SINGLE-USE HANDHELD DIAGNOSTIC TEST DEVICE, AND AN BIOLOGICAL AND ENVIRONMENTAL TEST SAMPLES

• US 20110165688A1
• Filed: 08/31/2009
• Published: 07/07/2011
• Est. Priority Date: 08/29/2008
• Status: Active Grant

• Current Assignee: Fio Corporation
• Original Assignee: Fio Corporation
• Inventors: Dupoteau, Francois, Dekel, Shlomit
• Granted Patent: US 9,459,200 B2
• Time in Patent Office: Days
• US Class Current: 436/55
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/1171 based on the shapes or appearances of their bodies or parts thereof
• CPC Class Codes: A61B 5/1172 using fingerprinting
• CPC Class Codes: A61B 5/1176 Recognition of faces
• CPC Class Codes: G01N 21/17 Systems in which incident light is modified in accordance with the properties of the material investigated where the material investigated is optically excited causing a change in wavelength of the incident light G01N21/63
• CPC Class Codes: G01N 21/77 by observing the effect on a chemical indicator
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: Y10T 436/12 Condition responsive control

Abstract

In a single-use handheld diagnostic test device and an associated system and method, a biological and/or environmental test sample is received and reacted with reagents. The test device tests a single sample and includes a sensor to detect test data. The test device mates with, and transmits the test data to, an electronic device. A processor of the electronic device applies algorithms to the test data to generate highly sensitive and accurate quantitative test results. A presentation element of the electronic device presents the test results to a user. The test device is adapted for disposal, or for sterilization and re-use, after the electronic device receives the test data. The electronic device may be, for example, a mobile communications device, a personal digital assistant, a laptop computer, a navigation device, a digital audio player, a camera, or a gaming device.

Claims

1. An electronic device and single-use handheld diagnostic test device system, for use with a biological and/or environmental test sample, the system comprising:

(a) a single-use handheld diagnostic test device adapted to receive and operatively react the sample with one or more reagents, with the test device having;

(i) at least one sensor operatively detecting test data from the sample after reaction with the reagents; and

(ii) a test connection element; and

(b) an electronic device having;

(i) a mating electronic connection element operatively connected with the test connection element and electronically receiving the test data from the test device;

(ii) a processor operatively applying one or more algorithms to the test data to generate highly sensitive and accurate quantitative test results and presentation data based on the quantitative test results; and

(iii) a presentation element operatively presenting to a user the presentation data based on the quantitative test results;

wherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after the electronic device receives the test data; and

wherein the test device has onboard memory which electronically stores the test data and/or the algorithms; and

wherein the processor of the electronic device operatively receives the algorithms from the test device via the test and electronic connection elements.

2. A system according to claim 1, further comprising an identification element operative to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the electronic device and/or the test device.

3. A system according to claim 2, wherein the identification element comprises a biometric identification element, preferably a fingerprint scanner, a retinal scanner, a microphone and voice recognition element, a camera and facial recognition element, and/or a genetic expression factor identification element.

4. A system according to claim 1, wherein the electronic device stores user identification data associated with the user and/or an owner of the electronic device, and wherein the identification element automatically accesses the user identification data stored in the electronic device.

5. A system according to claim 1,

further comprising an identification element operative to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the electronic device and/or the test device;

wherein the electronic device stores user identification data associated with the user and/or an owner of the electronic device, and wherein the identification element automatically accesses the user identification data stored in the electronic device; and

adapted for use with an account associated with the user identification data, and further comprising a billing element operatively debiting the account in association with the generation of the quantitative test results.

6. A system according to claim 1, wherein the processor operatively applies the algorithms to control the reaction of the sample with the reagents.

7. A system according to claim 1, wherein the presentation element comprises a display element, and the algorithms generate the quantitative test results and/or the presentation data for presentation from the display element in the form of one or more visually presentable (a) textual data, (b) graphical data, and/or (c) colored indicator light data.

8. A system according to claim 1,

wherein the test results are quantified as high, medium, and/or low results.

9. A system according to claim 1,

wherein the electronic device has a battery, and wherein the test connection element of the test device receives power, via the electronic connection element, from the battery.

10. A system according to claim 1, wherein the electronic device comprises:

(a) a test reader device;

(b) a cellular telephone;

(c) a mobile communications device;

(d) a personal digital assistant;

(e) a desktop computer;

(f) a laptop computer;

(g) a navigation device;

(h) a digital audio player;

(i) a camera;

(j) a gaming device;

(k) a television; and

/or (l) a radio.

11. A system according to claim 1, wherein the electronic device comprises a networking electronic device and automatically transmits the test data, the quantitative test results and/or the presentation data for recordal in one or more remote laboratory and/or hospital information systems.

12. A system according to claim 1,

wherein the presentation data presented to the user comprises treatment and follow-up suggestion data based on the test results.

13. A single-use handheld diagnostic test device for use with an electronic device having an electronic connection element, a presentation element, and a processor for operative application of one or more algorithms, with the test device adapted to receive and operatively react a biological and/or environmental test sample with one or more reagents, wherein the test device comprises:

(a) at least one sensor operatively detecting test data from the sample after reaction with the reagents; and

(b) a mating test connection element operatively connected with, and electronically transmitting the test data to the electronic device via, the electronic connection element;

such as to enable the processor to operatively apply the algorithms to the test data for generation of highly sensitive and accurate quantitative test results and presentation data based on the quantitative test results, and such as to enable the presentation element to operatively present to a user the presentation data based on the quantitative test results; and

wherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after electronic transmission of the test data to the electronic device; and

further comprising onboard memory which electronically stores the test data and/or the algorithms; and

wherein the test connection element electronically transmits the algorithms to the electronic connection element of the electronic device.

14. A device according to claim 13, further comprising an identification element operative to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the sensor and/or the test connection element.

15. A device according to claim 14, wherein the identification element comprises a biometric identification element, preferably a fingerprint scanner, a retinal scanner, a microphone and voice recognition element, a camera and facial recognition element, and/or a genetic expression factor identification element.

16. A device according to claim 14, adapted for use with user identification data which is stored in the electronic device and is associated with the user and/or an owner of the electronic device, wherein the identification element automatically accesses the user identification data stored in the electronic device.

17. A device according to claim 13,

further comprising an identification element operative to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the sensor and/or the test connection element;

adapted for use with user identification data which is stored in the electronic device and is associated with the user and/or an owner of the electronic device, wherein the identification element automatically accesses the user identification data stored in the electronic device; and

adapted for use with an account associated with the user identification data, and further comprising a billing element operatively debiting the account in association with the generation of the quantitative test results.

18. A device according to claim 13, wherein electronic transmission of the algorithms by the test connection element to the electronic connection element of the electronic device is such as to enable the processor to operatively apply the algorithms to control the reaction of the sample with the reagents.

19. A device according to claim 13, adapted for use with a display element as the presentation element, and wherein the algorithms are adapted to generate the quantitative test results and/or the presentation data for presentation from the display element in the form of one or more visually presentable (a) textual data, (b) graphical data and/or (c) colored indicator light data.

20. A device according to claim 13, wherein the algorithms are adapted to quantify the test results as high, medium, and/or low results.

21. A device according to claim 13,

the device being adapted for use with a battery onboard the electronic device, wherein the test connection element of the test device receives power, via the electronic connection element, from the battery.

22. A device according to claim 13, adapted for use with one or more of following as the electronic device:

(a) a test reader device;

(b) a cellular telephone;

(c) a mobile communications device;

(d) a personal digital assistant;

(e) a desktop computer;

(f) a laptop computer;

(g) a navigation device;

(h) a digital audio player;

(i) a camera;

(j) a gaming device;

(k) a television; and

/or (l) a radio.

23. A device according to claim 13, adapted for use with a networking electronic device as the electronic device, such as to enable the networking electronic device to automatically transmit the test data, the quantitative test results and/or the presentation data for recordal in one or more remote laboratory and/or hospital information systems.

24. A device according to claim 13,

adapted for use with presentation data presented to the user which comprises treatment and follow-up suggestion data based on the test results.

25. A method of testing a biological and/or environmental test sample, for use with one or more reagents, an electronic device, and a single-use handheld diagnostic test device adapted to receive and test a single one said sample, the method comprising:

(a) a connection step of connecting a test connection element of the test device with a mating electronic connection element of the electronic device;

(b) a reaction step of using the test device to react the sample with the reagents;

(c) a sensing step, after the connection step and the reaction step, of detecting test data from the sample using at least one sensor of the test device;

(c.

     1) a test device storage step of electronically storing the test data and/or one or more algorithms using onboard memory of the test device;

(d) a data transmission step, after the sensing step and the test device storage step, of electronically transmitting the test data to the electronic connection element of the electronic device using the test connection element of the test device;

(d.1) an algorithm transmission step of electronically transmitting the algorithms to a processor of the electronic device, via the electronic connection element, using the test connection element of the test device;

(e) a processing step, after the data transmission step and the algorithm transmission step, of applying the algorithms to the test data using the processor to generate highly sensitive and accurate quantitative test results and presentation data based on the quantitative test results;

(f) a presentation step, after the processing step, of presenting the presentation data based on the quantitative test results to a user using a presentation element of the electronic device; and

(g) a disposal step, after the data transmission step, of disposing of the test device or sterilizing and re-using the sensor and/or the test connection element.

26. A method according to claim 25, further comprising an identification step of using an identification element to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the electronic device and/or the test device.

27. A method according to claim 26, wherein in the identification step, the identification element comprises a biometric identification element and the user is biometrically identified, with the biometric identification element preferably comprising a fingerprint scanner, a retinal scanner, a microphone and voice recognition element, a camera and facial recognition element, and/or a genetic expression factor identification element.

28. A method according to claim 25, further comprising an ID storage step, before the identification step, of using the electronic device to store user identification data associated with the user and/or an owner of the electronic device, and wherein in the identification step, the identification element automatically accesses the user identification data stored in the electronic device.

29. A method according to claim 25,

further comprising an identification step of using an identification element to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the electronic device and/or the test device;

further comprising an ID storage step, before the identification step, of using the electronic device to store user identification data associated with the user and/or an owner of the electronic device, and wherein in the identification step, the identification element automatically accesses the user identification data stored in the electronic device; and

adapted for use with an account associated with the user identification data, and further comprising a billing step, after the identification step, of debiting the account in association with the generation of the quantitative test results.

30. A method according to claim 25, further comprising a reaction control step, before completion of the reaction step, of using the processor to apply the algorithms to control the reaction of the sample with the reagents.

31. A method according to claim 25, wherein in the presentation step, the quantitative test results and/or the presentation data are presented from a display element of the presentation element, and wherein in the processing step, the algorithms generate the quantitative test results and/or the presentation data for presentation from the display element in the form of one or more visually presentable (a) textual data, (b) graphical data, and/or (c) colored indicator light data.

32. A method according to claim 25,

wherein in the processing step, the test results are quantified as high, medium, and/or low results.

33. A method according to claim 25,

further comprising a powering step, before the data transmission step, of using the test connection element of the test device to receive, via the electronic connection element, power from a battery of the electronic device.

34. A method according to claim 25, adapted for use with one or more of following as the electronic device:

(a) a test reader device;

(b) a cellular telephone;

(c) a mobile communications device;

(d) a personal digital assistant;

(e) a desktop computer;

(f) a laptop computer;

(g) a navigation device;

(h) a digital audio player;

(i) a camera;

(j) a gaming device;

(k) a television; and

/or (l) a radio.

35. A method according to claim 25, adapted for use with a networking electronic device as the electronic device, and further comprising a network transmission step, after the data transmission step, of using the networking electronic device to automatically transmit the test data, the quantitative test results and/or the presentation data for recordal in one or more remote laboratory and/or hospital information systems.

36. A method according to claim 25,

wherein in the processing step, the presentation data generated by the algorithms comprises treatment and follow-up suggestion data based on the test results, and wherein in the presentation step, the treatment and follow-up suggestion data is presented by the presentation element.