# US 2019/0376121 A1 · Gene detection method, gene detection kit and gene detection device

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- Number: US 2019/0376121 A1
- Document ID: US20190376121A1
- Status: Published application
- Kind: A1
- Application number: 16/487,105
- Filed: 2018-06-06
- Published: 2019-12-12
- Earliest claimed: 2017-06-08
- Assignees: Hangzhou Lifereal Biotechnology Co., Ltd.
- Applicants: Hangzhou Lifereal Biotechnology Co., Ltd.
- Inventors: Qian SONG; Wenfei XU; Xin WANG; Xiangzhao ZHENG
- Web page: https://patentgrep.com/patent/US20190376121A1

## CPC

- C12Q 1/6806: Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay (C12Q1/6804 takes precedence)
- C12Q 1/686: Polymerase chain reaction [PCR]
- B01L 3/508: {Rigid containers without fluid transport within}
- B01L 7/04: Heat insulating devices, e.g. jackets for flasks
- B01L 2300/0654: Lenses; Optical fibres
- B01L 2300/1883: using thermal insulation
- B01L 2400/043: magnetic forces
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE

## Abstract

A gene detection method, a gene detection kit, and a gene detection device, including the following steps: providing a plurality of separation cavities on a kit, using a plunger to separate adjacent separation cavities, and respectively providing a lysate solution, a washing solution and a reaction solution in the separation cavities; when detecting a sample, pushing each plunger to align a plunger hole of the plunger with the separation cavity, thereby making the separation cavities interconnected; then, controlling magnetic beads in the kit to drive the sample to be tested to pass through the separation cavities in sequence by an electromagnetic control method, carrying out a lysing, a washing and a reaction in sequence; and finally, performing a optical detection on a gene in the reaction solution from outside.

## Claims

### Claim 1

A gene detection method, comprising:
providing a plurality of separation cavities on a kit, using a plunger to separate adjacent separation cavities, and respectively providing a lysate solution, a washing solution and a reaction solution in the separation cavities;
when detecting a sample, pushing each plunger to align a plunger hole of the each plunger with the adjacent separation cavities, thereby making the plurality of separation cavities interconnected; then,
controlling magnetic beads in the kit to drive the sample to be tested to pass through the plurality of separation cavities in sequence by an electromagnetic control method, carrying out a lysing, a washing and a reaction in sequence; and finally,
performing an optical detection on a gene in the reaction solution from outside.

### Claim 2 (depends on 1)

The gene detection method of claim 1, wherein, the reaction is a polymerase chain reaction (PCR) or an isothermal amplification reaction, an enzyme required for the reaction is provided in the plunger hole of the plunger, and when the plunger hole of the plunger is aligned with the separation cavity containing the reaction solution, the enzyme automatically falls into the reaction solution due to a gravity of the enzyme.

### Claim 3 (depends on 1)

The gene detection method of claim 1, wherein, a detection portion of the optical detection is located at a bottom of the separation cavity containing the reaction solution, and the bottom of the separation cavity containing the reaction solution is provided with a concave portion toward an outside of the kit; during a detection, the kit is in an inclined state, and the concave portion of the separation cavity containing the reaction solution faces downward, and the magnetic beads in the reaction solution are automatically concealed in the concave portion to avoid an interference on the optical detection.

### Claim 4 (depends on 1)

A gene detection kit for realizing the gene detection method of claim 1, comprising: a box body with a flip lid at a top, wherein, a lysing section and a washing section separated by the plunger are respectively provided in the box body from top to bottom, and a reaction section is provided below the washing section, a number of the washing section is at least one, the plunger is provided horizontally, and a plunger hole in a vertical direction is provided in the plunger; the lysing section is provided with the lysing solution, and the lysing solution is internally provided with ferromagnetic mixing balls and magnetic beads configured to pass through the plunger hole; the washing section is provided with the washing solution; and the reaction section is provided with the reaction solution.

### Claim 5 (depends on 4)

The gene detection kit of claim 4, wherein, a steel tube coated with an enzyme is provided in the plunger hole of the plunger between the washing section and the reaction section.

### Claim 6 (depends on 4)

The gene detection kit of claim 4, wherein, a spring is provided at an end of the plunger, an ejector rod protruding outside the box body is connected to the other end of the plunger; and a slope is provided at a lower side of an outer end of the ejector rod.

### Claim 7 (depends on 4)

The gene detection kit of claim 4, wherein, the reaction section is located in the box body, and a hidden section recessed toward an outside of the box body is provided at a bottom of the reaction section.

### Claim 8 (depends on 4)

The gene detection kit of claim 4, wherein, the plunger hole has a taper of 3°-5° and a center diameter of 3-5 mm, a bottom end of the lysing section is configured as a narrow-necked opening having a wide top and a narrow bottom, and each side of the narrow-necked opening is at an included angle of 25°-35° with a vertical direction.

### Claim 9 (depends on 4)

The gene detection kit of claim 4, wherein, the washing section is provided outside the box body, and the washing section is configured to be a thin-walled transparent cone-shaped tube.

### Claim 10 (depends on 1)

A gene detection device for realizing the gene detection method of claim 1, comprising: a kit holding tank, wherein, an electromagnetic coil array composed of a plurality of electromagnetic coils is provided at one side of the kit holding tank, and a plurality of heating aluminum blocks closely attached to the kit holding tank are provided at an other side of the kit holding tank, and a refrigerating fin is provided on each of the heating aluminum blocks; a detecting optical fiber having a top end directly facing a tank bottom is provided at the tank bottom of the kit holding tank, and the detecting optical fiber is connected to an optical detection module.

### Claim 11 (depends on 10)

The gene detection device of claim 10, wherein, an occulting bar in a depth direction of the tank is provided in the kit holding tank, during a process of inserting the kit into the kit holding tank, the occulting bar sequentially pushes the each plunger of the kit to move, thereby making all the plurality of separation cavities interconnected in the kit.

### Claim 12 (depends on 10)

The gene detection device of claim 10, wherein, the kit holding tank is provided obliquely at an included angle of 30° to 60° with the vertical direction.

### Claim 13 (depends on 10)

The gene detection device of claim 10, wherein, the electromagnetic coil array comprises a mixing array and a dragging array, the mixing array comprises a plurality of electromagnetic coils arranged in an annular distribution and close to a position of an opening of the kit holding tank, the dragging array comprises a plurality of electromagnetic coils linearly arranged from the mixing array to the bottom of the kit holding tank.

### Claim 14 (depends on 10)

The gene detection device of claim 10, wherein, the electromagnetic coils of the dragging array are divided into two rows including a left row and a right row, any one electromagnetic coil of one of the two rows is opposite to a space between two adjacent electromagnetic coils of the other one of the two rows.

### Claim 15 (depends on 10)

The gene detection device of claim 10, wherein, a heat dissipating aluminum block is provided on the electromagnetic coil array, and a heat dissipating fin is provided on the refrigerating fin.

### Claim 16 (depends on 4)

The gene detection kit of claim 4, wherein, the reaction is a polymerase chain reaction or an isothermal amplification reaction, an enzyme required for the reaction is provided in the plunger hole of the plunger, and when the plunger hole of the plunger is aligned with the separation cavity containing the reaction solution, the enzyme automatically falls into the reaction solution due to a gravity of the enzyme.

### Claim 17 (depends on 4)

The gene detection kit of claim 4, wherein, a detection portion of the optical detection is located at a bottom of the separation cavity containing the reaction solution, and the bottom of the separation cavity containing the reaction solution is provided with a concave portion toward an outside of the kit; during a detection, the kit is in an inclined state, and the concave portion of the separation cavity containing the reaction solution faces downward, and the magnetic beads in the reaction solution are automatically concealed in the concave portion to avoid an interference on the optical detection.

### Claim 18 (depends on 10)

The gene detection device of claim 10, wherein, the reaction is a polymerase chain reaction (PCR) or an isothermal amplification reaction, an enzyme required for the reaction is provided in the plunger hole of the plunger, and when the plunger hole of the plunger is aligned with the separation cavity containing the reaction solution, the enzyme automatically falls into the reaction solution due to a gravity of the enzyme.

### Claim 19 (depends on 10)

The gene detection device of claim 10, wherein, a detection portion of the optical detection is located at a bottom of the separation cavity containing the reaction solution, and the bottom of the separation cavity containing the reaction solution is provided with a concave portion toward an outside of the kit; during a detection, the kit is in an inclined state, and the concave portion of the separation cavity containing the reaction solution faces downward, and the magnetic beads in the reaction solution are automatically concealed in the concave portion to avoid an interference on the optical detection.