Sample analyzer and sample analysis method

Abstract

The application relates to a sample analyzer and a sample analysis method. The sample analyzer comprises: a sample preparation device configured to prepare a pretreatment test solution by using a blood sample and a pretreatment reagent, prepare an interferent detection test solution by using the pretreatment test solution and a first detection reagent, and prepare a to-be-tested sample solution by using the pretreatment test solution or the interferent detection test solution and a second detection reagent; a first detection device configured to detect the interferent detection test solution to obtain interferent information; a second detection device configured to detect the to-be-tested sample solution to obtain a hemoglobin detection result and / or a glycated hemoglobin detection result of the blood sample; and a controller configured to output prompt information when the interferent information indicates that there is an interferent in the blood sample which interferes with the hemoglobin detection and / or the glycated hemoglobin detection. The embodiments of the application can detect the interferent and output corresponding interferent prompt information when the hemoglobin and / or the glycated hemoglobin is detected.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of in vitro diagnostics, in particular to a sample analyzer and a sample analysis method. BACKGROUND

[0002] Hemoglobin is a special protein for transporting oxygen in red blood cells, which is widely used in clinical detection.

[0003] Glycated hemoglobin is the product of the combination of hemoglobin in red blood cells and blood glucose in human blood. The process of generating glycated hemoglobin by combining blood glucose and hemoglobin is an irreversible reaction and is proportional to the concentration of blood glucose. Since the average life span of red blood cells in blood circulation is 120 days, glycated hemoglobin can reflect the average blood glucose concentration in the past three months. Glycated hemoglobin, as the main marker for blood glucose monitoring, has the following advantages: (1) reflecting long-term blood glucose level; (2) can be used as a risk indicator for chronic complications; (3) biological variation is small, not affected by blood glucose fluctuations and stress; (4) less affected by drugs; (5) no need for fasting or blood sampling at a specific time, saving patient time and good patient compliance. Therefore, glycated hemoglobin, as an effective monitoring indicator for diabetes screening and diagnosis, long-term blood glucose control efficacy evaluation, is widely used in clinical practice.

[0004] There are various glycated hemoglobin detection technologies in the prior art. The commonly used detection methods in the clinic include immune method, enzyme method, borate affinity chromatography, ion exchange HPLC, capillary electrophoresis method, isoelectric focusing electrophoresis method, etc. The principle of the immune method is to use the first 4-8 amino acid residues at the N-terminal of the hemoglobin β chain as the antibody recognition site, prepare the corresponding monoclonal antibody, and combine the glycated hemoglobin with the corresponding monoclonal antibody to agglutinate, and then use the turbidimetry method to determine the content of glycated hemoglobin. The principle of the enzyme method is to digest the denatured hemoglobin into fructosylated short peptides by protease, and then oxidize the fructosylated short peptides by fructosyl peptide oxidase to produce hydrogen peroxide, which reacts with the chromogenic substrate under the action of peroxidase to produce color. The detection based on the immune method and the enzyme method is based on the specific hemoglobin sequence, which can be affected by interfering substances. SUMMARY

[0005] In order to at least partially solve the above technical problems, the task of the present application is to provide a solution that can detect interfering substances while detecting hemoglobin and / or glycated hemoglobin, which is of great significance for the accuracy of clinical detection of hemoglobin and / or glycated hemoglobin.

[0006] To achieve the above-mentioned tasks of the present application, the first aspect of the present application first provides a sample analyzer, comprising: a sample preparation device configured to prepare a pretreatment test solution by using a blood sample and a pretreatment reagent, prepare an interferent detection test solution by using the pretreatment test solution and a first detection reagent, and prepare a to-be-tested sample solution by using the pretreatment test solution and a second detection reagent; or, configured to prepare an interferent detection test solution by using a blood sample, a pretreatment reagent and a first detection reagent, and prepare a to-be-tested sample solution by using the interferent detection test solution and a second detection reagent; a first detection device configured to detect the interferent detection test solution to obtain interferent information of the blood sample; a second detection device configured to detect the to-be-tested sample solution to obtain a hemoglobin detection result and / or a glycated hemoglobin detection result of the blood sample; and a controller configured to output a prompt information when the interferent information indicates that there is an interferent that interferes with the hemoglobin detection and / or the glycated hemoglobin detection in the blood sample.

[0007] To achieve the above-mentioned tasks of the present application, the second aspect of the present application further provides a sample analyzer, comprising: a sample preparation device configured to prepare a pretreatment test solution by using a blood sample and a pretreatment reagent, and prepare a to-be-tested sample solution according to the pretreatment test solution and a second detection reagent; a first detection device configured to detect the pretreatment test solution to obtain interferent information of the blood sample; a second detection device configured to detect the to-be-tested sample solution to obtain a hemoglobin detection result and / or a glycated hemoglobin detection result of the blood sample; and a controller configured to output a prompt information when the interferent information indicates that there is an interferent that interferes with the hemoglobin detection and / or the glycated hemoglobin detection in the blood sample.

[0008] To achieve the above-mentioned tasks of the present application, the third aspect of the present application provides a sample analysis method, comprising: preparing a pretreatment test solution by using a blood sample and a pretreatment reagent, preparing an interferent detection test solution by using the pretreatment test solution and a first detection reagent, and preparing a to-be-tested sample solution by using the pretreatment test solution and a second detection reagent; or, preparing an interferent detection test solution by using a blood sample, a pretreatment reagent and a first detection reagent, and preparing a to-be-tested sample solution by using 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 to-be-tested sample solution to obtain a hemoglobin detection result and / or a glycated hemoglobin detection result of the blood sample; and outputting a prompt information when the interferent information indicates that there is an interferent that interferes with the hemoglobin detection and / or the glycated hemoglobin detection in the blood sample.

[0009] In the technical solutions provided in the aspects of the present application, not only the sample liquid to be detected can be prepared and detected, but also the interference substance detection liquid can be prepared and detected, so that not only the detection results of hemoglobin and / or glycated hemoglobin can be obtained, but also the detection results of the interference substance interfering with the detection of hemoglobin and / or glycated hemoglobin can be obtained, which is beneficial to improve the accuracy of clinical detection and reduce the misjudgment of clinical results. BRIEF DESCRIPTION OF DRAWINGS

[0010] The present application will be described in more detail with reference to the embodiments and accompanying drawings. The above-mentioned and other advantages will become apparent to those skilled in the art from the detailed description of the embodiments. The accompanying drawings are merely provided to illustrate the preferred embodiments, and should not be considered as limiting the present application. In all the drawings, the same or similar reference signs represent the same or similar components. In the drawings:

[0011] Figure 1 is a schematic block diagram of a sample analyzer according to some embodiments of the present application.

[0012] Figure 2 is a structural schematic diagram of a sample analyzer according to some embodiments of the present application.

[0013] Figure 3 is a structural schematic diagram of a first detection device according to some embodiments of the present application.

[0014] Figure 4 is a schematic block diagram of a sample analyzer according to some other embodiments of the present application.

[0015] Figure 5 is a flowchart of a sample analysis method according to some embodiments of the present application. DETAILED DESCRIPTION

[0016] The embodiments of the present application will be described in detail with reference to the accompanying drawings, it is obvious that the described embodiments are only some of the embodiments of the present application, but not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0017] It should be noted that the terms "first", "second", "third" involved in the embodiments of the present application are only to distinguish similar objects, and do not represent a specific order of the objects. Understandably, "first", "second", "third" can be interchanged with specific order or sequence as allowed.

[0018] Those skilled in the art can understand that, unless otherwise defined, all terms (including technical terms and scientific terms) used herein have the same meaning as commonly understood by those skilled in the art in the field to which the present application belongs.

[0019] As shown in Figure 1 Embodiments of the present application first propose a sample analyzer 100. The sample analyzer 100 comprises a sample preparation device 110, a first detection device 120, a second detection device 130, and a controller 140.

[0020] The sample preparation device 110 is configured to prepare a pretreatment reagent solution from a blood sample, e.g. a whole blood sample, and a pretreatment reagent, to prepare an interferent detection reagent solution from the pretreatment reagent solution and a first detection reagent, and to prepare a sample under test solution from the pretreatment reagent solution and a second detection reagent. Alternatively, the sample preparation device 110 is configured to prepare an interferent detection reagent solution from a blood sample, a pretreatment reagent, and a first detection reagent, and to prepare a sample under test solution from the interferent detection reagent solution and a second detection reagent.

[0021] The first detection device 120 is configured to detect the interferent detection reagent solution to obtain interferent information of the blood sample.

[0022] The second detection device 130 is configured to detect the sample under test solution to obtain a hemoglobin detection result and / or a glycated hemoglobin detection result of the blood sample.

[0023] The controller 140 is configured to output a prompt information when the interferent information indicates that there is an interferent in the blood sample that interferes with the hemoglobin detection and / or the glycated hemoglobin detection.

[0024] In the above embodiments, the sample analyzer 100 can obtain the prompt information whether the hemoglobin detection result and / or the glycated hemoglobin detection result is interfered by an interferent while obtaining the hemoglobin detection result and / or the glycated hemoglobin detection result, which is beneficial to improve the accuracy of clinical detection and diagnosis.

[0025] In some embodiments, the sample preparation device 110 is configured to first prepare a pretreatment reagent solution from a blood sample and a pretreatment reagent, then mix a portion of the pretreatment reagent solution with a first detection reagent to obtain an interferent detection reagent solution, and mix another portion of the pretreatment reagent solution with a second detection reagent to obtain a sample under test solution.

[0026] In some alternative embodiments, the sample preparation device 110 is configured to first prepare a pretreatment reagent solution from a blood sample and a pretreatment reagent, then mix a portion of the pretreatment reagent solution with a first detection reagent to obtain an interferent detection reagent solution, and then mix at least a portion of the interferent detection reagent solution with a second detection reagent to obtain a sample under test solution.

[0027] In some embodiments, the sample preparation device 110 can be further configured for preparing the sample under test solution based on an immunoassay or an enzymatic method. Here, the controller 140 may, for example, be further configured to:

[0028] The control sample preparation device 110 uses a pretreatment test solution or an interfering test solution and a first type of second detection reagent for glycated hemoglobin detection to prepare a first test sample solution. The first type of second detection reagent includes an enzyme reagent (e.g., a proteolytic enzyme, used to react with glycated hemoglobin in the second lysis solution to produce glycosylated peptides or glycosylated amino acids) or an immunoassay reagent (e.g., a glycated hemoglobin-specific antibody) for detecting hemoglobin content.

[0029] The second detection device 130 is controlled to detect the first sample solution to obtain the hemoglobin content in the blood sample.

[0030] The control sample preparation device 110 adds a second type of second detection reagent for glycated hemoglobin detection to the first test sample solution to prepare a second test sample solution. The second type of second detection reagent includes an enzyme reagent (e.g., a specific oxidase, used to react with glycosylated peptides or glycosylated amino acids in the first test sample solution to generate detectable products, such as hydrogen peroxide) or an immunoassay reagent (e.g., a multi-cluster monoantigen carrying several glycated hemoglobin antigenic determinants).

[0031] The second detection device 130 is controlled to detect the second sample solution to obtain the glycated hemoglobin content in the blood sample; and

[0032] The ratio of the glycated hemoglobin content to the hemoglobin content is calculated as the test result of the glycated hemoglobin detection item.

[0033] In some embodiments, the sample analyzer 100 may be configured as a biochemical analyzer. As some implementations, such as Figure 2 As shown, the sample preparation device 110, which is configured as a biochemical analyzer, includes a sample carrying component 111, a sample dispensing mechanism 112, a reagent carrying component 113, a reagent dispensing mechanism 114, and a reaction component 115.

[0034] The sample carrier 111 is used to carry blood samples. For example, the sample carrier 111 can be configured as a sample tray including multiple sample positions for placing the container 10, and the sample tray can be rotated to move the container containing the blood sample to a corresponding position, such as to a position for the sample dispensing mechanism 112 to draw the blood sample. The sample dispensing mechanism 112 is used to draw the blood sample from the container 10 and dispense it into a reaction cup to be dispensed. For example, the sample dispensing mechanism 112 may include a sample needle that can move in two or three dimensions in space via a two-dimensional or three-dimensional drive mechanism, so that the sample needle can move to the position for drawing the blood sample and to the reaction cup to be dispensed, and dispense the drawn blood sample into the reaction cup.

[0035] The reagent carrying component 113 is configured to carry reagents, including pre-treatment reagent, first detection reagent and second detection reagent. In some embodiments, the reagent carrying component 113 can be configured as a reagent disk having a disk-like structure with a plurality of positions for carrying reagent containers, and the reagent carrying component 113 is rotatable to rotate the reagent containers carried thereby to a specific position, such as a position for reagent dispensing by the reagent dispensing mechanism 114. The number of reagent carrying components 113 can be one or more. The reagent dispensing mechanism 114 is configured to aspirate reagents and dispense the reagents into a reaction cup to which the reagents are to be added. For example, the reagent dispensing mechanism 114 can include a reagent needle, which is movable in two or three dimensions by a two or three dimensional drive mechanism, so that the reagent needle can be moved to a position for aspirating reagents and to a reaction cup to which the reagents are to be added, and dispense the aspirated reagents into the reaction cup.

[0036] The reaction component 115 has at least one placement position for placing a reaction cup and incubating a test solution, such as a pre-treatment test solution, an interferent detection test solution and a sample solution to be tested, in the reaction cup. For example, the reaction component 115 can be configured as a reaction disk having a disk-like structure with one or more placement positions for placing reaction cups, and the reaction disk is rotatable to move the reaction cups in the placement positions to schedule the reaction cups within the reaction disk and incubate the test solutions in the reaction cups.

[0037] The first detection device 120 is configured to detect the interferent detection test solution mixed with the blood sample, the pre-treatment test solution and the first detection reagent in the reaction component 115 to obtain interferent information of the interferent detection test solution. The first detection device 120 is, for example, arranged outside the reaction component 115, and the reaction component 115 is rotated to move the container holding the interferent detection test solution to the first detection device 130 for detection.

[0038] The second detection device 130 is configured to detect the sample solution to be tested after incubation in the reaction component 115 to obtain a hemoglobin test result and / or a glycated hemoglobin test result. The second detection device 130 is, for example, also arranged outside the reaction component 115, and the reaction component 115 is rotated to move the container holding the sample solution to be tested to the second detection device 130 for target item detection. In some embodiments, the second detection device 130 is configured as a light measuring device for measuring absorbance of the sample solution to be tested at at least one wavelength of light, such as 505 nm or 660 nm, to obtain the hemoglobin test result and / or the glycated hemoglobin test result based on the absorbance.

[0039] Further, in Figure 2In the illustrated embodiment, the sample preparation device 110 can also include a reagent transfer portion (not shown) for transferring the pre-treatment reagent or interference detection reagent into the corresponding reaction cup. In some embodiments, the sample dispensing mechanism 112 can be used as the reagent transfer portion.

[0040] In the illustrated embodiment, the sample preparation device 110 can also include a reagent transfer portion (not shown) for transferring the pre-treatment reagent or interference detection reagent into the corresponding reaction cup. In some embodiments, the sample dispensing mechanism 112 can be used as the reagent transfer portion. Figure 2 In the illustrated embodiment, the sample preparation device 110 can also include a reagent transfer portion (not shown) for transferring the pre-treatment reagent or interference detection reagent into the corresponding reaction cup. In some embodiments, the sample dispensing mechanism 112 can be used as the reagent transfer portion.

[0041] In the illustrated embodiment, the sample preparation device 110 can also include a reagent transfer portion (not shown) for transferring the pre-treatment reagent or interference detection reagent into the corresponding reaction cup. In some embodiments, the sample dispensing mechanism 112 can be used as the reagent transfer portion. Figure 2 In the illustrated embodiment, the sample preparation device 110 can also include a reagent transfer portion (not shown) for transferring the pre-treatment reagent or interference detection reagent into the corresponding reaction cup. In some embodiments, the sample dispensing mechanism 112 can be used as the reagent transfer portion. In the illustrated embodiment, the sample preparation device 110 can also include a reagent transfer portion (not shown) for transferring the pre-treatment reagent or interference detection reagent into the corresponding reaction cup. In some embodiments, the sample dispensing mechanism 112 can be used as the reagent transfer portion.

[0042] As an example, the process of preparing the interference test solution and the sample solution is described below with reference to the biochemical analyzer shown in Figure 2 The controller 140 controls the reagent dispensing mechanism 114 to add the pre-treatment reagent containing the first detection reagent in the reagent carrying component 113 into the first reaction cup in the reaction component 115, and then the controller 140 controls the sample dispensing mechanism 112 to suck a portion of the blood sample, especially the whole blood sample, from the container 10 and add it into the first reaction cup to which the pre-treatment reagent has been added, so as to obtain the interference test solution. Then, the controller 140 controls the reagent dispensing mechanism 114 to add the second detection reagent in the reagent carrying component 113 into the second reaction cup in the reaction component 115, and then the controller 140 controls the test solution transfer component to suck a portion of the interference test solution from the first reaction cup and add it into the second reaction cup to which the second detection reagent has been added, so as to obtain the sample solution.

[0043] In some embodiments, as shown in Figure 3 The first detection device 120 can be further configured to irradiate the interference test solution with light and acquire the light signal generated by the interference test solution after being irradiated with the light, so as to obtain the interference information based on the light signal. For example, the first detection device 120 is configured to detect the absorbance of the interference test solution at at least one light wavelength, for example, 800 nm, so as to obtain the interference information based on the absorbance.

[0044] In the embodiment shown in Figure 3 The first detection device 120 includes a light source 121 and a light detector 122. The light source 121 is used to irradiate the interference test solution, and the light detector 122 is used to detect the light signal (transmitted light and / or scattered light) emitted by the light source 121 and passing through the interference test solution, so as to obtain the interference information based on the light signal.

[0045] In some embodiments, the first detection device 120 and the second detection device 130 can be the same detection device, so as to further reduce the cost. For example, the first detection device 120 and the second detection device 130 are the same light measurement device as shown in Figure 3 The light measurement device is configured to be able to detect the absorbance of the test solution at different light wavelengths.

[0046] Next, the pre-treatment reagent, the first detection reagent and the second detection reagent are introduced in combination with some embodiments.

[0047] In some embodiments, the pretreatment reagent can include a hemolytic agent for lysing red blood cells in the blood sample to release hemoglobin, and the first detection reagent can include a reagent for detecting a hemoglobin variant (i.e., the interferent is a hemoglobin variant). Further, the hemoglobin variant includes HbF variant and / or HbS variant.

[0048] Common hemoglobin variants include HbS, HbE, HbC, HbD, all of which are generated by substitution of one amino acid in the beta chain of hemoglobin. For HbS, also known as sickle hemoglobin, the glutamic acid at position 6 of the beta chain is mutated to valine. HbE is located at glutamic acid at position 26 of the beta chain is mutated to lysine. HbC is located at glutamic acid at position 6 of the beta chain is mutated to lysine. HbD is located at glutamic acid at position 121 of the beta chain is mutated to glutamine. Most hemoglobin variants or hemoglobin isoforms are usually asymptomatic in heterozygotes with normal red blood cell survival, and can not be noticed by clinicians if a diabetic patient also carries a hemoglobin isoform gene. In addition, HbF is also a common factor affecting the results of glycated hemoglobin detection. HbF is Hb in the fetal period, which is composed of 2 alpha chains and 2 gamma chains. In individuals with persistent HbF due to genetic reasons, the concentration of HbF can reach 30% of the total hemoglobin, while in patients with beta-thalassemia and sickle cell disease, the concentration of HbF accounts for 2% to 20% of the total hemoglobin, etc.

[0049] As some implementations, the pretreatment reagent can include a surfactant and a low-salt solution.

[0050] In some specific examples, the surfactant can be selected from the group consisting of polyoxyethylene alkyl ether, polyoxyethylene alkyl phenyl ether, polyoxyethylene polyoxypropylene ether, polyoxyethylene fatty acid ester, sucrose fatty acid ester, polyoxyethylene sorbitan fatty acid ester, alkyl glycoside, alkylacyl-N-methyl glucamide, (alkylcarbamoyl) methyl pyranose glucoside, alkyl pyranose glucoside, deoxycholic acid amide, saponin. Preferably, the volume percentage concentration of the surfactant in the pretreatment reagent is 0.1-10%.

[0051] In some specific examples, the low-salt solution can be selected from the group consisting of phosphate, citric acid, phthalic acid, acetic acid, succinic acid, imidazole, etc. general buffer, Good's series buffer (zwitterionic buffer), nitrite. Preferably, the concentration of the low-salt solution in the pretreatment reagent is 0.1-80 mmol / L, and the pH is 4.0-9.0.

[0052] As some implementations, the surfactant and the low-salt solution can be used in combination, i.e., mixed in the same solution. As other implementations, the surfactant and the low-salt solution can be used separately, i.e., exist in separate solutions.

[0053] As some implementations, the first detection reagent can include an HbF detection reagent. The HbF detection reagent, for example, is a reagent containing isopropyl alcohol. Preferably, the volume percentage concentration of isopropyl alcohol in the HbF detection reagent is 10-30%.

[0054] As some implementations, the first detection reagent can include an HbS detection reagent. The HbS detection reagent, for example, can include a buffer, a reducing reagent, and a surfactant. The buffer, for example, is a phosphate or a buffer in Good’s series. Preferably, the pH value of the buffer is 6-7. The reducing reagent, for example, is a sulfite such as sodium sulfite or potassium sulfite. The surfactant, for example, is a saponin.

[0055] As some implementations, the first detection reagent can include both the HbF detection reagent and the HbS detection reagent.

[0056] As some other implementations, the first detection reagent can include an antibody specific to a hemoglobin variant (e.g., including one or more of an HbS-specific antibody, an HbE-specific antibody, an HbC-specific antibody, an HbD-specific antibody, and an HbF-specific antibody), a buffer, a stabilizer, a preservative, etc.

[0057] As some implementations, the pretreatment reagent and the first detection reagent can be used in combination, i.e., mixed in the same solution. As some other implementations, the pretreatment reagent and the first detection reagent can be used separately, i.e., present in separate solutions.

[0058] As some implementations, the second detection reagent, for example, is a reagent for detecting the concentration of hemoglobin or glycated hemoglobin by using an immunological method or an enzymatic method. In the case of detecting the concentration of glycated hemoglobin by using an immunological method, the second detection reagent includes an immunological reagent, e.g., including a glycated hemoglobin-specific antibody and a multi-cluster monop antigen carrying several antigenic determinants of glycated hemoglobin. In the case of detecting the concentration of glycated hemoglobin by using an enzymatic method, the second detection reagent includes an enzymatic reagent, e.g., including a proteolytic enzyme and a specific oxidase.

[0059] In some embodiments, the controller 140 can be further configured to output prompt information including the type of the interfering substance according to the interfering substance information, e.g., output prompt information that the type of the interfering substance is HbF or output prompt information that the type of the interfering substance includes HbF and HbS. Further, the controller 140 can be further configured to output the content or concentration of the interfering substance, e.g., HbF and HbS. By outputting the content or concentration of the interfering substance, e.g., hemoglobin variant, the examining physician can determine whether the result of the detection of glycated hemoglobin is accurate or needs to be further analyzed by checking the concentration of the interfering substance, thereby reducing the occurrence of misdiagnosis.

[0060] In some embodiments, the controller 140 can be further configured to select a sample preparation parameter of the sample preparation device 110 for preparing the sample liquid to be tested according to the interferent information. Accordingly, the sample preparation device 110 can be further configured to prepare the sample liquid to be tested according to the selected sample preparation parameter. Here, the preparation parameter of the sample liquid to be tested is selected according to the interferent information, which is advantageous to improve the accuracy of hemoglobin or glycated hemoglobin detection.

[0061] As some implementations, the preparation parameter can include: an amount of the blood sample or the pretreatment reagent or the second detection reagent used for preparing the sample liquid to be tested or a proportion of the blood sample or the pretreatment reagent or the second detection reagent in the sample liquid to be tested, and / or a type of the second detection reagent used for preparing the sample liquid to be tested. The type of the second detection reagent is, for example, an enzyme method detection reagent or an immunological method detection reagent.

[0062] As some implementations, the controller 140 can be further configured to select an immunological method detection reagent as the second detection reagent used for preparing the sample liquid to be tested when the interferent information indicates that the HbS variant exists in the blood sample.

[0063] As shown in Figure 4 , the embodiments of the present application also propose a sample analyzer 100', which includes 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 test liquid by using a blood sample and a pretreatment reagent, and to prepare a sample liquid to be tested according to the pretreatment test liquid and a second detection reagent; the first detection device 120' is configured to detect the pretreatment test liquid to obtain interferent information of the blood sample; the second detection device 130' is configured to detect the sample liquid to be tested to obtain a hemoglobin detection result and / or a glycated hemoglobin detection result of the blood sample; and the controller 140' is configured to output a prompt information when the interferent information indicates that an interferent exists in the blood sample which interferes with the hemoglobin detection and / or the glycated hemoglobin detection.

[0064] In some embodiments, the sample analyzer 100' can be configured as a biochemical analyzer as shown in Figure 2 .

[0065] In some embodiments, the first detection device 120' is further configured to irradiate the pretreatment test liquid with light, and to obtain a light signal generated by the pretreatment test liquid after being irradiated with light, so as to obtain the interferent information based on the light signal, wherein the interferent includes bilirubin or lipemia.

[0066] In some embodiments, the first detection device 120' is configured to detect the absorbance of the pretreated sample solution at at least one optical wavelength to obtain interfering information based on the absorbance. For example, the first detection device 120' is configured to detect the absorbance of the pretreated sample solution at a first optical wavelength and the absorbance at a second optical wavelength, wherein the first optical wavelength is any wavelength in the range of 450-500 nm, and the second optical wavelength is any wavelength in the range of 500-600 nm. At the first optical wavelength, both hemoglobin and bilirubin exhibit characteristic absorption, while at the second optical wavelength, bilirubin shows no absorption, but hemoglobin shows characteristic absorption. The concentration of bilirubin can be calculated from the absorbance of the pretreated sample solution at the first optical wavelength and the absorbance at the second optical wavelength, thereby determining the presence of bilirubin interference in the blood sample.

[0067] In some embodiments, the controller 140' is further configured to select an immunoassay-based detection reagent as the second detection reagent for preparing the test sample solution when the interference information indicates the presence of bilirubin in the blood sample.

[0068] In a specific example, the whole blood sample to be tested is first lysed with a hemolysing agent (i.e., pretreatment reagent) in a certain proportion to obtain a pretreatment solution. The hemolysing agent ruptures the red blood cell membrane to release hemoglobin. When the hemolysing agent is mixed with the whole blood sample to be tested, the hemoglobin is oxidized to methemoglobin. The absorbance of the pretreatment solution is measured at a first wavelength and a second wavelength. The first wavelength is any wavelength in the range of 450-500 nm, and the second wavelength is any wavelength in the range of 500-600 nm. Hemoglobin and bilirubin both have characteristic absorption at the first wavelength, while bilirubin has no absorption at the second wavelength, but hemoglobin has characteristic absorption at the second wavelength. The hemoglobin concentration in the sample can be obtained based on the absorbance at the second wavelength and the extinction coefficient of hemoglobin at the second wavelength. The absorbance of hemoglobin at the first light wavelength can be obtained by using the hemoglobin concentration and the extinction coefficient of hemoglobin at the first light wavelength. The absorbance of bilirubin at the first light wavelength can be obtained by subtracting the absorbance of hemoglobin from the absorbance of the pretreated solution at the first light wavelength. The concentration of bilirubin in the sample can be obtained by dividing the absorbance of bilirubin at the first light wavelength by the extinction coefficient of bilirubin at that wavelength. When the bilirubin concentration is greater than a preset threshold, a test sample solution prepared using an immunoturbidimetric assay is selected.

[0069] like Figure 5 As shown in the embodiments of this application, a sample analysis method 200 is also proposed, including the following steps:

[0070] In step S210, a pretreatment reagent is used to prepare a pretreatment solution from the blood sample, a first detection reagent is used to prepare an interferent detection solution from the pretreatment solution, and a second detection reagent is used to prepare a sample solution from the pretreatment solution; or, a first detection reagent is used to prepare an interferent detection solution from the blood sample and a pretreatment reagent, and a second detection reagent is used to prepare a sample solution from the interferent detection solution.

[0071] In step S220, the interferent detection solution is detected to obtain interferent information of the blood sample.

[0072] In step S230, the sample solution is detected to obtain a hemoglobin detection result and / or a glycated hemoglobin detection result of the blood sample.

[0073] In step S240, when the interferent information indicates that there is an interferent in the blood sample that interferes with the hemoglobin detection and / or the glycated hemoglobin detection, a prompt information is output.

[0074] In some embodiments, the pretreatment reagent includes a hemolytic agent for lysing red blood cells in the blood sample to release hemoglobin. Further, the first detection reagent includes a reagent for detecting hemoglobin variants. Preferably, the hemoglobin variants include HbF variants and / or HbS variants.

[0075] As some implementations, the pretreatment reagent can be composed of a surfactant and a low-salt solution.

[0076] As some implementations, the first detection reagent can include an HbF detection reagent. The HbF detection reagent, for example, is a reagent containing isopropyl alcohol. Preferably, the volume percentage concentration of isopropyl alcohol in the HbF detection reagent is 10-30%.

[0077] As some implementations, the first detection reagent can include an HbS detection reagent. The HbS detection reagent, for example, can contain a buffer, a reducing reagent, and a surfactant. The buffer, for example, is a phosphate or a Good’s series buffer. Preferably, the pH value of the buffer is 6-7. The reducing reagent, for example, is a sulfite such as sodium sulfite or potassium sulfite. The surfactant, for example, is a saponin.

[0078] As some implementations, the first detection reagent can include both an HbF detection reagent and an HbS detection reagent.

[0079] In some embodiments, the second detection reagent includes an immunoassay-based or enzyme-based detection reagent.

[0080] In some embodiments, the method 200 further includes outputting a prompt information including an interferent type according to the interferent information.

[0081] In some embodiments, the method 200 further comprises: selecting a sample preparation parameter for preparing the sample liquid to be tested according to the interferent information, and preparing the sample liquid to be tested according to the sample preparation parameter in step S210.

[0082] As some implementations, the sample preparation parameter comprises an amount of the blood sample or the pretreatment reagent or the second detection reagent used for preparing the sample liquid to be tested or a proportion of the blood sample or the pretreatment reagent or the second detection reagent in the sample liquid to be tested, and / or a type of the second detection reagent used for preparing the sample liquid to be tested.

[0083] In some embodiments, the method 200 further comprises: when the interferent information indicates that the HbS variant or the bilirubin exists in the blood sample, selecting the immunological detection reagent as the second detection reagent used for preparing the sample liquid to be tested.

[0084] More features and advantages of the sample analysis method 200 provided by the embodiments of the present application can be referred to the above description of the sample analyzer 100 provided by the embodiments of the present application, which will not be described here again.

[0085] Next, some specific embodiments of the present application are described.

[0086] Embodiment 1

[0087] Using Figure 2 The blood sample is detected by the biochemical analyzer shown in the figure.

[0088] Please refer to Table 1, which shows the composition and concentration of the pretreatment reagent, the first detection reagent and the second detection reagent used by the biochemical analyzer in this embodiment 1.

[0089] Table 1

[0090]

[0091]

[0092] In embodiment 1, the process of detecting the blood sample on the biochemical analyzer is as follows:

[0093] The sample preparation device 110 adds 200 μL of the pretreatment reagent in the first reaction cup, and then 10 μL of the whole blood / red blood cell sample is sucked and added into the first reaction cup for mixing. After the pretreatment reagent and the whole blood / red blood cell sample are mixed, they are incubated at 37°C for 5-10 minutes, so as to prepare the pretreatment solution.

[0094] The sample preparation device 110 adds 200 μL of the first detection reagent into the second reaction cup, and the first detection device 120 reads the absorbance Al of the first detection reagent in the second reaction cup at 800 nm. Then, the sample preparation device 110 sucks 10 μL of the pretreatment solution from the first reaction cup and adds it into the second reaction cup to mix with the first detection reagent. After mixing, the pretreatment solution and the first detection reagent are incubated at 37°C for 10 minutes to prepare the interferent detection solution. Then, the first detection device 120 reads the absorbance A2 of the interferent detection solution in the second reaction cup at 800 nm. Thus, the HbF content can be obtained according to the difference between the absorbance A2 and the absorbance Al and the preset calibration model.

[0095] The sample preparation device 110 adds the second detection reagent 1 into the third reaction cup, and the second detection device 130 reads the absorbance A3 of the second detection reagent 1 in the third reaction cup at 505 nm. Next, the sample preparation device 110 sucks 12 μL of the pretreatment solution from the first reaction cup and mixes it with 180 μL of the second detection reagent 1 and incubates at 37°C for 5 minutes to prepare the first sample solution. Then, the second detection device 130 reads the absorbance A4 of the first sample solution in the third reaction cup at 660 nm and the absorbance A5 at 505 nm. Next, the sample preparation device 110 adds 60 μL of the second detection reagent 2 into the third reaction cup, mixes and incubates at 37°C for 5 minutes to prepare the second sample solution. Then, the second detection device 130 reads the absorbance A6 of the second sample solution in the third reaction cup at 660 nm. 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 glycated hemoglobin content can be obtained according to the difference between the absorbance A6 and the absorbance A4 and the preset calibration model. Finally, the HbF ratio (HbF%) can be obtained according to the total hemoglobin content and the HbF content, and the glycated hemoglobin ratio (HbAlc%) can be obtained according to the total hemoglobin content and the glycated hemoglobin content.

[0096] A plurality of blood samples with different HbF concentrations are collected, and the HPLC instrument is used to obtain the HbF% and HbAlc% of the samples as target values, and the samples are detected using Example 1 to obtain the HbF% and HbAlc% according to the present application as measured values, and finally the relative deviation between the target values and the measured values is calculated, and the results are shown in Table 2.

[0097] Table 2

[0098]

[0099] As can be seen from Table 2, the embodiments of the present application can effectively detect the HbF concentration, and as the HbF concentration increases, the result of the glycosylated hemoglobin % obtained based on the enzyme method is lower, so the experimenters can determine the accuracy of the result of the glycosylated hemoglobin % by the concentration of HbF.

[0100] Example 2

[0101] Using Figure 2 The blood sample is detected by the biochemical analyzer shown in the figure.

[0102] 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 by the biochemical analyzer in Example 2.

[0103] Table 3

[0104]

[0105] In Example 2, the process of detecting the blood sample on the biochemical analyzer is as follows:

[0106] The sample preparation device 110 adds 200 μL of the pretreatment reagent in the first reaction cup, and then sucks 2 μL of the whole blood / red blood cell sample and adds it into the first reaction cup for mixing. After the pretreatment reagent and the whole blood / red blood cell sample are mixed, they are incubated at 37°C for 5-10 minutes, thereby preparing a pretreatment solution.

[0107] The sample preparation device 110 adds 100 μL of the first detection reagent in the second reaction cup, and correspondingly, the first detection device 120 reads the absorbance A1 of the first detection reagent in the second reaction cup at 800 nm. Then, the sample preparation device 110 sucks 20 μL of the pretreatment solution from the first reaction cup and adds it into the second reaction cup for mixing with the first detection reagent. After the pretreatment solution and the first detection reagent are mixed, they are incubated at 37°C for 10 minutes, thereby preparing an interference detection solution. Then, the first detection device 120 reads the absorbance A2 of the interference detection solution in the second reaction cup at 800 nm. Thus, according to the difference between the absorbance A2 and the absorbance A1 and the preset calibration model, the HbS content can be obtained.

[0108] The sample preparation device 110 adds the second detection reagent 1 into the third reaction cup, and the second detection device 130 reads the absorbance A3 of the second detection reagent 1 in the third reaction cup at 505 nm. Next, the sample preparation device 110 mixes and incubates 12 μL of the pretreatment reagent with 300 μL of the second detection reagent 1 from the first reaction cup at 37°C for 5 minutes to prepare the first sample liquid to be tested. Then, the second detection device 130 reads the absorbance A4 of the first sample liquid to be tested in the third reaction cup at 340 nm and the absorbance A5 at 505 nm. Next, the sample preparation device 110 adds 60 μL of the second detection reagent 2 into the third reaction cup, mixes and incubates at 37°C for 5 minutes to prepare the second sample liquid to be tested. Then, the second detection device 130 reads the absorbance A6 of the second sample liquid to be tested in the third reaction cup at 340 nm. 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 glycated hemoglobin content can be obtained according to the difference between the absorbance A6 and the absorbance A4 and the preset calibration model. Finally, the HbS ratio (HbS%) can be obtained according to the total hemoglobin content and the HbS content, and the glycated hemoglobin ratio (HbAlc%) can be obtained according to the total hemoglobin content and the glycated hemoglobin content.

[0109] A plurality of blood samples with different HbS concentrations are collected, and the HbS% and HbAlc% of the samples are obtained as target values by using a high performance liquid chromatography (HPLC) instrument, and the samples are detected by using Example 2 to obtain the HbS% and HbAlc% according to the present application as measured values, and finally the relative deviation between the target values and the measured values is calculated, and the results are shown in Table 4.

[0110] Table 4

[0111]

[0112]

[0113] As can be seen from Table 4, the HbS concentration can be effectively detected by the present application, and as the HbS concentration increases, the glycated hemoglobin % result obtained based on the immunological method is low, so the accuracy of the glycated hemoglobin % result can be determined by the concentration of HbS by the experimenters.

[0114] Example 3

[0115] The blood samples are detected by using the biochemical analyzer shown in Figure 2

[0116] Please refer to Table 5, which shows the components and concentrations of the pretreatment reagent, the first detection reagent and the second detection reagent used by the biochemical analyzer in the present Example 3. ​

[0117] Table 1

[0118]

[0119]

[0120] In Example 3, the process of detecting the blood sample on the biochemical analyzer is as follows:

[0121] The sample preparation device 110 adds 200 μL of pretreatment reagent into the first reaction cup, and then sucks 2 μL of whole blood / red blood cell sample into the first reaction cup and mixes them. After the pretreatment reagent and the whole blood / red blood cell sample are mixed, they are incubated at 37°C for 5-10 minutes, so as to prepare pretreatment test solution.

[0122] The sample preparation device 110 adds 100 μL of HbF detection reagent into the second reaction cup. Correspondingly, the first detection device 120 reads the absorbance A11 of the HbF detection reagent in the second reaction cup at 800 nm. Then, the sample preparation device 110 sucks 20 μL of pretreatment test solution from the first reaction cup and adds it into the second reaction cup to mix with the HbF detection reagent. After the pretreatment test solution and the HbF detection reagent are mixed, they are incubated at 37°C for 10 minutes, so as to prepare interference detection test solution. Then, the first detection device 120 reads the absorbance A21 of the interference detection test solution in the second reaction cup at 800 nm. In this way, the HbF content can be obtained according to the difference between the absorbance A21 and the absorbance A11 and a preset calibration model.

[0123] The sample preparation device 110 adds 100 μL of HbS detection reagent into the third reaction cup. Correspondingly, the first detection device 120 reads the absorbance A12 of the HbS detection reagent in the third reaction cup at 800 nm. Then, the sample preparation device 110 sucks 20 μL of pretreatment test solution from the first reaction cup and adds it into the third reaction cup to mix with the HbS detection reagent. After the pretreatment test solution and the HbS detection reagent are mixed, they are incubated at 37°C for 10 minutes, so as to prepare interference detection test solution. Then, the first detection device 120 reads the absorbance A22 of the interference detection test solution in the third reaction cup at 800 nm. In this way, the HbS content can be obtained according to the difference between the absorbance A22 and the absorbance A12 and a preset calibration model.

[0124] The sample preparation device 110 adds the second detection reagent 1 into the fourth reaction cup, and the second detection device 130 reads the absorbance A3 of the second detection reagent 1 in the fourth reaction cup at 505 nm. Next, the sample preparation device 110 mixes and incubates 12 μL of the pretreated reagent and 300 μL of the second detection reagent 1 in the first reaction cup at 37°C for 5 minutes to prepare the first sample liquid to be tested. Then, the second detection device 130 reads the absorbance A4 of the first sample liquid to be tested in the fourth reaction cup at 340 nm and the absorbance A5 at 505 nm. Next, the sample preparation device 110 adds 60 μL of the second detection reagent 2 into the fourth reaction cup, mixes and incubates at 37°C for 5 minutes to prepare the second sample liquid to be tested. Then, the second detection device 130 reads the absorbance A6 of the second sample liquid to be tested in the fourth reaction cup at 340 nm. 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 glycated hemoglobin content can be obtained according to the difference between the absorbance A6 and the absorbance A4 and the preset calibration model. Finally, the HbF ratio (HbF%) can be obtained according to the total hemoglobin content and the HbF content, the HbS ratio (HbS%) can be obtained according to the total hemoglobin content and the HbS content, and the glycated hemoglobin ratio (HbA1c%) can be obtained according to the total hemoglobin content and the glycated hemoglobin content.

[0125] A plurality of blood samples with different HbF and HbS concentrations are collected, and the HbF%, HbS% and HbA1c% of the samples are obtained as target values by using a high performance liquid chromatography (HPLC) instrument, and the samples are detected by using Example 3 to obtain the HbF%, HbS% and HbA1c% according to the application as measured values, and finally the relative deviation between the target values and the measured values is calculated, and the results are shown in Table 6.

[0126] Table 6

[0127]

[0128]

[0129]

[0130] As can be seen from Table 6, the HbF and HbS concentrations can be effectively detected by the application, and as the HbF and HbS concentrations increase, the glycated hemoglobin % result obtained based on the immunological method is low, so the accuracy of the glycated hemoglobin % result can be judged by the concentration of HbF and HbS by the experimenters.

[0131] Example 4

[0132] Using Figure 2The biochemical analyzer shown detects a blood sample.

[0133] 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 by the biochemical analyzer in this embodiment 4. In this embodiment 4, the pretreatment reagent and the first detection reagent are used in combination, i.e. mixed in the same solution.

[0134] Table 7

[0135]

[0136]

[0137] In embodiment 4, the process of detecting a blood sample on the biochemical analyzer is as follows:

[0138] The sample preparation device 110 adds 200 μL of the pretreatment reagent in the first reaction cup, and correspondingly, the first detection device 120 reads the absorbance A1 of the pretreatment reagent in the first reaction cup at 800 nm. Then, the sample preparation device 110 sucks 10 μL of the whole blood / red blood cell sample and adds it into the first reaction cup for mixing, and after the pretreatment reagent is mixed with the whole blood / red blood cell sample, it is incubated at 37°C for 5 minutes to prepare a pretreatment solution (also a 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, according to the difference between the absorbance A2 and the absorbance A1 and a preset calibration model, the HbF content can be obtained.

[0139] The sample preparation device 110 adds the second detection reagent 1 into the second reaction cup, and the second detection device 130 reads the absorbance A3 of the second detection reagent 1 in the second reaction cup at 505 nm. Next, the sample preparation device 110 mixes and incubates 12 μL of the pretreated test solution with 180 μL of the second detection reagent 1 in the first reaction cup at 37°C for 5 minutes to prepare the first sample liquid to be tested. Then, the second detection device 130 reads the absorbance A4 of the first sample liquid to be tested in the second reaction cup at 660 nm and the absorbance A5 at 505 nm. Next, the sample preparation device 110 adds 60 μL of the second detection reagent 2 into the second reaction cup, mixes and incubates at 37°C for 5 minutes to prepare the second sample liquid to be tested. Then, the second detection device 130 reads the absorbance A6 of the second sample liquid to be tested in the second reaction cup at 660 nm. 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 glycated hemoglobin content can be obtained according to the difference between the absorbance A6 and the absorbance A4 and the preset calibration model. Finally, the HbF ratio (HbF%) can be obtained according to the total hemoglobin content and the HbF content, and the glycated hemoglobin ratio (HbAlc%) can be obtained according to the total hemoglobin content and the glycated hemoglobin content.

[0140] A plurality of blood samples with different HbF concentrations were collected, and the HbF% and HbAlc% of the samples were obtained as target values using a high performance liquid chromatography (HPLC) instrument, and the samples were detected using Example 4 to obtain the HbF% and HbAlc% according to the present application as measured values, and finally the relative deviation between the target values and the measured values was calculated, and the results are shown in Table 8.

[0141] Table 8

[0142]

[0143] In Table 8, the symbols "-", "+" and "++" represent the magnitude of HbF% respectively. As can be seen from Table 8, the present application can not only effectively detect the presence of HbF, but also the glycated hemoglobin% result is low with the increase of HbF concentration. Therefore, the accuracy of the glycated hemoglobin% result can be judged by the amount of HbF.

[0144] Example 5

[0145] The blood samples were detected using the biochemical analyzer shown in Figure 2

[0146] ​The ingredients and concentrations of the pretreatment reagent, the first detection reagent and the second detection reagent used in the biochemical analyzer in this embodiment 5 are shown in Table 9. In this embodiment 4, the pretreatment reagent and the first detection reagent are used in combination, i.e. mixed in the same solution.

[0147] Table 9

[0148]

[0149] In the embodiment 5, the process of detecting the blood sample on the biochemical analyzer is as follows:

[0150] The sample preparation device 110 adds 200 μL of the pretreatment reagent in the first reaction cup, and accordingly the first detection device 120 reads the absorbance A1 of the pretreatment reagent in the first reaction cup at 800 nm. Then, the sample preparation device 110 sucks 10 μL of the whole blood / red blood cell sample and adds it into the first reaction cup for mixing, and after the pretreatment reagent is mixed with the whole blood / red blood cell sample, it is incubated at 37°C for 5 minutes to prepare a pretreatment solution (also the interferent detection solution), and accordingly 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 according to the difference between the absorbance A2 and the absorbance A1 and the preset calibration model.

[0151] The sample preparation device 110 adds the second detection reagent 1 in the second reaction cup, and accordingly the second detection device 130 reads the absorbance A3 of the second detection reagent 1 in the second reaction cup at 505 nm. Next, the sample preparation device 110 sucks 3 μL of the pretreatment solution from the first reaction cup and mixes it with 300 μL of the second detection reagent 1 and incubates at 37°C for 5 minutes to prepare a first sample to be tested. Then, the second detection device 130 reads the absorbance A4 of the first sample to be tested in the second reaction cup at 340 nm and the absorbance A5 at 505 nm. Next, the sample preparation device 110 further adds 60 μL of the second detection reagent 2 into the second reaction cup, mixes and reacts at 37°C for 5 minutes to prepare a second sample to be tested. Then, the second detection device 130 reads the absorbance A6 of the second sample to be tested in the second reaction cup at 340 nm. 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 glycated hemoglobin content can be obtained according to the difference between the absorbance A6 and the absorbance A4 and the preset calibration model. Finally, the HbS proportion (HbS%) can be obtained according to the total hemoglobin content and the HbS content, and the glycated hemoglobin proportion (HbAlc%) can be obtained according to the total hemoglobin content and the glycated hemoglobin content.

[0152] A plurality of blood samples with different HbS concentrations were collected, HbS% and HbA1c% of the samples were obtained as target values by using a high performance liquid chromatography (HPLC) instrument, the samples were detected by using Example 5 to obtain HbS% and HbA1c% as measured values according to the present application, and finally the relative deviation between the target values and the measured values was calculated, and the results are shown in Table 10.

[0153] Table 10

[0154]

[0155] In Table 10, the symbols "-", "+" and "++" represent the magnitude of HbF% respectively. As can be seen from Table 10, the present application can not only effectively detect the presence of HbS, but also the result of glycosylated hemoglobin% based on immunological detection is lower with the increase of HbS concentration. Therefore, the accuracy of the result of glycosylated hemoglobin% can be judged by the amount of HbS by the experimenters.

[0156] The features or combinations of features mentioned in the specification, drawings and claims can be used or combined arbitrarily or individually within the scope of the present application as long as they are meaningful and do not contradict each other. The advantages and features described with reference to the sample analyzer provided by the embodiments of the present application are applicable to the sample analysis method provided by the embodiments of the present application in a corresponding manner, and vice versa.

[0157] The above only describes the preferred embodiments of the present application, and does not limit the patent scope of the present application. Any equivalent transformation scheme made by using the content of the specification and drawings of the present application, or direct / indirect application in other related technical fields within the inventive concept of the present application is included in the patent protection scope of the present application.

Claims

1. A sample analyzer characterized by, The sample preparation device is configured to prepare a pretreatment test solution by using a blood sample and a pretreatment reagent, prepare an interferent detection test solution by using the pretreatment test solution and a first detection reagent, and prepare a to-be-tested sample solution by using the pretreatment test solution and a second detection reagent. Alternatively, the sample preparation device is configured to prepare an interferent detection test solution by using a blood sample, a pretreatment reagent, and a first detection reagent, and prepare a to-be-tested sample solution by using the interferent detection test solution and a second detection reagent. The first detection device is configured to detect the interferent detection test solution to obtain interferent information of the blood sample. The second detection device is configured to detect the to-be-tested sample solution to obtain a hemoglobin detection result and / or a glycated hemoglobin detection result of the blood sample. The controller is configured to output prompt information when the interferent information indicates that there is an interferent that interferes with hemoglobin detection and / or glycated hemoglobin detection in the blood sample. The pretreatment reagent includes a hemolytic agent for lysing red blood cells in the blood sample to release hemoglobin, and the first detection reagent includes a reagent for detecting hemoglobin variants. The hemoglobin variants include HbF variants and / or HbS variants.

2. The sample analyzer of claim 1, wherein, The controller is further configured to output prompt information including an interferent type according to the interferent information.

3. The sample analyzer of claim 2, wherein, The controller is further configured to select a sample preparation parameter for the sample preparation device to prepare the to-be-tested sample solution according to the interferent information, and 4. The sample analyzer of any one of claims 1 to 3, wherein, The sample preparation device is further configured to prepare the to-be-tested sample solution according to the selected sample preparation parameter.

5. The sample analyzer of any one of claims 1 to 3, wherein, The controller is further configured to select a detection mode of the second detection device according to the interferent information, and the second detection device is further configured to detect the to-be-tested sample solution in the selected detection mode. The sample preparation parameter includes:

6. The sample analyzer of claim 5, wherein, an amount or a proportion of the blood sample or the pretreatment reagent or the second detection reagent used for preparing the to-be-tested sample solution; and / or 7. The sample analyzer of claim 5, wherein, a type of the second detection reagent used for preparing the to-be-tested sample solution. The controller is further configured to select an immunological detection reagent as the second detection reagent used for preparing the to-be-tested sample solution when the interferent information indicates that there is an HbS variant in the blood sample. The sample analyzer is configured as a biochemical analyzer, the sample preparation device is further configured to prepare the to-be-tested sample solution based on an immunological method or an enzymatic method, and the first detection device and the second detection device are configured as the same photometric device.

8. The sample analyzer of claim 7, wherein, The sample preparation device is configured to prepare a pretreatment test solution by using a blood sample and a pretreatment reagent, and prepare a to-be-tested sample solution according to the pretreatment test solution and a second detection reagent.

9. The sample analyzer of any one of claims 1 to 3, wherein, The first detection device is configured to detect the pretreatment test solution to obtain interferent information of the blood sample.

10. A sample analyzer characterized by, The second detection device is configured to detect the to-be-tested sample solution to obtain a hemoglobin detection result and / or a glycated hemoglobin detection result of the blood sample. The controller is configured to output prompt information when the interferent information indicates that there is an interferent that interferes with hemoglobin detection and / or glycated hemoglobin detection in the blood sample. ​ ​ ​ The controller is configured to output a prompt information when the interference information indicates that there is an interference substance in the blood sample which interferes with the detection of hemoglobin and / or glycated hemoglobin.

11. The sample analyzer of claim 10, wherein: The first detection device is further configured to irradiate the pretreatment test solution with light and obtain a light signal generated by the pretreatment test solution after being irradiated with light, so as to obtain interference information based on the light signal, wherein the interference substance includes bilirubin or lipemia.

12. The sample analyzer of claim 11, wherein, The controller is further configured to select an immunological detection reagent as the second detection reagent for preparing the sample liquid to be detected when the interference information indicates that there is bilirubin in the blood sample.

13. A sample analysis method, comprising: preparing a pretreatment test solution by using a blood sample and a pretreatment reagent, preparing an interference detection test solution by using the pretreatment test solution and a first detection reagent, and preparing a sample liquid to be detected by using the pretreatment test solution and a second detection reagent; or, preparing an interference detection test solution by using a blood sample, a pretreatment reagent and a first detection reagent, and preparing a sample liquid to be detected by using the interference detection test solution and a second detection reagent; detecting the interference detection test solution to obtain interference information of the blood sample; detecting the sample liquid to be detected to obtain a hemoglobin detection result and / or a glycated hemoglobin detection result of the blood sample; and outputting a prompt information when the interference information indicates that there is an interference substance in the blood sample which interferes with the detection of hemoglobin and / or glycated hemoglobin.

14. The sample analysis method of claim 13, wherein, The pretreatment reagent includes a hemolytic agent for lysing red blood cells in the blood sample to release hemoglobin, and the first detection reagent includes a reagent for detecting hemoglobin variants; and / or The second detection reagent includes an immunological or enzymatic detection reagent.

15. The sample analysis method of claim 14, wherein, The hemoglobin variants include HbF variants and / or HbS variants. The controller is configured to output a prompt information when the interference information indicates that there is an interference substance in the blood sample which interferes with the detection of hemoglobin and / or glycated hemoglobin. The first detection device is further configured to irradiate the pretreatment test solution with light and obtain a light signal generated by the pretreatment test solution after being irradiated with light, so as to obtain interference information based on the light signal, wherein the interference substance includes bilirubin or lipemia. The controller is further configured to select an immunological detection reagent as the second detection reagent for preparing the sample liquid to be detected when the interference information indicates that there is bilirubin in the blood sample.

13. A sample analysis method, comprising: preparing a pretreatment test solution by using a blood sample and a pretreatment reagent, preparing an interference detection test solution by using the pretreatment test solution and a first detection reagent, and preparing a sample liquid to be detected by using the pretreatment test solution and a second detection reagent; or, preparing an interference detection test solution by using a blood sample, a pretreatment reagent and a first detection reagent, and preparing a sample liquid to be detected by using the interference detection test solution and a second detection reagent; detecting the interference detection test solution to obtain interference information of the blood sample; detecting the sample liquid to be detected to obtain a hemoglobin detection result and / or a glycated hemoglobin detection result of the blood sample; and outputting a prompt information when the interference information indicates that there is an interference substance in the blood sample which interferes with the detection of hemoglobin and / or glycated hemoglobin. The pretreatment reagent includes a hemolytic agent for lysing red blood cells in the blood sample to release hemoglobin, and the first detection reagent includes a reagent for detecting hemoglobin variants; and / or The second detection reagent includes an immunological or enzymatic detection reagent. The hemoglobin variants include HbF variants and / or HbS variants.

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