Component of a device, a device, and a method for purifying and testing biomolecules from biological samples

Patent metadata

Field	Value
Publication number	US-2016354773-A1
Application number	US-201514732423-A
Country	US
Kind code	A1
Filing date	Jun 5, 2015
Priority date	Jun 5, 2015
Publication date	Dec 8, 2016
Grant date	—

Abstract

The present disclosure relates to, inter alia, an easy-to-operate, fully closed component, which can be part of an instrument, for purification of biomolecules from biological samples, and subsequent transfer, and testing of the biomolecules, as well as an instrument comprising the component, and a method for using the component.

First claim

We claim:

1 . A fully closed component for purifying a biomolecule from a biological sample, said component comprising: mixing chambers, connection tubes, storage containers, sealing membranes, pressure seals or switches, purified sample collection tubes or testing chambers, a biological sample, in a liquid, solid, or solid-liquid suspension form, magnetic beads, lysis/binding buffer (either lysis buffer or binding buffer, or both), washing solution, optionally eluent, optionally test solution, and optionally a sample collection device with a sealing cap;
wherein: each mixing chamber is a disposable plastic container, the mixing chambers being connected to each other by connection tubes, which are sealable soft tubes or switches; each mixing chamber is located adjacently and horizontally or vertically to the next mixing chamber; pressure seals or switches are adapted for opening and/or closing the connection tubes, to enable or disable the liquid exchange between adjacent mixing chambers, and are located on and around the middle of each connection tube; one or more of the mixing chambers are connected with one or more storage containers physically but not in liquid contact, with a sealing membrane between the connected mixing chamber and the storage container, said sealing membrane is a piercible membrane, piercible by syringe, pipette, capillary, or by pressure; the sealing membrane of the storage container prevents the transfer of a biological sample to the mixing chamber before the membrane is pierced; the storage containers can be stored at different places (for example, locations with different temperature), and attached to mixing chambers or testing chambers prior to operation; a biological sample, which can be pre-loaded in a sample collection device, which is a compressible plastic container with a sealing cap and a piercing device and which is not part of the component, but can be connected to the component to add the sample; or the biological sample can also enter a storage container/a mixing chamber through a sealing membrane or by injection with a syringe or by pipetting; or the biological sample can also be admixed with magnetic beads and lysis/binding solution prior to be added to the component; when there are more than one storage container mounted on a mixing chamber or a test chamber, they are located next to each other; each storage container comprises a puncture device; one or more storage containers comprise washing solution; one or more storage containers comprise eluent; one or more storage containers comprise lysis and/or binding buffer; one or more storage containers comprise magnetic beads; magnetic beads and lysis/binding buffer can be stored in the same storage container or different storage containers; one or more of the mixing chambers are connected by a connection tube, which is a sealable soft tube or a switch, and a pressure seal on and around the middle of the connection tube, with one or more testing chambers/purified sample collection tubes such that the biological sample isolated from the mixing chamber is transferred to the one or more testing chambers for testing or to the one or more sample collection tubes for collection, One or more storage containers attached to one or more testing chambers or one or more mixing chambers can comprise testing solution or dry powder; the magnetic beads are brought to contact with the biological sample by rotation or vibration; and the component is fully closed (i.e., sealed).

2 . The component of claim 1 , wherein the component is part of a machine.

3 . The component of claim 1 , wherein the sealing membrane of the storage container is sealed foil, plastic or rubber closure.

4 . The component of claim 1 , wherein one or more of the storage containers is mounted above each mixing chamber or a test chamber.

5 . The component of claim 1 , wherein different sets of magnetic beads and lysis/binding buffer are placed in different storage containers, each set having a different adsorption and binding profile such that each different set is for adsorption and binding of small molecule, protein and/or nucleic acids.

6 . The component of claim 1 , wherein the biomolecule is nucleic acids, proteins, or small molecules.

7 . The component of claim 1 , wherein the biological sample is a sample selected from the group consisting of blood, saliva, oral mucosa, body fluids, hair roots, tissues, serum, feces, bodily secretions, and medium.

8 . The component of claim 1 , further comprising a sample collection device, connected to a storage container or a mixing chamber through a sealing membrane or connected to a sealing membrane through a sealing cap, wherein the sample collection device is a blood collection device selected from the group consisting of a fingertip lancing device, a fingertip blood collection needle, a swab, absorbent paper, smears, capillary, and a dropper; or wherein the sample collection device is a scraper for collection of oral mucosa cells or a saliva collector; or wherein the sample collection device is a micro-sample collection device.

9 . The component of claim 1 , further comprising one or more detection sensors.

10 . The component of claim 1 , wherein each mixing chamber is located adjacently and horizontally or vertically to the next mixing chamber.

11 . The component of claim 1 , wherein qualitative or quantitative analyses are further performed in the testing chambers.

12 . The component of claim 11 , wherein the qualitative or quantitative analyses are performed by immunoassays, nucleic acids detection assays, or biochemical detection assays.

13 . An instrument comprising the component of claim 1 , a moving magnetic field adapted to allow the magnetic beads to be moved orderly between different mixing chambers, a motor, means to rotate, vibrate, or tilt said component, and optionally a detection sensor, and is adapted to be powered by a power supply (AC and/or DC).

14 . A method for purifying a biomolecule from a biological sample, comprising:
a. Providing a component of claim 1 , either by itself or housed in a machine; b. Adding a biological sample into said component; and c. Purifying a biomolecule using said component.

15 . The method of claim 14 , further comprising (d) conducting testing on said biomolecule using said component.

16 . The method of claim 14 , further comprising storing said biomolecule in said component.

17 . The method of claim 14 , wherein the component is housed inside a machine.

18 . A method for purifying a biomolecule from a biological sample, comprising:
(a) Providing a magnetic field and a component of claim 1 , either by itself or housed in a machine; (b) Introducing a biological sample to the component, by placing the biological sample in a first storage container, compressing the first storage container such that the puncture device damage the structural integrity of the sealing membrane, thereby allowing the biological sample, magnetic beads, and lysis/binding buffer to be mixed in the connected mixing chamber (first mixing chamber), which is the leftmost or the rightmost chamber of the component, wherein the magnetic beads and/or lysis/binding buffer, which can be either a binding buffer or a lysis buffer, or both, are introduced into the first mixing chamber either from the first storage container with the sample or another storage container in physical contact with the first mixing chamber and upon compressing that storage container, the puncture device damage the structural integrity

Assignees

• Li Yongmei
• Li Li

Inventors

• Li Yongmei
• Li Li

Classifications

• G01N1/38

  Diluting, dispersing or mixing samples · CPC title

• B01L3/52

  Containers specially adapted for storing or dispensing a reagent (B01L3/02 takes precedence; storing or dispensing test elements G01N33/4875; automated reagent dispensing G01N35/1002) · CPC title

• B01L2300/087

  Multiple sequential chambers · CPC title

• B01L3/561

  Tubes; Conduits · CPC title

• B01L2200/028

  Modular arrangements · CPC title