US-20260126355-A1 - Device and Method for Analyte Isolation

US20260126355A1US 20260126355 A1US20260126355 A1US 20260126355A1US-20260126355-A1

Abstract

The disclosure provides devices for easy and quick isolation of target analytes in a point-of-care setting. In some aspects, the devices comprise a first compartment, a second compartment, and an adaptor. The adaptor comprises a removable/positionable magnet and, in a first position of the adaptor, the magnet immobilizes magnetic particles within the first compartment and in a second position of the adaptor, the magnet immobilizes magnetic particles within the second compartment. Moving the adaptor from the first position into the second position causes a sealed gas-phase transfer of magnetic particles from the first compartment to the second compartment. The magnetic particles bind to target analytes and, thus, moving the magnetic particles from the first compartment into the second compartment isolates the target analytes. The target analytes can be retrieved from the second compartment and analyzed. Methods of isolating target analytes using the devices disclosed herein are also provided. WO

Inventors

Mi Jung Ji
Harry Turner
Thomas Edward Parker
Karen Yu
Simon Thorne
Rohit Mishra
Ian O'Loughlin
Andrew Kirkham
Declan J. Fox
Do Yeong Koh
Jin Woon KIM
Jun Yup Lee
Nicholas Collier

Assignees

Abbott Rapid Diagnostics International Unlimited Company

Dates

Publication Date: 20260507
Application Date: 20231006

Claims (20)

1 . An adaptor for isolating an analyte of interest from a sample, the adaptor comprising: a substantially cylindrical body comprising: a first opening opposite a second opening, wherein the first and second openings are located 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 cuff, wherein the cylindrical cuff is positionable within the cylindrical body such that a longitudinal axis of the cylindrical body is perpendicular to a longitudinal axis of the cylindrical cuff and the cylindrical cuff is rotatable with reference to the cylindrical body and wherein the cylindrical cuff is sized to occlude the interior of the cylindrical body to prevent flow of fluid from the first opening to the second opening, a platform comprising a first region configured for immobilizing a magnet and a second region for rotating the platform, wherein the platform is sized to fit inside the cylindrical cuff and rotate the cylindrical cuff upon rotation of the platform, the cylindrical cuff comprising an opening located in a surface at a position between the two ends of the cylindrical cuff, wherein the opening in the surface of the cylindrical cuff is in fluid communication with the magnet, wherein the platform and the cylindrical cuff are rotatable such that in a: first orientation, the opening in the surface of the cylindrical cuff faces an interior surface of the cylindrical body such that the opening is closed by the interior surface of the cylindrical body, second orientation, the opening in the surface of the cylindrical cuff 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 cuff, and third orientation, the opening in the surface of the cylindrical cuff 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 cuff.
2 . The adaptor of claim 1 , wherein the platform comprises a means for rotating the platform, which means is located outside the cylindrical body, and is a lever.
3 . The adaptor of claim 1 , wherein the cylindrical cuff comprises a means for rotating the platform, which means is located outside the cylindrical body, and is a lever.
4 . A system of components for isolating an analyte of interest from a sample, the system comprising the adaptor of any one of claims 1-3 and a vial for accepting the sample, wherein the first opening of the adaptor is attachable to an opening of the vial.
5 . The system of claim 4 , further comprising a tube for eluting the analyte, the tube comprising an opening for attaching to the second opening of the adaptor.
6 . The system of claim 5 , wherein the tube comprises an orifice opposite the opening for dispending the eluted analyte.
7 . The system of any one of claims 4-6 , further comprising magnetic particles functionalized to capture the analyte.
8 . The system of any one of claims 4-7 , further comprising a lateral flow device for detecting presence of the analyte.
9 . The system of any one of claims 4-8 , wherein the vial comprises a lysis solution.
10 . The system of any one of claims 5-8 , wherein the elution tube comprises an elution solution.
11 . A device for isolating a target analyte from a sample, the device comprising: an adaptor configured for mutually exclusively engaging with a first compartment and a second compartment, and the adaptor comprising a cap having a hole and a bead capture plunger, a magnetic housing and plunger comprising a magnet, wherein the bead capture plunger is a hollow elongated structure that is inserted into the first or the second compartment when the adaptor engages with the first or second compartment, and wherein the bead capture plunger also provides space for engaging with the magnet of the magnetic housing and plunger, wherein the magnet of the magnetic housing and plunger captures magnetic particles that may be present in the first compartment or in the second compartment, and wherein moving the adaptor from the first compartment to second compartment causes a sealed gas-phase transfer of magnetic particles from the first compartment to the second compartment.
12 . The device of claim 11 , wherein the adaptor engages with the first and/or the second compartments by a snap fit configuration, twist-cap configuration, or threaded screw-on configuration.
13 . The device of claim 11 or 12 , wherein the first compartment is a sample tube and the second compartment is an elution tube.
14 . The device of claim 13 , wherein the sample tube comprises a sample processing buffer and the elution tube comprises an elution buffer.
15 . The device of claim 14 , wherein the sample processing buffer comprises magnetic particles comprising a binding agent that specifically binds to the target analyte.
16 . A device for isolating a target analyte from a sample, the device comprising: an adaptor configured for engaging with a first compartment and a second compartment, wherein the first compartment is cylindrical tube and the second compartment is below the first compartment and is sealingly connected to the first compartment, the adaptor comprising a bead capture plunger, wherein the bead capture plunger passes through the center of the first compartment and comprises a hollow longitudinal center that provides a space for accommodating a magnet from a magnet housing and plunger, and wherein the bead capture plunger comprises a bead capture area, wherein the magnet housing and the plunger is configured to pass through the bead capture plunger and capture magnetic particles that may be present in the first compartment in the bead capture area of the bead capture plunger, and the magnetic housing and plunger further configured to piercably move 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 device of claim 16 , wherein the adaptor engages with the first compartment by a snap fit configuration, twist-cap configuration, or threaded screw-on configuration.
18 . The device of claim 16 or 17 , wherein the first compartment is a sample tube and the second compartment is an elution tube.
19 . The device of claim 18 , wherein the sample tube comprises a sample processing buffer and the elution tube comprises an elution buffer.
20 . The device of claim 19 , wherein the sample processing buffer comprises magnetic particles comprising a binding agent that specifically binds to the target analyte.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63/378,656, filed Oct. 6, 2022, U.S. Provisional Application No. 63/491,238, filed Mar. 20, 2023, and U.S. Provisional Application No. 63/471,663, filed June 7, 20123, which applications are incorporated herein by reference in their entireties and for all purposes. INTRODUCTION Analysis of a biological sample often involves determining the presence of a target analyte in the sample. The target analyte, if present, is isolated from the sample and analyzed using downstream applications, such as, amplification, immunoassay, and the like. Target analytes are isolated using approaches that include column-based isolation, reagent-based isolation, magnetic bead-based isolation, and other technologies. However, such approaches usually require complicated kits, instrumentation, and trained personnel leading to limited in-field application. There exist a need in improving isolation of a target analyte from samples by developing relatively low-cost devices that can be used in easy-to-perform methods and provide sample preparation for intended detection methods by way of increased concentration of the target analyte or reduced noise via background removal. SUMMARY The disclosure provides devices that allow easily and quickly isolating a target analyte from a sample. For example, the devices disclosed herein allow isolation of a target analyte in a point-of-care/point-of-need setting. In some aspects, the devices comprise a first compartment, e.g., a sample compartment, and a second compartment, e.g., an elution compartment, and an adaptor. The adaptor is configured to engage with the first compartment and the second compartment. In certain embodiments, the adaptor comprises a magnet and, in a first position of the adaptor, the magnet immobilizes magnetic particles (that can capture target molecules of interest or remove unwanted molecules) within the first compartment. The adaptor is also configured to move from the first position into a second position and, in the second position of the adaptor, the magnet immobilizes magnetic particles within the second compartment. Moving the adaptor from the first position into the second position causes a 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. In the second position of the adaptor, 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 immobilized magnetic particles in the first compartment as well as the second compartment can interact with the reagents in the corresponding compartments. In the release positions, the magnet cannot interact with the reagents in the corresponding compartments. The adaptor may also be in a third position and, in the third position of the adaptor, the adaptor, including the magnet comprised in the adaptor, cannot interact with the reagents in either the first compartment or the second compartment. Certain aspects of the present disclosure include an adaptor for isolating an analyte of interest from a sample. The isolation can be positive isolation or negative isolation as indicated below in more detail. The adaptor is configured for simultaneous attachment to an opening of a vial and to a conical structure comprising an orifice. The adaptor includes a magnet positioned on a rotatable platform configured to position the magnet in a facing orientation to either the vial or the conical structure comprising an orifice. Methods for using the adaptor to isolate the analyte of interest are also provided. Certain other aspects of the present disclosure include an adaptor configured for simultaneous attachment to a first compartment, e.g., a sample compartment and to a second compartment, e.g., an elution compartment. The adaptor includes a magnet positioned on a rotatable platform configured to position the magnet in a facing orientation to either the first compartment or the second compartment comprising an orifice. Methods for using the adaptor to isolate the analyte of interest are also provided. Further aspects of the present disclosure include an adaptor configured for mutually exclusive engagement to a first compartment, e.g., a sample compartment and to a second compartment, e.g., an elution compartment. The adaptor includes a removable magnet that can be positioned in a capture position in a bead capture plunger of the adaptor. When the magnet is positioned in the capture position in the bead capture plunger of the adaptor engaged with the first compartment, the magnet captures magnetic particles that may be present in the first compartment. The adaptor can be disengaged from the sample compartment and then