Distributed network of in-vitro diagnostic devices

• US 9,715,579 B2
• Filed: 09/09/2011
• Issued: 07/25/2017
• 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): Breene, John
• Assistant Examiner(s): ISLAM, MOHAMMAD K
• Application Number:
  US13/229,301
• Publication Number:
  US 20130066563A1
• Time in Patent Office: 2,146 Days
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system is disclosed in which a plurality of in-vitro diagnostic (IVD) devices each include a network communication device for connecting to a publicly accessible data network. For example, IVD devices are provided with a cellular modem for connecting to a public cellular network. These IVD devices connect to the data network upon completion of a diagnostic test, and upload results of the test, as well as other appropriate data, to a remote device which is also on the network. The IVD devices also download appropriate data from remote network elements. The remote network element may be a network element such as a Hospital Information System (HIS) or Laboratory Information System (LIS) database. Alternatively, the remote device may be a remote server or another IVD device. This connectivity enables the system to accumulate diagnostic test data, and to analyze, report, and/or update the IVD devices based on the accumulated data.

Claims

1. A diagnostic test analysis system comprising:

at least one processor;

an in-vitro diagnostic device including;

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, the in-vitro diagnostic device configured to generate a first test result of a diagnostic test based on a current testing protocol and data from the sensor indicating the presence or absence of the one or more lines, and

at least one network communication device configured to enable a telemetric connection over a publicly accessible network; 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 in-vitro diagnostic device and the at least one network communication device to;

receive, from the in-vitro diagnostic device, data indicating the first test result of the diagnostic test based on the current testing protocol,

receive, by the in-vitro diagnostic device via the telemetric connection over the publicly accessible network, additional data from at least one remote network element remote from the in-vitro diagnostic device, and

generate, by the in-vitro diagnostic device, a second test result for the diagnostic test based, at least in part, on verifying the first test result of the diagnostic test using the additional data.

2. The diagnostic test analysis system of claim 1, wherein the data indicating the first test result of the diagnostic test includes calibration data by which the current testing protocol was performed.

3. The diagnostic test analysis system of claim 1, wherein the biological sample is a physiological fluid.

4. The diagnostic test analysis system of claim 1, wherein the publicly accessible network is a cellular data network, and wherein the at least one network communication device includes a cellular modem.

5. The diagnostic test analysis system of claim 4, wherein the cellular data network is at least one of a 2G network, a 3G network, and a 4G network.

6. The diagnostic test analysis system of claim 1, wherein the plurality of instructions cause the at least one processor to operate with the at least one network communication device to receive at least one signal directly from a remote in-vitro diagnostic device to form an ad-hoc network of devices.

7. The diagnostic test analysis system of claim 1, wherein the plurality of instructions cause the at least one processor to operate with the at least one network communication device to send data indicative of the first test result of the diagnostic test to a remote network element over the publicly accessible network.

8. The diagnostic test analysis system of claim 7, wherein the plurality of instructions cause the at least one processor to operate with the at least one network communication device to send the data indicative of the first test result of the diagnostic test to a remote handheld device of a remote medical professional for display to the remote medical professional.

9. The diagnostic test analysis system of claim 1, wherein the at least one remote network element is configured to generate at least one report based on the first test result of the diagnostic test and based on a different result of a different diagnostic test performed by one of a plurality of remote in-vitro diagnostic devices.

10. The diagnostic test analysis system of claim 1, wherein the plurality of instructions cause the at least one processor to operate with the in-vitro diagnostic device and the at least one network communication device to receive the data indicating the first test result of the diagnostic test via a short-range link selected from the group consisting of:

Bluetooth, UART, USB, WiFi, Wireless USB, and ZigBee.

11. A diagnostic test analysis system comprising:

at least one processor;

an in-vitro diagnostic device including;

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, the in-vitro diagnostic device configured to generate a first test result of a diagnostic test based on a current testing protocol and data from the sensor indicating the presence or absence of the one or more lines, and

at least one network communication device configured to enable a telemetric connection over a publicly accessible network; 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 in-vitro diagnostic device and the at least one network communication device to;

receive, from the in-vitro diagnostic device, data indicating the first test result of the diagnostic test based on the current testing protocol,

receive, by the in-vitro diagnostic device via the telemetric connection over the publicly accessible network, additional data from at least one remote network element remote from the in-vitro diagnostic device, and

generate, by the in-vitro diagnostic device, a second test result for the diagnostic test based, at least in part, on augmenting the first test result of the diagnostic test using the additional data.

12. The diagnostic test analysis system of claim 11, wherein the data indicating the first test result of the diagnostic test includes calibration data by which the current testing protocol was performed.

13. The diagnostic test analysis system of claim 11, wherein the biological sample is a physiological fluid.

14. The diagnostic test analysis system of claim 11, wherein the publicly accessible network is a cellular data network, and wherein the at least one network communication device includes a cellular modem.

15. The diagnostic test analysis system of claim 14, wherein the cellular data network is at least one of a 2G network, a 3G network, and a 4G network.

16. The diagnostic test analysis system of claim 11, wherein the plurality of instructions cause the at least one processor to operate with the at least one network communication device to receive at least one signal directly from a remote in-vitro diagnostic device to form an ad-hoc network of devices.

17. The diagnostic test analysis system of claim 11, wherein the plurality of instructions cause the at least one processor to operate with the at least one network communication device to send data indicative of the first test result of the diagnostic test to a remote network element over the publicly accessible network.

18. The diagnostic test analysis system of claim 17, wherein the plurality of instructions cause the at least one processor to operate with the at least one network communication device to send the data indicative of the first test result of the diagnostic test to a remote handheld device of a remote medical professional for display to the remote medical professional.

19. The diagnostic test analysis system of claim 11, wherein the at least one remote network element is configured to generate at least one report based on the first test result of the diagnostic test and based on a different result of a different diagnostic test performed by one of a plurality of remote in-vitro diagnostic devices.

20. The diagnostic test analysis system of claim 11, wherein the plurality of instructions cause the at least one processor to operate with the in-vitro diagnostic device and the at least one network communication device to receive the data indicating the first test result of the diagnostic test via a short-range link selected from the group consisting of:

Bluetooth, UART, USB, WiFi, Wireless USB, and ZigBee.