# US 10,309,954 B2 · Assay apparatus

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- Number: US 10,309,954 B2
- Document ID: US10309954B2
- Status: Granted
- Kind: B2
- Application number: 14/651,167
- Filed: 2013-12-10
- Published: 2015-10-29
- Granted: 2019-06-04
- Earliest claimed: 2012-12-12
- Assignees: Green Domain Design, Inc.
- Applicants: Green Domain Design, LLC
- Inventors: Lonnie W. Adelman; Nitin C. Bhagwath
- Web page: https://patentgrep.com/patent/US10309954B2

## CPC

- G01N 33/48785: {Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply}
- A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature}
- G01N 21/25: Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N 21/6486: {Measuring fluorescence of biological material, e.g. DNA, RNA, cells (G01N21/6428 takes precedence)}
- G01N 33/487: of liquid biological material
- G01N 33/497: of gaseous biological material, e.g. breath
- H04W 4/80: Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
- H04W 12/02: Protecting privacy or anonymity, e.g. protecting personally identifiable information [PII]
- H04W 12/033: of the user plane, e.g. user's traffic
- H04W 12/08: Access security
- A61B 5/0059: {using light, e.g. diagnosis by transillumination, diascopy, fluorescence (photoacoustic A61B5/0093; optical measurement of heart rate A61B5/02416; optical measurement of blood flow A61B5/0261; optical measurement of analytes A61B5/1455)}
- A61B 5/0071: {by measuring fluorescence emission}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/02438: {with portable devices, e.g. worn by the patient}
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 5/1455: using optical sensors, e.g. spectral photometrical oximeters
- A61B 5/6898: {Portable consumer electronic devices, e.g. music players, telephones, tablet computers}
- H04W 88/06: adapted for operation in multiple networks {or having at least two operational modes}, e.g. multi-mode terminals
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- H04W: WIRELESS COMMUNICATION NETWORKS (broadcast communication H04H; communication systems using wireless links for non-selective communication, e.g. wireless extensions H04M1/72)

## Abstract

Provided herein is an assay apparatus comprising at least one assay module; and a portable frame adapted to releasably retain the at least one assay module. The at least one assay module is adapted to perform at least one assay. The assay module comprises a sample receiver and an assay device operatively associated with the sample receiver. In some embodiments, the assay apparatus further comprises at least one functional module releasably retained by the portable frame. The functional module is operatively associated with the assay module when retained by the portable frame.

## Claims

### Claim 1

An assay apparatus, comprising
two or more assay modules, wherein (i) each assay module of the two or more assay modules comprises an assay device adapted to perform an assay on a sample; and (ii) each assay device of each assay module of the two or more assay modules is adapted to perform a different assay on a sample;
a portable frame having one or more recessed receiving areas; and
a functional module,
wherein the portable frame, the two or more assay modules, and the functional module are configured such that the two or more assay modules and the functional module are insertable into and removable from the one or more recessed receiving areas of the portable frame;
wherein each assay module of the two or more assay modules (i) is configured to perform an assay on a sample upon insertion into a recessed receiving area of the one or more recessed receiving areas of the portable frame and (ii) is removable from the recessed receiving area of the one or more recessed receiving areas of the portable frame when the assay is completed;
wherein at least one assay module of the two or more assay modules comprises a light source and a detector; and
wherein the functional module comprises a wireless data transmission device that is operatively associated with an assay module of the two or more assay modules when the assay module is inserted into a recessed receiving area of the one or more recessed receiving areas of the portable frame.

### Claim 2 (depends on 1)

The assay apparatus of claim 1, wherein wireless data transmission device operates on one or more transmission technologies selected from the group consisting of 3G communication protocols, 4G communication protocols, GSM standards, CDMA protocols, IEEE 802.11 standards, Bluetooth protocols, satellite communications, visible light communications, infrared communications, and near field communications.

### Claim 3 (depends on 1)

The assay apparatus of claim 1, wherein each assay device of each assay module of the two or more assay modules is adapted to perform an assay selected from the group consisting of Sodium assay, Potassium assay, Chloride assay, BUN/Urea assay, Glucose assay, Hematocrit assay, Ionized Calcium assay, PO2 assay, pH assay, PCO2 assay, Creatinine assay, Lactate assay, Celite ACT assay, Prothrombin Time PT/INR assay, Kaolin ACT assay, Cardiac Troponin I/cTnI assay, Total Carbon Dioxide/TC02 assay, Creatine Kinase MB/CK-MB assay, and B-Type Natriuretic Peptide/BNP assay.

### Claim 4 (depends on 1)

The assay apparatus of claim 1, wherein (a) the portable frame comprises two or more recessed receiving areas, wherein the portable frame, the functional module, and the two or more assay modules are configured such that the functional module and an assay module of the two or more assay modules are insertable into and removable from recessed receiving areas of the two or more recessed receiving areas, and (b) the recessed receiving areas of the two or more recessed receiving areas are configured to allow transfer of electrical power, light, or optical information between the assay module and the functional module when the assay module and the functional module are inserted into the recessed receiving areas of the two or more recessed receiving areas of the portable frame.

### Claim 5 (depends on 1)

The assay apparatus of claim 1, wherein each assay device of each assay module of the two or more assay modules is adapted to perform an assay selected from the group consisting of an immunodiagnostic assay, a deoxyribonucleic acid (DNA) sequencing assay, a bioluminescent assay, a cell cytometry assay, a lateral flow assay, and an HbA1c assay.

### Claim 6 (depends on 1)

The assay apparatus of claim 1, wherein the functional module further comprises a functional device selected from the group consisting of a battery, a wired data transmission device, a microprocessor, an interface for receiving and recording signals from at least one vital sign detector, a luminescence recorder, a display device, a portable computing device, a data storage device, a camera, and combinations thereof.

### Claim 7 (depends on 6)

The assay apparatus of claim 6, wherein the functional module comprises a battery, and wherein an assay module of the two or more assay modules and the battery are electrically connected when the assay module is inserted into a recessed receiving area of the one or more recessed receiving areas of the portable frame.

### Claim 8 (depends on 6)

The assay apparatus of claim 6, wherein the functional module comprises a portable computing device.

### Claim 9 (depends on 8)

The assay apparatus of claim 8, wherein the portable computing device comprises a digital processor configured to perform one or more of the following: (a) providing step-by-step guidance for using the assay apparatus; (b) collecting, processing and organizing assay information acquired from an assay module of the two or more assay modules, the functional module, or a combination thereof; (c) communicating assay information to a user, wherein the assay information is acquired from an assay module of the two or more assay modules, the functional module, or a combination thereof.

### Claim 10 (depends on 6)

The assay apparatus of claim 6, wherein the functional module comprises an interface for at least one vital sign detector operatively associated with the functional module.

### Claim 11 (depends on 10)

The assay apparatus of claim 10, wherein the at least one vital sign detector collects information on a feature selected from the group consisting of body temperature, heart rate, blood pressure, respiratory rate, and combinations thereof.

### Claim 12 (depends on 6)

The assay apparatus of claim 6, wherein the functional module comprises a luminescence recorder adapted to record luminescence generated by an assay device of an assay module of the two or more assay modules.

### Claim 13 (depends on 12)

The assay apparatus of claim 12, wherein the luminescence recorder is selected from the group consisting of a camera, a fluorescent light recorder, a UV recorder, a diode/amplifier type receiver, and combinations thereof.

### Claim 14 (depends on 6)

The assay apparatus of claim 6, wherein the functional module comprises a display device adapted to display assay module information, functional module information, sample information, or combinations thereof.

### Claim 15

An assay apparatus, comprising
two or more assay modules, wherein each assay module of the two or more assay modules (i) is adapted to perform a different interactive assay comprising two or more assay steps, and (ii) comprises a sample receiver and an interactive assay device operatively associated with the sample receiver;
a functional module; and
a portable frame having one or more recessed receiving areas,
wherein the portable frame, the two or more assay modules, and the functional module are configured such that the two or more assay modules and the functional module are insertable into and removable from the one or more recessed receiving areas of the portable frame,
wherein each assay module of the two or more assay modules (i) is configured to, upon insertion into a recessed receiving area of the one or more recessed receiving areas of the portable frame, collect assay information of at least one assay step of the two or more assay steps of the interactive assay and to allow selective continuation of any remaining assay steps of the two or more assay steps of the interactive assay based on the collected assay information; and (ii) is removable from the recessed receiving area of the one or more recessed receiving areas of the portable frame when the interactive assay is completed;
wherein at least one assay module of the two or more assay modules comprises a light source and a detector; and
wherein the functional module comprises a wireless data transmission device that is operatively associated with an assay module of the two or more assay modules when the assay module is inserted into a recessed receiving area of the one or more recessed receiving areas.

### Claim 16 (depends on 15)

The assay apparatus of claim 15, wherein the interactive assay device of an assay module of the two or more assay modules comprises an optical device configured to collect the assay information.

### Claim 17 (depends on 15)

The assay apparatus of claim 15, wherein the selective continuation of any remaining assay steps of the two or more assay steps of the interactive assay of an assay module of the two or more assay modules is controlled by a user or by a microprocessor.

### Claim 18 (depends on 15)

The assay apparatus of any one of claim 15, wherein the interactive assay of an assay module of the two or more assay modules comprises at least one immunodiagnostic assay or microfluidic channel.
