ASSAY DEVICE

• US 20090104074A1
• Filed: 05/02/2007
• Published: 04/23/2009
• Est. Priority Date: 05/09/2006
• Status: Active Grant

• Current Assignee: Koninklijke Philips N.V.
• Original Assignee: Koninklijke Philips Electronics N.V. (Koninklijke Philips N.V.)
• Inventors: Bodlaender, Maarten Peter, Damen, Erik Petrus Nicolaas, Stut, Wilhelmus Johannes Joseph
• Granted Patent: US 7,927,559 B2
• Time in Patent Office: Days
• US Class Current: 422/50
• CPC Class Codes: B01L 2200/143 Quality control, feedback systems
• CPC Class Codes: B01L 2300/023 Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/024 Storing results with means integrated into the container
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: G01N 35/00871 Communications between instruments or with remote terminals
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis

Abstract

Disposable assay device (1), configured to assay one or more samples, and configured for transmitting assay data or information to a remote receiving system (30), wherein the device is provided with one or more assay context sensors configured to monitor one or more assay context factors. In this way, assay results can be made more reliable in a relatively simple manner.

Claims

1. Disposable assay device (1), configured to assay one or more samples, and configured for transmitting assay data or information to a remote receiving system (30), characterized in that the device is provided with one or more assay context sensors (8, 20, 21, 25) configured to monitor one or more assay context factors.

2. Device according to claim 1, wherein the device (1) is provided with one or more degradable assaying substances, the degradation of which is time-dependent, and at least one of the context sensors is a monitoring unit (8) to monitor degradation of the one or more degradable assaying substances, the monitoring unit (8) preferably being provided with a timer (25) to time at least one degradation period of the one or more degradable substances.

3. Device according to claim 2, wherein the device (1) is configured to be in a non-operating state, in which case the one or more degradable substances are not available to receive a sample, and in an operating state when the one or more degradable substances are available to receive a sample, the monitoring unit (8) and timer (25) being configured to cooperate to measure at least a first degradation period during which the device is in the non-operating state.

4. Device according to claim 3, wherein the monitoring unit (8) and timer (25) are configured to cooperate to measure at least a second degradation period, which period is the time between activation of the device, on the one hand, and the receiving of a sample by the one or more degradable substances, on the other hand, the degradation monitor (8) being preferably configured to take into account both the measured first degradation period and second degradation period to determine or estimate an overall degradation of the one or more degradable substances.

5. Device according to 1, wherein the device (1) is configured to disallow use of the device in case a monitored assay context factor has reached and/or passed a predetermined threshold.

6. Device according to claim 1, wherein the assay context sensor (8) is provided with or connected to an indicator, to indicate a time remaining for the user to use the device to assay a sample.

7. Device according to claim 1, wherein the device (1) is configured to detect activation of the device (1) and to detect the application of a sample to the device (1), and the device (1) is configured to store a time and/or date of the activation of the device, as well as a time and/or date of the device'"'"'s reception of the sample.

8. A device according to claim 1, wherein the assay device (1) is provided with at least one user condition sensor (20) configured to detect at least one physical condition of a user of the device (1).

9. Assay device according to claim 8, wherein the user condition sensor (20) comprises a personal activity sensor, for example comprising an acceleration sensor, to measure personal activity when the device is being carried by the user during a personal activity measuring period.

10. Assay device according to claim 1, comprising a temperature sensor (21) to measure the temperature of the environment of the device (1), wherein the device (1) is configured to allow the assaying of a sample only after a temperature detected by the temperature sensor (21) is within a predetermined temperature range, and/or to disallow the assaying of a sample in case the detected temperature is not in a predetermined temperature range.

11. Assay device according to claim 1, wherein the assay device (1) comprises a memory unit (10), and is configured to store each assay result in the memory unit (10) in combination with assay context information.

12. Assay device according to claim 1, wherein the assay device comprises a heart rate sensor (20), the assay device is configured to be carried in a heart rate detection position on a user body part, and the heart rate sensor (20) is arranged to detect a heart rate-related signal emanating from the user body part, for example pressure pulses and/or acoustic signals, in case the device (1) is in the heart rate detection position.

13. Assay device according to claim 12, being configured to measure the heart rate during a heart rate measuring period, to detect a lowest heart rate from respective measuring results and to store the lowest detected heart rate in a memory device (10).

14. Assay device (1) according to claim 1, configured to assay at least a first sample, wherein the device comprises:

at least one testing unit (w) to carry out the assaying of the sample, the testing unit being configured to provide a testing signal during at least part of a first time period, when the device (1) has not received the first sample, and during at least part of a second time period, when the device has received the first sample; and

a memory unit (10);

the device (1) being configured to store the testing signal, or information regarding the testing signal, both during the first and second time period, in the memory unit (10), and the device (1) being preferably configured to store the testing signal in combination with a respective testing signal generation time, and the device (1) being preferably configured to be in a non-operating state, in which case the testing unit is not available to receive the sample, and in an operating state when the testing unit is available to receive the sample, and the device (1) beings preferably configured to store the testing signal, or information regarding the testing signal, during at least part of a time period when the device (1) is in the non-operating state.

15. Device according to claim 14, wherein the testing unit (w) of the device is provided with at least one substance which is responsive to a specific analyte to be searched, and the testing signal is dependent on the amount and/or condition of the at least one substance.