Sample analyzer and computer program product

• US 10,401,351 B2
• Filed: 03/25/2019
• 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:
  US16/363,694
• Publication Number:
  US 20190219568A1
• Time in Patent Office: 162 Days
• Field of Search: 422 50, 422 681, 422 62, 422 63, 422 8201, 422 8205, 436 43, 436 47, 436 48, 436 49, 436 50, 436 63, 436 66, 436174, 436 17, 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, and 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 cells in the sample and (b) an analyzing operation comprising operations of analyzing sample measurements from the sensing operation 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 include 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;

display on an input screen (1) at least two sample-type options that comprise concurrent display of a blood sample option and a body fluid sample option each independently selectable from the other on the input screen and (2) one or more test modes displayed separately from a selected one of the at least two sample-type options, wherein selecting the body fluid sample option from the at least two sample-type options and setting a test mode from the one or more test modes is based on repective discrete user inputs separately received in the input screen;

in response to (I) a user input, on the input screen, of selecting the blood sample option from the displayed at least two sample-type options and (II) an additional user input, on the input screen, of setting one test mode from the displayed one or more test modes, perform the sensing operation in the blood measuring mode to;

prepare a blood measurement sample from the blood sample;

introduce at least part of the prepared blood measurement sample into a multi-mode detector; and

operate said multi-mode detector to sense cells in the introduced blood measurement sample, and further perform the analyzing operation in the blood measuring mode to;

analyze blood-sample measurements of cells sensed in the introduced blood measurement sample; and

display analysis results of the blood-sample measurements on a first test result screen; and

in response to (I) a user input, on the input screen, of selecting the body fluid sample option from the displayed at least two test-sample options and (II) an additional user input, on the input screen, of setting said one or a different test mode from the displayed one or more test modes, perform the sensing operation in the body fluid measuring mode to;

prepare a body fluid measurement sample from the body fluid sample;

introduce at least part of the prepared body fluid measurement sample into said multi-mode detector; and

operate said multi-mode detector to sense cells in the introduced body fluid measurement sample, and further perform the analyzing operation in the body fluid measuring mode to;

analyze body-fluid-sample measurements of the cells sensed in the introduced body fluid measurement sample; and

display analysis results of the body-fluid-sample measurements on a second test result screen.

2. The sample analyzer according to claim 1, wherein the sensing operation performed in the blood measuring mode comprises an operation of sensing the cells in the introduced blood measurement sample for a first measurement time, and

the sensing operation performed in the body fluid measuring mode comprises an operation of sensing the cells in the introduced body fluid measurement 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 2, wherein a ratio between the first and second measurement times falls within a predetermined range.

4. The sample analyzer according to claim 1, wherein the prepared blood measurement sample and the prepared body fluid measurement sample contain blood and body fluid, respectively, in an equal amount.

5. The sample analyzer according to claim 1, wherein the prepared blood measurement sample and the prepared body fluid measurement sample contain a reagent in an equal amount.

6. The sample analyzer according to claim 1, further comprising a conveyor device, wherein the sensing operation performed in the body fluid measuring mode comprises automatically transporting a sample container to a position for aspiration of the body fluid sample from the sample container.

29. 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 for measuring cells in a body fluid sample until the body fluid measuring mode is manually switched to the blood measuring mode.

7. A sample analyzer comprising:

a plurality of detectors comprising at least one optical detector for optically sensing cells in a sample and at least one electrical detector for electrically sensing cells in the 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 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 detecter to sense cells in the sample and (b) an analyzing operation comprising operations of analyzing measurements from the sensing operation and displaying analysis results, and further wherein the plurality of detectors include 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;

display on an input screen (1) at least two sample-type options that comprise concurrent display of a blood sample option and a body fluid sample option each independently selectable from the other on the input screen and (2) one or more test modes displayed separately from a selected one of the at least two sample-type options;

in response to (I) a user input, on the input screen, of selecting the blood sample option from the displayed at least two sample-type options and (II) an additional user input, on the input screen, of setting one test mode from the displayed one or more test modes, perform the sensing operation in the blood measuring mode to;

prepare a blood measurement sample from the blood sample;

introduce at least part of the prepared blood measurement sample into an optical detector; and

operate the optical detector to optically sense white blood cells in the introduced blood measurement sample, and further perform the analyzing operation in the blood measuring mode to;

analyze blood-sample measurements of the white blood cells sensed in the introduced blood measurement sample;

count each of five types of white blood cells based on the analyzed blood-sample measurements; and

display a count of each of the five types of white blood cells; and

in response to (I) a user input, on the input screen, of selecting the body fluid sample option from the displayed at least two sample-type options and (II) an additional user input, on the input screen, of setting said one or a different test mode from the displayed one or more test modes, perform the sensing operation in the body fluid measuring mode to;

prepare a body fluid measurement sample from the body fluid sample;

introduce at least part of the prepared body fluid measurement sample into an electrical detector;

operate said electrical detector to electrically sense cells in the introduced body fluid measurement sample, and further perform the analyzing operation in the body fluid measuring mode to;

analyze body-fluid-sample measurements of cells sensed in the introduced body fluid measurement sample;

count mono-nucleated cells and poly-nucleated cells based on the analyzed body-fluid-sample measurements; and

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

8. The sample analyzer according to claim 7, wherein the analyzing operation performed in the blood measuring mode comprises operations to obtain a total count of the white blood cells sensed in the introduced blood measurement sample and display the total count of the white blood cells, and the analyzing operation performed in the body fluid measuring mode comprises operations to obtain a total count of nucleated cells sensed in the introduced body fluid measurement sample and display the total count of the nucleated cells.

9. The sample analyzer according to claim 8, wherein the analyzing operation performed in the blood measuring mode comprises displaying a first test result screen for displaying test results obtained in the blood measuring mode, and the analyzing operation performed in the body fluid measuring mode comprises displaying a second test result screen for displaying test results obtained in the body fluid measuring mode.

10. The sample analyzer according to claim 9, wherein the first test result screen comprises first and second separate screen regions for displaying test results, wherein the first screen region is configured to display the total count of the white blood cells sensed in the introduced blood measurement sample, and the second screen region is configured to display the count of each of the five types of the white blood cells.

11. The sample analyzer according to claim 10, wherein the second test result screen comprises third screen region for displaying test results, wherein the third screen region is configured to separately display the count of the mono-nucleated cells and the count of the poly-nucleated cells.

12. The sample analyzer according to claim 11, wherein the analyzing operation performed in the body fluid measuring mode comprises calculating a relative cell amount of the mono-nucleated cells and a relative cell amount of poly-nucleated cells sensed in the introduced body fluid measurement sample, and

the third screen region is configured to separately display the relative cell amount of the mono-nucleated cells and the relative cell amount of the poly-nucleated cell.

13. The sample analyzer according to claim 11, wherein the second test result screen comprises a fourth screen region separate from the third screen region, wherein the fourth screen region is configured to display the total count of the nucleated cells.

14. The sample analyzer according to claim 13, wherein the second test result screen comprises a fifth screen region separate from the third and fourth screen regions, the fifth screen region being configured to display a flagging result representing a disease suspicion.

15. The sample analyzer according to claim 7, wherein the analyzing operation performed in the body fluid measuring mode comprises removing a red blood cell ghost from the body-fluid-sample measurements.

16. 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 a respective sequence of operations for measuring cells in the blood sample and in the body fluid sample comprises a sensing operation comprising operations of preparing for measurement and operating a detector to sense cells in the sample, and further wherein the plurality of detectors include 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;

display on an input screen (1) at least two sample-type options that comprise concurrent display of a blood sample option and a body fluid sample option each independently selectable from the other on the input screen, and (2) one or more test modes displayed separately from a selected one of the at least two sample type options, wherein selecting the body fluid sample option from the at least two sample-type options and setting a test mode from the one or more test modes is based on respective discrete user inputs separately received in the input screen;

in response to (I) a user input, on the input screen, of selecting the blood sample option from the displayed at least two sample-type options and (II) an additional user input, on the input screen, of setting one test mode from the displayed one or more test modes, perform the sensing operation in the blood measuring mode to;

prepare a blood measurement sample from the blood sample;

introduce at least part of the prepared blood measurement sample into a multi-mode detector; and

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

in response to (I) a user input, of selecting the body fluid sample option from the displayed at least two sample-type options and (II) an additional user input, on the input screen, of setting said one or a different test mode from the displayed one or more test modes, perform the sensing operation in the body fluid measuring mode to;

prepare a body fluid measurement sample from the body fluid sample;

introduce at least part of the prepared body fluid measurement sample into said multi-mode detector; and

operate said multi-mode detector to sense cells in the introduced body fluid measurement sample,

wherein the sensing operation performed in the body fluid measuring mode comprises an operation of pre-washing said multi-mode detector to reduce a carryover effect on measurements of the body fluid measurement sample, wherein the controller is programmed to automatically initiate said pre-washing, during said sensing operation in the body fluid measuring mode before introduction of the body fluid measurement sample into said multi-mode detector, and the controller is programmed not to introduce the prepared body fluid measurement sample into said multi-mode detector before said pre-washing is completed.

17. The sample analyzer according to claim 16, wherein said pre-washing 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.

18. The sample analyzer according to claim 16, wherein said pre-washing includes using a solution specifically prepared for said pre-washing.

19. The sample analyzer according to claim 16, wherein the controller is programmed to perform a blank check in which the controller:

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

senses the cell-free sample by said multi-mode detector; and

analyzes measurements of the cell-free sample and count cells carried over into the cell-free sample from a test sample previously measured.

20. The sample analyzer according to claim 19, wherein the controller is programmed to perform the blank check automatically without a manual operation by a user to initiate the blank check.

21. The sample analyzer according to claim 16, wherein said pre-washing includes more than one washing of said multi-mode detector during the same sensing operation in the body fluid measuring mode.

22. The sample analyzer according to claim 21, further comprising a post-detection chamber communicating with said multi-mode detector, wherein the post-detection chamber is located above said multi-mode detector and configured to receive and temporary store the measurement sample, which is already sensed by said multi-mode detector, for adjustment of pressure at said multi-mode detector, and further wherein the post-detection chamber automatically receives, more than once at a time interval, a solution used in said pre-washing during the same sensing operation in the body fluid measuring mode.

23. The sample analyzer according to claim 16, further comprising a conveyor device, wherein the sensing operation performed in the body fluid measuring mode comprises automatically transporting a sample container to a position for aspiration of the body fluid sample from the sample container.

24. 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 blood cells in the body fluid sample, and wherein a respective sequence of operations for measuring blood 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 cells in the sample, and (b) an analyzing operation comprising operations of analyzing sample measurements from the sensing operation and displaying analysis results, and further wherein the plurality of detectors include 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;

display on an input screen (1) at least two sample-type options that comprise concurrent display of a blood sample option and a body fluid sample option each selectable independently from the other on the input screen and (2) one or more test modes displayed separately from a selected one of the at least two sample-type options,

in response to (I) a user input, on the input screen, of selecting the body fluid sample option from the displayed at least two sample-type options and (II) an additional user input, on the input screen, of setting one test mode from the displayed one or more test modes,

(A) perform the sensing operation in the body fluid measuring mode to;

prepare a first body fluid measurement sample from the body fluid sample; and

sense cells in the first body fluid measurement sample, and further perform the analyzing operation in the body fluid measuring mode to;

analyze first measurements of the cells sensed in the first body fluid measurement sample and count red blood cells based on the analyzed first measurements, and

(B) perform the sensing operation in the body fluid measuring mode to;

prepare a second body fluid measurement sample from the body fluid sample; and

sense cells in the second body fluid measurement sample, and further perform the analyzing operation in the body fluid measuring mode to;

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

count mono-nucleated cells and poly-nucleated cells based on the analyzed second measurements, wherein the controller is programmed to 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.

25. The sample analyzer according to claim 24, wherein the analyzing operation performed in the blood measuring mode comprises displaying a first test result screen for displaying test results obtained in the blood measuring mode, and the analyzing operation performed in the body fluid measuring mode comprises displaying a second test result screen for displaying test results obtained in the body fluid measuring mode, and

wherein the second test result screen comprises first and second separate screen regions for displaying test results, wherein the first screen region is configured to display a total count of nucleated cells sensed in the second body fluid measurement sample, and the second screen region is configured to separately display the count of the mono-nucleated cells and the count of the poly-nucleated cells sensed in the second body fluid measurement sample.

26. The sample analyzer according to claim 25, wherein the analyzing operation performed in the body fluid measuring mode comprises calculating a relative cell amount of the mono-nucleated cells and a relative cell amount of the poly-nucleated cells in the second body fluid measurement sample, and the second screen region is configured to separately display the relative cell amount of the mono-nucleated cells and the relative cell amount of the poly-nucleated cells.

27. The sample analyzer according to claim 26, wherein the second test result screen comprises a third screen region separate from the first and second screen regions, the third screen region being configured to display a flagging result representing a disease suspicion.

28. The sample analyzer according to claim 24, wherein the analyzing operation performed in the body fluid measuring mode comprises removing a red blood cell ghost from the second measurements by application of a threshold to the second measurements.