Sample analyzer and computer program product

• US 10,401,350 B2
• Filed: 12/10/2018
• Issued: 09/03/2019
• Est. Priority Date: 02/01/2007
• Status: Active Grant

• Current Assignee: Sysmex America, Inc. (Sysmex Corporation), Sysmex Corporation
• Original Assignee: Sysmex Corporation
• Inventors: Nagai, Takaaki, Narisada, Noriyuki, Fukuma, Daigo, Imazu, Masanori
• Primary Examiner(s): Sines, Brian J.
• Application Number:
  US16/214,417
• Publication Number:
  US 20190107533A1
• Time in Patent Office: 267 Days
• Field of Search: 422 50, 422 681, 422 8201, 422 8205, 436 43, 436 47, 436 48, 436 49, 436 50, 436 63, 436 66, 436174, 436177, 436178, 436180
• CPC Class Codes: G01N 15/12 by observing changes in resistance or impedance across apertures when traversed by individual particles, e.g. by using the Coulter principle
• CPC Class Codes: G01N 15/1459 the analysis being performed on a sample stream
• CPC Class Codes: G01N 2015/012 Red blood cells
• CPC Class Codes: G01N 2015/014 Reticulocytes
• CPC Class Codes: G01N 2015/016 White blood cells
• CPC Class Codes: G01N 2015/1486 Counting the particles
• CPC Class Codes: G01N 33/5091 for testing the pathological state of an organism
• CPC Class Codes: G01N 33/5094 for blood cell populations red blood cells G01N33/80
• CPC Class Codes: G01N 33/721 Haemoglobin
• CPC Class Codes: G01N 33/726 Devices
• CPC Class Codes: Y10T 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/113332 with conveyance of sample along a test line in a container or rack

Abstract

A sample analyzer prepares a measurement sample from a blood sample or a body fluid sample which differs from the blood sample; measures the prepared measurement sample; obtains characteristic information representing characteristics of the components in the measurement sample; sets either a blood measurement mode for measuring the blood sample, or a body fluid measurement mode for measuring the body fluid sample as an operating mode; and measures the measurement sample prepared from the blood sample by executing operations in the blood measurement mode when the blood measurement mode has been set, and measuring the measurement sample prepared from the body fluid sample by executing operations in the body fluid measurement mode that differs from the operations in the blood measurement mode when the body fluid measurement mode has been set, is disclosed. A computer program product is also disclosed.

Claims

1. A sample analyzer comprising:

a plurality of detectors each configured to sense cells in a sample, the sample selectively comprising (i) a blood sample or (ii) a body fluid sample, wherein the body fluid sample contains body fluid, other than blood, which is selected from a group consisting of cerebrospinal fluid, thoracic fluid, abdominal fluid, fluid collected in a cardiac sac, synovial fluid, dialysate from peritoneal dialysis, and intraperitoneal rinse;

a controller programmed to selectively operate the sample analyzer in a blood measuring mode or a body fluid measuring mode, wherein the blood measuring mode includes a sequence of operations for measuring cells in the blood sample, and the body fluid measuring mode includes a sequence of operations for measuring cells in the body fluid sample, wherein a respective sequence of operations for measuring cells in the blood sample and in the body fluid sample comprises (a) a sensing operation comprising operations of preparing for measurement and operating a detector to sense the cells in the sample and (b) an analyzing operation comprising operations of analyzing sample measurements and displaying analysis results, the sensing operation performed in the body fluid measuring mode being different, at least partially, from the sensing operation performed in the blood measuring mode, and further wherein the plurality of detectors includes one or more multi-mode detectors configured to operate in both the blood measuring mode and the body fluid measuring mode, the controller programmed to;

perform the sensing operation in the blood measuring mode to;

introduce the blood sample into a multi-mode detector;

operate said multi-mode detector to sense cells in the introduced blood sample; and

derive blood-sample measurements of cells in the introduced blood sample; and

perform the sensing operation in the body fluid measuring mode to;

introduce the body fluid sample into said multi-mode detector;

operate said multi-mode detector to sense cells in the introduced body fluid sample; and

derive body-fluid-sample measurements of cells in the introduced body fluid sample.

2. The sample analyzer according to claim 1, wherein

the sensing operation performed in the blood measuring mode comprises sensing the cells in the introduced blood sample for a first measurement time, and

the sensing operation performed in the body fluid measuring mode comprises sensing the cells in the introduced body fluid sample for a second measurement time, wherein the second measurement time is longer than the first measurement time according to a cell concentration of the sample.

3. The sample analyzer according to claim 1, wherein the sensing operation performed in the body fluid measuring mode comprises automatically initiating pre-washing said multi-mode detector to reduce a carryover effect on measurements of the cells in the body fluid sample, wherein the controller is programmed to automatically initiate said pre-washing before introducing the body fluid sample into said multi-mode detector during said sensing operation in the body fluid measuring mode.

4. The sample analyzer according to claim 3, wherein the operation of pre-washing said multi-mode detector is automatically initiated in the sensing operation in the body fluid measuring mode but not automatically initiated in the sensing operation in the blood measuring mode.

5. The sample analyzer according to claim 4, wherein the operation of automatically initiated pre-washing includes using solution different from solution for washing said multi-mode detector in the blood measuring mode.

6. The sample analyzer according to claim 5, wherein the operation of automatically initiated pre-washing includes using a solution specifically prepared for the operation of automatically initiated pre-washing.

7. The sample analyzer according to claim 1, wherein the analyzing operation performed in the body fluid measuring mode comprises operations of:

analyzing the body-fluid-sample measurements; and

counting a type of cells among the cells in the introduced body fluid sample based on the analyzed body-fluid-sample measurements.

8. The sample analyzer according to claim 7, wherein the sensing operation performed in the body fluid measuring mode comprises operations of counting mono-nucleated cells and poly-nucleated cells among the cells in the introduced body fluid sample and separately displaying in a screen a count of the mono-nucleated cells and a count of the poly-nucleated cells.

9. The sample analyzer according to claim 8, wherein the analyzing operations performed in the body fluid measuring mode comprises operations of calculating a relative amount of the mono-nucleated cells and a relative amount of the poly-nucleated cells and separately displaying in a screen the relative amount of the mono-nucleated cells and the relative amount of the poly-nucleated cells.

10. The sample analyzer according to claim 9, wherein the analyzing operation performed in the body fluid measuring mode comprises an operation of counting a total of nucleated cells.

11. The sample analyzer according to claim 1, wherein the controller is programmed to:

introduce a cell-free sample into said multi-mode detector, the cell-free sample having no cells contained in the cell-free sample; and

sense the cell-free sample by said multi-mode detector, and

the controller is further programmed to analyze measurements of the cell-free sample and count cells carried over into the cell-free sample from a test sample previously measured.

22. The sample analyzer according to claim 1, wherein the controller is programmed to remain in the body fluid measuring mode after completing the sequence of operations in the body fluid measuring mode until the body fluid measuring mode is manually switched to the blood measuring mode.

27. The sample analyzer according to claim 3, wherein said automatically initiated pre-washing includes more than one washing of said multi-mode detector.

12. A sample analyzer comprising:

a plurality of detectors each configured to sense cells in a sample, the sample selectively comprising (i) a blood sample or (ii) a body fluid sample, wherein the body fluid sample contains body fluid, other than blood, which is selected from a group consisting of cerebrospinal fluid, thoracic fluid, abdominal fluid, fluid collected in a cardiac sac, synovial fluid, dialysate from peritoneal dialysis, and intraperitoneal rinse;

a controller programmed to selectively operate the sample analyzer in a blood measuring mode or a body fluid measuring mode, wherein the blood measuring mode includes a sequence of operations for measuring cells in the blood sample, and the body fluid measuring mode includes a sequence of operations for measuring cells in the body fluid sample, wherein a respective sequence of operations for measuring cells in the blood sample and in the body fluid sample comprises (a) a sensing operation comprising;

operations of preparing for measurement and operating a detector to sense the cells in the sample and (b) an analyzing operation comprising operations of analyzing sample measurements and displaying analysis results, the sensing operation performed in the body fluid measuring mode being different, at least partially, from the sensing operation performed in the blood measuring mode, and further wherein the plurality of detectors includes one or more multi-mode detectors configured to operate in both the blood measuring mode and the body fluid measuring mode, the controller programmed to;

perform the sensing operation in the blood measuring mode to;

introduce the blood sample into a multi-mode detector;

operate said multi-mode detector to sense cells in the introduced blood sample; and

derive blood-sample measurements of cells in the introduced blood sample, and further perform the analyzing operation in the blood measuring mode to;

analyze the blood-sample measurements; and

count a particular type of cells in the introduced blood sample based on the analyzed blood-sample measurements; and

perform the sensing operation in the body fluid measuring mode to;

introduce the body fluid sample into said multi-mode detector;

operate said multi-mode detector to sense cells in the introduced body fluid sample; and

derive body-fluid-sample measurements of cells in the introduced body fluid sample, and further perform the analyzing operation in the body fluid measuring mode to;

analyze the body-fluid-sample measurements; and

count the particular type of cells in the introduced body fluid sample based on the analyzed body-fluid-sample measurements.

13. The sample analyzer according to claim 12, wherein the particular type of cells are blood cells.

14. The sample analyzer according to claim 12, wherein the particular type of cells are white blood cells or a subclass of the white blood cells.

15. The sample analyzer according to claim 12, wherein the particular type of cells are red blood cells.

16. The sample analyzer according to claim 12, wherein the particular type of cells are platelets.

17. The sample analyzer according to claim 12, wherein the sensing operation performed in the blood measuring mode comprises sensing the particular type of cells in the introduced blood sample for a first measurement time, and

the sensing operation performed in the body fluid measuring mode comprises sensing the particular type of cells in the introduced body fluid sample for a second measurement time, wherein the second measurement time is longer than the first measurement time according to a cell concentration of the sample.

18. The sample analyzer according to claim 12, wherein the sensing operation performed in the body fluid measuring mode comprises automatically initiating pre-washing said multi-mode detector to reduce a carryover effect on measurements of the body fluid sample, wherein the controller is programmed to automatically initiate said pre-washing before introducing the body fluid sample into said multi-mode detector during said sensing operation in the body fluid measuring mode, and wherein said automatically initiated pre-washing includes more than one washing of said multi-mode detector.

23. The sample analyzer according to claim 12, wherein the controller is programmed to remain in the body fluid measuring mode after completing the sequence of operations in the body fluid measuring mode for measuring cells in one body fluid sample until the body fluid measuring mode is manually switched to the blood measuring mode.

19. A sample analyzer comprising:

a plurality of detectors each configured to sense cells in a sample, the sample selectively comprising (i) a blood sample or (ii) a body fluid sample, wherein the body fluid sample contains body fluid, other than blood, which is selected from a group consisting of cerebrospinal fluid, thoracic fluid, abdominal fluid, fluid collected in a cardiac sac, synovial fluid, dialysate from peritoneal dialysis, and intraperitoneal rinse;

a controller programmed to selectively operate the sample analyzer in a blood measuring mode or a body fluid measuring mode, wherein the blood measuring mode includes a sequence of operations for measuring cells in the blood sample, and the body fluid measuring mode includes a sequence of operations for measuring cells in the body fluid sample, and wherein the plurality of detectors includes one or more multi-mode detectors configured to operate in both the blood measuring mode and the body fluid measuring mode, the controller programmed to;

perform the sequence of operations in the blood measuring mode to;

introduce the blood sample into a multi-mode detector;

operate said multi-mode detector to sense cells in the introduced blood sample; and

derive blood-sample measurements of cells in the introduced blood sample; and

perform the sequence of operations in the body fluid measuring mode to;

introduce the body fluid sample into said multi-mode detector;

operate said multi-mode detector to sense cells in the introduced body fluid sample; and

derive body-fluid-sample measurements of cells in the introduced body fluid sample,

wherein the sequence of operations performed in the body fluid measuring mode comprises automatically initiating pre-washing said multi-mode detector to reduce a carryover effect on the body-fluid-sample measurements, wherein the controller is programmed to automatically initiate said pre-washing before introducing the body fluid sample into said multi-mode detector during said sequence of operations in the body fluid measuring mode.

24. The sample analyzer according to claim 19, wherein the controller is programmed to remain in the body fluid measuring mode after completing the sequence of operations in the body fluid measuring mode for measuring cells in one body fluid sample until the body fluid measuring mode is manually switched to the blood measuring mode.

28. The sample analyzer according to claim 19, wherein said automatically initiated pre-washing includes more than one washing of said multi-mode detector.

20. A sample analyzer comprising:

a plurality of detectors each configured to sense cells in a sample, the sample selectively comprising (i) a blood sample or (ii) a body fluid sample, wherein the body fluid sample contains body fluid, other than blood, which is selected from a group consisting of cerebrospinal fluid, thoracic fluid, abdominal fluid, fluid collected in a cardiac sac, synovial fluid, dialysate from peritoneal dialysis, and intraperitoneal rinse;

a controller programmed to selectively operate the sample analyzer in a blood measuring mode or a body fluid measuring mode, wherein the blood measuring mode includes a sequence of operations for measuring cells in the blood sample, and the body fluid measuring mode includes a sequence of operations for measuring cells in the body fluid sample, the controller programmed to;

perform the sequence of operations in the blood measuring mode to;

analyze blood-sample measurements of cells in the blood sample;

count each of five types of white blood cells in the blood sample; and

separately display in a screen a count of each of said five types of white blood cells; and

perform the sequence of operations in the body fluid measuring mode to;

analyze body-fluid-sample measurements of cells in the body fluid sample;

count mono-nucleated cells and poly-nucleated cells in the body fluid sample; and

separately display in a screen a count of the mono-nucleated cells and a count of the poly-nucleated cells.

25. The sample analyzer according to claim 20, wherein the controller is programmed to remain in the body fluid measuring mode after completing the sequence of operations in the body fluid measuring mode for measuring cells in one body fluid sample until the body fluid measuring mode is manually switched to the blood measuring mode.

21. A sample analyzer comprising:

a plurality of detectors each configured to optically or electrically sense cells in a sample, the sample selectively comprising (i) a blood sample or (ii) a body fluid sample, wherein the body fluid sample contains body fluid, other than blood, which is selected from a group consisting of cerebrospinal fluid, thoracic fluid, abdominal fluid, fluid collected in a cardiac sac, synovial fluid, dialysate from peritoneal dialysis, and intraperitoneal rinse;

a controller programmed to selectively operate the sample analyzer in a blood measuring mode or a body fluid measuring mode, wherein the blood measuring mode includes a sequence of operations for measuring cells in the blood sample, and the body fluid measuring mode includes a sequence of operations for measuring cells in the body fluid sample, the controller programmed to;

(A) perform the sequence of operations in the body fluid measuring mode to;

sense cells in a first body fluid sample;

analyze first measurements of the cells sensed in the first body fluid sample; and

count red blood cells in the first body fluid sample, and

(B) perform the sequence of operations in the body fluid measuring mode to;

sense cells in a second body fluid sample;

analyze second measurements of the cells sensed in the second body fluid sample;

count mono-nucleated cells and poly-nucleated cells in the second body fluid sample; and

separately display in a screen a count of the red blood cells, a count of the mono-nucleated cells and a count of the poly-nucleated cells.

26. The sample analyzer according to claim 21, wherein the controller is programmed to remain in the body fluid measuring mode after completing the sequence of operations in the body fluid measuring mode for measuring cells in one body fluid sample until the body fluid measuring mode is manually switched to the blood measuring mode.