# US 2025/0153162 A1 · Dual-component system and device for processing and analyzing polymerase chain reactions within a cartridge and corresponding methods of use

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- Number: US 2025/0153162 A1
- Document ID: US20250153162A1
- Status: Published application
- Kind: A1
- Application number: 18/942,193
- Filed: 2024-11-08
- Published: 2025-05-15
- Earliest claimed: 2023-11-09
- Assignees: InBios International, Inc.
- Applicants: InBios International, Inc.
- Inventors: James William Needham; Suvro Datta; Hillary Cartwright; Sharon Choi
- Web page: https://patentgrep.com/patent/US20250153162A1

## CPC

- B01L 3/502: {with fluid transport, e.g. in multi-compartment structures}
- B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces}
- B01L 3/50273: {characterised by the means or forces applied to move the fluids}
- B01L 7/52: {with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples}
- C12Q 1/686: Polymerase chain reaction [PCR]
- B01L 2200/026: Fluid interfacing between devices or objects, e.g. connectors, inlet details
- B01L 2200/027: for microfluidic devices
- B01L 2200/0684: Venting, avoiding backpressure, avoid gas bubbles
- B01L 2200/10: Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
- B01L 2200/16: Reagents, handling or storing thereof
- B01L 2300/048: enabling gas exchange, e.g. vents
- B01L 2300/0816: Cards, e.g. flat sample carriers usually with flow in two horizontal directions
- B01L 2300/0867: Multiple inlets and one sample wells, e.g. mixing, dilution
- B01L 2300/087: Multiple sequential chambers
- B01L 2300/0883: Serpentine channels
- B01L 2400/0406: capillary forces
- B01L 2400/0457: passive flow or gravitation
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- 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

## Abstract

A two-component system and device for efficient analysis of Nucleic Acid Amplification Tests (NAAT) on a cartridge that is portable, low cost, delivers rapid results with direct sample application, minimal sample volume, and has a user-friendly interface. The system and device can be used to perform NAAT reactions, either thermal or isothermal and either in single-plex or multi-plex, on a sample within a single-use test cartridge that is integrated for use with a reusable separately housed amplification module and analysis module to generate test results.

## Claims

### Claim 1

A test cartridge comprising a controlled fluid pathway connecting a sample receiving port to a siphon U-turn.

### Claim 2 (depends on 1)

The test cartridge of claim 1, further comprising a buffer mixing zone between the sample receiving port and the siphon U-turn.

### Claim 3 (depends on 1)

The test cartridge of claim 1, wherein the controlled fluid pathway also connects the siphon U-turn to a drawing tunnel, and the drawing tunnel connects to a reaction well.

### Claim 4 (depends on 1)

The test cartridge of claim 1, further comprising at least one of: a buffer region; a buffer control area; pre-loaded lyophilized reagent materials; and a vent connected to the reaction well.

### Claim 5 (depends on 1)

The test cartridge of claim 1, wherein the test cartridge comprises a reaction well sized and shaped to facilitate a thin spread of a solubilized reaction mixture over an internal surface area and, optionally, wherein the reaction well comprises a narrow zigzag pathway structure.

### Claim 6 (depends on 1)

The test cartridge of claim 1, wherein a sample introduced to the sample receiving port is automatically fully processed.

### Claim 7

A two-component device comprising:
a. a first component test cartridge; and
b. a second component comprising an amplification module and an analysis module.

### Claim 8 (depends on 7)

The device of claim 7, wherein the first component and the second component are readily combined.

### Claim 9 (depends on 7)

The device of claim 7, wherein the first component and the second component are readily separable.

### Claim 10 (depends on 7)

The device of claim 7, wherein the first component is a single-use test cartridge.

### Claim 11 (depends on 7)

The device of claim 7, wherein the second component further comprises a separate housing.

### Claim 12 (depends on 7)

The device of claim 7, wherein the first component test cartridge comprises a controlled fluid pathway comprising a siphon U-turn.

### Claim 13 (depends on 7)

The device of claim 7, wherein the first component test cartridge comprises a sample receiving port.

### Claim 14 (depends on 7)

The device of claim 7, wherein the first component test cartridge can be inserted into the second component in a generally vertical orientation.

### Claim 15 (depends on 7)

The device of claim 7, wherein the second component amplification module includes one or more thermal cycling components.

### Claim 16 (depends on 7)

The device of claim 7, wherein the first component test cartridge comprises a reaction well and, optionally, wherein the reaction well comprises a narrow zigzag pathway structure.

### Claim 17 (depends on 7)

The device of claim 7, wherein the reaction well of the first component test cartridge is configured to coincide with one or more thermal cycling components included in the second component amplification module.

### Claim 18 (depends on 7)

The device of claim 7, wherein temperature control is maintained within ±0.5° C. of a set point temperature over a 20 second time period, and this is reproducibly generated over a standard 40-cycle PCR run.

### Claim 19 (depends on 1)

A method of using the test cartridge of claim 1 to generate PCR test results in either a single plex or multiplex format.

### Claim 20 (depends on 8)

A method of using the device of claim 8 to generate PCR results in either a single plex or multiplex format.