# US 11,307,164 B2 · Lateral flow assay with controlled conjugate time and controlled flow time

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- Number: US 11,307,164 B2
- Document ID: US11307164B2
- Status: Granted
- Kind: B2
- Application number: 17/332,989
- Filed: 2021-05-27
- Published: 2021-09-16
- Granted: 2022-04-19
- Earliest claimed: 2018-11-28
- Assignees: 2Pi-Sigma Corp.
- Applicants: 2Pi-Sigma Corp.
- Inventors: Mehdi Hatamian
- Web page: https://patentgrep.com/patent/US11307164B2

## CPC

- B01L 3/5023: {with a sample being transported to, and subsequently stored in an absorbent for analysis}
- G01N 27/3275: {Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction}
- B01L 3/502: {with fluid transport, e.g. in multi-compartment structures}
- B01L 9/52: {Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips}
- G01N 33/53: Immunoassay; Biospecific binding assay; Materials therefor
- G01N 33/54388: {based on lateral flow}
- B01L 2200/026: Fluid interfacing between devices or objects, e.g. connectors, inlet details
- B01L 2300/0636: Integrated biosensor, microarrays
- B01L 2300/069: Absorbents; Gels to retain a fluid
- B01L 2300/0825: Test strips
- B01L 2300/0887: Laminated structure
- B01L 2400/0406: capillary forces
- B01L 2400/0475: specific mechanical means and fluid pressure
- B01L 2400/0633: with moving parts
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

A lateral flow assay device comprising a conjugate pad for receiving a quantity of fluid, and a membrane comprising a test line for determining whether the fluid comprises a target analyte. The device includes an actuator connected to a moving element comprising a shaft or a wheel. A first magnet is connected to the backing of the membrane. Second and third magnets are connected to the moving element. The actuator moves the moving element between first and second positions. In the first position, the opposite poles of the first and second magnets attract each other and maintain a gap between the membrane and the conjugate pad separate. In the second position, the similar poles of the first and third magnets repel each other and close the gap between membrane and the conjugate pad, allowing the fluid to flow from the conjugate pad into the membrane and the test line.

## Claims

### Claim 1

A lateral flow assay device, comprising:
a conjugate pad configured to receive a quantity of fluid after a start of a test, the conjugate pad configured to move the fluid by capillary action;
a membrane comprising a test line for determining whether the fluid comprises a target analyte, the membrane configured to move the fluid by capillary action;
a backing connected to the membrane;
a first magnet fixedly attached to the backing of the membrane, the first magnet comprising a first north pole and a second south pole;
a shaft connected to a second magnet and a third magnet, the second magnet comprising a north pole and a south pole, and positioned on the shaft such that the north pole of the second magnet is closer to the first magnet than the south pole of the second magnet, the third magnet comprising a north pole and a south pole, and positioned on the shaft such that the south pole of the third magnet is closer to the first magnet than the north pole of the third magnet;
an actuator connected to the shaft;
wherein the actuator is configured to receive one or more signals to move the shaft to a first position such that the north pole of the second magnet attracts the south pole of the first magnet to open a gap between the membrane and the conjugate pad, wherein the actuator is configured to keep the shaft at the first position prior to the start of the test; and
wherein the actuator is configured to receive one or more signals to move the shaft to a second position such that the south pole of the third magnet repels the south pole of the first magnet to close the gap between the membrane and the conjugate pad; and
a processor configured to:
receive a signal indicating the start of the test; and
send one or more signals after the start of the test to the actuator to move the shaft between the first and second positions to open and close the gap between the membrane and the conjugate pad a plurality of times to control an amount of time that the fluid travels across the membrane.

### Claim 2 (depends on 1)

The lateral flow assay device of claim 1, wherein the actuator is configured to move the shaft in a linear direction between the first and second positions.

### Claim 3 (depends on 1)

The lateral flow assay device of claim 1,
wherein the processor is configured to receive a conjugate time indicating an amount of time required for the fluid to remain on the conjugate pad prior to the membrane making contact with the conjugate pad; and
wherein the processor is configured to generate the one or more signals to change a direction of a current received by the actuator after determining that the conjugate time has elapsed since the start of the test.

### Claim 4 (depends on 1)

The lateral flow assay device of claim 1, wherein the actuator is a first actuator, and wherein the shaft is a first shaft, the lateral flow assay device further comprising:
a wicking pad;
a backing connected to the wicking pad;
a fourth magnet attached to the backing of the membrane, the fourth magnet comprising a north pole and a south pole;
a second shaft connected to a fifth magnet and a sixth magnet, the fifth magnet comprising a north pole and a south pole, and positioned on the second shaft such that the north pole of the fifth magnet is closer to the fourth magnet than the south pole of the fifth magnet, the sixth magnet comprising a north pole and a south pole, and positioned on the second shaft such that the south pole of the sixth magnet is closer to the fourth magnet than the north pole of the sixth magnet; and
a second actuator connected to the second shaft;
wherein the second actuator is configured to receive one or more signals to move the second shaft to a first position of the second shaft such that the north pole of the fifth magnet attracts the south pole of the fourth magnet to open a gap between the membrane and the wicking pad;
wherein the second actuator is configured to receive one or more signals to move the second shaft to a second position of the second shaft such that the south pole of the sixth magnet repels the south pole of the fourth magnet to close the gap between the membrane and the wicking pad;
wherein the processor is configured to:
send one or more signals after the start of the test to the second actuator to move the second shaft between the first and second positions of the second shaft to open and close the gap between the membrane and the wicking pad a plurality of times to control an amount of time that the fluid travels from the membrane into the wicking pad.

### Claim 5 (depends on 1)

The lateral flow assay device of claim 1, wherein the processor is configured to:
receive a value for a flow time indicating the amount of time that the fluid travels across the membrane;
determine, based on the value of the flow time, a duration for the conjugate pad and the membrane to have contact with each other, a duration for the conjugate pad and the membrane to have no contact with each other, and a number of times to connect and disconnect the conjugate pad and the membrane; and
generate said one or more signals to change the direction of an electric current received by the actuator by using the duration for the conjugate pad and the membrane to have contact with each other, the duration for the conjugate pad and the membrane to have no contact with each other, and the number of times to connect and disconnect the conjugate pad and the membrane.

### Claim 6 (depends on 5)

The lateral flow assay device of claim 5, wherein the processor is configured to control a flow rate of the fluid across the membrane by changing the duration for the conjugate pad and the membrane to have contact with each other a plurality of times.

### Claim 7 (depends on 5)

The lateral flow assay device of claim 5, wherein the processor is configured to control a flow rate of the fluid across the membrane by changing the duration for the conjugate pad and the membrane to have no contact with each other a plurality of times.

### Claim 8 (depends on 5)

The lateral flow assay device of claim 5, wherein the processor is configured to determine the duration for the conjugate pad and the membrane to have contact with each other, and the duration for the conjugate pad and the membrane to have no contact with each other by using experimental values stored in a one or more tables that map the duration for the conjugate pad and the membrane to have contact with each other, and the duration for the conjugate pad and the membrane to have no contact with each other to a set of flow times.

### Claim 9 (depends on 1)

The lateral flow assay device of claim 1, wherein the actuator is one of:
an electromagnet comprising an electromagnetically inductive coil wrapped around a metallic core, wherein the coil is configured to generate a magnetic field in a first direction when the actuator receives the current in the first direction, and wherein the coil is configured to generate a magnetic field in a second direction when the actuator receives the current in the second direction;
a piezoelectric actuator configured to convert an electrical current into a displacement;
a piezoelectric stack actuator comprising a stack of piezoelectric ceramic discs and metal electrode foils, the actuator configured to convert an electrical current into a displacement; and
an electric motor configured to convert the rotational movement of a rotating shaft to linear movement.

### Claim 10

A lateral flow assay device, comprising:
a conjugate pad configured to receive a quantity of fluid after a start of a test, the conjugate pad configured to move the fluid by capillary action;
a membrane comprising a test line for determining whether the fluid comprises a target analyte, the membrane configured to move the fluid by capillary action;
a backing connected to the membrane;
a first magnet fixedly attached to the backing of the membrane, the first magnet comprising a north pole and a south pole;
a shaft connected to a second magnet and a third magnet, the second magnet comprising a north pole and a south pole, and positioned on the shaft such that the north pole of the second magnet is closer to the first magnet than the south pole of the second magnet, the third magnet comprising a north pole and a south pole, and positioned on the shaft such that the south pole of the third magnet is closer to the first magnet than the north pole of the third magnet;
an actuator connected to the shaft; and
wherein the actuator is configured to receive one or more signals to move the shaft to a first position such that the north pole of the second magnet repels the north pole of the first magnet to open a gap between the membrane and the conjugate pad, wherein the actuator is configured to keep the shaft at the first position prior to the start of the test; and
wherein the actuator is configured to receive one or more signals to move the shaft to a second position such that the south pole of the third magnet attracts the north pole of the first magnet to close the gap between the membrane and the conjugate pad; and
a processor configured to:
receive a signal indicating the start of the test; and
send one or more signals after the start of the test to the actuator to move the shaft between the first and second positions to open and close the gap between the membrane and the conjugate pad a plurality of times to control an amount of time that the fluid travels across the membrane.

### Claim 11 (depends on 10)

The lateral flow assay device of claim 10, wherein the actuator is configured to move the shaft in a linear direction between the first and second positions.

### Claim 12 (depends on 10)

The lateral flow assay device of claim 10,
wherein the processor is configured to receive a conjugate time indicating an amount of time required for the fluid to remain on the conjugate pad prior to the membrane making contact with the conjugate pad; and
wherein the processor is configured to generate the one or more signals to change a direction of a current received by the actuator after determining that the conjugate time has elapsed since the start of the test.

### Claim 13 (depends on 10)

The lateral flow assay device of claim 10, wherein the actuator is a first actuator, and wherein the shaft is a first shaft, the lateral flow assay device further comprising:
a wicking pad;
a backing connected to the wicking pad;
a fourth magnet attached to the backing of the membrane, the fourth magnet comprising a north pole and a south pole;
a second shaft connected to a fifth magnet and a sixth magnet, the fifth magnet comprising a north pole and a south pole, and positioned on the second shaft such that the north pole of the fifth magnet is closer to the fourth magnet than the south pole of the fifth magnet, the sixth magnet comprising a north pole and a south pole, and positioned on the second shaft such that the south pole of the sixth magnet is closer to the fourth magnet than the north pole of the sixth magnet; and
a second actuator connected to the second shaft;
wherein the second actuator is configured to receive one or more signals to move the second shaft to a first position of the second shaft such that the north pole of the fifth magnet repels the north pole of the fourth magnet to open a gap between the membrane and the wicking pad;
wherein the second actuator is configured to receive one or more signals to move the second shaft to a second position of the second shaft such that the south pole of the sixth magnet attracts the north pole of the fourth magnet to close the gap between the membrane and the wicking pad;
wherein the processor is configured to:
send one or more signals after the start of the test to the second actuator to move the second shaft between the first and second positions of the second shaft to open and close the gap between the membrane and the wicking pad a plurality of times to control an amount of time that the fluid travels from the membrane into the wicking pad.

### Claim 14 (depends on 10)

The lateral flow assay device of claim 10, wherein the processor is configured to:
receive a value for a flow time indicating the amount of time that the fluid travels across the membrane;
determine, based on the value of the flow time, a duration for the conjugate pad and the membrane to have contact with each other, a duration for the conjugate pad and the membrane to have no contact with each other, and a number of times to connect and disconnect the conjugate pad and the membrane; and
generate said one or more signals to change the direction of an electric current received by the actuator by using the duration for the conjugate pad and the membrane to have contact with each other, the duration for the conjugate pad and the membrane to have no contact with each other, and the number of times to connect and disconnect the conjugate pad and the membrane.

### Claim 15 (depends on 14)

The lateral flow assay device of claim 14, wherein the processor is configured to control a flow rate of the fluid across the membrane by changing the duration for the conjugate pad and the membrane to have contact with each other a plurality of times.

### Claim 16 (depends on 14)

The lateral flow assay device of claim 14, wherein the processor is configured to control a flow rate of the fluid across the membrane by changing the duration for the conjugate pad and the membrane to have no contact with each other a plurality of times.

### Claim 17 (depends on 14)

The lateral flow assay device of claim 14, wherein the processor is configured to determine the duration for the conjugate pad and the membrane to have contact with each other, and the duration for the conjugate pad and the membrane to have no contact with each other by using experimental values stored in a one or more tables that map the duration for the conjugate pad and the membrane to have contact with each other, and the duration for the conjugate pad and the membrane to have no contact with each other to a set of flow times.

### Claim 18 (depends on 10)

The lateral flow assay device of claim 10, wherein the actuator is one of:
an electromagnet comprising an electromagnetically inductive coil wrapped around a metallic core, wherein the coil is configured to generate a magnetic field in a first direction when the actuator receives the current in the first direction, and wherein the coil is configured to generate a magnetic field in a second direction when the actuator receives the current in the second direction;
a piezoelectric actuator configured to convert an electrical current into a displacement;
a piezoelectric stack actuator comprising a stack of piezoelectric ceramic discs and metal electrode foils, the actuator configured to convert an electrical current into a displacement; and
an electric motor configured to convert the rotational movement of a rotating shaft to linear movement.

### Claim 19

A lateral flow assay device, comprising:
a conjugate pad configured to receive a quantity of fluid after a start of a test, the conjugate pad configured to move the fluid by capillary action;
a membrane comprising a test line for determining whether the fluid comprises a target analyte, the membrane configured to move the fluid by capillary action;
a backing connected to the membrane;
a first magnet fixedly attached to the backing of the membrane, the first magnet comprising a north pole and a south pole;
a shaft connected to a second magnet and a third magnet, the second magnet comprising a north pole and a south pole, and positioned on the shaft such that the south pole of the second magnet is closer to the first magnet than the north pole of the second magnet, the third magnet comprising a north pole and a south pole, and positioned on the shaft such that the north pole of the third magnet is closer to the first magnet than the south pole of the third magnet;
an actuator connected to the shaft;
wherein the actuator is configured to receive one or more signals to move the shaft to a first position such that the south pole of the second magnet attracts the north pole of the first magnet to open a gap between the membrane and the conjugate pad, wherein the actuator is configured to keep the shaft at the first position prior to the start of the test; and
wherein the actuator is configured to receive one or more signals to move the shaft to a second position such that the north pole of the third magnet repels the north pole of the first magnet to close the gap between the membrane and the conjugate pad; and
a processor configured to:
receive a signal indicating the start of the test; and
send one or more signals after the start of the test to the actuator to move the shaft between the first and second positions to open and close the gap between the membrane and the conjugate pad a plurality of times to control an amount of time that the fluid travels across the membrane.

### Claim 20 (depends on 19)

The lateral flow assay device of claim 19, wherein the actuator is configured to move the shaft in a linear direction between the first and second positions.

### Claim 21 (depends on 19)

The lateral flow assay device of claim 19,
wherein the processor is configured to receive a conjugate time indicating an amount of time required for the fluid to remain on the conjugate pad prior to the membrane making contact with the conjugate pad; and
wherein the processor is configured to generate the one or more signals to change a direction of a current received by the actuator after determining that the conjugate time has elapsed since the start of the test.

### Claim 22 (depends on 19)

The lateral flow assay device of claim 19, wherein the actuator is a first actuator, and wherein the shaft is a first shaft, the lateral flow assay device further comprising:
a wicking pad;
a backing connected to the wicking pad;
a fourth magnet attached to the backing of the membrane, the fourth magnet comprising a north pole and a south pole;
a second shaft connected to a fifth magnet and a sixth magnet, the fifth magnet comprising a north pole and a south pole, and positioned on the second shaft such that the south pole of the fifth magnet is closer to the fourth magnet than the north pole of the fifth magnet, the sixth magnet comprising a north pole and a south pole, and positioned on the second shaft such that the north pole of the sixth magnet is closer to the fourth magnet than the south pole of the sixth magnet; and
a second actuator connected to the second shaft;
wherein the second actuator is configured to receive one or more signals to move the second shaft to a first position of the second shaft such that the south pole of the fifth magnet attracts the north pole of the fourth magnet to open a gap between the membrane and the wicking pad;
wherein the second actuator is configured to receive one or more signals to move the second shaft to a second position of the second shaft such that the north pole of the sixth magnet repels the north pole of the fourth magnet to close the gap between the membrane and the wicking pad;
wherein the processor is configured to:
send one or more signals after the start of the test to the second actuator to move the second shaft between the first and second positions of the second shaft to open and close the gap between the membrane and the wicking pad a plurality of times to control an amount of time that the fluid travels from the membrane into the wicking pad.

### Claim 23 (depends on 19)

The lateral flow assay device of claim 19, wherein the processor is configured to:
receive a value for a flow time indicating the amount of time that the fluid travels across the membrane;
determine, based on the value of the flow time, a duration for the conjugate pad and the membrane to have contact with each other, a duration for the conjugate pad and the membrane to have no contact with each other, and a number of times to connect and disconnect the conjugate pad and the membrane; and
generate said one or more signals to change the direction of an electric current received by the actuator by using the duration for the conjugate pad and the membrane to have contact with each other, the duration for the conjugate pad and the membrane to have no contact with each other, and the number of times to connect and disconnect the conjugate pad and the membrane.

### Claim 24 (depends on 23)

The lateral flow assay device of claim 23, wherein the processor is configured to control a flow rate of the fluid across the membrane by changing the duration for the conjugate pad and the membrane to have contact with each other a plurality of times.

### Claim 25 (depends on 23)

The lateral flow assay device of claim 23, wherein the processor is configured to control a flow rate of the fluid across the membrane by changing the duration for the conjugate pad and the membrane to have no contact with each other a plurality of times.

### Claim 26 (depends on 23)

The lateral flow assay device of claim 23, wherein the processor is configured to determine the duration for the conjugate pad and the membrane to have contact with each other, and the duration for the conjugate pad and the membrane to have no contact with each other by using experimental values stored in a one or more tables that map the duration for the conjugate pad and the membrane to have contact with each other, and the duration for the conjugate pad and the membrane to have no contact with each other to a set of flow times.

### Claim 27 (depends on 19)

The lateral flow assay device of claim 19, wherein the actuator is one of:
an electromagnet comprising an electromagnetically inductive coil wrapped around a metallic core, wherein the coil is configured to generate a magnetic field in a first direction when the actuator receives the current in the first direction, and wherein the coil is configured to generate a magnetic field in a second direction when the actuator receives the current in the second direction;
a piezoelectric actuator configured to convert an electrical current into a displacement;
a piezoelectric stack actuator comprising a stack of piezoelectric ceramic discs and metal electrode foils, the actuator configured to convert an electrical current into a displacement; and
an electric motor configured to convert the rotational movement of a rotating shaft to linear movement.

### Claim 28

A lateral flow assay device, comprising:
a conjugate pad configured to receive a quantity of fluid after a start of a test, the conjugate pad configured to move the fluid by capillary action;
a membrane comprising a test line for determining whether the fluid comprises a target analyte, the membrane configured to move the fluid by capillary action;
a backing connected to the membrane;
a first magnet fixedly attached to the backing of the membrane, the first magnet comprising a north pole and a south pole;
a shaft connected to a second magnet and a third magnet, the second magnet comprising a north pole and a south pole, and positioned on the shaft such that the south pole of the second magnet is closer to the first magnet than the north pole of the second magnet, the third magnet comprising a north pole and a south pole, and positioned on the shaft such that the north pole of the third magnet is closer to the first magnet than the south pole of the third magnet;
an actuator connected to the shaft; and
wherein the actuator is configured to receive one or more signals to move the shaft to a first position such that the south pole of the second magnet repels the south pole of the first magnet to open a gap between the membrane and the conjugate pad, wherein the actuator is configured to keep the shaft at the first position prior to the start of the test; and
wherein the actuator is configured to receive one or more signals to move the shaft to a second position such that the north pole of the third magnet attracts the south pole of the first magnet to close the gap between the membrane and the conjugate pad; and
a processor configured to:
receive a signal indicating the start of the test; and
send one or more signals after the start of the test to the actuator to move the shaft between the first and second positions to open and close the gap between the membrane and the conjugate pad a plurality of times to control an amount of time that the fluid travels across the membrane.

### Claim 29 (depends on 28)

The lateral flow assay device of claim 28, wherein the actuator is configured to move the shaft in a linear direction between the first and second positions.

### Claim 30 (depends on 28)

The lateral flow assay device of claim 28,
wherein the processor is configured to receive a conjugate time indicating an amount of time required for the fluid to remain on the conjugate pad prior to the membrane making contact with the conjugate pad; and
wherein the processor is configured to generate the one or more signals to change a direction of a current received by the actuator after determining that the conjugate time has elapsed since the start of the test.

### Claim 31 (depends on 28)

The lateral flow assay device of claim 28, wherein the actuator is a first actuator, and wherein the shaft is a first shaft, the lateral flow assay device further comprising:
a wicking pad;
a backing connected to the wicking pad;
a fourth magnet attached to the backing of the membrane, the fourth magnet comprising a north pole and a south pole;
a second shaft connected to a fifth magnet and a sixth magnet, the fifth magnet comprising a north pole and a south pole, and positioned on the second shaft such that the south pole of the fifth magnet is closer to the fourth magnet than the north pole of the fifth magnet, the sixth magnet comprising a north pole and a south pole, and positioned on the second shaft such that the north pole of the sixth magnet is closer to the fourth magnet than the south pole of the sixth magnet; and
a second actuator connected to the second shaft;
wherein the second actuator is configured to receive one or more signals to move the second shaft to a first position of the second shaft such that the south pole of the fifth magnet repels the south pole of the fourth magnet to open a gap between the membrane and the wicking pad;
wherein the second actuator is configured to receive one or more signals to move the second shaft to a second position of the second shaft such that the north pole of the sixth magnet attracts the south pole of the fourth magnet to close the gap between the membrane and the wicking pad;
wherein the processor is configured to:
send one or more signals after the start of the test to the second actuator to move the second shaft between the first and second positions of the second shaft to open and close the gap between the membrane and the wicking pad a plurality of times to control an amount of time that the fluid travels from the membrane into the wicking pad.

### Claim 32 (depends on 28)

The lateral flow assay device of claim 28, wherein the processor is configured to:
receive a value for a flow time indicating the amount of time that the fluid travels across the membrane;
determine, based on the value of the flow time, a duration for the conjugate pad and the membrane to have contact with each other, a duration for the conjugate pad and the membrane to have no contact with each other, and a number of times to connect and disconnect the conjugate pad and the membrane; and
generate said one or more signals to change the direction of an electric current received by the actuator by using the duration for the conjugate pad and the membrane to have contact with each other, the duration for the conjugate pad and the membrane to have no contact with each other, and the number of times to connect and disconnect the conjugate pad and the membrane.

### Claim 33 (depends on 32)

The lateral flow assay device of claim 32, wherein the processor is configured to control a flow rate of the fluid across the membrane by changing the duration for the conjugate pad and the membrane to have contact with each other a plurality of times.

### Claim 34 (depends on 32)

The lateral flow assay device of claim 32, wherein the processor is configured to control a flow rate of the fluid across the membrane by changing the duration for the conjugate pad and the membrane to have no contact with each other a plurality of times.

### Claim 35 (depends on 32)

The lateral flow assay device of claim 32, wherein the processor is configured to determine the duration for the conjugate pad and the membrane to have contact with each other, and the duration for the conjugate pad and the membrane to have no contact with each other by using experimental values stored in a one or more tables that map the duration for the conjugate pad and the membrane to have contact with each other, and the duration for the conjugate pad and the membrane to have no contact with each other to a set of flow times.

### Claim 36 (depends on 28)

The lateral flow assay device of claim 28, wherein the actuator is one of:
an electromagnet comprising an electromagnetically inductive coil wrapped around a metallic core, wherein the coil is configured to generate a magnetic field in a first direction when the actuator receives the current in the first direction, and wherein the coil is configured to generate a magnetic field in a second direction when the actuator receives the current in the second direction;
a piezoelectric actuator configured to convert an electrical current into a displacement;
a piezoelectric stack actuator comprising a stack of piezoelectric ceramic discs and metal electrode foils, the actuator configured to convert an electrical current into a displacement; and
an electric motor configured to convert the rotational movement of a rotating shaft to linear movement.