WO2022155551A1 - Système et procédé de réalisation d'un test colorimétrique - Google Patents

Système et procédé de réalisation d'un test colorimétrique Download PDF

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Publication number
WO2022155551A1
WO2022155551A1 PCT/US2022/012641 US2022012641W WO2022155551A1 WO 2022155551 A1 WO2022155551 A1 WO 2022155551A1 US 2022012641 W US2022012641 W US 2022012641W WO 2022155551 A1 WO2022155551 A1 WO 2022155551A1
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WIPO (PCT)
Prior art keywords
pathogen
material group
processors
test result
color wavelength
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PCT/US2022/012641
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English (en)
Inventor
Aaron Adler
Bryan BARTLEY
Mike GAVIN
Jordan SEVILLE
Darby MCCHESNEY
Frank M. Laduca
Jiangshan WANG
Andres DEXTRE
Mohit Verma
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Purdue Research Foundation
Raytheon BBN Technologies, Corp.
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Publication of WO2022155551A1 publication Critical patent/WO2022155551A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/8483—Investigating reagent band
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6806—Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6844—Nucleic acid amplification reactions
    • 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
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64—Fluorescence; Phosphorescence
    • G01N21/6486—Measuring fluorescence of biological material, e.g. DNA, RNA, cells
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody

Definitions

  • a rapid diagnostic test (RDT) for infectious diseases typically refers to lateralflow immunochromatographic tests used to detect infections.
  • an RDT may constitute a point-of-care (POC) test.
  • POC point-of-care
  • some molecular diagnostics e.g., polymerase chain reaction (PCR)
  • PCR polymerase chain reaction
  • PCR polymerase chain reaction
  • many RDTs that may be used at a hospital and subsequently shipped for testing are impracticable in other use cases including large-scale (e.g., a concert, mall, university), medium scale (day care, restaurant, cafe), retail health, and at the home.
  • FIG. 1 depicts a flowchart for identifying a colorimetric test result from a pathogen test performed on a solid phase substrate in accordance with an example embodiment
  • FIG. 2 depicts a pathogen test performed on a solid phase substrate in accordance with an example embodiment
  • FIG. 3 depicts a flowchart for generating a confidence level in accordance with an example embodiment
  • FIG. 4 depicts a system for identifying a colorimetric test result from a pathogen test performed on a solid phase substrate in accordance with an example embodiment
  • FIG. 5 depicts a method of identifying a test result of a loop-mediated isothermal amplification (LAMP) reaction on a solid phase reaction medium in accordance with an example embodiment
  • FIG. 6 depicts a flowchart of a machine readable storage medium having instructions embodied thereon for identifying a test result of a loop-mediated isothermal amplification (LAMP) reaction in accordance with an example embodiment
  • FIG. 7 illustrates a computing system that includes a data storage device in accordance with an example embodiment.
  • Coupled can be used interchangeably and refer to a relationship between items or structures that are either directly or indirectly connected in an electrical or nonelectrical manner.
  • “Directly coupled” or “directly connected” objects or elements are in physical contact with one another.
  • recitation of “coupled” or “connected” provides express support for “directly coupled” or “directly connected” and vice versa.
  • Objects described herein as being “adjacent to” each other may be in physical contact with each other, in close proximity to each other, or in the same general region or area as each other, as appropriate for the context in which the phrase is used.
  • comparative terms such as “increased,” “decreased,” “better,” “worse,” “higher,” “lower,” “enhanced,” “maximized,” “minimized,” and the like refer to a property of a device, component, or activity that is measurably different from other devices, components, or activities in a surrounding or adjacent area, in a single device or in multiple comparable devices, in a group or class, in multiple groups or classes, or as compared to the known state of the art.
  • a sensor with “increased” sensitivity can refer to a sensor in a sensor array which has a lower level or threshold of detection than one or more other sensors in the array. A number of factors can cause such increased sensitivity, including materials, configurations, architecture, connections, etc.
  • the term “substantially” refers to the complete or nearly complete extent or degree of an action, characteristic, property, state, structure, item, or result.
  • an object that is “substantially” enclosed would mean that the object is either completely enclosed or nearly completely enclosed.
  • the exact allowable degree of deviation from absolute completeness may in some cases depend on the specific context. However, generally speaking the nearness of completion will be so as to have the same overall result as if absolute and total completion were obtained.
  • the use of “substantially” is equally applicable when used in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result.
  • compositions that is “substantially free of” particles would either completely lack particles, or so nearly completely lack particles that the effect would be the same as if it completely lacked particles.
  • a composition that is “substantially free of” an ingredient or element may still actually contain such item as long as there is no measurable effect thereof.
  • the term “about” is used to provide flexibility to a numerical range endpoint by providing that a given value may be “a little above” or “a little below” the endpoint. However, it is to be understood that even when the term “about” is used in the present specification in connection with a specific numerical value, that support for the exact numerical value recited apart from the “about” terminology is also provided.
  • Numerical amounts and data may be expressed or presented herein in a range format. It is to be understood that such a range format is used merely for convenience and brevity and thus should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. As an illustration, a numerical range of “about 1 to about 5” should be interpreted to include not only the explicitly recited values of about 1 to about 5, but also include individual values and sub-ranges within the indicated range.
  • Viral pathogens can spread from pre-symptomatic and asymptomatic individuals. Individuals can remain infectious for up to ten days in moderate cases, and up to two weeks in severe cases.
  • One diagnosis method is by real-time reverse transcription polymerase chain reaction (rRT-PCR) from a nasopharyngeal swab, but results are not usually available for at least a few hours to about a few days. Delays in testing can often led to delays in treatment and delays in mitigating the risk of further spreading the disease.
  • a POC test can provide an additional enhancement when errors in accuracy or undue uncertainty from the test result are minimized.
  • Some potential sources of testing error include when a test result falsely indicates that a diseased person does not have a disease (a false negative) or falsely indicates that a healthy person does have a disease (a false positive).
  • Additional sources of testing error can include: (i) a clinician error in interpreting the test results, or (ii) a user error in interpreting the test results. These clinician and user errors can be caused by inadequate knowledge, poor critical thinking skills, a lack of competency, issues in data gathering, failing to synthesize information, and the like.
  • testing equipment errors can lead to clinician/user errors, and clinician/user errors can also lead to testing equipment errors.
  • clinician/user errors can also lead to testing equipment errors.
  • a rapid diagnostic test that can be used in a POC setting while also minimizing testing equipment errors and clinician/user interpretation errors would also be beneficial.
  • test can provide an uncertain result when the test is inconclusive and an additional test or a different test is used to provide additional information. Therefore, a rapid diagnostic test in a POC setting that minimized testing equipment errors, minimized clinician/user interpretation errors, and minimized uncertain results would be desirable.
  • systems for identifying a colorimetric test result from a pathogen test performed on a solid phase substrate can comprise a sensor configured to detect a spectrum of color wavelengths, and one or more processors.
  • the one or more processors can be configured to receive color wavelength data.
  • the one or more processors can be configured to determine a wavelength threshold for providing a pathogen positive test result.
  • a wavelength threshold can be a threshold based on intensity levels at one or more wavelengths.
  • the one or more processors can be configured to identify whether the color wavelength data meets or exceeds the wavelength threshold for providing a pathogen positive test result.
  • the one or more processors can be configured to generate a result indicator indicating either a pathogen positive or pathogen negative test result.
  • methods of identifying a test result of a loop-mediated isothermal amplification (LAMP) reaction on a solid phase reaction medium can comprise detecting, using a sensor component, a spectrum of color wavelengths.
  • the method can further comprise receiving, at one or more processors, color wavelength data from the sensor component.
  • the method can further comprise determining, at the one or more processors, whether the color wavelength data meets or exceeds the wavelength threshold for providing a positive test result.
  • the method can further comprise generating, at the one or more processors, a result indicator indicating either a positive or negative test result.
  • the method can further comprise displaying, at a user interface, a test result based on the result indicator.
  • a system for identifying a colorimetric test result from a pathogen test performed on a solid phase substrate can comprise a sensor 120 configured to detect a spectrum of color wavelengths from a pathogen test 110, as shown in operation 101 .
  • the system can further comprise one or more processors 130 or a CPU 130.
  • the one or more processors 130 can be configured to receive color wavelength data, as shown in operation 103.
  • the color wavelength data can include data received by a sensor 120 including one or more of a photoconductive sensor, a photovoltaic sensor, a photodiode sensor, a phototransistor sensor, or combinations thereof a photoresistor, a photodiode array, a charge-coupled device (CCD) camera, a complementary metal-oxide semiconductor (CMOS) camera, the like, or combinations thereof.
  • a sensor 120 including one or more of a photoconductive sensor, a photovoltaic sensor, a photodiode sensor, a phototransistor sensor, or combinations thereof a photoresistor, a photodiode array, a charge-coupled device (CCD) camera, a complementary metal-oxide semiconductor (CMOS) camera, the like, or combinations thereof.
  • CCD charge-coupled device
  • the one or more processors 130 can be configured to determine a wavelength threshold for providing a pathogen positive test result, as shown in operation 105. In another example, the one or more processors 130 can be configured to identify whether the color wavelength data meets or exceeds the wavelength threshold for providing a pathogen positive test result, as shown in operation 107. In yet another example, the one or more processors 130 can be configured to generate a result indicator indicating either a pathogen positive or pathogen negative test result, as shown in operation 109. The one or more processors 130 can be configured to send the result indicator to a display 140, as shown in operation 109.
  • a pathogen test system 200 can comprise one or more of a substrate 202, an adhesive layer 204, a reaction layer 206 comprising one or more reaction sections 205a, 205b, and 205c, a plurality of spacing layers 207 separating the one or more reaction sections 205a-c, or a spreading layer 208.
  • a sensor can be configured to detect color wavelength data from the one or more reaction sections 205a, 205b, and 205c from the reaction layer 206.
  • the one or more processors can be configured to receive color wavelength data from one or more sensors, as shown in operation 302.
  • the color wavelength data can be received from discrete sections of a pathogen test (e.g., reaction sections 205a, 205b, or 205c), wherein each discrete section can be directed to the same pathogen or different pathogens.
  • the one or more processors can be configured to determine a wavelength threshold, as shown in operation 304.
  • the one or more processors can be configured to determine that the color wavelength data meets or exceeds the color wavelength threshold, as shown in operation 306.
  • the one or more processors can be configured to generate the test result indicator, as shown in operation 308.
  • the one or more processors can be configured to send the test result indicator to a display 330a.
  • a material group identifier can be used to identify the characteristics of reaction layers associated with a manufacturing group.
  • the one or more processors can be configured to determine a material group identifier, as shown in operation 310.
  • the material group identifier in operation 310 can be based on one or more of an average color wavelength of a material group, a median color wavelength of the material group, a variance of the color wavelength of the material group, a manufacturing date and time of the material group, one or more reagent types of the material group, or one or more solid-phase reaction medium types of the material group, the like, or combinations thereof.
  • the one or more processors can be configured to send the color wavelength data to a material group identifier database 340, as shown in operation 312.
  • the material group identifier database 340 can be configured to determine the material group identifier based on crowd-sourced information, as shown in operation 345.
  • the material group identifier database 340 can send the material group identifier to the one or more processors.
  • the material group identifier database 340 can send the material group identifier to a test results database 350.
  • the material group identifier database can exchange information from multiple devices.
  • the material group identifier can use the collected information to constantly update the determination of the material group identifier by the material group identifier database when color wavelength data is received from a device (e.g., when operation 345 is performed).
  • the one or more processors can be configured to adjust the wavelength threshold based on the material group identifier, as shown in operation 314.
  • the one or more processors can be configured to generate a confidence level, as shown in operation 316.
  • the one or more processors can be configured to calculate a number of nucleic acids, as shown in operation 318.
  • the one or more processors can be configured to send the test results to the test results database 350 as shown in operation 320, or repeat operation 308 or terminate, as shown in operation 322.
  • operation 308 can be repeated when the confidence level is below a selected threshold. For example, when the confidence level is less than about 95%, then operation 308 can be repeated through an iterative process until the confidence level has reached the threshold of 95%. In another aspect, the operation 308 can be repeated until the operation has been repeated a selected number of times. For example, when operation 308 has been repeated about 5 times, then the process can terminate.
  • test results can be accessed from the test results database 350 via a display 330b, a network 360, or a web server 370.
  • the one or more processors can adjust the wavelength threshold based on the material group identifier without sending or receiving information to the material group identifier database 340.
  • the material group can be included with the device.
  • the one or more processors can be configured to adjust the wavelength threshold based on a material group identifier.
  • the material group identifier can be based on one or more of: an average color wavelength of a material group, a median color wavelength of the material group, a variance of the color wavelength of the material group, a manufacturing date and time of the material group, one or more reagent types of the material group, or one or more solid-phase reaction medium types of the material group, the like, or combinations thereof.
  • the one or more processors can be configured to generate the material group identifier from color wavelength data aggregated from crowdsourced data.
  • the crowd-sourced data can be associated with a plurality of users associated with the pathogen test.
  • a confidence level of can be calculated from metadata associated with color wavelength data including one or more of a ratio of the number of aggregated test results from a specific material group identifier to the number of total test results from the specific group identifier; a variance of the aggregated test results associated with the specific material group identifier; a date and time when the aggregated test results are received from a user for each material group identifier, the like, or combinations thereof.
  • the one or more processors can be configured to adjust the wavelength threshold using color wavelength data having a wavelength from about 500 nm to about 565 nm.
  • the color wavelength data can be adjusted based on a colorimetric range associated with a pH-sensitive dye (e.g., phenol red).
  • the one or more processors can be configured to calculate a number of nucleic acid copies based on one or more of the color wavelength data, the material group identifier, a color change time, or a rate of color change time.
  • the number of nucleic acid copies can be calculated using data associated with the material group identifier including, but not limited to, an average color wavelength of a material group, a median color wavelength of the material group, a variance of the color wavelength of the material group, a manufacturing date and time of the material group, one or more reagent types of the material group, or one or more solid-phase reaction medium types of the material group.
  • the color change time can be the time between the initialization of a LAMP reaction and a positive test result.
  • the concentration of the pathogen can be higher than the average concentration for the average of the material group.
  • the concentration of the pathogen can be lower than the average concentration for the average of the material group.
  • the concentration of the pathogen can be calibrated against the material group to provide an approximate number of copies of nucleic acid per volume.
  • the one or more processors can be configured to generate a confidence level using the color wavelength data and the material group identifier.
  • a confidence level can be calculated using data associated with the material group identifier including, but not limited to, an average color wavelength of a material group, a median color wavelength of the material group, a variance of the color wavelength of the material group, a manufacturing date and time of the material group, one or more reagent types of the material group, or one or more solid-phase reaction medium types of the material group.
  • the one or more processors can be further configured to receive the color wavelength data for discrete sections (e.g., reaction sections 205a, 205b, or 205c) of the pathogen test.
  • the color wavelength data can be received from a first reaction section of a pathogen test and a second reaction section of a pathogen test, wherein the first reaction section and the second reaction section can be configured to test for the same pathogens or different pathogens.
  • the one or more processors can be further configured to determine the wavelength threshold for providing a pathogen positive test result based on the color wavelength data for discrete sections of the pathogen test.
  • a first reaction section of the pathogen test can be configured to have a first range of color wavelength data and a second reaction section of the pathogen test can be configured to have a second range of color wavelength data.
  • a first reaction section of the pathogen test can be configured to the same range of color wavelength data as the second reaction section of the pathogen test.
  • the one or more processors can be further configured to identify whether the color wavelength data meets or exceeds the threshold for providing the pathogen positive test result.
  • the threshold for the color wavelength data can be the same for each discrete section.
  • the additional data can provide a positive or negative test result with additional certainty compared to a test result based on color wavelength data from one section.
  • the threshold for the color wavelength data can be different for each discrete section (e.g., reaction sections 205a, 205b, or 205c).
  • the threshold for each discrete section can be based on a confidence level.
  • a first threshold when met or exceeded, may provide a confidence level of about 95%
  • a second threshold when met or exceeded, may provide a confidence level of about 99%.
  • the confidence level for each section can be based on the quality of color wavelength data obtained.
  • the quality of color wavelength obtained can differ based on the type of colorimetric indicator used in the pathogen test.
  • the one or more processors can be further configured to generate a confidence level for the pathogen positive test result based on the color wavelength data received from the discrete sections of the pathogen test (e.g., reaction sections 205a, 205b, or 205c).
  • the one or more processors can be further configured to: receive the color wavelength data for discrete sections of the pathogen test (e.g., reaction sections 205a, 205b, or 205c); determine an additional wavelength threshold for providing a different pathogen positive test result based on the color wavelength data for discrete sections of the pathogen test, and generate an additional result indicator indicating either an additional pathogen positive or additional pathogen negative test result when the discrete sections of the pathogen test are targeted to different pathogens.
  • a first section of the pathogen test can be targeted to SARS-CoV-2 and the second section of the pathogen test can be targeted to influenza.
  • the confidence level for a positive or negative test result for a first pathogen can be based on the confidence level for a positive or negative test result for a second pathogen. For example, a confidence level of about 90% for a positive test for influenza can negatively affect the confidence level for a positive test result for SARS-CoV-2.
  • the senor can comprise an RGB sensor configured to generate RGB values or a CMYK sensor configured to generate CMYK values.
  • the one or more processor can be configured to receive the RGB values from the RGB sensor.
  • the one or more processors can be configured to determine a wavelength threshold for providing a pathogen positive test result based on the RGB values.
  • the one or more processors can be configured to identify whether the color wavelength data meets or exceeds the wavelength threshold for providing a pathogen positive test result based on the RGB values.
  • the one or more processors can be configured to generate a result indicator indicating either a pathogen positive or pathogen negative test result based on the RGB values.
  • the one or more processor can be configured to receive the CMYK values from the CMYK sensor.
  • the one or more processors can be configured to determine a wavelength threshold for providing a pathogen positive test result based on the CMYK values.
  • the one or more processors can be configured to identify whether the color wavelength data meets or exceeds the wavelength threshold for providing a pathogen positive test result based on the CMYK values.
  • the one or more processors can be configured to generate a result indicator indicating either a pathogen positive or pathogen negative test result based on the CMYK values.
  • the senor can comprise a white light emitter, and a light receiver having a 540 nm filter.
  • the white light emitter can be configured to emit white light towards the pathogen test.
  • the reflected light intensity from a reaction layer of the pathogen test can be detected using a light receiver having a 540 nm filter.
  • the reflected light intensity from the reaction layer from the pathogen test can be detected using a light receiver having a filter configured to detect a wavelength in a testing range for the pathogen test.
  • the senor can comprise one or more of: a photoconductive sensor, a photovoltaic sensor, a photodiode sensor, a phototransistor sensor, or combinations thereof.
  • the sensor can comprise one or more of a photoresistor, a photodiode array, a charge-coupled device (CCD) camera, a complementary metal-oxide semiconductor (CMOS) camera, the like, or combinations thereof.
  • CCD charge-coupled device
  • CMOS complementary metal-oxide semiconductor
  • the system can further comprise a graphical user interface for interacting with a user.
  • the graphical user interface can include a display screen configured to display: (i) an inconclusive test result, (b) the pathogen negative test result, or (c) the pathogen positive test result.
  • the display screen can be configured to display other aspects of the tests results including one or more of the color wavelength data, the wavelength threshold, the material group identifier, the confidence level, the number of nucleic acids, the pathogens that are negative or positive, the like, or combinations thereof.
  • the pathogen can comprise a viral pathogen, a bacterial pathogen, a fungal pathogen, or a protozoa pathogen.
  • the pathogen can comprise a viral pathogen.
  • the viral pathogen can comprise a dsDNA virus, an ssDNA virus, a dsRNA virus, a positive-strand ssRNA virus, a negative-strand ssRNA virus, an ssRNA-RT virus, or a ds-DNA-RT virus.
  • each primer sequence can match a sequence from a viral target comprising H1 N1 , H2N2, H3N2, H1 N1 pdmO9, or SARS-CoV-2.
  • the specific target nucleotide sequences to be detected can be target nucleotides corresponding to human biomarkers.
  • Any disease that has a target nucleotide corresponding to a human biomarker for a disease can be detected.
  • Various types of diseases can be detected including one or more of: breast cancer, pancreatic cancer, colorectal cancer, ovarian cancer, gastrointestinal cancer, cervix cancer, lung cancer, bladder cancer, many types of carcinomas, salivary gland cancer, kidney cancer, liver cancer, lymphoma, leukemia, melanoma, prostate cancer, thyroid cancer, stomach cancer, the like, or combinations thereof.
  • biomarkers for various types of diseases can be detected by detecting target nucleotides corresponding to one or more of: alpha fetoprotein, CA15-3 and CA27-29, CA19-9, CI-125, calcitonin, calretinin, carcinoembryonic antigen, CD34, CD99MIC 2, CD117, chromogranin, chromosomes 3, 7, 17, and 9p21 , cytokeratin, cesmin, epithelial membrane antigen, factor VIII, CD31 FL1 , glial fibrillary acidic protein, gross cystic disease fluid protein, hPG80, HMB-45, human chorionic gonadotropin, immunoglobulin, inhibin, keratin, lymphocyte marker, MART-1 , Myo D1 , muscle-specific actin, neurofilament, neuronspecific enolase, placental alkaline phosphatase, prostate-specific antigen, PTPRC, S100 protein, smooth muscle action, synaptophysin
  • a method of identifying a test result of a loop- mediated isothermal amplification (LAMP) reaction on a solid phase reaction medium can comprise detecting, using a sensor component, a spectrum of color wavelengths.
  • the method can comprise receiving, at one or more processors, color wavelength data from the sensor component.
  • the method can comprise determining, at the one or more processors, whether the color wavelength data meets or exceeds the wavelength threshold for providing a positive test result.
  • the method can comprise generating, at the one or more processors, a result indicator indicating either a positive or negative test result.
  • the method can comprise displaying, at a user interface, a test result based on the result indicator.
  • the method can comprise adjusting, at the one or more processors, the wavelength threshold using RGB values or CMYK values from a material group identifier.
  • the method can comprise receiving, at the one or more processors, RGB values or CMYK values from the spectrum of color wavelengths.
  • the method can comprise generating, at the one or more processors, the result indicator indicating either the positive or negative test result based on the RGB or CMYK values.
  • At least one machine readable storage medium can have instructions embodied thereon for identifying a test result of a loop- mediated isothermal amplification (LAMP) reaction, wherein the instructions when executed by one or more processors can perform the following: receiving, at the one or more processors, color wavelength data from a sensor component.
  • the instructions when executed can perform: determining, at the one or more processors, whether the color wavelength data exceeds a wavelength threshold for providing a positive test result.
  • the instructions when executed can perform: generating, at the one or more processors, a result indicator indicating either a positive or negative test result.
  • the instructions when executed can perform adjusting the wavelength threshold based on a material group identifier.
  • the material group identifier can be based on one or more of: an average color wavelength of a material group, a median color wavelength of the material group, a variance of the color wavelength of the material group, a manufacturing date and time of the material group, one or more reagent types of the material group, or one or more solid-phase reaction medium types of the material group.
  • the instructions when executed can perform generating the material group identifier from color wavelength data aggregated from crowdsourced data.
  • the instructions when executed can perform calculating a number of nucleic acid copies based on the color wavelength data and the material group identifier.
  • the instructions when executed can perform generating a confidence level using the color wavelength data and the material group identifier.
  • the instructions when executed can perform: generating, at the one or more processors, a result indicator indicating either a positive or negative test result for a plurality of pathogens based on color wavelength data received for discrete sections of the pathogen test.
  • the system can comprise a sensor configured to detect a spectrum of color wavelengths.
  • the system can further comprise one or more processors.
  • the one or more processors can be configured to receive color wavelength data, as shown in block 410.
  • the one or more processors can be configured to determine a wavelength threshold for providing a pathogen positive test result, as shown in block 420.
  • the one or more processors can be configured to identify whether the color wavelength data meets or exceeds the wavelength threshold for providing a pathogen positive test result, as shown in block 430.
  • the one or more processors can be configured to generate a result indicator indicating either a pathogen positive or pathogen negative test result, as shown in block 440.
  • Another example provides a method 500 of identifying a test result of a loop- mediated isothermal amplification (LAMP) reaction on a solid phase reaction medium, as shown in the flow chart in FIG. 5.
  • the method can comprise detecting, using a sensor component, a spectrum of color wavelengths, as shown in block 510.
  • the method can comprise receiving, at one or more processors, color wavelength data from the sensor component, as shown in block 520.
  • the method can comprise determining, at the one or more processors, whether the color wavelength data meets or exceeds the wavelength threshold for providing a positive test result, as shown in block 530.
  • the method can comprise generating, at the one or more processors, a result indicator indicating either a positive or negative test result, as shown in block 540.
  • the method can comprise displaying, at a user interface, a test result based on the result indicator, as shown in block 550.
  • Another example provides at least one machine readable storage medium having instructions 600 embodied thereon for identifying a test result of a loop- mediated isothermal amplification (LAMP) reaction, as shown in FIG. 6.
  • the instructions can be executed on a machine, where the instructions are included on at least one computer readable medium or one non-transitory machine readable storage medium.
  • the instructions when executed can perform: receiving, at the one or more processors, color wavelength data from a sensor component, as shown in block 610.
  • the instructions when executed can perform: determining, at the one or more processors, whether the color wavelength data exceeds a wavelength threshold for providing a positive test result, as shown in block 620.
  • the instructions when executed can perform: generating, at the one or more processors, a result indicator indicating either a positive or negative test result, as shown in block 630.
  • FIG. 7 illustrates a general computing system or device 700 that can be employed in the present technology.
  • the computing system 700 can include a processor 702 in communication with a memory 704.
  • the memory 704 can include any device, combination of devices, circuitry, and the like that is capable of storing, accessing, organizing, and/or retrieving data.
  • Non-limiting examples include SANs (Storage Area Network), cloud storage networks, volatile or non-volatile RAM, phase change memory, optical media, hard-drive type media, and the like, including combinations thereof.
  • the computing system or device 700 additionally includes a local communication interface 718 for connectivity between the various components of the system.
  • the local communication interface can be a local data bus and/or any related address or control busses as may be desired.
  • the computing system or device 700 can also include an I/O (input/output) interface 714 for controlling the I/O functions of the system, as well as for I/O connectivity to devices outside of the computing system 700.
  • I/O input/output
  • a network interface 716 can also be included for network connectivity.
  • the network interface 716 can control network communications both within the system and outside of the system.
  • the network interface can include a wired interface, a wireless interface, a Bluetooth interface, optical interface, and the like, including appropriate combinations thereof.
  • the computing system 700 can additionally include a user interface 714, a display device 740, as well as various other components that would be beneficial for such a system.
  • the processor 702 can be a single or multiple processors, and the memory 704 can be a single or multiple memories.
  • the local communication interface 718 can be used as a pathway to facilitate communication between any of a single processor, multiple processors, a single memory, multiple memories, the various interfaces, and the like, in any useful combination.
  • a system for identifying a colorimetric test result from a pathogen test performed on a solid phase substrate can comprise a sensor configured to detect a spectrum of color wavelengths; and one or more processors configured to: receive color wavelength data; determine a wavelength threshold for providing a pathogen positive test result; identify whether the color wavelength data meets or exceeds the wavelength threshold for providing a pathogen positive test result; and generate a result indicator indicating either a pathogen positive or pathogen negative test result.
  • the one or more processors can be further configured to: adjust the wavelength threshold based on a material group identifier.
  • the material group identifier can be based on one or more of: an average color wavelength of a material group, a median color wavelength of the material group, a variance of the color wavelength of the material group, a manufacturing date and time of the material group, one or more reagent types of the material group, or one or more solid-phase reaction medium types of the material group.
  • the one or more processors can be further configured to: generate the material group identifier from color wavelength data aggregated from crowd-sourced data.
  • the one or more processors can be further configured to: calculate a number of nucleic acid copies based on one or more of the color wavelength data, the material group identifier, or a color change time.
  • the one or more processors can be further configured to: generate a confidence level using the color wavelength data and the material group identifier.
  • the one or more processors can be further configured to: receive the color wavelength data for discrete sections of the pathogen test; determine the wavelength threshold for providing a pathogen positive test result based on the color wavelength data for discrete sections of the pathogen test; and identify whether the color wavelength data meets or exceeds the threshold for providing the pathogen positive test result.
  • the one or more processors can be further configured to generate a confidence level for the pathogen positive test result based on the color wavelength data received from the discrete sections of the pathogen test.
  • the one or more processors can be further configured to: receive the color wavelength data for discrete sections of the pathogen test; determine an additional wavelength threshold for providing a different pathogen positive test result based on the color wavelength data for discrete sections of the pathogen test; and generate an additional result indicator indicating either an additional pathogen positive or additional pathogen negative test result when the discrete sections of the pathogen test are targeted to different pathogens.
  • the sensor can be configured to detect a spectrum of color wavelengths for discrete sections of the pathogen test.
  • the senor can comprise an RGB sensor configured to generate RGB values or a CMYK sensor configured to generate CMYK values.
  • the senor can comprise: a white light emitter; and a light receiver having a 540 nm filter.
  • the one or more processors can be further configured to: adjust the wavelength threshold using color wavelength data having a wavelength from about 500 nm to about 565 nm.
  • the senor can be one or more of: a photoconductive sensor, a photovoltaic sensor, a photodiode sensor, a phototransistor sensor, or combinations thereof.
  • system for identifying a colorimetric test result from a pathogen test performed on a solid phase substrate, can further comprise a graphical user interface configured to display the pathogen negative or pathogen positive test result.
  • a method of identifying a test result of a loop-mediated isothermal amplification (LAMP) reaction on a solid phase reaction medium can comprise: detecting, using a sensor component, a spectrum of color wavelengths; receiving, at one or more processors, color wavelength data from the sensor component; determining, at the one or more processors, whether the color wavelength data meets or exceeds the wavelength threshold for providing a positive test result; generating, at the one or more processors, a result indicator indicating either a positive or negative test result; and displaying, at a user interface, a test result based on the result indicator.
  • LAMP loop-mediated isothermal amplification
  • the method can further comprise adjusting, at the one or more processors, the wavelength threshold using RGB values or CMYK values from a material group identifier.
  • LAMP loop-mediated isothermal amplification
  • the method can further comprise receiving, at the one or more processors, RGB values or CMYK values from the spectrum of color wavelengths.
  • LAMP loop-mediated isothermal amplification
  • the method can further comprise generating, at the one or more processors, the result indicator indicating either the positive or negative test result based on the RGB or CMYK values.
  • LAMP loop-mediated isothermal amplification
  • At least one machine readable storage medium having instructions embodied thereon for identifying a test result of a loop-mediated isothermal amplification (LAMP) reaction, the instructions when executed by one or more processors can perform the following: receiving color wavelength data from a sensor component; determining whether the color wavelength data exceeds a wavelength threshold for providing a positive test result for a pathogen test; and generating a result indicator indicating either a positive or negative test result.
  • the method can further comprise instructions that when executed perform: adjusting the wavelength threshold based on a material group identifier.
  • the material group identifier is based on one or more of: an average color wavelength of a material group, a median color wavelength of the material group, a variance of the color wavelength of the material group, a manufacturing date and time of the material group, one or more reagent types of the material group, or one or more solid-phase reaction medium types of the material group.
  • the method can further comprise instructions that when executed perform: calculating a number of nucleic acid copies based on the color wavelength data and the material group identifier.
  • LAMP loop- mediated isothermal amplification
  • the method can further comprise instructions that when executed perform: generating a confidence level using the color wavelength data and the material group identifier.
  • LAMP loop- mediated isothermal amplification
  • the method can further comprise instructions that when executed perform: generating a result indicator indicating either a positive or negative test result for a plurality of pathogens based on color wavelength data received for discrete sections of the pathogen test.
  • LAMP loop- mediated isothermal amplification
  • Various techniques, or certain aspects or portions thereof, can take the form of program code (i.e. , instructions) embodied in tangible media, such as floppy diskettes, compact disc-read-only memory (CD-ROMs), hard drives, non-transitory computer readable storage medium, or any other machine-readable storage medium wherein, when the program code is loaded into and executed by a machine, such as a computer, the machine becomes an apparatus for practicing the various techniques.
  • Circuitry can include hardware, firmware, program code, executable code, computer instructions, and/or software.
  • a non-transitory computer readable storage medium can be a computer readable storage medium that does not include signal.
  • the computing device can include a processor, a storage medium readable by the processor (including volatile and non-volatile memory and/or storage elements), at least one input device, and at least one output device.
  • the volatile and non-volatile memory and/or storage elements can be a random-access memory (RAM), erasable programmable read only memory (EPROM), flash drive, optical drive, magnetic hard drive, solid state drive, or other medium for storing electronic data.
  • RAM random-access memory
  • EPROM erasable programmable read only memory
  • flash drive optical drive
  • magnetic hard drive magnetic hard drive
  • solid state drive or other medium for storing electronic data.
  • the low energy fixed location node, wireless device, and location server can also include a transceiver module (i.e. , transceiver), a counter module (i.e.
  • One or more programs that can implement or utilize the various techniques described herein can use an application programming interface (API), reusable controls, and the like. Such programs can be implemented in a high level procedural or object oriented programming language to communicate with a computer system. However, the program(s) can be implemented in assembly or machine language, if desired. In any case, the language can be a compiled or interpreted language, and combined with hardware implementations.
  • API application programming interface
  • processor can include general purpose processors, specialized processors such as VLSI, FPGAs, or other types of specialized processors, as well as base band processors used in transceivers to send, receive, and process wireless communications.
  • modules can be implemented as a hardware circuit comprising custom very-large-scale integration (VLSI) circuits or gate arrays, off-the-shelf semiconductors such as logic chips, transistors, or other discrete components.
  • VLSI very-large-scale integration
  • a module can also be implemented in programmable hardware devices such as field programmable gate arrays, programmable array logic, programmable logic devices or the like.
  • multiple hardware circuits or multiple processors can be used to implement the functional units described in this specification.
  • a first hardware circuit or a first processor can be used to perform processing operations and a second hardware circuit or a second processor (e.g., a transceiver or a baseband processor) can be used to communicate with other entities.
  • the first hardware circuit and the second hardware circuit can be incorporated into a single hardware circuit, or alternatively, the first hardware circuit and the second hardware circuit can be separate hardware circuits.
  • Modules can also be implemented in software for execution by various types of processors.
  • An identified module of executable code can, for instance, comprise one or more physical or logical blocks of computer instructions, which can, for instance, be organized as an object, procedure, or function. Nevertheless, the executables of an identified module need not be physically located together, but can comprise disparate instructions stored in different locations which, when joined logically together, comprise the module and achieve the stated purpose for the module.
  • a module of executable code can be a single instruction, or many instructions, and can even be distributed over several different code segments, among different programs, and across several memory devices.
  • operational data can be identified and illustrated herein within modules, and can be embodied in any suitable form and organized within any suitable type of data structure. The operational data can be collected as a single data set, or can be distributed over different locations including over different storage devices, and can exist, at least partially, merely as electronic signals on a system or network.
  • the modules can be passive or active, including agents operable to perform desired functions.

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Abstract

L'invention concerne une technologie se rapportant à un système pour identifier un résultat de test colorimétrique à partir d'un test d'agent pathogène réalisé sur un substrat en phase solide. Le système peut comprendre un capteur conçu pour détecter un spectre de longueurs d'onde de couleur. Le système peut comprendre un ou plusieurs processeurs. Le ou les processeurs peuvent être conçus pour : recevoir des données de longueur d'onde de couleur ; déterminer un seuil de longueur d'onde pour fournir un résultat positif d'agent pathogène ; identifier si les données de longueur d'onde de couleur satisfont ou dépassent le seuil de longueur d'onde pour fournir un résultat positif d'agent pathogène ; et générer un indicateur de résultat indiquant soit un résultat positif, soit un résultat négatif d'agent pathogène.
PCT/US2022/012641 2021-01-15 2022-01-15 Système et procédé de réalisation d'un test colorimétrique WO2022155551A1 (fr)

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US20200063197A1 (en) * 2017-05-15 2020-02-27 Arizona Board Of Regents On Behalf Of Arizona State University Quantitative detection and analysis of target dna with colorimetric rt-qlamp
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WO2020251460A1 (fr) * 2019-06-14 2020-12-17 Delaval Holding Ab Système de détermination de la validité d'un résultat de test à écoulement latéral

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Publication number Priority date Publication date Assignee Title
WO2015103293A2 (fr) * 2013-12-30 2015-07-09 Miroculus Inc. Systemes, compositions et procedes pour la detection et l'analyse de profils des micro-arn a partir d'un echantillon biologique
US20160139156A1 (en) * 2014-11-18 2016-05-19 Welltwigs LLC Apparatuses, methods, and systems for home monitoring of physiological states and conditions
US20180299385A1 (en) * 2015-10-09 2018-10-18 Hamamatsu Photonics K.K. Optical measuring device
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US20200063197A1 (en) * 2017-05-15 2020-02-27 Arizona Board Of Regents On Behalf Of Arizona State University Quantitative detection and analysis of target dna with colorimetric rt-qlamp
US20200309702A1 (en) * 2019-03-29 2020-10-01 Vital Vio, Inc. Contamination load sensing device
WO2020251460A1 (fr) * 2019-06-14 2020-12-17 Delaval Holding Ab Système de détermination de la validité d'un résultat de test à écoulement latéral

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