Portable clinical analysis system for hematocrit measurement

• US 10,188,327 B2
• Filed: 02/28/2018
• Issued: 01/29/2019
• 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, Zhao, Tian-Xian, Glavina, Paul
• Primary Examiner(s): Toatley, Gregory J
• Assistant Examiner(s): STIFTER JR, TERENCE E
• Application Number:
  US15/908,202
• Publication Number:
  US 20180184955A1
• Time in Patent Office: 335 Days
• Field of Search: None
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• 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 33/48 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: 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: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence

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 method of performing a hematocrit analysis, the method comprising:

inserting a test device comprising a hematocrit sensor into a port of an analyzer;

initiating, by the analyzer, a test cycle of the test device, the test cycle including performance of the hematocrit analysis, wherein the performance of the hematocrit analysis includes the test device generating an electric signal based on a hematocrit measurement of a biological sample;

determining spatial orientation and/or 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 and/or comparing the determined motion to a threshold rate of motion for the test device;

when the determined spatial orientation exceeds the threshold operating spatial plane, and/or the determined motion exceeds the threshold rate of motion, providing an alert prompting a user to take corrective action,

wherein the corrective action is instructed in the alert to be taken during the test cycle without having to reinitiate the test cycle including the performance of the hematocrit analysis.

2. The method of claim 1, further comprising correcting a result of the hematocrit analysis, when the determined spatial orientation exceeds the threshold operating spatial plane and/or the determined motion exceeds the threshold rate of motion.

3. The method of claim 1, further comprising suppressing the result of the hematocrit analysis, when the determined spatial orientation exceeds the threshold operating spatial plane and/or the determined motion exceeds the threshold rate of motion.

4. The method of claim 1, wherein the providing the alert prompting the user to take the corrective action comprises displaying the alert on the analyzer and the alert instructs the user to move the spatial orientation of the analyzer below the threshold operating spatial plane and/or to cease or decelerate movement of the analyzer.

5. The method of claim 1, wherein:

the analyzer further comprises a base having a horizontal plane; and

the threshold operating spatial plane is no more than about ±

15°

from the horizontal plane of the base.

6. The method of claim 5, wherein the threshold operating spatial plane is no more than about ±

10°

from the horizontal plane of the base.

7. The method of claim 1, wherein the threshold rate of motion is no more than about 50 meters/second.

8. The method of claim 1, wherein the hematocrit sensor is a conductivity sensor.

9. The method of claim 1, wherein:

the analyzer further comprises a base having a horizontal plane;

the port is substantially aligned to a first plane parallel to the horizontal plane of the base; and

the hematocrit sensor is substantially aligned to a second plane parallel to the horizontal plane of the base.

10. The method of claim 1, wherein the analyzer further comprises at least one accelerometer configured to collect static acceleration data on at least three axes to determine the spatial orientation of the analyzer and/or dynamic acceleration data to determine the motion of the analyzer.

11. A method of performing in vitro analysis of a sample comprising blood, the method comprising:

inserting a test device comprising at least one sensor configured to output a signal that is partially dependent on non-homogeneity of blood cells positioned in a region of the at least one sensor into a port of an analyzer;

initiating, by the analyzer, a test cycle of the test device, the test cycle including performance of the in vitro analysis, wherein the performance of the in vitro analysis includes the test device generating an electric signal based on a measurement of at least one target analyte or property of the sample;

determining spatial orientation and/or 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 and/or comparing the determined motion to a threshold rate of motion for the test device;

when the determined spatial orientation exceeds the threshold operating spatial plane, and/or the determined motion exceeds the threshold rate of motion, providing an alert prompting a user to take corrective action,

wherein the corrective action is instructed in the alert to be taken during the test cycle without having to reinitiate the test cycle including the performance of the in vitro analysis.

12. The method of claim 11, further comprising correcting a result of the in vitro analysis, when the determined spatial orientation exceeds the threshold operating spatial plane and/or the determined motion exceeds the threshold rate of motion.

13. The method of claim 11, further comprising suppressing the result of the in vitro analysis, when the determined spatial orientation exceeds the threshold operating spatial plane and/or the determined motion exceeds the threshold rate of motion.

14. The method of claim 11, wherein the providing the alert prompting the user to take the corrective action comprises displaying the alert on the analyzer and the alert instructs the user to move the spatial orientation of the analyzer below the threshold operating spatial plane and/or to cease or decelerate movement of the analyzer.

15. The method of claim 11, wherein:

the analyzer further comprises a base having a horizontal plane; and

the threshold operating spatial plane is no more than about ±

15°

from the horizontal plane of the base.

16. The method of claim 15, wherein the threshold operating spatial plane is no more than about ±

10°

from the horizontal plane of the base.

17. The method of claim 11, wherein the threshold rate of motion is no more than about 50 meters/second.

18. The method of claim 11, wherein the at least one sensor is an electrochemical sensor, a conductivity sensor, an immunosensor or a hematocrit sensor.

19. The method of claim 11, wherein:

the analyzer further comprises a base having a horizontal plane;

the port is substantially aligned to a first plane parallel to the horizontal plane of the base; and

the at least one sensor is substantially aligned to a second plane parallel to the horizontal plane of the base.

20. The method of claim 11, wherein the analyzer further comprises at least one accelerometer configured to collect static acceleration data on at least three axes to determine the spatial orientation of the analyzer and/or dynamic acceleration data to determine the motion of the analyzer.