WO2024026855A1 - Neutralizing antibody period reading and measurement method based on rapid screening test strip - Google Patents

Neutralizing antibody period reading and measurement method based on rapid screening test strip Download PDF

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Publication number
WO2024026855A1
WO2024026855A1 PCT/CN2022/110640 CN2022110640W WO2024026855A1 WO 2024026855 A1 WO2024026855 A1 WO 2024026855A1 CN 2022110640 W CN2022110640 W CN 2022110640W WO 2024026855 A1 WO2024026855 A1 WO 2024026855A1
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screening test
test paper
neutralizing antibody
line
reading
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PCT/CN2022/110640
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French (fr)
Chinese (zh)
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柯正浩
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柯正浩
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Priority to PCT/CN2022/110640 priority Critical patent/WO2024026855A1/en
Priority to CN202280002570.7A priority patent/CN117859050A/en
Publication of WO2024026855A1 publication Critical patent/WO2024026855A1/en

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01J—MEASUREMENT OF INTENSITY, VELOCITY, SPECTRAL CONTENT, POLARISATION, PHASE OR PULSE CHARACTERISTICS OF INFRARED, VISIBLE OR ULTRAVIOLET LIGHT; COLORIMETRY; RADIATION PYROMETRY
    • G01J3/00—Spectrometry; Spectrophotometry; Monochromators; Measuring colours
    • G01J3/28—Investigating the spectrum
    • G01J3/42—Absorption spectrometry; Double beam spectrometry; Flicker spectrometry; Reflection spectrometry
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers

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  • the invention relates to a rapid screening test paper neutralizing antibody cycle reading and measuring method, and in particular, a method for rapidly measuring the neutralizing antibody cycle reading and measuring method produced by screening the COVID-19 vaccine after vaccination.
  • 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 method of measuring the spectral signal using a spectrometer, and the method of measuring the spectral signal in this case is more accurate and can determine the neutralizing antibody response generated after vaccination.
  • 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 confirm the neutralizing antibody response generated after vaccination.
  • the screening test paper neutralizing antibody cycle 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 by the 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 neutralizing antibody coefficient N AB , and uses the neutralizing antibody coefficient N AB A periodic table of the neutralizing antibody coefficient calibration line of the screening test paper sample is established to measure and judge the neutralizing antibody cycle of the sample.
  • One of the purposes of the present invention is to disclose a rapid screening test paper neutralizing antibody cycle reading and measuring method, so as to achieve the effect of quickly screening and detecting the neutralizing antibody cycle produced after the COVID-19 vaccine is administered.
  • One object of the present invention is to disclose a rapid screening test paper neutralizing antibody cycle reading measurement method, when the optical analysis unit analyzes the reflection spectrum signal detected by the screening test paper reading system, wherein the reflection spectrum signal After calculation by the optical analysis unit, a neutralizing antibody coefficient NAB is obtained, and the neutralizing antibody coefficient NAB is used to establish a periodic table of neutralizing antibody coefficients of the screening test paper specimen to carry out the neutralizing antibody cycle of the specimen. Measurement and judgment.
  • a rapid screening test paper neutralizing antibody cycle reading and measurement method which includes the following steps: a first step is to provide a screening test paper with a screening test paper reaction area configured on it, and the screening test paper reaction area is The system can produce chemical reactions on certain specific specimens and change the color of the detection lines in the reaction area of the screening test paper and the reflection spectrum signal of the detection lines; in the second step, a screening test paper reading system is used, and the screening test paper reads The system is used 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, an optical analysis unit is further used to analyze the screen received by the screening test paper reading system.
  • the reflection spectrum signal of the detection line in the reaction area of the test paper; 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 After the calculation, a neutralizing antibody coefficient N AB is obtained, and the neutralizing antibody coefficient N AB is used to establish a periodic table of the neutralizing antibody coefficient calibration line of the screening test paper specimen to measure the neutralizing antibody cycle of the specimen Judgment; the fifth step is to end the measurement.
  • 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 acquisition system will read the reflection spectrum signal of the detection line illuminated by the emission 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.
  • the lighting device is a white light-emitting diode (White LED), an ultraviolet light-emitting diode (UV LED), or a near-infrared light-emitting diode. (NIR LED), laser diode (Laser diode), halogen lamp (Halogen lamp) or tungsten lamp (Tungsten lamp).
  • White LED white light-emitting diode
  • UV LED ultraviolet light-emitting diode
  • NIR LED near-infrared light-emitting diode
  • laser diode Laser diode
  • halogen lamp Halogen lamp
  • tungsten lamp Tungsten lamp
  • the rapid screening test paper neutralizing antibody cycle reading measurement method wherein the screening test paper reading system further includes an imaging magnifying device, the imaging magnifying device is provided to amplify the reaction area illuminated by the emitted light source. Used to detect line reflection spectrum signals.
  • the magnification of the imaging magnification device is selected to be between 1.5 times and 10 times.
  • the screening test paper is a COVID-19 screening test paper (COVID-19 IgM/IgG Rapid Test Kit), an immunochromatographic test paper or an immune neutralizing antibody rapid test paper Screening test paper is used for screening.
  • the detection line is a control line (C line) or a test line (T line).
  • the above-mentioned rapid screening test paper neutralizing antibody cycle reading measurement method wherein the calculation method of the neutralizing antibody coefficient N AB is the highest peak absorption wavelength of the control line of the screening test paper and the highest absorption light wavelength of the measurement line The slope calculation of the absorption difference calculated from the peak value.
  • the wavelength range of the absorbed light is between 400nm and 700nm.
  • the neutralizing antibody coefficient N AB further includes a detection limit (Limit of Detection, LOD) and a quantification limit (Limit of Quantification, LOQ),
  • the detection limit value range is 15IU/ml
  • the quantification limit value range is 50IU/ml.
  • optical analysis unit is an optical wavelength spectrometer device or a spectrum analyzer.
  • the imaging magnifying device is composed of a magnifying lens and a refractor, and provides amplification of the reflection spectrum signal of the detection line illuminated by the emitted light source in the reaction area.
  • Figure 1 is a schematic diagram of a conventional screening test strip.
  • Figure 2 is a flow chart of the rapid screening test paper neutralizing antibody cycle reading and measurement method of the present invention.
  • Figure 3 is a side view of the decomposed and stacked structure of the system of the rapid screening test paper neutralizing antibody cycle reading measurement method of the present invention.
  • Figure 4 is a schematic diagram of the imaging amplification device of the rapid screening test paper neutralizing antibody cycle reading and measurement method of the present invention.
  • Figure 5 is a calculation diagram of the neutralizing antibody coefficient of the neutralizing antibody cycle reading measurement method of the rapid screening test paper of the present invention.
  • Figure 6 is a diagram of the neutralizing antibody screening test strips for each cycle tested in the present invention.
  • Figure 7 is a screening test paper and cycle curve chart for detecting neutralizing antibodies in each cycle of the present invention.
  • Figure 8 is a periodic table diagram of a calibration curve for the neutralizing antibody coefficient N AB of a screening test paper specimen according to the present invention.
  • Figure 9 is a comparison chart between the periodic table of the neutralizing antibody coefficient N AB calibration curve of the present invention and ELISA.
  • FIG. 2 is a flow chart of the rapid screening test paper neutralizing antibody cycle reading and measuring method of the present invention.
  • the rapid screening test paper neutralizing antibody cycle reading and measuring method of the present invention When the user expects to perform quantitative test paper reading When taking the action 100 is started, and the first step 200 is continued to provide the user with a screening test paper 20.
  • the screening test paper 20 is equipped with a screening test paper reaction area 21.
  • the screening test paper reaction area 21 can be used for a plurality of Specific specimens produce chemical reactions such as (immunochromatographic changes/staining changes/color changes of C/IgM/IgG/control lines/test lines), and change the color and direction of the detection lines in the reaction area of the screening test paper
  • a screening test paper reading system 40 is used for the reflection spectrum signal.
  • the screening test paper reading system 40 is used 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 unit 30 is further 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 40; in the fourth step 500 , which is characterized in that when the optical analysis unit 30 analyzes the reflection spectrum signal detected by the screening test paper reading system 40, the reflection spectrum signal is calculated by the optical analysis unit 30 to obtain a neutralizing antibody coefficient N AB , and
  • the neutralizing antibody coefficient N AB is used to establish a periodic table of the neutralizing antibody coefficient calibration line of the screening test paper specimen to measure and judge the neutralizing antibody cycle of the specimen.
  • One of the neutralizing antibody coefficient N AB is as shown in the figure 5.
  • the neutralizing antibody coefficient calculation method of the rapid screening test paper neutralizing antibody cycle reading measurement method is shown in the calculation method of the neutralizing antibody coefficient N AB .
  • the calculation method of the neutralizing antibody coefficient N AB is the screening test.
  • the components of the embodiment of the present case are composed of a screening test paper 20 and a screening test paper reading
  • the system 40 is composed of a test paper carrier unit 41, wherein the screening test paper reading system 40 further includes a reading illumination device 10 and a reading device 11.
  • the reading 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 emitting light source, and subsequently transmits it to the optical
  • the analysis unit 30 performs computational analysis on the reflection spectrum signal.
  • 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 chemical reactions for certain specific samples (such as blood, etc.), and Change the color of the test line in the reaction area.
  • the above-mentioned screening test paper is a COVID-19 IgM/IgG Rapid Test Kit, which can quickly conduct COVID-19 screening or COVID-19 neutralizing antibody cycle screening test paper;
  • Another optical analysis unit 30 is connected to the reading illumination device 10.
  • the optical analysis unit is a micro spectrum analyzer for analyzing the spectrum of the detection line image of the reaction area of the screening test paper received by the reading device 11. signal or signal reflected by the gold nanoparticles of the detection line (not shown); in addition, as in the rapid screening test paper neutralizing antibody cycle reading measurement method of this embodiment, when the screening test paper reading system 40, wherein the test paper
  • the carrier unit 41 is used to accommodate the screening test paper 20. When the screening test paper 20 is fixed on the test paper carrier unit 41, the screening test paper reading system 40 reads the detection of the reaction area of the screening test paper.
  • the color of the line and the reflection spectrum signal of the detection line or the reflection signal of the gold nanoparticles of the detection line are further used to further use an optical analysis unit 30 to analyze the reaction area of the screening test paper received by the screening test paper reading system 40 If the reflection spectrum signal of the detection line or the signal reflected by the gold nanoparticles of the detection line is detected, 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 or detection line of the reaction area of the screening test paper illuminated by the emitting light source.
  • the signal reflected by the gold nanoparticles is subsequently transmitted to the optical analysis unit 30 for 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 will read the reflection image spectrum signal of the detection line illuminated by the emitted light source in the reaction area, and then transmit it to the optical analysis unit 30 for calculation and analysis of the reflection image spectrum signal.
  • the screening test paper in the above embodiment The specific sample can be applied to the blood range.
  • the screening test paper can be replaced by an immunochromatography test paper or an immune neutralizing antibody rapid screening test paper.
  • the illumination device 12 can be replaced by Ultraviolet light emitting diode (UV LED), near infrared light emitting diode (NIR LED), laser diode (Laser diode), halogen lamp (Halogen lamp) or tungsten lamp source (Tungsten lamp), the above implementation
  • the optical analysis unit can be replaced by an optical wavelength spectroscopic device.
  • the above-mentioned screening test paper 20 can be a new coronavirus pneumonia neutralizing antibody screening test paper, wherein the detection line of the screening test paper is IgM or IgG or a control line (C line) ) or test line (T line).
  • the above-mentioned screening test paper can quickly screen the new coronavirus neutralizing antibody cycle.
  • a neutralizing antibody negative reaction (NEG) test paper can be obtained, in which the control line (C line) and The two lines of the test line (T line) still exist after the specimen is tested, which means that the test paper that has passed the above test has not yet shown a positive reaction for neutralizing antibodies.
  • WPOS neutralizing antibodies
  • MPOS neutralizing antibody positive reaction
  • the two lines of the control line (C line) and the test line (T line) have completely changed after being tested by the specimen, and only the remaining The lines of the control line (C line) and the test line (T line) can no longer be distinguished by the naked eye.
  • the rapid screening test paper neutralizing antibody cycle reading measurement method can accurately measure the waiting time of the screening test paper.
  • the reaction spectrum signal and neutralizing antibody response of the test substance can be quickly screened for the neutralizing antibody response produced after the injection of the new coronavirus vaccine, and it can also solve the problem of crowd diversion of the neutralizing antibody reaction of the new coronavirus injection and subsequent subsidized injection of new coronavirus supplements. diversion planning.
  • Figure 4 is a schematic diagram of the imaging amplification device of the rapid screening test paper neutralizing antibody cycle reading and measurement method, in which the reading device 11 further includes an imaging amplification device, the imaging amplification device is to provide amplification
  • the reflected image spectrum signal of the detection line in the reaction area illuminated by the emitted light source is used, as shown in Figure 4, where the imaging magnifying device is composed of a magnifying lens 101 and a refractor 102, where the magnification of the imaging magnifying device is Select between 1.5 times and 10 times.
  • the reading device 11 When the reading device 11 reads the detection line reflection image spectrum signal of the reaction area illuminated by the emission light source, the detection line reflection image spectrum signal will first pass through the The magnifying lens 101, the refracting mirror 102 and a light receiving path 103 amplify the signal and then transmit it to the reading head 31 of the optical analysis unit for reception and subsequent optical analysis.
  • the reading device 11 when the reading device 11 reads When the detection line reflection image spectral signal of the reaction area is irradiated by the emitted light source, 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.
  • the image signal received by the read head 31 of the optical analysis unit becomes larger, and then the optical analysis unit 30 analyzes the received amplified signal.
  • the above device can solve and avoid the user's risk of COVID-19 screening test paper, immune layer Products that analyze the detection lines of test paper or immunoneutralizing antibody rapid screening test paper will not develop color or the lines will not be obvious after reacting with the substance to be tested, which may lead to misjudgment of the detection line status, thereby causing incorrect judgment of the test.
  • Figure 7 shows the screening test paper and cycle curve chart of the present invention that has detected neutralizing antibodies in each cycle.
  • the control line (C line) of the detection line of the screening test paper of the present detection method or The distribution status of the test line (T line) and the line color reaction status and corresponding light of the negative reaction (NEG) test paper, weak positive reaction (WPOS) test paper, medium positive reaction (MPOS) test paper and high positive reaction (HPOS) test paper Curve changes in the wavelength
  • the above method can quickly perform periodic screening of new coronavirus neutralizing antibody, continuing the above embodiment, in which a neutralizing antibody coefficient N AB in Figure 8 establishes a screening test paper sample neutralizing antibody coefficient calibration line period
  • the table can be obtained as shown in the figure, wherein the neutralizing antibody coefficient N AB wherein the numerical range is -0.8 to -1.4 is the neutralizing antibody reaction area of the negative reaction (NEG), wherein the neutralizing antibody coefficient N AB wherein the numerical range is - 0.2 to -1.8 is
  • Figure 9 is a comparison chart between the periodic table of the neutralizing antibody coefficient N AB calibration line and ELISA. From Figure 9, we can know the conventional ELISA detection method, in which the dotted line in the figure is within the range of 30% inhibition percentage. The area below 30% inhibition percentage is the negative reaction area (Negative), and the area above 30% inhibition percentage is the positive reaction area (Postive). The conventional ELISA method cannot determine the neutralizing antibody that occurs in the weak positive reaction (WPOS). Detection and classification of neutralizing antibody reactions and positive neutralizing antibody reactions (MPOS). The detection method invented in this case can use the antibody coefficient N AB calibration line periodic table to further clarify the various stages of antibodies produced after the injection of the new coronavirus vaccine. Neutralizing antibody response is used to solve the problem that conventional methods cannot measure the stages and cycles of antibodies produced after vaccination, and can also provide users with judgment and planning on whether to continue to inject COVID-19 supplements after vaccination. .

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Abstract

A neutralizing antibody period reading and measurement method based on a rapid screening test strip, comprising the steps of: step one (200): providing a screening test strip (20), having a screening test strip reaction area (21), wherein the screening test strip reaction area (21) can produce chemical reactions on a plurality of specific specimens, and change the color of a test line in the screening test strip reaction area (21) and a reflection spectrum signal of the test line; step two (300): using a screening test strip reading system (40) to read the color of the test line in the screening test strip reaction area (21) and the reflection spectrum signal of the test line; step three (400): further using an optical analysis unit (30) to analyze the reflection spectrum signal of the test line in the screening test strip reaction area (21) received by the screening test strip reading system (40); step four (500): when the optical analysis unit (30) analyzes the reflection spectrum signal detected by the screening test strip reading system (40), the reflection spectrum signal being subjected to computing operation by means of the optical analysis unit (30) to obtain a neutralizing antibody coefficient NAB, and using the neutralizing antibody coefficient NAB to create a periodic table of calibration curves of neutralizing antibody coefficients of a screening test strip specimen, so as to carry out the neutralizing antibody period measurement and determination of the specimen; and step five (600): ending the measurement.

Description

快速筛检试纸中和抗体周期读取量测方法Rapid screening test paper neutralizing antibody cycle reading measurement method 技术领域Technical field
[根据细则26改正 19.08.2022]
本发明系有关于一快速筛检试纸中和抗体周期读取量测方法，尤指一种打完疫苗后可快速量测筛检新冠肺炎疫苗所产生的中和抗体周期读取量测方法。[Amended 19.08.2022 in accordance with Rule 26]
The invention relates to a rapid screening test paper neutralizing antibody cycle reading and measuring method, and in particular, a method for rapidly measuring the neutralizing antibody cycle reading and measuring method produced by screening the COVID-19 vaccine after vaccination.
背景技术Background technique
[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 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. 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.
[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系统」，一种可携式快筛之体外检测系统，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，仍会有造成系统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打完疫苗后所产生的中和抗体反应确认。[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 method of measuring the spectral signal using a spectrometer, and the method of measuring the spectral signal in this case is more accurate and can determine the neutralizing antibody response generated after vaccination.
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，然后将试纸条插入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打完疫苗后所产生的中和抗体反应确认。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 confirm the neutralizing antibody response generated after vaccination.
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快速筛检试纸中和抗体周期读取量测方法，包含使用一光学分析单元，并用以分析该筛检试纸读取系统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系统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中和抗体系数N AB，并利用该中和抗体系数N AB建立一筛检试纸检体中和抗体系数检量线周期表，以进行该检体的中和抗体周期量测及判断。 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 rapid test paper. The screening test paper neutralizing antibody cycle 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 by the 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 neutralizing antibody coefficient N AB , and uses the neutralizing antibody coefficient N AB A periodic table of the neutralizing antibody coefficient calibration line of the screening test paper sample is established to measure and judge the neutralizing antibody cycle of the sample.
发明内容Contents of the invention
本发明的目的之一在于揭露一种快速筛检试纸中和抗体周期读取量测方法，以达到打完新冠肺炎疫苗后可以快速筛检出所产生的中和抗体周期之功效。One of the purposes of the present invention is to disclose a rapid screening test paper neutralizing antibody cycle reading and measuring method, so as to achieve the effect of quickly screening and detecting the neutralizing antibody cycle produced after the COVID-19 vaccine is administered.
本发明的目的之一在于揭露一种快速筛检试纸中和抗体周期读取量测方法，在于该光学分析单元分析该筛检试纸读取系统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中和抗体系数N AB，并利用该中和抗体系数N AB建立一筛检试纸检体中和抗体系数周期表，以进行该检体的中和抗体周期量测及判断。 One object of the present invention is to disclose a rapid screening test paper neutralizing antibody cycle reading measurement method, when the optical analysis unit analyzes the reflection spectrum signal detected by the screening test paper reading system, wherein the reflection spectrum signal After calculation by the optical analysis unit, a neutralizing antibody coefficient NAB is obtained, and the neutralizing antibody coefficient NAB is used to establish a periodic table of neutralizing antibody coefficients of the screening test paper specimen to carry out the neutralizing antibody cycle of the specimen. Measurement and judgment.
根据本发明揭露一种快速筛检试纸中和抗体周期读取量测方法，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系统，该筛检试纸读取系统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系统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系统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中和抗体系数N AB，并利用该中和抗体系数N AB建立一筛检试纸检体中和抗体系数检量线周期表，以进行该检体的中和抗体周期量测及判断；第五步骤，量测结束。 According to the present invention, a rapid screening test paper neutralizing antibody cycle reading and measurement method is disclosed, which includes the following steps: a first step is to provide a screening test paper with a screening test paper reaction area configured on it, and the screening test paper reaction area is The system can produce chemical reactions on certain specific specimens and change the color of the detection lines in the reaction area of the screening test paper and the reflection spectrum signal of the detection lines; in the second step, a screening test paper reading system is used, and the screening test paper reads The system is used 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, an optical analysis unit is further used to analyze the screen received by the screening test paper reading system. The reflection spectrum signal of the detection line in the reaction area of the test paper; 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 After the calculation, a neutralizing antibody coefficient N AB is obtained, and the neutralizing antibody coefficient N AB is used to establish a periodic table of the neutralizing antibody coefficient calibration line of the screening test paper specimen to measure the neutralizing antibody cycle of the specimen Judgment; the fifth step is to end the measurement.
如上述的快速筛检试纸中和抗体周期读取量测方法，其中该筛检试纸读取系统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，而该筛检试纸读取系统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-mentioned rapid screening test paper neutralizing antibody cycle reading measurement method, 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 acquisition system will read the reflection spectrum signal of the detection line illuminated by the emission 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.
如上述的快速筛检试纸中和抗体周期读取量测方法，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)。The above-mentioned rapid screening test paper neutralizing antibody cycle reading measurement method, wherein the lighting device is a white light-emitting diode (White LED), an ultraviolet light-emitting diode (UV LED), or a near-infrared light-emitting diode. (NIR LED), laser diode (Laser diode), halogen lamp (Halogen lamp) or tungsten lamp (Tungsten lamp).
如上述的快速筛检试纸中和抗体周期读取量测方法，其中该筛检试纸读取系统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 rapid screening test paper neutralizing antibody cycle reading measurement method, wherein the screening test paper reading system further includes an imaging magnifying device, the imaging magnifying device is provided to amplify the reaction area illuminated by the emitted light source. Used to detect line reflection spectrum signals.
如上述的快速筛检试纸中和抗体周期读取量测方法，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 rapid screening test paper neutralizing antibody cycle reading measurement method, the magnification of the imaging magnification device is selected to be between 1.5 times and 10 times.
如上述的快速筛检试纸中和抗体周期读取量测方法，其中该筛检试纸的特定检体应用为血液。The above-mentioned rapid screening test paper neutralizing antibody cycle reading measurement method, wherein the specific sample of the screening test paper is blood.
如上述的快速筛检试纸中和抗体周期读取量测方法，其中该筛检试纸为新冠肺炎筛检试纸(COVID-19 IgM/IgG Rapid Test Kit)、免疫层析试纸或免疫中和抗体快筛筛检试纸用以进行筛检使用。Such as the above-mentioned rapid screening test paper neutralizing antibody cycle reading measurement method, wherein the screening test paper is a COVID-19 screening test paper (COVID-19 IgM/IgG Rapid Test Kit), an immunochromatographic test paper or an immune neutralizing antibody rapid test paper Screening test paper is used for screening.
如上述的快速筛检试纸中和抗体周期读取量测方法，其中该该检测线条为一控制线(C line)或测试线(T line)。For example, in the above-mentioned rapid screening test paper neutralizing antibody cycle reading measurement method, the detection line is a control line (C line) or a test line (T line).
如上述的快速筛检试纸中和抗体周期读取量测方法，其中该中和抗体系数N AB的计算运算方式为该筛检试纸的控制线吸收光波长最高峰值与该测量线的 吸收光最高峰值所运算的吸收差值的斜率运算。 The above-mentioned rapid screening test paper neutralizing antibody cycle reading measurement method, wherein the calculation method of the neutralizing antibody coefficient N AB is the highest peak absorption wavelength of the control line of the screening test paper and the highest absorption light wavelength of the measurement line The slope calculation of the absorption difference calculated from the peak value.
如上述的快速筛检试纸中和抗体周期读取量测方法，其中该吸收光波长范围为400nm至700nm波长之间。As in the above-mentioned rapid screening test paper neutralizing antibody cycle reading measurement method, the wavelength range of the absorbed light is between 400nm and 700nm.
如上述的快速筛检试纸中和抗体周期读取量测方法，其中该中和抗体系数N AB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15IU/ml，该定量极限值范围为50IU/ml。 As in the rapid screening test paper neutralizing antibody cycle reading measurement method above, the neutralizing antibody coefficient N AB further includes a detection limit (Limit of Detection, LOD) and a quantification limit (Limit of Quantification, LOQ), The detection limit value range is 15IU/ml, and the quantification limit value range is 50IU/ml.
如上述的快速筛检试纸中和抗体周期读取量测方法，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。The above-mentioned rapid screening test paper neutralizing antibody cycle reading measurement method, wherein the optical analysis unit is an optical wavelength spectrometer device or a spectrum analyzer.
如上述的快速筛检试纸中和抗体周期读取量测方法，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 rapid screening test paper neutralizing antibody cycle reading measurement method, the imaging magnifying device is composed of a magnifying lens and a refractor, and provides amplification of the reflection spectrum signal of the detection line illuminated by the emitted light source in the reaction area. .
附图说明Description of the drawings
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图系为本发明快速筛检试纸中和抗体周期读取量测方法流程图。Figure 2 is a flow chart of the rapid screening test paper neutralizing antibody cycle reading and measurement method of the present invention.
第3图系为本发明快速筛检试纸中和抗体周期读取量测方法的系统之结构分解堆迭之侧视图。Figure 3 is a side view of the decomposed and stacked structure of the system of the rapid screening test paper neutralizing antibody cycle reading measurement method of the present invention.
第4图系为本发明快速筛检试纸中和抗体周期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 rapid screening test paper neutralizing antibody cycle reading and measurement method of the present invention.
第5图系为本发明快速筛检试纸中和抗体周期读取量测方法的中和抗体系数运算图。Figure 5 is a calculation diagram of the neutralizing antibody coefficient of the neutralizing antibody cycle reading measurement method of the rapid screening test paper of the present invention.
第6图系为本发明已检测各周期的中和抗体筛检试纸图。Figure 6 is a diagram of the neutralizing antibody screening test strips for each cycle tested in the present invention.
第7图系为本发明已检测各周期中和抗体的筛检试纸及周期曲线图。Figure 7 is a screening test paper and cycle curve chart for detecting neutralizing antibodies in each cycle of the present invention.
第8图系为本发明中和抗体系数N AB建立一筛检试纸检体中和抗体系数检量线周期表图。 Figure 8 is a periodic table diagram of a calibration curve for the neutralizing antibody coefficient N AB of a screening test paper specimen according to the present invention.
第9图系为本发明中和抗体系数N AB检量线周期表与ELISA比较图。 Figure 9 is a comparison chart between the periodic table of the neutralizing antibody coefficient N AB calibration curve of the present invention and ELISA.
具体实施方式Detailed ways
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图系分别为本发明快速筛检试纸中和抗体周期读取量测方法流程图，本发明的快速筛检试纸中和抗体周期读取量测方法，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化学反应例如(免疫层析变化/染色变化/C/IgM/IgG/控制线/测试线的显色变化)，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系统40，利用该筛检试纸读取系统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系统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系统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计算运算后取得一中和抗体系数N AB，并利用该中和抗体系数N AB建立一筛检试纸检体中和抗体系数检量线周期表，以进行该检体的中和抗体周期量测及判断，其中一中和抗体系数N AB如图5快速筛检试纸中和抗体周期读取量测方法的中和抗体系数运算所示，其中该中和抗体系数N AB的计算运算方式为中和抗体系数N AB的计算运算方式为该筛检试纸的控制线吸收光波长最高峰值与该测量线的吸收光最高峰值所运算的吸收差值的斜率运算，其中该反射光谱讯号范围为400nm波长至700nm波长之间，其中该中和抗体系数N AB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15IU/ml，该定量极限值范围为50IU/ml(未图示)，在如图8之间所示，并再利用该中和抗体系数N AB建立一筛检试纸检体中和抗体系数检量线周期表，如图8为一中和抗体系数N AB建立一筛检试纸检体中和抗体系数检量线周期表图所意示，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 rapid screening test paper neutralizing antibody cycle reading and measuring method of the present invention. The rapid screening test paper neutralizing antibody cycle reading and measuring method of the present invention. When the user expects to perform quantitative test paper reading When taking the action 100 is started, and the first step 200 is continued to provide the user with a screening test paper 20. The screening test paper 20 is equipped with a screening test paper reaction area 21. The screening test paper reaction area 21 can be used for a plurality of Specific specimens produce chemical reactions such as (immunochromatographic changes/staining changes/color changes of C/IgM/IgG/control lines/test lines), and change the color and direction of the detection lines in the reaction area of the screening test paper For the reflection spectrum signal, following the second step 300, a screening test paper reading system 40 is used. The screening test paper reading system 40 is used 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 unit 30 is further 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 40; in the fourth step 500 , which is characterized in that when the optical analysis unit 30 analyzes the reflection spectrum signal detected by the screening test paper reading system 40, the reflection spectrum signal is calculated by the optical analysis unit 30 to obtain a neutralizing antibody coefficient N AB , and The neutralizing antibody coefficient N AB is used to establish a periodic table of the neutralizing antibody coefficient calibration line of the screening test paper specimen to measure and judge the neutralizing antibody cycle of the specimen. One of the neutralizing antibody coefficient N AB is as shown in the figure 5. The neutralizing antibody coefficient calculation method of the rapid screening test paper neutralizing antibody cycle reading measurement method is shown in the calculation method of the neutralizing antibody coefficient N AB . The calculation method of the neutralizing antibody coefficient N AB is the screening test. The slope calculation of the absorption difference between the highest peak of the absorption light wavelength of the control line of the test paper and the highest peak of the absorption light of the measurement line, where the reflection spectrum signal range is between 400nm wavelength and 700nm wavelength, where the neutralizing antibody coefficient N AB further includes the limit of detection (LOD) and the limit of quantification (LOQ), where the detection limit range is 15IU/ml and the quantification limit range is 50IU/ml (not shown) (shown), as shown in Figure 8, and then use the neutralizing antibody coefficient N AB to establish a screening test paper sample neutralizing antibody coefficient calibration line periodic table, as shown in Figure 8 for a neutralizing antibody coefficient N AB Establish a screening test paper sample, as shown in the periodic table diagram of the neutralizing antibody coefficient calibration line. If the measurement action is not performed, the process will be terminated. For example, the measurement in step 600 of the fifth step is completed.
在如图3快速筛检试纸中和抗体周期读取量测方法的系统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、一筛检试纸读取系统40 及一试纸载台单元41所组成，其中该筛检试纸读取系统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，而该筛检试纸读取系统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系统40进行读取操作时，其中该筛检试纸读取系统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或新冠肺炎中和抗体周期筛检试纸；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或者检测线条的奈米金粒子所反射讯号(未图示)；另外如本实施例的快速筛检试纸中和抗体周期读取量测方法，当筛检试纸读取系统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，该筛检试纸读取系统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或检测线条的奈米金粒子所反射讯号，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系统40所接收该筛检试纸反应区的检测线条的反射光谱讯号或检测线条的奈米金粒子所反射讯号，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，而该筛检试纸读取系统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或检测线条的奈米金粒子所反射讯号，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血液范围，其中上述实施例中该筛检试纸可替换为免疫层析试纸或免疫中和抗体快筛筛检试纸，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 for rapid screening test paper and antibody cycle reading measurement method in Figure 3, the components of the embodiment of the present case are composed of a screening test paper 20 and a screening test paper reading The system 40 is composed of a test paper carrier unit 41, wherein 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 carrier unit 41 , then the reading 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 emitting light source, and subsequently transmits it to the optical The analysis unit 30 performs computational analysis on the reflection spectrum signal. 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 chemical reactions for certain specific samples (such as blood, etc.), and Change the color of the test line in the reaction area. The above-mentioned screening test paper is a COVID-19 IgM/IgG Rapid Test Kit, which can quickly conduct COVID-19 screening or COVID-19 neutralizing antibody cycle screening test paper; Another optical analysis unit 30 is connected to the reading illumination device 10. The optical analysis unit is a micro spectrum analyzer for analyzing the spectrum of the detection line image of the reaction area of the screening test paper received by the reading device 11. signal or signal reflected by the gold nanoparticles of the detection line (not shown); in addition, as in the rapid screening test paper neutralizing antibody cycle reading measurement method of this embodiment, when the screening test paper reading system 40, wherein the test paper The carrier unit 41 is used to accommodate the screening test paper 20. When the screening test paper 20 is fixed on the test paper carrier unit 41, the screening test paper reading system 40 reads the detection of the reaction area of the screening test paper. The color of the line and the reflection spectrum signal of the detection line or the reflection signal of the gold nanoparticles of the detection line are further used to further use an optical analysis unit 30 to analyze the reaction area of the screening test paper received by the screening test paper reading system 40 If the reflection spectrum signal of the detection line or the signal reflected by the gold nanoparticles of the detection line is detected, 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 or detection line of the reaction area of the screening test paper illuminated by the emitting light source. The signal reflected by the gold nanoparticles is subsequently transmitted to the optical analysis unit 30 for 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 will read the reflection image spectrum signal of the detection line illuminated by the emitted light source in the reaction area, and then transmit it to the optical analysis unit 30 for calculation and analysis of the reflection image spectrum signal. The screening test paper in the above embodiment The specific sample can be applied to the blood range. In the above embodiment, the screening test paper can be replaced by an immunochromatography test paper or an immune neutralizing antibody rapid screening test paper. In the above embodiment, the illumination device 12 can be replaced by Ultraviolet light emitting diode (UV LED), near infrared light emitting diode (NIR LED), laser diode (Laser diode), halogen lamp (Halogen lamp) or tungsten lamp source (Tungsten lamp), the above implementation For example, the optical analysis unit can be replaced by an optical wavelength spectroscopic device.
接续上述方法实施例如以检测，如图6中所示上述该筛检试纸20可为新冠肺炎中和抗体筛检试纸，其中该筛检试纸的检测线条系为IgM或IgG或控制线(C line)或测试线(T line)，上述筛检试纸可快速进行新冠肺炎中和抗体周期筛检，如图6中可得到一中和抗体阴性反应(NEG)试纸，其中控制线(C line)及测试线(T line)两个线条经过检体检测后仍然存在，代表经过上述检测的试纸尚未呈现中和抗体阳性反应，如另一中和抗体弱阳性反应(WPOS)试纸，其中控制线(C line)及测试线(T line)两个线条经过检体检测后仍然存在，但测试线(T line)的线条稍微偏淡不明显，代表经过上述检测的试纸已呈现弱阳性中和抗体阳性反应，再如一中和抗体中阳性反应(MPOS)试纸，其中控制线(C line)及测试线(T line)两个线条经过检体检测后已发生变化，其中测试线(T line)的线条已明显偏淡且不明显，另一中和抗体高阳性反应(HPOS)试纸，其中控制线(C line)及测试线(T line)两个线条经过检体检测后已完全产生变化，其中仅保留控制线(C line)的线条，另外测试线(T line)的线条已无法从肉眼分辨出，如利用本案快速筛检试纸中和抗体周期读取量测方法可以精准量测筛检试纸的待测物之反应光谱讯号及中和抗体反应，并且可以达到快速筛检注射新冠疫苗后产生的中和抗体反应，并可解决注射新冠肺炎的中和抗体反应人潮分流及后续补助注射新冠肺炎补充剂之分流规画。Continuing the above method implementation, for example, detection, as shown in Figure 6, the above-mentioned screening test paper 20 can be a new coronavirus pneumonia neutralizing antibody screening test paper, wherein the detection line of the screening test paper is IgM or IgG or a control line (C line) ) or test line (T line). The above-mentioned screening test paper can quickly screen the new coronavirus neutralizing antibody cycle. As shown in Figure 6, a neutralizing antibody negative reaction (NEG) test paper can be obtained, in which the control line (C line) and The two lines of the test line (T line) still exist after the specimen is tested, which means that the test paper that has passed the above test has not yet shown a positive reaction for neutralizing antibodies. For example, another weakly positive reaction for neutralizing antibodies (WPOS) test paper, in which the control line (C line) and test line (T line) still exist after the specimen is tested, but the line of the test line (T line) is slightly lighter and less obvious, which means that the test paper that has been tested above has shown a weak positive neutralizing antibody positive reaction. , and another example is a neutralizing antibody positive reaction (MPOS) test paper, in which the two lines of the control line (C line) and the test line (T line) have changed after being tested by the specimen, and the line of the test line (T line) has changed. It is obviously lighter and not obvious. On another neutralizing antibody high positive reaction (HPOS) test paper, the two lines of the control line (C line) and the test line (T line) have completely changed after being tested by the specimen, and only the remaining The lines of the control line (C line) and the test line (T line) can no longer be distinguished by the naked eye. For example, the rapid screening test paper neutralizing antibody cycle reading measurement method can accurately measure the waiting time of the screening test paper. The reaction spectrum signal and neutralizing antibody response of the test substance can be quickly screened for the neutralizing antibody response produced after the injection of the new coronavirus vaccine, and it can also solve the problem of crowd diversion of the neutralizing antibody reaction of the new coronavirus injection and subsequent subsidized injection of new coronavirus supplements. diversion planning.
再接续上述方法实施例，如图4快速筛检试纸中和抗体周期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、免疫层析试纸或免疫中和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误判检测线条状况，进而造成检测的误差判断。Continuing with the above method embodiment, Figure 4 is a schematic diagram of the imaging amplification device of the rapid screening test paper neutralizing antibody cycle reading and measurement method, in which the reading device 11 further includes an imaging amplification device, the imaging amplification device is to provide amplification The reflected image spectrum signal of the detection line in the reaction area illuminated by the emitted light source is used, as shown in Figure 4, where the imaging magnifying device is composed of a magnifying lens 101 and a refractor 102, where the magnification of the imaging magnifying device is Select between 1.5 times and 10 times. When the reading device 11 reads the detection line reflection image spectrum signal of the reaction area illuminated by the emission light source, the detection line reflection image spectrum signal will first pass through the The magnifying lens 101, the refracting mirror 102 and a light receiving path 103 amplify the signal and then transmit it to the reading head 31 of the optical analysis unit for reception and subsequent optical analysis. Continuing from the above embodiment, when the reading device 11 reads When the detection line reflection image spectral signal of the reaction area is irradiated by the emitted light source, 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. , the image signal received by the read head 31 of the optical analysis unit becomes larger, and then the optical analysis unit 30 analyzes the received amplified signal. The above device can solve and avoid the user's risk of COVID-19 screening test paper, immune layer Products that analyze the detection lines of test paper or immunoneutralizing antibody rapid screening test paper will not develop color or the lines will not be obvious after reacting with the substance to be tested, which may lead to misjudgment of the detection line status, thereby causing incorrect judgment of the test.
再接续上述方法实施例，如图7为本发明已检测各周期中和抗体的筛检试纸及周期曲线图，可得知本检测方法的筛检试纸的检测线条的控制线(C line)或测试线(T line)之分布状况及阴性反应(NEG)试纸、弱阳性反应(WPOS)试纸、中阳性反应(MPOS)试纸及高阳性反应(HPOS)试纸的线条显色反应状况及对应的光波长的曲线变化，上述方法可快速进行新冠肺炎中和抗体周期筛检，接续上述实施例其中如图8中一中和抗体系数N AB建立一筛检试纸检体中和抗体系数检量线周期表如图中所示可得到，其中该中和抗体系数N AB其中数值范围-0.8至-1.4为阴性反应(NEG)的中和抗体反应区，其中该中和抗体系数N AB其中数值范围-0.2至-1.8为弱阳性反应(WPOS)的中和抗体反应区，其中该中和抗体系数N AB其中数值范围-0.2至0.2为中阳性反应(MPOS)的中和抗体反应区，其中该中和抗体系数N AB其中数值范围0.2至0.4以上为高阳性反应(HPOS)的中和抗体反应区，由图8中可以得到利用一中和抗体系数检量线周期表，并提供后续该光学分析单元30可以快速筛检量测出各中和抗体的筛检试纸及中和抗体的周期判断及量测使用。 Continuing with the above method embodiment, Figure 7 shows the screening test paper and cycle curve chart of the present invention that has detected neutralizing antibodies in each cycle. It can be known that the control line (C line) of the detection line of the screening test paper of the present detection method or The distribution status of the test line (T line) and the line color reaction status and corresponding light of the negative reaction (NEG) test paper, weak positive reaction (WPOS) test paper, medium positive reaction (MPOS) test paper and high positive reaction (HPOS) test paper Curve changes in the wavelength, the above method can quickly perform periodic screening of new coronavirus neutralizing antibody, continuing the above embodiment, in which a neutralizing antibody coefficient N AB in Figure 8 establishes a screening test paper sample neutralizing antibody coefficient calibration line period The table can be obtained as shown in the figure, wherein the neutralizing antibody coefficient N AB wherein the numerical range is -0.8 to -1.4 is the neutralizing antibody reaction area of the negative reaction (NEG), wherein the neutralizing antibody coefficient N AB wherein the numerical range is - 0.2 to -1.8 is the neutralizing antibody reaction area of a weak positive reaction (WPOS), where the neutralizing antibody coefficient N AB is the value range -0.2 to 0.2 is the neutralizing antibody reaction area of a medium positive reaction (MPOS), where the neutralizing antibody coefficient NA And the antibody coefficient N AB , the value range of 0.2 to 0.4 and above is the neutralizing antibody reaction area of high positive reaction (HPOS). From Figure 8, a periodic table of the neutralizing antibody coefficient calibration line can be obtained, and subsequent optical analysis is provided. The unit 30 can quickly screen and measure the screening test strips for each neutralizing antibody and the periodic judgment and measurement of neutralizing antibodies.
如图9为中和抗体系数N AB检量线周期表与ELISA比较图，由图9中可得知其中习知的ELISA的检测方法其中如图中虚线所示在30％抑制百分比的范围，其中在30％抑制百分比以下为阴性反应区(Negative)，其中在30％抑制百分比以上为阳性反应区(Postive)，习知ELISA方法并无法判断当发生在弱阳性反应(WPOS)的中和抗体反应及中阳性的中和抗体反应(MPOS)时的检测及分类，而本案之发明检测方法可以使用抗体系数N AB检量线周期表可进一步厘清已注射新冠肺炎疫苗后所产生的各阶段的中和抗体反应，以解决习知的方法无法量测打完疫苗后所产生抗体各阶段周期判断，并且也可提使用者在注射疫苗后是否要继续追补注射新冠肺炎补充剂之判断规画使用。 Figure 9 is a comparison chart between the periodic table of the neutralizing antibody coefficient N AB calibration line and ELISA. From Figure 9, we can know the conventional ELISA detection method, in which the dotted line in the figure is within the range of 30% inhibition percentage. The area below 30% inhibition percentage is the negative reaction area (Negative), and the area above 30% inhibition percentage is the positive reaction area (Postive). The conventional ELISA method cannot determine the neutralizing antibody that occurs in the weak positive reaction (WPOS). Detection and classification of neutralizing antibody reactions and positive neutralizing antibody reactions (MPOS). The detection method invented in this case can use the antibody coefficient N AB calibration line periodic table to further clarify the various stages of antibodies produced after the injection of the new coronavirus vaccine. Neutralizing antibody response is used to solve the problem that conventional methods cannot measure the stages and cycles of antibodies produced after vaccination, and can also provide users with judgment and planning on whether to continue to inject COVID-19 supplements after vaccination. .
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 above 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)

  1. 一种快速筛检试纸中和抗体周期读取量测方法，其包含步骤：A rapid screening test paper neutralizing antibody cycle reading 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 chemical reactions for a number of specific specimens and change the color of the detection lines in the screening test paper reaction zone. And detect the reflection spectrum signal of the line;
    第二步骤，使用一筛检试纸读取系统，该筛检试纸读取系统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系统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系统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中和抗体系数N AB，并利用该中和抗体系数N AB建立一筛检试纸检体中和抗体系数检量线周期表，以进行该检体的中和抗体周期量测及判断；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 neutralizing antibody coefficient N AB , and Use the neutralizing antibody coefficient N AB to establish a periodic table of the neutralizing antibody coefficient calibration line of the screening test paper sample to measure and judge the neutralizing antibody cycle of the sample; and
    第五步骤，量测结束。The fifth step is to end the measurement.
  2. 根据权利要求1所述的快速筛检试纸中和抗体周期读取量测方法，其中该筛检试纸读取系统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，而该筛检试纸读取系统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 rapid screening test paper neutralizing antibody cycle reading and measurement 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 The screening test paper reading system will read the detection line reflection spectrum signal of the reaction area of the screening test paper illuminated by the emission light source, and then transmit it to the optical analysis unit for calculation and analysis of the reflection spectrum signal.
  3. 根据权利要求2所述的快速筛检试纸中和抗体周期读取量测方法，其中该筛检试纸读取系统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 rapid screening test paper neutralizing antibody cycle 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 light emitted by the emitted light source. The reflection spectrum signal of the detection line that illuminates the reaction area is used.
  4. 根据权利要求3所述的快速筛检试纸中和抗体周期读取量测方法，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 rapid screening test paper neutralizing antibody cycle 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.
  5. 根据权利要求4所述的快速筛检试纸中和抗体周期读取量测方法，其中该检测线条为一控制线(C line)或测试线(T line)。The rapid screening test paper neutralizing antibody cycle reading measurement method according to claim 4, wherein the detection line is a control line (C line) or a test line (T line).
  6. 根据权利要求5所述的快速筛检试纸中和抗体周期读取量测方法，其中该筛检试纸为新冠肺炎筛检试纸(COVID-19 IgM/IgG Rapid Test Kit)、免疫层析试纸或免疫中和抗体快筛筛检试纸用以进行筛检使用。The rapid screening test paper neutralizing antibody cycle reading measurement method according to claim 5, wherein the screening test paper is a new coronavirus pneumonia screening test paper (COVID-19 IgM/IgG Rapid Test Kit), an immune chromatography test paper or an immune chromatography test paper. Neutralizing antibody rapid screening test strips are used for screening.
  7. 根据权利要求1所述的快速筛检试纸中和抗体周期读取量测方法，其中该中和抗体系数N AB的计算运算方式为该筛检试纸的控制线吸收光波长最高峰值与该测量线的吸收光最高峰值所运算的吸收差值的斜率运算。 The rapid screening test paper neutralizing antibody cycle reading measurement method according to claim 1, wherein the calculation method of the neutralizing antibody coefficient N AB is the highest peak absorption wavelength of the control line of the screening test paper and the measurement line The slope calculation of the absorption difference calculated from the highest peak of absorbed light.
  8. 根据权利要求7所述的快速筛检试纸中和抗体周期读取量测方法，其中该吸收光波长范围为400nm至700nm波长之间。The rapid screening test paper neutralizing antibody cycle reading measurement method according to claim 7, wherein the wavelength range of the absorbed light is between 400 nm and 700 nm.
  9. 根据权利要求7所述的快速筛检试纸中和抗体周期读取量测方法，其中该中和抗体系数N AB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15IU/ml，该定量极限值范围为50IU/ml。 The rapid screening test paper neutralizing antibody cycle reading measurement method according to claim 7, wherein the neutralizing antibody coefficient N AB further includes a detection limit (Limit of Detection, LOD) and a quantification limit (Limit of Quantification). , LOQ), wherein the detection limit range is 15IU/ml, and the quantification limit range is 50IU/ml.
  10. 根据权利要求4所述的快速筛检试纸中和抗体周期读取量测方法，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 rapid screening test paper neutralizing antibody cycle reading and measuring method according to claim 4, wherein the imaging magnifying device is composed of a magnifying lens and a refractor, providing amplification of the detection lines illuminated by the emitted light source in the reaction area. Reflection spectrum signals are used.
PCT/CN2022/110640 2022-08-05 2022-08-05 Neutralizing antibody period reading and measurement method based on rapid screening test strip WO2024026855A1 (en)

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101887063A (en) * 2010-07-26 2010-11-17 沈鹤柏 Human C-reactive protein colloidal gold immunochromatographic assay quantitative test paper
CN105259342A (en) * 2013-06-08 2016-01-20 张沈平 Testing method for colloidal gold card reader and colloidal gold card reader
CN108254563A (en) * 2016-12-28 2018-07-06 广州瑞博奥生物科技有限公司 Detect time-resolved fluoroimmunoassay chromatograph test strip, kit of cTnI and preparation method thereof
CN108872601A (en) * 2018-07-10 2018-11-23 安徽九川生物科技有限公司 A kind of the immunofluorescence immue quantitative detection reagent box and its application method of porcine reproductive and respiratory syndrome antibody
WO2019138898A1 (en) * 2018-01-09 2019-07-18 東洋紡株式会社 Immunochromatography test piece, measurement kit, and measurement method
CN111781348A (en) * 2020-07-08 2020-10-16 中国中医科学院医学实验中心 Fluorescent quantitative immunochromatography detection test paper for pesticide ethofenprox and application thereof
CN113324957A (en) * 2021-04-25 2021-08-31 南京长健生物科技有限公司 Fluorescence immunoassay method
TW202208850A (en) * 2020-08-20 2022-03-01 柯正浩 Screening test paper reading system that includes a reading illumination unit, a screening test paper, an optical analysis unit, a test paper carrier unit, a displacement carrying platform unit, and a circuit board unit

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101887063A (en) * 2010-07-26 2010-11-17 沈鹤柏 Human C-reactive protein colloidal gold immunochromatographic assay quantitative test paper
CN105259342A (en) * 2013-06-08 2016-01-20 张沈平 Testing method for colloidal gold card reader and colloidal gold card reader
CN108254563A (en) * 2016-12-28 2018-07-06 广州瑞博奥生物科技有限公司 Detect time-resolved fluoroimmunoassay chromatograph test strip, kit of cTnI and preparation method thereof
WO2019138898A1 (en) * 2018-01-09 2019-07-18 東洋紡株式会社 Immunochromatography test piece, measurement kit, and measurement method
CN108872601A (en) * 2018-07-10 2018-11-23 安徽九川生物科技有限公司 A kind of the immunofluorescence immue quantitative detection reagent box and its application method of porcine reproductive and respiratory syndrome antibody
CN111781348A (en) * 2020-07-08 2020-10-16 中国中医科学院医学实验中心 Fluorescent quantitative immunochromatography detection test paper for pesticide ethofenprox and application thereof
TW202208850A (en) * 2020-08-20 2022-03-01 柯正浩 Screening test paper reading system that includes a reading illumination unit, a screening test paper, an optical analysis unit, a test paper carrier unit, a displacement carrying platform unit, and a circuit board unit
CN113324957A (en) * 2021-04-25 2021-08-31 南京长健生物科技有限公司 Fluorescence immunoassay method

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