Measurement apparatus and analysis method

Patent metadata

Field	Value
Publication number	US-12429424-B2
Application number	US-202318182951-A
Country	US
Kind code	B2
Filing date	Mar 13, 2023
Priority date	Mar 17, 2022
Publication date	Sep 30, 2025
Grant date	Sep 30, 2025

Abstract

Disclosed is a measurement apparatus for analyzing a cell contained in a specimen, comprising: a chamber for preparing a measurement sample in which the cell is stained with first and second fluorescent dyes contained in a reagent supplied from at least one reagent container; a liquid feeding section for feeding the reagent from the reagent container to the chamber via a liquid feeding tube provided between the reagent container and the chamber; and a detection section that acquires first and second signals each corresponding to fluorescence of a first wavelength and fluorescence of a second wavelength emitted from the cell stained with the first and second fluorescent dyes in response to irradiation of the measurement sample flowing in a flow cell with light; and an analysis section that analyzes the cell on the basis of the first and second signals.

First claim

What is claimed is:

1. A measurement apparatus operable to analyze a plurality of blood cells contained in a blood specimen, comprising:
at least one reagent container configured to store at least one type of reagent that contains first and second fluorescent dyes, wherein the first and second fluorescent dyes are optically interrogated to respectively emit first and second fluorescent lights at different peak wavelengths;
a mixing chamber configured for mixing therein of the blood specimen with the at least one type of reagent for preparation of a measurement sample, wherein the measurement sample includes blood cells including first and second cellular components stained, respectively, with the first and second fluorescent dyes;
a reagent feeder configured to feed the at least one type of reagent from the at least one reagent container to the mixing chamber via a reagent feeding tube provided between the at least one reagent container and the mixing chamber;
a detector formed with a plurality of light detectors configured to measure non-fluorescent and fluorescent lights from optically interrogated blood cells in the measurement sample, wherein measuring fluorescent lights comprises measuring the first and second fluorescent lights excited out at the different peak wavelengths from the stained first and second cellular components of the optically interrogated blood cells, and wherein the measured first and second fluorescent lights respectively carry first and second sets of fluorescence information indicative of cellular features of the stained first and second cellular components, respectively, of the optically interrogated blood cells; and
an analyzer programmed to analyze the first and second sets of fluorescence information to perform CBC (Complete Blood Count) and/or a white blood cell classification that classifies white blood cells in the optically interrogated blood cells into multiple subpopulations, including lymphocyte, monocyte, eosinophil, neutrophil and basophil, of the white blood cells.

2. The measurement apparatus according to claim 1 , wherein the reagent feeding tube comprises a first end disposed in the at least one reagent container and a second end connected to the mixing chamber.

3. The measurement apparatus according to claim 2 , wherein the first end of the reagent feeding tube is fixed at a predetermined position in the at least one reagent container.

4. The measurement apparatus according to claim 3 , wherein the mixing chamber is configured for preparation of a plurality of measurement samples, and the first end of the reagent feeding tube is fixed at the predetermined position throughout preparation of the plurality of measurement samples.

5. The measurement apparatus according to claim 2 , further comprising a tube insertion mechanism operable to insert the first end of the reagent feeding tube into the at least one reagent container at the predetermined position in the at least one reagent container.

6. The measurement apparatus according to claim 2 , wherein the reagent feeder further comprises a metering dispenser configured to feed a constant amount of the first and second dyes from the at least one reagent container to the mixing chamber via the reagent feeding tube.

7. The measurement apparatus according to claim 1 , wherein the at least one reagent container contains 20 mL or more and 100 mL or less of the at least one type of reagent.

8. The measurement apparatus according to claim 1 , wherein the at least one type of reagent has a storage period of 60 days or more and 90 days or less at an operating temperature of the measurement apparatus.

9. The measurement apparatus according to claim 8 , wherein the storage period of the at least one type of reagent contained is 60 days or more and 90 days or less at a temperature of 15° C. to 30° C.

10. The measurement apparatus according to claim 1 , wherein the at least one reagent container includes a bag-shaped reagent storage portion containing the at least one type of reagent.

11. The measurement apparatus according to claim 10 , wherein the at least one reagent container contains 200 mL or more and 500 mL or less of the at least one type of reagent.

12. The measurement apparatus according to claim 10 , wherein the storage period of the at least one type of reagent is 75 days or more and 1 year or less at an operating temperature of the measurement apparatus.

13. The measurement apparatus according to claim 12 , wherein the storage period of the at least one type of reagent is 75 days or more and 1 year or less at a temperature of 15° C. to 30° C.

14. The measurement apparatus according to claim 1 , wherein the first and second cellular components of the optically interrogated blood cells are stained, respectively, with a first compound including the first fluorescent dye and a second compound including the second fluorescent dye.

15. The measurement apparatus according to claim 1 , wherein the at least one type of reagent does not contain an antibody.

16. The measurement apparatus according to claim 1 , wherein the at least one type of reagent includes a hemolytic agent to be reacted with the blood cells to damage cell membranes of the blood cells so that the first and second fluorescent dyes permeate into the blood cells.

17. The measurement apparatus according to claim 1 , wherein the analyzer is programmed to analyze the first and second sets of fluorescence information to classify the plurality of blood cells.

18. The measurement apparatus according to claim 1 , wherein the analyzer is programmed with an artificial intelligence algorithm to analyze the first and second sets of fluorescence information and a third set of non-fluorescence information obtained from a scattered light generated in response to irradiation of the measurement sample.

19. The measurement apparatus according to claim 18 , wherein the analyzer comprises a parallel processing processor programmed with the artificial intelligence algorithm to perform a matrix operation.

20. The measurement apparatus according to claim 18 , wherein the artificial intelligence algorithm is a deep learning algorithm.

21. The measurement apparatus according to claim 1 , wherein the plurality of light detectors comprises first and second fluorescent light detectors configured to respectively measure the first and second fluorescent lights.

22. An analysis method for analyzing a plurality of blood cells contained in a blood specimen, comprising:
feeding at least one type of reagent from at least one reagent container to a mixing chamber, wherein the first and second fluorescent dyes are optically interrogated to emit first and second fluorescent lights, respectively, at different peak wavelengths;
mixing in the mixing chamber the blood specimen with the at least one type of reagent for preparation of a measurement sample, wherein the measurement sample includes blood cells including first and second cellular components stained, respectively, with the first and second fluorescent dyes;
measuring non-fluorescent and fluorescent lights from optically interrogated blood cells in the measurement sample, wherein measuring fluorescent lights comprises measuring the first and second fluorescent lights excited out at the different peak wavelengths from the stained first and second cellular components of the optically interrogated blood cells, and wherein the measured first and second fluorescent light respectively carry first and second sets of fluorescence

Assignees

• Sysmex Corp

Inventors

• Mizukami Toshihiro
• Kimura Konobu
• Hamada Yuuichi
• Toya Yuji
• Nakanishi Noriyuki
• Nagai Takaaki
• Kuze Masato
• Tanaka Hironori

Classifications

• G01N2015/016

  White blood cells · CPC title

• G01N2015/1402

  Data analysis by thresholding or gating operations performed on the acquired signals or stored data · CPC title

• G01N2015/1006

  for cytology · CPC title

• G01N15/1459

  the analysis being performed on a sample stream · CPC title

• G01N15/1434

  Optical arrangements · CPC title