IP Library Granted Patent US 10,195,606
Granted Patent B2
US 10,195,606 · App. 15/368,249 · Granted Feb 5, 2019

Systems and methods for detection and quantification of analytes

Inventors: Ayub Khattak (San Diego, CA); Clinton Sever (San Diego, CA)
Assignee: CUE HEALTH INC.
B01L3/502715B01L3/5027B01L3/5029B01L3/502723B01L3/502738B05D3/002C12Q1/6825F16K99/0032F16K99/0036G01N27/28G01N27/3271G01N27/3273G01N33/5438G01N33/54306G01N33/54326G01N33/54333G01N33/54366G01N33/54373G01N33/581G01N35/00029G01N35/0098G01N35/08G01N35/1095H04M1/72527B01L2200/025B01L2200/026B01L2200/027B01L2200/028B01L2200/04B01L2200/0668B01L2200/0684B01L2200/0689B01L2200/087B01L2200/10B01L2200/16B01L2300/023B01L2300/025B01L2300/04B01L2300/044B01L2300/06B01L2300/0627B01L2300/0645B01L2300/0681B01L2300/087B01L2300/0816B01L2300/0838B01L2300/0864B01L2300/0867B01L2300/12B01L2300/161B01L2300/1827B01L2400/0406B01L2400/0487B01L2400/0677B01L2400/0683B05D2518/00F16K2099/0084G01N27/3272G01N2001/027G01N2001/028G01N2035/00277G01N2035/00564G01N2458/30H04M1/7253Y10T137/1797
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Quick Facts
Patent No.
US 10,195,606
App. No.
15/368,249
Granted
Feb 5, 2019
Kind
B2
Abstract

Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. In some embodiments, the reader component communicates with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

Claims (41)

1. A sample analysis reader configured to be electrically coupled to a sample analysis cartridge, the sample analysis reader comprising:

a processor; and

a non-transitory computer readable medium having instructions stored thereon, wherein the instructions, when executed by the processor, cause the processor to:

detect a presence of the sample analysis cartridge electrically coupled to the sample analysis reader;

detect identification information associated with the sample analysis cartridge;

identify a proper test protocol for the sample analysis cartridge based at least in part on the identification information;

detect a sample collection device inserted into the sample analysis cartridge; and

initiate a mixing protocol to mix a sample received from the sample collection device with reagents in fluid in a reservoir in the sample analysis cartridge.

2. The sample analysis reader of claim 1 , wherein the processor is configured to initiate the mixing protocol by activating a piezoelectric transducer to mix the sample and the reagents in the fluid in the reservoir.

3. The sample analysis reader of claim 1 , wherein the processor is configured to initiate the mixing protocol to facilitate formation of a plurality of sandwich complexes formed of a target analyte from the sample directly or indirectly bound to both a magnetic particle and a signaling agent.

4. The sample analysis reader of claim 1 , wherein the processor is configured to initiate the mixing protocol to facilitate hybridization of at least some of the reagents with one or more target analytes from the sample.

5. The sample analysis reader of claim 1 , wherein the processor is further configured to receive a signal from the sample analysis cartridge indicative of at least one of a presence, absence, or quantity of one or more target analytes from the sample.

6. The sample analysis reader of claim 5 , wherein the processor is further configured to process the received signal and to generate a processed signal comprising information indicative of at least one of a presence, absence, or quantity of one or more target analytes from the sample,

wherein the processor is further configured to cause the processed signal to be transmitted to a mobile device.

7. The sample analysis reader of claim 1 , wherein the sample analysis reader is configured to be electrically coupled to a plurality of sample analysis cartridges that are each disposable.

8. The sample analysis reader of claim 1 , further comprising a magnetic field generator configured to localize magnetic particles in the mix of the sample and the reagents and the fluid from the reservoir over a sensor at least partially disposed in an analysis channel to form a localized sample over the sensor when the sample analysis cartridge is coupled to the sample analysis reader.

9. The sample analysis reader of claim 8 , wherein the processor is further configured to stimulate a first heater such that a first valve within the sample analysis cartridge melts and the mix of the sample and the reagents and the fluid flows out of the reservoir into the analysis channel of the sample analysis cartridge.

10. The sample analysis reader of claim 9 , wherein the processor is further configured to stimulate a second heater such that a second valve within the sample analysis cartridge melts and a wash solution flows out of a second reservoir of the sample analysis cartridge into the analysis channel,

wherein the wash solution removes, from the localized sample, the reagents that are not bound to magnetic particles.

11. The sample analysis reader of claim 10 , wherein the processor is further configured to stimulate a third heater such that a third valve within the sample analysis cartridge melts and a solution of substrates flows out of a third reservoir of the sample analysis cartridge into the analysis channel,

wherein the reagents comprise signaling agents and the signaling agents within the localized sample react with the substrates to generate a signal detected by the sensor indicative of at least one of a presence, absence, or quantity of one or more target analytes from the sample.

12. The sample analysis reader of claim 1 , further comprising a dock to physically couple the sample analysis reader to the sample analysis cartridge.

13. A kit comprising the sample analysis reader of claim 1 and the sample analysis cartridge.

14. The kit of claim 13 , further comprising the sample collection device.

15. A non-transitory computer readable medium having instructions stored thereon, wherein the instructions, when executed by a processor of a sample analysis reader, cause the processor to:

detect a presence of a sample analysis cartridge electrically coupled to the sample analysis reader;

detect identification information associated with the sample analysis cartridge;

identify a proper test protocol for the sample analysis cartridge based at least in part on the identification information;

detect a sample collection device inserted into the sample analysis cartridge; and

initiate a mixing protocol to mix a sample received from the sample collection device with reagents in fluid in a reservoir in the sample analysis cartridge.

16. The non-transitory computer readable medium of claim 15 , wherein the instructions, when executed by the processor, cause the processor to initiate the mixing protocol by activating a piezoelectric transducer to mix the sample and the reagents in the fluid in the reservoir.

17. The non-transitory computer readable medium of claim 15 , wherein the instructions, when executed by the processor, cause the processor to initiate the mixing protocol to facilitate formation of a plurality of sandwich complexes formed of a target analyte from the sample directly or indirectly bound to both a magnetic particle and a signaling agent.

18. The non-transitory computer readable medium of claim 15 , wherein the instructions, when executed by the processor, cause the processor to initiate the mixing protocol to facilitate hybridization of at least some of the reagents with one or more target analytes from the sample.

19. The non-transitory computer readable medium of claim 15 , wherein the instructions, when executed by the processor, cause the processor to receive a signal from the sample analysis cartridge indicative of at least one of a presence, absence, or quantity of one or more target analytes from the sample.

20. The non-transitory computer readable medium of claim 15 , wherein the instructions, when executed by the processor, cause the processor to process the received signal and to generate a processed signal comprising information indicative of at least one of a presence, absence, or quantity of one or more target analytes from the sample, and

wherein the instructions cause the processed signal to be transmitted to a mobile device.

21. The non-transitory computer readable medium of claim 15 , wherein the instructions, when executed by the processor, cause the processor to stimulate a first heater such that a first valve within the sample analysis cartridge melts and the mix of the sample and the reagents and the fluid flows out of the reservoir into an analysis channel to form a localized sample over a sensor at least partially disposed within the analysis channel of the sample analysis cartridge.

22. The non-transitory computer readable medium of claim 21 , wherein the instructions, when executed by the processor, cause the processor to stimulate a second heater such that a second valve within the sample analysis cartridge melts and a wash solution flows out of a second reservoir of the sample analysis cartridge into the analysis channel, and

wherein the wash solution removes, from the localized sample, the reagents that are not bound to magnetic particles.

23. The non-transitory computer readable medium of claim 22 , wherein the instructions, when executed by the processor, cause the processor to stimulate a third heater such that a third valve within the sample analysis cartridge melts and a solution of substrates flows out of a third reservoir of the sample analysis cartridge into the analysis channel,

wherein the reagents comprise signaling agents and the signaling agents within the localized sample react with the substrates to generate a signal detected by the sensor indicative of at least one of a presence, absence, or quantity of one or more target analytes from the sample.

Assignments (7)
ASSIGNMENT BY BANKRUPTCY Recorded Oct 4, 2024
From: CUE HEALTH INC.
To: SIRO DIAGNOSTICS, INC.
Reel/Frame 070226/0119 →
RELEASE OF SECURITY INTEREST Recorded May 17, 2024
From: EAST WEST BANK, AS COLLATERAL AGENT AND ADMINISTRATIVE AGENT
To: CUE HEALTH INC.
Reel/Frame 067456/0574 →
SECURITY AGREEMENT Recorded Jul 11, 2022
From: CUE HEALTH INC.
To: EAST WEST BANK, AS COLLATERAL AGENT AND ADMINISTRATIVE AGENT
Reel/Frame 060621/0319 →
RELEASE OF SECURITY INTEREST Recorded Jun 25, 2021
From: EAST WEST BANK
To: CUE HEALTH INC.
Reel/Frame 056668/0043 →
SECURITY INTEREST Recorded Apr 9, 2021
From: CUE HEALTH INC.
To: EAST WEST BANK, AS COLLATERAL AND ADMINISTRATIVE AGENT
Reel/Frame 055875/0575 →
MERGER AND CHANGE OF NAME Recorded May 3, 2018
From: CUE INC.; CUE HEALTH INC.
To: CUE HEALTH INC.
Reel/Frame 045711/0743 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 2, 2016
From: KHATTAK, AYUB; SEVER, CLINTON
To: CUE INC.
Reel/Frame 040502/0424 →
Continuity (5)
Continuation 14954817 · Nov 30, 2015
Continuation 14599372 · Jan 16, 2015
Continuation PCTUS2014023821 · Mar 11, 2014
Provisional Application 61776254 · Mar 11, 2013
Related Publication 20170080421A1 · Mar 23, 2017
Cited By (3)
US 1,063,100 US 12,208,389 US 12,590,945