CN116794340A

CN116794340A - Sample analyzer, sample detection method, and glycosylated hemoglobin detection method

Info

Publication number: CN116794340A
Application number: CN202310196850.2A
Authority: CN
Inventors: 孙梓灵; 郁琦; 杜少卿
Original assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd
Current assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd
Priority date: 2022-03-22
Filing date: 2023-02-24
Publication date: 2023-09-22

Abstract

The present application relates to a sample analyzer, a sample detection method, and a glycosylated hemoglobin detection method. The sample analyzer includes: sample preparation means for drawing a blood sample from a container containing a blood sample to be tested of a subject, and preparing a first pretreatment liquid using the drawn blood sample and a pretreatment reagent; the first detection device is used for detecting the first pretreatment test liquid so as to obtain intermediate detection information of the first pretreatment test liquid; a controller configured to select a detection mode to be performed from the plurality of different detection modes according to the intermediate detection information, and control the sample preparation device to prepare a sample liquid to be detected using a second pretreatment sample liquid and a detection reagent according to the selected detection mode to be performed; and the second detection device is used for detecting the sample liquid to be detected so as to obtain a detection result of the blood sample to be detected aiming at a target detection item. Thereby avoiding sample retesting as much as possible.

Description

Sample analyzer, sample detection method, and glycosylated hemoglobin detection method

Technical Field

The application relates to the field of in-vitro diagnosis, in particular to a sample analyzer, a sample detection method and a saccharification detection method.

Background

In sample testing, such as glycosylated hemoglobin testing, it may occur that the sample measurement is outside the effective measurement linear range, which may result in an abnormality in the sample measurement.

In existing solutions, it is often determined after obtaining a measurement result of a sample, whether the measurement result of the sample is outside a valid measurement range, and if the measurement result is outside the valid measurement range, the sample is retested in another detection mode. However, frequent retests result in reduced detection efficiency and increased costs.

Disclosure of Invention

In order to solve the above technical problems, an object of the present application is to provide a sample analyzer, a sample detection method, and a glycosylated hemoglobin detection method, which can expand a linear range, i.e., an effective measurement range, for detecting glycosylated hemoglobin, so as to avoid retesting a sample as much as possible.

To solve the above-mentioned task, a first aspect of the present application provides a sample analyzer, comprising:

sample preparation means for drawing a blood sample from a container containing a blood sample to be tested of a subject, and preparing a first pretreatment liquid using the drawn blood sample and a pretreatment reagent;

The first detection device is used for detecting the first pretreatment test solution to obtain intermediate detection information of the first pretreatment test solution;

a controller configured to select a detection mode to be performed from a plurality of different detection modes according to the intermediate detection information, and to control the sample preparation device to prepare a sample liquid to be tested using a second pretreatment liquid and a detection reagent according to the selected detection mode to be performed, the second pretreatment liquid being prepared by the sample preparation device from a blood sample to be tested and a pretreatment reagent of the subject; and

and the second detection device is used for detecting the sample liquid to be detected so as to obtain a detection result of the blood sample to be detected aiming at a target detection item.

Therefore, before preparing the sample liquid to be detected which is finally detected by the second detection device, intermediate detection information is obtained by detecting intermediate test liquid in the preparation process of the sample liquid to be detected, particularly pretreatment test liquid after pretreatment of a blood sample to be detected, and a detection mode for preparing the sample liquid to be detected is selected according to the intermediate detection information, so that the sample liquid to be detected is prepared according to the detection mode which is selected to be suitable for the current blood sample to be detected, an accurate detection result can be obtained through one-time detection, the effective detection range of one-time detection is improved, the retesting of the blood sample to be detected is reduced, and further the overall detection efficiency of the sample analyzer is improved and the total detection cost is reduced.

A second aspect of the present application provides a sample analyzer comprising:

the sample preparation device is used for preparing sample liquid to be detected corresponding to each detection mode in at least two different detection modes according to a blood sample to be detected, wherein the sample liquid to be detected is prepared from a pretreatment sample liquid and a detection reagent, and the pretreatment sample liquid is prepared from the blood sample to be detected and the pretreatment reagent;

the first detection device is used for detecting at least one pretreatment test solution so as to obtain intermediate detection information of the pretreatment test solution;

the second detection device is used for respectively detecting the sample liquid to be detected corresponding to the detection modes so as to obtain a plurality of detection results of the same target detection item; and

and the controller is configured to select and output at least one detection result from the plurality of detection results according to the intermediate detection information of the pretreatment liquid.

Therefore, multiple detection results aiming at the same detection item are obtained, and the detection result to be output is selected according to the intermediate detection information, so that retesting of the blood sample to be detected can be reduced or even avoided.

A third aspect of the present application provides a sample analyzer comprising:

Sample preparation means for preparing a sample liquid to be measured for glycosylated hemoglobin measurement from a blood sample to be measured of a subject;

information acquisition means for acquiring red blood cell-related information of the subject;

the second detection device is used for detecting the sample liquid to be detected to obtain a glycosylated hemoglobin detection result; and

a controller configured to control the operation of the device,

when a blood sample to be tested of a subject is subjected to primary test of a glycosylated hemoglobin item, a test mode to be executed is selected from a plurality of different glycosylated hemoglobin test modes according to red blood cell related information of the subject,

controlling the sample preparation device to prepare a sample liquid to be detected according to the selected detection mode to be executed, wherein the sample liquid to be detected is prepared according to a blood sample to be detected of the subject, a pretreatment reagent and a detection reagent for glycosylated hemoglobin detection, and

and controlling the second detection device to detect the sample liquid to be detected.

Therefore, when the primary detection of the glycosylated hemoglobin item is carried out on the blood sample to be detected of the subject, the glycosylated hemoglobin detection mode for preparing the sample liquid to be detected is selected according to the red blood cell related information of the subject, an accurate glycosylated hemoglobin detection result can be obtained through one-time detection, the effective detection range of one-time detection is improved, the re-detection of the glycosylated hemoglobin item is reduced or even avoided, the detection efficiency of the glycosylated hemoglobin item is improved, and the total detection cost is reduced.

A fourth aspect of the application provides a sample analyzer comprising:

the sample preparation device is used for preparing to-be-detected sample liquids corresponding to respective glycosylated hemoglobin detection modes in at least two different glycosylated hemoglobin detection modes according to a to-be-detected blood sample of a subject;

the second detection device is used for respectively detecting the sample liquid to be detected corresponding to the detection modes of the respective glycosylated hemoglobin so as to obtain a plurality of glycosylated hemoglobin detection results; and

and a controller configured to select and output at least one glycosylated hemoglobin detection result from the plurality of glycosylated hemoglobin detection results according to red blood cell related information of the subject.

Thus, after a plurality of types of glycated hemoglobin measurement results are obtained, the glycated hemoglobin measurement results to be output are selected based on the information on the red blood cells of the subject, and re-measurement of the glycated hemoglobin item can be avoided as much as possible.

A fifth aspect of the present application relates to a sample detection method, comprising:

drawing a blood sample from a container containing a blood sample to be tested of a subject, and pre-treating the drawn blood sample to obtain a first pre-treated test solution;

Detecting the first pretreatment test solution to obtain intermediate detection information of the first pretreatment test solution;

selecting a detection mode to be executed from a plurality of different detection modes aiming at the same target detection item according to the intermediate detection information of the first pretreatment test solution;

preparing a sample liquid to be detected by adopting a second pretreatment test liquid and a detection reagent according to the selected detection mode to be executed, wherein the second pretreatment test liquid is prepared by a blood sample to be detected of the subject and the pretreatment reagent; and is also provided with

And detecting the sample liquid to be detected to obtain a detection result of the blood sample to be detected aiming at the target detection item.

The advantages and features of the sample detection method according to the fifth aspect of the present application may be referred to the sample analyzer according to the first aspect of the present application.

A sixth aspect of the present application relates to a sample detection method, comprising:

preparing at least two sample liquids to be detected corresponding to respective detection modes in different detection modes according to a blood sample to be detected, wherein the sample liquid to be detected is prepared from a pretreatment test liquid and a detection reagent, and the pretreatment test liquid is prepared from the blood sample to be detected and the pretreatment reagent;

Detecting at least one pretreatment test solution to obtain intermediate detection information of the pretreatment test solution;

detecting the sample liquid to be detected corresponding to each detection mode to obtain a plurality of detection results of the same target detection item; and

and selecting and outputting at least one detection result from the plurality of detection results according to the intermediate detection information of the pretreatment test solution.

The advantages and features of the sample detection method provided in the sixth aspect of the present application may be referred to the sample analyzer provided in the second aspect of the present application.

A seventh aspect of the present application relates to a glycosylated hemoglobin detection method, comprising:

when a blood sample to be tested of a subject is subjected to primary detection of a glycosylated hemoglobin item, selecting a detection mode to be executed from a plurality of different glycosylated hemoglobin detection modes according to red blood cell related information of the subject;

preparing a sample liquid to be detected according to the selected detection mode to be executed; and is also provided with

And detecting glycosylated hemoglobin of the sample liquid to be detected.

The advantages and features of the glycosylated hemoglobin detection method according to the seventh aspect of the present application may be referred to the sample analyzer according to the third aspect of the present application.

An eighth aspect of the present application relates to a glycosylated hemoglobin detection method, comprising:

preparing to-be-tested sample liquid corresponding to each glycosylated hemoglobin detection mode in at least two different glycosylated hemoglobin detection modes according to a to-be-tested blood sample of a subject;

respectively detecting the sample liquid to be detected corresponding to each glycosylated hemoglobin detection mode so as to obtain a plurality of glycosylated hemoglobin detection results; and

selecting and outputting at least one glycosylated hemoglobin detection result from the plurality of glycosylated hemoglobin detection results according to red blood cell related information of the subject.

The advantages and features of the glycosylated hemoglobin detection method according to the eighth aspect of the present application may be referred to the sample analyzer according to the fourth aspect of the present application.

Drawings

The application will be more clearly elucidated in connection with the examples and the accompanying drawings. The above-described and other advantages will become apparent to those skilled in the art from the detailed description of embodiments of the application. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the application. The same or similar reference numbers will be used throughout the drawings to refer to the same parts. In the drawings:

FIG. 1 is a schematic block diagram of a sample analyzer according to a first embodiment of the present application;

FIG. 2 is a schematic block diagram of the sample analyzer of FIG. 1;

FIG. 3 is a schematic block diagram of a first detection device according to an embodiment of the present application;

FIG. 4 is an image of a first pre-treatment fluid according to one embodiment of the application;

FIG. 5 is a schematic flow chart of glycosylated hemoglobin measurement according to an embodiment of the present application;

FIG. 6 is a graph of absorbance difference versus estimated hemoglobin concentration according to one embodiment of the application;

FIG. 7 is another schematic flow chart diagram of glycosylated hemoglobin measurement according to an embodiment of the present application;

FIG. 8 is a schematic block diagram of a sample analyzer according to a second embodiment of the application;

FIG. 9 is a schematic block diagram of a sample analyzer according to a third embodiment of the present application;

FIG. 10 is a schematic block diagram of a sample analyzer according to a fourth embodiment of the present application;

FIG. 11 is a schematic flow chart of a sample detection method according to a fifth embodiment of the present application;

fig. 12 is a schematic flow chart of a sample detection method according to a sixth embodiment of the present application;

FIG. 13 is a schematic flow chart of a glycosylated hemoglobin detection method according to a seventh embodiment of the present application;

FIG. 14 is a schematic flow chart of a glycosylated hemoglobin detection method according to an eighth embodiment of the present application.

Detailed Description

Embodiments of the present application will now be described more fully hereinafter with reference to the accompanying drawings, in which it is shown, however, in which some, but not all embodiments of the application are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

It should be noted that, the term "first\second\third" related to the embodiment of the present application is merely to distinguish similar objects, and does not represent a specific order for the objects, it is to be understood that "first\second\third" may interchange a specific order or sequence where allowed.

It will be understood by those skilled in the art that all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs unless defined otherwise.

Fig. 1 shows a schematic block diagram of a sample analyzer 100 according to a first embodiment of the application. The sample analyzer 100 includes a sample preparation device 110, a first detection device 120, a second detection device 130, and a controller 140.

The sample preparation device 110 is used to aspirate a blood sample from a container 10 containing a blood sample to be tested of a subject, such as a whole blood sample, and to prepare a first pretreatment sample solution using the aspirated blood sample and a pretreatment reagent. The first detection device 120 is used for detecting the first pretreatment liquid prepared by the sample preparation device 110 to obtain intermediate detection information of the first pretreatment liquid.

The controller 140 is configured to: selecting a detection mode to be performed from a plurality of different detection modes according to the intermediate detection information detected by the first detection device 120, and controlling the sample preparation device 120 to prepare a sample liquid to be tested using a second pretreatment liquid and a detection reagent according to the selected detection mode to be performed, wherein the second pretreatment liquid is prepared by the sample preparation device 110 from a blood sample to be tested of the subject and the pretreatment reagent.

The second detection device 130 is configured to detect the sample fluid to be detected, so as to obtain a detection result of the blood sample to be detected for a target detection item.

Unlike the prior art in which two sample liquids to be measured are required to be prepared for an abnormal blood sample and two target item detections are performed, in the embodiment of the present application, before the sample liquid to be measured finally used for the second detection device 130 is prepared, an intermediate detection information is obtained by detecting an intermediate detection liquid, that is, a pretreatment detection liquid, and according to the intermediate detection information, a detection mode, particularly a preparation condition, for preparing the sample liquid to be measured is selected, so that a sample liquid to be measured suitable for a current blood sample to be measured can be prepared, a more accurate detection result can be obtained through one-time detection, sample retesting is reduced, and further, the overall detection efficiency of the sample analyzer is improved.

In one particular embodiment, as shown in FIG. 2, the sample analyzer 100 is configured as a biochemical instrument. In the embodiment shown in fig. 2, sample preparation device 110 includes a sample carrier 111, a sample dispensing mechanism 112, a reagent carrier 113, a reagent dispensing mechanism 114, and a reaction component 115.

The sample carrier 111 is for carrying a blood sample. For example, the sample carrier 111 may be configured as a sample tray comprising a plurality of sample locations where the containers 10 may be placed, and the sample tray is capable of being maneuvered by rotation to a corresponding position, for example, to a position where the sample dispensing mechanism 112 draws a blood sample. The sample dispensing mechanism 112 is used to draw a blood sample from the container 10 and discharge it into a reaction cup to be loaded. For example, the sample dispensing mechanism 112 may include a sample needle that is capable of two-dimensional or three-dimensional movement in space by a two-dimensional or three-dimensional drive mechanism, such that the sample needle is capable of moving to a position where a blood sample is drawn and to a reaction cup to be loaded and discharging the drawn blood sample to the reaction cup.

The reagent carrying part 113 is used for carrying reagents including pretreatment reagents and detection reagents. In some embodiments, the reagent carrier 113 may be configured as a reagent disk having a disk-like structure with a plurality of positions for carrying reagent containers, the reagent carrier 113 being capable of rotating and driving the reagent containers carried thereby to rotate the reagent containers to a specific position, such as a position where reagent is aspirated by the reagent dispensing mechanism 114. The number of reagent carrying members 113 may be one or more. The reagent dispensing mechanism 114 is used to aspirate and discharge the reagent into the cuvette to be filled with the reagent. For example, the reagent dispensing mechanism 114 may include a reagent needle that is capable of two-dimensional or three-dimensional movement in space by a two-dimensional or three-dimensional driving mechanism, so that the reagent needle can be moved to a position where reagent is sucked and to a cuvette to which reagent is to be added, and the sucked reagent is discharged to the cuvette.

The reaction part 115 has at least one place for placing a cuvette and incubating a test solution, such as a pretreatment test solution and a sample solution to be tested, in the cuvette. For example, the reaction block 115 may be configured as a reaction disk having a disk-like structure with one or more placement sites for placement of reaction cups, the reaction disk being capable of rotating and moving the reaction cups in its placement sites to facilitate the scheduling of reaction cups within the reaction disk and incubating reagents in the reaction cups.

The first detection device 120 is configured to detect a first pretreatment liquid in which a blood sample and a pretreatment reagent are mixed in the reaction part 115, to obtain intermediate detection information of the first pretreatment liquid. The first detecting means 120 is, for example, provided outside the reaction part 115, and the reaction part 115 rotates to drive the container containing the first pretreatment liquid to move to the first detecting means 130 for detection.

The second detection device 130 is used for detecting the sample liquid to be detected after incubation in the reaction part 115, so as to obtain a detection result for the target detection item. The second detecting device 140 is also disposed outside the reaction part 115, for example, and the reaction part 115 rotates to drive the container containing the sample liquid to be detected to move to the second detecting device 130 for detecting the target item. In some embodiments, the second detection device 130 is configured as a photometry device.

Further, in the embodiment shown in fig. 2, the sample preparation device 110 may further include a reagent transferring part (not shown) for transferring the pre-treated reagent into the corresponding cuvette. In some embodiments, the sample dispensing mechanism 112 may be used as the reagent transfer section.

In some embodiments, the pretreatment reagent may include a hemolyzing agent for lysing red blood cells in the blood sample to be tested to release hemoglobin, and the intermediate detection information includes a detection value related to the hemoglobin concentration of the first pretreatment reagent, such as the hemoglobin concentration of the first pretreatment reagent. That is, the detection mode to be executed is selected based on the detection value related to the hemoglobin concentration of the first pretreatment liquid.

Alternatively or additionally, the pretreatment reagent may include a hemolyzing agent for lysing red blood cells in the blood sample to be tested to release hemoglobin, and the intermediate detection information includes a detection value related to an interfering substance in the first pretreatment test solution that interferes with the target detection item. The interfering substance is, for example, a lipid interfering substance, and the detection value related to the interfering substance is, for example, a lipid blood concentration or a bilirubin concentration. That is, the detection mode to be executed is selected here based on the detection value related to the interfering substance in the first pretreatment liquid.

In other alternative embodiments, the pretreatment reagent may include a diluent for diluting the blood sample to be tested to detect the hematocrit, and the intermediate detection information includes a detection value related to the hematocrit of the first pretreatment test solution, such as the hematocrit of the first pretreatment test solution. That is, the detection mode to be executed is selected here based on the detection value related to the hematocrit of the first pretreatment liquid.

In some embodiments, the target test item may be a glycosylated hemoglobin test item and the second test device may be further configured to test glycosylated hemoglobin in the blood sample to be tested.

Glycosylated hemoglobin is also called glycosylated hemoglobin, and is the product of non-enzymatic catalytic reaction between sugar such as glucose and amino groups of hemoglobin, and its content is positively correlated with blood glucose concentration in blood. Since the protein glycation reaction is an irreversible reaction and the lifetime of red blood cells in the blood circulation is 120 days, the glycosylated hemoglobin can reflect the average blood glucose concentration of nearly three months and is widely used for clinical diagnosis and treatment monitoring as a blood glucose control index.

In clinical examination, the ratio or percentage of glycosylated hemoglobin to hemoglobin is generally used as a report unit, and there are mainly IFCC (mmol/mol), NGSP (%), JDS/JSCC (%) in Japan and Monos (%) in Sweden.

The existing measurement techniques of glycosylated hemoglobin include immunoaffinity chromatography, ion exchange chromatography, capillary electrophoresis, immunoturbidimetry, enzymatic method, and the like. In these measurement methods, retests may be caused by factors such as interference of turbid lipid samples or detection results exceeding the effective measurement range. The effective measurement range refers to the range of variation of the concentration of the linear to-be-measured object, wherein the precision and the accuracy of the test result obtained by using one method are both compounded with the requirement. Therefore, the technical scheme provided by the application can be advantageously used for reducing retesting of glycosylated hemoglobin detection projects.

Taking immunoturbidimetry and enzymatic methods for detecting glycosylated hemoglobin as an example, in some embodiments, the controller 140 may be further configured to:

controlling the sample preparation device 110 to prepare a first sample liquid to be tested using a second pretreatment test liquid and a first test reagent for a glycosylated hemoglobin test item according to the selected test mode to be performed, wherein the first test reagent comprises an enzyme reagent (e.g., a proteolytic enzyme for glycosylated hemoglobin in the second pretreatment test liquid to produce a glycosylated peptide or glycosylated amino acid) or an immunological reagent (e.g., a glycosylated hemoglobin-specific antibody) for detecting the hemoglobin content;

Controlling a second detection device 130 to detect the first sample liquid to be detected so as to obtain the content of hemoglobin in the blood sample to be detected;

controlling the sample preparation device 110 to add a second detection reagent for a glycosylated hemoglobin detection item to the first sample liquid to be detected to prepare a second sample liquid to be detected, wherein the second detection reagent comprises an enzyme reagent for detecting glycosylated hemoglobin (e.g., a specific oxidase for reacting with a glycosylated peptide or glycosylated amino acid in the first sample liquid to generate a detectable product such as hydrogen peroxide) or an immunological reagent (e.g., a multi-cluster single antigen carrying several glycosylated hemoglobin epitopes);

controlling the second detecting device 130 to detect the second sample liquid to be detected so as to obtain the glycosylated hemoglobin content in the blood sample to be detected; and is also provided with

And calculating the ratio of the glycosylated hemoglobin content to the hemoglobin content as a detection result of the glycosylated hemoglobin detection program.

In other embodiments, the second detection device 130 may be configured as a detection device that operates based on ion exchange chromatography. At this time, the detection reagent includes an equilibration buffer and an elution buffer.

In still other embodiments, the second detection device 130 may be configured as a detection device that operates based on affinity chromatography. At this time, the detection reagent includes an aminophenylboronic acid agarose gel, an asparagusamine buffer, a sorbitol buffer (eluent), and the like.

In some embodiments, as shown in fig. 3, the first detection device 120 may be further configured to irradiate the first pretreatment solution with light of at least one wavelength, and obtain an optical signal generated by the first pretreatment solution after the first pretreatment solution is irradiated with the light, so as to obtain the intermediate detection information based on the optical signal. In the embodiment shown in fig. 3, the first detection means 120 comprises a light source 121 and a light detector 122. The light source 121 is for irradiating the first pretreatment liquid with light of at least one wavelength, and the photodetector 122 is for detecting an optical signal (transmitted light and/or scattered light) emitted by the light source 121 and passing through the first pretreatment liquid, thereby obtaining the intermediate detection information based on the optical signal. In the embodiment shown in fig. 3, the pretreatment reagent comprises in particular a hemolysing agent for lysing erythrocytes in a blood sample to be tested, in particular a whole blood sample, to release hemoglobin, and the intermediate detection information comprises a detection value related to the hemoglobin concentration of the first pretreatment test solution, preferably the hemoglobin concentration, and/or the intermediate detection information comprises a detection value related to an interfering substance in the first pretreatment test solution interfering with the target detection item.

In other embodiments, the pretreatment reagent includes a hemolyzing agent for lysing erythrocytes in the blood sample to be tested to release hemoglobin. Here, the first detection device 120 is configured as a camera for photographing the first pretreatment liquid to acquire an image of the first pretreatment liquid, based on which a detection value related to the hemoglobin concentration of the first pretreatment liquid can be obtained, for example, the hemoglobin concentration of the first pretreatment liquid is estimated based on the red shade of the image.

Glycosylated hemoglobin is the product of a continuous and irreversible non-enzymatic protein glycosylation reaction of hemoglobin and glucose in red blood cells, and for the same test sample, glycosylated hemoglobin concentration is linear with hemoglobin concentration (HGB). It has been demonstrated through a number of experiments that the hemoglobin concentration in a blood sample is in turn linear with the hematocrit, i.e. "red blood cell volume/total sample volume" (HCT) in the blood sample after centrifugation or after natural settling. Thus, the detection mode may be selected depending on the HCT value in the blood sample after centrifugation or after natural resting sedimentation. That is, in still other embodiments, the sample preparation device 110 is configured to perform a centrifugation process or a natural standing sedimentation process on a blood sample to be tested to obtain a pretreatment sample solution; the first detection device 120 is configured as a camera and is used for photographing the first pretreatment liquid after centrifugation or after natural standing sedimentation to obtain an image of the first pretreatment liquid, on the basis of which a detection value related to the hemoglobin concentration of the first pretreatment liquid can be obtained. For example, as shown in the image of fig. 4, the hematocrit HCT (=h/L) of the first pretreatment liquid may be obtained based on the ratio of the bottom red blood cells to the upper plasma after centrifugation or natural resting sedimentation or the ratio of the red blood cell volume h to the total sample volume L of the first pretreatment liquid after centrifugation or natural resting sedimentation, thereby estimating the glycosylated hemoglobin concentration of the first pretreatment liquid; preferably, natural standing sedimentation takes at least half an hour to obtain a good photographing effect.

In yet other alternative embodiments, the first detection device 120 is further configured to pass a first pre-treatment fluid to obtain a pulse measurement signal, so as to obtain intermediate detection information based on the pulse measurement signal. The first detection device 120 is configured as a resistance measurement device, for example. Preferably, the pretreatment reagent comprises a diluent for diluting the blood sample to be tested for detecting hematocrit, and the intermediate detection information comprises hematocrit with the first pretreatment reagent.

In some embodiments, the first detecting device 120 and the second detecting device 130 may be the same detecting device, so as to further reduce the cost. For example, the first detection device 120 and the second detection device 130 are optical detection devices shown in fig. 3.

In the embodiment of the present application, after the detection mode to be performed is selected based on the intermediate detection information obtained by detecting the first pretreatment liquid, the sample liquid to be detected may be prepared in the following manner.

In the first manner of preparing a sample liquid to be measured, the controller 140 may be further configured to control the sample preparation device to prepare the sample liquid to be measured using the first pretreatment liquid as the second pretreatment liquid and the detection reagent when controlling the sample preparation device 110 to prepare the sample liquid to be measured using the second pretreatment liquid and the detection reagent according to the selected detection mode to be performed. That is, the second pretreatment liquid is a first pretreatment liquid, for example, the sample preparation device 110 mixes a portion of the first pretreatment liquid with a detection reagent to obtain a sample liquid to be tested. Thus, not only the overall detection efficiency of the sample analyzer can be improved, but also the overall detection cost can be reduced.

Taking the sample analyzer shown in fig. 2 as an example for describing the first way of preparing a sample liquid to be measured, the controller 140 controls the reagent dispensing mechanism 114 to add a pretreatment reagent, such as a hemolyzing agent, in the reagent carrying member 113 to the first reaction cuvette in the reaction member 115, and then the controller 140 controls the sample dispensing mechanism 112 to draw a portion of a blood sample to be measured, particularly a whole blood sample, from the container 10 and add it to the first reaction cuvette to which the pretreatment reagent has been added, to obtain a first pretreatment sample liquid. The controller 140 controls the first detecting means 130 to detect the first pre-treatment liquid in the first cuvette to obtain intermediate detection information of the first pre-treatment liquid, such as hemoglobin concentration. The controller 140 selects a detection mode to be performed according to the intermediate detection information of the first pretreatment liquid. The first pretreatment solution is then incubated in the reaction block 115 for a period of time. Next, the controller 140 controls the reagent dispensing mechanism 114 to add the detection reagent in the reagent carrying member 113 to the second cuvette located in the reaction member 115, and controls the reagent transferring section to transfer a part of the first pretreatment reagent in the first cuvette to the second cuvette to which the detection reagent has been added, to prepare the sample liquid to be measured. Then, the controller 140 controls the second detecting device 130 to detect the sample liquid to be detected in the second cuvette.

In the second manner of preparing a sample liquid to be tested, the controller 140 may be further configured to, when controlling the sample preparation device 110 to prepare the sample liquid to be tested using the second pretreatment sample liquid and the detection reagent according to the selected detection mode to be performed, control the sample preparation device 110 to re-suck the blood sample of the subject, re-prepare the second pretreatment sample liquid according to the re-sucked blood sample, and prepare the sample liquid to be tested according to the re-prepared second pretreatment sample liquid and the detection reagent. That is, the sample preparation device 110 prepares the sample liquid to be measured not with the first pretreatment liquid but with the newly prepared second pretreatment liquid.

Also described as an example of the second way of preparing a sample fluid to be tested using the sample analyzer shown in fig. 2, the controller 140 controls the reagent dispensing mechanism 114 to add a pretreatment reagent, such as a hemolyzing agent, in the reagent carrying member 113 to the first reaction cuvette in the reaction member 115, and then the controller 140 controls the sample dispensing mechanism 112 to draw a portion of the sample of blood to be tested, particularly the whole blood sample, from the container 10 and add it to the first reaction cuvette to which the pretreatment reagent has been added to obtain a first pretreatment sample fluid. The controller 140 controls the first detecting means 130 to detect the first pre-treatment liquid in the first cuvette to obtain intermediate detection information of the first pre-treatment liquid, such as hemoglobin concentration. The controller 140 selects a detection mode to be performed according to the intermediate detection information of the first pretreatment liquid. Then, the controller 140 controls the reagent dispensing mechanism 114 to add a pretreatment reagent, such as a hemolyzing agent, in the reagent carrying member 113 to a second reaction cup located in the reaction member 115 according to the detection mode to be performed, and then the controller 140 controls the sample dispensing mechanism 112 to again aspirate another portion of the blood sample to be tested from the container 10 or aspirate a portion of the blood sample to be tested from another container containing the blood sample to be tested of the same subject and add it to the second reaction cup to which the pretreatment reagent has been added, to obtain a second pretreatment test solution. The second pretreatment reagent is incubated in the reaction block 115 for a period of time. Next, the controller 140 controls the reagent dispensing mechanism 114 to add the detection reagent in the reagent carrying member 113 to the third cuvette in the reaction member 115, and controls the reagent transferring section to transfer a part of the second pretreatment reagent in the second cuvette to the third cuvette to which the detection reagent has been added, to prepare the sample liquid to be measured. Then, the controller 140 controls the second detecting device 130 to detect the sample liquid to be detected in the third reaction cup.

In the third way of preparing a sample fluid to be tested, the sample preparation device 110 may be further adapted to prepare a plurality of pretreatment fluids using the blood sample to be tested and the pretreatment reagent, wherein at least one of the components, the formulation and the amounts of the pretreatment reagent used to prepare the plurality of pretreatment fluids are different from each other and/or the amounts of the blood sample to be tested used to prepare the plurality of pretreatment fluids are different from each other. The first detection device 120 may be further configured to detect at least one first pretreatment solution of the plurality of pretreatment solutions, so as to obtain intermediate detection information of the first pretreatment solution. And at this time, the controller 140 may be further configured to control the sample preparation device 110 to select one of the plurality of pretreatment reagents as the second pretreatment reagent according to the selected detection mode to be performed and to prepare the sample solution to be tested using the selected pretreatment reagent and the detection reagent, when controlling the sample preparation device 110 to prepare the sample solution to be tested using the second pretreatment reagent and the detection reagent according to the selected detection mode to be performed.

Also described as a third way of preparing a sample liquid to be measured by way of example of the sample analyzer shown in fig. 2, the controller 140 controls the reagent dispensing mechanism 114 to add a pretreatment reagent, such as a hemolyzing agent, in the reagent carrying member 113 to the first reaction cup, the second reaction cup and the third reaction cup respectively located in the reaction member 115, and then the controller 140 controls the sample dispensing mechanism 112 to add a blood sample to be measured in the container 10 to the first reaction cup, the second reaction cup and the third reaction cup to which the pretreatment reagent has been added respectively, so as to obtain a plurality of pretreatment test liquids. The controller 140 controls the first detecting means 130 to detect the first pre-treatment liquid in the first cuvette to obtain intermediate detection information of the first pre-treatment liquid, such as hemoglobin concentration. The controller 140 selects a detection mode to be performed according to the intermediate detection information of the first pretreatment liquid. Then, the controller 140 controls the reagent dispensing mechanism 114 to add the detection reagent in the reagent carrying member 113 to the fourth cuvette in the reaction member 115 according to the detection mode to be performed, and controls the reagent transferring section to transfer a part of the second pretreatment reagent in the second cuvette to the fourth cuvette to which the detection reagent has been added, to prepare the sample liquid to be measured. Then, the controller 140 controls the second detecting device 130 to detect the sample liquid to be detected in the fourth cuvette.

In some embodiments, the plurality of different detection modes includes at least two detection modes, the effective detection ranges of the at least two detection modes being at least partially misaligned. Here, the intermediate detection information of the first pretreatment liquid can be used to estimate a detection result of the blood sample to be measured for the target detection item, for example, the hemoglobin concentration or the hematocrit of the first pretreatment liquid can be used to estimate the glycosylated hemoglobin concentration of the blood sample to be measured, so that a detection mode having an effective detection range suitable for the blood sample to be measured can be selected according to the intermediate detection information of the first pretreatment liquid, and further, the detection result is prevented from exceeding the effective detection range, and the detection of the target item is realized by one-time detection.

In the embodiment of the application, the effective detection range refers to the range of variation of the concentration of the linear to-be-detected object, wherein the precision and the accuracy of the test result obtained by using one method are both compounded with the requirements.

In some embodiments, the plurality of different detection modes may be different in at least one of the following:

the dosage of at least one of a blood sample to be measured, a pretreatment reagent and a detection reagent for preparing the sample liquid to be measured or the proportion of at least one of the blood sample to be measured, the pretreatment reagent and the detection reagent for preparing the sample liquid to be measured in the sample liquid to be measured;

The components, the formula or the dosage of the pretreatment reagent for preparing the sample liquid to be tested; and

the type or amount of the detection reagent used for preparing the sample liquid to be detected.

For example, when the glycosylated hemoglobin concentration of the blood sample to be detected is determined to be low, a detection mode for increasing the sample quantity is started to increase the glycosylated hemoglobin concentration in the reaction system, reduce the influence of the nonspecific background reaction on the glycosylated hemoglobin concentration detection, further solve the problem of inaccurate result when the glycosylated hemoglobin with low concentration is detected, and achieve the effect of obtaining an accurate glycosylated hemoglobin detection result in one detection.

Alternatively or additionally, the second detection device is further configured to detect the sample fluid to be detected according to the selected detection mode to be performed, so as to obtain a detection result of the blood sample to be detected for a target detection item. Here, the plurality of different detection modes may be different in at least one of the following aspects:

the wavelength of the light used for detecting the sample liquid to be detected aiming at the target detection item; and

and a methodology for detecting the sample fluid to be tested against the target detection item.

In some embodiments, the pretreatment reagent comprises a hemolyzing agent for lysing red blood cells in a blood sample to be tested to release hemoglobin and the intermediate detection information comprises a detection value related to the hemoglobin concentration of the first pretreatment reagent; or the pretreatment reagent comprises a diluent for diluting the blood sample to be tested to detect the hematocrit and the intermediate detection information comprises a detection value related to the hematocrit of the first pretreatment reagent. The target test item is a glycosylated hemoglobin test item, and the second test device 130 is further configured to test glycosylated hemoglobin in the blood sample to be tested. At this time, the controller 140 is further configured to:

when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is within a preset range, selecting a first detection mode as a detection mode to be executed; and is also provided with

When the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is higher than the upper limit of the preset range, selecting a second detection mode as a detection mode to be executed, wherein the proportion of the blood sample to be tested or the second pretreatment liquid used for preparing the sample liquid to be tested in the first detection mode to the sample liquid to be tested is larger than the proportion of the blood sample to be tested or the second pretreatment liquid used for preparing the sample liquid to be tested in the second detection mode to the sample liquid to be tested; and/or selecting the third detection mode as the detection mode to be executed when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is lower than the lower limit of the preset range, wherein the ratio of the blood sample to be tested or the second pretreatment liquid used for preparing the sample liquid to be tested in the first detection mode to the sample liquid to be tested is smaller than the ratio of the blood sample to be tested or the second pretreatment liquid used for preparing the sample liquid to be tested in the third detection mode to the sample liquid to be tested.

Here, the ratio of the blood sample or the second pretreatment liquid to the sample liquid to be measured for preparing the sample liquid to be measured may be increased by increasing the amount of the blood sample or the second pretreatment liquid to be measured for preparing the sample liquid to be measured and/or by decreasing the volume of the sample liquid to be measured. Similarly, the ratio of the blood sample or the second pretreatment liquid to the sample liquid to be measured for preparing the sample liquid to be measured can be reduced by reducing the amount of the blood sample or the second pretreatment liquid to be measured for preparing the sample liquid to be measured and/or increasing the volume of the sample liquid to be measured.

FIG. 5 shows a specific glycosylated hemoglobin measurement flow. In step S210, the sample preparation device 110 mixes the blood sample to be tested with the hemolysis agent to obtain a first pretreatment solution. In step S220, the first detecting device 120 detects an optical signal during the reaction of the blood sample to be tested and the hemolysis agent, so as to obtain the estimated hemoglobin concentration of the first pretreatment solution based on the optical signal. In step S230, the controller 140 determines whether the estimated hemoglobin concentration is out of a preset range. When the estimated hemoglobin concentration is not out of the preset range, step S240 is performed: the sample preparation device 110 prepares a sample liquid to be tested based on the first detection mode. When the estimated hemoglobin concentration is higher than the upper limit in the preset range, step S250 is executed: the sample preparation device 110 prepares a sample liquid to be tested based on the second detection mode. When the estimated hemoglobin concentration is lower than the lower limit in the preset range, step S260 is executed: the sample preparation device 110 prepares a sample liquid to be tested based on the third detection mode. In step S270, the second detecting device 130 detects glycosylated hemoglobin in the sample liquid to be detected.

An example of the present application will be described with reference to enzymatic detection of glycosylated hemoglobin. First, the hemoglobin measurement range of the enzymatic method is determined to be 70g/L to 400g/L by a plurality of samples having gradient hemoglobin concentrations, wherein the upper limit of measurement is 400g/L and the lower limit is 70g/L. Specific ways of determining the hemoglobin measurement range are for example: adopting samples with an upper measurement limit and a lower measurement limit to configure equal-proportion gradient samples, and testing the result of each sample; carrying out linear regression on the results of all samples, and calculating whether the regression deviation of each concentration point is smaller than the total error of the glycosylated hemoglobin detection item; if the error is smaller than the total error, the upper and lower measurement limits can be used as the measurement range of the sample analyzer; if the error is larger than the total error, the upper and lower limit intervals of measurement are reduced, and the experiment is repeated until the error requirement is met. Because of the narrow distribution of the amount of glycosylated hemoglobin in the population (4% -14%), the hemoglobin measurement range can also be used to characterize the glycosylated hemoglobin measurement range. In a specific detection process, a whole blood sample to be detected is first subjected to cracking treatment with a hemolytic agent (i.e., a pretreatment reagent) according to a certain proportion, for example, a proportion of 1:23, so as to obtain a first pretreatment test solution, wherein the hemolytic agent contains nitrite and other components capable of oxidizing hemoglobin into methemoglobin. The first pretreatment test solution is used as a test solution for preparing a blood sample to be tested later. When the hemolytic agent is mixed with the whole blood sample to be tested, the hemoglobin is oxidized into methemoglobin, and the estimated hemoglobin concentration of the first pretreatment test solution can be obtained by measuring the absorbance of the first pretreatment test solution at the wavelength of 630 nm; or the estimated hemoglobin concentration can be obtained by measuring the difference A between the absorbance of the first pretreatment sample at the main wavelength of 630nm and the absorbance at the secondary wavelength of 660nm (for reducing noise, grease and other interference), wherein the absorbance difference A and the estimated hemoglobin concentration g/L are in a linear relation, specifically: hemoglobin concentration g/L=A_ ((630 nm-660 nm))/72.5 as shown in FIG. 6. And then comparing the estimated hemoglobin concentration with preset upper and lower limits of hemoglobin measurement, and determining the dosage of the first pretreatment test solution participating in the preparation of the subsequent sample solution to be tested. When the estimated hemoglobin concentration is between the preset upper limit and the preset lower limit of hemoglobin measurement, selecting a first detection mode and adopting 5 mu l of a first pretreatment test solution to prepare a sample solution to be detected; when the estimated hemoglobin concentration is greater than the preset upper limit of hemoglobin measurement, selecting a second detection mode and preparing a sample liquid to be detected by adopting 3 μl of the first pretreatment liquid; when the estimated hemoglobin concentration is less than the preset lower hemoglobin measurement limit, selecting a third detection mode and preparing a sample liquid to be detected by adopting 8 mu l of the first pretreatment liquid. Here, in the first detection mode, the second detection mode, and the third detection mode, the amounts of the detection reagents used to prepare the sample liquid to be measured are the same. After determining the amount of the first pretreatment liquid, the determined first pretreatment liquid is mixed with a first detection reagent containing a proteolytic enzyme which reacts with glycosylated hemoglobin in the liquid to produce glycosylated peptide or glycosylated amino acid, and the absorbance of the first sample liquid at 480nm wavelength is measured at the same time, and the hemoglobin concentration of the blood sample to be measured is obtained based on the absorbance and the calibration curve. Then, a second detection reagent containing a specific oxidase is added into the first sample liquid to be detected to obtain a second sample liquid to be detected, the specific oxidase reacts with the glycosylated peptide or the glycosylated amino acid to generate a detectable product (such as hydrogen peroxide), the hydrogen peroxide reacts with sodium 10- (carboxymethyl aminocarbonyl) -3, 7-bis (dimethylamino) phenothiazine (color-developer), and the concentration of glycosylated hemoglobin is obtained by measuring the absorbance. And finally, obtaining a glycosylated hemoglobin detection result based on the hemoglobin concentration and the glycosylated hemoglobin concentration.

Another example of the present application will be described by taking an example of detecting glycosylated hemoglobin based on an immunoturbidimetry. First, the immunoturbidimetry hemoglobin measurement range of 40g/L to 410g/L was also determined by a plurality of samples having gradient hemoglobin concentrations, with the upper measurement limit of 410g/L and the lower limit of 40g/L. Because of the narrow distribution of the amount of glycosylated hemoglobin in the population (4% -14%), the hemoglobin measurement range can also be used to characterize the glycosylated hemoglobin measurement range. In a specific detection process, a whole blood sample to be detected is first subjected to cracking treatment with a hemolytic agent (i.e., a pretreatment reagent) according to a certain proportion, for example, a proportion of 1:50, so as to obtain a first pretreatment test solution, wherein the hemolytic agent contains nitrite and other components capable of oxidizing hemoglobin into methemoglobin. The first pretreatment test solution is used as a test solution for preparing a blood sample to be tested later. When the hemolytic agent is mixed with the whole blood sample to be measured, the hemoglobin is oxidized into methemoglobin, and the estimated hemoglobin concentration of the first pretreatment sample can be obtained by measuring the absorbance of the first pretreatment sample at the wavelength of 540nm or 570 nm. And then comparing the estimated hemoglobin concentration with preset upper and lower limits of hemoglobin measurement, and determining the dosage of the first pretreatment test solution participating in the preparation of the subsequent sample solution to be tested. When the estimated hemoglobin concentration is between the preset upper limit and the preset lower limit of hemoglobin measurement, selecting a first detection mode and adopting 6 mu l of a first pretreatment test solution to prepare a sample solution to be detected; when the estimated hemoglobin concentration is greater than the preset upper hemoglobin measurement limit, selecting a second detection mode and preparing a sample liquid to be detected by adopting 4 mu l of the first pretreatment liquid. Here, in the first detection mode and the second detection mode, the amounts of the detection reagents used to prepare the sample liquid to be detected are the same. After determining the amount of the first pretreatment liquid, mixing the determined first pretreatment liquid with a first detection reagent containing glycosylated hemoglobin specific antibody to obtain a first sample liquid to be tested, and simultaneously performing optical measurement on the first sample liquid to obtain the hemoglobin concentration of the blood sample to be tested. Then, a second detection reagent containing a plurality of clusters of single antigens loaded with a plurality of glycosylated hemoglobin antigenic determinants is added into the first sample liquid to be detected to obtain a second sample liquid to be detected, the clusters of single antigens react with excessive antibodies in the first sample liquid to form insoluble complexes, and if the glycosylated hemoglobin concentration in the second sample liquid to be detected is increased, the formation of immune complexes is reduced and turbidity is reduced, so that the glycosylated hemoglobin concentration in the second sample liquid to be detected can be detected. And finally, obtaining a glycosylated hemoglobin detection result based on the hemoglobin concentration and the glycosylated hemoglobin concentration.

Another example of the present application will be described with reference to enzymatic detection of glycosylated hemoglobin. First, the hemoglobin measurement range of the enzymatic method is determined to be 70g/L to 400g/L by a plurality of samples having gradient hemoglobin concentrations, wherein the upper limit of measurement is 400g/L and the lower limit is 70g/L. In a specific detection process, a whole blood sample to be detected is first subjected to cracking treatment with a hemolytic agent (i.e., a pretreatment reagent) according to a certain proportion, for example, a proportion of 1:23, so as to obtain a first pretreatment test solution, wherein the hemolytic agent contains nitrite and other components capable of oxidizing hemoglobin into methemoglobin. The first pretreatment test solution is used as a test solution for preparing a blood sample to be tested later. When the hemolytic agent is mixed with the whole blood sample to be measured, the hemoglobin is oxidized into methemoglobin, and the estimated hemoglobin concentration of the first pretreatment liquid can be obtained by measuring the absorbance of the first pretreatment liquid at the wavelength of 630 nm. And then comparing the estimated hemoglobin concentration with preset upper and lower limits of hemoglobin measurement, and determining the dosage of the first pretreatment test solution participating in the preparation of the subsequent sample solution to be tested. When the predicted hemoglobin concentration is between the preset upper limit and the preset lower limit of hemoglobin measurement, selecting a first detection mode, and preparing a sample liquid to be detected by adopting 5 mu l of a first pretreatment test liquid, 90ul of a first detection reagent containing proteolytic enzyme and 30ul of a second detection reagent containing specific oxidase; when the predicted hemoglobin concentration is greater than the preset upper hemoglobin measurement limit, selecting a second detection mode and preparing a sample liquid to be detected by adopting 5 mu l of a first pretreatment test liquid, 120ul of a first detection reagent containing proteolytic enzyme and 40ul of a second detection reagent containing specific oxidase; when the estimated hemoglobin concentration is less than the preset lower hemoglobin measurement limit, a third detection mode is selected and a sample liquid to be detected is prepared by using 5 μl of the first pretreatment liquid, 60ul of the first detection reagent containing proteolytic enzyme and 20ul of the second detection reagent containing specific oxidase. The relative adjustment of the first pretreatment reagent is achieved by adjusting the amount of the detection reagent used.

In other examples, the ratio of the amount of the first pretreatment reagent to the amount of the detection reagent may also be adjusted based on the intermediate detection information.

In some embodiments, in the case of detecting glycosylated hemoglobin based on ion exchange chromatography, the amount of pretreatment solution entering the ion column chromatography may be adjusted based on intermediate detection information.

In other embodiments, in the case of detecting glycosylated hemoglobin based on affinity chromatography, the amount of pretreatment solution entering the affinity chromatography column may be adjusted based on intermediate detection information.

In some alternative or additional embodiments, the pretreatment reagent comprises a hemolyzing agent for lysing red blood cells in the blood sample to be tested to release hemoglobin and the intermediate detection information comprises a detection value related to the hemoglobin concentration of the first pretreatment reagent; or the pretreatment reagent comprises a diluent for diluting the blood sample to be tested to detect the hematocrit and the intermediate detection information comprises a detection value related to the hematocrit of the first pretreatment reagent. Wherein the target test item is a glycosylated hemoglobin test item, and the second test device 130 is further used for testing glycosylated hemoglobin in a blood sample to be tested. At this time, the controller 140 is further configured to:

When the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is greater than a first preset threshold value, selecting a fourth detection mode as a detection mode to be executed; and is also provided with

And when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is smaller than a first preset threshold value, selecting a fifth detection mode as a detection mode to be executed, wherein the sample liquid to be tested is prepared based on a glycosylated hemoglobin enzyme method in a fourth detection mode, and the sample liquid to be tested is prepared based on a glycosylated hemoglobin immunoturbidimetry in a fifth detection mode.

FIG. 7 shows a specific glycosylated hemoglobin measurement flow. In step S310, the sample preparation device 110 mixes the blood sample to be tested with the hemolysis agent to obtain a first pretreatment solution. In step S320, the first detecting device 120 detects an optical signal during the reaction of the blood sample to be tested and the hemolysis agent, so as to obtain the estimated hemoglobin concentration of the first pretreatment solution based on the optical signal. In step S330, the controller 140 determines whether the estimated hemoglobin concentration is higher than a first preset threshold. When the estimated hemoglobin concentration is higher than the first preset threshold, step S340 is performed: the sample preparation device 110 prepares a sample liquid to be measured based on the fourth detection mode. When the estimated hemoglobin concentration is lower than the first preset threshold, step S350 is executed: the sample preparation device 110 prepares a sample liquid to be measured based on the fifth detection mode. In step S360, the second detecting device 130 detects glycosylated hemoglobin in the sample liquid to be detected.

In a specific example, first, an enzymatic hemoglobin measurement range of 90g/L to 400g/L is determined by a plurality of samples having gradient hemoglobin concentrations, wherein the upper measurement limit is 400g/L and the lower measurement limit is 90g/L. In addition, the measurement range of the immune turbidimetric hemoglobin is also determined to be 40g/L to 400g/L by a plurality of samples with gradient hemoglobin concentration, wherein the upper limit of measurement is 400g/L and the lower limit is 40g/L. In a specific detection process, a whole blood sample to be detected and a hemolytic agent (i.e. a pretreatment reagent) are subjected to cracking treatment according to a certain proportion to obtain a first pretreatment test solution, wherein the hemolytic agent contains nitrite and other components capable of oxidizing hemoglobin into methemoglobin. When the hemolytic agent is mixed with the whole blood sample to be measured, the hemoglobin is oxidized into methemoglobin, and the estimated hemoglobin concentration of the first pretreatment sample can be obtained by measuring the absorbance of the first pretreatment sample at the wavelength of 540nm or 570 nm. And then comparing the estimated hemoglobin concentration with the upper limit and the lower limit of the hemoglobin measurement of the enzymatic method, and determining the type of the detection reagent involved in the preparation of the subsequent sample liquid to be detected. When the estimated hemoglobin concentration is between the upper limit and the lower limit of the hemoglobin measurement of the enzyme method, selecting a detection reagent based on the enzyme method to prepare a sample liquid to be detected; when the estimated hemoglobin concentration is lower than the lower limit of hemoglobin measurement by an enzyme method, a detection reagent based on an immunoturbidimetry is selected to prepare a sample liquid to be detected.

Although the measurement lower limit of the glycosylated hemoglobin enzyme method is higher than the measurement lower limit of the glycosylated hemoglobin immunoturbidimetry, the single test cost of the glycosylated hemoglobin enzyme method is lower than the single test cost of the glycosylated hemoglobin immunoturbidimetry. By selecting the corresponding detection reagent by means of the detection value of the first pretreatment liquid in relation to the hemoglobin concentration and/or the hematocrit, a wider effective measurement range can be provided without increasing the costs as much as possible.

In some alternative or additional embodiments, the pretreatment reagent includes a hemolyzing agent for lysing red blood cells in the blood sample to be tested to release hemoglobin, and the intermediate detection information includes a detection value related to an interfering substance in the first pretreatment reagent that interferes with detection of the target item. The target measurement item is a glycosylated hemoglobin measurement item, and the second measurement device 140 is further configured to measure glycosylated hemoglobin in a blood sample to be measured. Here, the controller 140 is further configured to:

when the detection value related to the interfering object of the first pretreatment liquid exceeds a second preset threshold value, selecting a sixth detection mode as a detection mode to be executed, controlling a sample preparation device 110 to re-absorb the blood sample of the subject according to the sixth detection mode when preparing the sample liquid to be tested, preparing a new pretreatment liquid according to the re-absorbed blood sample and a new pretreatment reagent, and preparing the sample liquid to be tested by adopting the new pretreatment liquid and the detection reagent, wherein the new pretreatment reagent contains an anti-interference reagent for eliminating the interfering object; and is also provided with

When the detection value related to the interfering object of the first pretreatment liquid does not exceed the preset threshold value, a seventh detection mode is selected as a detection mode to be executed, and the sample preparation device 110 is controlled to prepare the sample liquid to be tested according to the seventh detection mode by adopting the first pretreatment liquid detected by the first detection device as the second pretreatment liquid and the detection reagent.

That is, when it is judged that an interfering substance, such as lipid interference, interfering with the detection of glycosylated hemoglobin exists in the blood sample to be measured based on the detection value related to the interfering substance of the first pretreatment liquid, an anti-interference agent for eliminating the interfering substance is added at the time of the subsequent preparation of the sample liquid to be measured, ensuring that an accurate glycosylated hemoglobin detection result can be obtained.

The detection value associated with the interfering substance of the first pretreatment liquid includes, in particular, a lipid blood concentration or a bilirubin concentration.

In some embodiments, the controller 140 is further configured to: when the intermediate detection information of the first pretreatment test solution meets the preset condition, for example, is lower than the lower limit of the effective detection range, the detection flow of the current blood sample to be detected is terminated, and an alarm prompt is output.

Fig. 8 shows a schematic block diagram of a sample analyzer 400 according to a second embodiment of the application. Sample analyzer 400 includes a sample preparation device 410, a first detection device 420, a second detection device 430, and a controller 440. The sample preparation device 410 is configured to prepare a sample liquid to be tested corresponding to each of at least two different detection modes according to a blood sample to be tested, where the sample liquid to be tested is prepared from a pretreatment sample liquid and a detection reagent, and the pretreatment sample liquid is prepared from the blood sample to be tested and the pretreatment reagent. The first detection device 420 is configured to detect at least one pretreatment solution, so as to obtain intermediate detection information of the at least one pretreatment solution. The second detecting device 430 is configured to detect the sample liquids to be detected corresponding to the respective detection modes, so as to obtain multiple detection results of the same target detection item. The controller 440 is configured to select and output at least one detection result from the plurality of detection results according to the intermediate detection information of the at least one pretreatment reagent.

In this second embodiment, by simultaneously detecting a plurality of sample liquids to be measured prepared according to a plurality of detection modes, thereby obtaining a plurality of detection results for the same detection item, for example, a glycosylated hemoglobin detection item, a detection result to be output is selected according to intermediate detection information, and retesting can be reduced or even avoided.

In some embodiments, the pretreatment reagent comprises a hemolyzing agent for lysing erythrocytes in a blood sample to be tested to release hemoglobin, and the intermediate detection information comprises a detection value related to the hemoglobin concentration of the pretreatment solution; or the pretreatment reagent comprises a diluent for diluting a blood sample to be tested to detect the hematocrit, and the intermediate detection information comprises a detection value related to the hematocrit of the pretreatment test solution; and the target test item is a glycosylated hemoglobin test item, the second test device 140 is further configured to test glycosylated hemoglobin in the blood sample to be tested.

In some embodiments, the different detection modes include at least two detection modes, the effective detection ranges of which are at least partially misaligned.

Further, the different detection modes are different in at least one of:

the type or the amount of the detection reagent used for preparing the sample liquid to be detected; and

In some embodiments, the sample analyzer 400 may be configured as a biochemical instrument as shown in fig. 2.

Further features and advantages of the sample analyzer 400 according to the second embodiment of the present application may be referred to the various embodiments of the sample analyzer 100 according to the first embodiment of the present application described above and advantages thereof.

Fig. 9 shows a schematic block diagram of a sample analyzer 500 according to a third embodiment of the application. The sample analyzer 500 includes a sample preparation device 510, an information acquisition device 520, a second detection device 530, and a controller 540. The sample preparation device 510 is used for preparing a sample liquid to be tested for glycosylated hemoglobin detection from a blood sample to be tested of a subject. The information acquisition device 520 is used for acquiring red blood cell related information of the subject. The second detecting device 530 is configured to detect the sample fluid to be detected to obtain a glycosylated hemoglobin detection result. The controller 540 is configured to:

controlling a sample preparation device 510 to prepare a sample liquid to be detected according to the selected detection mode to be executed, wherein the sample liquid to be detected is prepared according to a blood sample to be detected of the subject, a pretreatment reagent and a detection reagent for glycosylated hemoglobin detection; and is also provided with

The second detection device 530 is controlled to detect the sample liquid to be detected.

Therefore, a more accurate glycosylated hemoglobin detection result can be obtained through one-time detection, the re-measurement of the glycosylated hemoglobin project is reduced and even avoided, and the detection efficiency of the glycosylated hemoglobin project is further improved.

In some embodiments, the subject's red blood cell related information comprises the subject's hematocrit related information. As described above, the glycosylated hemoglobin concentration in a blood sample is linearly related to the hemoglobin concentration, which in turn is linearly related to the Hematocrit (HCT) of the blood sample. Therefore, when the first test of the glycosylated hemoglobin item is performed on the blood sample to be tested of the subject, the test mode to be performed may be selected from a plurality of different glycosylated hemoglobin test modes depending on the HCT value in the blood sample of the subject.

In one example, the sample preparation device 510 is used for performing centrifugation or natural standing sedimentation on a blood sample to be tested; the information acquisition device 520 is configured as a camera and is used for photographing the blood sample to be measured after centrifugation or after natural standing sedimentation to obtain an image of the blood sample to be measured, based on which the hematocrit of the blood sample to be measured can be obtained, and further the detection mode to be performed is selected from a plurality of different glycosylated hemoglobin detection modes according to the hematocrit. Preferably, natural standing sedimentation takes at least half an hour to obtain a good photographing effect. For example, when the concentration of the glycosylated hemoglobin of the blood sample to be measured is determined to be low according to the hematocrit of the blood sample to be measured, a detection mode for increasing the sample volume is started to increase the concentration of the glycosylated hemoglobin in the reaction system, reduce the influence of the non-specific background reaction on the detection of the concentration of the glycosylated hemoglobin, further solve the problem of inaccurate result when the glycosylated hemoglobin is detected at low concentration, and achieve the effect of obtaining an accurate detection result of the glycosylated hemoglobin in one detection.

In another example, the sample preparation device 510 is used to aspirate a blood sample from a container 10 containing a blood sample to be tested of a subject, such as a whole blood sample, and to prepare a sample fluid to be tested using the aspirated blood sample, a pretreatment reagent, and a detection reagent for glycosylated hemoglobin detection. Here, the sample preparation device 510 is configured to draw a blood sample at a sample drawing pressure that is related to HCT, which is a ratio of red blood cells to whole blood, and to draw a blood sample at a concentration (HCT) that is known to be positively related to a concentration of hemoglobin to whole blood, so that a relationship between the sample drawing pressure and the hemoglobin content can be established. Based on the relation, the hemoglobin content of the blood sample to be measured can be judged according to the sample suction pressure, so that the subsequent measurement of glycosylated hemoglobin is guided. For example, the sample preparation device 510 includes a sample suction needle for sucking a blood sample and a sensor for detecting the pressure inside the sample suction needle, i.e., the suction pressure, at the time of sucking the blood sample. Based on the suction pressure measured by the sensor, the amount of at least one of the blood sample to be measured, the pretreatment reagent, and the detection reagent used for preparing the sample liquid to be measured, or the ratio of at least one of the blood sample to be measured, the pretreatment reagent, and the detection reagent in the sample liquid to be measured may be determined, or the composition, the formulation, or the amount of the pretreatment reagent used for preparing the sample liquid to be measured may be determined, or the type or the amount of the detection reagent used for preparing the sample liquid to be measured may be determined.

In some embodiments, the controller 540 may be further configured to: when the primary detection of glycosylated hemoglobin items is carried out on a blood sample to be detected of a subject, and before a detection mode to be executed is selected, preparing a pretreatment test solution by adopting the blood sample to be detected and a pretreatment reagent; and the control information acquisition means 520 detects the pretreatment liquid to obtain intermediate detection information of the pretreatment liquid as red blood cell-related information of the subject. Here, the information acquisition device 520 is configured as the first detection device 120 described above, for example.

In some alternative embodiments, the information acquisition device 520 may be further configured to:

receiving user input to obtain red blood cell related information of the subject; or alternatively

Receiving red blood cell related information of the subject from a further detection instrument in communication with the sample analyzer (e.g., receiving a red blood cell pressure product from a blood cell analyzer in communication with the sample analyzer); or alternatively

Obtaining red blood cell related information of the subject according to the disease information of the subject.

In some embodiments, the controller 540 may be further configured to: selecting a detection mode to be executed from the plurality of different glycosylated hemoglobin detection modes according to intermediate detection information of the pretreatment liquid; and controlling the sample preparation device to prepare the sample liquid to be tested by using the pretreatment test liquid and a detection reagent for glycosylated hemoglobin detection according to the selected detection mode to be executed.

Other features and advantages of the sample analyzer 500 according to the third embodiment of the present application may be referred to the various embodiments of the sample analyzer 100 and the sample analyzer 400 described above and advantages thereof.

Fig. 10 shows a schematic block diagram of a sample analyzer 600 according to a fourth embodiment of the application. The sample analyzer 600 includes a sample preparation device 610, an information acquisition device 620, a second detection device 630, and a controller 640. The sample preparation device 610 is configured to prepare a sample liquid to be tested corresponding to each of at least two different glycosylated hemoglobin detection modes according to a blood sample to be tested of a subject. The information acquisition device 620 is used for acquiring red blood cell related information of the subject. The second detecting device 630 is configured to detect the sample liquids to be detected corresponding to the respective glycosylated hemoglobin detection modes, respectively, so as to obtain a plurality of glycosylated hemoglobin detection results. The controller 640 is configured to select and output at least one glycosylated hemoglobin detection result from the plurality of glycosylated hemoglobin detection results according to red blood cell related information of the subject.

In some embodiments, the information obtaining device 620 may be further configured to detect a pretreatment solution during the preparation of the sample solution to be tested by the sample preparation device 610, where the pretreatment solution is prepared by a blood sample to be tested and a pretreatment reagent, so as to obtain a detection value related to a hemoglobin concentration and/or a hematocrit of the pretreatment solution as the red blood cell related information of the subject.

In some alternative embodiments, the information acquisition device 630 may be further configured to:

receiving user input to obtain erythrocyte-related information of the subject, or

Receiving information about erythrocytes of the subject from a further testing instrument in communication with the glycosylated hemoglobin analyzer, or

Other features and advantages of the sample analyzer 600 according to the fourth embodiment of the present application may be referred to the respective examples of the sample analyzer 100, the sample analyzer 400 and the sample analyzer 500 described above and advantages thereof.

Fig. 11 shows a schematic flow chart of a sample detection method 700 according to a fifth embodiment of the application. The sample detection method 700 comprises the following method steps:

s710, sucking a blood sample from a container containing a blood sample to be tested of a subject, and preprocessing the sucked blood sample to obtain a first preprocessing sample;

s720, detecting the first pretreatment liquid to obtain intermediate detection information of the first pretreatment liquid;

s730, selecting a detection mode to be executed from a plurality of different detection modes aiming at the same target detection item according to the intermediate detection information of the first pretreatment liquid;

S740, preparing a sample liquid to be detected by adopting a second pretreatment test liquid and a detection reagent according to the selected detection mode to be executed, wherein the second pretreatment test liquid is prepared by a blood sample to be detected of the subject and the pretreatment reagent; and is also provided with

S750, detecting the sample liquid to be detected to obtain a detection result of the blood sample to be detected aiming at the target detection item.

In some embodiments, in step S710, the suctioned blood sample is subjected to pretreatment to obtain a first pretreatment solution, which may include: the aspirated blood sample is mixed with a pretreatment reagent to obtain a first pretreatment test solution. Wherein preferably the pretreatment reagent comprises a hemolyzing agent for lysing erythrocytes in a blood sample to be tested to release hemoglobin, and the intermediate detection information comprises a detection value related to the hemoglobin concentration of the first pretreatment solution; or the pretreatment reagent comprises a diluent for diluting the blood sample to be tested to detect the hematocrit, and the intermediate detection information comprises a detection value related to the hematocrit of the first pretreatment reagent.

In some alternative embodiments, in step S710, the suctioned blood sample is subjected to pretreatment to obtain a first pretreatment test solution, which may include: and carrying out centrifugal treatment or natural standing sedimentation on the sucked blood sample to obtain a first pretreatment test solution. Preferably, the intermediate detection information includes a detection value related to the hemoglobin concentration of the first pretreatment liquid or a detection value related to the hematocrit of the first pretreatment liquid, and the target detection item is a glycosylated hemoglobin detection item.

In some embodiments, the step S740 of preparing the sample liquid to be tested may include: and preparing the sample liquid to be tested by adopting a first pretreatment liquid as a second pretreatment liquid and a detection reagent, namely, the second pretreatment liquid is the first pretreatment liquid.

Alternatively, the step S740 of preparing the sample liquid to be tested may include: re-sucking the blood sample of the subject, re-preparing a second pretreatment liquid according to the re-sucked blood sample, and preparing the sample liquid to be tested according to the re-prepared second pretreatment liquid and the detection reagent.

In some embodiments, the plurality of different detection modes may include at least two detection modes, the effective detection ranges of which are at least partially misaligned.

Further, the plurality of different detection modes may be different in at least one of:

Further features and advantages of the sample detection method 700 according to the fifth embodiment of the present application may be found in the various examples of the sample analyzer 100 according to the first embodiment of the present application described above and in the advantages thereof.

Fig. 12 shows a schematic flow chart of a sample detection method 800 according to a sixth embodiment of the application. The sample detection method 800 includes the following method steps:

s810, preparing at least two sample liquids to be detected corresponding to respective detection modes in different detection modes according to a blood sample to be detected, wherein the sample liquids to be detected are prepared from pretreatment test liquids and detection reagents, and the pretreatment test liquids are prepared from the blood sample to be detected and the pretreatment reagents;

s820, detecting at least one pretreatment test solution to obtain intermediate detection information of the pretreatment test solution;

s830, detecting the sample liquid to be detected corresponding to the detection modes to obtain multiple detection results of the same target detection item; and

S840, selecting and outputting at least one detection result from the plurality of detection results according to the intermediate detection information of the pretreatment liquid.

In some embodiments, the different detection modes may include at least two detection modes, the effective detection ranges of which are at least partially misaligned.

Further, the different detection modes are different in at least one of:

Further features and advantages of the sample detection method 800 according to the sixth embodiment of the present application may be found in the various embodiments of the sample analyzer or sample detection method described above and their advantages.

Fig. 13 shows a schematic flow chart of a glycosylated hemoglobin detection method 900 according to a seventh embodiment of the present application. The glycosylated hemoglobin detection method 900 includes the following method steps:

s910, when the first detection of the glycosylated hemoglobin item is carried out on the blood sample to be detected of the subject, selecting a detection mode to be executed from a plurality of different glycosylated hemoglobin detection modes according to the red blood cell related information of the subject;

s920, preparing a sample liquid to be detected according to the selected detection mode to be executed; and is also provided with

S930, performing glycosylated hemoglobin detection on the sample liquid to be detected.

In some embodiments, the method may further comprise:

preparing a pretreatment test solution by using a blood sample to be tested and a pretreatment reagent when performing primary detection of a glycosylated hemoglobin item on the blood sample to be tested of a subject and before selecting a detection mode to be executed; and detecting the pretreatment test solution to obtain erythrocyte-related information of the subject.

Alternatively, the method may further include:

Further features and advantages of the sample detection method 900 according to the seventh embodiment of the present application may be found in the various embodiments of the sample analyzer or sample detection method described above and their advantages.

Fig. 14 shows a schematic flow chart of a glycosylated hemoglobin detection method 1000 according to an eighth embodiment of the present application. The glycosylated hemoglobin detection method 1000 includes:

s1100, preparing to-be-detected sample liquid corresponding to each glycosylated hemoglobin detection mode in at least two different glycosylated hemoglobin detection modes according to a to-be-detected blood sample of a subject;

s1200, respectively detecting the sample liquid to be detected corresponding to each glycosylated hemoglobin detection mode to obtain a plurality of glycosylated hemoglobin detection results; and

s1300, selecting and outputting at least one glycosylated hemoglobin detection result from the plurality of glycosylated hemoglobin detection results according to the erythrocyte-related information of the subject.

In some embodiments, the method may further comprise: and detecting the pretreatment test solution in the process of preparing the sample solution to be detected so as to obtain the red blood cell related information of the subject.

Alternatively, the method further comprises: receiving user input to obtain red blood cell related information of the subject, or obtaining red blood cell related information of the subject from disease information of the subject.

Further features and advantages of the sample detection method 1000 according to the eighth embodiment of the present application may be found in the various embodiments of the sample analyzer or sample detection method described above and their advantages.

The features or combinations of features mentioned above in the description, in the drawings and in the claims may be used in any combination with one another or individually, as long as they are significant and do not contradict one another within the scope of the application. The advantages and features described with reference to the sample analyzer provided by the embodiments of the present application are applicable in a corresponding manner to the detection method provided by the embodiments of the present application, and vice versa.

The foregoing description is only of the preferred embodiments of the present application, and is not intended to limit the scope of the application, but the equivalent transformation schemes made by the description and the drawings of the present application or the direct/indirect application in other related technical fields are included in the scope of the application.

Claims

1. A sample analyzer, comprising:

sample preparation means for drawing a blood sample from a container containing a blood sample to be tested of a subject, and preparing a pretreatment solution using the drawn blood sample and a first pretreatment reagent;

2. The sample analyzer of claim 1, wherein the pretreatment reagent includes a hemolyzing agent for lysing erythrocytes in the blood sample to be tested to release hemoglobin, and the intermediate detection information includes a detection value related to a hemoglobin concentration of the first pretreatment reagent.

3. The sample analyzer of claim 1, wherein the pretreatment reagent comprises a diluent for diluting a blood sample to be tested for detection of hematocrit, and the intermediate detection information comprises a detection value related to the hematocrit of the first pretreatment test solution.

4. The sample analyzer according to claim 2 or 3, wherein the target test item is a glycosylated hemoglobin test item, and the second test device is further configured to test glycosylated hemoglobin in the blood sample to be tested.

5. The sample analyzer of claim 4, wherein the controller is further configured to:

controlling the sample preparation device to prepare a first sample liquid to be tested by adopting a second pretreatment test liquid and a first detection reagent aiming at the glycosylated hemoglobin detection program according to the selected detection mode to be executed, wherein the first detection reagent comprises an enzyme reagent or an immunological reagent for detecting the content of hemoglobin;

controlling the second detection device to detect the first sample liquid to be detected so as to obtain the content of hemoglobin in the blood sample to be detected;

controlling the sample preparation device to add a second detection reagent for the glycosylated hemoglobin detection item to the first sample liquid to be detected to prepare a second sample liquid to be detected, wherein the second detection reagent comprises an enzyme reagent or an immunological reagent for detecting glycosylated hemoglobin;

Controlling the second detection device to detect the second sample liquid to be detected so as to obtain the glycosylated hemoglobin content in the blood sample to be detected; and is also provided with

6. The sample analyzer according to any one of claims 1 to 5, wherein the first detection device is further configured to irradiate the first pretreatment liquid with light of at least one wavelength, and acquire an optical signal generated by the first pretreatment liquid after being irradiated with the light, so as to obtain the intermediate detection information based on the optical signal; or alternatively

The first detection device is further used for allowing the first pretreatment test solution to pass through so as to obtain a pulse measurement signal, and the intermediate detection information is obtained based on the pulse measurement signal.

7. The sample analyzer of any one of claims 1-6, wherein the first detection device and the second detection device are the same detection device.

8. The sample analyzer of any one of claims 1-7, wherein the second pretreatment reagent is the first pretreatment reagent.

9. The sample analyzer according to any one of claims 1 to 7, wherein the controller is further configured to control the sample preparation device to re-aspirate the blood sample of the subject, re-prepare a second pre-treatment reagent from the re-aspirated blood sample, and prepare the sample to be tested from the re-prepared second pre-treatment reagent and detection reagent when controlling the sample preparation device to prepare the sample to be tested from the second pre-treatment reagent and detection reagent according to the selected detection mode to be performed.

10. The sample analyzer according to any one of claims 1 to 7, wherein the sample preparation device is further configured to prepare a plurality of pretreatment reagents using the blood sample to be tested and a pretreatment reagent, wherein at least one of the components, the formulation, and the amounts of the pretreatment reagents used to prepare the plurality of pretreatment reagents are different from each other, and/or the amounts of the blood sample to be tested used to prepare the plurality of pretreatment reagents are different from each other;

the first detection device is further used for detecting at least one first pretreatment test solution in the plurality of pretreatment test solutions so as to obtain intermediate detection information of the first pretreatment test solution; and is also provided with

The controller is further configured to control the sample preparation device to select one pretreatment liquid from the plurality of pretreatment liquids as the second pretreatment liquid according to the selected detection mode to be performed and to prepare the sample liquid to be tested by using the selected pretreatment liquid and detection reagent when controlling the sample preparation device to prepare the sample liquid to be tested by using the second pretreatment liquid and the detection reagent according to the selected detection mode to be performed.

11. The sample analyzer of any one of claims 1 to 10, wherein the plurality of different detection modes includes at least two detection modes, the effective detection ranges of the at least two detection modes being at least partially misaligned.

12. The sample analyzer of any one of claims 1 to 11, wherein the plurality of different detection modes are different in at least one of:

The components, the formula or the dosage of the pretreatment reagent for preparing the sample liquid to be tested;

13. The sample analyzer of any one of claims 1 to 12, wherein the pretreatment reagent includes a hemolyzing agent for lysing erythrocytes in a blood sample to be tested to release hemoglobin and the intermediate detection information includes a detection value related to a hemoglobin concentration of the first pretreatment reagent; or the pretreatment reagent comprises a diluent for diluting a blood sample to be tested to detect hematocrit and the intermediate detection information comprises a detection value related to the hematocrit of the first pretreatment test solution;

the target detection item is a glycosylated hemoglobin detection item, and the second detection apparatus is further configured to detect glycosylated hemoglobin in the blood sample to be detected; and

the controller may be further configured to,

when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is within a preset range, selecting a first detection mode as a detection mode to be performed, and

When the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is higher than the upper limit of the preset range, selecting a second detection mode as the detection mode to be performed, wherein the ratio of the blood sample to be tested or the second pretreatment liquid to the sample liquid to be tested used for preparing the sample liquid to be tested in the first detection mode is larger than the ratio of the blood sample to be tested or the second pretreatment liquid to the sample liquid to be tested in the second detection mode, and/or,

and when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is lower than the lower limit of the preset range, selecting a third detection mode as a detection mode to be executed, wherein the proportion of the blood sample to be tested or the second pretreatment liquid used for preparing the sample liquid to be tested in the first detection mode to the sample liquid to be tested is smaller than the proportion of the blood sample to be tested or the second pretreatment liquid used for preparing the sample liquid to be tested in the third detection mode to the sample liquid to be tested.

14. The sample analyzer of any one of claims 1 to 13, wherein the pretreatment reagent includes a hemolyzing agent for lysing erythrocytes in a blood sample to be tested to release hemoglobin and the intermediate detection information includes a detection value related to a hemoglobin concentration of the first pretreatment reagent; or the pretreatment reagent comprises a diluent for diluting a blood sample to be tested to detect hematocrit and the intermediate detection information comprises a detection value related to the hematocrit of the first pretreatment test solution;

The target detection item is a glycosylated hemoglobin detection item, and the second detection apparatus is further configured to detect glycosylated hemoglobin in a blood sample to be detected; and

the controller may be further configured to,

when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is greater than a first preset threshold value, selecting a fourth detection mode as a detection mode to be performed, and

and when the detection value related to the hemoglobin concentration and/or the hematocrit of the pretreatment liquid is smaller than a first preset threshold value, selecting a fifth detection mode as a detection mode to be executed, wherein the sample liquid to be detected is prepared based on a glycosylated hemoglobin enzyme method in a fourth detection mode, and the sample liquid to be detected is prepared based on a glycosylated hemoglobin immunoturbidimetry in a fifth detection mode.

15. The sample analyzer of any one of claims 1 to 14, wherein the pretreatment reagent includes a hemolyzing agent for lysing erythrocytes in a blood sample to be tested to release hemoglobin, and the intermediate detection information includes a detection value related to an interfering substance in the first pretreatment liquid that interferes with detection of a target item;

the controller may be further configured to,

when the detection value related to the interference of the first pretreatment test solution exceeds a second preset threshold value, selecting a sixth detection mode as a detection mode to be executed, controlling the sample preparation device to re-absorb the blood sample of the subject according to the sixth detection mode when preparing the sample solution to be tested, preparing a new pretreatment test solution according to the re-absorbed blood sample and a new pretreatment reagent, and preparing the sample solution to be tested by adopting the new pretreatment test solution and the detection reagent, wherein the new pretreatment reagent contains an anti-interference reagent for eliminating the interference; and is also provided with

When the detection value related to the interfering object of the first pretreatment liquid does not exceed a second preset threshold value, a seventh detection mode is selected as a detection mode to be executed, and the sample preparation device is controlled to prepare the sample liquid to be tested according to the seventh detection mode by adopting the first pretreatment liquid detected by the first detection device as the second pretreatment liquid and the detection reagent.

16. A sample analyzer, comprising:

the first detection device is used for detecting at least one pretreatment test solution so as to obtain intermediate detection information of the at least one pretreatment test solution;

and a controller configured to select and output at least one detection result from the plurality of detection results according to the intermediate detection information of the at least one pretreatment reagent.

17. The sample analyzer of claim 16, wherein the pretreatment reagent includes a hemolyzing agent for lysing erythrocytes in the blood sample to be tested to release hemoglobin, and the intermediate detection information includes a detection value related to a hemoglobin concentration of the pretreatment solution; or the pretreatment reagent comprises a diluent for diluting a blood sample to be tested to detect the hematocrit, and the intermediate detection information comprises a detection value related to the hematocrit of the pretreatment test solution; and is also provided with

The target detection item is a glycosylated hemoglobin detection item, and the second detection apparatus is further configured to detect glycosylated hemoglobin in the blood sample to be detected.

18. The sample analyzer of claim 16 or 17, wherein the different detection modes comprise at least two detection modes, the effective detection ranges of which are at least partially misaligned.

19. The sample analyzer of any one of claims 16 to 18, wherein the at least two different detection modes are different in at least one of:

the type or the amount of the detection reagent used for preparing the sample liquid to be detected; the method comprises the steps of carrying out a first treatment on the surface of the And

20. A sample analyzer, comprising:

a controller configured to control the operation of the device,

21. The sample analyzer of claim 20, wherein the controller is further configured to,

when the primary detection of glycosylated hemoglobin items is carried out on a blood sample to be detected of a subject, and before a detection mode to be executed is selected, preparing a pretreatment test solution by adopting the blood sample to be detected and a pretreatment reagent; and is also provided with

And controlling the information acquisition device to detect the pretreatment test liquid so as to acquire the red blood cell related information of the subject.

22. The sample analyzer of claim 20, wherein the information acquisition device is further configured to:

Receiving red blood cell related information of the subject from a further detection instrument communicatively coupled to the sample analyzer; or alternatively

23. The sample analyzer of claim 21, wherein the controller is further configured to,

selecting a detection mode to be performed from the plurality of different glycosylated hemoglobin detection modes according to red blood cell related information of the subject; and is also provided with

And controlling the sample preparation device to prepare the sample liquid to be detected by adopting the pretreatment test liquid and a detection reagent for detecting glycosylated hemoglobin according to the selected detection mode to be executed.

24. A sample analyzer, comprising:

25. The sample analyzer according to claim 24, wherein the information acquisition means is further for detecting a pretreatment liquid prepared from a blood sample to be measured and a pretreatment reagent in the process of preparing the sample liquid to be measured by the sample preparation means, to obtain a detection value related to a hemoglobin concentration and/or a hematocrit of the pretreatment liquid as the subject's erythrocyte-related information; or alternatively

The information acquisition device is further configured to:

Receiving erythrocyte-related information of the subject from another detection instrument communicatively connected to the sample analyzer, or

26. A sample detection method, comprising:

27. The method of claim 26, wherein pre-treating the aspirated blood sample to obtain a first pre-treated test solution, comprising: mixing the sucked blood sample with a pretreatment reagent to obtain a first pretreatment test solution;

Wherein the pretreatment reagent comprises a hemolyzing agent for lysing erythrocytes in a blood sample to be tested to release hemoglobin, and the intermediate detection information comprises a detection value related to the hemoglobin concentration of the first pretreatment solution; or the pretreatment reagent comprises a diluent for diluting a blood sample to be tested to detect the hematocrit, and the intermediate detection information comprises a detection value related to the hematocrit of the first pretreatment test solution.

28. The method of claim 26, wherein pre-treating the aspirated blood sample to obtain a first pre-treated test solution, comprising: centrifuging the sucked blood sample to obtain a first pretreatment test solution;

wherein the intermediate detection information includes a detection value related to the hematocrit of the first pretreatment liquid, and the target detection item is a glycosylated hemoglobin detection item.

29. The sample detection method of claim 27, wherein the second pretreatment reagent is the first pretreatment reagent; or alternatively

The preparation method of the sample liquid to be tested comprises the following steps: re-sucking the blood sample of the subject, re-preparing a second pretreatment liquid according to the re-sucked blood sample, and preparing the sample liquid to be tested according to the re-prepared second pretreatment liquid and the detection reagent.

30. The sample detection method of any one of claims 26 to 29, wherein the plurality of different detection modes comprises at least two detection modes, the effective detection ranges of the at least two detection modes being at least partially misaligned;

preferably the plurality of different detection modes are different in at least one of the following:

the type or the amount of the detection reagent used for preparing the sample liquid to be detected;

and

31. A sample detection method, comprising:

preparing at least two sample liquids to be detected corresponding to respective detection modes under different detection modes according to a blood sample to be detected, wherein the sample liquid to be detected is prepared from a pretreatment test liquid and a detection reagent, and the pretreatment test liquid is prepared from the blood sample to be detected and the pretreatment reagent;

32. The method of claim 31, wherein the different detection modes include at least two detection modes, the effective detection ranges of the at least two detection modes being at least partially misaligned;

preferably the different detection modes are different in at least one of the following:

33. A glycosylated hemoglobin detection method comprising:

And detecting glycosylated hemoglobin of the sample liquid to be detected.

34. The method of glycosylated hemoglobin detection according to claim 33, further comprising:

preparing a pretreatment test solution by using a blood sample to be tested and a pretreatment reagent when performing primary detection of a glycosylated hemoglobin item on the blood sample to be tested of a subject and before selecting a detection mode to be executed; detecting the pretreatment test solution to obtain erythrocyte related information of the subject; or alternatively

The method further comprises the steps of:

35. A glycosylated hemoglobin detection method comprising:

36. The method of glycosylated hemoglobin detection according to claim 35, further comprising:

detecting a pretreatment test solution in the process of preparing the sample solution to be detected so as to obtain red blood cell related information of the subject; or alternatively

The method further comprises the steps of: