Portable clinical analysis system for hematocrit measurement

• US 9,949,674 B2
• Filed: 12/06/2013
• Issued: 04/24/2018
• 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:
  US14/099,504
• Publication Number:
  US 20140172316A1
• Time in Patent Office: 1,600 Days
• Field of Search: 702 89, 702104
• 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 portable clinical system for performing a hematocrit analysis, the system comprising:

a test device comprising a hematocrit sensor configured to perform the hematocrit analysis, which includes generating an electric signal based on a hematocrit measurement of a biological sample; and

an analyzer comprising;

a port configured to receive the test device; and

a computing device configured to;

initiate a test cycle of the test device, the test cycle including performance of the hematocrit analysis;

determine spatial orientation of the analyzer during the test cycle of the test device;

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

when the determined spatial orientation exceeds the threshold operating spatial plane, provide an alert prompting a user to take corrective action, wherein the corrective action is taken without reinitiating the test cycle including the performance of the hematocrit analysis.

2. The system of claim 1, wherein the computing device is further configured to suppress the result of the hematocrit analysis, when the determined spatial orientation exceeds the threshold operating spatial plane.

3. The system of claim 1, wherein the computing device is further configured to correct the result of the hematocrit analysis, when the determined spatial orientation exceeds the threshold operating spatial plane.

4. The system 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.

5. The system 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

the computing device is further configured to;

detect a change in the spatial orientation of the analyzer during the test cycle;

determine a new spatial orientation of the analyzer;

compare the determined new spatial orientation to the threshold operating spatial plane; and

complete the test cycle and provide the result of the hematocrit analysis when the determined new spatial orientation is below the threshold operating spatial plane.

6. The system 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.

7. The system of claim 6, wherein the threshold operating spatial plane is no more than about 10°

from the horizontal plane of the base.

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

9. The system 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 system of claim 9, wherein the threshold operating spatial plane is no more than about 15°

from the horizontal plane of the base.

11. The system of claim 10, 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

the computing device is further configured to;

detect a change in the spatial orientation of the analyzer during the test cycle;

determine a new spatial orientation of the analyzer;

compare the determined new spatial orientation to the threshold operating spatial plane; and

complete the test cycle and provide the result of the hematocrit analysis when the determined new spatial orientation is below the threshold operating spatial plane.

12. The system of claim 1, wherein the computing device is further configured to:

determine motion of the analyzer during the test cycle of the test device;

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

at least one of (i) provide a different alert prompting the user to take different corrective action during the test cycle, (ii) correct the result of the hematocrit analysis, and/or (iii) suppress the result of the hematocrit analysis, 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.

13. The system of claim 12, wherein the threshold rate of motion is no more than about 50 meters/second².

14. The system of claim 1, wherein the computing device comprises at least one accelerometer and is further configured to measure static acceleration on at least three axes to determine the spatial orientation of the analyzer.

15. 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.

16. 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 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

when the determined spatial orientation exceeds the threshold operating spatial plane, providing an alert prompting a user to take corrective action, wherein the corrective action is taken without reinitiating the test cycle including the performance of the hematocrit analysis.

17. The method of claim 16, further comprising correcting a result of the hematocrit analysis, when the determined spatial orientation exceeds the threshold operating spatial plane.

18. The method of claim 16, further comprising suppressing the result of the hematocrit analysis, when the determined spatial orientation exceeds the threshold operating spatial plane.

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

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

an analyzer comprising;

a port configured to receive the test device; and

a computing device configured to;

initiate a test cycle of the test device that includes output of the signal;

determine spatial orientation and motion of the analyzer during the test cycle of the test device, the test cycle including performance of a hematocrit analysis;

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

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, provide an alert prompting a user to take corrective action, wherein the corrective action is taken without reinitiating the test cycle including the performance of the hematocrit analysis.

20. The system of claim 19, wherein the computing device is further configured to suppress the result of the hematocrit analysis, 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.

21. The system of claim 19, wherein the computing device is further configured to correct the result of the hematocrit analysis, 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.