Diagnostic cartridge tray assemblies & methods of using diagnostic cartridge tray assemblies

Abstract

Diagnostic assays can use the disclosed cartridge tray assemblies to run tests to identify disease states and physiological conditions. The disclosed cartridge tray assemblies include a cartridge with an interior cavity, a substrate upon which the assay diagnostic test occurs, and an applicator guide. The substrate is positioned within the interior cavity of the cartridge and has a fixed sample application location at which a prepared sample is applied for the diagnostic assay. The applicator guide has a channel that is aligned above and spaced apart from the fixed sample application location of the substrate to help apply the prepared sample in a precise and accurate location on the substrate.

Description

Attorney Ref. No. 1001.1036.WOPCT PATENTDIAGNOSTIC CARTRIDGE TRAY ASSEMBLIES & METHODS OF USINGDIAGNOSTIC CARTRIDGE TRAY ASSEMBLIESCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority and benefit from the U.S. Provisional Patent Application 63 / 713,994, filed October 30, 2024, and titled, “ELECTROPHORESIS ONE-STEP CARTRIDGE,” which is incorporated herein by reference in its entirety for all purposes.BACKGROUND

[0002] Immunoelectrophoresis and immunoassays are powerful tool used to test for many disease conditions. These include infectious disease, chronic disease, measurement of metabolic conditions and many more. The tests to diagnose and manage these diseases are generally expensive, slow, and complex and require a central laboratory. If used in a remote location, conventional tests may not offer the sensitivity and performance required for accurate results. Disease diagnostics are critical to global health in all countries - developing and developed - to prevent community spread of infectious disease and undiagnosed chronic disease and to avoid unnecessary morbidities and mortalities. Conventional disease diagnostics with the highest sensitivity and specificity require laboratories to process patient samples, which are expensive resources not widely available in under-resourced and remote regions. These laboratories often require substantial time, highly skilled personnel to prepare samples and perform the diagnostics, and expensive equipment to conduct the diagnostic tests.

[0003] Available point of care (POC) diagnostics, and some laboratory diagnostics, for many diseases often suffer from various testing fidelity drawbacks, such as how precisely the prepared sample is applied to the substrate on which the assay is then run. Currently available laboratory and POC diagnostics can suffer from smear of the patient sample when it is applied to the substrate on which the assay is run. This smearing of the patient sample can negatively impact the accuracy and precision of the assay test results. Still further, preparing the sample to be applied to the substrate is often challenging for diagnostic assays, in particular POC diagnostics that do not benefit from the extensive equipment and highly trained users that are typically available in a laboratory. Further, users often apply the prepared samples to the substrate manually by hand, which causes errors by applying the prepared sample to different locations onAttorney Ref. No. 1001.1036.WOPCT PATENT the substrate and applying the prepared sample to the substrate with different levels of force, which affects the assay results. Conventional preparation techniques result in excessive volumes of prepared patient samples, unevenly applied or concentrated prepared sample application, or uneven mixing of sample and various preparation fluids, such as marker fluids or other diluents. The conventional preparation techniques often require expensive, hard to use, and hard to maintain auxiliary tools.

[0004] Diagnostic assays would benefit from improved sample preparation and test run techniques to improve the ease of use, decrease user skill required, and increase precision and accuracy of results, especially in POC diagnostic devices.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] Non-limiting and non-exhaustive embodiments of the invention are described with reference to the following drawings. In the drawings, like reference numerals refer to like parts throughout the various figures, unless otherwise specified, wherein:

[0006] FIG. 1 is a top plan view of a closed diagnostic electrophoresis cartridge according to aspects of the disclosure.

[0007] FIG. 2 is a top plan view of the open diagnostic electrophoresis cartridge shown in FIG. 1.

[0008] FIG. 3 is an exploded view of the open diagnostic electrophoresis cartridge shown in FIG. 2.

[0009] FIG. 4 is a bottom plan view of a portion of an applicator guide and an applicator tip according to aspects of the disclosure.

[0010] FIGS. 5A - 5E are steps of an example method of using the disclosed diagnostic cartridge tray assemblies.

[0011] FIG. 6 is a top perspective view of an ornamental design of a diagnostic cartridge tray assembly.

[0012] FIG. 7 is a side view of the ornamental design of the diagnostic cartridge tray assembly shown in FIG. 6.Attorney Ref. No. 1001.1036.WOPCT PATENT

[0013] FIG. 8 is another side view of the ornamental design of the diagnostic cartridge tray assembly shown in FIG. 6.

[0014] FIG. 9 is yet another side view of the ornamental design of the diagnostic cartridge tray assembly shown in FIG. 6.

[0015] FIG. 10 is still another side view of the ornamental design of the diagnostic cartridge tray assembly shown in FIG. 6.

[0016] FIG. 11 is a top plan view of the ornamental design of the diagnostic cartridge tray assembly shown in FIG. 6.

[0017] FIG. 12 is a bottom plan view of the ornamental design of the diagnostic cartridge tray assembly shown in FIG. 6.DETAILED DESCRIPTION

[0018] The subject matter of embodiments disclosed herein is described with specificity to meet statutory requirements and to convey the scope of the subject matter to those skilled in the art, but this description does not limit the scope of the claims. The disclosed subject matter may be embodied in other ways, may include different elements or steps in the same or a different order, and may be used in conjunction with other existing or future technologies. Though certain elements, aspects, components, or the like are described in relation to one embodiment or example, such as an example diagnostic system or method, those elements, aspects, components, or the like can be included with any other diagnostic system or method, such as when it is desirous or advantageous to do so.

[0019] The disclosed diagnostic cartridge tray assemblies can be used in various diagnostic test readers that receive cartridges to perform diagnostic tests, such as electrophoresis, lateral flow, immunoassays, and other diagnostic tests. Many of the examples discussed herein are illustrated using an electrophoresis cartridge, but one of skill in the art will appreciate that the disclosed cartridge assemblies can be used with other diagnostic tests. The disclosed cartridge assemblies and the individual cartridges help improve the ability of the diagnostic tests to be performed a point-of-care (POC) location, oftentimes using portable readers, instead of in a laboratory with expensive equipment. However, many or all of the features of the disclosed cartridge assemblies are also useful in a laboratory so the benefits of the disclosed cartridge assemblies or individualAttorney Ref. No. 1001.1036.WOPCT PATENT cartridges are beneficial regardless of the physical location of the reader or type of reader (POC or a laboratory reader).

[0020] Specifically, the disclosed diagnostic cartridge tray assemblies have an applicator guide that helps apply a precise amount of prepared sample on a substrate of the cartridge in a specific location called a fixed sample application location. The ability to precisely apply the prepared sample at the fixed sample application location improves the specificity, sensitivity, and quantification accuracy of the diagnostic test because the sample is applied at the same starting location each time (within a small margin of error). Analysis of the diagnostic test results are more dependable because of the predictable application of the prepared sample at the fixed sample application location. For example, an applicator guide has a channel that receives an end of an applicator that has a prepared sample on its tip. When inserted into the channel, the tip of the applicator guide directs the tip of the application with the prepared sample towards the fixed sample application location on the substrate. In an electrophoresis assay, for example, separation of the compounds in the prepared patient sample migrate across the substrate over time in response to an applied potential, which leaves a migration pattern. The timing of band separation, band appearance (and disappearance in some examples) during the test, and the band migration pattern help determine the presence or absence of a compound or component of the prepared sample. Having a consistent starting location at the fixed sample application location on the substrate improves the ability to analyze the bands as they migrate across the substrate in response to the applied potential between electrodes at the opposing ends of the substrate.

[0021] Further, the applicator guide can also have a fluid control element that helps control the amount of prepared sample that is applied to the substrate. In the example discussed above, the fluid control element removes or causes a portion of the prepared sample on the tip of the applicator to separate from the applicator tip before the applicator tip applies the prepared sample to the substrate resulting in the applicator applying a controlled volume of prepared sample to the substrate. The controlled volume of prepared sample prevents over saturating the substrate at the location where the applicator tip contacts the substrate to avoid smearing the prepared sample on the substrate, which can affect the specificity, sensitivity, and quantification of the diagnostic test results. Still further, the applicator guide can have mechanical stops that place the applicator tip at a specified distance away from the substrate. This specified distance away from or “height”Attorney Ref. No. 1001.1036.WOPCT PATENT above the substrate allows the applicator tip to touch the substrate to apply the prepared sample but not apply too much force to the substrate to over saturate or damage it.

[0022] Most conventional diagnostic tests apply the prepared sample to the substrate manually by a user’s hand without a guide and without a controlled volume of prepared sample being applied to the substrate. This manual sample application process results in imprecise applications of the prepared sample to a range of locations on the substrate, a varied volume of prepared sample applied to the substrate, and sometimes causing damage to the substrate because too great a force was applied. Imprecise applications of the prepared substrate in an uncontrolled volume causes saturation of the substrate, smearing of the prepared sample on the substrate, and lowers sensitivity, specificity, and quantification accuracy of the test results because of the unpredictability of the location and volume of prepared sample that is applied to the substrate.

[0023] The disclosed cartridge assemblies also have a mixing well that, in some examples, is located on a tray that connects to the cartridge. The mixing well includes a piece of foam fitted in the bottom of the well into which the sample and any preparation fluids can be placed for mixing. The pieces of foam is snugly fit and compliments the shape interior of the mixing well. The user then uses the foam to help mix, combine, or otherwise prepare the sample for testing. The foam is fitted into the bottom of the mixing well to form its lower, interior surface. Some of the example trays “snap” or have another mechanical connecting mechanism that connects the tray and the cartridge together to allow a user to prepare the sample, then transfer it to the cartridge for the diagnostic test.

[0024] The mixing well and foam combination also help to load the applicator properly with the prepared sample. For example, the foam is able to help fill the applicator tip after the sample is prepared to be able to transfer it from the applicator tip to apply to the substrate that is located in the cartridge. In an example, the mixing well includes a closed cell foam that allows for a small sample volume to be mixed with the preparation fluids without being absorbed into the foam for applications in which a small sample volume is typical or is required to be able to detect the target analyte or compound. Some foams have special qualities, such as being hydrophobic, whether by the materials of the foam or a coating applied to the foam. For these example hydrophobic foams, the hydrophobic nature of the foam repels the prepared sample into or onto the applicator tip for easy transport by the applicator tip to the substrate of the cartridge. Further, the foam can wipe or “squeegee” a portion of the prepared sample from the applicator tip so thatAttorney Ref. No. 1001.1036.WOPCT PATENT it is not overloaded or over saturated before it transfers the prepared sample to the substrate. In this example, the foam controls the amount of the prepared fluid that is loaded onto or into the applicator tip for transport to the cartridge substrate.

[0025] The mixing well with foam provides the diagnostic cartridge assemblies with an easier, less technical way for users to prepare the sample, which requires proper mixing and the ability to apply a controlled volume of prepared sample on the applicator tip. Typically, conventional diagnostic systems require a user to mix the sample properly in a mixing chamber or well without an aid then transfer the prepared sample to the tip of the applicator, which requires a trained user with skill to both mix the sample with the correct preparation fluid(s) and to transfer the proper volume of prepared sample to the applicator tip. Reducing the skill required to prepare the sample and apply the proper volume of prepared sample to the applicator tip improves the accessibility of this diagnostic test and reduces the risk of poorly prepared samples or over / under applying the prepared sample to the applicator tip. This preparation aid improves the overall test accuracy and precision, which helps increase the overall specificity, sensitivity, and quantification accuracy of the diagnostic test. It also provides access to this diagnostic test outside of an environment with skilled users, which helps provide diagnostic tests to under resourced and remote communities.

[0026] In the example diagnostic tests that use electrophoresis to perform the diagnostic test, some example cartridges include cellulose acetate (CA) paper as the substrate, which is located in a cavity of the cartridge when the cartridge portions are closed. Often, conventional systems over saturate or “soak” or do not uniformly saturate the CA paper when it is wet with a preparation fluid, such as a buffer. Most conventional systems soak the CA paper in the buffer solution to prepare it for the diagnostic assay, which can produce non-uniform wetting of the CA paper and less specific, sensitive, and accurate test results when the conductive properties and pH of the CA paper are likewise non-uniform due to the buffer soaking process. The disclosed diagnostic cartridge assemblies include a moving bladder or absorbent pad that helps achieve uniform wetting of the CA paper with the buffer along its length. The buffer is applied directly to the absorbent pad, which is in contact with the CA paper and is used to wet the CA paper.

[0027] After a brief period of time due to the small capillary size of the absorbent pad and the CA paper, the absorbent pad and CA paper reach a wetness equilibrium between them. The equilibrium results in the CA paper being at or nearly 100% saturated with the buffer with theAttorney Ref. No. 1001.1036.WOPCT PATENT absorbent pad still having the ability to further saturate and absorb buffer. The CA paper has a smaller pore size than the absorbent pad, which means it will remain at or near the 100% saturation point if a threshold amount of buffer is applied to the absorbent pad. Further, because the absorbent pad remains under 100% saturated, it can be used with a wide range of volume of buffer and still wet the CA paper to 100% to produce consistent results regardless of the volume of the buffer used, which decreases the skill level required for the user preparing the sample and test. This CA paper wetting technique can be used for any electrophoresis diagnostic test that uses CA paper or other material requiring wetting to help provide a uniform conductive medium and stabilize the pH before the diagnostic assay is started.

[0028] These disclosed cartridge assemblies help untrained users perform the diagnostic test because no accurate pipetting is required, samples are easily prepared using the mixing well with the foam, and the applicator is able to apply a controlled amount of prepared sample in a precise location on the substrate. Reducing the user skill level required to perform the diagnostic tests ensures that more tests can be performed and more patients can access quality care to better understand their disease states, receive early treatment, and reduce their risk of mortality and morbidities associated with their disease states.

[0029] FIG. 1 shows an example diagnostic cartridge 100 in a closed position. FIG. 2 shows the example diagnostic cartridge 100 shown in FIG. 1 in an open position. The diagnostic cartridge 100 shown in FIGS. 1 and 2 becomes part of a diagnostic cartridge assembly when it has an applicator guide, which is discussed below in reference to FIG. 3. The cartridge 100 is generally rectangular with three rounded corners 108 and one beveled comer 110. The cartridge 100 has a first portion 102 and a second portion 112 that mate together to form an interior cavity 118 of the cartridge 100. When the cartridge 100 is closed, as shown in FIG. 1, the first portion 102 exposes a substrate 106 through an opening 107 that is located in the interior cavity 118 of the cartridge 100.

[0030] The first portion 102 and the second portion 112 mate together in any suitable form to allow them to form a hollow interior cavity 118. The mating of the first portion 102 and the second portion 112 can be by a press or compression fit or any other mechanical connector that causes them to be separable when in an open position and fit together when in a closed position. In the example shown in FIGS. 1 and 2, the first portion 102 and the second portion 112 are connected at an edge 120 of the cartridge 100 and the connection between the first portion 102Attorney Ref. No. 1001.1036.WOPCT PATENT and the second portion 112 can be foldable at the edge to fit together. Here, the first portion 102 and the second portion 112 are connected by two hinges 104 that rotate around an axis defined by the edge 120 of the cartridge 100 at which they are connected.

[0031] FIG. 2 shows the cartridge 100 in an open position that exposes the interior cavity 118 and its components. The substrate 106 is positioned within the interior cavity 118 and is shown on the first portion 102 fitted within a frame 122 that is attached to an interior surface 124 of the first portion 102 in the example shown in FIG. 2. Comers of the substrate 106 are fitted into the frame 122 in this example, although in alternative examples, the frame can extend around opposing edges of the substrate or other locations, as appropriate. An interior surface 126 of the second portion 112 of the cartridge includes two electrodes 114, 116 that are located at or near the opposing ends 128, 130 of the interior surface 126 of the second portion 112 of the cartridge 100. When the cartridge 100 is closed, the substrate 106 contacts the absorbent pad 140 that is saturated with buffer. The absorbent pad 140 electrically connects with the negative electrode 114 and the positive electrode 116 that are situated in respective wells 117, 119 that are filled with buffer as well. The CA paper 106 or other substrate electrically contacts the negative electrode 114 and the positive electrode 116 via the absorbent pad 140 and the buffer medium in each respective electrode well 117, 119. A voltage generator applies an electric potential across the negative electrode 114 and the positive electrode 116, which in turn conducts the electric potential through the buffer fluid to the CA paper, to cause a prepared sample that is applied to the CA paper to migrate across a length of the CA paper to separate into its components based on molecular charge and size.

[0032] Turning now to FIG. 3, an exploded view of a diagnostic cartridge assembly 132 cartridge 100 is shown with a cartridge 100, an applicator guide 132, and a tray 136. The cartridge 100 and tray 136 are shown connected together. The tray 136 has a mixing well 137 that includes foam 139. The foam 139 is inserted into the bottom of the mixing well 137 and is fitted within that space. A user adds both the sample and a preparation fluid to the mixing well with the foam. The user mixes the sample and preparation fluid(s) in the mixing well using the foam to help mixing. In some examples, the user uses a tip of an applicator in mixing the sample and the preparation fluid in the mixing well 137 by repeatedly applying and releasing force on the applicator tip against the foam 139. The foam 139 can be an open cell or closed cell foam. An open cell foam absorbs more of the sample and / or preparation fluid than a closed cell foam.Attorney Ref. No. 1001.1036.WOPCT PATENTWith a closed cell foam, a smaller sample volume is required because a smaller volume of sample and / or preparation fluid are absorbed into the foam cells than an open cell foam would absorb. In an example, patient blood is used as the sample. With a closed cell foam, less blood is required to be drawn from the patient, which often improves the patient experience and reduces the likelihood of later finding that volume of the drawn blood was insufficient to run the diagnostic assay.

[0033] The foam helps to wipe or “squeegee” off excess fluid from an applicator tip when it is inserted into the mixing well to apply the prepared sample. The foam cells wrap around and contact the applicator tip as it is inserted into the mixing well to pick up the prepared sample. This results in a controlled amount of fluid being applied to the applicator tip and thus being transferred to the substrate for testing. Further, some foams have properties that either attract or repel fluids. A foam that is hydrophobic or treated with a hydrophobic coating helps repel the prepared sample from the foam and onto an applicator tip to then transport it to the substrate for testing.

[0034] The first portion 102 of the cartridge 100 freely moves by folding around the hinges 104 at the edge 120 of the cartridge 100. The first portion 102 is foldable to mate with the second portion 112 after the prepared sample is applied to the substrate 106. The second portion 112 of the cartridge 100 is attached to or otherwise connected to the tray 136 using a releasable mechanical connector 138. After the prepared sample is applied to the substrate 106 and the first portion 102 is folded around the hinges 104 to mate with the second portion 112 of the cartridge 100, the second portion 112 of the cartridge 100 can be released from the tray 136 by disengaging the releasable mechanical connector 138. The released cartridge 100 is then ready for insertion into a reader that performs the diagnostic assay on the prepared sample.

[0035] Positioned on top of and in physical contact with the substrate 106 is an absorbent pad 140 that helps to wet the substrate 106. The absorbent pad 140 helps achieve uniform wetting of the substrate 106, which is often CA paper in an electrophoresis immunoassay. For example, a buffer is applied directly to the absorbent pad 140, which is in contact with the CA paper 106 or other substrate in alternative examples. After a brief period of time, the fluid applied to the absorbent pad 140 and CA paper 106 reach an equilibrium because of the small pore size of both the absorbent pad 140 and the CA paper 106. In this example, the equilibrium is nearly a 100% saturation of the CA paper 106 with the absorbent pad 140 having more ability to absorbAttorney Ref. No. 1001.1036.WOPCT PATENT additional fluid. Because CA paper 106 has a smaller pore size than the absorbent pad 140 (likewise the absorbent pad 140 has a larger pore size than the CA paper 106 or other substrate), the CA paper 106 is always near the 100% saturation point if a minimum threshold of preparation fluid, such as a buffer, is applied to the absorbent pad 140 to saturate the CA paper 106. The absorbent pad 140 remains under 100% saturation, which allows it to be used with a wide range of volumes of buffer, which lowers the user skill required to prepare the CA paper 106.

[0036] The applicator guide 134 fits over the absorbent pad 140 and substrate 106. The applicator guide 134 has a locking mechanism 142 that is inserted into a mating locking receptacle 144 formed into the interior surface 124 of the first portion 102. The applicator guide 134 includes an opening 144 that allows access from above the applicator guide 134 to apply fluid, such as a buffer, to the absorbent pad 140 to wet the substrate 106. The applicator guide 134 also has a channel 148 into which an applicator tip is inserted to guide the applicator tip with the prepared sample to a fixed sample application location 152 on the substrate 106. In some examples, the channel 148 is shaped to mate with a portion of the applicator as the applicator tip is inserted into the channel 148 to apply the prepared sample on the substrate 106. The channel 148 can include one or more shoulders that compliment one or more shoulders of the applicator tip to create a hard stop to position the applicator tip a specific distance away from or heigh above the substrate to avoid the applicator tip from applying too great a force on the substrate 106 when applying the prepared sample. The channel 148 of the applicator guide 134 is aligned above and spaced apart from a fixed sample application location 152 on the substrate 106. This fixed sample application location 152 is a precise location to apply the prepared sample onto the substrate 106 to produce the best diagnostic test results. The fixed sample application location 152 is located at or near the negative electrode so that when the electrical potential is applied between the negative electrode and the positive electrode, the components of the prepared sample applied at the fixed sample application location 152 migrate across the length of the substrate and separate into different bands. Having a consistent application location for the prepared sample allows the migration speed and pattern, and the distance between bands that appear and disappear through an electrophoresis test, for example, to be consistently formed, which makes analyzing the test results simpler and more precise.Attorney Ref. No. 1001.1036.WOPCT PATENT

[0037] FIG. 4 shows a partial view bottom, elevation perspective view of an applicator guide 134 with an applicator tip 154 inserted through the channel 148 of the applicator guide 134. The applicator tip 154 is generally rectangular in shape with parallel sides 156 and rounded short ends 158. The center portion 160 of the applicator tip 154 is a recessed cavity. The prepared sample is applied to the applicator tip 154 before it is inserted into the channel 148 of the applicator guide 134. The prepared sample is applied around the perimeter of the applicator tip 154 along the parallel sides 156 and rounded short ends 158 of the applicator tip 154. Additionally, prepared fluid is applied to recessed cavity 160 of the applicator tip 154.

[0038] A fluid control element 162 is positioned within the channel 148 of the applicator guide 134. The applicator tip 154 extends through the fluid control element 162 when it is inserted into the channel 148 of the applicator guide 134. The fluid control element 162 is fitted to extend around the entirety of an interior perimeter 164 of the channel 148 of the applicator guide 134. The fluid control element 162 includes multiple fingers 166 and multiple capillary channels 168 extending annularly around the interior perimeter of the channel 148 with a center opening 170. In the example shown in FIG. 4, the multiple fingers 166 alternate with the multiple capillary channels 168 as they extend annularly around the interior perimeter 164 of the channel 148. As the applicator tip 154 is inserted into the channel 148 and extends through the fluid control element 162, portions of the applicator tip 154 contact the multiple fingers 166 of the fluid control element 162 to remove a volume of the prepared sample from the applicator tip 154 before it is applied to the substrate 106. Some prepared sample removed by the multiple fingers 166 can flow into the multiple capillary channels 168 to avoid it dripping onto the substrate during the application process, which removes excess fluid helps to avoid smearing the prepared sample and unevenly applying the prepared sample to the CA paper when the applicator tip 154 contacts the substrate 106. Smearing and uneven application of the prepared sample reduces the specificity, sensitivity, and quantification accuracy of the diagnostic test.

[0039] FIGS. 5A - 5E show steps of a method of using the disclosed diagnostic cartridge tray assemblies to perform diagnostic tests 500, including various immunoassays. The example diagnostic test described in FIGS. 5 A - 5E is an electrophoresis test that evaluates a patient’s blood sample for a hemoglobin disease, deficiency, or abnormality. The steps shown in FIGS. 5A - 5E are those that a user performs with both the diagnostic cartridge tray assembly and a reader that performs the test. While most electrophoresis test cartridges must be prepared by aAttorney Ref. No. 1001.1036.WOPCT PATENT skilled user, such as a laboratory technician specially trained in preparing cartridges for electrophoresis diagnostic testing, a less skilled or even unskilled user can perform the disclosed methods. The lower training and / or skill requirement improves patient access to the diagnostic testing by increasing the number of users that can successfully perform the test.

[0040] In an example method of using the diagnostic cartridge assembly to perform a diagnostic test shown in FIG. 5A - 5E, a user starts the process by adding several drops of a buffer to wet the CA paper that is positioned in the first portion of the cartridge 502. Next, the user adds several drops of the buffer to the wells with the electrodes 504 in the second portion of the cartridge. The user then adds one or more drops of a marker fluid to the mixing well in the tray 506 to which the cartridge is attached. The user collects a patient sample in a pipette 508 and holds the pipette with the patient sample over the center of the mixing well located in the tray while gently squeezing the bulb of the pipette to release the patient sample into the mixing well 510. The user mixes the patient sample with the marker fluid that was already placed in the mixing well using the applicator tip of the applicator by moving the applicator towards and away from the foam in the bottom of the mixing well for a defined period of time, such as 20 seconds 512. Once mixed, the patient sample is applied to the applicator tip of the applicator that the user then holds over the applicator guide 514a to position it properly over the top of the fixed sample application location on the substrate within the interior cavity of the cartridge. In the example shown in FIG. 5B, the applicator is designed to snap into the channel of the applicator guide using a mechanical connector 514b.

[0041] The user waits a specified period of time, such as 5 seconds, after snapping the applicator into the applicator guide, which causes the applicator tip to contact the substrate to apply the prepared patient sample to the substrate at the fixed sample application location. After the waiting period, the user then removes the applicator guide with the connected applicator from the cartridge 516. The applicator guide is snapped or locked onto the first portion of the cartridge over the substrate to properly locate the applicator tip to apply the prepared patient sample at the fixed sample application location. After the applicator guide and applicator are removed from the cartridge, the user is able to fold the first portion of the cartridge onto the second portion of the cartridge by rotating the first portion around the hinges that connect the first portion to the second portion 518, which has the prepared sample applied to the fixed sample application location on the substrate. The user detaches the cartridge from the tray 520Attorney Ref. No. 1001.1036.WOPCT PATENT and then inserts the cartridge into a diagnostic reader to perform the diagnostic test 522. The user operates the reader to begin the electrophoresis test 524. The reader produces results of the electrophoresis test on its screen including the hemoglobin variant found in the patient sample 526 and the diagnosis based on the test results with a code, such as a QR code, which includes all the data from the diagnostic test and the results 528.

[0042] FIGS. 6-12 are design drawings for the disclosed diagnostic cartridge tray assemblies, which are new, original, and ornamental designs. FIG. 6 is a top perspective view of a diagnostic cartridge tray assembly. FIG. 7 is a side view thereof. FIG. 8 is another side view thereof. FIG. 9 is yet another side view thereof. FIG. 10 is still another side view thereof. FIG.11 is a top plan view thereof. FIG. 12 is a bottom plan view thereof.

[0043] The foregoing description, for purposes of explanation, use specific nomenclature to provide a thorough understanding of the disclosure. However, it will be apparent to one skilled in the art that the specific details are not required in order to practice the systems and methods described herein. The foregoing descriptions of specific embodiments are presented by way of example for purposes of illustration and description. They are not intended to be exhaustive of or to limit this disclosure to the precise forms described. Many modifications and variations are possible in view of the above teachings. The embodiments are shown and described in order to best explain the principles of this disclosure and practical applications, to thereby enable others skilled in the art to best utilize this disclosure and various embodiments with various modifications as are suited to the particular use contemplated. It is intended that the scope of this disclosure be defined by the following claims and their equivalents.

Claims

Attorney Ref. No. 1001.1036.WOPCT PATENTWhat is claimed is:

1. A cartridge tray assembly, comprising: a cartridge having an interior cavity; a substrate positioned within the interior cavity of the cartridge, the substrate having a fixed sample application location; and an applicator guide having a channel, the channel of the applicator guide structured to be aligned above and spaced apart from the fixed sample application location of the substrate.

2. The assembly of claim 1, wherein the cartridge has a first portion connected to a second portion at an edge of the cartridge.

3. The assembly of claim 2, wherein the edge is a foldable edge.

4. The assembly of claim 2, wherein the edge includes a hinge.

5. The assembly of claim 1, wherein the substrate is cellulose acetate paper.

6. The assembly of claim 5, further comprising a positive electrode and a negative electrode that are located on opposing ends of the cellulose acetate paper, the positive electrode and negative electrode are configured to apply an electric potential between the positive electrode and the negative electrode along a length of the cellulose acetate paper.

7. The assembly of claim 6, wherein the fixed sample application location is located at or near the negative electrode.

8. The assembly of claim 1, wherein the applicator guide includes a fluid control element positioned within the channel.

9. The assembly of claim 8, wherein the fluid control element includes multiple fingers and multiple capillary channels extending annularly around the channel.Attorney Ref. No. 1001.1036.WOPCT PATENT10. The assembly of claim 9, wherein the multiple fingers alternate with the multiple capillary channels that extend annularly around the channel.

11. The assembly of claim 1, further comprising an absorbent pad in contact with the substrate.

12. The assembly of claim 11, wherein the absorbent pad has a larger pore size than the substrate.

13. The assembly of claim 1, further comprising a mixing well with a foam, the mixing well configured to receive a sample and mix the sample with a preparation fluid using the foam.

14. The assembly of claim 13, wherein the foam is a closed cell foam.

15. The assembly of claim 13, wherein the foam is an open cell foam.

16. A cartridge tray assembly, comprising: a cartridge having two portions that mate together to form an interior cavity; a tray structured to attach to the cartridge, the tray having a mixing well with foam, the mixing well structured to receive a sample to mix with a sample preparation fluid using the foam; a substrate positioned within the interior cavity of the cartridge, the substrate having a fixed sample application location; an applicator guide having a channel aligned above and spaced apart from the fixed sample application location on the substrate; an applicator having an applicator tip, the applicator tip structured to be inserted into the mixing well to acquire the prepared sample and then be inserted into the channel of the applicator guide to apply the prepared sample at the fixed sample application location of the substrate.Attorney Ref. No. 1001.1036.WOPCT PATENT17. The assembly of claim 16, wherein the applicator guide includes a fluid control element positioned within the channel.

18. The assembly of claim wherein the fluid control element includes multiple fingers and multiple capillary channels extending annularly around the channel.

19. The assembly of claim 18, wherein the multiple fingers alternate with the multiple capillary channels that extend annularly around the channel.

20. The assembly of claim 1, further comprising an absorbent pad in contact with the substrate.

21. The assembly of claim 11, wherein the absorbent pad has a larger pore size than the substrate.

22. The assembly of claim 13, wherein the foam is a closed cell foam.

23. The assembly of claim 13, wherein the foam is an open cell foam.

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