# US 10,371,636 B2 · Modular testing device for analyzing biological samples

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- Number: US 10,371,636 B2
- Document ID: US10371636B2
- Status: Granted
- Kind: B2
- Application number: 15/561,901
- Filed: 2016-03-25
- Published: 2018-07-19
- Granted: 2019-08-06
- Earliest claimed: 2015-03-25
- Assignees: Agdia, Inc.
- Applicants: Agdia Inc.
- Inventors: Hans Mische; Grant Pexsa; Mark Baumgartner; Cory Hodgson; Andrew Bristow; John Steckelberg; Jared Patterson
- Web page: https://patentgrep.com/patent/US10371636B2

## CPC

- G01N 21/6428: {Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" (in vivo A61B5/00; immunoassay G01N33/53)}
- B01L 3/527: {for a plurality of reagents}
- B01L 7/52: {with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples}
- G01N 21/253: {for batch operation, i.e. multisample apparatus (analytical automats G01N35/00)}
- G01N 21/645: {Specially adapted constructive features of fluorimeters}
- G01N 33/50: Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing (measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q)
- B01L 2300/0609: Holders integrated in container to position an object
- B01L 2300/0893: having a very large number of wells, microfabricated wells
- G01N 2021/6439: {with indicators, stains, dyes, tags, labels, marks}
- G01N 2021/6482: {Sample cells, cuvettes}
- G01N 2201/024: Modular construction
- G01N 2201/062: LED's
- G01N 2201/0691: Modulated (not pulsed supply)
- 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)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE

## Abstract

A modular testing device includes a base unit and an expansion unit that communicates with the base unit. The expansion unit includes a housing, a receptacle in which a sample holder containing a biological sample and reagent mixture can be placed, and an optical assembly positioned in the housing. The optical assembly is configured to amplify and detect a signal from the biological sample and reagent mixture. Data that is collected in the optical assembly is communicated to the base unit.

## Claims

### Claim 1

A modular testing device comprising:
a base unit; and
an expansion unit that communicates with the base unit, wherein the expansion unit comprises:
a housing;
a receptacle in which a sample holder containing a biological sample and reagent mixture can be placed; and
an optical assembly positioned in the housing, wherein the optical assembly is configured to amplify and detect a signal from the biological sample and reagent mixture, wherein data that is collected in the optical assembly is communicated to the base unit, and wherein the optical assembly of the expansion unit includes an excitation filter that extends across the entire optical assembly and an emission filter that extends across the entire optical assembly.

### Claim 2 (depends on 1)

The modular testing device of claim 1, wherein the expansion unit communicates with the base unit over a hard wire connection.

### Claim 3 (depends on 1)

The modular testing device of claim 1, wherein the expansion unit communicates with the base unit over a wireless connection.

### Claim 4 (depends on 1)

The modular testing device of claim 1, wherein the modular testing device includes a plurality of expansion units that each communicate directly with the base unit.

### Claim 5 (depends on 1)

The modular testing device of claim 1, wherein the modular testing device includes a plurality of expansion units, wherein a first expansion unit communicates directly with the base unit and the other expansion units communicate with the base unit through the first expansion unit.

### Claim 6 (depends on 1)

The modular testing device of claim 1, wherein the base unit comprises:
a housing with an integrated touchscreen display;
a receptacle in which a sample holder containing a biological sample and reagent mixture can be placed; and
an optical assembly positioned in the housing, wherein the optical assembly is configured to amplify and detect a signal from the biological sample and reagent mixture; and
an electronic assembly that is configured to receive data from the optical assembly and transmit it for display on the touchscreen display; and
a power supply in the housing to power the base unit.

### Claim 7 (depends on 6)

The modular testing device of claim 6, wherein the optical assembly of the base unit includes an excitation filter that extends across the entire optical assembly and an emission filter that extends across the entire optical assembly.

### Claim 8 (depends on 1)

The modular testing device of claim 1, wherein the base unit is a computer selected from the group consisting of a desktop computer, a laptop computer, a tablet computer, a mobile phone, a smart watch, and an embedded PC.

### Claim 9 (depends on 1)

The modular testing device of claim 1, wherein the expansion unit further comprises:
an electronic assembly that is configured to receive data from the optical assembly and transmit it to the base unit; and
a power supply in the housing to power the expansion unit.

### Claim 10

A modular testing device comprising:
a base unit that comprises:
a housing with an integrated touchscreen display;
a receptacle in which a sample holder containing a biological sample and reagent mixture can be placed; and
an optical assembly positioned in the housing, wherein the optical assembly is configured to amplify and detect a signal from the biological sample and reagent mixture; and
an expansion unit that communicates with the base unit, wherein the expansion unit comprises:
a housing;
a receptacle in which a sample holder containing a biological sample and reagent mixture can be placed; and
an optical assembly positioned in the housing, wherein the optical assembly is configured to amplify and detect a signal from the biological sample and reagent mixture, and wherein the optical assembly in the expansion unit comprises:
a heating component to heat the biological sample and reagent mixture in the sample holder;
a plurality of light-emitting diodes configured to excite the biological sample and reagent mixture in the sample holder, wherein the plurality of light-emitting diodes are positioned on a first side of an excitation filter that extends across the entire optical assembly and the sample holder is positioned on a second side of the excitation filter; and
a plurality of photodetectors configured to detect a signal from the biological sample and reagent mixture in the sample holder, wherein the plurality of photodetectors are positioned on a first side of an emission filter that extends across the entire optical assembly and the sample holder is positioned on a second side of the emission filter.

### Claim 11 (depends on 10)

The modular testing device of claim 10, wherein the base unit further comprises:
an integrated handle to allow for transport of the base unit;
a lid over the receptacle that is movable between an open and closed position;
an electronic assembly that is configured to receive data from the optical assembly and transmit it for display on the touchscreen display, and that is configured to receive data from the expansion unit and transmit it for display on the touchscreen display;
a power supply in the housing to power the base unit; and
a machine readable code reader in the housing for reading a machine readable code.

### Claim 12 (depends on 10)

The portable testing device of claim 10, wherein the optical assembly in the base unit comprises:
a heating component to heat the biological sample and reagent mixture in the sample holder;
a plurality of light-emitting diodes to excite the biological sample and reagent mixture in the sample holder, wherein the plurality of light-emitting diodes are positioned on a first side of an excitation filter that extends across the entire optical assembly and the sample holder is positioned on a second side of the excitation filter; and
a plurality of photodetectors to detect a signal from the biological sample and reagent mixture in the sample holder, wherein the plurality of photodetectors are positioned on a first side of an emission filter that extends across the entire optical assembly and the sample holder is positioned on a second side of the emission filter.

### Claim 13 (depends on 10)

The modular testing device of claim 10, wherein the expansion unit further comprises:
an electronic assembly that is configured to receive data from the optical assembly and transmit it to the base unit; and
a power supply in the housing to power the expansion unit.

### Claim 14

A method of analyzing a biological sample and reagent mixture in a modular testing device, the method comprising:
preparing a biological sample and reagent mixture for testing and placing the biological sample and reagent mixture in a sample holder;
placing the sample holder in a receptacle in an expansion unit, wherein the expansion unit comprises an optical assembly comprising an excitation filter that extends across the entire optical assembly and an emission filter that extends across the entire optical assembly;
beginning an excitation and detection test sequence with the optical assembly to analyze the biological sample and reagent mixture in the expansion unit;
collecting data from the biological sample and reagent mixture in the expansion unit, wherein the data that is collected is collected by the optical assembly; and
communicating the data from the expansion unit to a base unit.

### Claim 15 (depends on 14)

The method of claim 14, wherein communicating the data from the expansion unit to the base unit includes communicating the data over a hard wired connection between the expansion unit and the base unit.

### Claim 16 (depends on 14)

The method of claim 14, wherein communicating the data from the expansion unit to the base unit includes communicating the data over a wireless connection between the expansion unit and the base unit.

### Claim 17 (depends on 14)

The method of claim 14, and further comprising:
processing the data in the expansion unit;
processing the data in the base unit; and
displaying the data on a screen of the base unit.

### Claim 18 (depends on 14)

The method of claim 14, and further comprising:
turning on the base unit and the expansion unit;
selecting the test protocol in the base unit;
communicating the selected test protocol from the base unit to the expansion unit; and
pre-heating the expansion unit in accordance with the selected test protocol.