TW202235855A - Electronic test result determination and confirmation - Google Patents

Abstract

A technology is described for a system for identifying a colorimetric test result from a pathogen test performed on a solid phase substrate. The system can comprise a sensor configured to detect a spectrum of color wavelengths. The system can comprise one or more processors. The one or more processors can be 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.

Description

Electronic test result determination and confirmation

field of invention

This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/138,323, filed January 15, 2021, which is incorporated herein by reference.

The present invention relates to determination and confirmation of electronic test results.

Background of the invention

Infectious disease rapid diagnostic tests (RDTs) generally refer to lateral flow immunochromatographic tests used to detect infections. In some cases, but not always, an RDT may constitute a point-of-care (POC) test. For example, certain molecular diagnostic techniques, such as polymerase chain reaction (PCR), may only be available in central laboratories that can be performed at high cost using top-of-the-line bench equipment. As a result, many RDTs that can be used in hospitals and subsequently shipped for testing are otherwise impractical, including large venues (e.g., concerts, malls, universities), medium-sized venues (daycare centers, restaurants, cafes), Health retail outlets, and at home.

Even when RDTs are available in POC settings, the use and interpretation of tests can be complex and confusing for many users. Influenza rapid antigen tests have low sensitivity and should not be used for treatment decisions. Rapid tests for rotavirus and norovirus are less sensitive than molecular tests. Accordingly, there is currently a considerable need for rapid diagnostic tests applicable at the point of care.

According to one aspect of the present invention, a system for identifying colorimetric test results from a pathogen test performed on a solid substrate is provided, comprising: 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 positive detection result for a pathogen; identify whether the color wavelength data meets or exceeds the wavelength threshold for providing a positive detection result for a pathogen; Or an outcome indicator for a negative test result for a pathogen.

According to another embodiment of the present invention, a method for identifying test results of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium is specially proposed, comprising: using a sensor component to detect a spectrum of color wavelengths ; receiving color wavelength data from the sensor assembly at one or more processors; determining whether the color wavelength data meets or exceeds a wavelength threshold providing a positive test result at one or more processors; processing at one or more generating a result indicator indicating a positive or negative test result; and displaying the test result based on the result indicator in a user interface.

According to another aspect of the present invention, a machine-readable storage medium is specifically provided, wherein at least one machine-readable storage medium has a test for identifying a loop-mediated isothermal amplification (LAMP) reaction contained thereon Resulting instructions that, when executed by the one or more processors, perform the following operations: receive color wavelength data from the sensor assembly; determine whether the color wavelength data exceeds a wavelength threshold that provides a positive test result for pathogen detection; As well as produce an outcome indicator that indicates a positive or negative test result.

Detailed Description of the Preferred Embodiment

Before the present invention is disclosed and described, it is to be understood that this invention is not limited to the particular structures, process steps or materials disclosed herein, but extends to equivalents thereof, as those of ordinary skill in the relevant art will recognize. It should also be understood that the terminology used herein is for the purpose of describing, specific and exemplary only, and is not limiting. The same reference numerals in different drawings denote the same elements. Numbers provided in flowcharts and processes are provided to clearly illustrate steps and operations and do not necessarily imply a particular sequence or sequence.

Furthermore, the described features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details are provided, such as layout examples, distance examples, network examples, etc., to provide a thorough understanding of various inventive embodiments. However, those skilled in the relevant art will realize that such detailed embodiments do not limit the overall technical concept set forth herein, but are merely representative thereof.

As used in this written description, the singular forms "a", "an" and "the" include explicit support for plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a sensor" includes a plurality of such sensors.

Reference throughout this specification to "an example" means that a particular feature, structure, or characteristic described in connection with the example is included in at least one embodiment of the invention. Thus, appearances of the phrases "in an example" or "an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment.

As used herein, multiple items, structural elements, constituent elements and/or materials may be presented in the same list for convenience. However, these lists should be construed as if each member of the list was individually identified as a separate and unique member. Accordingly, no single member of such list should be construed as a de facto equivalent to any other member of the same list solely based on its presentation in a common group without indications to the contrary. In addition, reference may be made herein to various embodiments and examples of the technology, along with alternatives to its various components. It should be understood that such embodiments, examples, and alternatives are not to be construed as de facto equivalents to each other, but rather as separate and independent representations under the present disclosure.

Furthermore, the described features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details are provided, such as layout examples, distances, network examples, etc., to provide a comprehensive understanding of the embodiments of the present invention. One skilled in the relevant art will recognize, however, that the techniques may be practiced without one or more of the specific details, or using other methods, components, arrangements, etc. In other instances, well-known structures, materials, or operations may not be shown or described in detail to avoid obscuring aspects of the disclosure.

In this disclosure, "comprises", "comprising", "containing" and "having", etc., may have the meanings assigned to them in U.S. Patent Law and may mean "comprising (includes), "including" and similar expressions, and are generally construed as open-ended terms. The term "consisting of" or "consists of" is a closed term and includes only the components, structures, steps and the like expressly listed with such term, and in accordance with U.S. Patent content of the law. "Consisting essentially of" or "consists essentially of" has the meaning generally assigned to them under US patent law. In particular, these terms are generally closed terms, except that exceptions are permitted to include additional items, materials, components, steps or elements that do not materially affect the basic and novel characteristics or functions of the item concerned. For example, trace elements that are present in the composition but do not affect the properties or characteristics of the composition are allowed if they are present in the language "consisting essentially of" even if not explicitly listed in the list of items following such term. When open-ended terms such as "comprising" or "including" are used in this written description, it is understood that the language "consisting essentially of" is directly supported as well as the language "consisting of" , if explicitly stated, and vice versa.

The terms "first", "second", "third", "fourth" and similar terms in the Detailed Description and Claims, if any, are used to distinguish similar elements and not necessarily to Describe a particular sequence or chronological order. It is to be understood that any terms so used are interchangeable under appropriate circumstances such that the embodiments described herein are, for example, capable of operation in sequences other than those illustrated or otherwise described herein. Similarly, if a method is described herein as comprising a series of steps, the order in which the steps are presented is not necessarily the only order in which the steps can be performed, and some steps described may be omitted, and/ Or some other steps not described here may be added to the method.

The terms "coupled" and "connected" are used interchangeably and refer to a relationship between items or structures that are directly or indirectly connected, either electrically or non-electrically. "Directly coupled" or "directly connected" items or elements are in physical contact with each other. In this written description, references to "coupled" or "connected" provide explicit support for "directly coupled" or "directly connected" and vice versa. Items 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 area or area as each other, depending on the context in which the phrase is used.

The phrases "in an embodiment" or "in an aspect" appearing herein are not necessarily all referring to the same embodiment or aspect.

As used herein, terms such as "increase", "decrease", "better", "worse", "higher", "lower", "enhance", "maximize", "minimize" and similar terms Comparative terms refer to the characteristics of a device, component or action in relation to other devices located in the surrounding or adjacent area, in a single device or in a plurality of comparable devices, in a group or group, in a plurality of groups or groups, component or act, or is significantly different from known prior art. For example, a sensor with "increased" sensitivity may refer to a sensor in a sensor array that has a lower detection level or threshold than one or more other sensors in the array. Many factors can contribute to this increased sensitivity, including materials, configuration, architecture, connectivity, and more.

As used herein, the term "substantially" refers to the complete or nearly complete extent or degree of an action, characteristic, property, state, structure, item or result. For example, an article that is "substantially" enclosed means that the article is completely or nearly completely enclosed. In some cases, the precise degree of permissible deviation from absolute completeness may depend on the circumstances. In general, however, closeness to completeness will have the same overall result as obtaining absolute completeness and totality. The use of "substantially" when used in a negative sense applies equally to the complete or almost total lack of an action, characteristic, characteristic, state, structure, item or result. For example, a composition that is "substantially free" of particles may be completely free of particles, or nearly completely free of particles such that the effect is the same as having no particles at all. In other words, a composition that is "substantially free" of a certain ingredient or element may still actually contain that item as long as it has no measurable effect.

As used herein, the term "about" is used to provide flexibility in the endpoints of a numerical range by providing that a given value can be "slightly above" or "slightly below" the endpoint. However, it should be understood that even when the term "about" is used in this specification in connection with a specific value, support is provided for the exact value recited in addition to the "about" term.

Numerical quantities and data may be expressed or presented herein in a range format. It should be understood that this range format is used merely for convenience and brevity, and thus should be construed flexibly to include not only the values expressly recited as limitations of the range, but also all individual values or sub-values contained within that range, as if each value and subranges are both explicitly referenced. 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 subranges within the indicated range. Thus, the numerical range includes single values such as 2, 3, and 4 and subranges such as from 1-3, from 2-4, and from 3-5, as well as 1, 1.5, 2, 2.3, 3, 3.8, 4, Single value of 4.6, 5 and 5.1.

This same principle applies to ranges that have only one numerical value as the minimum or maximum value. Moreover, such an interpretation should apply regardless of the breadth of the scope or the characteristics described. exemplary embodiment

A preliminary overview of technical embodiments is provided below, after which specific technical embodiments will be described in more detail. This preliminary overview is intended to help readers understand the technology more quickly, but it is not intended to identify key features or basic features of the technology, nor is it intended to limit the scope of the claimed subject matter.

Viral pathogens can be transmitted from presymptomatic and asymptomatic individuals. Individuals can remain infectious for up to ten days in moderate cases and up to two weeks in severe cases. One diagnostic method is real-time reverse transcription polymerase chain reaction (rRT-PCR) by nasopharyngeal swab, but it usually takes at least a few hours to several days to obtain results. Delays in testing often lead to delays in treatment and delays in reducing the risk of further spread of the disease.

The need for expensive laboratories to process test results reduces the usefulness of rapid diagnostic tests for pathogens. In many cases, a person with a medical condition will not know the test result until (1) the person has submitted the biological sample at the healthcare facility; (2) the healthcare facility has processed and shipped the biological sample to Laboratory; (3) The laboratory has tested the sample (may be limited by supplies and personnel); (4) The laboratory has sent the results back to the medical institution; (5) The medical staff of the medical institution have analyzed the results; ( 6) The medical staff communicates the test results to the patient. A rapid diagnostic test, meaning a point-of-care (POC) test (i.e., a short test duration with decision-making results that can be delivered in the same contact between a sick person and a healthcare provider), will provide further assistance. beneficial.

When timely test results are available from rapid diagnostic tests, POC tests can provide additional reinforcement when accuracy errors or excessive uncertainty from test results are minimized. Some potential sources of test error include test results that falsely indicate that a sick person does not have the disease (false negative), or falsely indicate that a healthy person has the disease (false positive). Additional sources of test error can include: (i) clinician errors in interpreting test results, or (ii) user errors in interpreting test results. These clinician and user errors may result from insufficient knowledge, poor critical thinking skills, lack of competence, data collection problems, failure to synthesize information, and similar factors. In some cases, test device errors can lead to clinician/user errors, and clinician/user errors can lead to test device errors. Therefore, a rapid diagnostic test that can be used in a POC setting while also minimizing test device errors and clinician/user interpretation errors would also be helpful.

Even when timely test results are obtained and the errors described above are minimized, the test provides inconclusive results when the test is inconclusive, and additional or different tests are used to provide additional information. Therefore, there is a need for rapid diagnostic testing in a POC environment to minimize test device errors, minimize clinician/user interpretation errors, and minimize indeterminate results.

In a disclosed embodiment, a system for identifying colorimetric test results from a pathogen test performed on a solid substrate may include a sensor configured to detect a spectrum of color wavelengths; and one or multiple processors. The one or more processors may be configured to receive color wavelength data. The one or more processors may be configured to determine a wavelength threshold that provides a positive detection result for a pathogen. As used herein, a wavelength threshold may be a threshold based on intensity levels at one or more wavelengths. The one or more processors may be configured to identify whether the color wavelength data meets or exceeds a wavelength threshold for providing a positive detection result for a pathogen. The one or more processors may be configured to generate a result indicator indicative of a pathogen-positive or pathogen-negative test result.

In another disclosed embodiment, a method of identifying test results of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium may include detecting a spectrum of color wavelengths using a sensor assembly. The method may further include receiving, at one or more processors, color wavelength data from the sensor element. The method may further include determining, in the one or more processors, whether the color wavelength data meets or exceeds a wavelength threshold providing a positive test result. The method may further comprise generating, at the one or more processors, a result indicator indicative of a positive or negative test result. The method may further include displaying test results based on the result indicators in a user interface.

In one embodiment, as shown in FIG. 1 , a system for identifying colorimetric test results from a pathogen test performed on a solid substrate may include a sensor 120 configured to detect a color from a pathogen test 110 A spectrum of wavelengths, as shown in operation 101.

In one aspect, the system may further include one or more processors 130 or CPUs 130 . In one example, the one or more processors 130 may be configured to receive color wavelength data, as shown in operation 103 . In one example, the color wavelength data may include data received by a sensor 120 including a photoconductive sensor, a photoelectric sensor, a photodiode sensor, a photoelectric crystal sensor, or One or more of combinations, photoresistors, photodiode arrays, charge-coupled device (CCD) cameras, complementary metal oxide semiconductor (CMOS) cameras, and the like, or combinations thereof.

In another example, the one or more processors 130 may be configured to determine a wavelength threshold that provides a positive detection result for a pathogen, as shown in operation 105 . In another example, the one or more processors 130 may be configured to identify whether the color wavelength data meets or exceeds a wavelength threshold providing a positive detection result for a pathogen, as shown in operation 107 . In yet another example, the one or more processors 130 may be configured to generate a result indicator indicative of a pathogen-positive or pathogen-negative test result, as shown in operation 109 . The one or more processors 130 may be configured to send the outcome indicator to a display 140 , as indicated by operation 109 .

In another aspect, as shown in FIG. 2, the pathogen testing system 200 may include a substrate 202, an adhesive layer 204, a reaction layer 206 (including one or more reaction sections 205a, 205b, and 205c), a plurality of spacer layers 207 (separating one or more reaction zones 205a-c), or one or more of the propagation layer 208. In an aspect, the sensor may be configured to detect color wavelength data from one or more reactive segments 205 a , 205 b , and 205 c of reactive layer 206 .

In another aspect, as shown in flowchart 300 in FIG. 3 , the one or more processors may be configured to receive color wavelength data from one or more sensors, as shown in operation 302 . Color wavelength data may be received from discrete sections of a pathogen test (eg, reaction sections 205a, 205b, or 205c), where each discrete section may be for the same pathogen or a different pathogen. The one or more processors may be configured to determine a wavelength threshold, as shown in operation 304 . The one or more processors may be configured to determine whether the color wavelength data meets or exceeds a color wavelength threshold, as shown in operation 306 . The one or more processors may be configured to generate test result indicators, as indicated by operation 308 . The one or more processors may be configured to send test result indicators to display 330a.

The material group identifier can be used to identify the characteristics of the reactive layer associated with the manufacturing group. In another aspect, the one or more processors may be configured to determine the material group identification code, as shown in operation 310 . The material set identification code in operation 310 may be based on the average color wavelength of the material set, the median color wavelength of the material set, the color wavelength variation of the material set, the date and time of manufacture of the material set, one or more reagent types of the material set, Or one or more solid phase reaction medium types and similar characteristics of a material group, or one or more of a combination thereof.

The one or more processors may be configured to send the color wavelength data to the material group identification code database 340 , as indicated by operation 312 . The material group identifier database 340 may be configured to determine the material group identifier based on the crowdsourced information, as indicated by operation 345 . The material group identification code database 340 can send the material group identification code to the one or more processors. The material group identification code database 340 may send the material group identification code to the test results database 350 .

The MID database can exchange information from multiple devices. When color wavelength data is received from a device (eg, when operation 345 is performed), the MID can use the collected information to continuously update the MID database's determination of the MID.

In another aspect, the one or more processors may be configured to adjust the wavelength threshold based on the material group identification code, as shown in operation 314 . The one or more processors may be configured to generate a confidence level, as shown in operation 316 . The one or more processors may be configured to calculate the amount of nucleic acid, as indicated by operation 318 . The one or more processors may be configured to send the test results to the test results database 350 as indicated by operation 320 , or to repeat operation 308 or terminate as indicated by operation 322 .

In an aspect, operation 308 may be repeated when the confidence level is below a selected threshold. For example, when the confidence level is less than about 95%, operation 308 may be repeated through an iterative process until the confidence level reaches the 95% threshold. In another aspect, operation 308 may 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 may terminate.

In another aspect, the test result can be obtained from the test result database 350 by the display 330 b , the network 360 or the web server 370 .

In some cases, the one or more processors can adjust the wavelength threshold based on the material set ID without sending or receiving information to material set ID database 340 . In this case, the set of materials may be included in the device.

In another aspect, the one or more processors may be configured to adjust the wavelength threshold based on the material group identification code. In one aspect, the material set identification code may be based on one or more of the following: average color wavelength of the material set, median color wavelength of the material set, color wavelength variation of the material set, date and time of manufacture of the material set, material One or more reagent types of a group, or one or more solid phase reaction medium types of a material group, similar properties, or combinations thereof.

In another aspect, the one or more processors may be configured to generate a material group identification code based on color wavelength data aggregated from crowdsourced data. In one aspect, the crowdsourced data can be associated with a plurality of users related to pathogen testing. In one aspect, the confidence level may be calculated from: metadata associated with the color wavelength data including one or more ratios of the number of aggregate test results from a particular material group identifier to the number of total test results from a particular group identifier ); the change in aggregate test results associated with a particular material group identifier; the date and time the user received aggregate test results for each material group identifier or its analog or combination thereof.

In another aspect, the one or more processors may be configured to adjust the wavelength threshold using color wavelength data having wavelengths from about 500 nm to about 565 nm. In one example, the color wavelength data can be adjusted based on a colorimetric range associated with a pH sensitive dye (eg, phenol red).

In another aspect, the one or more processors may be configured to calculate the number of nucleic acid copies based on one or more of color wavelength data, material group identification code, color change time, or color change time ratio. In one example, the number of nucleic acid copies can be calculated using data associated with the material set identifier, including, but not limited to, the average color wavelength of the material set, the median color wavelength of the material set, the color wavelength variation of the material set, the material The date and time of manufacture of the set, one or more reagent types of the material set, or one or more solid phase reaction medium types of the material set.

In another example, the color change time may be the time between the start of the LAMP reaction and a positive test result. In one example, when the color change time of a material group is about 30 minutes on average, and the color change time of the pathogen test is about 20 minutes, the concentration of the pathogen may be higher than the average concentration of the material group average. In another example, when the variation time of the pathogen test is about 40 minutes, the concentration of the pathogen may be an average concentration that is lower than the average value of the group of materials. The concentration of pathogens can be calibrated against the material set to provide an approximate number of copies per volume of nucleic acid.

In another aspect, the one or more processors may be configured to generate a confidence level using the color wavelength data and the material group identification code. In one example, the confidence level may be calculated using data associated with the material group identifier, including, but not limited to, the average color wavelength of the material group, the median color wavelength of the material group, the color wavelength variation of the material group, the material group date and time of manufacture, one or more reagent types for a material set, or one or more solid phase reaction medium types for a material set.

In yet another aspect, the one or more processors may be further configured to receive color wavelength data from discrete sections of the pathogen test (eg, reaction sections 205a, 205b, or 205c). In one example, 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 pathogen or different pathogen.

In yet another aspect, the one or more processors may be further configured to determine a wavelength threshold for providing a positive test result for a pathogen based on the color wavelength data for discrete segments of the pathogen test. In one example, a first reaction section of a pathogen test can be configured with a first range of color wavelength data, and a second reaction section of a pathogen test can be configured with a second range of color wavelength data. In another example, the first reaction section of the pathogen test can be configured with the same color wavelength data range as the second reaction section of the pathogen test.

In yet another aspect, the one or more processors may be further configured to identify whether the color wavelength data meets or exceeds a threshold providing a positive test result for a pathogen. In one example, the threshold for color wavelength data may be the same for each discrete segment. When the thresholds for the discrete segments are the same, the additional data can provide an additional conclusive positive or negative test result compared to a test result based on color wavelength data from a segment.

In another example, the color wavelength data threshold may be different for each discrete segment (eg, reaction segment 205a, 205b, or 205c). In this example, the threshold for each discrete segment may be based on a confidence level. In one example, a confidence level of about 95% may be provided when the first threshold is met or exceeded, and a confidence level of about 99% may be provided when the second threshold is met or exceeded. The confidence level for each segment may be based on the obtained color wavelength data characteristics. In one example, the color wavelength characteristics obtained may vary based on the type of colorimetric index used in the pathogen test.

In yet another aspect, the one or more processors may be further configured to generate a positive test result for a pathogen based on color wavelength data received from a discrete segment of the pathogen test (eg, reaction segment 205a, 205b, or 205c) level of trust.

In yet another aspect, the one or more processors may be further configured to: receive color wavelength data for discrete segments of a pathogen test (e.g., reaction segments 205a, 205b, or 205c); Color wavelength data to determine additional wavelength thresholds that provide positive test results for different pathogens and generate an additional outcome indicator indicating either additional pathogen positive or additional pathogen negative test results when discrete segments of the pathogen test target different pathogens . In one example, the first segment of the pathogen test can target SARS-CoV-2, while the second segment of the pathogen test can target influenza. In one aspect, the confidence level of the positive or negative test result for the first pathogen can be based on the confidence level of the positive or negative test result for the second pathogen. For example, a confidence level of about 90% for a positive test for influenza would negatively impact the confidence level for a positive test for SARS-CoV-2.

In yet another aspect, the sensor may comprise an RGB sensor configured to generate RGB values, or a CMYK sensor configured to generate CMYK values. In one example, the one or more processors may be configured to receive RGB values from an RGB sensor. The one or more processors may be configured to determine a wavelength threshold for providing a positive test result for a pathogen based on the RGB values. The one or more processors may be configured to identify whether the color wavelength data meets or exceeds the wavelength threshold for providing a positive test result for a pathogen based on RGB values. The one or more processors may be configured to generate a result indicator indicative of a pathogen-positive or pathogen-negative test result based on the RGB values.

In one example, the one or more processors may be configured to receive CMYK values from a CMYK sensor. The one or more processors may be configured to determine a wavelength threshold for providing a positive test result for a pathogen based on the CMYK values. The one or more processors may be configured to identify whether the color wavelength data meets or exceeds the wavelength threshold for providing a positive test result for a pathogen based on CMYK values. The one or more processors may be configured to generate a result indicator indicative of a pathogen-positive or pathogen-negative test result based on the CMYK values.

In another aspect, the sensor may include a white light emitter and a light receiver with a 540 nm filter. In one aspect, the white light emitter can be configured to emit white light to the pathogen test. In one example, the reflected light intensity from the reactive layer of the pathogen test can be detected using a photoreceiver with a 540 nm filter. In another example, the intensity of reflected light from a reactive layer of a pathogen test can be detected using a light receiver having a filter configured to detect wavelengths within the test range of the pathogen test.

In yet another aspect, the sensor may include one or more of the following: a photoconductive sensor, a photoelectric sensor, a photodiode sensor, a photoelectric crystal sensor, or a combination thereof. In another example, the sensor may comprise one or more of: a photoresistor, a photodiode array, a charge-coupled device (CCD) camera, a complementary metal oxide semiconductor (CMOS) camera, and the like, or its combination.

In yet another aspect, the system may further include a graphical user interface for interacting with the user. The graphical user interface may include a display screen configured to display (i) an indeterminate test result, (b) a pathogen negative test result, or (c) a pathogen positive test result. In another example, the display screen can be configured to display other aspects of test results, including color wavelength data, wavelength thresholds, material set identifiers, confidence levels, nucleic acid counts, pathogen positive or negative, similar information, or combinations thereof .

In one example, the pathogen can comprise a viral pathogen, a bacterial pathogen, a fungal pathogen, or a protozoan pathogen. In one aspect, the pathogen can comprise a viral pathogen. In one example, the viral pathogen may comprise a dsDNA virus, ssDNA virus, dsRNA virus, positive-strand ssRNA virus, negative-strand ssRNA virus, ssRNA-RT virus, or ds-DNA-RT virus. In one example, each primer sequence can match a target sequence from a virus comprising H1N1, H2N2, H3N2, H1N1pdm09 or SARS-CoV-2.

In another aspect, instead of a pathogen, the specific target nucleotide sequence to be detected may be a target nucleotide sequence corresponding to a human biomarker. Any disease with target nucleotides corresponding to human biomarkers for a disease can be detected. Detects various types of disease including one or more of the following: breast cancer, pancreatic cancer, colorectal cancer, ovarian cancer, gastrointestinal cancer, cervical cancer, lung cancer, bladder cancer, many types of adenocarcinoma, salivary gland cancer, kidney Cancer, liver cancer, lymphoma, leukemia, melanoma, prostate cancer, thyroid cancer, gastric cancer, and similar cancers, or combinations thereof. For example, various disease biomarkers can be detected via detection of target nucleotides corresponding to one or more of the following: α-fetoprotein, CA15-3 and CA27-29, CA19-9, C!-125, calcitonin , calmodulin, 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 markers, MART-1, Myo D1, muscle-specific actin, nerve Silk, neuron-specific enolase, placental alkaline phosphatase, prostate-specific antigen, PTPRC, S100 protein, smooth muscle action, synaptophysin, thymidine kinase, thyroglobulin, thyroid transcription factor-1, tumor M2- PK, vimentin, an analog thereof, or a combination thereof.

In another embodiment, a method of identifying test results of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium may comprise detecting a spectrum of color wavelengths using a sensor assembly. In one aspect, the method may include receiving, at one or more processors, color wavelength data from the sensor element. In another aspect, the method may include the one or more processors determining whether the color wavelength data meets or exceeds a wavelength threshold providing a positive test result. In another aspect, the method may include generating, at one or more processors, a result indicator indicative of a positive or negative test result. In another aspect, the method may include displaying test results based on the result indicators in a user interface.

In another aspect, the method may include adjusting the wavelength threshold in one or more processors using RGB values or CMYK values from the material group identification code. In another aspect, the method may include receiving, at one or more processors, RGB values or CMYK values from a color wavelength spectrum. In another aspect, the method may include generating, at one or more processors, an outcome indicator indicating a positive or negative test result based on the RGB or CMYK values.

In yet another embodiment, 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 are detected by one or When the plurality of processors are executed, the following operations are performed: one or more processors receive color wavelength data from sensor components. In another aspect, the instructions may, when executed, determine whether the color wavelength data exceeds a wavelength threshold providing a positive detection result for pathogen detection in one or more processors. In another aspect, the instructions, when executed, may: generate at one or more processors a result indicator indicative of a positive or negative test result. In another aspect, when the instruction is executed, the wavelength threshold can be adjusted based on the material group identification code.

In another aspect, the material set identification code may be based on one or more of the following: average color wavelength of the material set, median color wavelength of the material set, color wavelength variation of the material set, date and time of manufacture of the material set, material One or more reagent types for a group, or one or more solid phase reaction medium types for a material group. In another aspect, the instructions, when executed, can generate a material group identification code from color wavelength data aggregated from crowdsourced data. In another aspect, when the instruction is executed, the nucleic acid copy number can be calculated based on the color wavelength data and the material group identification code. In another aspect, the instructions, when executed, may generate a confidence level using the color wavelength data and the material group identification code.

In another aspect, the instructions, when executed, are operable to generate, at the one or more processors, an outcome indicator indicative of a positive or negative test result for a plurality of pathogens based on color wavelength data received by discrete segments of the pathogen test .

Another example provides the functionality 400 of a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, as shown in the flowchart of FIG. 4 . The system can include a sensor configured to detect a spectrum of color wavelengths. The system may further include one or more processors. The one or more processors may be configured to receive color wavelength data, as indicated at block 410. The one or more processors may be configured to determine a wavelength threshold that provides a positive detection result for a pathogen, as indicated at block 420 . The one or more processors may be configured to identify whether the color wavelength data meets or exceeds a wavelength threshold for providing a positive detection result for a pathogen, as indicated at block 430 . The one or more processors may be configured to generate a result indicator indicative of a pathogen-positive or pathogen-negative test result, as indicated at block 440 .

Another example provides a method 500 for identifying test results of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium, as shown in the flowchart in FIG. 5 . The method may include detecting a spectrum of color wavelengths using a sensor assembly, as shown in block 510 . The method may include receiving, at one or more processors, color wavelength data from the sensor element, as shown in block 520 . The method may include determining in one or more processors whether the color wavelength data meets or exceeds a wavelength threshold providing a positive test result, as shown at block 530 . The method may include generating, at one or more processors, a result indicator indicative of a positive or negative test result, as shown at block 540 . The method may include displaying test results based on the result indicators in a user interface, as shown at block 550 .

Another example provides at least one machine-readable storage medium having embodied thereon instructions 600 for identifying test results of a loop-mediated isothermal amplification (LAMP) reaction, as shown in FIG. 6 . The instructions are executable on a machine, where the instructions are included on at least one computer-readable medium or a non-transitory machine-readable storage medium. The instructions, when executed, may: receive, at one or more processors, color wavelength data from the sensor element, as indicated at block 610 . When the instructions are executed, the one or more processors may determine whether the color wavelength data meets or exceeds a wavelength threshold for providing a positive test result, as shown in block 620 . The instructions, when executed, may: generate, at one or more processors, a result indicator indicative of a positive or negative test result, as shown at block 630 .

Figure 7 shows a general computing system or device 700 that may be employed in the present technology. Computing system 700 may include a processor 702 in communication with memory 704 . Memory 704 may include any device, combination of devices, circuitry, and the like capable of storing, retrieving, organizing, and/or retrieving data. Non-limiting examples include SAN (storage area network), cloud storage network, 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 connection between the various components of the system. For example, the local communication interface may be a local data bus and/or any associated network or control bus that may be required.

Computing system or device 700 may also include an I/O (input/output) interface 714 for controlling the system's I/O functions and for I/O connections to devices external to computing system 700 . A network interface 716 may also be included for network connection. Network interface 716 can control network communications both within and outside the system. Network interfaces may include wired interfaces, wireless interfaces, Bluetooth interfaces, optical interfaces, and the like, including suitable combinations thereof. Furthermore, computing system 700 may additionally include a user interface 714, a display device 740, and various other components that facilitate such a system.

The processor 702 can be single or multiple processors, and the memory 704 can be single or multiple memories. Local communication interface 718 may be used as a path to facilitate communication between a single processor, multiple processors, a single memory, multiple memories, various interfaces, and the like, in any usable combination. example

In one example, a system for identifying colorimetric test results from a pathogen test performed on a solid substrate is provided, which may include a sensor configured to detect a spectrum of color wavelengths; and a or a plurality of processors configured to: receive color wavelength data; determine a wavelength threshold for providing a positive detection result for a pathogen; identify whether the color wavelength data meets or exceeds the wavelength threshold for providing a positive detection result for a pathogen; Outcome metrics for negative test results.

In one example of a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, the one or more processors may be further configured to: adjust the wavelength threshold based on a material group identification code.

In another example of a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, the material set identification code is based on one or more of the following: the average color wavelength of the material set, the The color wavelength median value, the color wavelength variation of the material set, the date and time of manufacture of the material set, the one or more reagent types of the material set, or the one or more solid phase reaction medium types of the material set.

In another example of a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, the one or more processors are further configured to: generate from color wavelength data aggregated from crowdsourced data Material group identifier.

In another example of a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, the one or more processors are further configured to: One or more of the times of change calculates the number of nucleic acid copies.

In another example of a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, the one or more processors are further configured to: use the color wavelength data and a material group identification code to generate level of trust.

In another example of a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, the one or more processors are further configured to: receive color wavelength data for discrete segments of the pathogen test ; Based on the color wavelength data of the discrete segment of the pathogen detection, determine the wavelength threshold for providing a positive detection result of the pathogen; and identify whether the color wavelength data meets or exceeds the threshold for providing a positive detection result of the pathogen.

In another example of a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, the one or more processors are further configured to based on colors received from discrete segments of the pathogen test Wavelength data that yields a level of confidence in pathogen positive test results.

In another example of a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, the one or more processors are further configured to: receive color wavelength data for discrete segments of the pathogen test ; determining an additional wavelength threshold for providing a positive test result for a different pathogen based on the color wavelength data of the discrete segment of the pathogen test; and generating an additional result indicator indicating the additional pathogen when the discrete segment of the pathogen test targets a different pathogen Positive or additional pathogen negative test results.

In another example of a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, the sensor is configured to detect discrete segments of a color wavelength spectrum of the pathogen test.

In another example of a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, the sensor may comprise an RGB sensor configured to generate RGB values, or configured to generate CMYK sensor for CMYK values.

In another example of a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, the sensor can include: a white light emitter; and a light emitting device with a 540 nm filter receiver.

In another example of a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, the one or more processors are further configured to: use a wavelength having a wavelength of about 500 nm to about 565 nm The color wavelength data to adjust the wavelength threshold.

In another example of a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, the sensor is one or more of the following: a photoconductive sensor, a photoelectric sensor, Photodiode sensors, photoelectric crystal sensors or combinations thereof.

In another example of a system for identifying a colorimetric test from a pathogen test performed on a solid substrate, the system can further comprise a graphical user interface configured to display a pathogen negative or pathogen positive test result .

In another example, a method of identifying test results of a loop-mediated isothermal amplification (LAMP) reaction on a solid phase reaction medium is provided, the method may include: detecting a spectrum of color wavelengths using a sensor assembly; receiving color wavelength data from the sensor element at one or more processors; determining at the one or more processors whether the color wavelength data meets or exceeds a wavelength threshold providing a positive test result; generating an indication at the one or more processors Outcome indicators for positive or negative test results; display test results based on the outcome indicators in the user interface.

In another example of a method of identifying a test result of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium, the method may further comprise using, at one or more processors, the RGB values or CMYK values adjust this wavelength threshold.

In another example of a method of identifying a test result of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium, the method can further comprise receiving, at one or more processors, RGB from a spectrum of color wavelengths value or CMYK value.

In another example of a method of identifying a test result of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium, the method may further comprise generating, at one or more processors, a result index indicating an RGB-based or positive or negative test results for CMYK values

In another example of a method of identifying a test result of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium, at least one machine-readable storage medium has embodied thereon a method for identifying a loop Instructions for mediating test results of an isothermal amplification (LAMP) reaction that, when executed by one or more processors, perform the following operations: receive color wavelength data from a sensor assembly; determine whether the color wavelength data Exceeding a wavelength threshold providing a positive test result for pathogen detection; and generating a result indicator indicating a positive or negative test result.

In another example of a method for identifying a test result of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium, the method may further include an instruction that, when executed: adjust based on the material group identifier the wavelength threshold.

In another example of a method of identifying test results of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium, the material set identification code is based on one or more of the following: the average color wavelength of the material set, the material The color wavelength median of the set, the color wavelength variation of the material set, the date and time of manufacture of the material set, one or more reagent types for the material set, or one or more solid phase reaction medium types for the material set.

In another example of a method of identifying test results of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium, further comprising instructions that, when executed, perform: color wavelengths assembled from crowdsourced data The data yields a material group identifier.

In another example of a method of identifying test results of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium, the method may further comprise instructions that, when executed, perform: based on color wavelength data and material The group identifier counts the number of nucleic acid copies.

In another example of a method of identifying a test result of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium, the method may further comprise instructions that, when executed: use the color wavelength data and The material group identifier yields a confidence level.

In another example of a method of identifying test results of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium, the method may further comprise instructions that, when executed, perform: based on discrete The color wavelength data received by the segment produces outcome indicators that indicate positive or negative test results for multiple pathogens.

Technologies, or some aspect or portion thereof, may take the form of program code (i.e., instructions) on a tangible medium, such as a floppy disk, compact disk read-only memory (CD-ROM), hard disk drive, non-transitory computer-readable storage medium or any other machine-readable storage medium in which, when the program code is loaded into and executed by a machine such as a computer, the machine becomes a means for implementing various techniques. Circuitry may include hardware, firmware, program code, executable code, computer instructions and/or software. A non-transitory computer-readable storage medium may be a computer-readable storage medium that does not include a signal. In the case of executing program code on a programmable computer, the computing device may 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 Random-Access Memory (RAM), Erasable Programmable Read-Only Memory (EPROM), Flash Drives, Optical Drives, Magnetic Hard Disk Drives , solid-state drives, or other media used to store electronic data. Low energy fixed location nodes, wireless devices, and location servers may also include transceiver modules (ie, transceivers), counter modules (ie, counters), processing modules (ie, processors), and/or clock modules (ie, clock ) or timer module (i.e. timer). Programs that may implement or utilize one or more of the various techniques described herein may use application programming interfaces (APIs), reusable controls, and the like. Such programs can be implemented in high-level programming or object-oriented programming languages to communicate with computer systems. However, the program can be implemented in assembly or machine language, if desired. In any case, the language may be a compiled or interpreted language, combined with hardware implementation.

As used herein, the term processor may include general purpose processors, special purpose processors such as VLSI, FPGA, or other types of special purpose processors, as well as baseband processors used in transceivers to transmit, receive, and process wireless communications.

It should be understood that many of the functional units described in this specification have been labeled as modules, in order to more particularly emphasize their implementation independence. For example, a module may 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. A module may also be implemented in programmable hardware devices such as field programmable gate arrays, programmable array logic, programmable logic devices, or the like.

In one example, a plurality of hardware circuits or a plurality of processors may be used to implement the functional units described in this specification. For example, a first hardware circuit or a first processor may be used to perform processing operations, while a second hardware circuit or second processor (eg, a transceiver or a baseband processor) may be used to communicate with other entities. The first hardware circuit and the second hardware circuit may be combined into a single hardware circuit, or the first hardware circuit and the second hardware circuit may be separate hardware circuits.

Modules can also be implemented in software for execution by various types of processors. An identified module of executable code may, for instance, comprise one or more physical or logical blocks of computer instructions which may, for instance, be organized as an object, procedure, or function. However, the executables of an identified module need not be physically located together, but may contain different instructions stored in different locations which, when logically joined together, contain the module and achieve a module stated purpose.

In practice, a module of executable code can be a single instruction or many instructions, and can even be distributed over several different code segments, between different programs, and across several memory devices. Similarly, operational data may be identified and represented within modules, and may be embodied in any suitable form and organized within any suitable type of data structure. Operational data may be collected in a single data set, or may be distributed in different locations including different storage devices, and may exist at least in part only as electronic signals on a system or network. Modules may be passive or active, and include agents operable to perform desired functions.

While the foregoing examples illustrate the principles of the invention in one or more particular applications, it will be apparent to those skilled in the art that many modifications in form, use, and implementation details can be made without uninventiveness, without departing from the principles and concepts of the invention. Accordingly, the invention is not intended to be limited except by the scope of the claims set forth below.

101: Operation 103: Operation 105: Operation 107: Operation 109: Operation 110: Pathogen testing 120: sensor 130: processor, CPU 140: Display 200: Pathogen Test System 202: base 204: Adhesive layer 206: Reaction layer 205a, 205b and 205c: reaction section 207: spacer layer 208: Propagation layer 300: Flowchart 302: Operation 304: Operation 306: Operation 308: Operation 310: Operation 312: Operation 314: Operation 316: Operation 318: Operation 320: operation 322: Operation 330a/330b: display 340: material group identification code database 345: Operation 350: Test result database 360: Internet 370:Web server 400: Functionality of Systems for Identifying Colorimetric Test Results from Pathogen Tests Conducted on Solid Substrates 410: box 420: box 430: box 440: box 500: Method for Recognition of Test Results of Loop-Mediated Isothermal Amplification (LAMP) Reaction on Solid Phase Reaction Medium 510: box 520: frame 530: frame 540: frame 550: frame 600: instruction 610: frame 620: frame 630: frame 702: Processor 704: memory device 710: Computing device 714: I/O device, I/O interface, user interface 716: Network device, network interface 718: Local communication interface 722: data storage 730:Module 740: monitor, display device

The features and advantages of the present disclosure will become more apparent from the following detailed description taken in conjunction with the accompanying drawings, which together illustrate the features of the present disclosure by way of example; and, wherein:

1 illustrates a flow chart for identifying colorimetric test results from pathogen testing performed on a solid substrate, according to an exemplary embodiment;

Figure 2 illustrates a pathogen test performed on a solid substrate according to an exemplary embodiment;

FIG. 3 illustrates a flowchart for generating confidence levels according to an exemplary embodiment;

4 illustrates a system for identifying colorimetric test results from a pathogen test performed on a solid substrate, according to an exemplary embodiment;

5 illustrates a method of identifying test results of a loop-mediated isothermal amplification (LAMP) reaction on a solid-phase reaction medium, according to an exemplary embodiment;

6 illustrates a flow diagram of a machine-readable storage medium comprising instructions for identifying test results of a loop-mediated isothermal amplification (LAMP) reaction, according to an exemplary embodiment; and

Figure 7 illustrates a computing system including a data storage device according to an exemplary embodiment.

Reference will now be made to the exemplary embodiments illustrated, and specific language will be used to describe the same herein. It should be understood, however, that no limitation of the scope of the invention is intended.

Claims (26)

A system for identifying colorimetric test results from a pathogen test performed on a solid substrate, comprising: a sensor configured to detect a spectrum of color wavelengths; and One or more processors configured as: Receive color wavelength data; Determine the wavelength threshold for providing a positive test result for the pathogen; Identifying whether the color wavelength data meets or exceeds the wavelength threshold for providing a positive detection result for the pathogen; and Generates an outcome indicator that indicates a pathogen-positive or pathogen-negative test result. The system according to claim 1, wherein the one or more processors are further configured to: The wavelength threshold is adjusted based on the material group identification code. The system of claim 2, wherein the material group identification code is based on one or more of the following: the average color wavelength of the material group, the median wavelength of the color of the material group, the color wavelength variation of the material group, the date and time of manufacture of the material group, One or more reagent types of the material group, or One or more solid phase reaction medium types for a material group. The system according to claim 2, wherein the one or more processors are further configured to: A material group identifier is generated from the color wavelength data aggregated from the crowdsourced data. The system according to claim 2, wherein the one or more processors are further configured to: The number of nucleic acid copies is calculated based on one or more of color wavelength data, material group identification code, or color change time. The system according to claim 2, wherein the one or more processors are further configured to: Confidence levels are generated using the color wavelength data and material group identifiers. The system according to claim 1, wherein the one or more processors are further configured to: receiving color wavelength data for discrete segments of a pathogen test; Based on the color wavelength data for discrete segments of pathogen detection, determine the wavelength threshold for providing a positive detection result for the pathogen; and Identifies whether the color wavelength data meets or exceeds a threshold to provide a positive detection result for a pathogen. The system according to claim 7, wherein the one or more processors are further configured to: A confidence level for a positive test result for a pathogen is generated based on the color wavelength data received from the discrete segments of the pathogen test. The system according to claim 1, wherein the one or more processors are further configured to: receiving color wavelength data for discrete segments of a pathogen test; Determine additional wavelength thresholds for providing positive test results for different pathogens based on color wavelength data for discrete segments of the pathogen test; and When the discrete segments of the pathogen test target different pathogens, an additional outcome indicator is generated that indicates either additional pathogen positive or additional pathogen negative test results. The system of claim 1, wherein the sensor is configured to detect a color wavelength spectrum of discrete segments of the pathogen test. The system of claim 1, wherein the sensor comprises an RGB sensor configured to generate RGB values, or a CMYK sensor configured to generate CMYK values. The system according to claim 1, wherein the sensor includes: a white light emitter; and A photoreceiver with a 540 nm filter. The system according to claim 1, wherein the one or more processors are further configured to: The wavelength threshold is adjusted using color wavelength data having wavelengths from about 500 nm to about 565 nm. The system according to claim 1, wherein the sensor is one or more of the following: a photoconductive sensor, a photoelectric sensor, a photodiode sensor, a photoelectric crystal sensor or a combination thereof. The system of claim 1, further comprising a graphical user interface configured to display a pathogen-negative or pathogen-positive test result. A method for identifying test results of a loop-mediated isothermal amplification (LAMP) reaction on a solid phase reaction medium, comprising: Using a sensor assembly to detect a spectrum of color wavelengths; receiving color wavelength data from the sensor element at one or more processors; determining whether the color wavelength data meets or exceeds a wavelength threshold for providing a positive test result in one or more processors; generating a result indicator at one or more processors indicative of a positive or negative test result; and Display test results based on outcome indicators in the user interface. The method of claim 16, further comprising: The wavelength threshold is adjusted at one or more processors using RGB values or CMYK values from the material group identifier. The method of claim 16, further comprising: RGB values or CMYK values from a color wavelength spectrum are received at one or more processors. The method of claim 18, further comprising: A result indicator is generated at the one or more processors indicating a positive or negative test result based on RGB or CMYK values. A machine-readable storage medium, wherein at least one machine-readable storage medium has embodied thereon instructions for identifying a test result of a loop-mediated isothermal amplification (LAMP) reaction, the instructions being processed by one or more The following operations will be performed when the controller is executed: receiving color wavelength data from the sensor assembly; Determine whether the color wavelength data exceeds the wavelength threshold providing a positive test result for pathogen detection; and Produce an outcome indicator that indicates a positive or negative test result. As the machine-readable storage medium of claim 20, the at least one machine-readable storage medium further includes instructions that will be performed when executed: The wavelength threshold is adjusted based on the material group identification code. The machine-readable storage medium of claim 21, wherein the material group identification code in the at least one machine-readable storage medium is based on one or more of the following: the average color wavelength of the material group, the median wavelength of the color of the material group, the color wavelength variation of the material group, Date and time of manufacture of the material group, One or more reagent types of the material group, or One or more solid phase reaction medium types for a material group. As the machine-readable storage medium of claim 21, the at least one machine-readable storage medium further includes instructions that will be performed when executed: A material group identifier is generated from the color wavelength data aggregated from the crowdsourced data. As the machine-readable storage medium of claim 21, the at least one machine-readable storage medium further includes instructions that will be performed when executed: The number of nucleic acid copies is calculated based on the color wavelength data and the material group identifier. As the machine-readable storage medium of claim 21, the at least one machine-readable storage medium further includes instructions that will be performed when executed: Confidence levels are generated using the color wavelength data and material group identifiers. As the machine-readable storage medium of claim 20, the at least one machine-readable storage medium further includes instructions that will be performed when executed: An outcome indicator indicative of a positive or negative test result for a plurality of pathogens is generated based on the color wavelength data received by the discrete segments of the pathogen test.

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