In-vitro diagnostic device using external information in conjunction with test results

• US 9,524,372 B2
• Filed: 09/09/2011
• Issued: 12/20/2016
• 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
• Primary Examiner(s): Henson, Mischita
• Assistant Examiner(s): Bloss, Stephanie
• Application Number:
  US13/229,292
• Publication Number:
  US 20130066562A1
• Time in Patent Office: 1,929 Days
• Field of Search: 702/19
• US Class Current: 1/1
• 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:

an in-vitro diagnostic device for conducting a biological test, the in-vitro diagnostic device comprising;

a sensor positioned to detect the presence or absence of one or more lines on a lateral flow assay test strip following application of a biological sample to the lateral flow assay test strip;

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 the in-vitro diagnostic device to provide the biological sample to the lateral flow assay test strip,

determine, using the in-vitro diagnostic device, a first result of the biological test based on data from the sensor indicating the presence or absence of the one or more lines, the first result having a first level of detail,

display the first result of the biological test to the local user via the at least one display device,

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

perform at least one correlation analysis based, at least in part, on the received set of additional data, 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 correlation 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 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.

6. The diagnostic test analysis system of claim 5, 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.

7. The diagnostic test analysis system of claim 6, wherein the set of additional data includes data about the network.

8. The diagnostic test analysis system of claim 7, wherein the set of additional data includes data about a location of the at least one processor within the network.

9. The diagnostic test analysis system of claim 8, wherein the data about the location of the at least one processor within the network includes an address of the at least one processor.

10. 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.

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 1, wherein the network connection is a wireless connection.

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

14. The diagnostic test analysis system of claim 1, wherein the set of additional data indicative of a characteristic of the diagnostic test device 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.

15. A diagnostic test analysis system comprising:

a diagnostic test device for conducting a biological test, the diagnostic test comprising;

a sensor positioned to detect the presence or absence of one or more lines on a lateral flow assay test strip following application of a biological sample to the lateral flow assay test strip;

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 diagnostic test device, the at least one input device, and the at least one display device to;

enable a local user of the in vitro diagnostic test device to provide the biological sample to the lateral flow assay test strip,

determine, using the diagnostic test device, a first result of the biological test based on data from the sensor indicating the presence or absence of the one or more lines, the first result having a first level of detail,

display the first result of the biological test to the local user via the at least one display device,

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

determine, using the diagnostic test device, a second result of the biological 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.

16. The diagnostic test analysis system of claim 15, wherein the set of additional data includes at least one selected from the group consisting of:

diagnostic information, hardware information, and environmental information.

17. The diagnostic test analysis system of claim 15, wherein the plurality of instructions cause the at least one processor to send an indication of the second result to the remote server, the remote server configured to store data about a plurality of different diagnostic tests.

18. The diagnostic test analysis system of claim 17, 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.

19. The diagnostic test analysis system of claim 15, 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.

20. The diagnostic test analysis system of claim 15, wherein the at least one input device includes a keypad or a barcode scanner.

21. The diagnostic test analysis system of claim 15, wherein the set of additional data indicative of a characteristic of the diagnostic test device 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.

22. A diagnostic test analysis system comprising:

a diagnostic test device for conducting a diagnostic test, the diagnostic test device comprising;

a sensor positioned to detect the presence or absence of one or more lines on a lateral flow assay test strip following application of a biological sample to the lateral flow assay test strip;

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 diagnostic test device, the at least one input device, and the at least one display device to;

determine, based at least partly on data from the sensor indicating the presence or absence of the one or more lines, a first set of data indicative, at least in part, of an analysis of a biological sample by the diagnostic test device following application of the biological sample to the lateral flow assay test strip,

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

determine, using the diagnostic test device, 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, and

display either the first result or the second result.

23. The diagnostic test analysis system of claim 22, 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 22, wherein the plurality of instructions cause the at least one processor to receive the additional set of data from a remote diagnostic device over an ad-hoc network connection.

26. The diagnostic test analysis system of claim 25, wherein the additional set of data includes data indicative of a result of a different diagnostic test performed by the remote diagnostic device.

27. The diagnostic test analysis system of claim 25, 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.

28. The diagnostic test analysis system of claim 27, wherein the remote network device includes a Hospital Information System (HIS) or Laboratory Information System (LIS) database.