Diagnostic device

Abstract

The invention discloses a diagnostic device comprising a housing defining an inner space; a tube holder positioned on a top surface of the housing and configured to receive a sample tube, comprising a sample, to be applied to a running buffer, therein; a puncturing element extending vertically from a bottom of the tube holder and located inside the tube holder; the puncturing element comprising at least one side opening configured to allow passage of all the sample and located at a base of the puncturing element; a collection pocket located within the inner space and configured to receive the at least one sample; a plurality of immunochromatographic strips having a proximal end and a distal end; the proximal end positioned within the collection pocket and the distal end positioned away from the collection pocket and within the inner space.

Description

[0001] DIAGNOSTIC DEVICE

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 560,886 filed on 4 March 2024, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND OF THE INVENTION

[0005] The present invention, in some embodiments thereof, relates to a diagnostic device and, more particularly, but not exclusively, to a diagnostic device configured for small quantity samples.

[0006] Additional background art includes U.S. Patent Application Publication No. US2022299508A1 disclosing rapid diagnostic tests to detect one or more target nucleic acid sequences (e.g., a nucleic acid sequence of one or more pathogens). The pathogens are viral, bacterial, fungal, parasitic, or protozoan pathogens, such as SARS-CoV-2 or an influenza virus. Additionally it discloses methods of detecting genetic abnormalities. Diagnostic tests comprising a sample-collecting component, one or more reagents (e.g., lysis reagents, nucleic acid amplification reagents), and a detection component (e.g., a component comprising a lateral flow assay strip) are disclosed.

[0007] U.S. Patent Application Publication No. US2014273270A1 disclosing an optical lateral flow fluid analyte testing device including a test strip having at least one zone for measuring the concentration of a target analyte in a fluid sample. Additionally, devices and methods for facilitating a reliable reading are disclosed.

[0008] U.S. Patent Application Publication No. US2020086318A1 disclosing a system that relies upon an assay card employing only capillary action and no outside energy source containing cargo- loaded gated porous nanoparticles, an optional device cartridge, an optional reagent container, and optional software for detection and / or quantitation of at least one target analyte of a liquid sample.

[0009] U.S. Patent No. US11759783B2 disclosing an assay device for determining the presence and / or amount of an analyte of interest in a sample, the assay device comprises: a) a housing that includes a liquid receiving unit that is adapted to accommodate one or more types of liquid; b) a mixing chamber adapted for containing a solution that is a product of one more types of liquid, and for receiving a sample to interact with said solution; c) an actuating lid which is capable of being actuated to enable the transfer of the liquid into the mixing chamber; and d) an assay means that is in fluid communication with said mixing chamber for determining the presence and / or amount of an analyte of interest in the sample after the interaction of said sample with said solution in the mixing chamber.

[0010] U.S. Patent No. US11639926B2 disclosing a detection device comprising a sample liquid bearing device, test strips, a test strips bearing plate and a signal acquisition positioning assisting device, wherein the sample liquid bearing device comprises two or more samples cells used for containing sample liquid, each of the test strips at least comprises an identity information bearing part, a developing part and a capillary part, the test strip bearing plate is used for placing the test strips in the same circular ring in a circumferential array radial manner, and the signal acquisition positioning assisting device is arranged on the test strip bearing plate and is used for positioning the test strips.

[0011] U.S. Patent Application Publication No. US2014072959A1 disclosing rapid test devices, kits and systems comprising the rapid test devices for assessing at least two analytes in a sample derived from a life or health insurance applicant, the at least two analytes being selected from the group consisting of a human immunodeficiency virus (HIV) antigen (e.g., a HIV polypeptide), a HIV polynucleotide, an anti-HIV antibody, a hepatitis C virus (HCV) antigen (e.g., a HCV polypeptide), a HCV polynucleotide, an anti-HCV antibody, a liver enzyme alanine transaminase (ALT), a liver enzyme aspartate transaminase (AST), nt-probnp (or NT -proBNP), probnp (or proBNP), cotinine, nicotine, cocaine, a metabolite of cocaine (e.g., benzoylecgonine), prostatespecific antigen (PSA), apolipoprotein A-l (ApoAl), apolipoprotein B (ApoB), Hemoglobin Ale and high- sensitivity C-reactive protein (hsCRP). The invention also discloses methods for using the rapid test devices, kits and systems as part of the assessment of the life or health insurance applications.

[0012] U.S. Patent No. US7674616B2 disclosing test strips designed to prevent or reduce false results when measuring the condition of a sample. The test strips can be used for analysis of samples by methods including electrical and optical measurements. The reagent test strips and methods are particularly suited for use in the detection of blood coagulation.

[0013] U.S. Patent Application Publication No. US2014134073A1 disclosing a screening device for testing bodily fluids for the presence of certain constituents. The device can include a planar front face through which all of the test strips are viewed. The device also includes an inclined surface that directs the fluid under test to test strips with more efficiency, and partitions the fluid that is directed to a given test strip to better assure that the test strip receives an adequate amount of bodily fluid for a valid analysis. In one embodiment, the device includes a three-dimensional gasket that creates a pressurized environment upon insertion of the sampling stem for improved diffusion of the bodily fluid into the test strips. U.S. Patent Application Publication No. US2016216261A1 disclosing a system for reducing noise in a lateral flow system includes a cartridge having first, second, third, and fourth lateral flow test strips, the lateral flow test strips providing for a detectable indication of an analyte in the presence of the analyte. The system further includes a meter including a cartridge reading system and a microprocessor, the cartridge reading system configured to detect a signal from each of the first, second, third, and fourth lateral flow test strips, the microprocessor including instructions and configured to average each of the signals.

[0014] SUMMARY OF THE INVENTION

[0015] Following is a non-exclusive list including some examples of embodiments of the invention. The invention also includes embodiments which include fewer than all the features in an example and embodiments using features from multiple examples, also if not expressly listed below.

[0016] Example 1. A diagnostic device, comprising: a. a housing defining an inner space; b. a tube holder positioned on a top surface of said housing and configured to receive a sample tube therein; said sample tube comprising at least one sample; c. a puncturing element extending vertically from a bottom of said tube holder and located inside said tube holder; said puncturing element comprising at least one side opening located at a base of said puncturing element; d. a collection pocket located within said inner space and configured to receive said at least one sample; e. a plurality of immunochromatographic strips having a proximal end and a distal end; said proximal end positioned within said collection pocket and said distal end positioned away from said collection pocket and within said inner space; wherein said at least one side opening is configured to allow passage of all of said at least one sample from said sample tube into said inner space of said housing.

[0017] Example 2. The diagnostic device according to example 1, wherein said puncturing element is configured for puncture a bottom of said sample tube.

[0018] Example 3. The diagnostic device according to example 1 or example 2, wherein said at least one sample flows to said collection pocket after said at least one sample passes through said at least one side opening. Example 4. The diagnostic device according to any one of the examples 1-3, further comprising a tilted surface located below said puncturing element and configured to direct the flow of said sample towards said collection pocket.

[0019] Example 5. The diagnostic device according to any one of the examples 1-4, further comprising one or more protrusions located between said tilted surface and said collection pocket, and configured to guide and collect said sample before entering said collection pocket.

[0020] Example 6. The diagnostic device according to any one of the examples 1-5, wherein said diagnostic device requires a minimum of sample in running buffer of between 40 pl and 80 pl per immunochromatographic strip to perform an assay.

[0021] Example 7. The diagnostic device according to any one of the examples 1-6, wherein said tube holder is an integral part of said housing.

[0022] Example 8. The diagnostic device according to any one of the examples 1-7, wherein when said tube holder is an integral part of said housing, then said puncture element is an independent part from said tube holder.

[0023] Example 9. The diagnostic device according to any one of the examples 1-8, wherein said puncture element is an integral part of said tube holder.

[0024] Example 10. A method of performing a diagnostic assay, comprising: a. inserting a sample tube into a tube holder of a diagnostic device; b. puncturing a bottom of said sample tube by means of a puncturing element; c. allowing a sample in said sample tube to flow by into an inner space of the diagnostic device; d. directing said sample towards a collection pocket within said diagnostic device; e. allowing said sample to come in contact with a proximal end of at least one strip located within said collection pocket.

[0025] Example 11. The method according to example 10, further comprising acquiring a sample.

[0026] Example 12. The method according to example 10 or 11, further comprising applying said sample in a running buffer located in said sample tube before said inserting.

[0027] Example 13. The method according to any one of the examples 10-12, wherein said allowing said sample to flow is by gravity.

[0028] Example 14. The method according to any one of the examples 10-13, wherein said allowing said sample to flow is through a side opening in the puncture element.

[0029] Example 15. A diagnostic device comprising at least one immunochromatographic strip, wherein said device requires a minimum of sample in running buffer of between 40 pl and 80 pl of diluted sample to perform an assay. Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0030] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0031] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0032] In the drawings:

[0033] Figure 1 is a schematic diagram representation of an exemplary diagnostic device, according to some embodiments of the invention;

[0034] Figure 2a is a schematic external view representation of an exemplary diagnostic device 100 according to some embodiments of the invention;

[0035] Figure 2b is a schematic exploded view representation of an exemplary diagnostic device 100 according to some embodiments of the invention;

[0036] Figures 3a-e are schematic representations of an exemplary housing and features thereof, according to some embodiments of the invention;

[0037] Figures 4a-b are schematic representations of exemplary tube holders 104, according to some embodiments of the invention;

[0038] Figures 5a-d are schematic representations of exemplary puncturing element 106, according to some embodiments of the invention;

[0039] Figures 6a-c are schematic representations of exemplary collection pocket 108, according to some embodiments of the invention; and

[0040] Figure 7 is a flowchart of an exemplary method of performing an assay, according to some embodiments of the invention. DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0041] The present invention, in some embodiments thereof, relates to a diagnostic device and, more particularly, but not exclusively, to a diagnostic device configured for small quantity samples. Overview

[0042] An aspect of some embodiments of the invention relates to a diagnostic device suitable for pre-analytical sample preparation and simultaneous, one step application of the prepared sample to one or more immunochromatographic test strips (referred hereinafter just as “test strip” or “strip”). In some embodiments, the diagnostic device is configured to allow the use of small quantities of samples. In some embodiments, the diagnostic device is configured to use all the quantity of the sample in the sample tube. In some embodiments, the diagnostic device comprises a tube holder and a puncturing element. In some embodiments, the tube holder guides the tube towards the puncturing element. In some embodiments, the puncturing element is configured to allow the release of all the quantity of the sample from the tube. In some embodiments, released samples are guided towards a collection pocket located below and / or adjacent the puncturing element. In some embodiments, the samples are allowed to move towards the collection pocket by gravity. In some embodiments, a distal end of the one or more strips are positioned within the collection pocket. In some embodiments, the diagnostic device is configured to allow the sample to contact multiple strips simultaneously.

[0043] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0044] Referring now to Figure 1, showing a schematic diagram representation of an exemplary diagnostic device, according to some embodiments of the invention. In some embodiments, the diagnostic device 100 comprises a housing 102 defining an inner space; the housing is configured to house parts of the diagnostic device 100 either on the outside or in the inner space. In some embodiments, the diagnostic device 100 comprises a tube holder 104, located on an external surface of the housing 102, configured for receiving at least one test tube (referred hereinafter just as “sample tube” or just “tube”). In some embodiments, the tube that inserted in the tube holder comprises a running buffer onto which the sample is applied. The term “running buffer” refers hereinafter to any type of liquid required to perform an assay. For example, known buffers in the art are called: running buffer, extraction buffer, lysis buffer, reaction buffer, solutions, etc. It should be understood that “running buffer” refers to any of the above and any other similar liquid used and / or known in the art. In some embodiments, within the tube holder 104 there is a puncturing element 106 extending vertically from the bottom part of the tube holder 104. In some embodiments, the diagnostic device 100 comprises a collection pocket 108 in said inner space configured to receive the samples (running buffer + samples) released from the tube. In some embodiments, the diagnostic device 100 comprises one or more, preferably a plurality, of test strips 110 (also known as immunochromatographic test strips), where one side of the strips is positioned within the collection pocket 108 and the other side extends within the inner space of the housing. In some embodiments, the diagnostic device 100 comprises dedicated openings (not shown in Figure 1), configured to allow a user to visualize the results of the assay.

[0045] In the following paragraphs, one or more exemplary embodiments of diagnostic devices will be presented. It should be understood that these embodiments are provided to allow a person having skills in the art to understand the invention and are not intended to limit the scope invention in any way.

[0046] Referring now to Figure 2a, showing a schematic external view representation of an exemplary diagnostic device 100 according to some embodiments of the invention. Same parts are marked using same reference number in all figures. In some embodiments, as mentioned above, an exemplary diagnostic device 100 comprises a housing 102 defining an inner space (not shown), a tube holder 104 extending vertically from an external surface of the housing 102, a puncturing element 106 within the tube holder 104, the puncturing element 106 extending vertically from the bottom of the tube holder 104; and a plurality of strips 110, which are shown through dedicated viewing openings on the surface of the housing 102. While the housing shown in Figure 2a and in the following figures is flat, it should be understood that any suitable geometry is applicable to an exemplary diagnostic device.

[0047] Referring now to Figure 2b showing a schematic exploded view representation of an exemplary diagnostic device 100 according to some embodiments of the invention. In some embodiments, as mentioned above, an exemplary diagnostic device 100 comprises a housing 102 (here shown as two parts 102a / 102b, which are a top part of the housing 102 and a bottom part of the housing 102, respectively) defining an inner space, a tube holder 104 (here shown as an independent part - see below), a puncturing element 106, a collection pocket 108 and a plurality of strips 110.

[0048] Exemplary explanations of the different parts of an exemplary diagnostic device 100

[0049] Exemplary housing 102

[0050] In some embodiments, the housing 102 is a body comprising a dedicated geometry and / or is sized and shaped to house and / or include parts of the exemplary diagnostic device 100, either on the outer surface or on the inside (inner space). In some embodiments, the housing 102 defines an inner space where different parts of the diagnostic device 100 are positioned. In some embodiments, a sample is extracted from a sample tube and allowed to enter the inner space (see below), where the strips are located. In some embodiments, the housing 102 is made of plastic, optionally recycled plastic. In some embodiments, different parts of the diagnostic device 100 are manufactured onto / with / within the housing 102. For example, in some embodiments, the tube holder 104 is an integral part of the housing 102 (see Figure 4b), while in other embodiments, the tube holder 104 is a disconnected part (see Figure 4a) that is assembled into the housing 102. In some embodiments, the housing 102 comprises dedicated functional elements that facilitate the mounting and coupling of different parts of the diagnostic device 100, for example, connectors and / or guiding protrusions and / or holders (see below in Figure 3b - for example elements 306 / 308 / 310).

[0051] Referring now to Figures 3a-d, showing schematic representations of an exemplary housing and features thereof, according to some embodiments of the invention.

[0052] In some embodiments, the housing 102 comprises a fan-like geometry, as schematically shown, for example in Figure 3a. In some embodiments, the housing 102 comprises a central area 302 (the area where the tube holder 104 - not shown, the puncturing element 106 - not shown, and the collection pocket 108 - shown, are located) and a peripheral area extending in a fan-like fashion. In some embodiments, the different strips extend, from the central area towards the peripheral area, as schematically shown, for example in Figure 3e.

[0053] In some embodiments, as mentioned above, the housing 102 comprises dedicated elements that facilitate the mounting and coupling of different parts of the diagnostic device 100, for example:

[0054] Strips guiding holders 306, each configured to receive a strip and keep it in a determined position.

[0055] Connecting ramps 308, each configured to bring a proximal end of a strip down into the collection pocket 108.

[0056] Guiding protrusions 310, configured to collect and guide the sample that exists the through the puncturing element 106 into the collection pocket 108.

[0057] Dedicated protrusions and connectors (not shown) are found to allow the connection of the two parts 102a / 102b.

[0058] Referring now to Figures 3c and 3d showing two exemplary embodiments of exemplary top part 102a of the housing 102, according to some embodiments of the invention. In some embodiments, the top part 102a of the housing 102 comprises a plurality of viewing openings 312, each positioned above a strip, and configured to allow visualization of the strip below for assessing the results of the test. In some embodiments, the top part 102a comprises an opening to allow the connection / positioning of the tube holder 104 (not shown), as schematically shown for example in Figure 3c. In some embodiments, the top part 102a comprises, built-in, the tube holder 104, as schematically shown in Figure 3d. In some embodiments, a potential advantage of having the tube holder 104 built-in on the top part 102a is that it potentially simplifies the manufacturing of the diagnostic device 100. Additionally, Figures 3c and 3d schematically show dedicated protrusions / connectors 314 configured to allow the connection between the two parts 102a / 102b.

[0059] Exemplary tube holder 104

[0060] Referring now to Figures 4a-b, showing schematic representations of exemplary tube holders 104, according to some embodiments of the invention. In some embodiments, as mentioned above, the tube holder 104 is a separated part of the diagnostic device 100, as schematically shown, for example, in Figure 4a. In some embodiments, also as mentioned above, the tube holder 104 is a built-in part of the top part 102a, as schematically shown, for example, in Figure 4b.

[0061] In the following paragraphs, different features related to the tube holder 104 will be disclosed. Each feature can be applied to any type of embodiment of the tube holder (either a separated part or a built-in part).

[0062] In some embodiments, the tube holder 104 is sized and shaped to receive a sample tube. In some embodiments, the tube holder 104 comprises a tubular elongated body 402, extending vertically, having an upper aperture 404 and a lower aperture 406. In some embodiments, the upper aperture 404 is left open to allow the insertion of the sample tube therein. In some embodiments, the lower aperture 406 is at least partially blocked by the puncturing element 106 (not shown) or by a puncturing element holder 408, as schematically shown in Figure 4a. In some embodiments, puncturing element holder 408 comprises an opening 410 configured to receive the puncturing element 106 (not shown). In some embodiments, the lower aperture is completely blocked by the puncturing element 106 (see description below related to Figures 5c-5d). In some embodiments, the tubular elongated body 402 comprises a round shape. In some embodiments, the tubular elongated body 402 comprises an oval shape. Figures 4a and 4b show a tubular body 402 having an irregular oval geometry. In some embodiments, the tubular elongated body comprises any geometrical shape that allows the provision of the functional role of holding a tube sample. In some embodiments, the tube holder 104 comprises one or more additional elements, for example, protrusions 412, configured to engage with the sample tube and ensure a type of deformation to the tube that enhances the release of the sample found within the sample tube, while holding the sample tube in place. In some embodiments, optionally, the tubular elongated body 402 comprises an additional opening 414 on the back side, as schematically shown in Figure 4b. In some embodiments, the additional opening 414 allows a user to observe the sample tube once is has been inserted within the tube holder 104 and visually assess whether all the sample has been released.

[0063] Exemplary puncturing element 106

[0064] In some embodiments, exemplary puncturing elements are made of and / or manufactured using rigid or relatively rigid materials capable to withstand the pressure applied when pushing the sample tube during the puncturing action. For example, the puncturing element is made of plastic, for example Nylon 12 (with or without embedded glass fibers, Polyether ether ketone (PEEK) and others.

[0065] Referring now to Figure 5a, showing a schematic representation of an exemplary puncturing element 106, according to some embodiments of the invention. In some embodiments, the puncturing element 106 is configured to puncture the sample tube and allow the use of the whole quantity of liquid found in a sample tube. In some embodiments, a potential advantage of ensuring the use of the whole sample is that it allows the use of very small quantities of sample without compromising the quality of the assay. In some embodiments, the puncturing element 106 comprises an elongated body 502 extending vertically from the bottom part of the tube holder 104. In some embodiments, the elongated body comprises a distal end 504 having a sharp surface, optionally having an angle a in relation, for example, to a longitudinal axis AA of the elongated body 502 (see Figure 5a), and a proximal end 506, optionally flat. In some embodiments, the elongated body 502 is completely hollow, meaning there is an opening extending from the distal end 504 to the proximal end 506. In some embodiments, the elongated body 502 is partially hollow, meaning there is an opening only at the proximal end 506 (see for example Figure 5b), which is the bottom part of the elongated body 502. In some embodiments, the elongated body 502 comprises a side opening 508. In some embodiments, the side opening is configured to allow passage of the sample from within the sample tube into the inner space of the diagnostic device 100, once the sample tube is punctured. In Figure 5a, the puncturing element 106 is an independent element configured to be inserted in the tube holder 104 (using the aperture 410 as shown for example in Figure 4a), as schematically shown in Figure 5a.

[0066] Referring now to Figure 5b, showing an embodiment of an exemplary puncturing element 106, according to some embodiments of the invention. In some embodiments, for example and optionally, when the tube holder 104 is an integral part of the top part 102a (see Figure 3d), the puncturing element 106 comprises a one piece puncturing element, as schematically shown in Figure 5b. In some embodiments, the one piece puncturing element comprises an elongated body 510 extending vertically from a base 512. In some embodiments, similarly to the elongated body 502, the elongated body 510 also comprises a distal end having a sharp surface, optionally having an angle in relation, for example, to a longitudinal axis of the elongated body 510. In some embodiments, the elongated body comprises a side opening 514 configured to allow passage of the sample from within the sample tube into the inner space of the diagnostic device 100, once the sample tube is punctured. In some embodiments, the side opening 514 also extends on the surface of the base 512, thereby increasing the area where the sample can flow. In some embodiments, the elongated body 510 can be hollow or can be semi hollow, similar to what was explained for the elongated body 502. As can be seen in Figures 5c and 5d, the one piece puncturing element is configured to be inserted from below the tube holder 104. In some embodiments, the one piece puncturing element completely blocks the lower aperture of the tube holder 104, thereby allowing the sample to flow only through the side opening 514 to the inner space of the housing 102. In some embodiments, a potential advantage of having a one piece puncturing element is that it potentially simplifies the manufacturing of the puncturing element and the whole diagnostic device in general.

[0067] Exemplary collection pocket 108

[0068] Referring now to Figures 6a-c, showing a schematic representation of an exemplary collection pocket 108, according to some embodiments of the invention. In some embodiments, once the sample tube is punctured, the sample (running buffer + sample) is allowed to fall by gravity through the side opening 508 / 514 of the puncturing element 106 into the inner space of the housing 102, as schematically shown by arrow 602, into the collection pocket 108. In some embodiments, the area 604 leading towards the collection pocket 108 is tilted to facilitate the flow of the sample into the collection pocket 108. In some embodiments, strips 110 are positioned so a proximal end is located within the collection pocket 108, going up following the ramps 308 and extending towards the periphery area 304. As can be seen by the arrows 608, once reaching the collection pocket 108 the sample is equally distributed between the strips 110. In some embodiments, a potential advantage of having a collection pocket 108 is that it allows to use a very small quantity of sample that is guaranteed to reach all the strips 110. In some embodiments, as mentioned above, between the area 604 leading towards the collection pocket 108, which is tilted, and the collection pocket 108, comprise a pair of protrusions 310, configured to guide and collect the sample before entering the collection pocket 108. Exemplary volume required for an exemplary assay

[0069] In some embodiments, contrary to known diagnostic devices, the diagnostic device requires very little quantity of sample (running buffer + sample) to work. For example, the minimum quantity required per strip is about 60 pl, optionally from about 55 pl to about 65 pl, optionally from about 40 pl to about 80 pl. In some embodiments, even smaller minimum amounts are used, for example, according to the type of strips, the minimum quantity required per strip is about 40 pl. This means, for example, that a sample can be diluted for example, in 200 pl and it will be enough to perform a three- strip assay.

[0070] General information

[0071] In some embodiments, the diagnostic device 100 is a disposable diagnostic device. In some embodiments, the diagnostic device 100 is manufactured using 3D printing technology and / or injection molding and / or CNC.

[0072] Exemplary methods

[0073] In some embodiments, an exemplary method of performing an assay comprises the following actions:

[0074] 1. Acquiring a sample (702), for example using a swab or any other means of collecting a sample;

[0075] 2. Inserting the sample tube into the tube holder of the diagnostic device (704);

[0076] 3. Applying the sample into a running buffer contained in a sample tube (706);

[0077] In some embodiments, the tube can be inserted into the tube holder of the diagnostic device after the sample is applied into the running buffer contained in the sample tube. Meaning step (706) is done before (704).

[0078] As mentioned above, the term “running buffer” refers hereinafter to any type of liquid required to perform an assay. For example, known buffers in the art are called: running buffer, extraction buffer, lysis buffer, reaction buffer, solutions, etc. It should be understood that “running buffer” refers to any of the above and any other similar liquid used and / or known in the art.

[0079] 4. Further inserting the sample tube to cause puncturing of the bottom of the sample tube by the puncturing element (708);

[0080] 5. Allowing the diluted sample to flow by gravity through a side opening in the puncture element into an inner space of the diagnostic device (710);

[0081] 6. Directing the diluted sample towards a collection pocket (712);

[0082] 7. Allowing the diluted sample to come in contact with a proximal end of the strips located within the collection pocket (714). It is expected that during the life of a patent maturing from this application many relevant assay strips will be developed; the scope of the term immunochromatographic strip is intended to include all such new technologies a priori.

[0083] As used herein with reference to quantity or value, the term “about” means “within ± 10 % of’.

[0084] The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

[0085] The term “consisting of’ means “including and limited to”.

[0086] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0087] As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

[0088] Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0089] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween. Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

[0090] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0091] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0092] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0093] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. A diagnostic device, comprising: a. a housing defining an inner space; b. a tube holder positioned on a top surface of said housing and configured to receive a sample tube therein; said sample tube comprising at least one sample; c. a puncturing element extending vertically from a bottom of said tube holder and located inside said tube holder; said puncturing element comprising at least one side opening located at a base of said puncturing element; d. a collection pocket located within said inner space and configured to receive said at least one sample; e. a plurality of immunochromatographic strips having a proximal end and a distal end; said proximal end positioned within said collection pocket and said distal end positioned away from said collection pocket and within said inner space; wherein said at least one side opening is configured to allow passage of all of said at least one sample from said sample tube into said inner space of said housing.

2. The diagnostic device according to claim 1, wherein said puncturing element is configured for puncture a bottom of said sample tube.

3. The diagnostic device according to claim 1 or claim 2, wherein said at least one sample flows to said collection pocket after said at least one sample passes through said at least one side opening.

4. The diagnostic device according to any one of claims 1-3, further comprising a tilted surface located below said puncturing element and configured to direct the flow of said sample towards said collection pocket.

5. The diagnostic device according to claim 4, further comprising one or more protrusions located between said tilted surface and said collection pocket, and configured to guide and collect said sample before entering said collection pocket.

6. The diagnostic device according to any one of claims 1-5, wherein said diagnostic device requires a minimum of sample in running buffer of between 40 pl and 80 pl per immunochromatographic strip to perform an assay.

7. The diagnostic device according to any one of claims 1-6, wherein said tube holder is an integral part of said housing.

8. The diagnostic device according to claim 7, wherein when said tube holder is an integral part of said housing, then said puncture element is an independent part from said tube holder.

9. The diagnostic device according to any one of claims 1-8, wherein said puncture element is an integral part of said tube holder.

10. A method of performing a diagnostic assay, comprising: a. inserting a sample tube into a tube holder of a diagnostic device; b. puncturing a bottom of said sample tube by means of a puncturing element; c. allowing a sample in said sample tube to flow by into an inner space of the diagnostic device; d. directing said sample towards a collection pocket within said diagnostic device; e. allowing said sample to come in contact with a proximal end of at least one strip located within said collection pocket.

11. The method according to claim 10, further comprising acquiring a sample.

12. The method according to claim 11, further comprising applying said sample in a running buffer located in said sample tube before said inserting.

13. The method according to any one of claims 10-12, wherein said allowing said sample to flow is by gravity.

14. The method according to any one of claims 10-13, wherein said allowing said sample to flow is through a side opening in the puncture element.

15. A diagnostic device comprising at least one immunochromatographic strip, wherein said device requires a minimum of sample in running buffer of between 40 pl and 80 pl of diluted sample to perform an assay.

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