth judgment result;
and if the fifth judgment result shows that the quotient obtained by dividing the first difference value by the second difference value is in a third interval, outputting an instruction that the pregnancy period is 3+ weeks.
According to the specific embodiment provided by the invention, the invention discloses the following technical effects:
the invention provides an electronic display device and method for early pregnancy detection, which can obtain the pregnancy condition of a sample by processing and judging a quality control line, a detection line and an optical signal of a blank area of a test strip detected by a photoelectric sensor group through a control center data processing module. Therefore, the sample is arranged on the test strip, and the judgment result of whether the sample is pregnant or not and the pregnancy time can be obtained by combining the control center data processing module, so that the purposes of simple operation, convenience and quickness are achieved.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to these drawings without creative efforts.
FIG. 1 is a schematic structural diagram of an electronic display device test strip for early pregnancy detection according to the present invention;
FIG. 2 is a schematic view of the housing of the electronic detection device of the electronic display device test strip for early pregnancy detection according to the present invention;
FIG. 3 is a flow chart of an electronic detection method for early pregnancy detection in accordance with the present invention;
FIG. 4 is a schematic diagram of the photoelectric conversion of the test strip of the electronic display device for early pregnancy detection according to the present invention;
FIG. 5 is a schematic diagram of a HCG standard curve of the test strip of the electronic display device for early pregnancy detection according to the present invention;
FIG. 6 is a flowchart illustrating the test execution of the test strip of the electronic display device for early pregnancy testing according to the present invention;
fig. 7 is a schematic diagram of the test strip and the photoelectric sensor of the electronic display device test strip for early pregnancy detection according to the present invention.
Description of the symbols:
the device comprises a bottom liner-1, a sample pad-2, a gold pad-3, an absorption pad-4, a nitrocellulose membrane-5, a detection line-T, a quality control line-C, a first photoelectric sensor-6, a second photoelectric sensor-7, a third photoelectric sensor-8, an electronic detection device shell-9, an electronic display screen-10, a light emitting diode-11, a battery-12, a control center data processing module-13 and a sample rod-14.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.
The invention aims to provide an electronic display device and method for early pregnancy detection, so as to achieve the purpose of conveniently and quickly detecting whether a sample is pregnant or not and a pregnancy period.
In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in further detail below.
Example one
As shown in fig. 1, the present embodiment provides an electronic display device for early pregnancy detection, which includes: the system comprises a photoelectric sensor group, a control center data processing module 13 and a test strip; the test strip comprises a bottom lining 1, an absorption pad 4, a nitrocellulose membrane 5, a gold pad 3 and a sample pad 2; the sample pad 2, the gold pad 3, the nitrocellulose membrane 5 and the absorbent pad 4 are adhered to one side of the bottom liner 1 to the other side in sequence; the gold pad 3 is disposed between the nitrocellulose membrane 5 and the sample pad 2; one side of the gold pad 3 overlaps with part of the nitrocellulose membrane 5, and the other side of the gold pad 3 overlaps with part of the sample pad 2; the nitrocellulose membrane 5 is coated with a quality control line C and a detection line T; the quality control line C is positioned at one side close to the absorption pad 4; the nitrocellulose membrane 5 also overlaps with part of the absorbent pad 4.
The photoelectric sensor group is used for detecting optical signals of the quality control line C, the detection line T and the blank area; wherein the blank region is a region between the quality control line C and the detection line T.
The control center data processing module 13 is used for determining whether the sample in the sample pad 2 is pregnant or not and the pregnancy period according to the optical signals detected by the photoelectric sensor group.
Preferably, the detection line T is coated with a murine anti- β -hCG monoclonal antibody; the quality control line C coats the goat anti-mouse IgG polyclonal antibody.
Preferably, the gold pad 3 is made of a mixture of colloidal gold β -hCG monoclonal antibodies.
Preferably, the photosensor assembly includes a light emitting diode 11; the light emitting diodes 11 are used for providing light sources for the quality control line C, the detection line T and the blank area.
Preferably, the photoelectric sensor group further comprises a photoelectric sensor; the photoelectric sensor is used for detecting optical signals of the quality control line C, the detection line T and the blank area.
Preferably, the number of the photoelectric sensors is 3; the quality control line C, the detection line T and the blank area correspond to one photoelectric sensor respectively.
Preferably, the electronic display device for the early pregnancy test further comprises an electronic test device housing 9 as shown in fig. 2, and the photoelectric sensor group, the control center data processing module 13 and the test strip are all disposed in the electronic test device housing 9.
Preferably, the electronic display device for the early pregnancy test further comprises an electronic display screen 10, the electronic display screen 10 is arranged outside the electronic test device shell 9, and the electronic display screen 10 is used for displaying whether the sample is pregnant or not and the pregnancy period.
Example two
As shown in fig. 3, the electronic detection method for early pregnancy detection provided in this embodiment specifically includes:
step 101: and acquiring optical signal values of a quality control line, a detection line and a blank area which are detected by the photoelectric sensor group.
Step 102: and judging whether the optical signal value of the quality control line is greater than the optical signal value of the blank area or not to obtain a first judgment result. If the first determination result indicates that the optical signal value of the quality control line is smaller than the optical signal value of the blank area, step 104 is executed, and if the first determination result indicates that the optical signal value of the quality control line is greater than or equal to the optical signal value of the blank area, step 103 is executed.
Step 103: and judging whether the optical signal value of the detection line is greater than the optical signal value of the blank area or not to obtain a second judgment result. If the second determination result indicates that the optical signal value of the detection line is less than or equal to the optical signal value of the blank area, step 106 is executed, and if the second determination result indicates that the optical signal value of the detection line is greater than the optical signal value of the blank area, step 105 is executed.
Step 104: and outputting an invalid detection instruction.
Step 105: and outputting a pregnancy instruction.
Step 106: outputting a non-pregnant instruction.
Preferably, the method for electronically detecting an early pregnancy test further comprises:
and calculating a first difference value, wherein the first difference value is the difference value between the optical signal value of the detection line and the optical signal value of the blank area.
And calculating a second difference value, wherein the second difference value is the difference value between the optical signal value of the quality control line and the optical signal value of the blank area.
And judging whether the quotient of the first difference value divided by the second difference value is positioned in a first interval or not to obtain a third judgment result.
And if the third judgment result shows that the quotient of the first difference value divided by the second difference value is positioned in the first interval, outputting an instruction that the pregnancy period is 1-2 weeks.
And if the third judgment result shows that the quotient of the first difference value divided by the second difference value is not in the first interval, judging whether the quotient of the first difference value divided by the second difference value is in the second interval or not to obtain a fourth judgment result.
And if the fourth judgment result shows that the quotient obtained by dividing the first difference value by the second difference value is positioned in a second interval, outputting an instruction that the pregnancy period is 2-3 weeks.
And if the fourth judgment result shows that the quotient of the first difference value divided by the second difference value is not in the second interval, judging whether the quotient of the first difference value divided by the second difference value is in a third interval or not to obtain a fifth judgment result.
And if the fifth judgment result shows that the quotient obtained by dividing the first difference value by the second difference value is in a third interval, outputting an instruction that the pregnancy period is 3+ weeks. Wherein the first interval is [0.1238,0.1412], the second interval is [0.1412,1.52], and the third interval is [1.52, + ∞ ].
EXAMPLE III
The embodiment provides a specific electronic display device for early pregnancy detection, which comprises:
1. preparation of test paper strip of electronic display device for early pregnancy detection
1. Preparation of anti-human beta-hCG antibody and determination of paired antibody
Preparing and purifying monoclonal antibodies: purchasing a Zhongzhong hospital human chorionic gonadotropin beta subunit (HCG-beta) as an immunizing antigen, immunizing a 6-week-old healthy BALB/c female mouse, preparing and screening monoclonal antibody cell strains according to a conventional hybridoma technology and a limiting dilution method, further proliferating and culturing the specific antibody cell strains, injecting the specific antibody cell strains into the mouse to prepare ascites, and purifying the obtained ascites by an octanoic acid-ammonium sulfate precipitation method.
Screening of monoclonal antibodies: screening to obtain 60 monoclonal cell strain antibodies, and detecting by ELISA additive test to obtain monoclonal antibody 2A which are mutually matched antibodies 2 B 1 G 6 And 10F 2 B 11 C 9 The addition index is the highest, the addition index AI =98.6%, the conformational epitopes of the two antibodies after being respectively combined with the antigens are different and far away, and 2A is detected 2 B 1 G 6 The titer of the monoclonal antibody is 2.56 x 106, 10F 2 B 11 C 9 The titer of the monoclonal antibody is 5.12 x 106, the subtypes are IgG1, the protein concentration is 6.5mg/mL and 7.2mg/mL respectively, and the monoclonal antibody is suitable for preparing a colloidal gold detection reagent card device in the next step.
2. Preparation of colloidal gold
Colloidal gold (Colloidal gold) is chloroauric acid (HAuCl) 4 ) Under the action of reducing agent, chloroauric acid is polymerized into gold particles with specific size, and becomes a stable colloidal state-colloidal gold particles due to electrostatic action. The colloidal gold has negative charge in weak alkali environment, can form firm combination with the positive charge group of protein molecules (immunoglobulin) to further form a colloidal gold label, and the combination is electrostatic combination, so the biological characteristics of the protein are not influenced.
This example prepared 41nm colloidal gold using the trisodium citrate method. Taking one 250mL triangular flask, adding 100mL double distilled water and 1mL1% gold chloride, and heating to boil; adding 1% sodium citrate into the above solution at different amounts, mixing, boiling for 30min, and making the solution black and red to obtain purple final product. Then, 1mL of trisodium citrate was added to the solution after mixing and boiling for 30min to obtain 41nm colloidal gold particles (in wine red) for the next experiment. According to the test, the optimum pH value of the colloidal gold is 8.0, and the amount of the optimum labeled protein of 1mL of the stabilized colloidal gold is 25 mu g.
3. Colloidal gold labeled human beta-hCG monoclonal antibody
1mL of 41nm colloidal gold solution (pH 8.0) was taken out, and 25. Mu.g of 2A was added 2 B 1 G 6 Mixing the purified antibody, standing at room temperature for 10min, adding 10 μ L of 2% PEG20000, and standing at room temperature for 5min; centrifuging at 10000rpm for 20min, and slightly sucking the supernatant; re-dissolving the colloidal gold precipitate with 0.1MPBST solution, mixing, and spraying onto glass fiber membrane.
4. Determination of the concentration of detection line T on nitrocellulose membrane 5: in this example, the quality control line C was coated with goat anti-mouse IgG antibody, and the detection line T was coated with 10F 2 B 11 C 9 An antibody. Preliminary experiments determine that the concentration of the quality control line C is 1.0mg/mL, the concentration of the detection line T is optimized, and the optimal concentration of the detection line T for scratching the membrane is selected by taking the color depth, the sensitivity and the like of the detection line T as references. The detection test shows that when the membrane scratching concentration of the detection line T is 1.2mg/mL, the color development is very dark, the identification is easy, and the antibody is not wasted, so that the optimal membrane scratching concentration of the detection line T is 1.2mg/mL.
The specific determination scheme of the concentrations of the quality control line C and the detection line T on the nitrocellulose membrane 5 is as follows:
(1) And preparing a corresponding test strip for detection according to the following test factors by using a preliminary determination scheme of the membrane scratching concentration of the detection line T and the quality control line C.
Factor A: detection line T coated antibody 10F 2 B 11 C 9 The concentrations were 0.5mg/mL, 1.0mg/mL and 1.5mg/mL, respectively.
Factor B: the concentration of goat anti-mouse IgG polyclonal antibody coated by the quality control line C is respectively set to be 0.5mg/mL, 1.0mg/mL and 1.5mg/mL.
Factor C: the amount of scratching was set to 1uL/cm.
And (3) judging an experimental result: HCG standard substances with a series of concentrations are selected, 9 test strips are combined according to the factor A and the factor B for detection, the color development conditions of a detection line T and a quality control line C are observed, the film scratching concentrations of the detection line T and the quality control line C are preliminarily determined according to technical indexes, the film scratching concentration of the quality control line C is 1.0mg/mL, and the film scratching concentrations of the detection line T are both 1.0mg/mL and 1.5mg/mL and can meet the technical requirements.
(2) And preliminarily determining the experimental result according to the membrane scratching concentrations of the two antibodies, refining the membrane scratching concentration of the detection line T again, and determining the optimal membrane scratching concentration of the detection line T. According to the following test factors, a corresponding test strip is prepared for detection.
Factor A: the concentrations of the mouse anti-beta-hCG monoclonal antibodies were set to 1.0mg/mL, 1.1mg/mL, 1.2mg/mL, 1.3mg/mL, 1.4mg/mL, and 1.5mg/mL, respectively.
Factor B: the membrane scribing concentration of the goat anti-mouse IgG polyclonal antibody coating quality control line C is 1.0mg/mL.
Factor C: the amount of scratching was set to 1uL/cm.
And (3) judging an experimental result: HCG standard substances with a series of concentrations are selected, the factor A and the factor B are combined into 6 test strips for detection, the color development conditions of a detection line T and a quality control line C are observed, and the film scratching concentration of the detection line T is determined to be 1.2mg/mL according to technical indexes.
5. And (5) assembling the test strips, and sequentially assembling according to the figure 1. The absorption pad 4, the nitrocellulose membrane 5, the gold pad 3 and the sample pad 2 are sequentially adhered to the bottom lining 1, and the absorption pad 4, the nitrocellulose membrane 5, the gold pad 3 and the sample pad 2 are overlapped at different degrees adjacently. As shown in FIG. 2, a sample rod 14 is placed on the sample pad 2, the sample rod 14 is located outside the housing 9 of the electronic detection device, and the urine sample directly drops on the sample rod 14 and then permeates into the sample pad 2.
The test strip is used for detecting the concentration of human chorionic gonadotropin in a urine sample, and the sample soaking or adding position is a sample pad 2; the test strip is a colloidal gold immunochromatographic assay, and the linear range is wide; the linear range is: 10-12000mIU/mL.
The test strip comprises: a bottom lining 1, an absorption pad 4, a nitrocellulose membrane 5, a gold pad 3 and a sample pad 2; a quality control line C and a detection line T are coated on the cellulose nitrate membrane 5, the quality control line C is a goat anti-mouse IgG polyclonal antibody and is close to the absorption pad 4, and the detection line T is a mouse anti-beta-hCG monoclonal antibody and is close to the gold pad 3; the gold pad 3 is a colloidal gold β -hCG antibody conjugate.
The different colors reacted by the test paper strip generate light signals and are converted into electric signals with different intensities, then specific numerical values are transmitted to the control center data processing module 13, and the concentration of the corresponding human chorionic gonadotropin is calculated through specific functions and the pregnancy cycle number of the urine sample is displayed.
The color change of the test strip is used for reading an optical signal and converting the optical signal into an electric signal, a display screen is used for displaying a detection result, and a light-emitting diode 11, a photoelectric sensor and a control center data processing module 13 are used for realizing a photoelectric conversion function.
The light emitting diode 11 is used for providing a light source and irradiating a quality control line C, a detection line T and a blank area of the test strip.
The photoelectric sensor is used for receiving the reflected light of the quality control line C, the detection line T and the blank area of the test strip and generating an electric signal, and the strength of the electric signal is in direct proportion to the strength of the reflected light.
The control center data processing module 13 is used for receiving the electric signal of the photoelectric sensor and calculating the pregnancy cycle number of the sample.
The method comprises the steps of reacting different colors through a test strip to generate electric signals with different intensities, transmitting a specific numerical value, calculating the concentration of the corresponding human chorionic gonadotropin through a specific function and displaying the pregnancy cycle number of a sample, reacting different colors through the test strip to generate optical signals with different intensities, wherein the specific expression is that 3 photoelectric sensors are provided, a first photoelectric sensor 6 is a signal of a transmitter control line C area, a second photoelectric sensor 7 is used for transmitting a signal of a detection line T area, and a third photoelectric sensor 8 is used for transmitting a signal of a blank area; transmitting specific numerical values, namely transmitting signals of different areas at different reaction times; the specific function calculates the corresponding concentration of the human chorionic gonadotropin, and the electric signals in different areas after different time pass through the data processing module 13 of the control center to calculate the sample concentration by the standard curve of the human chorionic gonadotropin.
The number of gestational weeks of the sample is determined according to reference values of HCG in different periods in a urine sample of a pregnant woman recorded in national clinical test operating procedures, wherein HCG <25mIU/mL in the urine sample is not pregnant, HCG <25mIU/mL is less than or equal to 250mIU/mL in the urine sample is pregnant for 1-2 weeks, HCG < 250mIU/mL is less than or equal to 10000mIU/mL in the urine sample is pregnant for 2-3 weeks, and HCG < 10000mIU/mL in the urine sample is pregnant for 3+ weeks (more than 3 weeks).
The transmission of a specific numerical value means that signals in different areas transmitted at different reaction times react for 10 minutes, and each minute of the signals are transmitted by the photoelectric sensor and the result is calculated by the control center data processing module 13.
The length of the test strip is 6cm; the width of the quality control line C is 1mm, the length of the quality control line C is 6mm, and the distance between the quality control line C and the upper end of the test strip is 2.5cm; the width of the detection line T is 1mm, the length of the detection line T is 6mm, and the distance between the detection line T and the upper end of the test strip is 2.8cm; the blank distance between the quality control line C and the detection line T is 0.5cm.
As shown in fig. 4 and 7, each of the photosensors has a width of 1.5mm and a length of 5mm, and the distance between adjacent photosensors is 1.5mm on the electronic display device for early pregnancy detection; the distance between the upper end of the third photoelectric sensor 8 and the lower end of the quality control line C is 1.75mm, and the distance between the lower end of the third photoelectric sensor 8 and the upper end of the detection line T is 1.75mm; the first photoelectric sensor 6 is superposed with the quality control line C to cover the quality control line C; the sensor of the second photoelectric sensor 7 is superposed with the detection line T to cover the detection line T; the third photosensor 8 coincides with a blank region between the quality control line C and the detection line T.
In addition, the electronic display device for the early pregnancy detection also comprises a battery 12. The battery 12 is used to supply power to the light emitting diode 11 and the photosensor.
2. Operation process of electronic display device for early pregnancy detection
Electronic display device using early pregnancy test as shown in fig. 1The sample pad 2 is dipped or the sample to be tested is added, and the electronic display screen 10 waits for the operation shown in FIG. 6
Figure BDA0002611589380000111
And (6) an icon. Each area on the test strip can generate different color reactions, and the light-emitting diode 11 provides a light source for the test strip and irradiates on the quality control line C, the detection line T and the blank area. After the detection and calculation for 10 minutes, the electronic display screen 10 displays the result, and the electronic display screen 10 displays that the person is not pregnant, namely the person is not pregnant, and does not display the information of the number of weeks; the electronic display screen 10 displays "pregnant" and "1-2", indicating that it is pregnant and is pregnant for 1-2 weeks; the electronic display screen 10 displays "pregnant" and "2-3", indicating that the child is pregnant and is pregnant for 2-3 weeks; the electronic display screen 10 displays "pregnant" and "3+", indicating that it has been pregnant and is pregnant for more than 3 weeks.
3. Processing of control center data processing module 13
1. Data processing of signal transmission and control center data processing module 13 of photoelectric sensor
The photoelectric sensor is connected with the control center data processing module 13, and is used for receiving reflected light signals of the quality control line C, the detection line T and the blank area of the test strip, converting the reflected light signals into electric signals and transmitting the electric signals to the control center data processing module 13; the intensity of the electric signal is in direct proportion to the intensity of the reflected light signal; 3 photoelectric sensors are arranged, a first photoelectric sensor 6 receives an optical signal reflected by a quality control line C area, a second photoelectric sensor 7 receives an optical signal reflected by a detection line T area, and a third photoelectric sensor 8 receives an optical signal reflected by a blank area; different reaction time delivers electric signals of different areas; and a judgment result is obtained through the processing of the control center data processing module 13. The light emitting diode 11 is used for providing a light source and irradiating on the quality control line C, the detection line T and the blank area of the test strip.
The electric signal value of the quality control line region output by the first photoelectric sensor is c, the electric signal value of the detection line region output by the second photoelectric sensor is t, and the electric signal value of the blank region output by the third photoelectric sensor is g. The control center data processing module 13 determines a result according to the strength of the electrical signals of the 3 photoelectric sensors, outputs specific values of the first photoelectric sensor, the second photoelectric sensor and the third photoelectric sensor according to the strength of the electrical signals, and obtains a detection result according to the calculation of the following values:
(1) The different time refers to that a signal is transmitted every 10 minutes of reaction, any signal of the first photoelectric sensor, the second photoelectric sensor and the third photoelectric sensor is not received, the detection is considered to be invalid, and the detection fails; the first photosensor signal is always stronger than the third photosensor signal, otherwise, the signal is regarded as invalid, and the detection fails.
(2) Preparing the standard substance of the chorionic gonadotropin of the detected hospital into a series of standard solutions of 10mIU/mL,25mIU/mL,250mIU/mL,1000mIU/mL,5000mIU/mL,10000mIU/mL,12000mIU/mL and the like. With the test strip of this example, each concentration was repeated 3 times, and the reading of the electronic display device for early pregnancy test was taken, thereby obtaining a standard curve of light concentration versus HCG concentration. The corresponding relation between the HCG concentration and the optical concentration is determined, the HCG concentration is determined through the strength of the electric signal of the photoelectric sensor by taking the corresponding relation as a standard in actual detection, and then the pregnancy week is obtained.
Finally, a standard curve as shown in fig. 5 was determined. The detection sensitivity of the detection reagent card prepared by the embodiment reaches 10mIU/mL, and the linearity is R2=0.9999 within the range of 10-12000mIU/mL.
(3) There are 4 cases of correct detection results, when t is less than or equal to g, the result shows that "not pregnant" indicates not pregnant; when t-g/c-g is less than or equal to 0.1412 and less than or equal to 0.1238, the result shows that the Chinese medicinal composition is pregnant and 1-2, which indicates that the Chinese medicinal composition is pregnant and is pregnant for 1-2 weeks; when t-g/c-g is more than or equal to 0.1412 and less than or equal to 1.52, the result shows that the Chinese medicinal composition is pregnant and 2-3, which indicates that the Chinese medicinal composition is pregnant and is pregnant for 2-3 weeks; when t-g/c-g is more than or equal to 1.52, the result shows that the Chinese medicinal composition is pregnant and 3 +', which indicates that the Chinese medicinal composition is pregnant and is pregnant for more than 3 weeks.
4. Validation of clinical urine samples
The electronic display device for early pregnancy detection provided by the embodiment is used for early pregnancy detection of an actual sample in a certain hospital in Hebei, 216 suspected pregnant persons in 2018.6-2019.12 are clinically verified, the ages are 23-38, and the detection results are shown in Table 1.
TABLE 1 suspected pregnant person examination table
Figure BDA0002611589380000121
And (4) conclusion: 216 cases of detection are carried out by adopting an electronic display device for early pregnancy detection, the results are 56 cases of no pregnancy and 160 cases of pregnancy, and the results are consistent with the detection results of human chorionic gonadotropin beta (beta-HCG) detected by hospital blood; b-ultrasonic detection is carried out on 76 cases which have been pregnant for more than 3 weeks, and the detection result is consistent with that of the electronic display device adopting early pregnancy detection in the embodiment; at the same time, the urine of 20 cases of pregnancies for 1-2 weeks and 64 cases of pregnancies for 2-3 weeks is detected by similar products on the market, and the detection result is consistent with the electronic display device for early pregnancy detection.
The embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other.
The principles and embodiments of the present invention have been described herein using specific examples, which are provided only to help understand the method and the core concept of the present invention; meanwhile, for a person skilled in the art, according to the idea of the present invention, the specific embodiments and the application range may be changed. In view of the foregoing, the description is not to be taken in a limiting sense.

Claims (8)

1. An electronic display device for early pregnancy detection, comprising: the system comprises a photoelectric sensor group, a control center data processing module and a test strip;
the test strip comprises a bottom lining, an absorption pad, a nitrocellulose membrane, a gold pad and a sample pad; the sample pad, the gold pad, the nitrocellulose membrane and the absorbent pad are adhered to one side of the bottom lining from the other side in sequence; the gold pad is disposed between the nitrocellulose membrane and the sample pad; one side of the gold pad overlaps with a portion of the nitrocellulose membrane, and the other side of the gold pad overlaps with a portion of the sample pad; the nitrocellulose membrane coats the quality control line and the detection line; the quality control line is positioned at one side close to the absorption pad; the nitrocellulose membrane also overlaps a portion of the absorbent pad;
the photoelectric sensor group is used for detecting optical signals of the quality control lines, the detection lines and the blank area; wherein the blank region is a region between the quality control line and the detection line;
the control center data processing module is used for determining whether the sample in the sample pad is pregnant or not and a pregnancy period according to the optical signals detected by the photoelectric sensor group;
the photoelectric sensor group also comprises a photoelectric sensor; the photoelectric sensor is used for detecting optical signals of the quality control line, the detection line and the blank area; the number of the photoelectric sensors is 3; the quality control line, the detection line and the blank area correspond to one photoelectric sensor respectively.
2. The electronic display device for the detection of early pregnancy according to claim 1, wherein, the detection line is coated with a mouse anti- β -hCG monoclonal antibody; the quality control line coats the goat anti-mouse IgG polyclonal antibody.
3. The electronic display device for the detection of early pregnancy according to claim 1, wherein the gold pad is made of colloidal gold β -hCG monoclonal antibody mixture.
4. The electronic display device for early pregnancy detection as claimed in claim 1, wherein said set of photoelectric sensors comprises light emitting diodes; the light emitting diodes are used for providing light sources for the quality control lines, the detection lines and the blank areas.
5. The electronic display device for the early pregnancy test according to claim 1, wherein the electronic display device for the early pregnancy test further comprises an electronic test device housing, and the set of photoelectric sensors, the control center data processing module and the test strip are all disposed in the electronic test device housing.
6. The electronic display device for early pregnancy test according to claim 5, further comprising an electronic display screen, disposed outside the housing of the electronic test device, for displaying the pregnancy status of the sample and the pregnancy period.
7. An electronic detection method for early pregnancy detection, comprising:
acquiring optical signal values of a quality control line, a detection line and a blank area which are detected by a photoelectric sensor group;
judging whether the optical signal value of the quality control line is larger than the optical signal value of the blank area or not to obtain a first judgment result;
if the first judgment result shows that the optical signal value of the quality control line is smaller than the optical signal value of the blank area, outputting an invalid detection instruction;
if the first judgment result shows that the optical signal value of the quality control line is greater than or equal to the optical signal value of the blank area, judging whether the optical signal value of the detection line is greater than the optical signal value of the blank area or not to obtain a second judgment result;
if the second judgment result indicates that the optical signal value of the detection line is smaller than or equal to the optical signal value of the blank area, outputting a non-pregnant instruction;
and if the second judgment result indicates that the optical signal value of the detection line is greater than the optical signal value of the blank area, outputting a pregnancy instruction.
8. The method of claim 7, wherein the method of electronically detecting an early pregnancy test further comprises:
calculating a first difference value, wherein the first difference value is a difference value between the optical signal value of the detection line and the optical signal value of the blank area;
calculating a second difference value, where the second difference value is a difference value between the optical signal value of the quality control line and the optical signal value of the blank area;
judging whether a quotient obtained by dividing the first difference value by the second difference value is located in a first interval or not to obtain a third judgment result;
if the third judgment result shows that the quotient of the first difference value divided by the second difference value is positioned in a first interval, outputting an instruction that the pregnancy period is 1-2 weeks;
if the third judgment result shows that the quotient of the first difference value divided by the second difference value is not located in the first interval, judging whether the quotient of the first difference value divided by the second difference value is located in the second interval or not to obtain a fourth judgment result;
if the fourth judgment result shows that the quotient of the first difference value divided by the second difference value is in a second interval, outputting an instruction that the pregnancy period is 2-3 weeks;
if the fourth judgment result indicates that the quotient of the first difference value divided by the second difference value is not located in the second interval, judging whether the quotient of the first difference value divided by the second difference value is located in a third interval or not to obtain a fifth judgment result;
and if the fifth judgment result shows that the quotient obtained by dividing the first difference value by the second difference value is in a third interval, outputting an instruction that the pregnancy period is 3+ weeks.
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