Rapid testing device with multiple different diagnostic methods

Abstract

One embodiment includes a first diagnostic element including a sample receiving area, one or more colorimetric analysis areas, and a second diagnostic element including one or more lateral flow assay analysis areas. The embodiment also includes a first flow path that allows a portion of liquid deposited at the sample receiving area to flow to the first diagnostic element. The embodiment also includes a second flow path that allows a portion of liquid deposited at the sample receiving area to flow to the second diagnostic element.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates generally to systems and methods for chemical and biochemical samples, and more particularly to systems and methods for rapid testing of chemical samples. [Background technology]

[0002] Portable diagnostic testing devices, also known as point-of-care testing (POCT) or rapid testing devices, have become increasingly popular in recent years. Commercially available rapid testing devices are being deployed in a variety of healthcare applications, as well as in veterinary testing, agriculture, environmental testing, and product quality assessment.

[0003] Existing rapid testing devices include lateral flow assays (LFAs) and colorimetric test strips. These two types of paper-based test strips operate in different ways and have different requirements for sample volume and deposition mechanisms.

[0004] LFAs are used to perform biological screening, such as detecting the presence of specific antibodies in a test sample. A typical LFA is a portable testing device with a test pad for receiving the test sample. This deposited test sample flows through a series of different overlapping porous membranes. One of these membranes contains an area with particles that react with antibodies or antigens and other particles on the sample in specific result areas (e.g., test and control line areas) to produce a color deposit that provides a visual indication of the test result.

[0005] Other existing testing devices include colorimetric test strips used for chemical screening, such as detecting the presence of specific chemicals in test samples. Colorimetric test strips are paper-based chemical test strips that typically require dipping into the test sample. Colorimetric test strips typically exhibit a range of colorimetric responses to a chemical reaction between specific test sample compounds and reagents embedded in the paper fibers of the test strip. The resulting color intensity is typically one of several possible color results, each correlated to the respective concentration of the target chemical element in the test sample. While both LFAs and colorimetric test strips use a paper-based diagnostic substrate, LFAs differ from colorimetric test strips in several respects, including many different operating principles. For example, LFAs and colorimetric test strips require different sample volumes, apply different means to allow contact with the reagent, require different reaction times, and may display results in different formats.

[0006] Therefore, there is a need in the art to solve the aforementioned problems. Summary of the Invention

[0007] Viewed from a first aspect, the present invention provides a device comprising a sample receiving area, a first diagnostic element comprising one or more colorimetric analysis areas, a second diagnostic element comprising one or more lateral flow assay analysis areas, a first flow path that allows a first portion of a liquid deposited in the sample receiving area to flow to the first diagnostic element, and a second flow path that allows a second portion of a liquid deposited in the sample receiving area to flow to the second diagnostic element.

[0008] Viewed from a further aspect, the present invention provides a device further comprising: a first diagnostic element comprising a sample receiving area, one or more colorimetric analysis areas; a second diagnostic element comprising one or more lateral flow assay analysis areas; a first distribution substrate comprising a first hydrophilic area and a first hydrophobic area defining a boundary of the first hydrophilic area, the first hydrophilic area receiving liquid deposited in the sample receiving area; a second hydrophilic area receiving a first portion of the liquid from the first hydrophilic area and allowing the liquid to flow to the first diagnostic element; a third hydrophilic area receiving a second portion of the liquid from the first hydrophilic area and allowing the liquid to flow to the second diagnostic element; and a second hydrophobic area impeding traversal of the liquid from the second hydrophilic area to the third hydrophilic area.

[0009] Viewed from a further aspect, the present invention provides a device comprising a first diagnostic element including a sample receiving area and one or more colorimetric analysis areas; a second diagnostic element including one or more lateral flow assay analysis areas; a first flow path including a hydrophilic material between the sample receiving area and the first diagnostic element; a second flow path including a hydrophilic material between the sample receiving area and the second diagnostic element; and a liquid-repellent flow barrier between a portion of the first flow path and the second flow path.

[0010] Viewed from a further aspect, the present invention provides a device comprising a sample receiving area, a first diagnostic element including one or more colorimetric analysis areas, a second diagnostic element including one or more lateral flow assay analysis areas, and a multiplexing flow path that receives liquid deposited in the sample receiving area and allows a first portion of the liquid to flow to the first diagnostic element and a second portion of the liquid to flow to the second diagnostic element.

[0011] Viewed from a further aspect, the present invention is a system including a rapid test device, the rapid test device comprising: a housing having a visible graphical element; a sample receiving area; first and second diagnostic elements supported by the housing, the first and second diagnostic elements performing different analyses from one another, at least one of the first and second diagnostic elements including a colorimetric area; a hydrophobic structure defining a first flow path from the sample receiving area to the first diagnostic element and a second flow path from the sample receiving area to the second diagnostic element; a processor; and one or more and program instructions collectively stored on the one or more computer-readable storage media, the program instructions being executable by a processor to cause the processor to perform operations including: capturing an image of a housing including a graphical element; and performing at least one data processing function on the captured image, the data processing function including comparing a color attribute of a readout region in the captured image to a color reference in the captured image to determine at least one chemical attribute of the test sample.

[0012] Viewed from a further aspect, the present invention provides a system including a rapid test device, the rapid test device comprising: a housing having a visible graphical element; a device of the present invention, wherein first and second diagnostic elements are supported by the housing, the first diagnostic element and the second diagnostic element performing mutually distinct analyses, a hydrophobic structure defining a first flow path from the sample receiving area to the first diagnostic element and a hydrophobic structure defining a second flow path from the sample receiving area to the second diagnostic element; a processor; one or more computer readable storage media; and program instructions collectively stored on the one or more computer readable storage media, the program instructions being executable by the processor to cause the processor to perform operations including capturing an image of the housing including the graphical element; and performing at least one data processing function on the captured image, the data processing function including comparing a color attribute of the readout area in the captured image to a color reference in the captured image to determine at least one chemical attribute of the test sample.

[0013] Exemplary embodiments provide a rapid test device with multiple diagnostic methods. One embodiment includes a sample receiving area, a first diagnostic element including a colorimetric analysis area, and a second diagnostic element including a lateral flow assay analysis area. This embodiment also includes a first flow path that allows a first portion of a liquid deposited in the sample receiving area to flow to the first diagnostic element. This embodiment also includes a second flow path that allows a second portion of a liquid deposited in the sample receiving area to flow to the second diagnostic element.

[0014] An alternative embodiment includes a first diagnostic element including a sample receiving region and a colorimetric region, and a second diagnostic element including a lateral flow assay region. This embodiment also includes a first distribution substrate including a first hydrophilic region and a first hydrophobic region defining a boundary of the first hydrophilic region, the first hydrophilic region receiving a liquid deposited in the sample receiving region. This embodiment further includes a second distribution substrate including a second hydrophilic region that receives a first portion of the liquid from the first hydrophilic region and allows the liquid to flow to the first diagnostic element, a third hydrophilic region that receives a second portion of the liquid from the first hydrophilic region and allows the liquid to flow to the second diagnostic element, and a second hydrophobic region that prevents the liquid from crossing from the second hydrophilic region to the third hydrophilic region.

[0015] An alternative embodiment includes a first diagnostic element including a sample receiving area and a colorimetric analysis area, and a second diagnostic element including a lateral flow assay analysis area. This embodiment also includes a first flow path including a hydrophilic material between the sample receiving area and the first diagnostic element, and a second flow path including a hydrophilic material between the sample receiving area and the second diagnostic element. This embodiment further includes a liquid-repellent flow barrier between a portion of the first flow path and the second flow path.

[0016] An alternative embodiment includes a first diagnostic element including a sample receiving area, a colorimetric analysis area, and a second diagnostic element including a lateral flow assay analysis area. This embodiment also includes a multiplexed flow path that receives a liquid deposited in the sample receiving area and allows a first portion of the liquid to flow to the first diagnostic element and a second portion of the liquid to flow to the second diagnostic element.

[0017] An alternative embodiment includes a first diagnostic element including a sample receiving area, a colorimetric analysis area, and a second diagnostic element including a lateral flow assay analysis area. This embodiment also includes a hydrophobic structure defining a first flow path from the sample receiving area to the first diagnostic element and a second flow path from the sample receiving area to the second diagnostic element.

[0018] Any of these embodiments may further include a housing, wherein the sample receiving area comprises an opening defined by the housing. Some such embodiments further include a graphical element on the impermeable housing, the graphical element encoded with information related to the first diagnostic element and the second diagnostic element.

[0019] In any of these embodiments, the first diagnostic element includes a sample transport portion that directs a first portion of the liquid to the colorimetric reaction area. In some such embodiments, the colorimetric reaction area includes a first colorimetric reaction area, a second colorimetric reaction area, and a hydrophobic region at least partially disposed between the first and second colorimetric reaction areas.

[0020] Any of these embodiments may further include a pressure point element that biases the first membrane of the second diagnostic element toward the second membrane of the second diagnostic element.

[0021] Various embodiments advantageously provide multiple different diagnostic methods that effectively provide different respective test results from a single test sample. Various embodiments advantageously allow for the flow of a sample to each of multiple different diagnostic methods, allowing multiple tests to be performed using a single test sample.

[0022] The novel features believed characteristic of the invention are set forth in the appended claims. However, the invention itself, together with its preferred modes of use, further objects and advantages, will best be understood by reference to the following detailed description of illustrative embodiments when read in connection with the accompanying drawings. [Brief explanation of the drawings]

[0023] [Figure 1] 1 is a plan view of a multiplexed rapid testing device according to one embodiment of the present invention; [Figure 2] 1 is an exploded view of a multiplexed rapid test device according to one embodiment of the present invention. [Figure 3]1 illustrates a top view of a flow path representation of a multiplexed rapid test device according to an exemplary embodiment. [Figure 4] 1 illustrates a top view of a flow path representation of a multiplexed rapid test device according to an exemplary embodiment. [Figure 5] 1 shows a perspective view of a lateral flow assay according to an exemplary embodiment. [Figure 6] 1 illustrates an exploded view of a fluid distribution assembly according to an exemplary embodiment. [Figure 7] 1 illustrates an exploded view of a multiplexed rapid test device according to an exemplary embodiment. [Figure 8] 1 is a perspective view of a multiplexed rapid test device according to an exemplary embodiment. [Figure 9] 9 illustrates a cross-sectional view taken along section line IX-IX of FIG. 8 in accordance with an exemplary embodiment. [Figure 10] 9 illustrates a cross-sectional view taken along section line XX of FIG. 8 in accordance with an exemplary embodiment. [Figure 11] 1 illustrates a plan view of a multiplexed rapid test device according to an exemplary embodiment. [Figure 12] 1 illustrates a plan view of a multiplexed rapid test device according to an exemplary embodiment. [Figure 13] 1 illustrates a mobile application for use with a multiplexed rapid test device according to an exemplary embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0024] In recent years, various rapid testing devices have been developed that can rapidly obtain test results in non-laboratory environments without the need for laboratory equipment. Two representative types of such devices are lateral flow assays (LFAs) and colorimetric test strips.

[0025] A desirable characteristic of a rapid test device is the ability to perform various tests from a single test sample on a single rapid test device. The ability to perform multiple tests from a single test sample saves time and money and reduces ambiguity caused by changing sample conditions over time as different test devices are employed for different types of tests. Performing multiple tests from a single test sample also reduces the complexity of planning, conducting, and evaluating the results of multiple tests using separate test devices for different types of tests. For example, different test devices require different testing techniques and may be subject to inadvertent substitution or confusion due to human error.

[0026] Some tests, e.g., serological tests, use LFAs to detect the presence or absence of target antibodies. Other tests use colorimetric reaction indicators on paper strips or dipsticks (e.g., colorimetric test strips) to assess the concentration of specific chemical elements in the test sample. Thus, it is often desirable to test a particular sample for the presence or absence of target antibodies while simultaneously assessing the concentration of some chemicals in the same test sample.

[0027] Despite the desirability of performing multiple tests from a single test sample, fundamental differences between LFAs and colorimetric test strips have prevented these different types of tests from being integrated into a single testing device. For example, colorimetric test strips generally require immersion in a liquid test sample for a specific period of time to ensure sufficient contact with the test sample. However, the amount of liquid used by colorimetric test strips presents a challenge for LFAs. The amount of liquid applied to an LFA is limited by the use of a wicking pad, which prevents excess liquid from flowing back from the test droplet on the test reaction area. Otherwise, excess liquid would reduce the sensitivity of the LFA reaction area. Immersing a colorimetric test strip completely in an LFA compresses the wicking pad, rendering the LFA test results inconclusive.

[0028] The present embodiments recognize that the integration of LFA and colorimetric test strip-type tests into a test device that performs both types of tests from a single test sample is possible, despite challenges that have prevented such integration in the past. Exemplary embodiments address and solve this technical problem by introducing asymmetric sample distribution capabilities into a rapid test device, resulting in disproportionate amounts of a single test sample being distributed to different diagnostic elements of the test device. Advantageously, asymmetric sample distribution allows for relatively large sample volumes to be run through diagnostic elements that benefit from exposure to a larger amount of test sample, while allowing for relatively small sample volumes to be run through other diagnostic elements that would be damaged or obstructed by exposure to too much test sample. For example, one embodiment of a rapid test device has a colorimetric-type diagnostic element and an LFA-type diagnostic element, allowing for a disproportionately large amount of a single test sample to be run through the colorimetric-type diagnostic element and a disproportionately small amount of a single test sample to be run through the LFA-type diagnostic element. This allows the colorimetric type diagnostic element to receive a sufficient amount of liquid to produce a test result without overwhelming the LFA type diagnostic element, allowing test results to be produced from a smaller but more appropriate amount of test sample.

[0029] As used herein, the term "sample" or "test sample" refers to a volume of a liquid, solution, or suspension intended for the qualitative or quantitative determination of one of its properties, such as the presence or absence of a component or the concentration of a component. Typical samples in the context of the present embodiments described herein are human or animal bodily fluids, such as blood, plasma, serum, lymph, urine, saliva, semen, amniotic fluid, gastric juice, phlegm, expectoration, mucus, tears, and stool. Another type of sample is derived from a human or animal tissue sample, which has been processed into a liquid, solution, or suspension to reveal specific tissue components for testing. Still other types of samples are liquids of any kind, such as water quality analysis or tap water quality testing, industrial and environmental testing, pool and hot spring testing, lake and stream testing, aquarium testing, food safety monitoring, and water for environmental contamination detection. Simple, rapid, and accurate testing is advantageous, and test strips must possess the necessary detection capabilities. Thus, the disclosed embodiments are equally applicable to bodily and non-bodily samples.

[0030] The term "lateral flow assay" as discussed herein refers to any device that receives a fluid, such as a chemical or biochemical sample, with specific regions providing reagents and various functions, such as filters, and that includes a laterally arranged fluid transport or flow path through which the sample traverses under the influence of a capillary or other applied force.

[0031] The terms "region" and "area" are used in the context of this specification, examples and claims to define a portion of a fluid flow path on a substrate.

[0032] The term "reaction" is used to define any reaction that occurs between a component of a sample and at least one or more reagents on or in a substrate, or between two or more components present in a sample. In particular, the term "reaction" is used to define a reaction that occurs between an analyte and a reagent as part of a qualitative or quantitative determination of the analyte.

[0033] In some embodiments, the rapid test device includes a sample receiving area, a first diagnostic element including a colorimetric analysis area, and a second diagnostic element including a lateral flow assay analysis area. In some such embodiments, asymmetric sample distribution is provided by first and second flow paths, where the first flow path allows a first portion of liquid deposited at the sample receiving area to flow to the first diagnostic element, and the second flow path allows a second portion of liquid deposited at the sample receiving area to flow to the second diagnostic element.

[0034] In some embodiments, asymmetric sample distribution is provided by first and second distribution substrates. In such embodiments, the first distribution substrate includes a first hydrophilic region that receives liquid deposited in the sample receiving region. The first distribution substrate also includes a first hydrophobic region that defines the boundary of the first hydrophilic region. The second distribution substrate includes second and third hydrophilic regions, each of which receives a respective portion of the liquid from the first hydrophilic region. The second hydrophilic region allows the liquid to flow to the first diagnostic element, and the third hydrophilic region allows the liquid to flow to the second diagnostic element. The second distribution substrate also includes a second hydrophobic region that prevents the liquid from passing from the second hydrophilic region to the third hydrophilic region and vice versa. In some embodiments, the second hydrophobic region allows the size of each of the second and third hydrophilic regions to be controlled according to the desired proportion of liquid to be delivered to each of the diagnostic elements.

[0035] In some embodiments, asymmetric sample distribution is provided by a first flow path including a hydrophilic material between the sample receiving area and the first diagnostic element, and a second flow path including a hydrophilic material between the sample receiving area and the second diagnostic element. In some such embodiments, a liquid-repellent flow barrier is provided between a portion of the first flow path and the second flow path. In some such embodiments, the flow barrier allows the size of each of the second and third hydrophilic regions to be controlled according to the desired proportion of liquid to be delivered to each of the diagnostic elements.

[0036] In some embodiments, asymmetric sample distribution is provided by a multiplexing flow path that receives liquid deposited in a sample receiving area and allows a first portion of the liquid to flow to a first diagnostic element and a second portion of the liquid to flow to a second diagnostic element. In some such embodiments, the multiplexing flow path allows for control of the respective portions of liquid that flow to the diagnostic elements according to the desired ratio of liquid to be delivered to each of the diagnostic elements.

[0037] Also, in some embodiments, asymmetric sample distribution is provided by a hydrophobic structure defining a first flow path from the sample receiving area to the first diagnostic element and a second flow path from the sample receiving area to the second diagnostic element. In some such embodiments, the hydrophobic structure allows for control of the size of each of the first and second flow paths according to the desired proportion of liquid to be delivered to each of the diagnostic elements.

[0038] Referring to FIG. 1, this figure shows a plan view of a multiplexed rapid test device 100 according to an exemplary embodiment. A top cover 102 has an opening (e.g., a window) for sample deposition for testing and for displaying test results. For example, the top cover 102 has a sample receiving area 104 positioned above a reservoir that holds the sample. The top cover 102 also has multiple test result windows 106A-106D that display respective test results. While the illustrated embodiment includes a circular sample receiving area 104, the embodiment is not limited to any particular shape. For example, the sample receiving area can be square, rectangular, triangular, oval, irregular, etc. Similarly, the illustrated embodiment includes four test results in windows 106A-106D because the multiplexed rapid test device includes four diagnostic areas. However, the number of diagnostic areas may be greater or fewer, and a test result window 106 may exist for each diagnostic area. Alternatively, there may be a single test result window large enough to display the test results for multiple diagnostic areas.

[0039] 2, an exploded view of an exemplary embodiment of a multiplexed rapid test device 200 is shown. In a particular embodiment, the multiplexed rapid test device 200 is an example of the multiplexed rapid test device 100 of FIG.

[0040] In the illustrated embodiment, the multiplexed rapid test device 200 includes a top cover 202 and a bottom cover 208 attached to opposite sides of a spacer element 220, such that the top cover 202, the bottom cover 208, and the spacer element 220 collectively constitute an example of a housing. In some embodiments, the top cover 202, the bottom cover 208, and the spacer element 220 are formed of an impermeable material, such as paper, having a hydrophobic coating so as to be impermeable to the test sample and buffer solution. In some embodiments, the top cover 202, the bottom cover 208, and the spacer element 220 are all formed of an impermeable material and collectively constitute an example of an impermeable housing.

[0041] In the illustrated embodiment, the multiplexed rapid test device 200 comprises an internal pressure point element 210 having a body with an upper surface, a lower surface, and an opening within the body that defines an internal reservoir 212 that receives a test sample deposited in the sample receiving area 204. Furthermore, the internal reservoir 212 is configured to receive an expected sample volume of liquid (e.g., a predetermined microliter volume) at a time and hold the sample volume for a period of time while the liquid is wicked to the fluid distribution assembly 214. By integrating the internal reservoir 212 within the rapid test device 200, there is a reduction / elimination of sample overflow outside the top cover 202 and bottom cover 208. Furthermore, the integration of the internal reservoir 212 reduces / eliminates sample loss due to spillage.

[0042] Continuing with reference to the exemplary embodiment of FIG. 2 , fluid distribution assembly 214 is positioned in fluid communication with the underside of internal reservoir 212. Fluid distribution assembly 214 includes multiple distribution substrates 216A-216B that collectively divide a portion of a test sample deposited in internal reservoir 212 among multiple flow paths. The flow paths, in turn, are in fluid communication with each of the flow paths of multiple diagnostic elements 218A and 218B. While the illustrated embodiment of fluid distribution assembly 214 includes two distribution substrates 216A-216B, alternative embodiments of fluid distribution assembly 214 include more or fewer distribution substrates. Also, while the illustrated embodiment of multiplexed rapid test device 200 includes two diagnostic elements 218A and 218B, alternative embodiments of multiplexed rapid test device 200 include more or fewer diagnostic elements.

[0043] In the illustrated embodiment, distribution substrates 216A and 216B each have a respective wax-defined hydrophilic channel fabricated in the same sample pad material of diagnostic elements 218A and 218B, enhancing sample distribution to diagnostic elements 218A and 218B. By using the same material for distribution substrates 216A and 216B as diagnostic elements 218A and 218B, more efficient fluid transfer from distribution substrates 216A and 216B to diagnostic elements 218A and 218B is achieved. Additionally, the use of carefully designed wax-defined channels reduces the amount of test sample retained by fluid distribution assembly 214. Furthermore, the design of the wax-defined channels achieves desirable distribution under various conditions (e.g., when multiplexed rapid test device 200 is tilted, dropped, etc.).

[0044] In the illustrated embodiment, the multiplexed rapid test device 200 includes a spacer element 220 as an intermediate support layer. As shown in the exemplary embodiment of FIG. 2, the spacer element 220 is constructed of a material that has been pre-treated (e.g., coated) to make it impermeable to liquid samples and buffers. The material used to construct the spacer element 220 in this embodiment is cardboard, although the construction is not limited to this material. For example, chipboard may also be used.

[0045] In the illustrated embodiment, the spacer element 220 includes at least one divider strip 222 positioned to separate the diagnostic elements 218A, 218B contained in the respective regions 224A, 224B defined by the spacer element 220 to prevent cross-contamination. The divider strip 222, along with the remainder of the spacer element 220, can also serve to ensure a gap exists between the top cover 202 and the diagnostic elements 218A and 218B to prevent contamination of the flow path or impedance to the flow path due to inadvertent contact of the top cover 202 with the surfaces of the diagnostic elements 218A, 218B. In some embodiments, if the quantity of diagnostic elements 218A and 218B exceeds two, the spacer element 220 can include more than one divider strip 222. For example, an alternative embodiment includes three diagnostic elements 218 and two divider strips 222, with two divider strips 222 separating the three diagnostic elements 218; another alternative embodiment includes n diagnostic elements 218 and n-1 divider strips 222, with n-1 divider strips 222 separating the n diagnostic elements 218, where n is any desired integer. By permitting the use of multiple diagnostic elements 218 housed in spacer element 220, multiple reagent tests can be performed from a single deposited sample. Also, in this embodiment, it is shown that divider strip 222 does not separate the entire area defined by spacer element 220. Due to the placement of fluid distribution assembly 214 and internal reservoir 212, an undivided area 226 exists. The impermeable bottom cover 208 and spacer element 220 combine to form (together with the top cover 202 ) a housing element for placement and alignment of the internal reservoir 212 , the fluid distribution assembly 214 and two or more diagnostic elements 218 .

[0046] In the illustrated embodiment, the internal pressure point elements 210 are positioned to enhance contact reliability at the interface between the fluid distribution assembly 214 and the diagnostic elements 218A and 218B.

[0047] Referring to Figure 3, this figure shows a top view of a fluid channel representation 300 of a multiplexed rapid test device according to an example embodiment. Fluid channel representation 300 is an example of a fluid channel that highlights the hydrophilic regions of multiplexed rapid test device 100 of Figure 1 or multiplexed rapid test device 200 of Figure 2.

[0048] In the illustrated embodiment, flow path representation 300 includes diagnostic elements 318A and 318B, which are examples of diagnostic elements 218A and 218B, respectively, of Figure 2. Flow path representation 300 also includes a fluid distribution assembly 314 that includes distribution substrates 316A and 316B, which are examples of fluid distribution assembly 214 and distribution substrates 316A and 316B, which are examples of 216A and 216B of Figure 2. In the representation shown in Figure 3, the hydrophobic portions of distribution substrates 316A and 316B are not shown for clarity.

[0049] In flow path representation 300, diagnostic element 318A is a representation of a colorimetric-type diagnostic element, and diagnostic element 318B is a representation of a lateral flow assay-type diagnostic element. Diagnostic element 318A includes a hydrophilic channel 320 and multiple colorimetric reagent regions 322A-322C defined by hydrophobic regions 328 (shown shaded). In the illustrated embodiment, diagnostic element 318B also includes a hydrophilic material 326. Typically, liquid flow from test sample 324 travels from distribution substrate 316A, through distribution substrate 316B, toward hydrophilic channel 320 and hydrophilic material 326, and, for diagnostic element 318A, from hydrophilic channel 320 into each of colorimetric reagent regions 322A-322C. In the flow channel representation 300, the hydrophilic channel 320 and the colorimetric reagent regions 322A-322C, 326 include a porous material such as paper, and liquid is drawn in by the wicking effect of the porous material without the need for an external pump.

[0050] 4, which shows a plan view of a flow path representation 400 of a multiplexed rapid test device according to an exemplary embodiment. In certain embodiments, flow path representation 400 is substantially the same as flow path representation 300 of FIG. 3, except as described.

[0051] In the illustrated embodiment, flow path representation 400 includes an alternative embodiment of a colorimetric-type diagnostic element 418A. Diagnostic element 418A includes a hydrophilic channel 420 and multiple colorimetric reagent regions 422A-422C defined by a hydrophobic region 424. Diagnostic element 418A also includes hydrophilic subchannels 426A-426C extending toward common point 428, as illustrated by the dashed line extending through subchannels 426A-426C to common point 428. Compared to the representation shown in FIG. 3 , subchannels 426A-426C are an example of a flow path design that allows liquid from test sample 430 to reach colorimetric reagent regions 422A-422C more quickly.

[0052] 5, which is a perspective view of an exemplary embodiment of a lateral flow assay 500. In certain embodiments, the lateral flow assay 500 is an example of the lateral flow assay type of diagnostic element 318B of FIG.

[0053] In the illustrated embodiment, the lateral flow assay 500 includes a sample pad / blood separator 502, a conjugate pad 504, a membrane 506 having a test line 508 and a control line 510, and a wicking pad 512. Typically, the sample pad 502, conjugate pad 504, membrane 506, and wicking pad 512 comprise a porous medium such as paper. In such an embodiment, liquid flows from the sample pad 502 toward the wicking pad 512, drawn by the wicking effect of the porous medium, without the need for an external pump.

[0054] 6, an exploded view of an exemplary embodiment of a fluid distribution assembly 600 is shown. In a particular embodiment, the fluid distribution assembly 600 is an example of the fluid distribution assembly 214 of FIG.

[0055] In the illustrated embodiment, the fluid distribution assembly 600 includes multiple distribution substrates 616A and 616B that collectively divide a portion of a test sample deposited in an internal reservoir (e.g., internal reservoir 212 in FIG. 2) among multiple flow paths. The flow paths, in turn, are in fluid communication with the flow paths of each of multiple diagnostic elements (e.g., diagnostic elements 218A and 218B in FIG. 2). While the illustrated embodiment of the fluid distribution assembly 214 includes two distribution substrates 616A and 616B, alternative embodiments of the fluid distribution assembly 600 include more or less distribution substrates.

[0056] The fluid distribution assembly 600 is a multi-layer assembly disposed in fluid communication with the internal reservoir and the diagnostic elements. The multi-layer fluid distribution assembly 600 includes a distribution substrate 616A as an upper surface and a distribution substrate 616B as a lower surface. The distribution substrate 616A includes a hydrophobic wax-filled region 618 and a hydrophilic paper channel 620. The hydrophilic paper channel 620 is in fluid communication with multiple flow paths configured to distribute at least a portion of the test sample deposited in the internal reservoir to multiple diagnostic elements in ratios that meet the liquid volume requirements of the various diagnostic elements. For example, in some embodiments, the amount of test sample liquid required by the diagnostic elements may differ depending on whether the diagnostic elements are colorimetric or lateral flow assay-type diagnostic elements.

[0057] In the illustrated embodiment, distribution substrate 616B includes a hydrophobic wax-filled region 622 and multiple hydrophilic paper channels 624A and 624B. Both hydrophilic paper channels 624A and 624B are in fluid communication with hydrophilic paper channel 620 of distribution substrate 616A. Furthermore, hydrophilic paper channel 624A is in fluid communication with a first diagnostic element, and hydrophilic paper channel 624B is in fluid communication with a second diagnostic element. The amount of test sample liquid that flows to the diagnostic element depends on the area of ​​the hydrophilic paper channel between the internal reservoir and each diagnostic element. Therefore, hydrophilic paper channel 624A is much larger than hydrophilic paper channel 624B, allowing more liquid to flow to the diagnostic element in fluid communication with hydrophilic paper channel 624A than would flow to the diagnostic element in fluid communication with hydrophilic paper channel 624B. In this manner, the multiple flow paths are configured to distribute portions of the test sample deposited in the internal reservoir to the multiple diagnostic elements in proportions that meet the fluid volume requirements of the various diagnostic elements.

[0058] In some embodiments, the size of the hydrophilic paper channels in each distribution substrate 616 is controlled based on various structures of the distribution substrate's wax pattern consistent with exemplary embodiments of the present disclosure. In the illustrated embodiment, distribution substrate 616A has a different wax pattern than distribution substrate 616B. In some embodiments, the wax pattern is deposited on the top or bottom surface, or both, of the paper sheet using a wax printer or other known methods to define the channel design before undergoing a reflow process. In some embodiments, the reflow process includes applying heat to melt the wax and impregnate the thickness of the paper sheet to create a hydrophobic barrier against fluid migration. Depending on the thickness of the paper sheet, grayscale wax features can be used to partially penetrate the thickness of the paper, creating a three-dimensional wax barrier, i.e., a barrier that extends both planarly and through the thickness of the paper. In some embodiments, the grayscale wax features remain hydrophobic after reflow.

[0059] 7, an exploded view of an exemplary embodiment of a multiplexed rapid test device 700 is shown. In a particular embodiment, the multiplexed rapid test device 700 is an example of the multiplexed rapid test device 200 of FIG.

[0060] In the illustrated embodiment, the multiplexed rapid test device 700 may be substantially similar to the multiplexed rapid test device 200 shown in Figure 2. The diagram in Figure 7 includes flow lines showing the location and direction of the flow path from the sample receiving area 704 to the internal reservoir 712, then to the hydrophilic paper channel 720 in the distribution substrate 716A, and then split between the hydrophilic paper channels 724A and 724B in the distribution substrate 716B to allow liquid flow to the diagnostic elements 718A and 718B, respectively.

[0061] Referring to Figure 8, this figure shows a perspective view of a multiplexed rapid test device 800 according to an exemplary embodiment. In the view shown in Figure 8, the top cover is not shown to more clearly illustrate the internal assembly of the test device 800. In certain embodiments, the multiplexed rapid test device 800 is an example of the multiplexed rapid test device 200 of Figure 2.

[0062] The multiplexed rapid test device 800 may be substantially similar to the multiplexed rapid test device 200 shown in FIG. 2. The view in FIG. 8 shows the assembled components without a top cover (e.g., top cover 202 in FIG. 2). The multiplexed rapid test device 800 includes a spacer element 820 as an intermediate support layer. As shown in the exemplary embodiment of FIG. 8, the spacer element 820 includes at least one divider strip 822 positioned to separate the diagnostic elements 818A, 818B contained in respective regions 824A, 824B defined by the spacer element 820 to prevent cross-contamination. The divider strip 822, together with the remainder of the spacer element 820, can also serve to ensure a gap exists between the top cover (e.g., top cover 202 in FIG. 2) and the diagnostic elements 818A, 818B to prevent contamination of the flow path or impedance to the flow path due to the top cover inadvertently contacting the surfaces of the diagnostic elements 818A, 818B.

[0063] In some embodiments, when the number of diagnostic elements 818A and 818B exceeds two, the spacer element 820 can include two or more divider strips 822. For example, an alternative embodiment includes three diagnostic elements 818 and two divider strips 822, with two divider strips 822 separating the three diagnostic elements 818; another alternative embodiment includes n diagnostic elements 818 and n-1 divider strips 822, with n-1 divider strips 822 separating the n diagnostic elements 818, where n is any desired integer. By permitting the use of multiple diagnostic elements 818 housed in the spacer element 820, multiple reagent tests can be performed from a single deposited sample. Also, in this embodiment, the divider strips 822 are shown not to divide the entire area defined by the spacer element 820. Due to the location of the fluid distribution assembly 214 and the internal reservoir 812, an undivided area 826 exists. Internal pressure point element 810 is nested within undivided region 826 defined by spacer element 820 and positioned to enhance contact reliability at the interface of diagnostic elements 818A and 818B.

[0064] Referring to FIG. 9, this figure shows a cross-sectional view 900 taken along section line IX-IX of FIG. 8 in accordance with an exemplary embodiment. In the illustrated embodiment, block arrows indicate the direction of force applied to the inner layers by the internal pressure point element 810 and bottom cover 914. The internal pressure point element 810 is positioned to enhance contact reliability at the interface between the diagnostic element 818B and the distribution substrates 916A and 916B along the flow path 912 taken by the liquid of the test sample 902. The test sample 902 migrates through the hydrophilic regions of the distribution substrates 916A and 916B to the lateral flow assay-type diagnostic element 818B, specifically the sample pad 904, then the conjugate pad 906, and then the membrane 908. The interfaces between these various components are thus pressed together, forcing the liquid to migrate through the various components rather than leaking over or between the layers.

[0065] Referring to FIG. 10 , this figure depicts a cross-sectional view 1000 taken along section line XX in FIG. 8 in accordance with an exemplary embodiment. In the illustrated embodiment, block arrows indicate the direction of force applied to the inner layers by the internal pressure point element 810 and bottom cover 914. The internal pressure point element 810 is positioned to enhance contact reliability at the interface between the diagnostic element 818A and the distribution substrates 916A and 916B along the flow path 1012 taken by the liquid in the test sample 902. The test sample 902 migrates through the hydrophilic regions of the distribution substrates 916A and 916B into the colorimetric diagnostic element 818A, specifically into the hydrophilic channels 1006 of the diagnostic element 818A. Thus, the interfaces between these various components are pressed together, forcing the liquid to migrate through the various components rather than leaking over or between the layers.

[0066] Referring to FIG. 11 , this figure shows a top view of a multiplexed rapid test device 1100 according to an exemplary embodiment. The test device 1100 includes a top cover 1102 having a sample receiving area 1104 and test result windows 1106A and 1106B. The disclosed test device embodiments may include various graphical elements on the exterior, such as text, codes, and other instructions. For example, as shown in FIG. 11 , the graphical elements may include a test name 1108 indicating the type of test performed by the multiplexed rapid test device 1100, a color reference 1110, and a QR code 1112 or other such graphical element encoded with information related to one or more of the diagnostic elements. In some embodiments, the color reference 1110 is provided for image processing that enables machine detection of the test results, such as an application on a smartphone or other such computing device that captures an image of the test results and reference 1110. In some embodiments, the application interprets the QR code for information such as the type of test performed, the test serial number, lot number, or other information. In some embodiments, the application stores the test results in a repository or database, such as cloud-based storage, where they can be later retrieved and analyzed.

[0067] Referring to FIG. 12 , this figure shows a top view of a multiplexed rapid test device 1200 according to an exemplary embodiment. The test device 1200 includes a bottom cover 1208. The disclosed test device embodiments may include various graphical elements on the exterior, such as text, codes, and other indicia. For example, as shown in FIG. 12 , the graphical elements may include various messages to a user or consumer, such as instructions 1210 for using the test device, a reference image 1212 for interpreting a first type of test performed by the test device 1200, and an additional reference image 1214 for interpreting a second type of test performed by the test device 1200.

[0068] 13, which illustrates an environment 1300 in which a mobile application according to an exemplary embodiment is used with a multiplexed rapid test device 1100. In the illustrated embodiment, a mobile device 1302 is used to capture an image 1304 of at least a portion of the multiplexed rapid test device 1100. However, in alternative embodiments, the mobile device may be a tablet computer, laptop computer, or any known computing device comprising a processor, one or more computer-readable storage media, and program instructions collectively stored on the one or more computer-readable storage media, the program instructions executable by the processor to cause the processor to perform operations including one or more of those described herein. For example, in some embodiments, the operations include capturing an image of a housing including graphical elements (e.g., test result windows 1106A and 1106B, color reference 1110, and QR code 1112, etc.). In some embodiments, the operation includes performing at least one data processing function on the captured image, the data processing function including comparing a color attribute at a readout region in the captured image with a color reference in the captured image to determine at least one chemical attribute of the test sample.

[0069] Computer-readable storage medium as used herein (including computer-readable storage medium(s) as used herein) should not be construed as a transitory signal per se, such as an electric wave or other freely propagating electromagnetic wave, an electromagnetic wave propagating through a waveguide or other transmission medium (e.g., a light pulse passing through a fiber optic cable), or an electrical signal transmitted over a wire.

[0070] In the illustrated embodiment, the mobile device 1302 is running an application specifically for imaging an inspection device, such as the multiplexed rapid inspection device 1100. In some embodiments, the mobile device 1302 runs an application that allows a user to capture an image of one or more graphical elements on the exterior of the inspection device. For example, in the illustrated embodiment, the mobile device 1302 is running an application specifically for imaging an inspection device, such as the multiplexed rapid inspection device 1100. 302The mobile device 1302 executes an application that enables a user to instruct the mobile device 1302 to capture images of the test result windows 1106A and 1106B, the color reference 1110, and the QR code 1112 using camera technology. In some embodiments, the mobile device 1302 evaluates the images of the test result windows 1106A and 1106B by comparing the color of the stripes in the test result windows 1106A and 1106B to the color of the color reference 1110 to determine the test results. In the illustrated embodiment, the multiplexed rapid test device 1100 includes two colorimetric types of tests, although alternative embodiments may include other types of tests. In some embodiments, the mobile device 1302 evaluates the image of the QR code 1112 by decoding the QR code 1112 to extract the network location (e.g., URL or IP address) of a cloud application or cloud storage device. In some such embodiments, the mobile device 1302 transmits the test results to the network location encoded in the QR code 1112 for storage, or for further processing of the test results, or both. In some embodiments, the mobile device 1302 also extracts and displays and / or transmits data features from the mobile device along with the test results, such as the geographic location of the sample analyzed, the timestamp when the analysis was performed on the sample, or the user who performed the chemical analysis, or a combination thereof.

[0071] The following definitions and abbreviations shall be used for interpreting the claims and the specification. As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having," "contains," or "containing," or other variations thereof, are intended to cover a non-exclusive inclusion. For example, a composition, mixture, process, method, article, or device that includes a list of elements is not necessarily limited to only those elements, but may include other elements not expressly listed or inherent in such composition, mixture, process, method, article, or device.

[0072] Additionally, the term "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments or designs. The terms "at least one" and "one or more" are understood to include one or more, i.e., any integer number such as 1, 2, 3, 4, etc. The term "plurality" is understood to include two or more, i.e., any integer number such as 2, 3, 4, 5, etc. The term "connected" can include both indirect and direct "connections."

[0073] As used herein, the phrases "one embodiment," "an embodiment," "an example embodiment," or similar phrases indicate that the described embodiment may include a particular feature, structure, or characteristic, but that not all embodiments may include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described.

[0074] The terms "about," "substantially," "approximately," and variations thereof are intended to include the degree of error associated with measurement of a particular quantity based on equipment available at the time of filing. For example, "about" can include a range of ±8%, 5%, or 2% of a particular value.

[0075] The description of various embodiments of the present invention is presented for illustrative purposes, but is not intended to be exhaustive or limited to the disclosed embodiments. It will be apparent to those skilled in the art that many modifications and variations are possible without departing from the scope of the described embodiments. The terms used herein have been selected to best explain the principles of the embodiments, practical applications or technical improvements to technology found in the market, or to enable those skilled in the art to understand the embodiments described herein.

Claims

1. a sample receiving area; a first diagnostic element including one or more colorimetric regions; a second diagnostic element comprising one or more lateral flow assay analysis areas; 1. A fluid distribution assembly comprising a hydrophobic structure deposited on a distribution substrate, the hydrophobic structure comprising: a first flow path that allows a first portion of liquid deposited at the sample receiving area to flow to the first diagnostic element; a second flow path that allows a second portion of the liquid deposited at the sample receiving area to flow to the second diagnostic element, the second portion having a different size than the first portion; a fluid distribution assembly asymmetrically defining Including, Device.

2. The device of claim 1 , further comprising an impermeable housing, wherein the sample receiving area comprises an opening defined by the housing.

3. The device of claim 2 , further comprising a graphical element on the impermeable housing, the graphical element encoded with information relating to the first diagnostic element and the second diagnostic element.

4. The device of any one of claims 1 to 3, wherein the first diagnostic element includes a sample transport portion that guides the first portion of the liquid to a colorimetric reaction area.

5. 5. The device of claim 4, wherein each of the one or more colorimetric analysis regions includes a first colorimetric reaction region, a second colorimetric reaction region, and a hydrophobic region disposed at least partially between the first colorimetric reaction region and the second colorimetric reaction region.

6. The device of any preceding claim, further comprising a pressure point element facilitating fluid communication along the first and second flow paths.

7. a first distribution substrate including a first hydrophilic region and a first hydrophobic region defining a boundary of the first hydrophilic region, the first hydrophilic region receiving a liquid deposited in the sample receiving region; a second distribution substrate including: a second hydrophilic region that receives a first portion of the liquid from the first hydrophilic region and allows the liquid to flow to the first diagnostic element; a third hydrophilic region that receives a second portion of the liquid from the first hydrophilic region and allows the liquid to flow to the second diagnostic element; and a second hydrophobic region that prevents the liquid from passing from the second hydrophilic region to the third hydrophilic region; The apparatus of any one of claims 1 to 6, further comprising:

8. the first flow path includes a hydrophilic material between the sample receiving area and the first diagnostic element; the second flow path includes a hydrophilic material between the sample receiving area and the second diagnostic element, and further includes a liquid-repellent flow barrier between a portion of the first flow path and the second flow path. An apparatus according to any one of claims 1 to 7.

9. 10. The device of claim 8, wherein the first diagnostic element includes a sample transport that directs fluid from the first flow path to the one or more colorimetric analysis regions.

10. a multiplexed flow path that receives the liquid deposited in the sample receiving area, allows a first portion of the liquid to flow to the first diagnostic element, and allows a second portion of the liquid to flow to the second diagnostic element; The apparatus of any one of claims 1 to 9, further comprising:

11. The device of claim 2 , further comprising a machine-readable identifier on the housing, the machine-readable identifier encoded with information related to the type of device.

12. A system including a rapid testing device, the rapid testing device comprising: a housing having a visible graphical element; 10. The apparatus of claim 1, the first and second diagnostic elements are supported by the housing; an apparatus, wherein the first diagnostic element and the second diagnostic element perform different analyses from each other; a hydrophobic structure defining the first flow path from the sample receiving area to a first diagnostic element and defining the second flow path from the sample receiving area to the second diagnostic element; a processor; one or more computer-readable storage media; and program instructions collectively stored on the one or more computer-readable storage media, the program instructions executable by the processor to cause the processor to perform operations, the operations including: capturing an image of a housing including the graphical element; performing at least one data processing function on the captured image, the data processing function including comparing a color attribute of a readout region in the captured image with a color reference in the captured image to determine at least one chemical attribute of the test sample.

13. 13. The system of claim 12, wherein the test sample is selected from the group consisting of blood, plasma, serum, lymph, urine, saliva, semen, amniotic fluid, gastric fluid, phlegm, sputum, mucus, tears, stool, and water.

14. The program instructions further include instructions executable by the processor to cause the processor to perform operations, the operations including: decoding at least a portion of the graphical element to obtain a remote data storage location; transmitting data regarding the at least one chemical attribute of the test sample to the remote data storage location; The system of claim 13 further comprising:

15. The method of claim 1, wherein the size of the first flow path is controlled by a first wax pattern deposited on the distribution substrate; the size of the second flow channel is controlled by a second wax pattern deposited on the distribution substrate; 10. The apparatus of claim 1.

16. A first wax pattern that controls the first flow path; a second wax pattern that controls the second flow path; wherein the first and second flow channels are deposited on a lower surface of the distribution substrate.

10. The apparatus of claim 1.

17. A first wax pattern that controls the first flow path; a second wax pattern that controls the second flow path; wherein the first and second flow channels are deposited on an upper and lower surface of the distribution substrate.

10. The apparatus of claim 1.

18. The method according to claim 1, further comprising a first wax pattern controlling the first flow path, wherein the wax material of the first wax pattern penetrates into the thickness of the distribution substrate.

10. The apparatus of claim 1.

19. The wax material of the first wax pattern only partially penetrates the thickness of the distribution substrate, forming a three-dimensional hydrophobic barrier that penetrates the thickness of the distribution substrate.

20. The apparatus of claim 18.

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