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

• US 10,180,417 B2
• Filed: 12/16/2016
• Issued: 01/15/2019
• 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): BLOSS, STEPHANIE E
• Application Number:
  US15/381,590
• Publication Number:
  US 20170160258A1
• Time in Patent Office: 760 Days
• Field of Search: 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 indicating that a condition is present or absent,

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 indicating a severity of the condition, and

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

2. 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.

3. The diagnostic test analysis system of claim 1, 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.

4. The diagnostic test analysis system of claim 3, 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.

5. 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.

6. The diagnostic test analysis system of claim 5, wherein the set of additional data includes data about the network.

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

8. 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.

9. The diagnostic test analysis system of claim 1, wherein the at least one processor determines the first result based on the presence of a line on an assay test strip, and wherein the additional data enables the at least one processor to determine the severity of the condition based on an intensity of the line.

10. 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 indicating that a condition is present or absent,

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, wherein the third result indicates a severity of the condition.

11. The diagnostic test analysis system of claim 10, 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.

12. The diagnostic test analysis system of claim 10, 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.

13. The diagnostic test analysis system of claim 12, 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.

14. The diagnostic test analysis system of claim 13, 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.

15. The diagnostic test analysis system of claim 14, 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.

16. The diagnostic test analysis system of claim 10, 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.