Sample Analyzer and Computer Program Product

• US 20190219568A1
• Filed: 03/25/2019
• Published: 07/18/2019
• 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
• Granted Patent: US 10,401,351 B2
• Time in Patent Office: Days
• 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 optically or electrically sense blood cells in a sample for measurement of the blood 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 blood 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, which is different, at least partially, from the sequence of operations for measuring blood cells in the blood 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;

preparing a measurement sample;

introducing the prepared measurement sample into a detector; and

operating the detector to sense blood cells in the prepared measurement sample and (b) an analyzing operation comprising;

analyzing measurements of blood cells from the detector; 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 (1) at least two sample-type options, displayed separately from each other, for selection of one of the at least two sample-type options, which is selectable independently from another of the at least two sample-type options, wherein the at least two sample-type options comprise concurrent display of a blood sample option and a body fluid sample option and (2) one or more test-type options, separately displayed from the at least two sample-type options, for selection of one of the one or more test-type options, said one of the one or more test-type options being selectable independently from selection of any one of the at least two sample-type options, wherein a selected one of the at least two sample-type options and a selected one of the one or more test-type options are displayed separately on a screen;

in response to both (I) selection of the blood sample option from the displayed at least two sample-type options and (II) additional selection of the one from the displayed one or more test-type options, perform the sensing operation in the blood measuring mode to;

prepare a blood measurement sample from the blood sample;

introduce the prepared blood measurement sample into a multi-mode detector; and

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

analyze first measurements, from said multi-mode detector, of individual blood cells sensed in the introduced blood measurement sample; and

display analysis results from the first measurements in a first test result screen; and

in response to both (I) selection of the body fluid sample option from the displayed at least two test-sample options and (II) additional selection of the one from the displayed one or more test-type options, perform the sensing operation in the body fluid measuring mode to;

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

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

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

analyze second measurements, from said multi-mode detector, of the individual cells sensed in the introduced body fluid measurement sample; and

display analysis results from the second measurements in a second test result screen, wherein the first test result screen is different from the 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 blood cells in the introduced blood measurement sample for a first measurement time, using said multi-mode detector, and

the sensing operation performed in the body fluid measuring mode comprises an operation of sensing the blood cells in the introduced body fluid measurement sample for a second measurement time, using said multi-mode detector, 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 an operation to automatically transport a sample container to a position for aspiration of the body fluid sample from the sample container.

7. A sample analyzer comprising:

a plurality of detectors comprising at least one optical detector for optically sensing blood cells in a sample for measurement of the blood cells in the sample or at least one electrical detector electrically sensing blood cells in the sample for measurement of the blood 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 blood 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, which is different, at least partially, from the sequence of operations for measuring blood cells in the blood 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;

preparing a measurement sample, introducing the prepared measurement sample into a detector; and

operating the detector to sense blood cells in the prepared measurement sample, and (b) an analyzing operation comprising;

analyzing measurements of blood cells from the detector; 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 (1) at least two sample-type options, separately displayed from each other, for selection of one of the at least two sample-type options, which is selectable independently from another of the at least two sample-type options, wherein the at least two sample-type options comprise concurrent display of a blood sample option and a body fluid sample option and (2) one or more test-type options, separately displayed from the at least two sample-type options, for selection of one of the one or more test-type options, said one of the one or more test-type options being selectable independently from selection of any one of the at least two sample-type options, wherein a selected one of the at least two sample-type options and a selected one of the one or more test-type options are displayed separately on a screen;

in response to both (I) selection of the blood sample option from the displayed at least two sample-type options and (II) additional selection of the one from the one or more test-type options, perform the sensing operation in the blood measuring mode to;

prepare a blood measurement sample from the blood sample;

introduce 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 first measurements, from the optical detector, of individual white blood cells sensed in the introduced blood measurement sample;

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

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

in response to both (I) selection of the body fluid sample option from the displayed at least two sample-type options and (II) additional selection of the one from the one or more test-type options, perform the sensing operation in the body fluid measuring mode to;

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

introduce the prepared body fluid measurement sample into a multi-mode detector;

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 second measurements, from said multi-mode detector, of individual cells sensed in the introduced body fluid measurement sample;

count each of mono-nucleated cells and poly-nucleated cells based on the analyzed second measurements; and

display a count of each of the mono-nucleated cells and 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, and the analyzing operation performed in the body fluid measuring mode comprises operations to obtain a combined count of the mono-nucleated cells and the poly-nucleated cells sensed in the introduced body fluid measurement sample and display the combined count.

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

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 display the count of each of the mono-nucleated cells and the poly-nucleated cells.

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

the third screen region is configured to display the relative cell amount between the mono-nucleated cells and the poly-nucleated cells, in addition to the count of each of the mono-nucleated cells and the poly-nucleated cells.

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 a total count of 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 an operation to remove a red blood cell ghost from the second measurements.

16. A sample analyzer comprising:

a plurality of detectors each configured to optically or electrically sense blood cells in a sample for measurement of the blood 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 blood 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, which is different, at least partially, from the sequence of operations for measuring blood cells in the blood sample, and wherein a respective sequence of operations for measuring blood cells in the blood sample and in the body fluid sample comprises a sensing operation comprising;

preparing a measurement sample;

introducing the prepared measurement sample into a detector; and

operating the detector to sense blood cells in the prepared measurement 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 (1) at least two sample type options, separately displayed from each other, for selection of one of the at least two sample-type options, which is selectable independently from another of the at least two sample-type options, wherein the at least two sample-type options comprise concurrent display of a blood sample option and a body fluid sample-type option, and (2) one or more test-type options, separately displayed from the at least two sample type options, for selection of one of the one or more test-type options, said one of the one or more test-type options being selectable independently from selection of any one of the at least two sample-type options, wherein a selected one of the at least two sample-type options and a selected one of the one or more test-type options are displayed separately on a screen from;

in response to both (I) selection of the blood sample option from the displayed at least two sample-type options and (II) additional selection of the one from the displayed one or more test-type options, perform the sensing operation in the blood measuring mode to;

prepare a blood measurement sample from the blood sample;

introduce the prepared blood measurement sample into a multi-mode detector; and

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

in response to both (I) selection of both the body fluid option from the displayed at least two sample-type options and (II) additional selection of the one from the one or more test-type options, perform the sensing operation in the body fluid measuring mode to;

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

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

operate said multi-mode detector to sense blood 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, in response to selection of the body fluid sample option and additional selection of said one of the one or more test-type options, during said sensing operation 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 not included in the sequence of operations for measuring cells in the blood measurement sample performed 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.

21. The sample analyzer according to claim 16, wherein the controller is programmed to automatically perform said pre-washing more than once during said sensing operation before introduction of the body fluid measurement sample into said multi-mode detector.

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, a solution used in said pre-washing.

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 an operation to automatically transport a sample container to a position for aspiration of the body fluid sample from the sample container.

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

24. A sample analyzer comprising:

a plurality of detectors each configured to optically or electrically sense blood cells in a sample for measurement of the blood 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 blood 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, which is different at least partially from the sequence of operations for measuring blood cells in the blood 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;

preparing a measurement sample;

introducing the prepared measurement sample into a detector; and

operating the detector to sense blood cells in the prepared measurement sample, and (b) an analyzing operation comprising;

analyzing measurements of blood cells from the detector; 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 a screen (1) at least two sample-type options, separately displayed from each other, for selection of one of the at least two sample-type options, which is selectable independently from another of the at least two sample-type options, wherein the at least two sample-type options comprise concurrent display of a blood sample option and a body fluid sample option and (2) one or more test-type options, displayed separately from the at least two sample-type options, for selection of one of the one or more test-type options, said one of the one or more test-type options being selectable independently from selection of any one of the at least two sample-type options, wherein a selected one of the at least two sample-type options and a selected one of the one or more test-type options are displayed separately on a screen;

in response to both (I) selection of the body fluid sample option from the displayed at least two sample-type options and (II) additional selection of the one from the displayed one or more test-type options,

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

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

introduce the first body fluid measurement sample into said one or more multi-mode detectors;

operate said one or more multi-mode detectors to sense red blood cells in the introduced first body fluid measurement sample, and perform the analyzing operation in the body fluid measuring mode to;

analyze first measurements, from said one or more multi-mode detectors, of individual blood cells sensed in the introduced 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;

introduce the second body fluid measurement sample into said one or more multi-mode detectors; and

operate said one or more multi-mode detectors to sense individual cells in the introduced second body fluid measurement sample, and perform the analyzing operation in the body fluid measuring mode to;

analyze second measurements, from said one or more multi-mode detectors, of the individual cells sensed in the introduced second body fluid measurement sample; and

count each of mono-nucleated cells and poly-nucleated cells based on the analyzed second measurements, wherein

the controller is programmed to display a count of each of the red blood cells, the mono-nucleated cells and the poly-nucleated cells, wherein the analyzing operation performed in the blood measuring mode comprises an operation to display 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 an operation to display a second test result screen for displaying test results obtained in the body fluid measuring mode, wherein the first test result screen is different from the second test result screen.

25. The sample analyzer according to claim 24, 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 introduced second body fluid measurement sample, and the second screen regions is configured to display the count of each of the mono-nucleated cells and the poly-nucleated cells sensed in the introduced 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 an operation to calculate relative cell amounts between the mono-nucleated cells and the poly-nucleated cells in the introduced second body fluid measurement sample, and the second screen region is configured to display the relative cell amounts between the mono-nucleated cells and the poly-nucleated cells, in addition to the count of each of the mono-nucleated cells and 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 an operation to remove a red blood cell ghost from the measurements from the multi-mode detector by application of a threshold to the measurements from the multi-mode detector.