Point of care sensor systems

• US 10,520,501 B2
• Filed: 09/09/2016
• Issued: 12/31/2019
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Nanomix Incorporated (CJY Holdings Ltd.)
• Original Assignee: Nanomix Incorporated (CJY Holdings Ltd.)
• Inventors: Johnson, Bradley N., Yang, Jui-Ming, Joshi, Kanchan A., Radtkey, Ray R., Gruener, Garrett, Skarupo, Sergei
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US15/261,641
• Publication Number:
  US 20170153230A1
• Time in Patent Office: 1,208 Days
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0809 rectangular shaped
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0883 Serpentine channels
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0633 with moving parts
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: G01N 2035/1018 Detecting inhomogeneities, e.g. foam, bubbles, clots
• CPC Class Codes: G01N 2035/1034 Transferring microquantities of liquid
• CPC Class Codes: G01N 27/27 Association of two or more measuring systems or cells, each measuring a different parameter, where the measurement results may be either used independently, the systems or cells being physically associated, or combined to produce a value for a further parameter
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence
• CPC Class Codes: G01N 33/492 Determining multiple analytes
• CPC Class Codes: G01N 33/5438 Electrodes
• CPC Class Codes: G01N 35/1079 with means for piercing stoppers or septums

Abstract

Provided are point of care sensor systems that include portable readers and disposable cartridges for receiving and analyzing samples. A cartridge may be equipped with one or more sensor channels, each containing one or more sensors. After providing a sample to a cartridge, the cartridge can be inserted into a reader, which can interact with the cartridge to perform on-cartridge sensing and receive signals indicating the presence and/or quantity of one or more targets in the sample. Examples of cartridges can include cardiac panels, sepsis panels and the like. In some embodiments, the same sensor hardware may be configured for multiple measurements of different targets conducted at different time frames. Also provided herein are novel on-cartridge solid and liquid reagent storage and delivery mechanisms.

Claims

1. A cartridge comprising:

a sample inlet chamber for receiving a sample;

a detection channel providing a flow path over a first sensor surface coated with an enzyme and a second sensor surface having a capture species attached thereto, wherein the cartridge is configured for non-capture enzymatic sensing and enzyme-linked immunosorbent assay (ELISA) sensing on the sample in the detection channel.

2. The cartridge of claim 1, wherein the second sensor surface is closer along the flow path to the sample inlet chamber than the first sensor surface.

3. The cartridge of claim 1, further comprising a mixing circuit connected to the sample inlet chamber configured to mix the sample with reagent outside the detection channel.

4. The cartridge of claim 1, wherein the cartridge is configured to receive only pneumatic and electric inputs from a reader.

5. The cartridge of claim 3, wherein the mixing circuit comprises a mixing chamber and a reagent chamber.

6. The cartridge of claim 1, wherein the first sensor surface is coated with a water soluble polymer.

7. The cartridge of claim 1, wherein the flow path is unidirectional.

8. The cartridge of claim 1, wherein the cartridge is configured to sense lactate and one of procalcitonin (PCT) or C-reactive protein (CRP) in the sample.

9. The cartridge of claim 1, wherein the cartridge is configured to sense at least one of a biomarker for sepsis selected from the group consisting of:

CRP, PCT, IL-6, lactate, endotoxin, and 1-3 beta glucan in the sample.

10. The cartridge of claim 1, wherein cartridge is configured to sense creatinine and a cardiac troponin in the sample.

11. The cartridge of claim 1, wherein the first sensor surface is further coated with one or more mediators.

12. The cartridge of claim 1, further comprising a plasma filtration membrane.

13. The cartridge of claim 1, wherein the cartridge is configured to be utilized with one of an electrochemical, optical, colorimetric, luminescent, fluorescent, or photometric detection system.

14. The cartridge of claim 1, wherein the cartridge is configured to be utilized with an optical detection system.

15. The cartridge of claim 1, wherein the detection channel is a microfluidic channel.

16. The cartridge of claim 1, wherein the detection channel is a well or chamber.

17. An electrochemical sensor assembly comprising:

a cartridge configured to be inserted into a reader, the cartridge comprising a sample inlet port and a sensor well including one or more sensors configured to detect biomolecules in the sample; and

a reader configured to receive the cartridge, the reader configured to provide a plurality of pneumatic inputs to the cartridge and receive electric signals from the cartridge indicating detection information of one or more target analytes in a sample,

wherein the cartridge and reader are configured such that after insertion into the reader, the cartridge is configured to receive no mechanical inputs and only pneumatic and electric inputs from the reader.

18. The electrochemical sensor assembly of claim 17, wherein the reader is configured to supply vacuum at a set level Pv and pressure at a set level Pp, wherein Pp is greater than Pv.

19. The electrochemical sensor assembly of claim 18, wherein reader comprises a single motor single head pump, a first check valve on a first side of the pump and a second check valve on the second side of the pump, the first check valve having a cracking pressure of Pv and the second check valve having a cracking pressure of Pp.

20. The reader of claim 17, wherein the reader is configured to display results of the detection.

21. A reader configured to receive a cartridge, comprising:

a pneumatic assembly configured to supply vacuum to the cartridge, at a set level Pv and pressure at a set level Pp, wherein Pp is greater than Pv, wherein the pneumatic assembly comprises a single motor single head pump, a first check valve on a first side of the pump and a second check valve on the second side of the pump, the first check valve having a cracking pressure of Pv and the second check valve having a cracking pressure of Pp; and

a detection assembly configured to receive electrical signal information from the cartridge.

22. The reader of claim 21, wherein the reader is configured to identify at least two assays associated with the cartridge, and apply first and second measurement voltages, the first measurement voltage associated with a first assay and the second measurement voltage associated with the second assay, wherein the second measurement voltage is applied after the first measurement voltage.

23. The reader of claim 22, wherein the first and second measurement voltages are applied to the same electrode on the cartridge.

24. The reader of claim 21, wherein the reader is configured to detect the presence of bubbles on an electrode on the cartridge.