IN-VITRO DIAGNOSTIC DEVICE USING EXTERNAL INFORMATION IN CONJUNCTION WITH TEST RESULTS

• US 20130066562A1
• Filed: 09/09/2011
• Published: 03/14/2013
• Est. Priority Date: 09/09/2011
• Status: Active Grant

• Current Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Original Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Inventors: Hengstler, Stephan, Xie, Tong
• Granted Patent: US 9,524,372 B2
• Time in Patent Office: Days
• US Class Current: 702/19
• CPC Class Codes: G01N 33/48 Biological material, e.g. blood, urine G01N33/02, G01N33/26, G01N33/44, G01N33/46 take precedence; Haemocytometers counting blood corpuscules distributed over a surface by scanning the surface G06M11/02
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system and method for augmenting or adding to the information used by an in-vitro diagnostic or other diagnostic device to generate results of a test is disclosed. A diagnostic device is capable of generating test results based on a sample, such as a sample provided by a patient, and is also capable of receiving additional information to enhance the results providable by the device. For example, an in-vitro diagnostic device is configured to read a lateral flow assay test, and is configured to receive additional diagnostic, network, test identification, or environmental information over a network. Using both the result of the diagnostic test and the additional information, the disclosed device provides more thorough, accurate, and reliable diagnostic information. The results generated by the device may be communicated to an appropriate remote device to enhance the results obtainable by such tests.

Claims

1. A diagnostic test analysis system comprising:

at least one processor;

at least one display device;

at least one input device; and

at least one memory device which stores a plurality of instructions which, when executed by the at least one processor, cause the at least one processor to operate with the at least one input device and the at least one display device to;

enable a local user of a diagnostic test to provide a biological sample,

determine a first result of the biological test based on the biological sample, the first result having a first level of detail,

display the first result of the biological test to the local user,

receive a set of additional data via a network connection, the set of additional data indicative of a characteristic of the diagnostic test not determinable based on the biological sample; and

perform at least one statistical analysis based, at least in part, on the received set of additional data, the at least one statistical analysis being of a characteristic of the diagnostic test; and

generate a modified result by modifying the first result based on the received set of additional data.

2. The diagnostic test system of claim 1, wherein the plurality of instructions, when executed by the at least one processor, cause the at least one processor to operate with the at least one display device to display the modified result to the local user.

3. The diagnostic test system of claim 1, wherein the plurality of instructions, when executed by the at least one processor, cause the at least one processor to operate with at least one network interface device to send at least one of the first result, the modified result, and the statistical analysis to a remote server.

4. The diagnostic test analysis system of claim 1, wherein the plurality of instructions, when executed by the at least one processor, cause the at least one processor to:

(a) determine a second result of the diagnostic test based on the first result and based on the set of additional data, the second result having a second level of detail and being more specific than the first result, and (b) send data indicative of the second result to a remote server for storage in association with display either the first result or the second result.

5. The diagnostic test analysis system of claim 1, wherein the diagnostic test includes an in-vitro diagnostic test.

6. The diagnostic test analysis system of claim 1, wherein the diagnostic test includes an assay test strip.

7. The diagnostic test analysis system of claim 4, wherein the first level of detail is less than the second level of detail.

8. The diagnostic test analysis system of claim 1, wherein the set of additional data includes at least one selected from the group consisting of:

diagnostic information, network information, hardware information, and environmental information.

9. The diagnostic test analysis system of claim 4, wherein the plurality of instructions cause the at least one processor to send an indication of the second result to a remote server, the remote server configured to store data about a plurality of different diagnostic tests.

10. The diagnostic test analysis system of claim 9, wherein the remote server is further configured to determine a third result based, at least in part, on the first result, the second result, and a different result from a different diagnostic test.

11. The diagnostic test analysis system of claim 1, wherein the network connection enables communication with a network selected from the group consisting of a wide area network, a local area network, an Internet, a public cellular network, and a global positioning system network.

12. The diagnostic test analysis system of claim 10, wherein the set of additional data includes data about the network.

13. The diagnostic test analysis system of claim 12, wherein the set of additional data includes data about a location of the at least one processor within the network.

14. The diagnostic test analysis system of claim 13, wherein the data about the location of the at least one processor within the network includes an address of the at least one processor.

15. The diagnostic test analysis system of claim 1, wherein the network connection is a wireless connection.

16. The diagnostic test analysis system of claim 1, wherein the at least one input device includes a keypad or a barcode scanner.

17. The diagnostic test analysis system of claim 1, wherein the characteristic of the diagnostic test includes at least one selected from the group consisting of:

device quality data, a calibration date, calibration data, an environmental temperature, an environmental humidity, a characteristic of manufacture of the diagnostic test, and a characteristic of storage of the diagnostic test.

18. A diagnostic test analysis system comprising:

at least one processor;

at least one display device;

at least one input device; and

at least one memory device which stores a plurality of instructions which, when executed by the at least one processor, cause the at least one processor to operate with the at least one input device and the at least one display device to;

enable a local user of a diagnostic test to provide a biological sample,

determine a first result of the biological test based on the biological sample, the first result having a first level of detail,

receive a set of additional data via a network connection, the set of additional data indicative of a characteristic of the diagnostic test not determinable based on the biological sample;

alter the first result of the biological test based, at least in part, on the additional data, said alteration improving an accuracy of the first result of the biological test, and

display the altered first result of the biological test to the local user.

19. The diagnostic test analysis system of claim 18, wherein the plurality of instructions cause the at least one processor to alter the first result of the biological test by re-calibrating the biological test based on the received set of additional data.

20. A diagnostic test analysis system comprising:

at least one processor;

at least one display device;

at least one input device; and

at least one memory device which stores a plurality of instructions which, when executed by the at least one processor, cause the at least one processor to operate with the at least one input device and the at least one display device to;

enable a local user of a diagnostic test to provide a biological sample,

determine a first result of the biological test based on the biological sample, the first result having a first level of detail,

display the first result of the biological test to the local user,

receive a set of additional data via a network connection, the set of additional data indicative of a characteristic of the diagnostic test not determinable based on the biological sample,

determine a second result of the diagnostic test based on the first result and based on the set of additional data, the second result having a second level of detail and being more specific than the first result, and

send data indicative of the second result to a remote server for storage in association with display either the first result or the second result.

21. The diagnostic test analysis system of claim 20, wherein the first level of detail is less than the second level of detail.

22. The diagnostic test analysis system of claim 20, wherein the set of additional data includes at least one selected from the group consisting of:

diagnostic information, network information, hardware information, and environmental information.

23. The diagnostic test analysis system of claim 20, wherein the plurality of instructions cause the at least one processor to send an indication of the second result to a remote server, the remote server configured to store data about a plurality of different diagnostic tests.

24. The diagnostic test analysis system of claim 23, wherein the remote server is further configured to determine a third result based, at least in part, on the first result, the second result, and a different result from a different diagnostic test.

25. The diagnostic test analysis system of claim 20, wherein the network connection enables communication with a network selected from the group consisting of a wide area network, a local area network, an Internet, a public cellular network, and a global positioning system network.

26. The diagnostic test analysis system of claim 25, wherein the set of additional data includes data about the network.

27. The diagnostic test analysis system of claim 20, wherein the at least one input device includes a keypad or a barcode scanner.

28. The diagnostic test analysis system of claim 20, wherein the characteristic of the diagnostic test includes at least one selected from the group consisting of:

device quality data, a calibration date, calibration data, an environmental temperature, an environmental humidity, a characteristic of manufacture of the diagnostic test, and a characteristic of storage of the diagnostic test.

29. A diagnostic test analysis system comprising:

at least one processor;

at least one display device;

at least one input device; and

at least one memory device which stores a plurality of instructions which, when executed by the at least one processor, cause the at least one processor to operate with the at least one input device and the at least one display device to;

enable a local user of a diagnostic test to provide a biological sample,

determine a first result of the biological test based on the biological sample, the first result having a first level of detail,

display the first result of the biological test to the local user,

receive, from a remote device via a network connection, data indicative of a second result of a second biological test based on a biological sample provided by a remote user, and

determine a third result of the biological test based on the determined first result and the received data indicative of the second result, the third result based, at least in part, on the biological test of the remote device and also based on a set of additional data indicative of a characteristic of the diagnostic test not determinable based on the biological sample.

30. The diagnostic test analysis system of claim 29, wherein the set of additional data includes at least one selected from the group consisting of diagnostic information, network information, hardware information, and environmental information.

31. The diagnostic test analysis system of claim 29, wherein the remote device is an in-vitro diagnostic device connected to the at least one processor in an ad-hoc network via the network connection.

32. The diagnostic test analysis system of claim 31, wherein the plurality of instructions cause the at least one processor to determine the third result based, at least in part, on an aggregation of data from the remote device and at least one additional in-vitro diagnostic device.

33. The diagnostic test analysis system of claim 32, wherein the aggregation of data includes data about diagnostic information associated with each of the remote devices and the at least one additional in-vitro diagnostic device.

34. The diagnostic test analysis system of claim 33, wherein the aggregation of data includes data about a location of the remote device and the at least one additional in-vitro diagnostic device within the network.

35. The diagnostic test analysis system of claim 29, wherein the plurality of instructions cause the at least one processor to operate with the at least one display device to display an indication that the remote server has determined the second result of the biological test.

36. A diagnostic test analysis system comprising:

at least one processor;

at least one display device;

at least one input device; and

at least one memory device which stores a plurality of instructions which, when executed by the at least one processor, cause the at least one processor to operate with the at least one input device and the at least one display device to;

determine a first set of data indicative, at least in part, of an analysis of a biological sample by a diagnostic test,

receive an additional set of data indicative of a characteristic of the diagnostic test, said additional set of data being independent of the biological sample,

determine a first result of the diagnostic test based on the first set of data,

determine a second result of the diagnostic test based on the first set of data and the additional set of data, the second result being more specific than the first result, said second result, and

display either the first result or the second result.

37. The diagnostic test analysis system of claim 36, wherein the plurality of instructions cause the at least one processor to send an indication of the second result to a remote server, the remote server configured to store data about a plurality of different diagnostic tests.

38. The diagnostic test analysis system of claim 37, wherein the remote server is further configured to determine a third result based, at least in part, on the first result, the second result, and a different result from a different diagnostic test.

39. The diagnostic test analysis system of claim 36, wherein the plurality of instructions cause the at least one processor to receive the additional set of data from a remote in-vitro diagnostic device over an ad-hoc network connection.

40. The diagnostic test analysis system of claim 39, wherein the additional set of data includes data indicative of a result of a different diagnostic test performed by the remote in-vitro diagnostic device.

41. The diagnostic test analysis system of claim 39, wherein the plurality of instructions cause the at least one processor to send the first result, the second result, and the result of the different diagnostic test to a remote network device via a publicly accessible network connection.

42. The diagnostic test analysis system of claim 41, wherein the remote network device includes an HIS or LIS database.