TWI845909B - Screening test strip reading measurement method - Google Patents

Abstract

A method for reading and measuring a screening test paper comprises the following steps: a first step, providing a screening test paper, on which a screening test paper reaction area is arranged, the screening test paper reaction area can produce a periodic chemical reaction to a number of specific samples, and change the color of the detection line of the screening test paper reaction area and the reflection spectrum signal of the detection line; a second step, using a screening test paper reading system, the screening test paper reading system reads the detection of the screening test paper reaction area The color of the line and the reflection spectrum signal of the detection line; the third step, further using an optical analysis unit, and used to analyze the reflection spectrum signal of the detection line of the reaction area of the screening paper received by the screening paper reading system; the fourth step, its characteristic is that when the optical analysis unit analyzes the reflection spectrum signal detected by the screening paper reading system, the reflection spectrum signal is calculated by the optical analysis unit to obtain a reflectivity characteristic value α , and the reflectivity characteristic value α is used to establish a screening paper sample cycle table to perform the sample cycle measurement and judgment; the fifth step, the measurement is completed.

Description

Screening test strip reading measurement method

The present invention relates to a screening test paper reading and measuring method, in particular to a screening test paper reading and measuring method that can achieve rapid and large-scale screening and measurement of the new coronavirus epidemic and confirmation of the infection cycle.

As people 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 commonly used screening test paper. As shown in the figure, the screening test paper 80 is equipped with a reaction area 81. When the user drops the sample on the reaction area 81, the reaction area 81 will react chemically with the sample, causing the color of the reaction area 81 to change. The user can judge whether the sample is normal or not based on the color change of the reaction area and the contrast color. However, the accuracy of color change recognition by the human eye is very poor, which may cause misjudgment or false negatives. For example, the impact of the COVID-19 pandemic since the beginning of 2020 has had a significant impact on the world's economy, transportation and life. Therefore, governments, research institutions and manufacturers are actively developing technologies and methods for rapid screening of confirmed epidemics, such as using rapid screening test strips for large-scale and rapid testing methods. If retesting or reconfirming precision screening is necessary during the testing process, spectrometers are mostly used for detailed testing methods.

A portable in vitro rapid screening test system is disclosed in Taiwan Patent I612306, which includes an in vitro detector and an electronic device. The in vitro detector is a closed environment, which contains a sample box for accommodating a rapid screening test paper after testing, a photographing image processor for capturing a display image of the rapid screening test paper after testing in the sample box, and a transmission interface control processor for transmitting the display image to the electronic device. The electronic device has an analysis unit. The software compares a data parameter downloaded from the cloud of an invention to generate a test report of the subject's physiological reaction and the degree of physiological reaction, achieving the function of early detection, early prevention and planning. The previous case technology uses image recognition technology for detection, which may still cause the system to be false negative because it cannot judge the image of the screening test paper. The previous case image judgment technology and the present case technology use the spectral signal measurement method of the spectrometer, and the spectral signal measurement method of the present case is more accurate and can determine the cycle of infection.

I know that China's patent CN104020286 "An immunochromatographic test strip quantitative detection instrument and detection method" is an immunochromatographic quantitative detection instrument and detection method for quantitative detection of immunochromatographic test strips using colloidal gold, latex, etc. The sample to be tested is dripped onto a horizontal immunochromatographic test strip pre-labeled and coated with the corresponding antigen antibody, and then the test strip is inserted into the detection slot of the immunochromatographic quantitative detection instrument. The immunochromatographic quantitative detection instrument confirms the color chromaticity of the C and T line area position and background chromaticity on the nitrocellulose membrane of the test strip through multi-wavelength scanning, and the quality control band is calibrated according to the built-in algorithm of the instrument. The optical density value of the test strip is used for identification, calculation and analysis to 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 used multi-wavelength scanning to scan the color chromaticity and background chromaticity, which is different from the technology of this case that uses the spectrometer to measure the spectral signal. The spectral signal measurement of this case is more accurate and can determine the period of infection.

However, when using a spectrometer for screening, users should avoid manually placing the screening test paper in the corresponding position for the spectrometer to capture the color signal of the reaction area. This can easily lead to inaccurate placement and the inability to capture the color signal. It wastes a lot of time to adjust the position of the screening test paper. In addition, if the screening test paper does not fully develop color, it may also cause misjudgment. Therefore, it is difficult to be practical. The invention discloses another method for measuring and reading a screening paper, comprising using an optical analysis unit to analyze the reflected light spectrum signal of the detection line of the reaction area of the screening paper received by the screening paper reading system. The characteristic of the method is that when the optical analysis unit analyzes the reflected light spectrum signal detected by the screening paper reading system, the reflected light spectrum signal is calculated by the optical analysis unit to obtain a reflectivity characteristic value α , and a screening paper sample cycle table is established using the reflectivity characteristic value α to perform the sample cycle measurement and judgment.

One of the purposes of the present invention is to disclose a method for reading and measuring a screening test strip to achieve the effects of rapid screening and repeated screening of the test strip.

One of the purposes of the present invention is to disclose a screening paper reading and measuring method, wherein the optical analysis unit analyzes the reflected light spectrum signal detected by the screening paper reading system, wherein the reflected light spectrum signal is calculated by the optical analysis unit to obtain a reflectivity characteristic value α , and the reflectivity characteristic value α is used to establish a screening paper sample cycle table to perform the sample cycle measurement and judgment.

According to the present invention, a method for reading and measuring a screening test paper is disclosed, which comprises the following steps: a first step, providing a screening test paper, on which a screening test paper reaction area is arranged, the screening test paper reaction area can produce a periodic chemical reaction to a number of specific samples, and change the color of the detection line of the screening test paper reaction area and the reflection spectrum signal of the detection line; a second step, using a screening test paper reading system, the screening test paper reading system reads the screening test paper reaction area The color of the detection line and the reflection spectrum signal of the detection line; the third step, further using an optical analysis unit, and 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; the fourth step, its characteristic is 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 reflectivity characteristic value α , and the reflectivity characteristic value α is used to establish a screening test paper sample cycle table to perform the sample cycle measurement and judgment; the fifth step, the measurement is completed.

In the above-mentioned screening test paper reading and measuring method, the screening test paper reading system further includes an illumination device, and the illumination 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 of the reaction area of the screening test paper illuminated by the light source, and then transmit it to the optical analysis unit for calculation and analysis of the reflection spectrum signal.

As in the above-mentioned screening test paper reading and measuring method, the illumination device is a white light emitting diode (White LED), an ultraviolet light emitting diode (UV LED), a near infrared light emitting diode (NIR LED), a laser diode, a halogen lamp or a tungsten lamp.

As in the above-mentioned screening test paper reading and measuring method, the screening test paper reading system further comprises an imaging amplification device, and the imaging amplification device is used to provide amplification of the reflected spectral signal of the detection line of the reaction area illuminated by the emitting light source.

As in the above-mentioned screening test paper reading and measuring method, the magnification of the imaging magnification device is selected to be between 1.5 times and 10 times.

As in the above-mentioned screening test strip reading and measuring method, the specific sample application of the screening test strip is saliva, urine, blood, water, food, toxic and harmful substances or microorganisms.

As described above, the screening test strip reading and measuring method, wherein the screening test strip is a COVID-19 screening test strip (COVID-19 IgM/IgG Rapid Test Kit), an immunoassay test strip, a biological rapid screening test strip, or an immune antibody rapid screening test strip for use in screening.

In the above-mentioned screening test paper reading and measuring method, the calculation method of the reflectivity characteristic value α is to divide the reflected spectral signal of non-absorbed light by the reflected spectral signal of absorbed light.

As in the above-mentioned screening test paper reading and measuring method, the reflected spectrum signal range of the non-absorbed light is 650nm wavelength, and the reflected spectrum signal range of the absorbed light is 540nm wavelength.

As described above, the screening test strip reading and measuring method, wherein the screening test strip sample cycle table further includes a detection limit (LOD) and a quantification limit (LOQ), wherein the detection limit range is 100pg/ml, and the quantification limit range is 1,000pg/ml.

As in the above-mentioned screening test paper reading and measuring method, the optical analysis unit is an optical wavelength spectrometer or a spectrometer.

As in the above-mentioned screening test paper reading and measuring method, the imaging magnification device is composed of a magnifying lens and a refracting mirror, which is used to amplify the reflected spectral signal of the detection line of the reaction area illuminated by the emitting light source.

As in the above-mentioned screening test strip reading and measurement method, the detection line is used to measure the color change of IgM or IgG.

10: A reading and lighting device

11: Reading device

12: Lighting device

100: Start action when reading

101: Magnifying lens

102: Refractor

103: A light receiving path

20: A screening test paper

30: An optical analysis unit

31: Read header

40: Screening test strip reading system

41: Test paper carrier unit

200: First Step

300: Second step

400: Step 3

500: Step 4

600: Step 5

80: Screening test strips

81: Reaction area

Figure 1 is a schematic diagram of a commonly used screening test paper.

Figure 2 is a flow chart of the test paper reading and measuring method of the present invention.

Figure 3 is a side view of the structural decomposition and stacking of the system of the screening paper reading and measuring method of the present invention.

Figure 4 is a schematic diagram of the imaging magnification device of the present hair screening test paper reading and measuring method.

FIG. 5 is a curve diagram of the reflectivity characteristic value α of the screening paper reading and measuring method of the present invention.

Figure 6 is a curve diagram of antibody of a screening test paper sample of the present invention.

Figure 7 is a diagram showing the range of absorption and non-absorption reflection spectrum signals for various IgM/IgG concentration tests of the present invention.

Figure 8 is a color diagram of various IgM/IgG concentration test strips of the present invention.

Certain terms are used in this specification and subsequent patent applications to refer to specific components. A person with ordinary knowledge in the field should understand 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 rather use differences in the functions of the components as the criteria for distinction. The term "including" mentioned throughout the specification and subsequent claims is an open term and should be interpreted as "including but not limited to".

FIG. 2 is a flow chart of the test strip reading and measuring method of the present invention. The test strip reading and measuring method of the present invention starts action 100 when the user intends to read the test strip, and then proceeds to the first step 200, providing the user with a test strip 20, on which a test strip reaction area 21 is disposed. The test strip reaction area 21 can produce a periodic chemical reaction to a number of specific specimens, such as (immunoassay change/staining change/C/ IgM/IgG color change), and change the color of the detection line of the reaction area of the screening test paper and the reflected light spectrum signal of the detection line, and then continue to the second step 300, use a screening test paper reading system 40, use the screening test paper reading system 40 to read the color of the detection line of the reaction area of the screening test paper and the reflected light spectrum signal of the detection line, and then in the third step 400, further use an optical analysis unit 30 to analyze the screening test paper reading system 40. The reflected light spectrum signal of the detection line of the reaction area of the screening test paper is received; in the fourth step 500, the optical analysis unit 30 analyzes the reflected light spectrum signal detected by the screening test paper reading system 40, wherein the reflected light spectrum signal is calculated by the optical analysis unit 30 to obtain a reflectivity characteristic value α curve, as shown in the reflectivity characteristic value α curve of the screening test paper reading measurement method in FIG. 5, wherein the calculation method of the reflectivity characteristic value α is not The reflected spectrum signal of the absorbed light is divided by the reflected spectrum signal of the absorbed light, wherein the reflected spectrum signal range of the non-absorbed light is between 650nm wavelength, and the reflected spectrum signal range of the absorbed light is between 540nm wavelength, as shown in FIG7, and then the reflectivity characteristic value α is used to establish a screening test paper specimen antibody curve table, as shown in FIG6 - a screening test paper specimen antibody curve diagram, wherein as shown in FIG6 further includes a detection limit value (Limit The detection limit (LOD) and quantification limit (LOQ) are marked, wherein the detection limit range is between 100pg/ml and the quantification limit range is between 1,000pg/ml. The above screening test strip reading measurement method is used to provide the user with the screening test strip for the sample measurement cycle for a specific sample to measure and judge. If no measurement action is performed, the end procedure is performed, such as the fifth step 600 measurement end.

As shown in the side view of the structure decomposition stack of the system of the screening test paper reading and measuring method in FIG3, 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 carrier unit 41, wherein the screening test paper reading system 40 further includes a reading illumination device 10 and a reading device 11, the When the screening test paper 20 is placed in the test paper carrier unit 41, the reading and illuminating device 10 emits light source for illumination, 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 light source, and then transmits it to the optical analysis unit 30 for calculation and analysis of the reflection spectrum signal. Continuing with the reading method of an embodiment of the present invention as shown in FIG. 3 , when a screening test strip reading system 40 performs a reading operation, the screening test strip reading system 40 includes a reading illumination device 10 and a reading device 11, and the above devices are used for reading illumination; there is also a screening test strip 20, on which a reaction area is configured, and the reaction area can produce a chemical reaction to a number of specific specimens (such as urine or blood, etc.) and change the color of the detection line of the reaction area. The above screening test strip is a COVID-19 screening test strip (COVID-19 IgM/IgG Rapid Test The optical analysis unit 30 is connected to the reading and illuminating device 10, and the optical analysis unit is a micro-spectrophotometer for analyzing the spectrum signal of the detection line image of the reaction area of the screening test paper received by the reading device 11; in addition, in the screening test paper reading and measuring method of the present embodiment, when the screening test paper reading system 40, wherein the test paper 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 color of the detection line of the reaction area of the screening test paper and the reflection spectrum signal of the detection line, and further uses an optical The analysis unit 30 is used to analyze the reflected spectrum signal of the detection line of the reaction area of the test paper received by the test paper reading system 40. The reading illumination device 10 will emit a light source to illuminate the test paper 20. The reading illumination device 10 further includes an illumination device 12. The illumination device 12 will emit a light source to illuminate the test paper 20, and the test paper reading system 40 will read the reflected spectrum signal of the detection line of the reaction area of the test paper illuminated by the light source, and then transmit it to the optical analysis unit 30 for calculation and analysis of the reflected spectrum signal. Continuing from the above embodiment, the illumination device 12 is a white light emitting diode (White The reading device 11 reads the reflected image spectrum signal of the detection line of the reaction area irradiated by the emitting light source, and then transmits it to the optical analysis unit 30 for calculation and analysis of the reflected image spectrum signal. The specific specimen of the screening test paper in the above embodiment can be applied to saliva, urine, blood plague, water, food, toxic and harmful substances or microorganisms. The screening test paper in the above embodiment can be replaced by immunoassay test paper, biological rapid screening test paper or immune antibody rapid screening test paper. The illumination device 12 in the above embodiment can be replaced by ultraviolet light emitting diode (UV LED), near infrared light emitting diode (NIR LED), laser diode, halogen lamp (Halogen lamp) or tungsten lamp, the optical analysis unit in the above embodiment can be replaced by an optical wavelength spectrometer.

Continuing with the above method, for example, taking the example of detecting the patient's urine glucose value, if it has been determined that the screening test paper is for urine glucose, the test can be performed directly, that is, the urine to be tested is contacted with the reaction area of the screening test paper 20 (usually by dripping or infiltration), and the components in the reaction area will react chemically with the urine to be tested and change the color of the reaction area. In addition, the reaction area can include a variety of different detection areas for detecting glucose, protein, pH value, occult blood value or other physiological values in urine, so as to achieve 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 in the test paper carrier unit 41, and the subsequent optical analysis unit 30 performs the reading device 11 to read the detection line reflection image spectrum signal of the reaction area irradiated by the emission light source, and then transmits it to the optical analysis unit 30 to perform calculation analysis on the reflection image spectrum signal, as shown in FIG6. The above screening test paper 20 can be replaced by the COVID-19 IgM/IgG Rapid Test Kit), wherein the detection line of the screening test paper is IgM or IgG. The above screening test paper can quickly screen for COVID-19. In addition, the technology of this case can accurately measure the reaction spectrum signal of the test object of the screening test paper, and can achieve the purpose of rapid screening and rapid replacement of screening test paper, and solve the false negative line of COVID-19 that may be caused by general rapid screening test paper.

Continuing with the above method embodiment, as shown in FIG4 , a schematic diagram of an imaging magnifying device for the screening test paper reading and measuring method, the reading device 11 further includes an imaging magnifying device, which is used to provide amplified reflection image spectrum signals of the detection lines of the reaction area illuminated by the emission light source. As shown in FIG4 , the imaging magnifying device is composed of a magnifying lens 101 and a refracting mirror 102. The magnification of the imaging magnification device is selected to be between 1.5 times and 10 times. When the reading device 11 reads the detection line reflected image spectrum signal of the reaction area irradiated by the emission light source, the detection line reflected image spectrum signal will first pass through the magnifying lens 101 and the refraction mirror 102 and a light receiving channel 103 to amplify the signal and then transmit it to the reading head of the optical analysis unit. 31 receives and then performs subsequent optical analysis, continuing with the above-mentioned embodiment, when the reading device 11 reads the detection line reflected image spectrum signal of the reaction area irradiated by the emission light source, when the magnification of the imaging magnification device is selected in the embodiment of the present case, the original reading detection line reflected image width is magnified by the imaging magnification device, and the image signal received by the reading head 31 of the optical analysis unit becomes The optical analysis unit 30 then analyzes the received amplified signal. The above device can solve and prevent users from making erroneous judgments due to the fact that the detection lines of the COVID-19 screening test strips, immunoassay test strips, biological rapid screening test strips or immune antibody rapid screening test strips do not show color or the lines are not obvious after reacting with the test object, or may cause false negative lines.

Continuing with the above method embodiment, the method of the present invention is characterized in that the optical analysis unit 30 analyzes the reflected spectrum signal detected by the screening test paper reading system 40, wherein the reflected spectrum signal is calculated by the optical analysis unit 30 to obtain a reflectance characteristic value α , wherein the calculation method of the reflectance characteristic value α is to divide the reflected spectrum signal of non-absorbed light by the reflected spectrum signal of absorbed light, wherein the range of the reflected spectrum signal of non-absorbed light is between 650nm wavelength, and the range of the reflected spectrum signal of absorbed light is between 540nm wavelength, as shown in FIG7 which is a graph of the range of the reflected spectrum signal of absorbed light and non-absorbed light for various IgM/IgG concentration detection.

Regarding the above-mentioned method implementation example, the screening test paper reading method invented in this case can solve the false negative error judgment and the user can use this test paper carrier unit 41 to quickly replace the screening test paper 20 to achieve the purpose of repeated screening.

As shown in Figure 8, the color development diagram of various IgM/IgG concentration test strips shows various detection screening test strips 20, in which the detection of the screening test strips can screen out IgM/IgG in the range of 0.5ng/ml to 1000ng/ml. The method of this case can be used to further detect and measure the color change and numerical confirmation of IgM or IgG.

After describing in detail the various preferred embodiments of the present invention, those familiar with the technology can clearly understand that various changes and modifications can be made without departing from the scope and spirit of the patent application below, such as various implementation modes of the limiter unit, etc., and are not limited to the implementation methods of the embodiments in the specification.

100: Start action when reading

200: First Step

300: Second step

400: Step 3

500: Step 4

600: Step 5

Claims (9)

A method for reading and measuring a screening test paper comprises the following steps: a first step, providing a screening test paper, on which a screening test paper reaction zone is arranged, wherein the screening test paper reaction zone can produce a periodic chemical reaction to a number of specific samples and change the color of the detection line of the screening test paper reaction zone and the reflected light spectrum signal of the detection line; a second step, using a screening test paper reading system, wherein the screening test paper reading system reads the color of the detection line of the screening test paper reaction zone and the reflected light spectrum signal of the detection line; a third step, further using an optical analysis unit to analyze the screening test paper received by the screening test paper reading system. The fourth step is characterized in that when the optical analysis unit analyzes the reflected spectral signal detected by the screening paper reading system, the reflected spectral signal is calculated by the optical analysis unit to obtain a reflectivity characteristic value α, and the reflectivity characteristic value α is used to establish a screening paper specimen antibody curve table to perform the specimen cycle measurement and judgment; wherein the calculation method of the reflectivity characteristic value α is to divide the reflected spectral signal of non-absorbed light by the reflected spectral signal of absorbed light, and the calculation method of the reflectivity characteristic value α is, y=0.0382X ² -0.034X+0.998 R ² =0.9964 or y=0.9945+((0.6038)/(1+10 ^{0.6423(5.234-x)} )) R ² =0.9467Step 5, measurement is completed. For example, in the test paper reading and measuring method of item 1 of the patent application, the test paper reading system further comprises an illumination device, the illumination device will emit a light source to illuminate the test paper, and the test paper reading system will read the reflected spectrum signal of the detection line of the reaction area of the test paper illuminated by the light source, and then transmit it to the optical analysis unit for calculation and analysis of the reflected spectrum signal. For example, the test paper reading and measuring method of item 2 of the patent application scope, wherein the test paper reading system further comprises an imaging amplification device, and the imaging amplification device is used to provide amplification of the reflected spectral signal of the detection line of the reaction area illuminated by the emitting light source. For example, in the method for measuring the reading of a screening test paper in item 3 of the patent application, the magnification of the imaging magnification device is selected to be between 1.5 times and 10 times. For example, the screening test strip reading and measuring method in item 1 of the patent application scope, wherein the specific sample of the screening test strip is saliva, urine, blood, water, food, toxic and harmful substances or microorganisms. For example, the method for reading and measuring the screening test paper in item 5 of the patent application, wherein the reflected spectrum signal range of the non-absorbed light is 650nm wavelength, and the reflected spectrum signal range of the absorbed light is 540nm wavelength. For example, the screening test strip reading and measuring method of item 6 of the patent application scope, wherein the screening test strip specimen antibody curve table further includes a detection limit (LOD) and a quantification limit (LOQ), wherein the detection limit range is 100pg/ml, and the quantification limit range is 1,000pg/ml. For example, in the method for reading and measuring the screening test paper in item 4 of the patent application, the imaging magnification device is composed of a magnifying lens and a refracting mirror, which is used to amplify the reflected spectral signal of the detection line of the reaction area illuminated by the emitting light source. For example, the method for reading and measuring a screening test strip in item 7 of the patent application, wherein the detection line is a color change for measuring IgM or IgG.

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