WO2024026853A1 - Screening test strip-based reading and measurement method - Google Patents
Screening test strip-based reading and measurement method Download PDFInfo
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- WO2024026853A1 WO2024026853A1 PCT/CN2022/110638 CN2022110638W WO2024026853A1 WO 2024026853 A1 WO2024026853 A1 WO 2024026853A1 CN 2022110638 W CN2022110638 W CN 2022110638W WO 2024026853 A1 WO2024026853 A1 WO 2024026853A1
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- 238000012360 testing method Methods 0.000 title claims abstract description 204
- 238000012216 screening Methods 0.000 title claims abstract description 187
- 238000000691 measurement method Methods 0.000 title claims abstract description 30
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- 230000003287 optical effect Effects 0.000 claims abstract description 38
- 230000000737 periodic effect Effects 0.000 claims abstract description 14
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- 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
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
Definitions
- the present invention relates to a screening test paper reading and measuring method, and in particular, to a screening test paper reading and measuring method that can achieve rapid large-scale screening and measurement of the COVID-19 epidemic and confirmation of the epidemic period.
- Figure 1 is a schematic diagram of a conventional screening test paper. As shown in the figure, the screening test paper 80 is equipped with a reaction zone 81. When the user drops the specimen on the reaction area 81, the reaction area 81 will react chemically with the specimen, causing the color of the reaction area 81 to change. Users can judge whether the specimen is normal or not based on the color change and contrasting color of the reaction area. However, the accuracy of identifying color changes through the human eye is very poor, which may result in misjudgment or false negatives.
- a commonly known Taiwan patent I612306 Portable rapid screening in vitro detection system
- the in vitro detector is a closed environment, with an internal It is provided with a specimen box for accommodating a tested rapid screening test paper, a photographing image processor for capturing a display image of the tested rapid screening test paper in the specimen box, and a transmission interface.
- the control processor is used to transmit the display image to the electronic device, and compare it with a data parameter downloaded from the cloud of the invention through an analysis software in the electronic device to generate a test result of the subject.
- the test report of physiological reaction and physiological reaction degree achieves the function of early detection, early prevention and planning.
- the technology in the previous case uses image recognition technology for detection, which may still cause the system to become a false negative because it cannot judge the image of the screening test paper.
- the previous case The image judgment technology and the technology in this case are still different in the spectral signal measurement method using a spectrometer, and the spectral signal measurement method in this case is more accurate and can determine the period of infection.
- a common Chinese patent CN104020286 "An immunochromatographic test strip quantitative detector and a detection method", a colloidal gold, latex and other immunochromatographic quantitative detector and detection method used for quantitative detection of immunochromatographic test strips .
- the sample to be tested is dropped onto the transverse immunochromatography test paper strip that is pre-labeled and coated with the corresponding antigen and antibody, and then the test paper strip is inserted into the detection slot of the immunochromatography quantitative detector.
- the immunochromatography quantitative detector passes Multi-wavelength scanning confirms the color, chromaticity and background chromaticity of the C and T line areas on the nitrocellulose membrane of the test strip. Based on the built-in algorithm of the instrument, the optical density values of the quality control band and detection band are identified, calculated and analyzed.
- the previous case uses multi-wavelength scanning to scan the color chroma and background chroma, and the technology of this case uses the spectral signal measurement of the spectrometer. It is still different, and the spectral signal measurement in this case is more accurate and can determine the periodic confirmation of the infection.
- the test paper reading measurement method includes the use of an optical analysis unit and is used to analyze the reflection spectrum signal of the detection line of the screening test paper reaction area received by the screening test paper reading system, and is characterized in that the optical analysis unit analyzes the When the screening test paper reads the reflection spectrum signal detected by the system, the reflection spectrum signal is calculated by the optical analysis unit to obtain a reflectance characteristic value ⁇ , and uses the reflectance characteristic value ⁇ to establish a screening test paper sample
- the periodic table is used to measure and judge the period of the specimen.
- One of the objects of the present invention is to disclose a screening test paper reading and measurement method to achieve the effects of rapid screening and repeated screening test paper.
- One object of the present invention is to disclose a screening test paper reading and measurement method.
- the optical analysis unit analyzes the reflection spectrum signal detected by the screening test paper reading system, the reflection spectrum signal passes through the optical analysis unit. After calculation, a reflectance characteristic value ⁇ is obtained, and the reflectance characteristic value ⁇ is used to establish a periodic table of the screening test paper specimen for periodic measurement and judgment of the specimen.
- a screening test paper reading and measuring method which includes the following steps: in the first step, a screening test paper is provided with a screening test paper reaction zone configured on it.
- the screening test paper reaction zone can be used for several specific tests.
- the specimen produces periodic chemical reactions and changes the color of the detection line in the reaction area of the screening test paper and the reflection spectrum signal of the detection line; in the second step, a screening test paper reading system is used, and the screening test paper reading system performs Read the color of the detection line in the reaction area of the screening test paper and the reflection spectrum signal of the detection line; in the third step, further use an optical analysis unit to analyze the reaction of the screening test paper received by the screening test paper reading system The reflection spectrum signal of the detection line in the area; the fourth step is characterized in that when the optical analysis unit analyzes the reflection spectrum signal detected by the screening test paper reading system, the reflection spectrum signal is obtained after calculation by the optical analysis unit A reflectance characteristic value ⁇ , and using the reflectance characteristic value ⁇ to establish a periodic table of the screening test paper specimen
- the screening test paper reading system further includes a lighting device, then the lighting device will emit a light source to illuminate the screening test paper, and the screening test paper reading system will read The detection line reflection spectrum signal irradiated by the emission light source in the reaction area of the screening test paper is obtained, and subsequently transmitted to the optical analysis unit for calculation and analysis of the reflection spectrum signal.
- the lighting device is a white light emitting diode (White LED), an ultraviolet light emitting diode (UV LED), a near infrared light emitting diode (NIR LED), Laser diode, halogen lamp or tungsten lamp.
- White LED white light emitting diode
- UV LED ultraviolet light emitting diode
- NIR LED near infrared light emitting diode
- Laser diode halogen lamp or tungsten lamp.
- the screening test paper reading and measuring method wherein the screening test paper reading system further includes an imaging amplification device, the imaging amplification device is provided to amplify the reflection spectrum of the detection line irradiated by the emitted light source in the reaction area. Signal usage.
- the magnification of the imaging magnification device is selected to be between 1.5 times and 10 times.
- screening test paper reading measurement method wherein the specific sample application of the screening test paper is saliva, urine, blood, water, food, toxic and harmful substances or microorganisms.
- screening test paper is a new coronavirus pneumonia screening test paper (COVID-19 IgM/IgG Rapid Test Kit), an immunochromatography test paper or a biological rapid screening screening test paper or an immune antibody Rapid screening test strips are used for screening.
- COVID-19 IgM/IgG Rapid Test Kit coronavirus pneumonia screening test paper
- immunochromatography test paper or a biological rapid screening screening test paper or an immune antibody Rapid screening test strips are used for screening.
- the reflectance characteristic value ⁇ is calculated by dividing the reflection spectrum signal of non-absorbing light by the reflection spectrum signal of absorbing light.
- the reflection spectrum signal range of the non-absorbing light is a wavelength of 650 nm
- the reflection spectrum signal range of the absorbing light is a wavelength of 540 nm.
- the screening test paper sample periodic table further includes a detection limit (Limit of Detection, LOD) and a quantitative limit (Limit of Quantification, LOQ), wherein the detection
- LOD detection limit
- LOQ quantitative limit
- the detection The limiting value range is 100 pg/ml and the quantitative limit value range is 1,000 pg/ml.
- the optical analysis unit is an optical wavelength spectrometer or a spectrum analyzer.
- the imaging amplification device is composed of a magnifying lens and a refractor, and is used to amplify the reflection spectrum signal of the detection line illuminated by the emitted light source in the reaction area.
- the above-mentioned screening test paper reading measurement method wherein the detection line is to measure the color change of IgM or IgG.
- Figure 1 is a schematic diagram of a conventional screening test strip.
- Figure 2 is a flow chart of the screening test paper reading and measurement method of the present invention.
- Figure 3 is an exploded and stacked side view of the system of the screening test strip reading and measurement method of the present invention.
- Figure 4 is a schematic diagram of the imaging amplification device of the screening test paper reading and measurement method of the present invention.
- Figure 5 is a graph of the reflectance characteristic value ⁇ of the screening test paper reading measurement method of the present invention.
- Figure 6 is a sample antibody curve chart of a screening test paper of the present invention.
- Figure 7 is a diagram showing the range of absorbed light and non-absorbed light reflection spectrum signals detected at various IgM/IgG concentrations according to the present invention.
- Figure 8 is a color diagram of various IgM/IgG concentration test papers of the present invention.
- FIG. 2 is a flow chart of the screening test paper reading and measuring method of the present invention.
- Step 200 Provide the user with a screening test paper 20, which is equipped with a screening test paper reaction zone 21.
- the screening test paper reaction zone 21 can produce periodic chemical reactions for a number of specific samples, such as ( Immunochromatographic changes/staining changes/C/IgM/IgG color changes), and change the color of the detection line in the reaction area of the screening test paper and the reflection spectrum signal of the detection line, continue with the second step 300, use a screening test
- the test paper reading system 40 uses the screening test paper reading system 40 to read the color of the detection line in the reaction area of the screening test paper and the reflection spectrum signal of the detection line.
- an optical analysis is further used.
- the unit 30 is used to analyze the reflection spectrum signal of the detection line of the reaction area of the screening test paper received by the screening test paper reading system 40; in the fourth step 500, the feature is that the optical analysis unit 30 analyzes the screening test paper When reading the reflection spectrum signal detected by the system 40, the reflection spectrum signal is calculated by the optical analysis unit 30 to obtain a reflectance characteristic value ⁇ curve, as shown in Figure 5. Reflectance characteristics of the screening test paper reading measurement method. As shown in the value ⁇ curve, the calculation method of the reflectivity characteristic value ⁇ is the reflection spectrum signal that does not absorb light divided by the reflection spectrum signal that absorbs light, and the range of the reflection spectrum signal that does not absorb light is 650nm.
- the reflection spectrum signal range of the absorbed light is between 540nm wavelengths, as shown in Figure 7, and then use the reflectivity characteristic value ⁇ to establish a screening test paper sample antibody curve table, as shown in Figure 6
- the antibody curve of the screening test paper sample is shown in Figure 6, which further includes the detection limit (Limit of Detection, LOD) and the quantification limit (Limit of Quantification, LOQ) annotation, where the detection limit is The range is between 100pg/ml, and the quantitative limit range is between 1,000pg/ml.
- the above-mentioned screening test paper reading measurement method is used to provide the user with the amount of the specific sample in the screening test paper for a specific sample. Measurement and judgment are performed during the measurement cycle. If no measurement action is performed, the end procedure will be performed. For example, the fifth step 600 ends the measurement.
- the components of the embodiment of the present case are composed of a screening test paper 20, a screening test paper reading system 40 and a test paper
- the screening test paper reading system 40 further includes a reading illumination device 10 and a reading device 11.
- the reading system 40 further includes a reading illumination device 10 and a reading device 11.
- the illumination device 10 emits a light source
- the screening test paper reading system 40 reads the detection line reflection spectrum signal of the reaction area of the screening test paper illuminated by the emitted light source, and subsequently transmits it to the optical analysis unit 30 for the Computational analysis of reflection spectrum signals.
- the screening test paper reading system 40 when a screening test paper reading system 40 performs a reading operation, the screening test paper reading system 40 includes a reading illumination device 10 and a reading illumination device 10. Reading device 11, the above device is also used for reading illumination; there is also a screening test paper 20, which is equipped with a reaction zone, which can produce chemicals for certain specific samples (such as urine or blood, etc.) reaction, and changes the color of the detection line in the reaction area.
- the above-mentioned screening test paper is a new coronavirus pneumonia screening test paper (COVID-19 IgM/IgG Rapid Test Kit), which can quickly conduct new coronavirus pneumonia screening; another optical analysis unit 30, Connected to the reading illumination device 10, the optical analysis unit is a micro spectrum analyzer, used to analyze the spectral signal of the detection line image of the reaction area of the screening test paper received by the reading device 11; in addition, as in this embodiment
- the test paper carrier unit 41 is used to accommodate the screening test paper 20, and when the screening test paper 20 is fixed on the test paper carrier unit 41, the screening test paper reading system 40 reads the color of the detection line in the reaction area of the screening test paper and the reflection spectrum signal of the detection line, and then further uses an optical analysis unit 30 to analyze the reading of the screening test paper.
- the reading lighting device 10 Taking the reflection spectrum signal of the detection line of the reaction area of the screening test paper received by the system 40, the reading lighting device 10 will emit a light source to illuminate the screening test paper 20, and the reading lighting device 10 further includes a lighting device 12, Then the lighting device 12 will emit a light source to illuminate the screening test paper 20, and the screening test paper reading system 40 will read the detection line reflection spectrum signal of the reaction area of the screening test paper illuminated by the emitted light source, and subsequently transmit it.
- the optical analysis unit 30 performs calculation and analysis of the reflection spectrum signal.
- the lighting device 12 is a white light emitting diode (White LED), and the reading device 11 reads the light irradiated by the emitting light source.
- the detection lines in the reaction area reflect the image spectrum signal, and are subsequently sent to the optical analysis unit 30 for calculation and analysis of the reflected image spectrum signal.
- the specific sample of the screening test paper in the above embodiment can be applied to saliva, urine , blood epidemic, water, food, toxic and harmful substances or microorganism range, wherein in the above embodiment, the screening test paper can be replaced by an immune chromatography test paper, a biological rapid screening screening test paper or an immune antibody rapid screening screening test paper, wherein the above
- the lighting device 12 can be replaced by an ultraviolet light emitting diode (UV LED), a near infrared light emitting diode (NIR LED), a laser diode (Laser diode), or a halogen lamp. Or a tungsten lamp source (Tungsten lamp), the optical analysis unit in the above embodiment can be replaced by an optical wavelength spectrometer device.
- UV LED ultraviolet light emitting diode
- NIR LED near infrared light emitting diode
- Laser diode laser di
- the detection can be directly performed, that is, the reaction between the urine to be tested and the screening test paper 20 After contact (usually by dripping or infiltration), the components in the reaction zone will react chemically with the urine to be tested and change the color of the reaction zone.
- the reaction area can contain a variety of different detection areas for detecting glucose, protein, pH value, occult blood value or other physiological values in urine, achieving the effect of screening multiple values at one time.
- the screening test paper 20 can be placed into the test paper carrier unit 41, and the subsequent optical analysis unit 30 can be used to read the reading device 11.
- the reflection image spectrum signal of the detection line illuminated by the emitted light source in the reaction area is subsequently transmitted to the optical analysis unit 30 for calculation and analysis of the reflection image spectrum signal.
- the above-mentioned screening test paper 20 can be replaced by a new coronavirus Pneumonia screening test kit (COVID-19 IgM/IgG Rapid Test Kit), in which the detection line of the screening test paper is IgM or IgG.
- COVID-19 IgM/IgG Rapid Test Kit the detection line of the screening test paper is IgM or IgG.
- the above-mentioned screening test paper can quickly screen for new coronavirus pneumonia.
- the test paper detects the reaction spectrum signal of the substance to be tested, and can achieve the purpose of rapid screening and rapid replacement of the screening test paper, and solve the error judgment of false negative lines that may be caused by the general rapid screening test paper of the new coronavirus epidemic.
- FIG 4 a schematic diagram of the imaging amplification device of the screening test paper reading and measurement method, wherein the reading device 11 further includes an imaging amplification device, the imaging amplification device is provided to amplify the image captured by the emitted light source.
- the reflected image spectrum signal of the detection line irradiating the reaction area is used, as shown in Figure 4, in which the imaging magnifying device is composed of a magnifying lens 101 and a refractor 102, and the magnification of the imaging magnifying device is selected to be 1.5 times.
- the reading device 11 reads the detection line reflection image spectrum signal illuminated by the emitted light source in the reaction area
- the detection line reflection image spectrum signal will first pass through the magnifying lens 101 and refraction
- the mirror 102 and a light receiving path 103 amplify the signal and then send it to the reading head 31 of the optical analysis unit to receive and then perform subsequent optical analysis.
- the reading device 11 when the reading device 11 reads the light emitted by the emitted light source, when the detection line reflection image spectral signal of the reaction area is irradiated, when the magnification of the imaging amplification device is selected in the embodiment of this case, the width of the original read detection line reflection image is amplified by the imaging amplification device, and then in the optical analysis unit The image signal received by the reading head 31 becomes larger, and the optical analysis unit 30 subsequently analyzes the received amplified signal.
- the above device can solve and avoid the user's problems with COVID-19 screening test paper, immunochromatography test paper, biological test paper, etc. Rapid screening test strips or immune antibody rapid screening test strips have detection lines that do not develop color or have unclear lines after reacting with the substance to be tested, or may cause false negative lines, thereby causing incorrect detection judgments.
- the method of the present invention is characterized in that the optical analysis unit 30 analyzes the reflection spectrum signal detected by the screening test paper reading system 40, wherein the reflection spectrum signal is calculated by the optical analysis unit 30 Obtain a reflectance characteristic value ⁇ , where the calculation method of the reflectance characteristic value ⁇ is to divide the reflection spectrum signal that does not absorb light by the reflection spectrum signal that absorbs light, and the range of the reflection spectrum signal that does not absorb light is The reflection spectrum signal range of the absorbed light is between the wavelength of 650nm and the wavelength of 540nm.
- Figure 7 shows the range of the reflection spectrum signal of absorbed light and non-absorbed light detected at various IgM/IgG concentrations.
- the screening test paper reading method of the present invention can solve the false negative error judgment and the user can use the test paper carrier unit 41 to quickly replace the screening test paper 20 to achieve the purpose of repeated screening.
- the color diagrams of various IgM/IgG concentration test papers are various detection screening test papers 20.
- the screening test paper can detect IgM/IgG in a range from 0.5ng/ml to 1000ng/ml.
- the method in this case further detects and measures the color changes of IgM or IgG and confirms the values.
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Abstract
A screening test strip-based reading and measurement method, comprising the steps of: a first step (200): providing a screening test strip (20), provided with a screening test strip reaction zone (21), wherein the screening test strip reaction zone (21) can chemically react with a plurality of specific specimens periodically, and change the color of a test line of the screening test strip reaction zone (21) and a reflection spectrum signal of the test line; a second step (300): using a screening test strip reading system (40), wherein the screening test strip reading system (40) reads the color of the test line of the screening test strip reaction zone (21) and the reflection spectrum signal of the test line; a third step (400): further using an optical analysis unit (30) to analyze the reflection spectrum signal of the test line of the screening test strip reaction zone (21) received by the screening test strip reading system (40); a fourth step (500): when the optical analysis unit (30) analyzes the reflection spectrum signal detected by the screening test strip reading system (40), calculating, by the optical analysis unit (30), the reflection spectrum signal to obtain a reflectivity feature value α, and using the reflectivity feature value α to establish a screening test strip specimen periodic table, so as to perform specimen periodic measurement and determination; and a fifth step (600): completing the measurement.
Description
[根据细则26改正 19.08.2022]
本发明系有关于一筛检试纸读取量测方法，尤指一种可达到快速大量筛检量测新冠肺炎疫情及染疫周期确认的筛检试纸读取量测方法。[Amended 19.08.2022 in accordance with Rule 26]
The present invention relates to a screening test paper reading and measuring method, and in particular, to a screening test paper reading and measuring method that can achieve rapid large-scale screening and measurement of the COVID-19 epidemic and confirmation of the epidemic period.
本发明系有关于一筛检试纸读取量测方法，尤指一种可达到快速大量筛检量测新冠肺炎疫情及染疫周期确认的筛检试纸读取量测方法。[Amended 19.08.2022 in accordance with Rule 26]
The present invention relates to a screening test paper reading and measuring method, and in particular, to a screening test paper reading and measuring method that can achieve rapid large-scale screening and measurement of the COVID-19 epidemic and confirmation of the epidemic period.
[根据细则26改正 19.08.2022]
按，随着人类越来越注重自我身体健康状态筛检，包含生理筛检或环境筛检，就成为了一项非常热门的议题。第1图为一种习用筛检试纸示意图，如图所示该筛检试纸80上配置有反应区81。当使用者将检体滴于反应区81上后，该反应区81就会与检体起化学反应，而使该反应区81的颜色产生变化。使用者即可根据反应区的颜色变化与对比颜色来研判检体的正常与否。惟，透过人眼辨识颜色变化的精准度非常差，可能会造成误判或者出现伪阴性，例如2020年初迄今的新冠肺炎疫情影响，使得全世界经济与交通和生活受到重大影响，因此各国政府及研究机构与厂商都在积极研发可以进行快速筛检的确诊疫情的技术及方法，例如利用快筛检测试纸进行大量及快速检测方法，然后在检测过程如有需要再进行复检或者再次确认进行精密筛检时，大多利用光谱分析仪来进行详细检测方方法。[Amended 19.08.2022 in accordance with Rule 26]
Press, as humans pay more and more attention to self-health screening, including physiological screening or environmental screening, it has become a very hot topic. Figure 1 is a schematic diagram of a conventional screening test paper. As shown in the figure, the screening test paper 80 is equipped with areaction zone 81. When the user drops the specimen on the reaction area 81, the reaction area 81 will react chemically with the specimen, causing the color of the reaction area 81 to change. Users can judge whether the specimen is normal or not based on the color change and contrasting color of the reaction area. However, the accuracy of identifying color changes through the human eye is very poor, which may result in misjudgment or false negatives. For example, the impact of the COVID-19 epidemic so far in 2020 has significantly affected the world's economy, transportation, and life. Therefore, governments And research institutions and manufacturers are actively developing technologies and methods for rapid screening to diagnose the epidemic, such as using rapid screening test strips to conduct large-scale and rapid testing methods, and then re-testing or reconfirming if necessary during the testing process. In precision screening, spectrum analyzers are mostly used to perform detailed detection methods.
按，随着人类越来越注重自我身体健康状态筛检，包含生理筛检或环境筛检，就成为了一项非常热门的议题。第1图为一种习用筛检试纸示意图，如图所示该筛检试纸80上配置有反应区81。当使用者将检体滴于反应区81上后，该反应区81就会与检体起化学反应，而使该反应区81的颜色产生变化。使用者即可根据反应区的颜色变化与对比颜色来研判检体的正常与否。惟，透过人眼辨识颜色变化的精准度非常差，可能会造成误判或者出现伪阴性，例如2020年初迄今的新冠肺炎疫情影响，使得全世界经济与交通和生活受到重大影响，因此各国政府及研究机构与厂商都在积极研发可以进行快速筛检的确诊疫情的技术及方法，例如利用快筛检测试纸进行大量及快速检测方法，然后在检测过程如有需要再进行复检或者再次确认进行精密筛检时，大多利用光谱分析仪来进行详细检测方方法。[Amended 19.08.2022 in accordance with Rule 26]
Press, as humans pay more and more attention to self-health screening, including physiological screening or environmental screening, it has become a very hot topic. Figure 1 is a schematic diagram of a conventional screening test paper. As shown in the figure, the screening test paper 80 is equipped with a
[根据细则26改正 19.08.2022]
一习知台湾专利I612306「可携式快筛之体外检测***」，一种可携式快筛之体外检测***，包含一体外检测器以及一电子装置，该体外检测器为一封闭环境，内设有一检体盒，用以容置一受测后之快筛试纸，一拍摄影像处理器，用以撷取该检体盒内之受测后之快筛试纸之一显示影像，一传输介面控制处理器，用以传送该显示影像至该电子装置，透过该电子装置内具有之一分析软体与自一本发明之云端所下载之一资料参数进行比对，以产生一受测者之生理反应以及生理反应程度之检测报告，达到早期发现早期预防及规划之功能，前案技术为利用影像辨识技术进行检测，仍会有造成***因为无法判断筛检试纸影像而成为伪阴性，前案影像判断技术与本案技术利用光谱仪的光谱讯号量测方法仍不相同，且本案光谱讯号量测方法较为准确且可判断染病的周期确认。[Amended 19.08.2022 in accordance with Rule 26]
A commonly known Taiwan patent I612306 "Portable rapid screening in vitro detection system", a portable rapid screening in vitro detection system, includes an in vitro detector and an electronic device. The in vitro detector is a closed environment, with an internal It is provided with a specimen box for accommodating a tested rapid screening test paper, a photographing image processor for capturing a display image of the tested rapid screening test paper in the specimen box, and a transmission interface. The control processor is used to transmit the display image to the electronic device, and compare it with a data parameter downloaded from the cloud of the invention through an analysis software in the electronic device to generate a test result of the subject. The test report of physiological reaction and physiological reaction degree achieves the function of early detection, early prevention and planning. The technology in the previous case uses image recognition technology for detection, which may still cause the system to become a false negative because it cannot judge the image of the screening test paper. The previous case The image judgment technology and the technology in this case are still different in the spectral signal measurement method using a spectrometer, and the spectral signal measurement method in this case is more accurate and can determine the period of infection.
一习知台湾专利I612306「可携式快筛之体外检测***」，一种可携式快筛之体外检测***，包含一体外检测器以及一电子装置，该体外检测器为一封闭环境，内设有一检体盒，用以容置一受测后之快筛试纸，一拍摄影像处理器，用以撷取该检体盒内之受测后之快筛试纸之一显示影像，一传输介面控制处理器，用以传送该显示影像至该电子装置，透过该电子装置内具有之一分析软体与自一本发明之云端所下载之一资料参数进行比对，以产生一受测者之生理反应以及生理反应程度之检测报告，达到早期发现早期预防及规划之功能，前案技术为利用影像辨识技术进行检测，仍会有造成***因为无法判断筛检试纸影像而成为伪阴性，前案影像判断技术与本案技术利用光谱仪的光谱讯号量测方法仍不相同，且本案光谱讯号量测方法较为准确且可判断染病的周期确认。[Amended 19.08.2022 in accordance with Rule 26]
A commonly known Taiwan patent I612306 "Portable rapid screening in vitro detection system", a portable rapid screening in vitro detection system, includes an in vitro detector and an electronic device. The in vitro detector is a closed environment, with an internal It is provided with a specimen box for accommodating a tested rapid screening test paper, a photographing image processor for capturing a display image of the tested rapid screening test paper in the specimen box, and a transmission interface. The control processor is used to transmit the display image to the electronic device, and compare it with a data parameter downloaded from the cloud of the invention through an analysis software in the electronic device to generate a test result of the subject. The test report of physiological reaction and physiological reaction degree achieves the function of early detection, early prevention and planning. The technology in the previous case uses image recognition technology for detection, which may still cause the system to become a false negative because it cannot judge the image of the screening test paper. The previous case The image judgment technology and the technology in this case are still different in the spectral signal measurement method using a spectrometer, and the spectral signal measurement method in this case is more accurate and can determine the period of infection.
一习知中国大陆专利CN104020286「一种免疫层析试纸条定量检测仪及检测方法」，一种免疫层析试纸条定量检测使用的胶体金、乳胶等免疫层析定量检测 仪及检测方法。将待测样本滴加在预先标记包被了相应的抗原抗体的横向免疫层析试纸条上，然后将试纸条***免疫层析定量检测仪的检测槽内，免疫层析定量检测仪通过多波长扫描确认试纸条的硝酸纤维素膜上的C、T线区域位置颜色色度及背景色度，依据仪器的内置演算法，对质控带和检测带的光密度值进行识别计算分析，得出待测样本所含的阳性标志物的浓度并列印汇报及储存结果值，前案利用多波长扫描多波长扫描颜色色度及背景色度，与与本案技术利用光谱仪的光谱讯号量测仍不相同，且本案光谱讯号量测较为准确且可判断染病的周期确认。A common Chinese patent CN104020286 "An immunochromatographic test strip quantitative detector and a detection method", a colloidal gold, latex and other immunochromatographic quantitative detector and detection method used for quantitative detection of immunochromatographic test strips . The sample to be tested is dropped onto the transverse immunochromatography test paper strip that is pre-labeled and coated with the corresponding antigen and antibody, and then the test paper strip is inserted into the detection slot of the immunochromatography quantitative detector. The immunochromatography quantitative detector passes Multi-wavelength scanning confirms the color, chromaticity and background chromaticity of the C and T line areas on the nitrocellulose membrane of the test strip. Based on the built-in algorithm of the instrument, the optical density values of the quality control band and detection band are identified, calculated and analyzed. , obtain the concentration of the positive marker contained in the sample to be tested and print the report and store the result value. The previous case uses multi-wavelength scanning to scan the color chroma and background chroma, and the technology of this case uses the spectral signal measurement of the spectrometer. It is still different, and the spectral signal measurement in this case is more accurate and can determine the periodic confirmation of the infection.
然而，利用光谱分析仪进行筛检时，使用者应避免以手动方式将筛检试纸制放于对应的位置供光谱分析仪对反应区进行颜色讯号撷取，容易导致置放位置不准确而发生无法撷取的窘境，浪费许多时间于筛检试纸位置调校，另外筛检试纸如果显色不完全也有可能造成误判的结果，因此难以堪称实用，而本案发明则是另用一种筛检试纸读取量测方法，包含使用一光学分析单元，并用以分析该筛检试纸读取***所接收该筛检试纸反应区的检测线条的反射光谱讯号，其特征在于该光学分析单元分析该筛检试纸读取***所检测的反射光谱讯号时，其中该反射光谱讯号经该光学分析单元计算运算后取得一反射率特征值α，并利用该反射率特征值α建立一筛检试纸检体周期表，以进行该检体周期量测及判断。However, when using a spectrum analyzer for screening, users should avoid manually placing the screening test paper in the corresponding position for the spectrum analyzer to capture the color signal of the reaction area, which may easily lead to inaccurate placement and accidents. The dilemma of not being able to capture the test paper wastes a lot of time in adjusting the position of the screening test paper. In addition, if the color development of the screening test paper is incomplete, it may also cause misjudgment. Therefore, it is difficult to be called practical. The invention in this case uses another kind of screening test paper. The test paper reading measurement method includes the use of an optical analysis unit and is used to analyze the reflection spectrum signal of the detection line of the screening test paper reaction area received by the screening test paper reading system, and is characterized in that the optical analysis unit analyzes the When the screening test paper reads the reflection spectrum signal detected by the system, the reflection spectrum signal is calculated by the optical analysis unit to obtain a reflectance characteristic value α, and uses the reflectance characteristic value α to establish a screening test paper sample The periodic table is used to measure and judge the period of the specimen.
发明内容Contents of the invention
本发明的目的之一在于揭露一种筛检试纸读取量测方法，以达到快速筛检以及重复筛检试纸之功效。One of the objects of the present invention is to disclose a screening test paper reading and measurement method to achieve the effects of rapid screening and repeated screening test paper.
本发明的目的之一在于揭露一种筛检试纸读取量测方法，在于该光学分析单元分析该筛检试纸读取***所检测的反射光谱讯号时，其中该反射光谱讯号经该光学分析单元计算运算后取得一反射率特征值α，并利用该反射率特征值α建立一筛检试纸检体周期表，以进行该检体周期量测及判断。One object of the present invention is to disclose a screening test paper reading and measurement method. When the optical analysis unit analyzes the reflection spectrum signal detected by the screening test paper reading system, the reflection spectrum signal passes through the optical analysis unit. After calculation, a reflectance characteristic value α is obtained, and the reflectance characteristic value α is used to establish a periodic table of the screening test paper specimen for periodic measurement and judgment of the specimen.
根据本发明揭露一种筛检试纸读取量测方法，其包含步骤：第一步骤，提供一筛检试纸，其上配置有一筛检试纸反应区，该筛检试纸反应区系可对若干特定检体产生周期性化学反应，并改变该筛检试纸反应区的检测线条的颜色及检测线条的反射光谱讯号；第二步骤，使用一筛检试纸读取***，该筛检试纸读取***进行读取该筛检试纸反应区的检测线条的颜色及检测线条的反射光谱讯号；第三 步骤，再进一步使用一光学分析单元，并用以分析该筛检试纸读取***所接收该筛检试纸反应区的检测线条的反射光谱讯号；第四步骤，其特征在于该光学分析单元分析该筛检试纸读取***所检测的反射光谱讯号时，其中该反射光谱讯号经该光学分析单元计算运算后取得一反射率特征值α，并利用该反射率特征值α建立一筛检试纸检体周期表，以进行该检体周期量测及判断；第五步骤，量测结束。According to the present invention, a screening test paper reading and measuring method is disclosed, which includes the following steps: in the first step, a screening test paper is provided with a screening test paper reaction zone configured on it. The screening test paper reaction zone can be used for several specific tests. The specimen produces periodic chemical reactions and changes the color of the detection line in the reaction area of the screening test paper and the reflection spectrum signal of the detection line; in the second step, a screening test paper reading system is used, and the screening test paper reading system performs Read the color of the detection line in the reaction area of the screening test paper and the reflection spectrum signal of the detection line; in the third step, further use an optical analysis unit to analyze the reaction of the screening test paper received by the screening test paper reading system The reflection spectrum signal of the detection line in the area; the fourth step is characterized in that when the optical analysis unit analyzes the reflection spectrum signal detected by the screening test paper reading system, the reflection spectrum signal is obtained after calculation by the optical analysis unit A reflectance characteristic value α, and using the reflectance characteristic value α to establish a periodic table of the screening test paper specimen to measure and judge the period of the specimen; in the fifth step, the measurement is completed.
如上述的筛检试纸读取量测方法，其中该筛检试纸读取***进一步含有一照光装置，则该照光装置会发射光源照射该筛检试纸，而该筛检试纸读取***会进行读取经该发射光源所照射该筛检试纸反应区的检测线条反射光谱讯号，并后续传送至该光学分析单元进行该反射光谱讯号的运算分析。For example, in the above screening test paper reading and measurement method, the screening test paper reading system further includes a lighting device, then the lighting device will emit a light source to illuminate the screening test paper, and the screening test paper reading system will read The detection line reflection spectrum signal irradiated by the emission light source in the reaction area of the screening test paper is obtained, and subsequently transmitted to the optical analysis unit for calculation and analysis of the reflection spectrum signal.
如上述的筛检试纸读取量测方法，其中该照光装置系为白光发光二极体(White LED)、紫外光发光二极体(UV LED)、近红外线发光二极体(NIR LED)、雷射二极体(Laser diode)、卤素灯泡(Halogen lamp)或钨丝灯源(Tungsten lamp)。Such as the above-mentioned screening test paper reading measurement method, wherein the lighting device is a white light emitting diode (White LED), an ultraviolet light emitting diode (UV LED), a near infrared light emitting diode (NIR LED), Laser diode, halogen lamp or tungsten lamp.
如上述的筛检试纸读取量测方法，其中该筛检试纸读取***再进一步含有一成像放大装置，该成像放大装置系以提供放大经该发射光源所照射反应区的检测线条的反射光谱讯号使用。As described above, the screening test paper reading and measuring method, wherein the screening test paper reading system further includes an imaging amplification device, the imaging amplification device is provided to amplify the reflection spectrum of the detection line irradiated by the emitted light source in the reaction area. Signal usage.
如上述的筛检试纸读取量测方法，其中该成像放大装置的放大倍率系选至为1.5倍-10倍之间。As in the above-mentioned screening test paper reading measurement method, the magnification of the imaging magnification device is selected to be between 1.5 times and 10 times.
如上述的筛检试纸读取量测方法，其中该筛检试纸的特定检体应用为唾液、尿液、血液、水、食品、有毒有害物质或微生物。Such as the above-mentioned screening test paper reading measurement method, wherein the specific sample application of the screening test paper is saliva, urine, blood, water, food, toxic and harmful substances or microorganisms.
如上述的筛检试纸读取量测方法，其中该筛检试纸为新冠肺炎筛检试纸(COVID-19 IgM/IgG Rapid Test Kit)、免疫层析试纸或生物性快筛筛检试纸或免疫抗体快筛筛检试纸用以进行筛检使用。Such as the above-mentioned screening test paper reading measurement method, wherein the screening test paper is a new coronavirus pneumonia screening test paper (COVID-19 IgM/IgG Rapid Test Kit), an immunochromatography test paper or a biological rapid screening screening test paper or an immune antibody Rapid screening test strips are used for screening.
如上述的筛检试纸读取量测方法，其中该反射率特征值α的计算运算方式为不吸收光的反射光谱讯号除以吸收光的反射光谱讯号进行运算所得。For example, in the above-mentioned screening test paper reading measurement method, the reflectance characteristic value α is calculated by dividing the reflection spectrum signal of non-absorbing light by the reflection spectrum signal of absorbing light.
如上述的筛检试纸读取量测方法，其中该不吸收光的反射光谱讯号范围为650nm波长，该吸收光的反射光谱讯号范围为540nm波长。As in the above-mentioned screening test paper reading measurement method, the reflection spectrum signal range of the non-absorbing light is a wavelength of 650 nm, and the reflection spectrum signal range of the absorbing light is a wavelength of 540 nm.
如上述的筛检试纸读取量测方法，其中该筛检试纸检体周期表进一步包含侦测极限值(Limit of Detection，LOD)及定量极限值(Limit of Quantification，LOQ)，其中该侦测极限值范围为100pg/ml，该定量极限值范围为1,000pg/ml。Such as the above-mentioned screening test paper reading measurement method, wherein the screening test paper sample periodic table further includes a detection limit (Limit of Detection, LOD) and a quantitative limit (Limit of Quantification, LOQ), wherein the detection The limiting value range is 100 pg/ml and the quantitative limit value range is 1,000 pg/ml.
如上述的筛检试纸读取量测方法，其其中该光学分析单元为一光学波长分光 装置或一光谱分析仪。As in the above-mentioned screening test paper reading measurement method, the optical analysis unit is an optical wavelength spectrometer or a spectrum analyzer.
如上述的筛检试纸读取量测方法，其中该成像放大装置为一放大透镜与折射镜所组成，提供放大经该发射光源所照射反应区的检测线条的反射光谱讯号使用。As in the above-mentioned screening test paper reading and measurement method, the imaging amplification device is composed of a magnifying lens and a refractor, and is used to amplify the reflection spectrum signal of the detection line illuminated by the emitted light source in the reaction area.
如上述的筛检试纸读取量测方法，其中该检测线条为量测IgM或IgG的显色变化。The above-mentioned screening test paper reading measurement method, wherein the detection line is to measure the color change of IgM or IgG.
第1图系为一种习用筛检试纸示意图。Figure 1 is a schematic diagram of a conventional screening test strip.
第2图系为本发明筛检试纸读取量测方法流程图。Figure 2 is a flow chart of the screening test paper reading and measurement method of the present invention.
第3图系为本发明筛检试纸读取量测方法的***之结构分解堆迭之侧视图。Figure 3 is an exploded and stacked side view of the system of the screening test strip reading and measurement method of the present invention.
第4图系为本发筛检试纸读取量测方法的成像放大装置示意图。Figure 4 is a schematic diagram of the imaging amplification device of the screening test paper reading and measurement method of the present invention.
第5图系为本发明筛检试纸读取量测方法的反射率特征值α曲线图。Figure 5 is a graph of the reflectance characteristic value α of the screening test paper reading measurement method of the present invention.
第6图系为本发明一筛检试纸检体抗体曲线图。Figure 6 is a sample antibody curve chart of a screening test paper of the present invention.
第7图系为本发明各种IgM/IgG浓度检测吸收光及不吸收光反射光谱讯号范围图。Figure 7 is a diagram showing the range of absorbed light and non-absorbed light reflection spectrum signals detected at various IgM/IgG concentrations according to the present invention.
第8图系为本发明各种IgM/IgG浓度试纸显色图。Figure 8 is a color diagram of various IgM/IgG concentration test papers of the present invention.
在说明书及后续的申请专利范围当中使用了某些词汇来指称特定的元件。所属领域中具有通常知识者应可理解，硬体制造商可能会用不同的名词来称呼同一个元件。本说明书及后续的申请专利范围并不以名称的差异来作为区分元件的方式，而是以元件在功能上的差异来作为区分的准则。在通篇说明书及后续的请求项当中所提及的「包含」系为一开放式的用语，故应解释成「包含但不限定于」。Certain words are used in the description and subsequent patent claims to refer to specific components. It will be understood by those with ordinary knowledge in the art that hardware manufacturers may use different terms to refer to the same component. This specification and subsequent patent applications do not use differences in names as a way to distinguish components, but differences in functions of components as a criterion for distinction. The "include" mentioned throughout the description and subsequent claims is an open-ended term, so it should be interpreted as "include but not limited to".
第2图系分别为本发明筛检试纸读取量测方法流程图，本发明的筛检试纸读取量测方法，当使用者预计进行量测试纸读取时启动动作100，接续进行第一步骤200，提供使用者使用一筛检试纸20，该筛检试纸20其上配置有一筛检试纸反应区21，该筛检试纸反应区21系可对若干特定检体产生周期性化学反应例如(免疫层析变化/染色变化/C/IgM/IgG显色变话)，并改变该筛检试纸反应区的检测线条的颜色及检测线条的反射光谱讯号，接续第二步骤300，使用一筛检试纸 读取***40，利用该筛检试纸读取***40进行读取该筛检试纸反应区的检测线条的颜色及检测线条的反射光谱讯号，在如第三步骤400，再进一步使用一光学分析单元30，并用以分析该筛检试纸读取***40所接收该筛检试纸反应区的检测线条的反射光谱讯号；在接续第四步骤500，其特征在于该光学分析单元30分析该筛检试纸读取***40所检测的反射光谱讯号时，其中该反射光谱讯号经该光学分析单元30计算运算后取得一反射率特征值α曲线，如图5筛检试纸读取量测方法的反射率特征值α曲线图所示，其中该反射率特征值α的计算运算方式为不吸收光的反射光谱讯号除以吸收光的反射光谱讯号进行运算所得，其中该不吸收光的反射光谱讯号范围为650nm波长之间，该吸收光的反射光谱讯号范围为540nm波长之间，如图7之间所示，并再利用该反射率特征值α建立一筛检试纸检体抗体曲线表，如图6一筛检试纸检体抗体曲线图所意示，其中如图6中的进一步包含侦测极限值(Limit of Detection，LOD)及定量极限值(Limit of Quantification，LOQ)标注，其中该侦测极限值范围为100pg/ml之间，该定量极限值范围为1,000pg/ml之间，上述筛检试纸读取量测方法用以提供使用者进行该筛检试纸中针对特定检体的该检体量测周期进行量测及判断，接续如不进行量测动作则进行结束程序，如第五步骤600量测结束。Figure 2 is a flow chart of the screening test paper reading and measuring method of the present invention. In the screening test paper reading and measuring method of the present invention, when the user expects to read the measuring test paper, action 100 is started, and the first step is continued. Step 200: Provide the user with a screening test paper 20, which is equipped with a screening test paper reaction zone 21. The screening test paper reaction zone 21 can produce periodic chemical reactions for a number of specific samples, such as ( Immunochromatographic changes/staining changes/C/IgM/IgG color changes), and change the color of the detection line in the reaction area of the screening test paper and the reflection spectrum signal of the detection line, continue with the second step 300, use a screening test The test paper reading system 40 uses the screening test paper reading system 40 to read the color of the detection line in the reaction area of the screening test paper and the reflection spectrum signal of the detection line. In the third step 400, an optical analysis is further used. The unit 30 is used to analyze the reflection spectrum signal of the detection line of the reaction area of the screening test paper received by the screening test paper reading system 40; in the fourth step 500, the feature is that the optical analysis unit 30 analyzes the screening test paper When reading the reflection spectrum signal detected by the system 40, the reflection spectrum signal is calculated by the optical analysis unit 30 to obtain a reflectance characteristic value α curve, as shown in Figure 5. Reflectance characteristics of the screening test paper reading measurement method. As shown in the value α curve, the calculation method of the reflectivity characteristic value α is the reflection spectrum signal that does not absorb light divided by the reflection spectrum signal that absorbs light, and the range of the reflection spectrum signal that does not absorb light is 650nm. Between wavelengths, the reflection spectrum signal range of the absorbed light is between 540nm wavelengths, as shown in Figure 7, and then use the reflectivity characteristic value α to establish a screening test paper sample antibody curve table, as shown in Figure 6 The antibody curve of the screening test paper sample is shown in Figure 6, which further includes the detection limit (Limit of Detection, LOD) and the quantification limit (Limit of Quantification, LOQ) annotation, where the detection limit is The range is between 100pg/ml, and the quantitative limit range is between 1,000pg/ml. The above-mentioned screening test paper reading measurement method is used to provide the user with the amount of the specific sample in the screening test paper for a specific sample. Measurement and judgment are performed during the measurement cycle. If no measurement action is performed, the end procedure will be performed. For example, the fifth step 600 ends the measurement.
在如图3筛检试纸读取量测方法的***之结构分解堆迭之侧视图中所示，为本案之实施例构件由一筛检试纸20、一筛检试纸读取***40及一试纸载台单元41所组成，其中该筛检试纸读取***40进一步含有一读取照光装置10及一读取装置11，该筛检试纸20放入该试纸载台单元41时，则该读取照光装置10发射光源照射，而该筛检试纸读取***40会进行读取经该发射光源所照射该筛检试纸反应区的检测线条反射光谱讯号，并后续传送至该光学分析单元30进行该反射光谱讯号的运算分析。接续上述如图3中本案一实施例的读取方法，当一种筛检试纸读取***40进行读取操作时，其中该筛检试纸读取***40其包含一读取照光装置10及一读取装置11，上述装置并进行读取照光之使用；另外有一筛检试纸20，其上配置有一反应区，该反应区系可对若干特定检体(如尿液或血液等等)产生化学反应，并改变该反应区的检测线条的颜色，上述该筛检试纸为新冠肺炎筛检试纸(COVID-19 IgM/IgG Rapid Test Kit)可快速进行新冠肺炎筛检；另一光学分析单元30，系连接该读取照光装置10，该光学分析单元为一微型光谱分析仪，用以分析经该读取装置11所接收该筛检试纸反应区的检测线条影像 之光谱讯号；另外如本实施例的筛检试纸读取量测方法，当筛检试纸读取***40，其中该试纸载台单元41，用以容置该筛检试纸20，当该筛检试纸20固定于该试纸载台单元41上，该筛检试纸读取***40进行读取该筛检试纸反应区的检测线条的颜色及检测线条的反射光谱讯号，再进一步使用一光学分析单元30，并用以分析该筛检试纸读取***40所接收该筛检试纸反应区的检测线条的反射光谱讯号，则该读取照光装置10会发射光源照射该筛检试纸20，则该读取照光装置10进一步含有一照光装置12，则该照光装置12会发射光源照射该筛检试纸20，而该筛检试纸读取***40会进行读取经该发射光源所照射该筛检试纸反应区的检测线条反射光谱讯号，并后续传送至该光学分析单元30进行该反射光谱讯号的运算分析，接续上述实施例该照光装置12系为白光发光二极体(White LED)，该读取装置11会进行读取经该发射光源所照射该反应区的检测线条反射影像光谱讯号，并后续传送至该光学分析单元30进行该反射影像光谱讯号的运算分析，上述实施例中的该筛检试纸的特定检体可应用为唾液、尿液、血疫、水、食品、有毒有害物质或微生物范围，其中上述实施例中该筛检试纸可替换为免疫层析试纸、生物性快筛筛检试纸或免疫抗体快筛筛检试纸，其中上述该实施例中该照光装置12系可替为紫外光发光二极体(UV LED)、近红外线发光二极体(NIR LED)、雷射二极体(Laser diode)、卤素灯泡(Halogen lamp)或钨丝灯源(Tungsten lamp)，上述实施例该光学分析单元可替换为一光学波长分光装置。As shown in the side view of the structure of the system of the screening test paper reading measurement method in Figure 3, which is an exploded and stacked structure, the components of the embodiment of the present case are composed of a screening test paper 20, a screening test paper reading system 40 and a test paper The screening test paper reading system 40 further includes a reading illumination device 10 and a reading device 11. When the screening test paper 20 is placed in the test paper carrying stage unit 41, the reading system 40 further includes a reading illumination device 10 and a reading device 11. The illumination device 10 emits a light source, and the screening test paper reading system 40 reads the detection line reflection spectrum signal of the reaction area of the screening test paper illuminated by the emitted light source, and subsequently transmits it to the optical analysis unit 30 for the Computational analysis of reflection spectrum signals. Continuing the reading method of the embodiment of the present invention shown in Figure 3, when a screening test paper reading system 40 performs a reading operation, the screening test paper reading system 40 includes a reading illumination device 10 and a reading illumination device 10. Reading device 11, the above device is also used for reading illumination; there is also a screening test paper 20, which is equipped with a reaction zone, which can produce chemicals for certain specific samples (such as urine or blood, etc.) reaction, and changes the color of the detection line in the reaction area. The above-mentioned screening test paper is a new coronavirus pneumonia screening test paper (COVID-19 IgM/IgG Rapid Test Kit), which can quickly conduct new coronavirus pneumonia screening; another optical analysis unit 30, Connected to the reading illumination device 10, the optical analysis unit is a micro spectrum analyzer, used to analyze the spectral signal of the detection line image of the reaction area of the screening test paper received by the reading device 11; in addition, as in this embodiment In the screening test paper reading and measurement method, when the screening test paper reading system 40 is provided, the test paper carrier unit 41 is used to accommodate the screening test paper 20, and when the screening test paper 20 is fixed on the test paper carrier unit 41, the screening test paper reading system 40 reads the color of the detection line in the reaction area of the screening test paper and the reflection spectrum signal of the detection line, and then further uses an optical analysis unit 30 to analyze the reading of the screening test paper. Taking the reflection spectrum signal of the detection line of the reaction area of the screening test paper received by the system 40, the reading lighting device 10 will emit a light source to illuminate the screening test paper 20, and the reading lighting device 10 further includes a lighting device 12, Then the lighting device 12 will emit a light source to illuminate the screening test paper 20, and the screening test paper reading system 40 will read the detection line reflection spectrum signal of the reaction area of the screening test paper illuminated by the emitted light source, and subsequently transmit it. The optical analysis unit 30 performs calculation and analysis of the reflection spectrum signal. Following the above embodiment, the lighting device 12 is a white light emitting diode (White LED), and the reading device 11 reads the light irradiated by the emitting light source. The detection lines in the reaction area reflect the image spectrum signal, and are subsequently sent to the optical analysis unit 30 for calculation and analysis of the reflected image spectrum signal. The specific sample of the screening test paper in the above embodiment can be applied to saliva, urine , blood epidemic, water, food, toxic and harmful substances or microorganism range, wherein in the above embodiment, the screening test paper can be replaced by an immune chromatography test paper, a biological rapid screening screening test paper or an immune antibody rapid screening screening test paper, wherein the above In this embodiment, the lighting device 12 can be replaced by an ultraviolet light emitting diode (UV LED), a near infrared light emitting diode (NIR LED), a laser diode (Laser diode), or a halogen lamp. Or a tungsten lamp source (Tungsten lamp), the optical analysis unit in the above embodiment can be replaced by an optical wavelength spectrometer device.
接续上述方法实施例如以检测病患的尿醣数值的例子来说，如果已经确定拿取的筛检试纸为尿醣专用，则可直接进行检测，即将待检尿液与筛检试纸20的反应进行接触(通常为滴入或是渗入的方式来进行)，反应区里面的成分就会与待检尿液产生化学反应，并改变反应区的颜色。此外，反应区内可以包含多种不同的检测区，用以检测尿液中的葡萄糖、蛋白质、酸碱值、潜血值或其他生理数值，达到一次筛检多种数值的功效。待检尿液与筛检试纸的反应区进行接触反应后，可将筛检试纸20置入该试纸载台单元41，并将后续光学分析单元30进行该读取装置11会进行读取经该发射光源所照射该反应区的检测线条反射影像光谱讯号，并后续传送至该光学分析单元30进行该反射影像光谱讯号的运算分析，如图6中所示上述该筛检试纸20可替为新冠肺炎筛检试纸(COVID-19 IgM/IgG Rapid Test Kit)，其中该筛检试纸的检测线条系为IgM或IgG，上述筛检试纸可快速进行新冠肺炎筛检，另外本案技术可以精准量测筛检试纸的待测物之反应光 谱讯号，并且可以达到快速筛检及快速替换筛检试纸之目的，并解决可能一般快速筛检试纸可能会造成新冠肺炎疫情的伪阴性线条之误差判断。Continuing with the implementation of the above method, taking the example of detecting the patient's urine sugar value, if it has been determined that the screening test paper taken is specifically for urine sugar, the detection can be directly performed, that is, the reaction between the urine to be tested and the screening test paper 20 After contact (usually by dripping or infiltration), the components in the reaction zone will react chemically with the urine to be tested and change the color of the reaction zone. In addition, the reaction area can contain a variety of different detection areas for detecting glucose, protein, pH value, occult blood value or other physiological values in urine, achieving the effect of screening multiple values at one time. After the urine to be tested contacts and reacts with the reaction area of the screening test paper, the screening test paper 20 can be placed into the test paper carrier unit 41, and the subsequent optical analysis unit 30 can be used to read the reading device 11. The reflection image spectrum signal of the detection line illuminated by the emitted light source in the reaction area is subsequently transmitted to the optical analysis unit 30 for calculation and analysis of the reflection image spectrum signal. As shown in Figure 6, the above-mentioned screening test paper 20 can be replaced by a new coronavirus Pneumonia screening test kit (COVID-19 IgM/IgG Rapid Test Kit), in which the detection line of the screening test paper is IgM or IgG. The above-mentioned screening test paper can quickly screen for new coronavirus pneumonia. In addition, the technology of this case can accurately measure the screening test kit. The test paper detects the reaction spectrum signal of the substance to be tested, and can achieve the purpose of rapid screening and rapid replacement of the screening test paper, and solve the error judgment of false negative lines that may be caused by the general rapid screening test paper of the new coronavirus epidemic.
再接续上述方法实施例，如图4筛检试纸读取量测方法的成像放大装置示意图，其中该读取装置11进一步含有一成像放大装置，该成像放大装置系以提供放大经该发射光源所照射反应区的检测线条的反射影像光谱讯号使用，如图4中所示其中该成像放大装置为一放大透镜101与折射镜102所组成，其中该成像放大装置的放大倍率系选至为1.5倍-10倍之间，其中当该读取装置11进行读取经该发射光源所照射该反应区的检测线条反射影像光谱讯号时，该检测线条反射影像光谱讯号会先经过该放大透镜101与折射镜102及一光接收通路103进行放大讯号后将传送至该光学分析单元的读取头31接收再进行后续光学分析，接续上述实施例，其中当读取装置11进行读取经该发射光源所照射该反应区的检测线条反射影像光谱讯号时，如本案实施例所选定成像放大装置的放大倍率时，其中该原本的读取检测线条反射影像宽度经成像放大装置放大后，在光学分析单元的读取头31接收的影像讯号变大，而后续该光学分析单元30就所接收到放大讯号进行分析，上述装置得以解决及避免使用者因新冠肺炎筛检试纸、免疫层析试纸、生物性快筛筛检试纸或免疫抗体快筛筛检试纸的检测线条的产品，发生与待测物反应之后不显色或者线条不明显或可能造成伪阴性线条状况，进而造成检测的误差判断。Continuing with the above method embodiment, as shown in Figure 4, a schematic diagram of the imaging amplification device of the screening test paper reading and measurement method, wherein the reading device 11 further includes an imaging amplification device, the imaging amplification device is provided to amplify the image captured by the emitted light source. The reflected image spectrum signal of the detection line irradiating the reaction area is used, as shown in Figure 4, in which the imaging magnifying device is composed of a magnifying lens 101 and a refractor 102, and the magnification of the imaging magnifying device is selected to be 1.5 times. -10 times, when the reading device 11 reads the detection line reflection image spectrum signal illuminated by the emitted light source in the reaction area, the detection line reflection image spectrum signal will first pass through the magnifying lens 101 and refraction The mirror 102 and a light receiving path 103 amplify the signal and then send it to the reading head 31 of the optical analysis unit to receive and then perform subsequent optical analysis. Continuing the above embodiment, when the reading device 11 reads the light emitted by the emitted light source, When the detection line reflection image spectral signal of the reaction area is irradiated, when the magnification of the imaging amplification device is selected in the embodiment of this case, the width of the original read detection line reflection image is amplified by the imaging amplification device, and then in the optical analysis unit The image signal received by the reading head 31 becomes larger, and the optical analysis unit 30 subsequently analyzes the received amplified signal. The above device can solve and avoid the user's problems with COVID-19 screening test paper, immunochromatography test paper, biological test paper, etc. Rapid screening test strips or immune antibody rapid screening test strips have detection lines that do not develop color or have unclear lines after reacting with the substance to be tested, or may cause false negative lines, thereby causing incorrect detection judgments.
再接续上述方法实施例，当本发明方法其特征在于该光学分析单元30分析该筛检试纸读取***40所检测的反射光谱讯号时，其中该反射光谱讯号经该光学分析单元30计算运算后取得一反射率特征值α，其中该反射率特征值α的计算运算方式为不吸收光的反射光谱讯号除以吸收光的反射光谱讯号进行运算所得，其中该不吸收光的反射光谱讯号范围为650nm波长之间，该吸收光的反射光谱讯号范围为540nm波长之间，如图7为各种IgM/IgG浓度检测吸收光及不吸收光反射光谱讯号范围图所示。Continuing with the above method embodiment, the method of the present invention is characterized in that the optical analysis unit 30 analyzes the reflection spectrum signal detected by the screening test paper reading system 40, wherein the reflection spectrum signal is calculated by the optical analysis unit 30 Obtain a reflectance characteristic value α, where the calculation method of the reflectance characteristic value α is to divide the reflection spectrum signal that does not absorb light by the reflection spectrum signal that absorbs light, and the range of the reflection spectrum signal that does not absorb light is The reflection spectrum signal range of the absorbed light is between the wavelength of 650nm and the wavelength of 540nm. Figure 7 shows the range of the reflection spectrum signal of absorbed light and non-absorbed light detected at various IgM/IgG concentrations.
就上述举例的方法实施例，本案发明筛检试纸读取方法可解决伪阴性误差判断及使用者可利用此能试纸载台单元41达到快速替换筛检试纸20已达到重复筛检目的。According to the above example method embodiment, the screening test paper reading method of the present invention can solve the false negative error judgment and the user can use the test paper carrier unit 41 to quickly replace the screening test paper 20 to achieve the purpose of repeated screening.
如图8各种IgM/IgG浓度试纸显色图为各种检测筛检试纸20，其中筛检试纸的检测可筛检出IgM/IgG的范围值从0.5ng/ml至1000ng/ml皆可以利用本案 方法进一步检测及进行量测IgM或IgG的显色变化及数值确认。As shown in Figure 8, the color diagrams of various IgM/IgG concentration test papers are various detection screening test papers 20. The screening test paper can detect IgM/IgG in a range from 0.5ng/ml to 1000ng/ml. The method in this case further detects and measures the color changes of IgM or IgG and confirms the values.
详细说明上述本发明的各项较佳实施例之后，熟悉该项技术人士可清楚的了解，在不脱离下述申请专利范围与精神下可进行各种变化与改变，如限位单元的各种实施态样等等，亦不受限于说明书之实施例的实施方式。After describing in detail the various preferred embodiments of the present invention, those skilled in the art can clearly understand that various changes and changes can be made without departing from the scope and spirit of the following patent application, such as various changes in the limiting unit. Implementation aspects, etc. are not limited to the implementation modes of the examples in the description.
Claims (10)
- 一种筛检试纸读取量测方法，其包含步骤：A screening test paper reading and measurement method, which includes the steps:第一步骤，提供一筛检试纸，其上配置有一筛检试纸反应区，该筛检试纸反应区系可对若干特定检体产生周期性化学反应，并改变该筛检试纸反应区的检测线条的颜色及检测线条的反射光谱讯号；The first step is to provide a screening test paper with a screening test paper reaction zone configured on it. The screening test paper reaction zone can produce periodic chemical reactions to a number of specific specimens and change the detection lines of the screening test paper reaction zone. The color and reflection spectrum signal of the detection line;第二步骤，使用一筛检试纸读取***，该筛检试纸读取***进行读取该筛检试纸反应区的检测线条的颜色及检测线条的反射光谱讯号；In the second step, a screening test paper reading system is used. The screening test paper reading system reads the color of the detection line in the reaction area of the screening test paper and the reflection spectrum signal of the detection line;第三步骤，再进一步使用一光学分析单元，并用以分析该筛检试纸读取***所接收该筛检试纸反应区的检测线条的反射光谱讯号；In the third step, an optical analysis unit is further used to analyze the reflection spectrum signal of the detection line of the reaction area of the screening test paper received by the screening test paper reading system;第四步骤，其特征在于该光学分析单元分析该筛检试纸读取***所检测的反射光谱讯号时，其中该反射光谱讯号经该光学分析单元计算运算后取得一反射率特征值α，并利用该反射率特征值α建立一筛检试纸检体周期表，以进行该检体周期量测及判断；以及The fourth step is characterized in that when the optical analysis unit analyzes the reflection spectrum signal detected by the screening test paper reading system, the reflection spectrum signal is calculated by the optical analysis unit to obtain a reflectance characteristic value α, and uses The reflectivity characteristic value α establishes a periodic table of the screening test paper sample for periodic measurement and judgment of the sample; and第五步骤，量测结束。The fifth step is to end the measurement.
- 根据权利要求1所述的筛检试纸读取量测方法，其中该筛检试纸读取***进一步含有一照光装置，则该照光装置会发射光源照射该筛检试纸，而该筛检试纸读取***会进行读取经该发射光源所照射该筛检试纸反应区的检测线条反射光谱讯号，并后续传送至该光学分析单元进行该反射光谱讯号的运算分析。The screening test paper reading and measuring method according to claim 1, wherein the screening test paper reading system further includes a lighting device, then the lighting device emits a light source to illuminate the screening test paper, and the screening test paper reads The system will read the reflection spectrum signal of the detection line illuminated by the emitted light source in the reaction area of the screening test paper, and then transmit it to the optical analysis unit for calculation and analysis of the reflection spectrum signal.
- 根据权利要求2所述的筛检试纸读取量测方法，其中该筛检试纸读取***再进一步含有一成像放大装置，该成像放大装置系以提供放大经该发射光源所照射反应区的检测线条的反射光谱讯号使用。The screening test paper reading and measuring method according to claim 2, wherein the screening test paper reading system further includes an imaging amplification device, the imaging amplification device is provided to amplify the detection of the reaction area illuminated by the emitted light source. The reflection spectrum signal of the line is used.
- 根据权利要求3所述的筛检试纸读取量测方法，其中该成像放大装置的放大倍率系选至为1.5倍-10倍之间。The screening test paper reading and measuring method according to claim 3, wherein the magnification of the imaging magnification device is selected to be between 1.5 times and 10 times.
- 根据权利要求1所述的筛检试纸读取量测方法，其中该筛检试纸的特定检体应用为唾液、尿液、血液、水、食品、有毒有害物质或微生物。The screening test paper reading and measuring method according to claim 1, wherein the specific sample of the screening test paper is saliva, urine, blood, water, food, toxic and harmful substances or microorganisms.
- 根据权利要求5所述的筛检试纸读取量测方法，其中该反射率特征值α的计算运算方 式为不吸收光的反射光谱讯号除以吸收光的反射光谱讯号进行运算所得。The screening test paper reading and measuring method according to claim 5, wherein the reflectance characteristic value α is calculated by dividing the reflection spectrum signal of non-absorbing light by the reflection spectrum signal of absorbing light.
- 根据权利要求6所述的筛检试纸读取量测方法，其中该不吸收光的反射光谱讯号范围为650nm波长，该吸收光的反射光谱讯号范围为540nm波长。The screening test paper reading and measuring method according to claim 6, wherein the reflection spectrum signal range of the non-absorbing light is a wavelength of 650 nm, and the reflection spectrum signal range of the absorbing light is a wavelength of 540 nm.
- 根据权利要求7所述的筛检试纸读取量测方法，其中该筛检试纸检体周期表进一步包含侦测极限值(Limit of Detection，LOD)及定量极限值(Limit of Quantification，LOQ)，其中该侦测极限值范围为100pg/ml，该定量极限值范围为1,000pg/ml。The screening test paper reading measurement method according to claim 7, wherein the periodic table of the screening test paper sample further includes a detection limit (Limit of Detection, LOD) and a quantitative limit (Limit of Quantification, LOQ), The detection limit range is 100pg/ml, and the quantification limit range is 1,000pg/ml.
- 根据权利要求4所述的筛检试纸读取量测方法，其中该成像放大装置为一放大透镜与折射镜所组成，提供放大经该发射光源所照射反应区的检测线条的反射光谱讯号使用。The screening test paper reading and measuring method according to claim 4, wherein the imaging magnifying device is composed of a magnifying lens and a refractor, and is used to amplify the reflection spectrum signal of the detection line in the reaction area illuminated by the emitting light source.
- 根据权利要求8所述的筛检试纸读取量测方法，其中该检测线条为量测IgM或IgG的显色变化。The screening test paper reading measurement method according to claim 8, wherein the detection line measures the color change of IgM or IgG.
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