Assay apparatus

• US 10,309,954 B2
• Filed: 12/10/2013
• Issued: 06/04/2019
• Est. Priority Date: 12/12/2012
• Status: Active Grant

• Current Assignee: iAssay, Inc.
• Original Assignee: Green Domain Design LLC
• Inventors: Adelman, Lonnie W., Bhagwath, Nitin C.
• Primary Examiner(s): Geisel, Kara E.
• Application Number:
  US14/651,167
• Publication Number:
  US 20150309008A1
• Time in Patent Office: 2,002 Days
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: 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
• CPC Class Codes: G01N 21/6486 Measuring fluorescence of biological material, e.g. DNA, RNA, cells G01N21/6428 takes precedence
• CPC Class Codes: G01N 33/487 of liquid biological material
• CPC Class Codes: 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
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath
• CPC Class Codes: H04W 12/02 Protecting privacy or anonymity, e.g. protecting personally identifiable information [PII]
• CPC Class Codes: H04W 12/033 of the user plane, e.g. user's traffic
• CPC Class Codes: H04W 12/08 Access security
• CPC Class Codes: H04W 4/80 Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
• CPC Class Codes: H04W 88/06 adapted for operation in multiple networks or having at least two operational modes, e.g. multi-mode terminals

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

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

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

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

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.

16. 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.

17. 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.

18. 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.