Self Correction for Spatial Orientation and Motion of Portable Clinical Analyzers

• US 20140172341A1
• Filed: 12/06/2013
• Published: 06/19/2014
• Est. Priority Date: 12/17/2012
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Inventors: Vandersleen, Gary, Emeric, Pierre, Wasserman, Paul, Soman, Narendra, Davis, Graham
• Granted Patent: US 9,904,761 B2
• Time in Patent Office: Days
• US Class Current: 702/89
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
• CPC Class Codes: G16B 99/00 Subject matter not provided for in other groups of this subclass

Abstract

The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth'"'"'s gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof.

Claims

1. A portable clinical system for in vitro analysis, the system comprising:

an analyzer comprising;

a port configured to receive a test device; and

a computing device configured to;

determine spatial orientation and motion of the analyzer during a test cycle of the test device;

compare the determined spatial orientation to a threshold operating spatial plane for the test device;

compare the determined motion to a threshold rate of motion for the test device; and

correct a result of the analytical test when at least one of;

(i) the determined spatial orientation exceeds the threshold operating spatial plane, and/or (ii) the determined motion exceeds the threshold rate of motion.

2. The system of claim 1, further comprising the test device.

3. The system of claim 1, wherein the computing device is further configured to provide an alert prompting a user to take corrective action during the test cycle, and correct the result of the analytical test, when the at least one of:

(i) the determined spatial orientation exceeds the threshold operating spatial plane, and/or (ii) the determined motion exceeds the threshold rate of motion.

4. The system of claim 1, wherein the correcting the result comprises applying a correction factor to the result.

5. The system of claim 4, wherein the correction factor comprises at least one of:

a blood non-homogeneity correction factor, a blood cell sedimentation correction factor, and a blood motion factor.

6. The system of claim 4, wherein the analyzer further comprises a processor configured to determine the correction factor to be applied to the result of the analytical test.

7. The system of claim 1, wherein the test device comprises at least one electrochemical sensor in a conduit.

8. The system of claim 1, wherein the test device is further configured to receive a sample comprising whole blood, and perform the analytical test on the sample.

9. The system of claim 8, wherein the test device comprises at least one electrochemical sensor in a conduit, and cells from the sample at least partially sediment on the at least one electrochemical sensor during the test cycle.

10. The system of claim 9, wherein a rate of cell sedimentation with respect to the at least one electrochemical sensor is dependent on at least one of the spatial orientation and the motion of the analyzer during the test cycle.

11. The system of claim 1, wherein the test device comprises a sensor and a calibration fluid for the sensor.

12. The system of claim 1, wherein the test device comprises:

a sensor configured to perform an immunoassay;

a wash fluid; and

a computing reagent for the sensor.

13. The system of claim 1, wherein:

the test device comprises a pump configured to move a sample; and

the test device is further configured to receive the sample and actuate the pump.

14. The system of claim 1, wherein the test device comprises at least one sensor configured to detect at least one target analyte selected from the group consisting of:

hematocrit, troponin, creatine kinase myocardial band (CKMB), brain natriuretic peptide (BNP), beta human chorionic gonadotropin (bHCG), carbon dioxide partial pressure (pCO₂), partial pressure oxygen (pO₂), pH, prothrombin time (PT), activated clotting time (ACT), activated partial thromboplastin time (APTT), sodium, potassium, chloride, calcium, urea, glucose, creatinine, lactate, oxygen, and carbon dioxide.

15. The system of claim 1, wherein the computing device comprises at least one accelerometer and is further configured to measure dynamic acceleration and static acceleration to determine the motion and the spatial orientation of the analyzer respectively.

16. The system of claim 1, wherein the computing device is configured to measure static acceleration on at least three axes of the analyzer to determine the spatial orientation of the analyzer, and the determining the spatial orientation comprises determining at least one of roll, pitch, and yaw of the analyzer based on the measured static acceleration on the at least three axes of the analyzer.

17. The system of claim 16, wherein:

the comparing the determined spatial orientation to the threshold operating spatial plane comprises at least one of;

comparing the determined roll of the analyzer to a threshold roll;

comparing the determined pitch of the analyzer to a threshold pitch; and

comparing the determined yaw of the analyzer to a threshold yaw; and

the correcting the result of the analytical test when the determined spatial orientation exceeds the threshold operating spatial plane comprises correcting the result when at least one of;

(i) the determined roll of the analyzer exceeds the threshold roll, (ii) the determined pitch of the analyzer exceeds the threshold pitch, and/or (iii) the determined yaw of the analyzer exceeds the threshold yaw.

18. The system of claim 1, wherein:

the analyzer further comprises a processor configured to determine a stage of the test cycle;

the computing device is further configured to determine at least one of the threshold operating spatial plane and the threshold rate of motion based on the determined stage of the test cycle;

at least one of;

the comparing the determined spatial orientation to the threshold operating spatial plane comprises comparing the determined spatial orientation to the determined threshold operating spatial plane for the determined stage of the test cycle; and

the comparing the determined motion to the threshold rate of motion comprises comparing the determined motion to the determined threshold rate of motion for the determined stage of the test cycle; and

at least one of;

the correcting the result of the analytical test when the determined spatial orientation exceeds the threshold operating spatial plane comprises correcting the result of the analytical test when the determined spatial orientation exceeds the determined threshold operating spatial plane for the determined stage of the test cycle; and

the correcting the result of the analytical test when the determined motion exceeds the threshold rate of motion comprises correcting the result of the analytical test when the determined motion exceeds the determined rate of motion for the determined stage of the test cycle.

19. A method of performing an analytical test, the method comprising:

inserting a test device in a port of an analyzer;

initiating a test cycle of the test device;

determining spatial orientation and motion of the analyzer during the test cycle of the test device;

comparing the determined spatial orientation to a threshold operating spatial plane for the test device;

comparing the determined motion to a threshold rate of motion for the test device; and

correcting a result of the analytical test, when at least one of;

(i) the determined spatial orientation exceeds the threshold operating spatial plane, and/or (ii) the determined motion exceeds the threshold rate of motion.

20. A portable clinical system for in vitro analysis, the system comprising:

an analyzer comprising;

a port configured to receive the test device; and

a computing device configured to;

determine spatial orientation and motion of the analyzer during a test cycle of the test device;

compare the determined spatial orientation to a threshold operating spatial plane for the test device;

compare the determined motion to a threshold rate of motion for the test device; and

modify a timing of the test cycle when at least one of;

(i) the determined spatial orientation exceeds the threshold operating spatial plane, and/or (ii) the determined motion exceeds the threshold rate of motion.