# US 2023/0053732 A1 · Sample holders, pcr station assemblies, and methods of operating pcr testing system

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2023/0053732 A1
- Document ID: US20230053732A1
- Status: Published application
- Kind: A1
- Application number: 17/759,378
- Filed: 2021-02-08
- Published: 2023-02-23
- Earliest claimed: 2020-03-16
- Assignees: Siemens Healthcare Diagnostics Inc.
- Applicants: Siemens Healthcare Diagnostics Inc.
- Inventors: Daniel CHU; Paul PATT; Garret BAUTISTA; David John GUCKENBERGER, JR.
- Web page: https://patentgrep.com/patent/US20230053732A1

## CPC

- B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces}
- B01L 3/565: {Seals}
- B01L 7/52: {with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples}
- B01L 9/50: {Clamping means, e.g. tongs}
- G01N 33/487: of liquid biological material
- B01L 2200/0689: Sealing
- B01L 2200/12: Specific details about manufacturing devices
- B01L 2200/147: Employing temperature sensors
- B01L 2300/12: Specific details about materials
- C12Q 1/686: Polymerase chain reaction [PCR]
- 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)
- 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 sample holder for PCR processing. The sample holder includes a body with an inlet and outlet grooves formed alongside each other, a detection recess that is connected to the inlet and outlet grooves, and a fill port interconnected to both the inlet and outlet grooves, and a cover interfacing with the body to form an inlet channel interconnected to the fill port, a detection region interconnected to the inlet channel, and an outlet channel interconnected to the detection region and the fill port. The detection region is configured to receive a PCR solution from the fill port and replication occurs within the detection region via heating and cooling cycles. Thereafter, fluorescent emissions from tagged replicated DNA/RNA in the detection region are detected and measured. PCR stations, PCR station assemblies, PCR testing systems, and methods of operating a PCR testing systems are provided, as are other aspects.

## Claims

### Claim 1

A sample holder, comprising:
a body having a top surface and a bottom surface, the body further comprising:
an inlet groove formed into the bottom surface;
an outlet groove formed into the bottom surface alongside the inlet groove;
a detection recess formed into the bottom surface and connected to the inlet groove and the outlet groove;
a fill port interconnected to both the inlet groove and the outlet groove; and
a cover connected to the bottom surface wherein the cover interfaces with the body to form an inlet channel interconnected to the fill port, a detection region interconnected to the inlet channel, and an outlet channel interconnected to the detection region and the fill port.

### Claim 2 (depends on 1)

The sample holder assembly of claim 1, wherein the inlet channel comprises an inlet first channel portion and an inlet second channel portion that is wider than the inlet first channel portion.

### Claim 3 (depends on 1)

The sample holder assembly of claim 1, wherein the outlet channel comprises an outlet first channel portion and an outlet second channel portion that is wider than the outlet first channel portion.

### Claim 4 (depends on 1)

The sample holder assembly of claim 1, wherein a volume of a PCR solution contained in the sample holder when undergoing detection is from 3 μL to 20 μL.

### Claim 5 (depends on 1)

The sample holder assembly of claim 1, wherein the cover connected to the bottom surface comprises a film of a plastic or metal material.

### Claim 6 (depends on 1)

The sample holder assembly of claim 1, wherein the body is formed of a transparent or translucent material.

### Claim 7 (depends on 1)

The sample holder assembly of claim 1, comprising providing at least one sealing member to seal a PCR solution in the reservoir.

### Claim 8 (depends on 7)

The sample holder assembly of claim 7, wherein the at least one sealing member comprises a heat-sealed area or a deformed area along the length of one or more of the inlet channel and the outlet channel.

### Claim 9 (depends on 7)

The sample holder assembly of claim 7, wherein the at least one sealing member can be a sealing film sealed to a top of the fill port.

### Claim 10 (depends on 7)

The sample holder assembly of claim 7, wherein the at least one sealing member comprises two sealed areas along at least one of the first channel or the second channel, or both.

### Claim 11 (depends on 1)

A PCR station assembly, comprising:
a base configured to receive a sample holder of claim 1;
a clamp member configured to secure the sample holder to the base; and
a temperature-controlling element operable to heat and cool the base in intimate thermal contact with the sample holder.

### Claim 12 (depends on 11)

The PCR station assembly of claim 11, comprising a thermal sensor thermally coupled to the base.

### Claim 13 (depends on 11)

The PCR station assembly of claim 11, wherein the temperature-controlling element is configured to produce temperature cycles of between about 55° C. to about 95° C.

### Claim 14

A method of operating a PCR testing system, comprising:
providing a PCR station comprising a base, a clamp member, and a temperature-controlling element thermally coupled to the base;
securing a sample holder between the base and clamp member, the sample holder including an inlet channel interconnected to a fill port, a detection region interconnected to the inlet channel, and an outlet channel interconnected to the detection region and the fill port;
inserting a volume of PCR solution into the fill port thus filling the detection region;
subjecting the PCR solution to heating and cooling by subjecting the base to cycles of heating and cooling with the temperature-controlling element to replicate tagged DNA/RNA templates to produce tagged replicated DNA/RNA; and
after a predetermined number of heating and cooling cycles, measuring fluorescent emissions from the detecting region with an optical interrogation apparatus by exciting the tagged replicated DNA/RNA with a particular wavelength of light.
