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

• US 10,458,972 B2
• Filed: 12/16/2016
• Issued: 10/29/2019
• 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:
  US15/381,527
• Publication Number:
  US 20180128805A1
• Time in Patent Office: 1,047 Days
• 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, the in vitro-diagnostic device 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 diagnostic test based on the biological sample, the first result indicating at least the presence or absence of a condition,

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 diagnostic test based, at least in part, on the additional data, to generate an altered first result, the altered first result having an improved accuracy relative to the first result of the diagnostic test, and

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

2. The diagnostic test analysis system of claim 1, wherein the plurality of instructions cause the at least one processor to alter the first result of the diagnostic test by re-calibrating the diagnostic test based on the received set of additional data.

3. The diagnostic test analysis system of claim 2, wherein the received set of additional data comprises configuration data, and wherein the plurality of instructions cause the at least one processor to determine the altered first result as a more precise result than the first result based on the configuration data.

4. The diagnostic test analysis system of claim 1, further comprising a sensor positioned to optically detect a change in a characteristic of an assay test device, wherein the plurality of instructions cause the at least one processor to determine the first result of the diagnostic test based on data from the sensor indicating the change in the characteristic of the assay test device.

5. The diagnostic test analysis system of claim 1, further 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 the biological sample to the lateral flow assay test strip, wherein the plurality of instructions cause the at least one processor to determine the first result of the diagnostic test based on data from the sensor indicating the presence of absence of the one or more lines.

6. The diagnostic test analysis system of claim 5, wherein the received set of additional data comprises calibration data, and wherein the plurality of instructions cause the at least one processor to use the calibration data to:

determine an intensity of the one or more lines; and

alter the first result of the diagnostic test based on the determined intensity.

7. The diagnostic test analysis system of claim 6, wherein the plurality of instructions cause the at least one processor to determine a severity of a condition based on the intensity of the one or more lines.

8. The diagnostic test analysis system of claim 1, further comprising at least one network communication device configured to provide the network connection by enabling a telemetric connection over a publicly accessible network.

9. The diagnostic test analysis system of claim 8, wherein the plurality of instructions cause the at least one processor to automatically transmit the altered test result to a remote network element via the telemetric connection.

10. The diagnostic test analysis system of claim 8, wherein the publicly accessible network is a cellular data network, and wherein the at least one network communication device includes a cellular modem.

11. The diagnostic test analysis system of claim 1, wherein the set of additional data comprises hardware data or environmental data associated with the in vitro-diagnostic device.

12. A diagnostic test analysis method comprising:

receiving data from a sensor within a patient care facility 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;

determining a first result of a diagnostic test associated with the sensor based on data from the sensor indicating the presence or absence of the one or more lines;

receiving a set of additional data via a network connection, the additional data comprising hardware data or environmental data associated with the patient care facility and indicative of a characteristic of the diagnostic test not determinable based on the data from the sensor;

altering the first result of the diagnostic test based, at least in part, on the additional data, to generate an altered first result, the altered first result having an improved accuracy relative to the first result of the diagnostic test, and

outputting the altered first result of the diagnostic test for display to a user.

13. The diagnostic test analysis method of claim 12, performed by at least one processor in communication with at least one memory device storing a plurality of instructions which, when executed by the at least one processor, cause the at least one processor to perform the method.

14. The diagnostic test analysis method of claim 12, further comprising altering the first result of the diagnostic test by re-calibrating the diagnostic test based on the additional data.

15. The diagnostic test analysis method of claim 12, further comprising combining the additional data with the first result to generate the altered first result.

16. The diagnostic test analysis method of claim 12, further comprising:

determining an intensity of the one or more lines; and

altering the first result of the diagnostic test based on the determined intensity.

17. The diagnostic test analysis method of claim 16, further comprising determining a severity of a condition based on the intensity of the one or more lines.

18. The diagnostic test analysis method of claim 17, wherein the determining the first result comprises determining a presence of the condition based on a presence of the one or more lines, and wherein the altered test result comprises the severity of the condition.

19. The diagnostic test analysis method of claim 12, further comprising automatically transmitting the altered test result to a remote network element via a telemetric connection.

20. The diagnostic test analysis method of claim 12, further comprising receiving the additional data automatically without a request from the user.

21. The diagnostic test analysis method of claim 12, wherein an in vitro-diagnostic device comprises the sensor and wherein the first test result comprises a voltage detected by the sensor, the method further comprising:

providing the voltage to another device in an ad-hoc network with the in vitro-diagnostic device;

receiving the additional data as an analysis of the voltage from the another device; and

determining the altered first result as a valid test result in the absence of correct functioning of the in vitro-diagnostic device.