CN116930105A

CN116930105A - Sample analyzer and sample analysis method

Info

Publication number: CN116930105A
Application number: CN202210325030.4A
Authority: CN
Inventors: 杜少卿; 廖伟聪; 江明
Original assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd
Current assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd
Priority date: 2022-03-30
Filing date: 2022-03-30
Publication date: 2023-10-24

Abstract

The present application relates to a sample analyzer and a sample analysis method. The sample analyzer includes: a sample preparation device configured to prepare a pretreatment liquid sample using a blood sample and a pretreatment reagent, prepare an interfering substance detection liquid sample using the pretreatment liquid sample and a first detection reagent, and prepare a sample liquid sample to be measured using the pretreatment liquid sample or the interfering substance detection liquid sample and a second detection reagent; the first detection device is configured to detect an interferent detection test solution so as to obtain interferent information; the second detection device is configured to detect a sample liquid to be detected so as to obtain a hemoglobin detection result and/or a glycosylated hemoglobin detection result of the blood sample; and a controller configured to output a prompt message when the interferent information indicates that an interferent interfering with the hemoglobin detection and/or the glycosylated hemoglobin detection is present in the blood sample. The embodiment of the application can detect the interference object and give the corresponding interference object prompt information when detecting the hemoglobin and/or the glycosylated hemoglobin.

Description

Sample analyzer and sample analysis method

Technical Field

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

Background

Hemoglobin is a special protein for transporting oxygen in erythrocytes and is widely used in clinical tests.

Glycosylated hemoglobin is the product of the binding of hemoglobin in erythrocytes in human blood to blood glucose. The process of combining blood glucose and hemoglobin to produce glycosylated hemoglobin is an irreversible reaction and is proportional to blood glucose concentration. Since the average life of red blood cells in the blood circulation is 120 days, glycosylated hemoglobin can reflect the average blood glucose concentration of nearly three months. Glycosylated hemoglobin is used as a main marker for blood glucose monitoring, and has the following advantages: (1) reflects long-term blood glucose levels; (2) can be used as a risk indicator for chronic complications; (3) The biological variation is small, and the influence of blood sugar fluctuation and stress is avoided; (4) the drug effect is small; (5) The blood drawing is not needed to be performed on an empty stomach or in a specific time, so that the time of a patient is saved, and the compliance of the patient is good. Therefore, the glycosylated hemoglobin is used as an effective monitoring index for evaluating the long-term blood sugar control curative effect of diabetes screening diagnosis and is widely applied in clinic.

In the prior art, various glycosylated hemoglobin detection technologies exist, and currently, the detection methods commonly used in clinic include an immunological method, an enzymatic method, a borate affinity chromatography method, an ion exchange HPLC (high performance liquid chromatography), a capillary electrophoresis method, an isoelectric focusing electrophoresis method and the like. The principle of the immune method is that the first 4-8 amino acid residues at the N end of the beta chain of hemoglobin are used as antibody recognition sites to prepare corresponding monoclonal antibodies, glycosylated hemoglobin is combined with the corresponding monoclonal antibodies to generate agglutination, and the content of the glycosylated hemoglobin is measured by a turbidimetry method. The principle of the enzyme method is that denatured blood is digested with protease and Cheng Guotang-glycosylated short peptide, and then oxidized by fructosyl peptide oxidase to generate hydrogen peroxide, and the hydrogen peroxide reacts with a chromogenic substrate under the action of peroxidase. Both immunological and enzymatic based assays are based on specific hemoglobin sequences and are subject to interference.

Disclosure of Invention

In order to solve at least partially the above-mentioned technical problems, the object of the present application is to provide a solution capable of detecting an interfering substance while detecting hemoglobin and/or glycosylated hemoglobin, which is of great importance for the accuracy of clinical detection of hemoglobin and/or glycosylated hemoglobin.

To achieve the above object, a first aspect of the present application provides a sample analyzer, including: a sample preparation device configured to prepare a pretreatment reagent using a blood sample and a pretreatment reagent, prepare an interferent detection reagent using the pretreatment reagent and a first detection reagent, and prepare a sample solution to be tested using the pretreatment reagent and a second detection reagent; or preparing an interferent detection solution by adopting a blood sample, a pretreatment reagent and a first detection reagent, and preparing a sample solution to be detected by adopting the interferent detection solution and a second detection reagent; a first detection device configured to detect the interfering substance detection reagent to obtain interfering substance information of the blood sample; a second detection device configured to detect the sample liquid to be detected to obtain a hemoglobin detection result and/or a glycosylated hemoglobin detection result of the blood sample; and a controller configured to output a prompt message when the interferent information indicates that interferents interfering with hemoglobin detection and/or glycosylated hemoglobin detection are present in the blood sample.

In order to achieve the above object, a second aspect of the present application provides a sample analyzer, comprising: a sample preparation device configured to prepare a pretreatment reagent using a blood sample and a pretreatment reagent and to prepare a sample solution to be tested according to the pretreatment reagent and a second detection reagent; a first detection device configured to detect the pretreatment liquid to obtain interferent information of the blood sample; a second detection device configured to detect the sample liquid to be detected to obtain a hemoglobin detection result and/or a glycosylated hemoglobin detection result of the blood sample; and a controller configured to output a prompt message when the interferent information indicates that an interferent interfering with hemoglobin detection and/or glycosylated hemoglobin detection is present in the blood sample.

In order to achieve the above object, a third aspect of the present application provides a sample analysis method, including: preparing a pretreatment test solution by adopting a blood sample and a pretreatment reagent, preparing an interfering substance detection test solution by adopting the pretreatment test solution and a first detection reagent, and preparing a sample solution to be detected by adopting the pretreatment test solution and a second detection reagent; or preparing an interferent detection test solution by adopting a blood sample, a pretreatment reagent and a first detection reagent, and preparing a sample solution to be detected by adopting the interferent detection test solution and a second detection reagent; detecting the interferent detection test solution to obtain interferent information of the blood sample; detecting the sample liquid to be detected to obtain a hemoglobin detection result and/or a glycosylated hemoglobin detection result of the blood sample; and outputting a prompt message when the interferent information indicates that interferents interfering with hemoglobin detection and/or glycosylated hemoglobin detection are present in the blood sample.

According to the technical scheme provided by the aspects of the application, not only can the sample liquid to be detected be prepared and detected, but also the interfering substance detection liquid can be prepared and detected, so that not only can the detection result of the hemoglobin and/or the glycosylated hemoglobin be obtained, but also the detection result of the interfering substance interfering with the detection of the hemoglobin and/or the glycosylated hemoglobin can be obtained, the accuracy of clinical detection can be improved, and the erroneous judgment on the clinical result can be reduced.

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 some embodiments of the application.

Fig. 2 is a schematic diagram of a sample analyzer according to some embodiments of the application.

Fig. 3 is a schematic structural view of a first detection device according to some embodiments of the present application.

Fig. 4 is a schematic block diagram of a sample analyzer according to further embodiments of the application.

Fig. 5 is a flow chart of a sample analysis method according to some embodiments of the 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.

As shown in fig. 1, an embodiment of the present application first proposes a sample analyzer 100. 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 configured to prepare a pretreatment reagent using a blood sample, such as a whole blood sample, and a pretreatment reagent, prepare an interferent detection reagent using the pretreatment reagent and a first detection reagent, and prepare a sample solution to be tested using the pretreatment reagent and a second detection reagent. Alternatively, the sample preparation device 110 is configured to prepare an interferent test solution using a blood sample, a pretreatment reagent, and a first detection reagent, and to prepare a sample solution to be tested using the interferent test solution and a second detection reagent.

The first detection device 120 is configured to detect an interferent detection reagent to obtain interferent information of the blood sample.

The second detecting device 130 is configured to detect a sample fluid to be detected to obtain a hemoglobin detection result and/or a glycosylated hemoglobin detection result of the blood sample.

The controller 140 is configured to output a prompt when the interferent information indicates that interferents interfering with hemoglobin detection and/or glycosylated hemoglobin detection are present in the blood sample.

In the above embodiment, the sample analyzer 100 can obtain the detection result of hemoglobin and/or glycosylated hemoglobin and simultaneously obtain the prompt information about whether the detection result is affected by the interfering substance, which is beneficial to improving the accuracy of clinical detection and diagnosis.

In some embodiments, the sample preparation device 110 is configured to first prepare a pretreatment solution using a blood sample and a pretreatment reagent, then mix a portion of the pretreatment solution with a first detection reagent to obtain an interferent detection solution, and mix another portion of the pretreatment solution with a second detection reagent to obtain a sample solution to be tested.

In yet other alternative embodiments, the sample preparation device 110 is configured to first prepare a pretreatment solution using a blood sample and a pretreatment reagent, then mix a portion of the pretreatment solution with a first detection reagent to obtain an interferent detection solution, and then mix at least a portion of the interferent detection solution with a second detection reagent to obtain a test sample solution.

In some embodiments, the sample preparation device 110 may be further configured to prepare a sample fluid to be tested based on an immunological or enzymatic method. Here, the controller 140 may be further configured to, for example:

controlling the sample preparation device 110 to prepare a first sample solution to be tested using a pretreatment sample solution or an interferent detection sample solution and a first second detection reagent for a glycosylated hemoglobin detection item, wherein the first second detection reagent comprises an enzyme reagent (e.g., a proteolytic enzyme for reacting with glycosylated hemoglobin in a second lysate to produce a glycosylated peptide or glycosylated amino acid) or an immunological reagent (e.g., a glycosylated hemoglobin-specific antibody) for detecting a hemoglobin content;

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

controlling the sample preparation device 110 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 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; 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 some embodiments, the sample analyzer 100 may be configured as a biochemical analyzer. As some implementations, as shown in fig. 2, a sample preparation device 110 configured as a biochemical analyzer 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 a pretreatment reagent, a first detection reagent and a second detection reagent. 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 placement site for placing a cuvette and incubating a test solution, such as a pretreatment test solution, an interferent detection 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 an interfering substance detection reagent in which a blood sample, a pretreatment reagent, and a first detection reagent are mixed in the reaction member 115, so as to obtain interfering substance information of the interfering substance detection reagent. 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 interfering substance detecting solution to move to the first detecting means 130 for detection.

The second detecting means 130 is used for detecting the sample liquid to be detected for which incubation is completed in the reaction part 115 to obtain a hemoglobin detection result and/or a glycosylated hemoglobin detection result. 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 photometric device for detecting the absorbance of the sample fluid to be measured at least one light wavelength, for example 505nm or 660nm, in order to obtain a hemoglobin detection result and/or a glycosylated hemoglobin detection result based on the absorbance.

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 pretreatment reagent or the interfering substance detecting reagent into the corresponding cuvette. In some embodiments, the sample dispensing mechanism 112 may be used as the reagent transfer section.

Taking the biochemical analyzer shown in fig. 2 as an example, an exemplary process of preparing an interferent test solution and a sample solution to be tested is described. 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 first reaction cup located in the reaction member 115, and then the controller 140 controls the sample dispensing mechanism 112 to draw a portion of a blood sample, particularly a whole blood sample, from the container 10 and add it to the first reaction cup to which the pretreatment reagent has been added, to obtain a pretreatment test solution. Then, the controller 140 controls the reagent dispensing mechanism 114 to add the first detection reagent in the reagent carrying member 113 to the second reaction cuvette in the reaction member 115, and then the controller 140 controls the reagent transferring section to suck a part of the pretreatment reagent from the first reaction cuvette and add it to the second reaction cuvette to which the first detection reagent has been added, to obtain the interfering substance detection reagent. Next, the controller 140 controls the reagent dispensing mechanism 114 to add the second detection reagent in the reagent carrying member 113 to the third reaction cuvette in the reaction member 115, and then the controller 140 controls the reagent transferring section to suck a part of the pretreatment reagent from the first reaction cuvette and add it to the third reaction cuvette to which the second detection reagent has been added, so as to obtain the sample liquid to be measured.

Taking the biochemical analyzer shown in fig. 2 as an example, another exemplary process of preparing an interferent test solution and a sample solution to be tested is described. 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 first reaction cup located in the reaction member 115, and then the controller 140 controls the sample dispensing mechanism 112 to draw a portion of a blood sample, particularly a whole blood sample, from the container 10 and add it to the first reaction cup to which the pretreatment reagent has been added, to obtain a pretreatment test solution. Then, the controller 140 controls the reagent dispensing mechanism 114 to add the first detection reagent in the reagent carrying member 113 to the second reaction cuvette in the reaction member 115, and then the controller 140 controls the reagent transferring section to suck a part of the pretreatment reagent from the first reaction cuvette and add it to the second reaction cuvette to which the first detection reagent has been added, to obtain the interfering substance detection reagent. Then, the controller 140 controls the reagent dispensing mechanism 114 to add the second detection reagent in the reagent carrying member 113 to the third reaction cuvette in the reaction member 115, and then the controller 140 controls the reagent transfer section to suck the interfering substance detection reagent from the second reaction cuvette and add it to the third reaction cuvette to which the second detection reagent has been added, so as to obtain the sample liquid to be measured.

Taking the biochemical analyzer shown in fig. 2 as an example, still another exemplary process of preparing an interferent test solution and a sample solution to be tested is described. The controller 140 controls the reagent dispensing mechanism 114 to add the pretreatment reagent containing the first detection reagent in the reagent carrying member 113 to the first reaction cup located in the reaction member 115, and then the controller 140 controls the sample dispensing mechanism 112 to draw a portion of the blood sample, particularly the whole blood sample, from the container 10 and add it to the first reaction cup to which the pretreatment reagent has been added, to obtain the interferent detection reagent. Then, the controller 140 controls the reagent dispensing mechanism 114 to add the second detection reagent in the reagent carrying member 113 to the second cuvette in the reaction member 115, and then the controller 140 controls the reagent transfer section to suck a part of the interfering substance detection reagent from the first cuvette and add it to the second cuvette to which the second detection reagent has been added, so as to obtain the sample liquid to be measured.

In some embodiments, as shown in fig. 3, the first detection device 120 may be further configured to irradiate the interferent detection solution with light and acquire an optical signal generated by the interferent detection solution after being irradiated with light, so as to obtain interferent information based on the optical signal. For example, the first detection device 120 is configured to detect absorbance of the interferent detection solution at least one light wavelength, e.g., 800nm, to obtain interferent information based on the absorbance.

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 used to irradiate the interfering substance detection reagent, and the photodetector 122 is used to detect an optical signal (transmitted light and/or scattered light) emitted by the light source 121 and passing through the interfering substance detection reagent, thereby obtaining interfering substance information based on the optical signal.

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 the same photometry device shown in fig. 3, and the photometry device is configured to be able to detect absorbance of a sample solution at different light wavelengths, for example.

The pretreatment reagent, the first detection reagent, and the second detection reagent are described below in connection with some embodiments.

In some embodiments, the pretreatment reagent may include a hemolyzing agent for lysing red blood cells in the blood sample to release hemoglobin, and the first detection reagent may include a reagent for detecting a hemoglobin variant (i.e., the interfering substance is a hemoglobin variant). Further, the hemoglobin variant includes a HbF variant and/or a HbS variant.

Common hemoglobin variants include HbS, hbE, hbC, hbD, where all 4 hemoglobin variants are produced by substitution of 1 amino acid of the hemoglobin beta chain. For HbS, sickle cell hemoglobin, glutamic acid at position 6 of the beta chain is mutated to valine. Glutamic acid with HbE at position 26 of the beta chain is mutated to lysine. Glutamic acid with HbC at position 6 of the beta chain is mutated to lysine. Glutamic acid with HbD at position 121 of the beta chain is mutated to glutamine. Most hemoglobin variants or heterozygotes of hemoglobin isomers are usually asymptomatic and have normal erythrocyte survival, and if diabetics carry the hemoglobin isomer genes at the same time, they are not easily brought to the attention of clinicians. In addition, hbF, which is a Hb in embryo period and is composed of 2 alpha chains and 2 gamma chains, is also a common factor affecting the measurement result of glycosylated hemoglobin. In individuals with persistent presence of genetic HbF, hbF concentrations can reach 30% of total hemoglobin, whereas in patients with beta-thalassemia and sickle cell, hbF concentrations can be 2% to 20% of total hemoglobin, etc.

As some implementations, the pretreatment reagent may include a surfactant and a low salt solution.

In some specific examples, the surfactant may be selected from the group consisting of polyoxyethylene alkyl ethers, polyoxyethylene alkylphenyl ethers, polyoxyethylene polyoxypropylene ethers, polyoxyethylene fatty acid esters, sucrose fatty acid esters, polyoxyethylene sorbitan fatty acid esters, alkyl glycosides, alkanoyl-N-methyl glucamides, (alkylcarbamoyl) methyl glucopyranosides, alkyl glucopyranosides, deoxycholamides, saponins. Preferably, the volume percentage concentration of the surfactant in the pretreatment agent is 0.1-10%.

In some specific examples, the low salt solution may be selected from the group consisting of phosphate, citric acid, phthalic acid, acetic acid, succinic acid, imidazole and other universal buffers, good' S series buffers (zwitterionic buffers), nitrite salts. Preferably, the concentration of the low salt solution in the pretreatment reagent is 0.1-80mmol/L and the pH is 4.0-9.0.

As some implementations, the surfactant and the low salt solution may be used in combination, i.e., mixed in the same solution. As other implementations, the surfactant and the low salt solution may be used alone, i.e., in separate solutions.

As some implementations, the first detection reagent may include an HbF detection reagent. The HbF detecting reagent is, for example, a reagent containing isopropyl alcohol. Preferably, the volume percentage concentration of isopropanol in the HbF detecting reagent is 10-30%.

As some implementations, the first detection reagent may include an HbS detection reagent. The HbS detecting reagent can include, for example, a buffer, a reducing reagent, and a surfactant. The buffer is, for example, phosphate or Good' S series buffer. Preferably, the pH of the buffer is between 6 and 7. The reducing agent is sulfite such as sodium sulfite and potassium sulfite. The surfactant is, for example, a saponin.

As some implementations, the first detection reagent may include the HbF detection reagent and the HbS detection reagent described above.

As further implementations, the first detection reagent may include antibodies specific for the hemoglobin variant (e.g., including one or more of HbS-specific antibodies, hbE-specific antibodies, hbC-specific antibodies, hbD-specific antibodies, and HbF-specific antibodies), buffers, stabilizers, preservatives, and the like.

As some implementations, the pretreatment reagent and the first detection reagent may be used in combination, i.e., mixed in the same solution. As other implementations, the pretreatment reagent and the first detection reagent may be used alone, i.e., in separate solutions.

As some implementations, the second detection reagent is, for example, a reagent that detects the concentration of hemoglobin or glycosylated hemoglobin using an immunological method or an enzymatic method. In the case of detecting the concentration of glycosylated hemoglobin by an immunological method, the second detection reagent includes an immunological reagent, for example, including a glycosylated hemoglobin specific antibody and a multi-cluster single antigen carrying a plurality of glycosylated hemoglobin antigenic determinants. In the case of detecting the concentration of glycosylated hemoglobin by an enzymatic method, the second detection reagent includes an enzymatic reagent including, for example, a proteolytic enzyme and a specific oxidase.

In some embodiments, the controller 140 may be further configured to output a hint information including a type of interferent based on the interferent information, e.g., to output a hint information that the type of interferent is HbF or to output a hint information that the type of interferent includes HbF and HbS. Further, the controller 140 may also be configured to output the content or concentration of interferents, such as HbF and HbS. By outputting the content or concentration of the interfering substance, such as the hemoglobin variant, the examining physician can determine whether the glycosylated hemoglobin detection result is accurate or not by checking the concentration of the interfering substance, and whether further analysis results are needed, thereby reducing the occurrence of misdiagnosis.

In some embodiments, the controller 140 may be further configured to select sample preparation parameters of the sample preparation device 110 for preparing a sample fluid to be tested based on the interferent information. Accordingly, the sample preparation device 110 may be further configured to prepare a sample fluid to be tested according to the selected sample preparation parameters. The preparation parameters of the sample liquid to be detected are selected according to the interference object information, so that the accuracy of hemoglobin or glycosylated hemoglobin detection is improved.

As some implementations, the preparation parameters may include: the amount of the blood sample or the pretreatment reagent or the second detection reagent used for preparing the sample liquid to be tested or the proportion of the blood sample or the pretreatment reagent or the second detection reagent to the sample liquid to be tested and/or the type of the second detection reagent used for preparing the sample liquid to be tested. The type of second detection reagent is, for example, an enzymatic detection reagent or an immunological detection reagent.

As some implementations, the controller 140 may be further configured to select an immunoassay-based detection reagent as the second detection reagent for preparing the sample fluid to be tested when the interferent information indicates the presence of HbS variants in the blood sample.

As shown in fig. 4, an embodiment of the present application also proposes a sample analyzer 100' including a sample preparation device 110', a first detection device 120', a second detection device 130', and a controller 140'. Wherein the sample preparation device 110' is configured to prepare a pretreatment sample solution using a blood sample and a pretreatment reagent and to prepare a sample solution to be tested according to the pretreatment sample solution and a second detection reagent; the first detection device 120' is configured to detect the pretreatment liquid to obtain the interfering substance information of the blood sample; the second detection device 130' is configured to detect the sample liquid to be detected, so as to obtain a hemoglobin detection result and/or a glycosylated hemoglobin detection result of the blood sample; and the controller 140' is configured to output a prompt when the interferent information indicates that interferents interfering with hemoglobin detection and/or glycosylated hemoglobin detection are present in the blood sample.

In some embodiments, the sample analyzer 100' may be configured as a biochemical analyzer as shown in fig. 2.

In some embodiments, the first detection device 120' is further configured to illuminate the pretreatment solution with light and to acquire an optical signal generated by the pretreatment solution after being illuminated with light, so as to obtain interferent information based on the optical signal, wherein the interferent comprises bilirubin or lipidemia.

In some embodiments, the first detection device 120' is configured to detect absorbance of the pretreatment reagent at least one light wavelength in order to obtain interferent information based on the absorbance. For example, the first detection device 120' is configured to detect absorbance of the pretreatment solution at a first light wavelength and absorbance of the pretreatment solution at the first light wavelength, wherein the first light wavelength is any light wavelength in a range of 450-500nm, the second light wavelength is any light wavelength in a range of 500-600nm, and both hemoglobin and bilirubin have characteristic absorption at the first light wavelength, and bilirubin has no absorption at the second light wavelength and hemoglobin has characteristic absorption. The concentration of bilirubin can be calculated by preprocessing the absorbance of the test solution at the first light wavelength and the absorbance at the first light wavelength, so as to judge that bilirubin interference exists in the blood sample.

In some embodiments, the controller 140' is further configured to select an immunoassay-based detection reagent as the second detection reagent for preparing the sample fluid to be tested when the interferent information indicates the presence of bilirubin in the blood sample.

In a specific example, a whole blood sample to be tested is first subjected to a lysis treatment with a hemolyzing agent (i.e., a pretreatment reagent) according to a certain proportion to obtain a pretreatment solution, wherein the hemolyzing agent plays a role in breaking red cell membranes to release hemoglobin. When the hemolytic agent is mixed with the whole blood sample to be tested, the hemoglobin is oxidized into methemoglobin, and the absorbance of the pretreatment test solution at a first optical wavelength and a second optical wavelength is measured, wherein the first optical wavelength is any optical wavelength in the range of 450-500nm, and the second optical wavelength is any optical wavelength in the range of 500-600nm, wherein the hemoglobin and the bilirubin have characteristic absorption at the first optical wavelength, the bilirubin has no absorption at the second optical wavelength, and the hemoglobin has characteristic absorption at the second optical wavelength. And obtaining the concentration of the hemoglobin in the sample according to the absorbance of the second light wavelength and the extinction coefficient of the hemoglobin at the second light wavelength. The absorbance of the hemoglobin at the first light wavelength can be obtained through the concentration of the hemoglobin and the extinction coefficient of the hemoglobin at the first light wavelength; subtracting the absorbance of hemoglobin at the first light wavelength from the absorbance of the pretreatment solution at the first light wavelength to obtain the absorbance of bilirubin at the first light wavelength; the concentration value of bilirubin in a sample can be obtained by dividing the absorbance of bilirubin at a first light wavelength by the extinction coefficient of bilirubin at that light wavelength. When the bilirubin concentration is larger than a preset threshold value, selecting a detection reagent based on an immunoturbidimetry to prepare a sample liquid to be detected.

As shown in fig. 5, an embodiment of the present application further provides a sample analysis method 200, including the following steps:

step S210, preparing a pretreatment test solution by adopting a blood sample and a pretreatment reagent, preparing an interferent detection test solution by adopting the pretreatment test solution and a first detection reagent, and preparing a sample solution to be detected by adopting the pretreatment test solution and a second detection reagent; alternatively, a blood sample, a pretreatment reagent, and a first detection reagent are used to prepare an interferent detection reagent, and an interferent detection reagent and a second detection reagent are used to prepare a sample solution to be tested.

Step S220, detecting the interferent detection solution to obtain interferent information of the blood sample.

Step S230, detecting the sample liquid to be detected to obtain the hemoglobin detection result and/or the glycosylated hemoglobin detection result of the blood sample.

Step S240, outputting a prompt message when the interferent information indicates that there is an interferent interfering with hemoglobin detection and/or glycosylated hemoglobin detection in the blood sample.

In some embodiments, the pretreatment reagent includes a hemolyzing agent for lysing red blood cells in the blood sample to release hemoglobin. Further, the first detection reagent includes a reagent for detecting a hemoglobin variant. Preferably, the hemoglobin variant comprises a HbF variant and/or a HbS variant.

As some implementations, the pretreatment reagent may be comprised of a surfactant and a low salt solution.

As some implementations, the first detection reagent may include an HbF detection reagent and an HbS detection reagent.

In some embodiments, the second detection reagent comprises an immunoassay or an enzymatic-based detection reagent.

In some embodiments, the method 200 further comprises: and outputting prompt information comprising the type of the interferent according to the interferent information.

In some embodiments, the method 200 further comprises: sample preparation parameters for preparing a sample liquid to be tested are selected according to the interferent information, and the sample liquid to be tested is prepared according to the sample preparation parameters in step S210.

As some implementations, the sample preparation parameters include an amount of blood sample or pretreatment reagent or second detection reagent used to prepare the sample fluid to be tested or a proportion thereof to the sample fluid to be tested, and/or a type of second detection reagent used to prepare the sample fluid to be tested.

In some embodiments, the method 200 further comprises: when the interferent information indicates the presence of HbS variant or bilirubin in the blood sample, an immunoassay-based detection reagent is selected as a second detection reagent for preparing a sample fluid to be tested.

Further features and advantages of the sample analysis method 200 according to the embodiment of the present application may be referred to the above description of the sample analyzer 100 according to the embodiment of the present application, and will not be repeated here.

Some specific embodiments of the present application are described below.

Example 1

The blood sample was tested using the biochemical analyzer shown in fig. 2.

Referring to table 1, table 1 shows the components and concentrations of the pretreatment reagent, the first detection reagent, and the second detection reagent used in the biochemical analyzer of example 1.

TABLE 1

In example 1, the procedure for detecting blood samples on a biochemical analyzer is as follows:

the sample preparation device 110 adds 200 μl of the pretreatment reagent into the first reaction cup, and then draws 10 μl of the whole blood/erythrocyte sample into the first reaction cup for mixing, and incubates at 37 ℃ for 5-10 minutes after the pretreatment reagent and the whole blood/erythrocyte sample are mixed, thereby preparing a pretreatment reagent.

The sample preparation device 110 adds 200. Mu.L of the first detection reagent to the second cuvette, and accordingly, the first detection device 120 reads the absorbance A1 at 800nm of the first detection reagent in the second cuvette. Then, the sample preparation device 110 draws 10. Mu.L of the pretreatment reagent from the first cuvette, and adds it to the second cuvette to mix with the first detection reagent, and incubate for 10 minutes at 37℃after mixing the pretreatment reagent with the first detection reagent, thereby preparing an interferent detection reagent. Then, the first detection device 120 reads the absorbance A2 at 800nm of the interfering substance detection solution in the second cuvette. Thus, the HbF content can be obtained from the difference between the absorbance A2 and the absorbance A1 and the preset calibration model.

The sample preparation device 110 adds the second detection reagent 1 to the third reaction cup, and accordingly, the second detection device 130 reads the absorbance A3 at 505nm of the second detection reagent 1 in the third reaction cup. Next, the sample preparation device 110 suctions 12 μl of the pretreatment liquid from the first cuvette, mixes it with 180 μl of the second detection reagent 1, and incubates at 37 ℃ for 5 minutes to prepare a first sample liquid to be tested. Then, the second detecting means 130 reads the absorbance A4 at 660nm and the absorbance A5 at 505nm of the first sample liquid to be measured in the third cuvette. Next, the sample preparation device 110 further adds 60 μl of the second detection reagent 2 to the third reaction cup, mixes them well and reacts at 37 ℃ for 5 minutes to prepare a second sample liquid to be measured. Then, the second detection device 130 reads the absorbance A6 at 660nm of the second sample liquid to be measured in the third reaction cup. Thus, the total hemoglobin content can be obtained according to the difference between the absorbance A5 and the absorbance A3 and the preset calibration model, and the glycosylated hemoglobin content can be obtained according to the difference between the absorbance A6 and the absorbance A4 and the preset calibration model. Finally, a HbF ratio (HbF%) can be obtained from the total hemoglobin content and the HbF content, and a glycosylated hemoglobin ratio (HbA 1 c%) can be obtained from the total hemoglobin content and the glycosylated hemoglobin content.

A plurality of blood samples of different HbF concentrations were collected, hbF% and HbA1c% of these samples were obtained as target values using a High Performance Liquid Chromatography (HPLC) instrument, and these samples were detected using example 1, to obtain HbF% and HbA1c% according to the present application as actual measurement values, and finally the relative deviation of the target values from the actual measurement values was calculated, and the results are shown in table 2.

TABLE 2

As can be seen from table 2, the present embodiment can not only effectively detect the HbF concentration, but also obtain a lower result of the glycosylated hemoglobin based on the enzymatic method as the HbF concentration increases, so that an experimenter can determine the accuracy of the result of the glycosylated hemoglobin based on the HbF concentration.

Example 2

The blood sample was tested using the biochemical analyzer shown in fig. 2.

Referring to Table 3, table 3 shows the components and concentrations of the pretreatment reagent, the first detection reagent, and the second detection reagent used in the biochemical analyzer in example 2.

TABLE 3 Table 3

In example 2, the procedure for detecting blood samples on a biochemical analyzer is as follows:

the sample preparation device 110 adds 200 μl of the pretreatment reagent into the first reaction cup, and then draws 2 μl of the whole blood/erythrocyte sample into the first reaction cup for mixing, and incubates at 37 ℃ for 5-10 minutes after the pretreatment reagent and the whole blood/erythrocyte sample are mixed, thereby preparing a pretreatment reagent.

The sample preparation device 110 adds 100. Mu.L of the first detection reagent to the second cuvette, and accordingly, the first detection device 120 reads the absorbance A1 at 800nm of the first detection reagent in the second cuvette. Then, the sample preparation device 110 draws 20. Mu.L of the pretreatment reagent from the first cuvette, and adds it to the second cuvette to mix with the first detection reagent, and incubate for 10 minutes at 37℃after mixing the pretreatment reagent with the first detection reagent, thereby preparing an interferent detection reagent. Then, the first detection device 120 reads the absorbance A2 at 800nm of the interfering substance detection solution in the second cuvette. Thus, the HbS content can be obtained from the difference between the absorbance A2 and the absorbance A1 and the preset calibration model.

The sample preparation device 110 adds the second detection reagent 1 to the third reaction cup, and accordingly, the second detection device 130 reads the absorbance A3 at 505nm of the second detection reagent 1 in the third reaction cup. Next, the sample preparation device 110 suctions 12 μl of the pretreatment liquid from the first cuvette, mixes it with 300 μl of the second detection reagent 1, and incubates at 37 ℃ for 5 minutes to prepare a first sample liquid to be tested. Then, the second detecting means 130 reads the absorbance A4 at 340nm and the absorbance A5 at 505nm of the first sample liquid to be measured in the third cuvette. Next, the sample preparation device 110 further adds 60 μl of the second detection reagent 2 to the third reaction cup, mixes them well and reacts at 37 ℃ for 5 minutes to prepare a second sample liquid to be measured. Then, the second detection device 130 reads the absorbance A6 at 340nm of the second sample liquid to be measured in the third reaction cup. Thus, the total hemoglobin content can be obtained according to the difference between the absorbance A5 and the absorbance A3 and the preset calibration model, and the glycosylated hemoglobin content can be obtained according to the difference between the absorbance A6 and the absorbance A4 and the preset calibration model. Finally, hbS ratio (HbS%) can be obtained from the total hemoglobin content and HbS content, and glycosylated hemoglobin ratio (HbA 1 c%) can be obtained from the total hemoglobin content and glycosylated hemoglobin content

Blood samples of various HbS concentrations were collected, hbS% and HbA1c% of these samples were obtained as target values using a High Performance Liquid Chromatography (HPLC) apparatus, and these samples were examined using example 2 to obtain HbS% and HbA1c% according to the present application as actual measurement values, and finally the relative deviation of the target values from the actual measurement values was calculated, and the results are shown in Table 4.

TABLE 4 Table 4

As can be seen from table 4, the present embodiment can not only effectively detect HbS concentration, but also obtain a lower result of the glycosylated hemoglobin based on the immune method as the HbS concentration increases, so that an experimenter can judge the accuracy of the result of the glycosylated hemoglobin based on the HbS concentration.

Example 3

The blood sample was tested using the biochemical analyzer shown in fig. 2.

Referring to Table 5, table 5 shows the components and concentrations of the pretreatment reagent, the first detection reagent, and the second detection reagent used in the biochemical analyzer in example 3.

TABLE 1

In example 3, the procedure for detecting blood samples on a biochemical analyzer is as follows:

The sample preparation device 110 adds 100. Mu.L of HbF detecting reagent to the second cuvette, and accordingly, the first detecting device 120 reads the absorbance A11 at 800nm of HbF detecting reagent in the second cuvette. Then, the sample preparation device 110 draws 20. Mu.L of the pretreatment reagent from the first cuvette, and adds it to the second cuvette to mix with the HbF detecting reagent, and incubate for 10 minutes at 37℃after mixing the pretreatment reagent with the HbF detecting reagent, thereby preparing an interferent detecting reagent. Then, the first detection device 120 reads the absorbance A21 of the interfering substance detection solution in the second cuvette at 800 nm. Thus, the HbF content can be obtained from the difference between the absorbance A21 and the absorbance A11 and the preset calibration model.

The sample preparation device 110 adds 100. Mu.L of HbS detecting reagent to the third cuvette, and accordingly, the first detecting device 120 reads the absorbance A12 at 800nm of HbS detecting reagent in the third cuvette. Then, the sample preparation device 110 draws 20. Mu.L of the pretreatment reagent from the first cuvette, and adds it to the third cuvette to mix with the HbS detecting reagent, and incubate for 10 minutes at 37℃after mixing the pretreatment reagent with the HbS detecting reagent, thereby preparing an interferent detecting reagent. Then, the first detection device 120 reads the absorbance A22 at 800nm of the interfering substance detection solution in the third cuvette. Thus, the HbS content can be obtained from the difference between the absorbance A22 and the absorbance A12 and the preset calibration model.

The sample preparation device 110 adds the second detection reagent 1 to the fourth cuvette, and accordingly, the second detection device 130 reads the absorbance A3 at 505nm of the second detection reagent 1 in the fourth cuvette. Next, the sample preparation device 110 suctions 12 μl of the pretreatment liquid from the first cuvette, mixes it with 300 μl of the second detection reagent 1, and incubates at 37 ℃ for 5 minutes to prepare a first sample liquid to be tested. Then, the second detecting means 130 reads the absorbance A4 at 340nm and the absorbance A5 at 505nm of the first sample liquid to be measured in the fourth cuvette. Next, the sample preparation device 110 adds 60 μl of the second detection reagent 2 to the fourth reaction cuvette, mixes them well and reacts at 37 ℃ for 5 minutes to prepare a second sample liquid to be measured. Then, the second detection device 130 reads the absorbance A6 at 340nm of the second sample liquid to be measured in the fourth cuvette. Thus, the total hemoglobin content can be obtained according to the difference between the absorbance A5 and the absorbance A3 and the preset calibration model, and the glycosylated hemoglobin content can be obtained according to the difference between the absorbance A6 and the absorbance A4 and the preset calibration model. Finally, a HbF ratio (HbF%) can be obtained from the total hemoglobin content and the HbF content, a HbS ratio (HbS%) can be obtained from the total hemoglobin content and the HbS content, and a glycosylated hemoglobin ratio (HbA 1 c%) can be obtained from the total hemoglobin content and the glycosylated hemoglobin content.

Blood samples of a plurality of different HbF and HbS concentrations were collected, hbF%, hbS% and HbA1c% of these samples were obtained as target values using a High Performance Liquid Chromatography (HPLC) instrument, and these samples were examined using example 3 to obtain HbF%, hbS% and HbA1c% according to the present application as actual measurement values, and finally the relative deviation of the target values from the actual measurement values was calculated, and the results are shown in Table 6.

TABLE 6

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As can be seen from table 6, the present application not only can effectively detect HbF and HbS concentrations, but also can obtain a lower result of glycosylated hemoglobin based on an immune method with increasing HbF and HbS concentrations, so that an experimenter can determine the accuracy of the result of glycosylated hemoglobin based on the HbF and HbS concentrations.

Example 4

The blood sample was tested using the biochemical analyzer shown in fig. 2.

Referring to Table 7, table 7 shows the components and concentrations of the pretreatment reagent, the first detection reagent, and the second detection reagent used in the biochemical analyzer of example 4, and in this example 4, the pretreatment reagent and the first detection reagent are used in combination, i.e., mixed in the same solution.

TABLE 7

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In example 4, the procedure for detecting blood samples on a biochemical analyzer is as follows:

The sample preparation device 110 adds 200. Mu.L of the pretreatment reagent to the first cuvette, and accordingly, the first detection device 120 reads the absorbance A1 at 800nm of the pretreatment reagent in the first cuvette. Then, the sample preparation device 110 draws 10 μl of the whole blood/red blood cell sample, adds the whole blood/red blood cell sample to the first reaction cup, mixes the whole blood/red blood cell sample, and incubates the whole blood/red blood cell sample at 37 ℃ for 5 minutes, thereby preparing a pretreatment solution (also referred to as an interferent detection solution), and correspondingly the first detection device 120 reads the absorbance A2 of the interferent detection solution in the first reaction cup at 800 nm. Thus, the HbF content can be obtained from the difference between the absorbance A2 and the absorbance A1 and the preset calibration model.

The sample preparation device 110 adds the second detection reagent 1 to the second cuvette, and accordingly, the second detection device 130 reads the absorbance A3 of the second detection reagent 1 in the second cuvette at 505 nm. Next, the sample preparation device 110 suctions 12 μl of the pretreatment liquid from the first cuvette, mixes it with 180 μl of the second detection reagent 1, and incubates at 37 ℃ for 5 minutes to prepare a first sample liquid to be tested. Then, the second detecting means 130 reads the absorbance A4 at 660nm and the absorbance A5 at 505nm of the first sample liquid to be measured in the second cuvette. Next, the sample preparation device 110 adds 60 μl of the second detection reagent 2 to the second reaction cup, mixes them well and reacts at 37 ℃ for 5 minutes to prepare a second sample liquid to be measured. Then, the second detection device 130 reads the absorbance A6 at 660nm of the second sample liquid to be detected in the second cuvette. Thus, the total hemoglobin content can be obtained according to the difference between the absorbance A5 and the absorbance A3 and the preset calibration model, and the glycosylated hemoglobin content can be obtained according to the difference between the absorbance A6 and the absorbance A4 and the preset calibration model. Finally, a HbF ratio (HbF%) can be obtained from the total hemoglobin content and the HbF content, and a glycosylated hemoglobin ratio (HbA 1 c%) can be obtained from the total hemoglobin content and the glycosylated hemoglobin content.

Blood samples of various HbF concentrations were collected, hbF% and HbA1c% of the samples were obtained as target values using a High Performance Liquid Chromatography (HPLC) apparatus, and the samples were examined using example 4 to obtain HbF% and HbA1c% according to the present application as actual measurement values, and finally, the relative deviation of the target values from the actual measurement values was calculated, and the results are shown in Table 8.

TABLE 8

In table 8, symbols "-", "+" and "++" respectively indicate the magnitude of HbF%. As can be seen from Table 8, the present example was not only effective in detecting the presence of HbF, but also resulted in a lower% glycosylated hemoglobin as the HbF concentration was increased. Therefore, the experimenter can judge the accuracy of the glycosylated hemoglobin% result by the HbF.

Example 5

The blood sample was tested using the biochemical analyzer shown in fig. 2.

Referring to Table 9, table 9 shows the components and concentrations of the pretreatment reagent, the first detection reagent, and the second detection reagent used in the biochemical analyzer of example 5, and in example 4, the pretreatment reagent and the first detection reagent are used in combination, i.e., mixed in the same solution.

TABLE 9

In example 5, the procedure for detecting blood samples on a biochemical analyzer is as follows:

The sample preparation device 110 adds the second detection reagent 1 to the second cuvette, and accordingly, the second detection device 130 reads the absorbance A3 of the second detection reagent 1 in the second cuvette at 505 nm. Next, the sample preparation device 110 suctions 3 μl of the pretreatment liquid from the first cuvette, mixes it with 300 μl of the second detection reagent 1, and incubates at 37 ℃ for 5 minutes to prepare a first sample liquid to be tested. Then, the second detecting means 130 reads the absorbance A4 at 340nm and the absorbance A5 at 505nm of the first sample liquid to be measured in the second cuvette. Next, the sample preparation device 110 adds 60 μl of the second detection reagent 2 to the second reaction cup, mixes them well and reacts at 37 ℃ for 5 minutes to prepare a second sample liquid to be measured. Then, the second detection device 130 reads the absorbance A6 at 340nm of the second sample liquid to be detected in the second cuvette. Thus, the total hemoglobin content can be obtained according to the difference between the absorbance A5 and the absorbance A3 and the preset calibration model, and the glycosylated hemoglobin content can be obtained according to the difference between the absorbance A6 and the absorbance A4 and the preset calibration model. Finally, a HbS proportion (HbS%) can be obtained from the total hemoglobin content and the HbS content, and a glycosylated hemoglobin proportion (HbA 1 c%) can be obtained from the total hemoglobin content and the glycosylated hemoglobin content.

Blood samples of various HbS concentrations were collected, hbS% and HbA1c% of the samples were obtained as target values using a High Performance Liquid Chromatography (HPLC) apparatus, and the samples were examined using example 5 to obtain HbS% and HbA1c% according to the present application as actual measurement values, and finally, the relative deviation of the target values from the actual measurement values was calculated, and the results are shown in Table 10.

Table 10

In table 10, symbols "-", "+" and "++" respectively indicate the magnitude of HbF%. As can be seen from table 10, the present example was not only able to effectively detect the presence of HbS, but also the results of the detection of glycosylated hemoglobin based on the immunological method were lower as the HbS concentration was increased. Therefore, the experimenter can judge the accuracy of the glycosylated hemoglobin% result through the HbS.

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 sample analysis 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:

a sample preparation device configured to prepare a pretreatment reagent using a blood sample and a pretreatment reagent, prepare an interferent detection reagent using the pretreatment reagent and a first detection reagent, and prepare a sample solution to be tested using the pretreatment reagent and a second detection reagent; or preparing an interferent detection solution by adopting a blood sample, a pretreatment reagent and a first detection reagent, and preparing a sample solution to be detected by adopting the interferent detection solution and a second detection reagent;

a first detection device configured to detect the interfering substance detection reagent to obtain interfering substance information of the blood sample;

a second detection device configured to detect the sample liquid to be detected to obtain a hemoglobin detection result and/or a glycosylated hemoglobin detection result of the blood sample; and is also provided with

And a controller configured to output a prompt message when the interferent information indicates that an interferent interfering with hemoglobin detection and/or glycosylated hemoglobin detection is present in the blood sample.

2. The sample analyzer of claim 1, wherein the pretreatment reagent comprises a hemolyzing agent for lysing red blood cells in a blood sample to release hemoglobin, and the first detection reagent comprises a reagent for detecting hemoglobin variants.

3. The sample analyzer of claim 2, wherein the hemoglobin variant comprises a HbF variant and/or a HbS variant.

4. The sample analyzer of any of claims 1-3, wherein the controller is further configured to output a hint information including an interferent type based on the interferent information.

5. The sample analyzer of any one of claims 1-4, wherein the controller is further configured to select a sample preparation parameter of the sample preparation device to prepare the sample fluid to be tested based on the interferent information; and is also provided with

The sample preparation device is further configured to prepare the sample fluid to be tested according to the selected sample preparation parameters.

6. The sample analyzer of claim 5, wherein the controller is further configured to select a detection mode of the second detection device based on the interferent information, and wherein the second detection device is further configured to detect the sample fluid under test in the selected detection mode.

7. The sample analyzer of claim 5, wherein the sample preparation parameters comprise:

the dosage of the blood sample or the pretreatment reagent or the second detection reagent used for preparing the sample liquid to be tested or the proportion of the dosage to the sample liquid to be tested; and/or

The type of second detection reagent used to prepare the sample fluid to be tested.

8. The sample analyzer of claim 7, wherein the controller is further configured to select an immunoassay-based detection reagent as the second detection reagent for preparing the sample fluid to be tested when the interferent information indicates the presence of HbS variants in the blood sample.

9. The sample analyzer according to any one of claims 1 to 8, wherein the sample analyzer is configured as a biochemical analyzer, the sample preparation device is further configured to prepare the sample liquid to be measured based on an immunological method or an enzymatic method, and the first detection device and the second detection device are configured as the same photometry device.

10. A sample analyzer, comprising:

a sample preparation device configured to prepare a pretreatment reagent using a blood sample and a pretreatment reagent and to prepare a sample solution to be tested according to the pretreatment reagent and a second detection reagent;

a first detection device configured to detect the pretreatment liquid to obtain interferent information of the blood sample;

11. The sample analyzer of claim 10, wherein the first detection device is further configured to irradiate the pretreatment liquid with light and acquire an optical signal generated by the pretreatment liquid after being irradiated with the light, so as to obtain interferent information based on the optical signal, wherein the interferent comprises bilirubin or lipidemia.

12. The sample analyzer of claim 11, wherein the controller is further configured to select an immunoassay-based detection reagent as the second detection reagent for preparing the sample fluid to be tested when the interferent information indicates the presence of bilirubin in the blood sample.

13. A method of sample analysis, comprising:

preparing a pretreatment test solution by adopting a blood sample and a pretreatment reagent, preparing an interfering substance detection test solution by adopting the pretreatment test solution and a first detection reagent, and preparing a sample solution to be detected by adopting the pretreatment test solution and a second detection reagent; or preparing an interferent detection test solution by adopting a blood sample, a pretreatment reagent and a first detection reagent, and preparing a sample solution to be detected by adopting the interferent detection test solution and a second detection reagent;

detecting the interferent detection test solution to obtain interferent information of the blood sample;

detecting the sample liquid to be detected to obtain a hemoglobin detection result and/or a glycosylated hemoglobin detection result of the blood sample; and is also provided with

Outputting a prompt message when the interference information indicates that an interference which interferes with hemoglobin detection and/or glycosylated hemoglobin detection exists in the blood sample.

14. The method of claim 13, wherein the pretreatment reagent comprises a hemolyzing agent for lysing red blood cells in a blood sample to release hemoglobin, and the first detection reagent comprises a reagent for detecting hemoglobin variants; and/or

The second detection reagent comprises an immunological method or an enzymatic method based detection reagent.

15. The method of claim 13 or 14, wherein the hemoglobin variant comprises a HbF variant and/or a HbS variant.