QUANTIFICATION OF A CHANGE IN ASSAY

• US 20150260713A1
• Filed: 03/12/2015
• Published: 09/17/2015
• Est. Priority Date: 03/12/2014
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: Ghaffari, Roozbeh, Lee, Stephen, Aranyosi, Alexander
• Granted Patent: US 9,810,623 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2300/023 Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/5055 Hinged, e.g. opposable surfaces
• CPC Class Codes: G01N 2021/7783 Transmission, loss
• CPC Class Codes: G01N 2035/00881 network configurations
• CPC Class Codes: G01N 21/272 for following a reaction, e.g. for determining photometrically a reaction rate (photometric cinetic analysis)
• CPC Class Codes: G01N 35/00871 Communications between instruments or with remote terminals

Abstract

The present invention relates to portable devices for point-of-care diagnostics that can perform measurements on a sample (e.g., blood, serum, saliva, or urine) and relay data to an external device for, e.g., data analysis. The device can comprise a paper-based diagnostic substrate and a base substrate that include electronic circuitry and electronic elements necessary for performing the measurements. The device can also comprise an antenna for near field communication with an external device. Another aspect of the invention relates to methods of using these devices.

Claims

1. A measurement device comprising:

a diagnostic substrate comprising (a) a sample receiver to receive a sample, wherein the sample receiver is at least partially formed in or disposed on the diagnostic substrate;

(b) a fluidic channel connected to the sample receiver;

(c) a detection region at least partially formed in or disposed on the diagnostic substrate, wherein the detection region is coupled to the sample receiver by the fluidic channel;

(d) a control region at least partially formed in or disposed on the diagnostic substrate, wherein the control region is coupled to the detection region by the fluidic channel, and

a base substrate comprising (e) an antenna for near-field communication (NFC) at least partially formed in or disposed on the base substrate;

(f) electronic circuitry connected to the antenna and at least partially formed in or disposed on the base substrate, wherein the electronic circuitry generates data as a function of an output signal from the sample or a derivative thereof;

(g) a first portion comprising a first photodetector and a second photodetector connected to the electronic circuitry and at least partially formed in or disposed on the first portion;

(h) a second portion comprising a first light source and a second light source connected to the electronic circuitry and at least partially formed in or disposed on the second portion, wherein the first portion and the second portion are positioned to align the photodetectors and the light sources such that light from the first light source passes through the detection region and gets detected by the first photodetector, the light from the second light source passes through the control region and gets detected by the second photodetector, and (i) a thin-film battery connected to the electronic circuitry and configured to provide power to the at least one photodetector and light source.

2. The measurement device of claim 1, wherein the diagnostic substrate further comprises a reagent to react with the sample or the derivative of the sample.

3. The measurement device of claim 2, wherein the reagent is a plurality of dyed nanoparticles.

4. The measurement device of claim 1, further comprising a data storage device connected to the electronic circuitry and configured to store the data.

5. The measurement device of claim 1, further comprising a sensor coupled to the sample receiver to detect the presence of the sample.

6. The measurement device of claim 5, wherein the sensor is polled periodically or according to a pre-set schedule to determine the presence of the sample.

7. The measurement device of claim 5, further comprising a timer coupled to the sensor and the photodetector, wherein the timer is activated for a predetermined time when the sample is detected, the predetermined time representing the amount of time to read the sample, the timer activating the photodetector after the predetermined time has been reached, the photodetector outputting a measurement value.

8. The measurement device of claim 7, wherein the sensor is deactivated after the predetermined time.

9. The measurement device of claim 1, further comprising a housing for enclosing at least a portion of the measurement device.

10. The measurement device of claim 1, wherein the measurement device is initiated by an external device through a first NFC transaction.

11. The measurement device of claim 10, wherein the measurement device transmits the data to the external device through a second NFC transaction, whereby the external device processes the data to provide quantitative information related to the sample.

12. The measurement device of claim 10 or 11, wherein the external device is a hand-held device or a wearable device.

13. The measurement device of claim 11, wherein the quantitative information comprises at least one of:

a glucose level;

a T-cell concentration;

a microorganism concentration;

a water-based pathogen concentration;

a bovine serum albumin (BVA) concentration;

a bacterial concentration;

a viral load;

an antigen level;

an antibody level;

a diagnosis of tuberculosis;

a diagnosis of dengue fever;

a cardiac enzyme concentration; and

a diagnosis of malaria.

14. The measurement device of claim 1, wherein the first portion is folded over the second portion such that the first portion and the second portion sandwich the diagnostic substrate.

15. The measurement device of claim 1, wherein the second portion is folded over the first portion such that the first portion and the second portion sandwich the diagnostic substrate.

16. The measurement device of claim 1, wherein the sample is a fluid sample.

17. The measurement device of claim 16, wherein the fluid sample is selected from the group consisting of blood, serum, saliva, and urine.

18. The measurement device of claim 1, wherein the diagnostic substrate comprises a paper-based portion.

32. A method of providing quantitative information on a sample using a measurement device of claim 1, the method comprising:

(i) initiating the measurement device with an external device through a first near-field communication (NFC) transaction, wherein the measurement device performs a first transmission measurement on the detection region and the control region to produce a first data;

(ii) contacting the sample receiver of the measurement device with the sample, wherein the measurement device performs a second transmission measurement on the detection region and the control region at a first predetermined time period after the contacting to produce a second data;

(iii) performing a third transmission measurement on the detection region and the control region at a second predetermined time period after the second transmission measurement to produce a third data;

(iv) transferring the first, second, and third data from the measurement device to the external device through a second NFC transaction; and

(v) providing quantitative information based on analysis of the first, second, and third data.

33. The method of claim 32, wherein the sample is a fluid sample.

34. The method of claim 32, wherein the analysis comprises normalizing the third data against the first and second data.

35. The method of claim 32, further comprising storing the first, second, and third data in a data storage device prior to the transferring.

36. The method of claim 32, wherein the external device is a hand-held device or a wearable device.

37. The method of claim 32, wherein the quantitative information comprises at least one of:

a glucose level;

a T-cell concentration;

a microorganism concentration;

a water-based pathogen concentration;

a bovine serum albumin (BVA) concentration;

a bacterial concentration;

a viral load;

an antigen level;

an antibody level;

a diagnosis of tuberculosis;

a diagnosis of dengue fever;

a cardiac enzyme concentration; and

a diagnosis of malaria.

38. The method of claim 33, wherein the fluid sample is selected from the group consisting of blood, serum, saliva, and urine.

39. The method of claim 32, wherein the first and second light sources each gradually increases the light intensity during each of the transmission measurements, and the first and second photodetectors each detects light transmission in response to the increase in light intensity.

19. A measurement device for measuring a value from a sample, the device comprising:

a sample receiver for receiving a sample;

a sensor coupled to the sample receiver to detect the presence of the sample;

a detection region fluidly coupled to the sample receiver via a fluidic channel, thereby receiving the sample or a derivative thereof from the sample receiver;

a detector coupled to the detection region and configured to read a characteristic of the sample or the derivative thereof; and

a timer coupled to the sensor and the detector, wherein the timer is activated for a predetermined time when a sample is detected, the predetermined time representing the amount of time to read the sample, the timer activating the detector after the predetermined time has been reached, the detector outputting a measurement value.

20. The device of claim 19, wherein the sample is a fluid sample.

21. The device of claim 19, wherein the sensor comprises a light source and a photodetector, wherein the light source and the photodetector are positioned such that light from the light source passes through the sample receiver and gets detected by the photodetector.

22. The device of claim 21, wherein a change in transmission detected by the sensor indicates the presence of the sample.

23. The device of claim 19, wherein the sensor comprises electrical components configured to detect an electrical signal from the sample.

24. The device of claim 23, wherein a change in electrical conductivity detected by the sensor indicates the presence of the sample.

25. The device of claim 19, wherein the sensor is polled periodically or according to a pre-set schedule to determine the presence of the sample.

26. The device of claim 19, wherein the sensor is deactivated after the predetermined time.

27. The device of claim 19, further comprising a communications interface coupled to the sample receiver, the communications interface receiving a command signal from an external device to initiate the accepting of the sample.

28. The device of claim 27, wherein the external device is a hand-held device or a wearable device.

29. The device of claim 19, further comprising a data storage device coupled to the detector, the detector storing the measured value in the data storage device.

30. The device of claim 27, wherein the communications interface sends a signal indicative of the measured value.

31. The device of claim 20, wherein the fluid sample is selected from the group consisting of blood, serum, saliva, and urine.