Assay device

• US 7,927,559 B2
• Filed: 05/02/2007
• Issued: 04/19/2011
• Est. Priority Date: 05/09/2006
• Status: Expired due to Fees

• Current Assignee: Koninklijke Philips N.V.
• Original Assignee: Koninklijke Philips Electronics N.V. (Koninklijke Philips N.V.)
• Inventors: Stut, Wilhelmus Gijsbert Johannes Joseph, Damen, Erik Petrus Nicolaas, Bodlaender, Maarten Peter
• Primary Examiner(s): Jarrett; Lore
• Application Number:
  US12/299,680
• Publication Number:
  US 20090104074A1
• Time in Patent Office: 1,448 Days
• Field of Search: 422/401, 734/31, 705/3, 702/188
• US Class Current: 422/401
• 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

A disposable assay device that assays one or more samples, and transmits assay data or information to a remote receiving system. The device is provided with one or more assay context sensors configured to monitor one or more assay context factors.

Claims

1. A disposable assay device to assay one or more samples, the disposable assay device comprising:

at least one sample application area for receiving the one or more samples;

a controller for performing the assay of the one or more samples and forming assay data;

a transmitter for transmitting the assay data to a remote receiving system; and

one or more assay context sensors to monitor one or more assay context factors,

wherein the at least one sample application area includes a first area for receiving a first sample and a second area for receiving a second sample for performing a sequence of measurements using the first sample and the second sample, and wherein a carrier of the controller is between the first area and the second area.

2. The disposable assay device of claim 1, further comprising one or more degradable assaying substances having a degradation of which is time-dependent, and wherein the controller monitors the degradation of the one or more degradable assaying substances, the controller including a timer to time at least one degradation period of the one or more degradable assaying substances.

3. The disposable assay device of claim 2, wherein the controller and the timer cooperate to measure at least a first degradation period during which the device is in a non-operating state where the one or more degradable assaying substances are not available to receive the one or more samples, the disposable assay device having an operating state when the one or more degradable assaying substances are available to receive the one or more samples.

4. The disposable assay device of claim 3, wherein the controller and the timer cooperate to measure at least a second degradation period which is a time between activation of the disposable assay device and receiving of the one or more samples by the one or more degradable assaying substances, and wherein the controller takes into account both the first degradation period and the second degradation period to determine an overall degradation of the one or more degradable assaying substances.

5. The disposable assay device of claim 1, wherein the controller disallows use of the disposable assay device in case a monitored assay context factor is equal or greater than a predetermined threshold.

6. The disposable assay device of claim 1, further comprising an indicator to indicate a time remaining for a user of the disposable assay device to use the disposable assay device to assay the one or more samples.

7. The disposable assay device of claim 1, wherein the controller detects activation of the disposable assay device and detects application of the one or more samples to the disposable assay device, and stores at least one of a time and a date of the activation of the disposable assay device, as well as at least one of a time and a date of the application of the sample.

8. The disposable assay device of claim 1, wherein the one or more assay context sensors comprises a personal activity sensor comprising an acceleration sensor to measure personal activity when the disposable assay device is being carried by a user of the disposable assay device during a personal activity measuring period.

9. The disposable assay device of claim 1, wherein the one or more assay context sensors comprises a temperature sensor to measure a temperature of an environment of the disposable assay device, wherein the controller allows the assay of the one or more samples only after a temperature detected by the temperature sensor is within a predetermined temperature range, and disallows the assay of the one or more samples in case the detected temperature is not in the predetermined temperature range.

10. The disposable assay device of claim 1, further comprising a memory unit to store each assay result in the memory unit in combination with assay context information.

11. The disposable assay device of claim 1, wherein the one or more assay context sensors comprises a heart rate sensor to be carried in a heart rate detection position on a body part of a user of the disposable assay device, wherein the heart rate sensor detects a heart rate-related signal emanating from the body part when the disposable assay device is in the heart rate detection position.

12. The disposable assay device of claim 11, wherein the heart rate sensor measures 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.

13. The disposable assay device of claim 1, further comprising a memory unit, wherein the controller provides a testing signal during at least part of a first time period, when the disposable assay device has not received a first sample, and during at least part of a second time period, when the device has received the first sample;

wherein the memory unit stores the testing signal during the first time period and the second time period, in combination with a respective testing signal generation time.

14. The disposable assay device of claim 13, wherein the at least one sample application area includes at least one substance which is responsive to a specific analyte to be searched, and the testing signal is dependent on at least one of an amount and a condition of the at least one substance.

15. The disposable assay device of claim 1, wherein the first area and the second area are independently removable from the carrier of the controller.

16. The disposable assay device of claim 1, further comprising at least one user condition sensor configured to detect at least one physical condition of a user of the disposable assay device.

17. The disposable assay device of claim 1, wherein the controller detects removal of the at least one sample application area from a carrier of the controller and stores time of the removal in a memory.

18. The disposable assay device of claim 1, wherein the assay data includes measurement values and respective times when the measurement values are obtained to form a testing signal as a function of time.

19. The disposable assay device of claim 1 wherein, based on at least one factor detected by the one or more assay context sensors, the controller automatically adjusts at least one of an expiration time for using the disposable assay device and an expiration time for performing the assay after reception of the one or more samples by the at least one sample application area.

20. The disposable assay device of claim 1 wherein the at least one factor includes temperature.