# US 12,216,115 B2 · Blood analysis method, control device and blood cell analyzer

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- Number: US 12,216,115 B2
- Document ID: US12216115B2
- Status: Granted
- Kind: B2
- Application number: 17/733,570
- Filed: 2022-04-29
- Published: 2022-08-18
- Granted: 2025-02-04
- Earliest claimed: 2013-07-16
- Assignees: Chengdu Shen Mindray Medical Electronics Technology Research Institute Co., Ltd.; Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Applicants: Chengdu Shen Mindray Medical Electronics Technology Research Institute Co., Ltd.; Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Inventors: Wenjun Tong; Yijie Yang; Huaming Xu; Xing Shi
- Web page: https://patentgrep.com/patent/US12216115B2

## CPC

- G01N 33/5094: {for blood cell populations (red blood cells G01N33/80)}
- G01N 1/18: with provision for splitting samples into portions (G01N1/12, G01N1/14 take precedence; fraction-collection apparatus for chromatography B01D15/08)
- G01N 1/38: Diluting, dispersing or mixing samples
- G01N 15/10: Investigating individual particles
- G01N 15/14: Optical investigation techniques, e.g. flow cytometry
- G01N 33/721: {Haemoglobin}
- G01N 33/726: {Devices}
- G01N 35/00871: {Communications between instruments or with remote terminals}
- G01N 35/1097: {characterised by the valves (valves in general F16K)}
- G01N 15/1459: {the analysis being performed on a sample stream}
- G01N 35/1095: {for supplying the samples to flow-through analysers (for a specific analyser see relevant groups, e.g. under G01N15/00, G01N21/00, G01N27/00, G01N30/00, H01J49/00)}
- G01N 2015/011: {with lysing, e.g. of erythrocytes}
- G01N 2015/016: {White blood cells}
- G01N 2015/055: {for hematocrite determination}
- G01N 2015/1006: {for cytology}
- G01N 2015/1024: {Counting particles by non-optical means}
- G01N 2015/1486: {Counting the particles}
- G01N 2333/805: Haemoglobins; Myoglobins
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The present disclosure provided a blood cell analyzer, a control device and a blood analysis method thereof. In the method, a first reagent is mixed with a sample to obtain a first testing sample, and then a second reagent is mixed with the first testing sample for a further reaction to get a second testing sample for basophil classification and/or HGB measurement. A blood sample may be tested in one reaction cell through time-division multiplexing technology to obtain four groups leukocytes classification result and HGB result by single detection channel. Thus, the structure of the analyzer may be greatly simplified on the premise of guaranteeing the performance of the analyzer, the size and cost of the analyzer may reduce and a performance-price ratio of the analyzer may increase.

## Claims

### Claim 1

A blood analysis method for a blood cell analyzer, the blood cell analyzer comprising a common reaction cell for classifying leukocytes where a first testing sample and a second testing sample are prepared from a same blood sample, and a detection apparatus which detects the first testing sample and the second testing sample, said method comprising:
when performing leukocyte five-group classification:
transferring a first aliquot of the blood sample to the common reaction cell;
delivering a first reagent into the common reaction cell, wherein the first reagent lyses erythrocytes and reacts with leukocytes in the blood sample to form the first testing sample;
transferring the first testing sample from the common reaction cell to the detection apparatus;
detecting the first testing sample in the detection apparatus for a first detection that classifies the leukocytes into lymphocyte group, monocyte group, neutrophil & basophil group and eosinophil group;
delivering a second reagent into the common reaction cell after the first testing sample is transferred for detection, wherein the second reagent shrinks leukocytes other than basophils to form the second testing sample;
transferring the second testing sample from the common reaction cell to the detection apparatus, and
detecting the second testing sample in the detection apparatus for a second detection that classifies the basophils.

### Claim 2 (depends on 1)

The method according to claim 1, further comprising detecting the second testing sample for hemoglobin measurement.

### Claim 3 (depends on 1)

The method according to claim 1, further comprising:
after the first testing sample is transferred for detection, transferring a second aliquot of the blood sample into the common reaction cell for preparing the second testing sample.

### Claim 4 (depends on 1)

The method according to claim 1, further comprising counting leukocytes based on a signal acquired during the first detection or a signal acquired during the second detection.

### Claim 5 (depends on 1)

The method according to claim 1, further comprising:
transferring the first testing sample from the common reaction cell to the detection apparatus via pipelines of the analyzer, and
cleaning the pipelines and the detection apparatus through which the first testing sample has passed, before transferring the second testing sample for the second detection via the pipelines.

### Claim 6 (depends on 1)

The method according to claim 1, further comprising:
acquiring first detecting information after the first testing sample is detected in the detection apparatus;
acquiring second detecting information after the second testing sample is detected in the detection apparatus; and
performing the leukocyte five-group classification based on the first and second detecting information.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the detection apparatus is an optical detection apparatus.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the detection apparatus comprises an optical detection apparatus and an impedance detection apparatus;
the method further comprises:
acquiring first detecting information after the first testing sample is detected in the optical detection apparatus;
acquiring second detecting information after the second testing sample is detected in the impedance detection apparatus; and
performing the leukocyte five-group classification based on the first and second detecting information.

### Claim 9

A blood analysis method for a blood cell analyzer, the blood cell analyzer comprising a common reaction cell where a first testing sample for leukocyte detection and a second testing sample for hemoglobin measurement are prepared from a same blood sample, a detection apparatus which detects the first testing sample for a first detection of leukocyte detection and a hemoglobin measurement apparatus which detects the second testing sample for a second detection of hemoglobin measurement, and said method comprising:
transferring a first aliquot of the blood sample to the common reaction cell;
delivering a first reagent into the common reaction cell, wherein the first reagent lyses erythrocytes and reacts with leukocytes in the blood sample to form the first testing sample for leukocyte detection;
transferring the first testing sample from the common reaction cell to the detection apparatus;
detecting the first testing sample in the detection apparatus for the first detection of leukocyte detection;
delivering a second reagent into the common reaction cell to form the second testing sample hemoglobin measurement; and
detecting the second testing sample in the hemoglobin measurement apparatus for the second detection of hemoglobin measurement.

### Claim 10 (depends on 9)

The method according to claim 9, further comprising:
after the first testing sample is transferred for detection, transferring a second aliquot of the blood sample into the common reaction cell for preparing the second testing sample for hemoglobin measurement.

### Claim 11 (depends on 9)

The method according to claim 9, further comprising counting leukocytes based on a signal acquired during the first detection.

### Claim 12 (depends on 9)

The method according to claim 9, further comprising transferring a part of the second testing sample to the detection apparatus for leukocyte counting detection.

### Claim 13 (depends on 9)

The method according to claim 9, further comprising classifying leukocytes into lymphocyte, monocyte, neutrophil, basophil and eosinophil according to the first detection.