Quantification of a change in assay

• US 9,810,623 B2
• Filed: 03/12/2015
• Issued: 11/07/2017
• Est. Priority Date: 03/12/2014
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: Ghaffari, Roozbeh, Aranyosi, Alexander, Lee, Stephen
• Primary Examiner(s): Crawford, Erik B
• Application Number:
  US14/656,046
• Publication Number:
  US 20150260713A1
• Time in Patent Office: 971 Days
• 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 is folded with respect to the second portion whereby the photodetectors and the light sources are aligned 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 of the first photodetector and the second photodetector, and to provide power to at least one of the first light source and the second 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 at least one of the first photodetector and the second photodetector after the predetermined time has been reached, the activated 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 (BV A) 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.