Apparatus and method for analyte separation

Abstract

The present disclosure provides a device for easily and quickly separating a target analyte in a point-of-care environment. In some aspects, the apparatus includes a first compartment, a second compartment, and an adapter. The adapter includes a removable / positionable magnet, and in a first position of the adapter, the magnet secures the magnetic particles within the first compartment, and in a second position of the adapter, the magnet secures the magnetic particles within the second compartment. Moving the adapter from the first position into the second position causes a sealed vapor phase transfer of the magnetic particles from the first compartment to the second compartment. The magnetic particles bind to the target analyte, and thus, the magnetic particles are moved from the first compartment into the second compartment to separate the target analyte. The target analyte may be retrieved from the second compartment and analyzed. Also provided are methods of separating a target analyte using the devices disclosed herein.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 378,656, filed on October 6, 2022, U.S. Provisional Application No. 63 / 491,238, filed on March 20, 2023, and U.S. Provisional Application No. 63 / 471,663, filed on June 7, 2012, which are incorporated herein by reference in their entirety and for all purposes.

[0003] introduction

[0004] Analysis of biological samples typically involves determining the presence of a target analyte in the sample. If present, the target analyte is isolated from the sample and analyzed using downstream applications such as amplification and immunoassays. Target analytes are isolated using methods including column-based separations, reagent-based separations, magnetic bead-based separations, and other techniques. However, such methods often require complex kits, instrumentation, and highly trained personnel, resulting in limited field application.

[0005] There is a need to improve the separation of target analytes from samples by developing relatively low-cost devices that can be used in easy-to-perform methods and provide sample preparation for the intended detection method by increasing the concentration of the target analyte or reducing noise through background subtraction. Summary of the Invention

[0006] The present disclosure provides devices that allow for easy and rapid separation of target analytes from samples.For example, the devices disclosed herein allow for separation of target analytes in a point-of-care / point-of-need environment.

[0007] In some aspects, the device includes a first compartment (e.g., a sample compartment) and a second compartment (e.g., an elution compartment) and an adapter. The adapter is configured to engage with the first compartment and the second compartment. In certain embodiments, the adapter includes a magnet, and in the first position of the adapter, the magnet fixes magnetic particles (which can capture target molecules of interest or remove unwanted molecules) in the first compartment. The adapter is also configured to move from the first position to the second position, and in the second position of the adapter, the magnet fixes magnetic particles in the second compartment. Moving the adapter from the first position to the second position causes the sealed gas phase transfer of magnetic particles from the first compartment (e.g., the sample compartment) to the second compartment under the influence of the magnetic field.

[0008] In the second position of the adapter, the magnet allows the magnetic particles to be released into the second compartment, for example by moving the magnet from the second position to allow the magnetic particles to be released. Thus, the magnet is configured such that in the capture position the fixed magnetic particles in the first compartment and the second compartment can interact with the reagents in the corresponding compartments. In the release position, the magnet cannot interact with the reagents in the corresponding compartments. The adapter can also be in a third position, and in the third position of the adapter, the adapter (including the magnet included in the adapter) cannot interact with the reagents in the first compartment or the second compartment.

[0009] Certain aspects of the present disclosure include an adapter for isolating an analyte of interest from a sample. The isolation can be positive or negative isolation, as indicated in more detail below.

[0010] The adapter is configured for simultaneous attachment to an opening of a vial and a conical structure including an orifice. The adapter includes a magnet positioned on a rotatable platform configured to position the magnet in an orientation facing the vial or the conical structure including the orifice. Methods for isolating an analyte of interest using the adapter are also provided.

[0011] Certain other aspects of the present disclosure include an adapter configured for simultaneous attachment to a first compartment (e.g., a sample compartment) and a second compartment (e.g., an elution compartment). The adapter includes a magnet positioned on a rotatable platform configured to position the magnet in an orientation facing the first compartment or the second compartment including an orifice. Methods for isolating an analyte of interest using the adapter are also provided.

[0012] Further aspects of the present disclosure include an adapter configured for mutually exclusive engagement to a first compartment (e.g., a sample compartment) and a second compartment (e.g., an elution compartment). The adapter includes a removable magnet that can be positioned in a capture position in a bead capture plunger of the adapter. When the magnet is positioned in the capture position in the bead capture plunger of the adapter engaged with the first compartment, the magnet captures magnetic particles that can be present in the first compartment. The adapter can be disengaged from the sample compartment and then engaged to the elution compartment. When the adapter is engaged to the elution compartment, the magnet can be moved from the capture position to a release position, thereby releasing the magnetic particles into the elution compartment. Methods for isolating an analyte of interest using the adapter are also provided.

[0013] Still further aspects of the present disclosure provide an adapter configured for engagement with a first compartment (e.g., a sample compartment) and a second compartment (e.g., an elution compartment). The adapter includes a removable magnet that can be positioned in a capture position in a bead capture plunger of the adapter. When the magnet is positioned in the capture position in the bead capture plunger of the adapter engaged with the first compartment, the magnet captures magnetic particles that can be present in the first compartment, including binding agents that specifically bind to a target analyte. The adapter can be engaged with the second compartment, which is sealingly connected to the first compartment.

[0014] When the adapter is engaged with the elution compartment, the magnet secures the magnet within the elution compartment, and an elution reagent in the elution compartment causes the captured analyte to dissociate from the binding agents, and thus from the magnetic particles. The released analyte can then be obtained from the second compartment. Methods for isolating an analyte of interest using the adapter are also provided.

[0015] Certain aspects of the present disclosure also provide a cap configured for simultaneous engagement to a first compartment (e.g., a sample compartment) and a second compartment (e.g., an elution compartment). The cap includes an adapter that includes a removable magnet that can be positioned in a first position, where the magnet is engaged with a reagent in the first compartment. The magnet is movable from the first position to a second position, where the magnet is engaged with a reagent in the second compartment. In the first position, the magnet captures magnetic particles from the first compartment. In the second position, the magnet delivers the magnetic particles into the second compartment, and the reagent in the second compartment can cause analytes attached to the magnetic particles, e.g., by a coupled binding agent, to be released into the second compartment.

[0016] In certain such embodiments, the adapter is mounted on a rotating cap such that the adapter can be moved between the first and second positions by rotating a rotating top of the cap.

[0017] In some embodiments, the adapter is mounted on a sliding cap such that the adapter can be moved from the first position to the second position by linearly sliding the sliding cap in a first direction, and the adapter can be moved from the second position to the first position by linearly sliding the sliding cap in a second direction opposite the first direction.

[0018] In further embodiments, the adapter is a piston mounted on the cap such that the adapter can be moved between the first and second positions by moving the piston.

[0019] Methods for isolating an analyte of interest using the adapters described herein are also provided. BRIEF DESCRIPTION OF DRAWINGS

[0020] Figure 1An exploded view of an adapter 100 according to one embodiment is depicted. A tube 101 and a dropper 102 are also depicted.

[0021] Figure 2 An exploded view of an adapter 200 according to one embodiment is depicted. A tube 1 and a dropper 2 are also depicted.

[0022] Figure 3 Illustrative components for separating and detecting target analytes are illustrated.

[0023] Figure 4 An exemplary method for separating and detecting an analyte of interest according to one embodiment of the present disclosure is depicted.

[0024] Figure 5 An exemplary method for separating and detecting an analyte of interest according to one embodiment of the present disclosure is depicted.

[0025] Figure 6 An exemplary analyte separation device is depicted.

[0026] Figure 7 Depicts Figure 6 Exploded view of the analyte separation device.

[0027] Figures 8A-8E Depicts Figures 6-7 The operation of the analyte separation device is described in.

[0028] Figure 9 An exemplary analyte separation device is depicted.

[0029] Figure 10 Depicts Figure 9 Exploded view of the analyte separation device.

[0030] Figure 11 An exemplary analyte separation device is depicted.

[0031] Figure 12 Depicts Figure 12 Exploded view of the analyte separation device.

[0032] Figures 13A-13C Depicts Figures 11-12 The operation of the analyte separation device is described in.

[0033] Figure 14 Depicted are exemplary analyte separation devices and exploded views of cross-sections of analyte separation devices.

[0034] Figure 15 Depicted are exemplary analyte separation devices and exploded views of cross-sections of analyte separation devices.

[0035] Figure 16An exploded view of an exemplary analyte separation apparatus is depicted, as well as a cross-section of an analyte separation apparatus. DETAILED DESCRIPTION

[0036] Aspects of the present disclosure include an adapter for isolating an analyte of interest from a sample. The adapter is configured for attachment to both an opening of a vial and a conical structure comprising an orifice. The adapter comprises a magnet positioned on a rotatable platform configured to position the magnet in an orientation facing the vial or the conical structure comprising an orifice. Methods for isolating an analyte of interest using the adapter are also provided.

[0037] Before the devices and methods of the present application are described in more detail, it is to be understood that the present disclosure is not limited to the particular embodiments described and as such can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[0038] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the device and method. The upper and lower limits of these smaller ranges can independently be included in the smaller ranges, and are also encompassed within the device and method, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of the included limits are also included in the device and method.

[0039] Certain ranges presented herein are presented herein with the terminology "about." The term "about" when used before a numeral or numeric designation is used herein to provide literal support for the exact numerical value that follows, but also to encompass numbers close to the value being described but also numbers close to the value being described but also numbers that are approximately or nearly the same as the value being described. In determining whether a number is close to or approximately the same as a particular recited number, a number is either within a 10% range of the recited number or within a 5% range of the recited number.

[0040] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present device and method, representative devices and methods are now described.

[0041] The present disclosure can be more easily understood by reference to the following detailed description of desired embodiments and the examples included therein. In the following description, numerous specific details are discussed to provide a thorough and complete understanding of embodiments. By way of example, one or more embodiments of the present disclosure will be described with reference to the following figures:

[0042] Although specific terms are used in the following description for the sake of clarity, these terms are intended to refer only to particular structure of embodiments selected for illustration in the drawings, and are not intended to limit or restrict the scope of the disclosure in any way. In the drawings and the following description, it is to be understood that like reference numerals designate like structural elements in a view when there is a conceptual possibility that a structural element could have been named differently in a different view.

[0043] The term "comprising" is used herein as an open-ended term that refers to the inclusion of any stated component or step, but not to the exclusion of any additional components or steps. The term "comprising" should be interpreted as including the terms "consisting of and "consisting essentially of." "Consisting of allows for the presence of additional components that do not alter the fundamental structure of the component that is the basis for the claim. "Consisting essentially of allows for the presence of additional components that do not alter the fundamental structure of the component that is the basis for the claim, but do not include the presence of additional components that alter that fundamental structure.

[0044] Numerical values should be understood to include values when rounded to the same number of significant figures as the number of significant figures used in the respective number. The number of significant figures is the count of alphanumerics in the number. The difference between an experimentally determined value and the theoretical value for a given value can be within experimental error, which is the predictable error associated with the measurement of that value.

[0045] All ranges disclosed herein are inclusive of the endpoints and the independent combination of any of the range limits that define the range. Numerical ranges are inclusive of the endpoints and all sub-ranges falling within the range. All ranges disclosed herein are inclusive of the endpoints and the independent combination of any of the range limits that define the range.

[0046] The modifier "about" used in connection with a quantity is inclusive of the stated value and has the meaning dictated by the context, (When used in the context of a range, the modifier "about" should also be considered to be inclusive of the range defined by the two endpoints. For example, a range from about "2 to about 10" is also disclosing a range from 2 to 10. The term "about" can mean plus or minus 10% of the indicated number. For example, "about 10%" can indicate a range of 9% to 11%, and "about 1" can mean from 0.9 to 1.1.

[0047] It should be noted that many of the terms used herein are relative terms. For example, the terms "upper" and "lower" are relative to one another in position, i.e., in a given orientation, the upper component is at a higher elevation than the lower component, but these terms can change if the components are flipped. The terms "inlet" and "outlet" are relative to the fluid flowing through them, with respect to a given structure, e.g., the fluid flows through the inlet into the structure and through the outlet out of the structure.

[0048] The terms "horizontal" and "vertical" are used to indicate direction relative to an absolute reference, namely the ground plane. However, these terms should not be interpreted to require structures to be absolutely parallel or absolutely perpendicular to each other. For example, a first vertical structure and a second vertical structure are not necessarily parallel to each other. The terms "top" and "bottom" are used to refer to a surface that is always higher than the bottom with respect to an absolute reference, namely the surface of the Earth. The terms "up" and "down" are also relative to the absolute reference; up is always opposite to the Earth's gravity, while down is always towards the Earth's gravity.

[0049] The term "parallel" should be interpreted in its ordinary meaning as two surfaces that maintain a generally constant distance between them, rather than in the strict mathematical sense as surfaces that never meet if extended to infinity.

[0050] Separating an analyte refers to removing the analyte from additional molecules present with the analyte (e.g., other components in a biological sample containing the analyte).

[0051] All publications and patents cited in this specification are herein incorporated by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference and are incorporated herein by reference to disclose and describe the methods and / or materials in connection with which the publications are cited. The citation of any publication is for its disclosure prior to the filing date of this application. Nothing herein is to be construed as an admission that the present application is not entitled to antedate such publication by virtue of prior application. Further, the dates of publication provided can be different from the actual publication dates which can need to be independently confirmed.

[0052] It should be noted that, as used herein and in the appended claims, the singular form "a", "an", and "the" include plural references unless the context clearly dictates otherwise. It should also be noted that the claims can be drafted to exclude any optional element. Thus, this statement is intended to serve as antecedent basis for the use of such exclusive terminology as "solely", "only" and the like in

[0053] As will be apparent to those of ordinary skill in the art in the art in light of the present disclosure, each of the individual embodiments described and illustrated herein has discrete components and features that can be readily separated from or combined with features of any of the other several embodiments without departing from the scope or spirit of the devices and methods of the present application. Any recited method can be performed in the order of events recited or in any other order that is logically possible.

[0054] Apparatus

[0055] As outlined above, aspects of the present disclosure include an adapter for isolating an analyte of interest from a sample. In certain aspects, the device includes a first compartment (e.g., a sample compartment) and a second compartment (e.g., an elution compartment) and an adapter. The adapter is configured to interface with the first compartment and the second compartment. In certain embodiments, the adapter includes a magnet, and in a first position of the adapter, the magnet secures the magnetic particles within the first compartment. The adapter is also configured to move from the first position to a second position, and in the second position of the adapter, the magnet secures the magnetic particles within the second compartment. Moving the adapter from the first position to the second position causes the magnetic particles to be transferred from the first compartment (e.g., the sample compartment) to the second compartment (e.g., the elution compartment) in a sealed gas phase under the influence of the magnetic field.

[0056] In the second position of the adapter, the magnet allows the magnetic particles to be released into the second compartment, for example by moving the magnet from the second position to allow the magnetic particles to be released. Thus, the magnet is configured such that in the capture position the magnet secures the magnetic particles in either the first compartment or the second compartment. In the release position, the magnet is unable to interact with the reagents in the corresponding compartment. The adapter can also be in a third position, and in the third position of the adapter, the adapter (including the magnet included in the adapter) is unable to interact with the reagents in either the first compartment or the second compartment.

[0057] In some cases, the device includes more than two compartments. Such embodiments allow additional steps to be incorporated into the design if needed for the assay / sample processing. For example, a buffer stored in an intermediate compartment can be used to wash the beads between two compartments.

[0058] In certain aspects, the adapter includes a substantially cylindrical body including a first open end opposite a second open end. The first open end can be configured to sealingly attach to an opening of a vial. The second open end can be configured to sealingly attach to an opening of a conical structure including an orifice. The adapter can also include an opening on a surface of the cylindrical body, where the opening is substantially centrally located between the first open end and the second open end of the cylindrical body.

[0059] The adapter can also include a platform sized to slidably fit through the opening in the surface of the cylindrical structure. The platform can include a first region configured for placement inside the cylindrical structure and a second region that remains positioned outside of the cylindrical structure when the platform is slid through the opening into the cylindrical structure. The platform is configured to hold the magnet in place during rotation of the platform.

[0060] In some embodiments, the adapter further includes a cylindrical barrel that slidably fits through an opening on a surface of the cylindrical body. The cylindrical barrel includes at least one opening sized to slidably fit the first region of the platform, where the at least one opening is positioned on a first end or a second end of the cylindrical barrel. The cylindrical barrel further includes an opening on a surface thereof. The opening on the surface of the cylindrical barrel can be substantially centrally located between the first end and the second end of the cylindrical barrel.

[0061] In a first embodiment, the second region of the platform can include means for rotating the platform by rotating the cylindrical barrel. In a second embodiment, the cylindrical barrel can include means for rotating the platform by rotating the cylindrical barrel. In both embodiments, the platform and the cylindrical barrel are engaged such that they rotate as a unit. The cylindrical barrel is sized to occupy and occlude the interior of the cylindrical body such that fluid cannot flow directly between the two ends.

[0062] In certain embodiments, the means for rotating the platform can include a lever that can be twisted to rotate the platform. In certain embodiments, the lever can include a marker to indicate the orientation of the platform. In a first orientation, the adapter can include the cylindrical barrel in the cylindrical body such that the opening in the surface of the cylindrical barrel faces the interior surface of the cylindrical body, where the surface occludes the opening. In this orientation, fluid cannot enter the cylindrical barrel through the opening. In certain embodiments, the marker to indicate the orientation of the platform can be an arrow. The arrow can be in an orientation parallel to the ground to indicate the first orientation of the cylindrical barrel. This orientation can be used to occlude the opening of a vial or tube that includes a sample and magnetic particles for binding to an analyte that can be present in the sample. In a second orientation, the adapter can include the cylindrical barrel in the cylindrical body such that the opening in the surface of the cylindrical barrel is aligned with the opening of a tube that is sealingly engaged with the adapter. In this first orientation, the sample present in the vial can be in contact with a magnet positioned in the platform that is positioned in the cylindrical barrel. In this first orientation, the lever can be in a second position. The marker on the lever can indicate that the cylindrical barrel is in the second position. For example, the arrow can be pointing downward.

[0063] After the sample has been in contact with the magnet and the magnetic particles present in the sample have attached to the magnet, the means for rotating the platform, such as the lever, can be moved, such as flipped or twisted, to a third orientation. In this third orientation, the opening in the surface of the cylindrical barrel is aligned with the opening in the conical structure that includes the orifice. In this third orientation, the solution present in the conical structure that includes the orifice is in contact with the magnet.

[0064] An exemplary adapter is depicted inFigure 1 , Figure 2 and Figure 6 in.

[0065] Figure 1 An adapter 100 is depicted having a substantially cylindrical body 111 and having a first opening 112 opposite a second opening 113. The interior of the cylindrical body 111 is substantially hollow such that the first and second openings are in fluid communication. In some cases, this fluid communication is only opened / closed when controlled by an insert, such as a cylindrical cartridge 116.

[0066] The surface of the cylindrical body 111 includes at least one opening 114. In some embodiments, the surface of the cylindrical body 111 can include an additional opening 115 diametrically opposite the opening 114. The cylindrical cartridge 116 is configured to slide through the opening 114 and fit inside the cylindrical body 111. In certain embodiments, the cylindrical cartridge 116 is supported by both the opening 114 and the opening 115. The cylindrical cartridge 116 includes an opening 117 on its surface. The opening 117 is positioned substantially centrally with respect to the end of the cylindrical cartridge 116. A platform 118 is depicted configured for holding a magnet 119. The platform 118 includes a first region 120 that fits inside the cylindrical cartridge 116 and is oriented such that the magnet is in an orientation facing the opening 117. The platform 118 includes a second region 121 configured for positioning outside of the cylindrical cartridge 116. The second region 121 provides a means for rotating the platform 118 and the cylindrical cartridge 116. The cylindrical cartridge 116 and the platform 118 are sized to engage such that they move as a single unit.

[0067] Figure 1 A tube 101 and a dropper 102 are also depicted in. These components can not be part of the adapter of the present disclosure, but can be included in a kit that includes the adapter. The tube 101 can be any tube suitable for containing a sample. The open end of the tube and the first opening of the adapter are configured for sealingly engaging one another. For example, the open end of the tube and the first opening of the adapter can include a means for mating the open end and the first opening, such as a snap-fit configuration, a twist-cap configuration, a threaded screw-in configuration, etc. Similarly, the dropper 102 can include an opening that sealingly attaches to the second opening of the cylindrical body. The dropper 102 can include a solution, such as an elution buffer. The dropper can also include an orifice and a compressible body. Upon application of compression to the dropper body, the orifice can dispense a solution containing a target analyte present in the dropper 102. The orifice can include a cap 122 that can be removed prior to dispensing.

[0068] Figure 2An embodiment of an adapter of the present disclosure is depicted. The adapter 200 has a substantially cylindrical body 231 and has a first opening 232 opposite a second opening 233. The first opening 232 is configured for attachment to an opening of a tube 221. The second opening 233 is configured for attachment to an opening of a conical structure having an orifice, such as a dropper 202, where the opening of the conical structure is opposite the orifice. While depicted in Figure 2 the tube 221 and the dropper 202 can not be components of the adapter.

[0069] As can be seen in Figure 2 the cylindrical body 231 includes a cylindrical barrel 241 positioned at a radial axis of the cylindrical body 231. The cylindrical barrel 241 is rotatable relative to the cylindrical body 231. The cylindrical barrel 241 includes a means for rotating the cylindrical barrel 241, such as a lever 242. Figure 2 A platform 250 configured to hold a magnet is also depicted in

[0070] As can be seen in Figure 2 the lever 242 can include indicia for indicating an orientation of the cylindrical barrel 241 and the platform 250.

[0071] In certain embodiments, the adapter can be pre-assembled such that the platform with the fixed magnet is positioned within the cylindrical barrel 116, 241. The adapter can be pre-assembled such that the magnet and the opening in the cylindrical barrel are oriented in a manner that allows liquid to flow through the opening in the cylindrical barrel and contact the magnet. The means for rotating the platform and the cylindrical barrel can include indicia that indicate an orientation of the opening in the cylindrical barrel relative to the first and second openings in the cylindrical body. In some embodiments, the first and second openings in the cylindrical body of the adapter can be covered with caps. The caps can be removed prior to attaching the adapter to a tube or dropper.

[0072] Additional indicia for indicating an orientation of the cylindrical barrel can direct a user to the opening of the adapter that can be attached to a tube.

[0073] A tube engaged with the adapter can be any suitable tube, such as a vial including a solution for processing a sample. The solution can be a lysis solution, such as a lysis buffer.

[0074] The dropper can be any suitable substantially conical structure that includes an opening for attachment to the adapter and an orifice for dispensing liquid. The dropper can include a cap that covers the opening prior to attachment to the adapter. The dropper can also include a cap for covering the orifice. The dropper can include a solution for eluting an analyte that binds to paramagnetic particles (PMPs) that are immobilized on a magnet.

[0075] The sample can be mixed with a lysis buffer. Any suitable lysis buffer can be used, such as those for rupturing cells or viruses. In some cases, the lysis buffer can include a chaotropic agent such as guanidine hydrochloride. An elution buffer can be used to elute an analyte of interest from the PMPs.

[0076] In some cases, paramagnetic particles (PMPs) or capture beads (e.g., beads coated with an agent that binds to an analyte of interest) can be added to the sample. The agent can be an oligonucleotide, a peptide, or a protein or other target analyte.

[0077] In some cases, the lysis buffer can be formulated to release nucleic acids and / or proteins from a broad spectrum of samples, such as tissue samples, cells, viruses, or body fluid samples. The lysis buffer can also be designed to lyse all types of pathogens, such as viral, bacterial, fungal, and protozoan pathogens.

[0078] In some cases, the analyte of interest can be an analyte associated with a pathogen or an infection such as tuberculosis. In some cases, the analyte of interest can be a LAM (lipoarabinomannan) antigen (LAM). In some cases, the sample can be a body fluid sample, e.g., urine, saliva, or blood or a portion thereof. In some cases, the PMPs can include anti-LAM antibodies.

[0079] The elution buffer can be suitable for facilitating the detachment of a target analyte (e.g., a nucleic acid or a protein) from the PMPs. For example, the elution buffer can include a high concentration of salt (e.g., sodium chloride) or a basic agent (e.g., sodium hydroxide) or a low ionic strength solution such as Tris-EDTA buffer (10 mm Tris-HCl, 0.1 mm EDTA (pH 8.0)) or nuclease-free water.

[0080] As used herein, the term “cylinder” or “cylindrical” refers to a substantially cylindrical structure in which the sides or walls are substantially parallel and the cross-section is substantially circular or elliptical. Substantially means that there can be minor deviations from the shape. Cylinders and cylindrical shapes include hollow cylinders, solid cylinders, and cylinders with partially filled interiors.

[0081] Figure 6An adapter 602 is depicted having a substantially cylindrical body and having a first opening toward a bottom, the first opening opposite a second opening toward a top. The interior of the cylindrical body is substantially hollow such that the first opening and the second opening are in fluid communication.

[0082] The surface of the cylindrical body includes at least the first opening in a horizontal direction. In some embodiments, the surface of the cylindrical body can include an additional opening diametrically opposite the first opening. A cylindrical cartridge can be included in the cylindrical body. The cylindrical cartridge is described above and such discussion applies here as well. The adapter 602 also includes a magnet holder 603 that provides a magnet that engages with reagents in the sample tube 601 and the elution tube 605.

[0083] Figure 6 The sample tube 601 and the elution tube 605 are also depicted in Figure 7 The sample tube can be any tube suitable for containing a sample. The open end of the sample tube and the first opening of the adapter are configured for sealingly engaging one another. For example, the open end of the sample tube and the first opening of the adapter can include means for mating the open end and the first opening, such as a snap-fit configuration, a twist-cap configuration, a threaded screw-in configuration, and the like. Similarly, the elution tube 605 can include an opening that sealingly attaches to the second opening of the cylindrical body. The elution tube can include a solution, for example, an elution buffer. The elution tube can also include an orifice and a compressible body. The elution tube can be configured to dispense a solution that will elute a target analyte from magnetic particles. The elution tube can also include a cap that can be removed to dispense the elution buffer containing the target analyte.

[0084] As described in Figure 6 and Figure 7 The adapter 602 has a substantially cylindrical body and has a first opening opposite a second opening. The first opening is configured for attaching to an opening of a sample tube 601. The second opening is configured for attaching to an opening of an elution tube 605. Although depicted as such in Figure 6 and Figure 7 The sample tube and the elution tube can not be components of the adapter.

[0085] As can be seen in Figure 6 and Figure 7 The cylindrical body includes a cylindrical cartridge positioned at a radial axis of the cylindrical body. The cylindrical cartridge is rotatable relative to the cylindrical body. The cylindrical cartridge includes means for rotating the cylindrical cartridge, for example, a rotary valve 604. Figure 6 and Figure 7Also depicted is a magnet holder 603 configured to hold a magnet. The magnet holder is sized to fit within the cylindrical barrel so that the cylindrical barrel and the platform rotate as a unit when the rotary valve 604 is actuated. The cylindrical barrel includes an opening in its surface that is substantially centrally located between the two ends of the cylindrical barrel. The opening and the magnet are oriented so that the magnet substantially faces the opening.

[0086] like Figure 6 and Figure 7 As shown in , rotary valve 604 may include a mark, such as an arrow, for indicating the orientation of the cylindrical barrel and the platform. For example, when the arrow on the rotary valve points to the sample tube, an adapter (e.g., a magnet inside the adapter) engages with the reagent in the sample tube. Alternatively, when the arrow points to the elution tube, an adapter (e.g., a magnet inside the adapter) engages with the reagent in the elution tube. When the arrow of the rotary valve does not point to the sample tube or the elution tube, the adapter may not engage with either tube.

[0087] Figures 8A-8E Provided in Figures 1-2 and Figures 6-7 Example operation of the device.

[0088] Figure 8A Steps 1 and 2 of FIG. 4 show that the device may be provided to the user in a package such as a sealed bag (e.g., a sterile sealed bag). The package may contain individual components (e.g., Figure 2 or Figure 7 (shown on the right) or as Figure 1 、 Figure 6 or Figure 7 The pre-assembled device is shown (left).

[0089] Once removed from the bag, the user can add the sample to the sample tube ( Figure 8B , step 3). The sample tube may contain a sample processing buffer in its packaged state, or the sample processing buffer may be added by the user. In addition, the sample processing buffer may contain magnetic particles including a conjugated binding agent, or such magnetic particles may be added separately.

[0090] Once the sample and sample processing buffer are in the sample tube, the user can then screw the valve onto the top of the sample tube ( Figure 8B , step 4). The sample tube may be shaken to facilitate sample processing, such as lysis of sample components (such as cells) and binding of target analytes to binding agents coupled to magnetic particles ( Figure 8B , step 5).

[0091] Any suitable magnetic particle coupled to a binding agent can be used, and many such examples are well known in the art. The binding agent can be a binding protein, an aptamer, an antibody or its binding fragment, or a protein binding partner of the target analyte. Many such binding agents are well known in the art, and the use of any such agent is within the scope of the present invention.

[0092] Once sample processing is complete, for example after shaking and / or incubation for a period of time, the user can then insert the magnet and invert the device so that the sample is on top of the valve ( Figure 8B , step 6). The elution tubing can then be attached to the valve (( Figure 8B , step 7).

[0093] The user can then turn the valve so that the magnet engages the reagent in the sample tube and binds the magnetic particles from the sample tube. The user can then turn the valve to cause a sealed gas phase transfer of the magnetic particles from the sample tube to the elution tube ( Figure 8C , step 8).

[0094] The magnet can then be removed, releasing the magnetic particles into the elution tube ( Figure 8C , step 9). The elution tube can then be mixed or shaken to allow the elution buffer to cause the target analyte to be released from the binding agent. Many conditions in the elution buffer can cause the release of the target analyte. Such conditions include high or low salt concentrations, high or low pH, high concentrations of another ligand that competes with the binding agent, etc. Many such options are known in the art, and the use of such embodiments is within the scope of this disclosure.

[0095] The magnetic particles can then be recaptured by reinserting the magnet into the valve ( Figure 8C , step 11).

[0096] Once the magnetic particles are attached to the magnet, the elution tube can be pierced, for example by breaking off the tip designed so ( Figure 8D , steps 12 to 13). The eluted target analyte can then be introduced into an analytical device, such as a lateral flow assay device for assaying the eluted target analyte.

[0097] After observing the results of the assay, the device of the present disclosure and the assay device ( Figure 8E , steps 15 to 16).

[0098] Figures 9-10Additional aspects of the present disclosure are described. In such aspects, the adapter is configured to engage with a first compartment (e.g., a sample compartment) and a second compartment (e.g., an elution compartment) in a mutually exclusive manner. The adapter can engage with the first compartment and / or the second compartment by any suitable configuration, such as a snap-fit ​​configuration, a twist-on cap configuration, a threaded screw-in configuration, etc.

[0099] like Figure 10 As shown in FIG, in some cases, the adapter includes a cap 1003 and a bead capture plunger 1002. The bead capture plunger 1002 is a hollow, elongated structure that is inserted into the first compartment or the second compartment when the cap 1003 is placed on the first compartment or the second compartment. The hollow region (e.g., elongated tubular region) of the bead capture plunger 1002 provides a suitable space for engaging with the magnet of the magnetic housing and plunger 1004.

[0100] exist Figure 10 In operation of the device, a user can add a sample, a sample processing buffer, and magnetic particles including a conjugate binding agent that specifically binds to a target analyte to a sample tube 1001. The user can then place a cap 1003 onto the sample tube 1001. The bead capture plunger contacts the reagents within the sample tube 1001. The user can shake the contents of the sample tube and incubate the reagents under appropriate conditions and for an appropriate time to cause the target reagent to bind to the binding agent and, therefore, to bind to the magnetic particles.

[0101] The user can then insert the magnetic housing and plunger 1004 into the cap 1003 so that the magnetic plunger is positioned inside the bead capture plunger 1002. The magnet causes the magnetic particles from the sample tube to attach to the bead capture plunger 1002. Thus, the magnet captures the target analyte.

[0102] The user can then remove the cap, thereby removing the magnetic particles comprising the target analyte, and then place the cap onto an elution tube 1005 containing elution buffer. This constitutes a sealed gas phase transfer of the magnetic particles from the sample tube to the elution tube.

[0103] The magnetic housing and plunger 1004 can then be removed to release the magnetic particles into the elution tube. The elution tube can then be mixed or shaken to allow the elution buffer to cause the target analyte to be released from the binding agent. As discussed above, many options for causing the release of the target analyte from the binding agent are known in the art, and the use of such embodiments is within the scope of this disclosure.

[0104] After sufficient processing to allow the target analyte to be released from the magnetic particles, the magnetic particles can be recaptured by reinserting the magnetic housing and plunger 1004 into the elution tube. The cap 1003 containing the magnetic housing and plunger can then be removed to remove the magnetic particles from the elution buffer.

[0105] The elution buffer remaining in the elution buffer contains the target analyte free of the magnetic particles. The elution buffer can then be analyzed for the target analyte, for example, using a lateral flow assay device.

[0106] In one aspect, as depicted in Figure 11 , the sample tube and elution tube are sealingly connected to one another. Such a device works similarly to the device described in Figure 10 , except that the user does not need to transfer the cap 1003 of the sample tube to the elution tube.

[0107] As shown in Figures 11-12 , in certain embodiments, the devices disclosed herein include a sample tube 1101 that is cylindrical in shape. A bead capture plunger 1103 passes through the center of the cylindrical sample tube 1101. The bead capture plunger also provides a housing for the magnetic housing and plunger 1104.

[0108] The sample tube 1101 is sealingly connected to an elution tube 1106. As used herein, the term "sealingly connected" refers to a connection that prevents leakage of liquid. Thus, a second compartment sealingly connected to a first compartment indicates that liquid will not leak from the first compartment into the second compartment.

[0109] The magnetic housing and plunger are configured to engage with a reagent in the sample tube and capture magnetic particles therein. The magnetic housing and plunger are also configured to be moved from the sample tube 1101 into the elution tube 1106 piercably, and thus cause a sealed gas phase transfer of the magnetic particles from the sample tube to the elution tube 1106.

[0110] Once in the elution tube 1106, the elution buffer can allow the target analyte to be eluted from the magnetic particles. The eluted target analyte can be retrieved from the elution tube 1106.

[0111] Figures 13A-13C Exemplary operations of the devices of Figure 11 and Figure 12 are provided. As shown in Figure 13A (left side illustration), a user can add a sample to the sample tube 1001 with magnetic particles including a conjugate binding agent for the target analyte, such as an antibody. The sample tube 1101 can be sealed Figure 13A (middle illustration) and shaken Figure 13A (right side illustration) to mix the sample with the magnetic particles including the binding agent for the target analyte.

[0112] After the sample is appropriately processed to allow the target analyte to bind to the magnetic particles, the magnetic housing and plunger 1104 are inserted into the bead capture plunger 1103 to capture the magnetic particles from the sample tube ( Figure 13B , shown on the left). The bead capture plunger includes a bead capture region, and a magnet brings magnetic particles from the sample into the bead capture region.

[0113] After the magnetic particles are captured, the magnetic housing and plunger 1104 can be pushed into the elution tube 1106. The sample tube, elution tube, and magnetic housing and plunger are configured so that the magnetic housing and plunger can penetrate through the sample tube into the elution tube, carrying only the magnetic particles and not allowing any other reagents to leak from the sample tube into the elution tube.

[0114] Once in the elution tube, the magnetic particles come into contact with the elution buffer. Elution of the target analyte can be promoted by shaking or mixing the device, such as Figure 13B as shown in the figure on the right.

[0115] Finally, the removable bottom of the elution tube can be removed, e.g. Figure 13C As shown in the figure on the left. By further pushing the magnetic housing and plunger ( Figure 13C , middle picture) or squeeze elution tube ( Figure 13C , shown on the right), the elution buffer containing the target analytes can be removed.

[0116] A further aspect of the present disclosure provides an apparatus for separating a target analyte, the apparatus comprising a lid that engages with a first compartment (e.g., a sample compartment) and a second compartment (e.g., an elution compartment) simultaneously. The lid comprises an adapter comprising a removable magnet that can be positioned in a first position, wherein the magnet engages with a reagent in the first compartment. The magnet can be moved from the first position to a second position, in which the magnet engages with a reagent in the second compartment. In the first position, the magnet captures magnetic particles from the first compartment. In the second position, the magnet delivers the magnetic particles into the second compartment, and the reagent in the second compartment can cause, for example, an analyte attached to the magnetic particles by a coupling binding agent to be released into the second compartment.

[0117] Figures 14-16 Examples of some such embodiments are provided in .

[0118] like Figure 14 As shown in FIG, in some embodiments, the device 1400 includes a sample tube 1401 and an elution tube 1405. A fixed cap 1402 is engaged with both the sample tube and the elution tube. The engagement between the fixed cap and the sample tube and the elution tube can be sealed by an O-ring 1406, which can be formed of a suitable flexible material such as rubber.

[0119] The lid of the device also includes a rotating lid 1404 that includes an adapter 1403 that includes a magnet. The rotating lid is engaged with the fixed lid such that rotating the rotating lid relative to the fixed lid allows the magnet in the rotating lid to engage with the sample tube in one position and the elution tube in a second position.

[0120] During operation of the device described in Figure 14 , the user can treat the sample with sample treatment buffer and magnetic particles to allow capture of the target analyte onto the magnetic particles, as described elsewhere in this disclosure.

[0121] Once treatment is complete, the rotating lid can be positioned such that the magnet in the adapter engages with the sample tube. The sample tube can be shaken or even inverted such that the reagents, including the magnetic particles, within the sample tube interact with the magnet in the adapter, resulting in the magnetic particles being captured by the magnet.

[0122] The user can then rotate the rotating lid such that the adapter is in a second position in which the magnet in the adapter engages with the elution tube. Thus, rotation of the rotating lid results in a sealed gas phase transfer of the magnetic particles from the sample tube to the elution tube.

[0123] Once the magnet in the adapter engages with the elution tube, i.e. the magnetic particles are in the elution tube, the magnetic particles can be contacted with elution buffer to result in release of the target analyte. Many options for eluting the target analyte are known in the art, and use of such embodiments is within the scope of this disclosure.

[0124] As shown in Figure 15 , in some embodiments, the device 1500 includes a sample tube 1501 and an elution tube 1504. A sliding lid 1502 engages with both the sample tube and the elution tube. The engagement between the fixed lid and the sample tube and the elution tube can be sealed by a ring 1505, which can be formed of a suitable flexible material such as rubber.

[0125] The sliding lid of the device also includes an adapter 1503 that includes a magnet. The sliding lid is engaged with the sample tube and the elution tube such that sliding the sliding lid allows the magnet in the adapter to engage with the sample tube in one position and the elution tube in a second position.

[0126] During operation of the device described in Figure 15 , the user can treat the sample with sample treatment buffer and magnetic particles to allow capture of the target analyte onto the magnetic particles, as described elsewhere in this disclosure.

[0127] Once processing is complete, the sliding cover can be positioned so that the magnet in the adapter engages the sample tube. The sample tube can be shaken or even inverted so that the reagents in the sample tube (including magnetic particles) interact with the magnet in the adapter, causing the magnetic particles to be captured by the magnet.

[0128] The user can then slide the sliding cover so that the adapter is in a second position where the magnet in the adapter engages the elution tube. Therefore, the sliding of the sliding cover causes the sealed gas phase transfer of the magnetic particles from the sample tube to the elution tube.

[0129] Once the magnet in the adapter is engaged with the elution tube, i.e., the magnetic particles are in the elution tube, the magnetic particles can come into contact with the elution buffer to cause the release of the target analyte. Many options for eluting the target analyte are known in the art, and the use of such embodiments is within the scope of the present disclosure.

[0130] In addition, if Figure 16 As shown in FIG, in some embodiments, the device 1600 includes a sample tube 1601 and an elution tube 1604. A cap 1602 is coupled to both the sample tube and the elution tube. The coupling between the cap and the sample tube and the elution tube can be sealed by a ring that can be formed of a suitable flexible material such as rubber.

[0131] The lid of the device also includes a transfer piston 1603 that includes a magnet. The transfer piston engages the sample tube and the elution tube such that moving the transfer piston allows the magnet in the sample piston to engage the sample tube in one position and the elution tube in a second position.

[0132] exist Figure 16 During operation of the device described in, a user can treat a sample with a sample processing buffer and magnetic particles to allow capture of target analytes onto the magnetic particles, as described elsewhere in this disclosure.

[0133] Once processing is complete, the transfer piston can be positioned so that the magnet in the transfer piston engages the sample tube. The sample tube can be shaken or even inverted so that the reagents in the sample tube (including the magnetic particles) interact with the magnet in the transfer piston, causing the magnetic particles to be captured by the magnet.

[0134] The user can then twist knob 1604 so that the adapter is in a second position in which the magnet in the adapter engages the elution tube. Thus, twisting the knob results in a sealed gas phase transfer of the magnetic particles from the sample tube to the elution tube.

[0135] Once the magnet in the adapter engages with the elution tube, with the magnetic particles in the elution tube, the magnetic particles can be contacted with an elution buffer to cause release of the target analyte. Numerous options for eluting the target analyte are known in the art, and use of such embodiments is within the scope of the present disclosure.

[0136] Sample preparation

[0137] The adapters disclosed herein can be used to isolate an analyte of interest from a sample (positive isolation) or to remove molecules other than the target of interest (negative isolation). The analyte of interest or target analyte and the sample can be as described in the previous section.

[0138] In one embodiment, a method for isolating an analyte of interest from a sample using the adapters disclosed herein can include Figure 4 the steps illustrated in FIG. 1, which illustrates a sample preparation method that includes transferring a sample (e.g., urine) to a tube (e.g., Figure 1 and Figure 2 the tube 101 illustrated in FIGS. 1, 2, and 3). The volume of sample transferred to the tube can be about 0.5 mL - 10 mL, such as at least 1 mL, at least 2 mL, at least 3 mL, at least 4 mL, at least 5 mL, or more.

[0139] Magnetic particles functionalized to bind to the analyte of interest (also referred to as PMPs) are added to the sample, and the sample is mixed with the magnetic particles. Mixing can involve agitation, inversion, shaking, etc. The magnetic particles can be functionalized with antibodies that bind to the analyte. After the PMPs are added, the tube can be covered with a cap and optionally inverted for mixing the PMPs. Alternatively, a stirrer such as a swab can be used to mix the sample with the PMPs. In certain embodiments, the tube can be attached to an opening of an adapter as described herein (e.g., adapter 100 or adapter 200). For example, the tube 101 or 221 can be attached to the opening 112 or 232 of the adapter 100 or adapter 200, respectively, and inverted multiple times to mix the sample and PMPs. In this embodiment, the adapter functions as a cap, and the orientation of the cylindrical sleeve relative to the cylindrical body is such that the opening in the surface of the cylindrical sleeve faces the inner surface of the cylindrical body, thereby closing the opening. The cylindrical sleeve occludes the interior of the cylindrical body, thereby preventing the sample from flowing to the second opening in the cylindrical body. This can be referred to as a first orientation of the cylindrical sleeve. This first orientation can be indicated with an arrow attached to the stem of the sleeve or platform, which can be parallel to the ground.

[0140] The PMPs can be incubated with the sample for a period of time sufficient to allow the analyte to bind to the PMPs, such as 1 - 30 minutes, such as at least 5 minutes, at least 10 minutes, at least 15 minutes, at least 20 minutes, or more.

[0141] The opening in the cylindrical cartridge is oriented towards the first opening in the cylindrical body of the adapter and the magnet is oriented such that it is in fluid communication with the fluid entering through the opening in the cylindrical cartridge. The adapter is attached to the opening of the tube after incubation. This step can involve removing the caps of both the tube and the first opening in the cylindrical body of the adapter.

[0142] Alternatively, the adapter is used as a cap and after incubating the PMPs with the sample, the cylindrical cartridge is rotated such that the opening in the cylindrical cartridge faces the first opening in the cylindrical body of the adapter, thereby allowing the sample to flow into the cylindrical cartridge and allowing the PMPs to be captured by the magnet fixed in the platform. This can be referred to as a second orientation of the cylindrical cartridge. This second orientation can be indicated with an arrow attached to the rod of the cartridge or platform, which can point downwards.

[0143] After the incubation step, the test tube is inverted such that the sample and PMPs are in contact with the magnet. After a period of time sufficient to allow the PMPs to be captured by the magnet, the tube can be inverted back such that the sample flows back into the tube and is no longer in the cylindrical cartridge.

[0144] An elution tube including an elution buffer is attached to the second opening of the adapter after or before the tube is inverted back. This step can also include removing the caps from the second opening of the adapter and from the opening of the elution tube. Alternatively, the adapter can not include a cap on the second opening and the method can involve rotating the cylindrical cartridge to the first orientation and attaching the second opening to the elution tube. As indicated in the previous section, the elution tube can be in the form of a conical structure having an orifice that can be covered with a cap.

[0145] After the elution tube is attached to the adapter, the orientation of the cylindrical cartridge is changed by actuating the rotation device such that the opening in the cylindrical cartridge is in fluid communication with the solution in the elution tube. This can be referred to as a third orientation of the cylindrical cartridge. This third orientation can be indicated with an arrow attached to the rod of the cartridge or platform, which can point upwards. The magnet and the PMPs attached to it can be in contact with the solution in the elution tube and after a period of time sufficient to elute the target from the PMPs, the solution containing any analyte (e.g., elution buffer) can be dispensed onto a lateral flow assay device or other diagnostic device for detecting the analyte.

[0146] The lateral flow device can be a device known in the art for detecting an analyte. When the analyte is LAM Ag, the device for detecting the analyte can be the DETERMINE TM TB LAM Ag.

[0147] In one embodiment, a method for isolating an analyte of interest from a sample using the adapter disclosed herein can compriseFigure 5 The steps are illustrated in FIG. 1. The first step can include adding the sample to the sample tube and mixing it with the PMP. After a sufficient period of time, the PMP is captured by the magnet present in the adapter of the present disclosure by inverting the tube, as explained for Figure 4 After the capture step, the tube is inverted back and the elution vial is attached to the adapter. The orientation of the cylindrical cartridge is changed by rotating the cylindrical cartridge to bring the magnet into contact with the elution buffer present in the elution tube. After eluting the analyte, the elution buffer is dispensed onto the detection device.

[0148] In further embodiments, Figures 6-16 The devices described in the foregoing are used to isolate a target analyte. The operation of these devices and thus the methods of using these devices to isolate a target analyte are described above. Additional details described herein with respect to the devices of Figures 1-6 apply to the devices of Figures 7-16 and such embodiments are within the scope of the present disclosure.

[0149] Accordingly, the foregoing merely illustrates the principles of the present disclosure. It will thus be appreciated that those skilled in the art will be able to devise various arrangements that, although not explicitly described or shown herein, embody the principles of the application and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended to be only for pedagogical purposes to aid the reader in understanding the principles of the application and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the application, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. The scope of the present application, therefore, is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of the present application is embodied by the appended claims.

Claims

1. An adapter for separating an analyte of interest from a sample, the adapter comprising: A substantially cylindrical body comprising: a first opening opposite a second opening, wherein the first opening and the second opening are positioned along a longitudinal axis of the substantially cylindrical body; an opening on a surface of the cylindrical body, the opening defining a space for slidable engagement with a cylindrical barrel, wherein the cylindrical barrel is positionable within the cylindrical body such that the longitudinal axis of the cylindrical body is perpendicular to the longitudinal axis of the cylindrical barrel, and the cylindrical barrel is rotatable relative to the cylindrical body, and wherein the cylindrical barrel is sized to occlude the interior of the cylindrical body to prevent fluid from flowing from the first opening to the second opening, a platform comprising a first region configured for securing the magnet and a second region for rotating the platform, wherein the platform is sized to fit inside the cylindrical barrel and rotate the cylindrical barrel when the platform rotates, The cylindrical barrel comprises an opening in the surface at a position between the two ends of the cylindrical barrel, wherein the opening in the surface of the cylindrical barrel is in fluid communication with the magnet, wherein the platform and the cylindrical barrel are rotatable such that: In a first orientation, the opening in the surface of the cylindrical barrel faces the inner surface of the cylindrical body such that the opening is closed by the inner surface of the cylindrical body, In a second orientation, the opening in the surface of the cylindrical barrel faces the first opening in the cylindrical body, thereby allowing fluid entering through the first opening in the cylindrical body to flow into the cylindrical barrel, and In a third orientation, the opening in the surface of the cylindrical barrel is aligned with the second opening in the cylindrical body, thereby allowing fluid entering through the second opening in the cylindrical body to flow into the cylindrical barrel.

2. The adapter according to claim 1, wherein The platform includes means for rotating the platform, which are located outside the cylindrical body and are rods.

3. The adapter according to claim 1, wherein The cylindrical barrel comprises means for rotating the platform, which are located outside the cylindrical body and are rods.

4. A system having components for separating an analyte of interest from a sample, the system comprising an adapter according to any one of claims 1 to 3 and a vial for receiving the sample, wherein The first opening of the adapter is attachable to the opening of the vial.

5. The system of claim 4, further comprising a tube for eluting the analyte, the tube comprising an opening for attachment to the second opening of the adapter.

6. The system according to claim 5, wherein: The tube includes an orifice opposite the opening for dispensing the eluted analyte.

7. The system according to any one of claims 4 to 6, further comprising magnetic particles functionalized to capture the analyte.

8. The system of any one of claims 4 to 7, further comprising a lateral flow device for detecting the presence of the analyte.

9. The system according to any one of claims 4 to 8, wherein: The vial includes lysis solution.

10. The system according to any one of claims 5 to 8, wherein: The elution tube includes an elution solution.

11. A device for separating a target analyte from a sample, the device comprising: an adapter configured for mutually exclusive engagement with the first compartment and the second compartment, the adapter comprising a cap having an aperture and a bead capture plunger, a magnetic housing and a plunger comprising a magnet, wherein the bead capture plunger is a hollow elongated structure that is inserted into the first compartment or the second compartment when the adapter is engaged with the first compartment or the second compartment, and wherein the bead capture plunger also provides space for engaging with the magnet of the magnetic housing and plunger, wherein the magnets of the magnetic housing and plunger capture magnetic particles that may be present in the first compartment or the second compartment, And wherein moving the adapter from the first compartment to the second compartment results in a sealed gas phase transfer of magnetic particles from the first compartment to the second compartment.

12. The apparatus according to claim 11, wherein The adapter engages with the first compartment and / or the second compartment by a snap-fit ​​configuration, a twist-cap configuration, or a screw-in configuration.

13. The apparatus according to claim 11 or 12, wherein: The first compartment is a sample tube, and the second compartment is an elution tube.

14. The apparatus according to claim 13, wherein The sample tube includes a sample processing buffer, and the elution tube includes an elution buffer.

15. The apparatus according to claim 14, wherein The sample processing buffer includes magnetic particles comprising a binding agent that specifically binds to the target analyte.

16. A device for separating a target analyte from a sample, the device comprising: an adapter configured to engage a first compartment and a second compartment, wherein the first compartment is a cylindrical tube and the second compartment is located below the first compartment and sealingly connected to the first compartment, The adapter includes a bead capture plunger, wherein the bead capture plunger passes through the center of the first compartment and includes a hollow longitudinal center that provides space for receiving a magnet from a magnetic housing and plunger, and wherein the bead capture plunger includes a bead capture region, wherein the magnetic housing and plunger are configured to pass through the bead capture plunger and capture magnetic particles that may be present in the first compartment in the bead capture region of the bead capture plunger, and The magnetic housing and plunger are further configured to be pierceably movable from the first compartment into the sealingly connected second compartment, thereby causing a sealed gas-phase transfer of magnetic particles from the first compartment to the second compartment.

17. The apparatus according to claim 16, wherein The adapter engages with the first compartment via a snap-fit ​​configuration, a twist-on cap configuration, or a threaded-in configuration.

18. The apparatus according to claim 16 or 17, wherein The first compartment is a sample tube, and the second compartment is an elution tube.

19. The apparatus according to claim 18, wherein The sample tube includes a sample processing buffer, and the elution tube includes an elution buffer.

20. The apparatus according to claim 19, wherein The sample processing buffer includes magnetic particles comprising a binding agent that specifically binds to the target analyte.

21. A device for separating a target analyte from a sample, the device comprising: a lid that engages both the first compartment and the second compartment, the cover comprising an adapter comprising a removable magnet positionable in a first position in which the magnet captures magnetic particles that may be present in the first compartment, or in a second position in which the magnet captures magnetic particles that may be present in the second compartment, And wherein the cover comprises means for moving the adapter from the first position to the second position to cause sealed gas phase transfer of magnetic particles from the first compartment to the second compartment.

22. The apparatus according to claim 21, wherein The means for moving the adapter from the first position to the second position comprises a rotating cap on which the adapter is mounted, and wherein rotating the rotating cap causes the adapter to move from the first position to the second position.

23. The apparatus of claim 21, wherein: The means for moving the adapter from the first position to the second position comprises a sliding cover on which the adapter is mounted, and wherein sliding the sliding cover causes the adapter to move from the first position to the second position.

24. The apparatus of claim 21, wherein The means for moving the adapter from the first position to the second position includes a transfer piston mounted on the cover and including the adapter, and moving the transfer piston laterally causes the adapter to move from the first position to the second position.

25. Apparatus according to any one of claims 21 to 24, wherein The cover engages with the first compartment and / or the second compartment by a snap-fit ​​configuration, a twist-cap configuration, or a screw-in configuration.

26. Apparatus according to any one of claims 21 to 25, wherein The first compartment is a sample tube, and the second compartment is an elution tube.

27. The apparatus of claim 26, wherein: The sample tube includes a sample processing buffer, and the elution tube includes an elution buffer.

28. The apparatus of claim 27, wherein The sample processing buffer includes magnetic particles comprising a binding agent that specifically binds to the target analyte.

29. A method of separating a target analyte from a sample, the method comprising processing the sample in an apparatus according to any one of claims 1 to 28.

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