Specimen analyzer and specimen analysis method

Patent metadata

Field	Value
Publication number	US-11604201-B2
Application number	US-201916697423-A
Country	US
Kind code	B2
Filing date	Nov 27, 2019
Priority date	Nov 30, 2018
Publication date	Mar 14, 2023
Grant date	Mar 14, 2023

Abstract

Disclosed is a specimen analyzer configured to perform analysis on a specimen for a plurality of measurement items, the specimen analyzer including a measurement section configured to perform a specimen measurement for measuring a measurement sample prepared from a specimen and a reagent corresponding to a measurement item, and configured to perform a quality control measurement for measuring a measurement sample prepared from a quality control substance and a reagent corresponding to a measurement item; and a controller programmed to set a quality control for each measurement item, from a quality control group that includes at least two types of quality controls selected from a first quality control in which the quality control measurement is performed at a predetermined time, a second quality control in which the quality control measurement is performed every time the specimen measurement is performed a predetermined number of times of measurement, and a third quality control in which the quality control measurement is performed every predetermined time interval, the controller being programmed to control the measurement section in accordance with the set quality control.

First claim

What is claimed is:

1. A specimen analyzer configured to perform analysis on a specimen for a plurality of measurement items, the specimen analyzer comprising:
a measurement section comprising a detector, the measurement section configured to perform a specimen measurement for measuring a measurement sample, the measurement sample prepared from a specimen and a reagent corresponding to a measurement item, the measurement item from among the plurality of measurement items, and the measurement section further configured to perform a quality control measurement for measuring another measurement sample prepared from a quality control substance and the reagent corresponding to the measurement item; and
a controller programmed to set a quality control for each of the measurement items, the quality control being from a quality control group that includes at least two types of quality controls selected from:
a first quality control in which the quality control measurement is performed at a predetermined time,
a second quality control in which the quality control measurement is performed every time the specimen measurement is performed a predetermined number of times, and
a third quality control in which the quality control measurement is performed every predetermined time interval,
the controller being programmed to receive a selection of the measurement item and control the measurement section to measure the another measurement sample in accordance with the quality control set by the controller for the received measurement item.

2. The specimen analyzer of claim 1 , wherein
the measurement section includes a reagent dispensing unit configured to open a cap portion covering an opening of a reagent container and dispense the reagent contained in the reagent container when the measurement sample is prepared.

3. The specimen analyzer of claim 1 , wherein
the measurement section includes:
a light source part configured to apply light to the measurement sample; and
a light receiver configured to receive light that has been generated from the measurement sample, and
the specimen measurement and the quality control measurement are each a measurement related to blood coagulation.

4. The specimen analyzer of claim 1 , wherein
the controller is programmed to alternatively set either one of the second quality control and the third quality control for the respective measurement items.

5. The specimen analyzer of claim 1 , wherein
when the first quality control and the second quality control are set for the received measurement item, the controller is programmed to reset a count of a number of times the specimen is measured according to the second quality control when the quality control measurement is performed based on the first quality control, and/or
when the first quality control and the third quality control are set for the received measurement item, the controller is programmed to reset a count of an elapsed time in the third quality control when the quality control measurement is performed based on the first quality control.

6. The specimen analyzer of claim 1 , wherein
the quality control group further includes a fourth quality control in which, when a remaining amount of the reagent in a first reagent container has become smaller than a predetermined amount, the quality control measurement is performed based on a reagent in a second reagent container of a same reagent type corresponding to the received measurement item.

7. The specimen analyzer of claim 6 , wherein
the controller is programmed to estimate a number of times the specimen measurement is executable in a time period required for the quality control measurement, and is programmed to calculate, as the predetermined amount, a reagent amount necessary for the specimen measurement to be performed the estimated number of times.

8. The specimen analyzer of claim 7 , comprising
a memory configured to store history information regarding past execution history of the specimen measurement performed by the measurement section, wherein
the controller is programmed to estimate the number of times based on the history information.

9. The specimen analyzer of claim 8 , wherein
the number of times is a number of times of the specimen measurement predicted to be performed in a day of a week or a predetermined time frame to which a current time belongs.

10. The specimen analyzer of claim 1 , comprising
a display, wherein
the controller is programmed to cause the display to display a reception screen for receiving a setting of each quality control included in the quality control group, and
the controller is programmed to cause the display to display, for each measurement item, recommendation information that suggests which of the quality controls in the quality control group is preferable.

11. The specimen analyzer of claim 10 , comprising
a memory configured to store history information regarding past execution history of the specimen measurement performed by the measurement section, wherein
the controller is programmed to cause the display unit to display the recommendation information based on the history information.

12. The specimen analyzer of claim 11 , wherein
the controller is programmed to:
predict an execution frequency of the specimen measurement based on the history information;
cause, when the execution frequency is greater than an execution frequency threshold, the recommendation information to include an indication that the second quality control is preferable; and
cause, when the execution frequency is smaller than the execution frequency threshold, the recommendation information to include an indication that the third quality control is preferable.

13. The specimen analyzer of claim 10 , wherein
the controller is programmed to cause the display unit to display the recommendation information based on reagent information of the reagent.

14. The specimen analyzer of claim 13 , wherein
the controller is programmed to cause, when a value indicating reagent stability is greater than a reagent stability threshold, the recommendation information to include an indication that the first quality control is preferable.

15. The specimen analyzer of claim 13 , wherein
the quality control group further includes a fourth quality control in which, when a remaining amount of a reagent in a first reagent container has become smaller than a predetermined amount, the quality control measurement is performed on the basis of a reagent in a second reagent container containing a reagent of the same reagent type corresponding to the received measurement item, and
the controller is programmed to cause, when a reagent property corresponds to a freeze-dried article, the recommendation information to include an indication that the fourth quality control is preferable.

16. The specimen analyzer of claim 1 , wherein
the controller is programmed to select, for each measurement item, a candidate quality control to be performed from among the quality controls included in the quality control group.

17. The specimen analyzer of claim 16 , further comprising
a memory configured to store history information regarding past execution history of the specimen measurement performed by the measurement section, wherein
the controller is programmed to predict an execution frequency of the specimen measurement for each measurement item based on the history information, and is programmed to select the candidate quality control to be performed based on the predicted execution frequency.

18. The speci

Assignees

• Sysmex Corp

Inventors

• Kurono Hiroshi

Classifications

• G01N2035/00673

  of reagents · CPC title

• G01N35/00594 Primary

  Quality control, including calibration or testing of components of the analyser · CPC title

• G01N35/00663 Primary

  of consumables · CPC title

• G01N35/00871

  Communications between instruments or with remote terminals · CPC title

• G01N35/00712

  Automatic status testing, e.g. at start-up or periodic · CPC title