CN116794335A - Sample analyzer and sample detection method - Google Patents
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Abstract
The application relates to a sample analyzer and a method. The analyzer includes: a glycosylated hemoglobin measurement unit for obtaining a glycosylated hemoglobin measurement result of a blood sample; a mode selection unit configured to select a first detection mode or a second detection mode; and a controller configured to control the glycosylated hemoglobin measurement section to perform a first measurement flow when the first detection mode is selected, and to control the glycosylated hemoglobin measurement section to perform a second measurement flow when the second detection mode is selected, the second measurement flow including: the first pretreatment test solution is prepared by adopting a blood sample and a pretreatment reagent, the first pretreatment test solution is detected to obtain intermediate detection information, the first sample solution to be detected is prepared by adopting a second pretreatment test solution and a glycosylated hemoglobin detection reagent according to the intermediate detection information, the glycosylated hemoglobin detection result is obtained, and the first measurement flow and the second measurement flow are at least partially different. Thereby improving detection accuracy and providing selectivity.
Description
Technical Field
The present application relates to the field of in vitro diagnostics, and in particular to a sample analyzer and a sample detection method.
Background
Glycosylated hemoglobin is also called glycosylated hemoglobin, and is the product of non-enzymatic catalytic reaction between sugar such as glucose and amino groups of hemoglobin, and its content is positively correlated with blood glucose concentration in blood. Since the protein glycation reaction is an irreversible reaction and the lifetime of red blood cells in the blood circulation is 120 days, the glycosylated hemoglobin can reflect the average blood glucose concentration of nearly three months and is widely used for clinical diagnosis and treatment monitoring as a blood glucose control index.
In clinical examination, the ratio or percentage of glycosylated hemoglobin to hemoglobin is generally used as a report unit, and there are mainly IFCC (mmol/mol), NGSP (%), JDS/JSCC (%) in Japan and Monos (%) in Sweden.
The existing measurement techniques of glycosylated hemoglobin include immunoaffinity chromatography, ion exchange chromatography, capillary electrophoresis, immunoturbidimetry, enzymatic method, and the like. In these measurement methods, retests may be caused by factors such as interference of turbid lipid samples or detection results exceeding the effective measurement range.
In existing solutions, it is often determined whether the glycosylated hemoglobin measurement of a sample is out of the effective measurement range after the glycosylated hemoglobin measurement of the sample is obtained, and if the glycosylated hemoglobin measurement of the sample is out of the effective measurement range, the sample is retested in another test mode. However, frequent retests result in reduced detection efficiency and increased costs.
Disclosure of Invention
In order to solve at least partially the above-mentioned problems, an object of the present application is to provide a sample analyzer and a sample detection method in which two detection modes are provided for selection, which can improve the accuracy of glycosylated hemoglobin detection and increase the selectivity for a user.
To achieve the above-described object, a first aspect of the present application provides a sample analyzer comprising:
a glycosylated hemoglobin measurement unit for obtaining a glycosylated hemoglobin measurement result of a blood sample of a subject;
a mode selection unit for selecting the first glycosylated hemoglobin measurement mode or the second glycosylated hemoglobin measurement mode; and
a controller configured to control the operation of the device,
receiving a mode selection of the mode selection section,
when the mode selection section selects the first glycosylated hemoglobin measurement mode, controlling the glycosylated hemoglobin measurement section to execute a first measurement flow, and
when the mode selection unit selects the second glycosylated hemoglobin measurement mode, the glycosylated hemoglobin measurement unit is controlled to execute a second measurement flow including: preparing a first pretreatment test solution by adopting a blood sample of the subject and a pretreatment reagent, detecting the first pretreatment test solution to obtain intermediate detection information, preparing a first sample solution to be detected by adopting a second pretreatment test solution and a glycosylated hemoglobin detection reagent according to the intermediate detection information, and detecting the first sample solution to be detected to obtain a glycosylated hemoglobin detection result, wherein the second pretreatment solution is prepared by adopting the blood sample of the subject and the pretreatment reagent, and the first measurement flow and the second measurement flow are at least partially different.
A second aspect of the present application provides a sample analyzer comprising:
a glycosylated hemoglobin measurement unit for obtaining a glycosylated hemoglobin measurement result of a blood sample of a subject;
a mode selection unit for selecting the first glycosylated hemoglobin measurement mode or the second glycosylated hemoglobin measurement mode; and
a controller configured to control the operation of the device,
receiving a mode selection of the mode selection section,
when the mode selection section selects the first glycosylated hemoglobin measurement mode, controlling the glycosylated hemoglobin measurement section to execute a first measurement flow, and
controlling the glycosylated hemoglobin measurement section to execute a second measurement flow when the mode selection section selects the second glycosylated hemoglobin measurement mode; the effective detection range of the first measurement procedure for the primary glycosylated hemoglobin detection of the blood sample is smaller than the effective detection range of the second measurement procedure for the primary glycosylated hemoglobin detection of the blood sample.
A third aspect of the present application provides a sample detection method, comprising:
selecting a first glycosylated hemoglobin measurement mode or a second glycosylated hemoglobin measurement mode;
executing a first measurement flow when the first glycosylated hemoglobin measurement mode is selected; and
When the second glycated hemoglobin measurement mode is selected, performing a second measurement procedure, the second measurement procedure including: preparing a first pretreatment test solution by adopting a blood sample of a subject and a pretreatment reagent, detecting the first pretreatment test solution to obtain intermediate detection information, preparing a first sample solution to be detected by adopting a second pretreatment test solution and a glycosylated hemoglobin detection reagent according to the intermediate detection information, and detecting the first sample solution to be detected to obtain a glycosylated hemoglobin detection result, wherein the second pretreatment solution is prepared by adopting the blood sample to be detected of the subject and the pretreatment reagent, and the first measurement flow and the second measurement flow are at least partially different.
A fourth aspect of the present application provides a sample detection method, comprising:
selecting a first glycosylated hemoglobin measurement mode or a second glycosylated hemoglobin measurement mode;
executing a first measurement flow when the first glycosylated hemoglobin measurement mode is selected; and
executing a second measurement flow when the second glycosylated hemoglobin measurement mode is selected; the effective detection range of the first measurement procedure for the primary glycosylated hemoglobin detection of the blood sample is smaller than the effective detection range of the second measurement procedure for the primary glycosylated hemoglobin detection of the blood sample.
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 an embodiment of the application;
FIG. 2 is another schematic block diagram of a sample analyzer in accordance with an embodiment of the present application;
FIG. 3 is a schematic block diagram of the sample analyzer of FIG. 2;
FIG. 4 is a schematic block diagram of a first detection device according to an embodiment of the present application;
FIG. 5 is an image of a first pretreatment fluid according to an embodiment of the present application;
FIG. 6 is a schematic flow chart of glycosylated hemoglobin measurement according to an embodiment of the present application;
FIG. 7 is a graph of absorbance difference versus estimated hemoglobin concentration according to one embodiment of the application;
FIG. 8 is another schematic flow chart diagram of glycosylated hemoglobin measurement according to an embodiment of the present application; and
Fig. 9 is a schematic flow chart of a sample detection method according to an embodiment 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.
Fig. 1 is a schematic block diagram of a sample analyzer 1 according to an embodiment of the present application. The sample analyzer includes a glycosylated hemoglobin measurement unit 100, a mode selection unit 200, and a controller 300. The glycosylated hemoglobin measurement unit 100 is used to obtain a glycosylated hemoglobin measurement result of a blood sample of a subject. The mode selection unit 200 is configured to select a first glycosylated hemoglobin measurement mode or a second glycosylated hemoglobin measurement mode. The controller 300 is configured to:
A reception mode selection unit 200;
when the mode selection unit 200 selects the first glycosylated hemoglobin measurement mode, the glycosylated hemoglobin measurement unit 100 is controlled to execute the first measurement flow; and
when the mode selection unit 200 selects the second glycosylated hemoglobin measurement mode, the glycosylated hemoglobin measurement unit 100 is controlled to execute a second measurement flow including: preparing a first pretreatment test solution by adopting a blood sample of the subject and a pretreatment reagent, detecting the first pretreatment test solution to obtain intermediate detection information, preparing a first sample solution to be detected by adopting a second pretreatment test solution and a glycosylated hemoglobin detection reagent according to the intermediate detection information, and detecting the first sample solution to be detected to obtain a glycosylated hemoglobin detection result, wherein the second pretreatment solution is prepared by adopting the blood sample of the subject and the pretreatment reagent, and the first measurement flow and the second measurement flow are at least partially different;
alternatively, the controller 300 is configured to:
receiving a mode selection of the mode selection section,
when the mode selection section selects the first glycosylated hemoglobin measurement mode, controlling the glycosylated hemoglobin measurement section to execute a first measurement flow, and
Controlling the glycosylated hemoglobin measurement section to execute a second measurement flow when the mode selection section selects the second glycosylated hemoglobin measurement mode; the effective detection range of the first measurement procedure for the primary glycosylated hemoglobin detection of the blood sample is smaller than the effective detection range of the second measurement procedure for the primary glycosylated hemoglobin detection of the blood sample.
The sample analyzer in the embodiment of the application can be a single glycosylated hemoglobin analyzer for detecting glycosylated hemoglobin only, or can be a multifunctional analyzer for detecting other items besides glycosylated hemoglobin, such as ISE or other biochemical detection items.
In the embodiment of the application, the effective detection range refers to the range of variation of the concentration of the linear to-be-detected object, wherein the precision and the accuracy of the test result obtained by using one method are both compounded with the requirements.
In the embodiment of the application, by providing two types of glycosylated hemoglobin detection modes, the increase in the selectivity of the glycosylated hemoglobin detection mode can be achieved. In addition, by providing a glycosylated hemoglobin detection mode for guiding a subsequent glycosylated hemoglobin detection based on intermediate detection information of a pre-treatment sample solution, accuracy of glycosylated hemoglobin detection can be improved, retests can be reduced, and overall detection efficiency of a sample analyzer can be improved.
In some embodiments, as shown in fig. 2, the glycosylated hemoglobin measurement portion 100 may include a sample preparation device 110, a first detection device 120, and a second detection device 130. The sample preparation device 110 is for sucking a blood sample from a container 10 containing the blood sample of a subject, for example, a whole blood sample, and preparing a first pretreatment reagent using the sucked blood sample and a pretreatment reagent; and preparing a second pretreatment reagent using the blood sample of the subject and a pretreatment reagent and preparing a first sample solution to be tested using the second pretreatment reagent and a glycosylated hemoglobin detection reagent. The first detection device 120 is used for detecting the first pretreatment liquid prepared by the sample preparation device 110 to obtain intermediate detection information of the first pretreatment liquid. The second detecting means 130 is for detecting the first sample liquid to be detected prepared by the sample preparation means 110 to obtain a glycated hemoglobin detection result.
In a specific embodiment, as shown in fig. 3, the sample analyzer 1 is configured as a biochemical instrument. In the embodiment shown in fig. 3, sample preparation device 110 includes a sample carrier 111, a sample dispensing mechanism 112, a reagent carrier 113, a reagent dispensing mechanism 114, and a reaction component 115.
The sample carrier 111 is for carrying a blood sample. For example, the sample carrier 111 may be configured as a sample tray comprising a plurality of sample locations where the containers 10 may be placed, and the sample tray is capable of being maneuvered by rotation to a corresponding position, for example, to a position where the sample dispensing mechanism 112 draws a blood sample. The sample dispensing mechanism 112 is used to draw a blood sample from the container 10 and discharge it into a reaction cup to be loaded. For example, the sample dispensing mechanism 112 may include a sample needle that is capable of two-dimensional or three-dimensional movement in space by a two-dimensional or three-dimensional drive mechanism, such that the sample needle is capable of moving to a position where a blood sample is drawn and to a reaction cup to be loaded and discharging the drawn blood sample to the reaction cup.
The reagent carrying part 113 is used for carrying reagents including pretreatment reagents and detection reagents. In some embodiments, the reagent carrier 113 may be configured as a reagent disk having a disk-like structure with a plurality of positions for carrying reagent containers, the reagent carrier 113 being capable of rotating and driving the reagent containers carried thereby to rotate the reagent containers to a specific position, such as a position where reagent is aspirated by the reagent dispensing mechanism 114. The number of reagent carrying members 113 may be one or more. The reagent dispensing mechanism 114 is used to aspirate and discharge the reagent into the cuvette to be filled with the reagent. For example, the reagent dispensing mechanism 114 may include a reagent needle that is capable of two-dimensional or three-dimensional movement in space by a two-dimensional or three-dimensional driving mechanism, so that the reagent needle can be moved to a position where reagent is sucked and to a cuvette to which reagent is to be added, and the sucked reagent is discharged to the cuvette.
The reaction part 115 has at least one place for placing a cuvette and incubating a test solution, such as a pretreatment test solution and a sample solution to be tested, in the cuvette. For example, the reaction block 115 may be configured as a reaction disk having a disk-like structure with one or more placement sites for placement of reaction cups, the reaction disk being capable of rotating and moving the reaction cups in its placement sites to facilitate the scheduling of reaction cups within the reaction disk and incubating reagents in the reaction cups.
The first detection device 120 is configured to detect a first pretreatment liquid in which a blood sample and a pretreatment reagent are mixed in the reaction part 115, to obtain intermediate detection information of the first pretreatment liquid. The first detecting means 120 is, for example, provided outside the reaction part 115, and the reaction part 115 rotates to drive the container containing the first pretreatment liquid to move to the first detecting means 130 for detection.
The second detecting means 130 is for detecting the sample liquid to be detected for which incubation is completed in the reaction part 115 to obtain a detection result of the glycosylated hemoglobin. 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 measured to the second detecting device 130 for the glycosylated hemoglobin detection. In some embodiments, the second detection device 130 is configured as a photometry device.
Further, in the embodiment shown in fig. 3, the sample preparation device 110 may further include a reagent transferring part (not shown) for transferring the pre-treated reagent into the corresponding cuvette. In some embodiments, the sample dispensing mechanism 112 may be used as the reagent transfer section.
Taking an immunoturbidimetry and an enzymatic method for detecting glycosylated hemoglobin as an example, in some embodiments, the controller 300 may be further configured to, when controlling the glycosylated hemoglobin measurement portion 100 to perform the second measurement flow, perform the following steps:
controlling the sample preparation device 110 to prepare an intermediate sample liquid to be tested using the second pretreatment liquid and a first detection reagent for glycosylated hemoglobin detection, wherein the first detection reagent comprises an enzyme reagent (e.g., a proteolytic enzyme for glycosylated hemoglobin in the second pretreatment liquid to produce glycosylated peptides or glycosylated amino acids) or an immunological reagent (e.g., a glycosylated hemoglobin-specific antibody) for detecting the hemoglobin content;
controlling the second detecting device 130 to detect the middle 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 intermediate test sample liquid to prepare a first test sample liquid, 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 intermediate test 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 first 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 other embodiments, the second detection device 130 may be configured as a detection device that operates based on ion exchange chromatography. At this time, the detection reagent includes an equilibration buffer and an elution buffer.
In still other embodiments, the second detection device 130 may be configured as a detection device that operates based on affinity chromatography. At this time, the detection reagent includes an aminophenylboronic acid agarose gel, an asparagusamine buffer, a sorbitol buffer (eluent), and the like.
In some embodiments, the first assay procedure may include:
preparing a second sample liquid to be detected by adopting a blood sample of a subject, a pretreatment reagent and a glycosylated hemoglobin detection reagent, and detecting the second sample liquid to be detected to obtain a glycosylated hemoglobin detection result;
when the glycosylated hemoglobin detection result is abnormal, preparing a third sample liquid to be detected by adopting the blood sample of the subject, the pretreatment reagent and the glycosylated hemoglobin detection reagent, and detecting glycosylated hemoglobin of the third sample liquid to be detected;
Wherein, the dosage or proportion of at least one of the blood sample, pretreatment reagent and glycosylated hemoglobin detection reagent of the third sample liquid to be tested and the second sample liquid to be tested is different; or preparing a third sample liquid to be tested and a second sample liquid to be tested, wherein the components, the formulas or the dosage of the pretreatment reagent are different; alternatively, the types or amounts of the glycosylated hemoglobin detection reagents for preparing the third sample liquid to be measured and the second sample liquid to be measured are different.
In some embodiments, the mode selection part 200 may further be used to select the first glycosylated hemoglobin detection mode or the second glycosylated hemoglobin detection mode according to red blood cell related information of the subject. For example, the mode selection section may be configured to: receiving user input to obtain red blood cell related information of the subject; receiving red blood cell related information of the subject from another detecting instrument in communication with the glycosylated hemoglobin sample analyzer, or obtaining red blood cell related information by an information obtaining device, which may be disposed on the sample analyzer or in communication with the sample analyzer; or obtaining red blood cell related information of the subject according to the disease information of the subject.
In some embodiments, the subject's red blood cell related information comprises the subject's hematocrit related information. As described above, the glycosylated hemoglobin concentration in a blood sample is linearly related to the hemoglobin concentration, which in turn is linearly related to the Hematocrit (HCT) of the blood sample. Therefore, when the first test of the glycosylated hemoglobin item is performed on the blood sample to be tested of the subject, the first glycosylated hemoglobin test mode or the second glycosylated hemoglobin test mode may be selected according to the HCT value in the blood sample of the subject.
In one example, the sample preparation device 110 is used for performing centrifugal treatment or natural standing sedimentation treatment on a blood sample to be tested; the above-described information acquisition device may be configured such that the camera photographs the blood sample to be measured after centrifugation or after natural standing sedimentation to obtain an image of the blood sample to be measured, based on which the hematocrit of the blood sample to be measured can be obtained, and the mode selection portion 200 further selects the first glycosylated hemoglobin detection mode or the second glycosylated hemoglobin detection mode according to the hematocrit. Preferably, natural standing sedimentation takes at least half an hour to obtain a good photographing effect. For example, when the concentration of the glycosylated hemoglobin of the blood sample to be measured is determined to be low according to the hematocrit of the blood sample to be measured, the second glycosylated hemoglobin detection mode is started, the first pretreatment liquid and the glycosylated hemoglobin detection reagent are adopted to prepare the first sample liquid to be measured according to the intermediate detection information, and the first sample liquid to be measured is detected according to the intermediate detection information, so that the glycosylated hemoglobin detection node is obtained, the problem that the result is inaccurate when the glycosylated hemoglobin is detected at low concentration is solved, and the effect that the accurate glycosylated hemoglobin detection result can be obtained in one detection is achieved.
In another example, the sample preparation device 110 is used to aspirate a blood sample from a container 10 containing a blood sample to be tested of a subject, such as a whole blood sample, and to prepare a sample fluid to be tested using the aspirated blood sample, a pretreatment reagent, and a detection reagent for glycosylated hemoglobin detection. Here, the sample preparation device 110 absorbs the blood sample, and the sample absorbing pressure is related to the ratio of red blood cells to whole blood, i.e., HCT, whereas the concentration of red blood cells (HCT) to whole blood is known to be positively related to the concentration of hemoglobin to whole blood, so that the relationship between the sample absorbing pressure and the hemoglobin content can be established. Based on the relation, the hemoglobin content of the blood sample to be measured can be judged according to the sample suction pressure, so that the subsequent measurement of glycosylated hemoglobin is guided. For example, the sample preparation device 110 includes a sample suction needle for sucking a blood sample and a sensor for detecting the pressure inside the sample suction needle, i.e., the suction pressure, at the time of sucking the blood sample. The mode selection unit 200 may select the first glycosylated hemoglobin detection mode or the second glycosylated hemoglobin detection mode based on the sample suction pressure measured by the sensor.
In some alternative embodiments, the mode selection portion 200 is configured to:
Receiving user input to obtain red blood cell related information of the subject; or alternatively
Receiving red blood cell related information of the subject from a further detection instrument in communication with the sample analyzer (e.g., receiving a red blood cell pressure product from a blood cell analyzer in communication with the sample analyzer); or obtaining red blood cell related information of the subject according to the disease information of the subject.
In some embodiments, the mode selection portion 200 is further configured to select the first glycosylated hemoglobin detection mode or the second glycosylated hemoglobin detection mode based on a user input. For example, the mode selection part 200 includes a user interaction interface for displaying a control for selecting the glycosylated hemoglobin detection mode and receiving an operation of the control to select the first glycosylated hemoglobin detection mode or the second glycosylated hemoglobin detection mode.
In some embodiments, in the second assay procedure, preparing the first sample fluid to be tested using the second pretreatment test fluid and the glycosylated hemoglobin detection reagent according to the intermediate detection information may include:
selecting a detection mode to be executed from a plurality of different glycosylated hemoglobin sub-detection modes according to the intermediate detection information; and
And preparing the first sample liquid to be tested by adopting the second pretreatment test liquid and the glycosylated hemoglobin detection reagent according to the detection mode to be executed.
Preferably, the second pretreatment reagent is the first pretreatment reagent. Thus, not only the overall detection efficiency of the sample analyzer can be improved, but also the overall detection cost can be reduced.
Taking the biochemical apparatus shown in FIG. 3 as an example, it is described how to prepare a first sample liquid to be tested using a first pretreatment liquid and a glycosylated hemoglobin detection reagent. The controller 300 controls the reagent dispensing mechanism 114 to add a pretreatment reagent, such as a hemolyzing agent, in the reagent carrying member 113 to the first reaction cup located in the reaction member 115, and then the controller 300 controls the sample dispensing mechanism 112 to draw a portion of the blood sample to be measured, 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 a first pretreatment reagent. The controller 300 controls the first detecting device 130 to detect the first pre-treatment liquid in the first cuvette to obtain intermediate detection information, such as hemoglobin concentration, of the first pre-treatment liquid. The controller 300 selects a detection mode to be performed from among a plurality of different glycosylated hemoglobin sub-detection modes according to intermediate detection information of the first pretreatment liquid. The first pretreatment solution is then incubated in the reaction block 115 for a period of time. Next, the controller 300 controls the reagent dispensing mechanism 114 to add the glycosylated hemoglobin detection reagent in the reagent carrying member 113 to the second cuvette located in the reaction member 115, and controls the reagent transferring section to transfer a part of the first pretreatment reagent in the first cuvette to the second cuvette to which the detection reagent has been added, to prepare the first sample liquid to be measured. Then, the controller 300 controls the second detecting device 130 to detect the first sample liquid to be detected in the second cuvette.
Alternatively, in other embodiments, it may be provided that the first sample liquid to be tested is not prepared using the first pretreatment liquid in the second measurement flow path, but rather the first sample liquid to be tested is prepared using the second pretreatment liquid that is prepared again.
Also, taking the biochemical apparatus shown in fig. 3 as an example, how the first sample liquid to be tested is prepared using the newly prepared second pretreatment liquid. The controller 300 controls the reagent dispensing mechanism 114 to add a pretreatment reagent, such as a hemolyzing agent, in the reagent carrying member 113 to the first reaction cup located in the reaction member 115, and then the controller 300 controls the sample dispensing mechanism 112 to draw a portion of the blood sample to be measured, 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 a first pretreatment reagent. The controller 300 controls the first detecting device 130 to detect the first pre-treatment liquid in the first cuvette to obtain intermediate detection information, such as hemoglobin concentration, of the first pre-treatment liquid. The controller 300 selects a detection mode to be performed from among a plurality of different glycosylated hemoglobin sub-detection modes according to intermediate detection information of the first pretreatment liquid. Then, the controller 300 controls the reagent dispensing mechanism 114 to add a pretreatment reagent, such as a hemolyzing agent, in the reagent carrying member 113 to a second reaction cup located in the reaction member 115 according to the detection mode to be performed, and then the controller 300 controls the sample dispensing mechanism 112 to again aspirate another portion of the blood sample to be tested from the container 10 or aspirate a portion of the blood sample to be tested from another container containing the blood sample to be tested of the same subject and add it to the second reaction cup to which the pretreatment reagent has been added, to obtain a second pretreatment test solution. The second pretreatment reagent is incubated in the reaction block 115 for a period of time. Next, the controller 300 controls the reagent dispensing mechanism 114 to add the detection reagent in the reagent carrying member 113 to the third cuvette in the reaction member 115, and controls the reagent transferring section to transfer a part of the second pretreatment reagent in the second cuvette to the third cuvette to which the detection reagent has been added, to prepare the first sample liquid to be measured. Then, the controller 300 controls the second detecting device 130 to detect the first sample liquid to be detected in the third reaction cup.
Alternatively, in yet other embodiments, it may be provided that the following steps are performed in the second assay flow:
preparing pretreatment test solutions corresponding to respective glycosylated hemoglobin sub-detection modes in a plurality of different glycosylated hemoglobin sub-detection modes by using a blood sample of the subject and a pretreatment reagent;
detecting at least one pretreatment liquid serving as the first pretreatment liquid in the pretreatment liquid to obtain intermediate detection information of the first pretreatment liquid;
selecting a detection mode to be executed from the plurality of different glycosylated hemoglobin sub-detection modes according to the intermediate detection information; and
and selecting a pretreatment test solution corresponding to the detection mode to be executed from the pretreatment test solutions according to the detection mode to be executed as the second pretreatment test solution, and preparing the first sample solution to be tested by adopting the selected pretreatment test solution and the glycosylated hemoglobin detection reagent.
Also, how to prepare the first sample liquid to be measured in this embodiment will be described by taking the biochemical apparatus shown in fig. 3 as an example. The controller 300 controls the reagent dispensing mechanism 114 to add the pretreatment reagent, such as the hemolysis reagent, in the reagent carrying member 113 to the first, second and third reaction cups, respectively, located in the reaction member 115, and then the controller 300 controls the sample dispensing mechanism 112 to add the blood sample to be measured in the container 10 to the first, second and third reaction cups, respectively, to which the pretreatment reagent has been added, to obtain a plurality of pretreatment reagents, wherein at least one of the components, the formulation and the amounts of the pretreatment reagents for preparing the plurality of pretreatment reagents are different from each other, and/or the amounts of the blood sample to be measured for preparing the plurality of pretreatment reagents are different from each other. The controller 300 controls the first detecting device 130 to detect the first pre-treatment liquid in the first cuvette to obtain intermediate detection information, such as hemoglobin concentration, of the first pre-treatment liquid. The controller 300 selects a detection mode to be performed according to the intermediate detection information of the first pretreatment liquid. Then, the controller 300 controls the reagent dispensing mechanism 114 to add the detection reagent in the reagent carrying member 113 to the fourth cuvette in the reaction member 115 according to the detection mode to be performed, and controls the reagent transferring section to transfer a part of the second pretreatment reagent in the second cuvette to the fourth cuvette to which the detection reagent has been added, to prepare the first sample liquid to be measured. Then, the controller 300 controls the second detecting device 130 to detect the first sample liquid to be detected in the fourth cuvette.
Alternatively, in the second measurement procedure, preparing the first sample liquid to be measured using the second pretreatment liquid and the glycosylated hemoglobin detection reagent according to the intermediate detection information includes:
preparing a first sample liquid to be tested corresponding to each glycosylated hemoglobin detection mode in a plurality of different glycosylated hemoglobin detection modes by adopting a blood sample of the subject, a pretreatment reagent and a glycosylated hemoglobin detection reagent;
respectively detecting the first to-be-detected sample liquid corresponding to the detection modes of the respective glycosylated hemoglobin to obtain a plurality of glycosylated hemoglobin detection results; and
and selecting and outputting at least one glycosylated hemoglobin detection result from the plurality of glycosylated hemoglobin detection results according to the intermediate information.
In some embodiments, the plurality of different glycosylated hemoglobin sub-detection modes may include at least two sub-detection modes having effective detection ranges that are at least partially misaligned. Here, the intermediate detection information of the first pretreatment liquid can be used to estimate a detection result of the blood sample to be measured for glycosylated hemoglobin, for example, the hemoglobin concentration or hematocrit of the first pretreatment liquid can be used to estimate the glycosylated hemoglobin concentration of the blood sample to be measured, so that a detection mode having an effective detection range suitable for the blood sample to be measured can be selected according to the intermediate detection information of the first pretreatment liquid, and further, the detection result is prevented from exceeding the effective detection range, and the glycosylated hemoglobin detection is realized by one-time detection.
In some embodiments, the plurality of different glycosylated hemoglobin sub-detection patterns are different in at least one of the following:
the amount of at least one of the blood sample, the pretreatment reagent, the glycosylated hemoglobin detection reagent used for preparing the first sample liquid to be tested or the ratio of at least one of the blood sample to be tested, the pretreatment reagent, the glycosylated hemoglobin detection reagent used for preparing the first sample liquid to be tested in the first sample liquid to be tested;
the components, the formula or the dosage of the pretreatment reagent for preparing the first sample liquid to be tested; and
the type or amount of glycosylated hemoglobin detection reagent used to prepare the first sample fluid to be tested.
Alternatively or additionally, in the second measurement procedure, it may also be provided that the first sample liquid to be measured is measured according to the selected measurement mode to be performed, in order to obtain a measurement result of glycosylated hemoglobin of the blood sample to be measured. Here, the plurality of different glycosylated hemoglobin sub-detection patterns may be different in at least one of the following aspects:
a wavelength of light for detecting the glycosylated hemoglobin of the first sample liquid to be measured; and
Methodology for detecting glycosylated hemoglobin of the first sample fluid to be tested.
In some embodiments, in the second assay procedure, detecting the first pretreatment test solution to obtain intermediate detection information may further include:
the first pretreatment liquid is irradiated with light of at least one wavelength, and an optical signal generated by the first pretreatment liquid after being irradiated with light is acquired, so that the intermediate detection information is obtained based on the optical signal.
For example, as shown in fig. 4, the first detection device 120 may be further configured to irradiate the first pretreatment liquid with light of at least one wavelength and acquire an optical signal generated by the first pretreatment liquid after being irradiated with the light, so as to obtain the intermediate detection information based on the optical signal. In the embodiment shown in fig. 4, the first detection means 120 comprises a light source 121 and a light detector 122. The light source 121 is for irradiating the first pretreatment liquid with light of at least one wavelength, and the photodetector 122 is for detecting an optical signal (transmitted light and/or scattered light) emitted by the light source 121 and passing through the first pretreatment liquid, thereby obtaining the intermediate detection information based on the optical signal. In the embodiment shown in fig. 4, the pretreatment reagent comprises in particular a hemolyzing agent for lysing erythrocytes in a blood sample to be tested, in particular a whole blood sample, to release hemoglobin, and the intermediate detection information comprises a detection value related to the hemoglobin concentration of the first pretreatment sample, preferably the hemoglobin concentration, and/or the intermediate detection information comprises a detection value related to an interfering substance in the first pretreatment sample interfering with the detection of glycosylated hemoglobin.
In other embodiments, the pretreatment reagent includes a hemolyzing agent for lysing erythrocytes in the blood sample to be tested to release hemoglobin. Here, in the second measurement flow, detecting the first pretreatment liquid to obtain the intermediate detection information may further include: the first pretreatment liquid is photographed to acquire an image of the first pretreatment liquid, and a detection value (the intermediate detection information) related to the hemoglobin concentration of the first pretreatment liquid is obtained based on the image.
For example, the first detection device 120 is configured as a camera for photographing the first pretreatment liquid to acquire an image of the first pretreatment liquid, based on which a detection value related to the hemoglobin concentration of the first pretreatment liquid can be obtained, for example, the hemoglobin concentration of the first pretreatment liquid is estimated based on the red shade of the image.
Glycosylated hemoglobin is the product of a continuous and irreversible non-enzymatic protein glycosylation reaction of hemoglobin and glucose in red blood cells, and for the same test sample, glycosylated hemoglobin concentration is linear with hemoglobin concentration (HGB). It has been demonstrated through a number of experiments that the hemoglobin concentration in a blood sample is in turn linear with the hematocrit, i.e. "red blood cell volume/total sample volume" (HCT) in the blood sample after centrifugation or after natural settling. Thus, the detection mode may be selected depending on the HCT value in the blood sample after centrifugation or after natural resting sedimentation. That is, in yet other embodiments, the pretreatment reagent comprises a diluent, where in the second assay procedure, detecting the first pretreatment reagent to obtain the intermediate detection information may further comprise: and carrying out centrifugal treatment or natural standing sedimentation treatment on the first pretreatment test solution, and shooting the first pretreatment test solution after the centrifugal treatment or the natural standing sedimentation treatment so as to obtain an image of the first pretreatment test solution. Based on the image, a detection value related to the hemoglobin concentration of the first pretreatment liquid can be obtained, for example, as shown in fig. 5, based on the ratio of the red blood cells at the bottom of the first pretreatment liquid after centrifugation or natural standing sedimentation to the upper plasma or the ratio of the red blood cell volume h of the first pretreatment liquid after centrifugation or natural standing sedimentation to the total sample volume L, the red blood cell packed volume HCT (=h/L) of the first pretreatment liquid can be obtained, and further the glycosylated hemoglobin concentration of the first pretreatment liquid can be estimated; preferably, natural standing sedimentation takes at least half an hour to obtain a good photographing effect. The first detection device 120 may be configured as a camera.
In yet other alternative embodiments, in the second assay procedure, detecting the first pretreatment test solution to obtain intermediate detection information may further include: a pulse measurement signal is detected when the first pretreatment liquid passes through a resistance measurement device, so that the intermediate detection information is obtained based on the pulse measurement signal.
The first detection device 120 is designed, for example, as a resistance measurement device and serves for the passage of a first pretreatment sample to obtain a pulse measurement signal, in order to obtain intermediate detection information on the basis of the pulse measurement signal. Preferably, the pretreatment reagent comprises a diluent for diluting the blood sample to be tested for detecting hematocrit, and the intermediate detection information comprises hematocrit with the first pretreatment reagent.
In some embodiments, the first detecting device 120 and the second detecting device 130 may be the same detecting device, so as to further reduce the cost. For example, the first detecting device 120 and the second detecting device 130 are optical detecting devices shown in fig. 4.
In some embodiments, the pretreatment reagent comprises a hemolyzing agent for lysing red blood cells in a blood sample to release hemoglobin, and the intermediate detection information comprises a detection value related to the hemoglobin concentration of the first pretreatment reagent; alternatively, the pretreatment reagent includes a diluent for diluting the blood sample to detect the hematocrit, and the intermediate detection information includes a detection value related to the hematocrit of the first pretreatment reagent. In this case, the following steps may be performed in the second measurement sequence:
When the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is within a first preset range, selecting a first sub-detection mode as a detection mode to be executed; and is also provided with
When the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is higher than the upper limit of the first preset range, selecting a second sub-detection mode as a detection mode to be executed, wherein the ratio of the blood sample for preparing the first sample liquid to be tested or the second pretreatment liquid to the first sample liquid in the first sub-detection mode is larger than the ratio of the blood sample for preparing the first sample liquid to be tested or the second pretreatment liquid to the first sample liquid in the second sub-detection mode; and/or the number of the groups of groups,
when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is lower than the lower limit of the first preset range, a third sub-detection mode is selected as the detection mode to be executed, wherein the ratio of the blood sample for preparing the first sample liquid to be tested or the second pretreatment liquid to the first sample liquid in the first sub-detection mode is smaller than the ratio of the blood sample for preparing the first sample liquid to be tested or the second pretreatment liquid to the first sample liquid in the third sub-detection mode.
Here, the ratio of the blood sample to be tested or the second pretreatment liquid to the first sample liquid to be tested for preparing the first sample liquid may be increased by increasing the amount of the blood sample to be tested or the second pretreatment liquid to be used for preparing the first sample liquid to be tested and/or by decreasing the volume of the first sample liquid to be tested. Similarly, the ratio of the blood sample to be tested or the second pretreatment liquid to the first sample liquid to be tested can be reduced by reducing the amount of the blood sample to be tested or the second pretreatment liquid to be used for preparing the first sample liquid to be tested and/or increasing the volume of the first sample liquid to be tested.
FIG. 6 shows a specific glycosylated hemoglobin measurement flow. In step S210, the sample preparation device 110 mixes the blood sample to be tested with the hemolysis agent to obtain a first pretreatment solution. In step S220, the first detecting device 120 detects an optical signal during the reaction of the blood sample to be tested and the hemolysis agent, so as to obtain the estimated hemoglobin concentration of the first pretreatment solution based on the optical signal. In step S230, the controller 140 determines whether the estimated hemoglobin concentration is out of a preset range. When the estimated hemoglobin concentration is not out of the preset range, step S240 is performed: the sample preparation device 110 prepares a first sample liquid to be tested based on the first detection mode. When the estimated hemoglobin concentration is higher than the upper limit in the preset range, step S250 is executed: the sample preparation device 110 prepares a first sample liquid to be tested based on the second detection mode. When the estimated hemoglobin concentration is lower than the lower limit in the preset range, step S260 is executed: the sample preparation device 110 prepares a first sample liquid to be tested based on the third detection mode. In step S270, the second detecting device 130 performs glycosylated hemoglobin detection on the first sample liquid to be detected.
An example of the present application will be described with reference to enzymatic detection of glycosylated hemoglobin. First, the hemoglobin measurement range of the enzymatic method is determined to be 70g/L to 400g/L by a plurality of samples having gradient hemoglobin concentrations, wherein the upper limit of measurement is 400g/L and the lower limit is 70g/L. Specific ways of determining the hemoglobin measurement range are for example: adopting samples with an upper measurement limit and a lower measurement limit to configure equal-proportion gradient samples, and testing the result of each sample; carrying out linear regression on the results of all samples, and calculating whether the regression deviation of each concentration point is smaller than the total error of the glycosylated hemoglobin detection item; if the error is smaller than the total error, the upper and lower measurement limits can be used as the measurement range of the sample analyzer; if the error is larger than the total error, the upper and lower limit intervals of measurement are reduced, and the experiment is repeated until the error requirement is met. Because of the narrow distribution of the amount of glycosylated hemoglobin in the population (4% -14%), the hemoglobin measurement range can also be used to characterize the glycosylated hemoglobin measurement range. In a specific detection process, a whole blood sample to be detected is first subjected to cracking treatment with a hemolytic agent (i.e., a pretreatment reagent) according to a certain proportion, for example, a proportion of 1:23, so as to obtain a first pretreatment test solution, wherein the hemolytic agent contains nitrite and other components capable of oxidizing hemoglobin into methemoglobin. The first pretreatment test solution is used as a test solution for preparing a blood sample to be tested later. When the hemolytic agent is mixed with the whole blood sample to be tested, the hemoglobin is oxidized into methemoglobin, and the estimated hemoglobin concentration of the first pretreatment test solution can be obtained by measuring the absorbance of the first pretreatment test solution at the wavelength of 630 nm; or the estimated hemoglobin concentration can be obtained by measuring the difference A between the absorbance of the first pretreatment sample at the main wavelength of 630nm and the absorbance at the secondary wavelength of 660nm (for reducing noise, grease and other interference), wherein the absorbance difference A and the estimated hemoglobin concentration g/L are in a linear relation, specifically: hemoglobin concentration g/L=A_ ((630 nm-660 nm))/72.5 as shown in FIG. 7. And then comparing the estimated hemoglobin concentration with preset upper and lower limits of hemoglobin measurement and determining the dosage of the first pretreatment test solution which participates in the preparation of the subsequent first sample solution to be tested. When the estimated hemoglobin concentration is between the preset upper limit and the preset lower limit of hemoglobin measurement, selecting a first detection mode and preparing a first sample liquid to be detected by adopting 5 mu l of a first pretreatment sample liquid; when the estimated hemoglobin concentration is greater than the preset upper limit of hemoglobin measurement, selecting a second detection mode and preparing a first sample liquid to be detected by adopting 3 mu l of a first pretreatment sample liquid; when the estimated hemoglobin concentration is less than the preset lower hemoglobin measurement limit, a third detection mode is selected and 8 μl of the first pretreatment liquid is used to prepare a first sample liquid to be tested. Here, in the first detection mode, the second detection mode, and the third detection mode, the amounts of the detection reagents used for preparing the first sample liquid to be detected are the same. After determining the amount of the first pretreatment liquid, mixing the determined first pretreatment liquid with a first detection reagent containing a proteolytic enzyme which reacts with glycosylated hemoglobin in the liquid to produce glycosylated peptides or glycosylated amino acids, and simultaneously measuring absorbance of the intermediate liquid at 480nm wavelength and obtaining hemoglobin concentration of the blood sample based on the absorbance and a calibration curve. Then, a second detection reagent containing a specific oxidase is added into the intermediate sample liquid to be detected to obtain a first sample liquid to be detected, the specific oxidase reacts with the glycosylated peptide or amino acid to generate a detectable product (such as hydrogen peroxide), the hydrogen peroxide reacts with sodium 10- (carboxymethyl aminocarbonyl) -3, 7-bis (dimethylamino) phenothiazine (color-developing agent) to generate color-development reaction, and the glycosylated hemoglobin concentration is obtained by measuring the absorbance. And finally, obtaining a glycosylated hemoglobin detection result based on the hemoglobin concentration and the glycosylated hemoglobin concentration.
Another example of the present application will be described by taking an example of detecting glycosylated hemoglobin based on an immunoturbidimetry. First, the immunoturbidimetry hemoglobin measurement range of 40g/L to 410g/L was also determined by a plurality of samples having gradient hemoglobin concentrations, with the upper measurement limit of 410g/L and the lower limit of 40g/L. Because of the narrow distribution of the amount of glycosylated hemoglobin in the population (4% -14%), the hemoglobin measurement range can also be used to characterize the glycosylated hemoglobin measurement range. In a specific detection process, a whole blood sample to be detected is first subjected to cracking treatment with a hemolytic agent (i.e., a pretreatment reagent) according to a certain proportion, for example, a proportion of 1:50, so as to obtain a first pretreatment test solution, wherein the hemolytic agent contains nitrite and other components capable of oxidizing hemoglobin into methemoglobin. The first pretreatment test solution is used as a test solution for preparing a blood sample to be tested later. When the hemolytic agent is mixed with the whole blood sample to be measured, the hemoglobin is oxidized into methemoglobin, and the estimated hemoglobin concentration of the first pretreatment sample can be obtained by measuring the absorbance of the first pretreatment sample at the wavelength of 540nm or 570 nm. And then comparing the estimated hemoglobin concentration with preset upper and lower limits of hemoglobin measurement and determining the dosage of the first pretreatment test solution which participates in the preparation of the subsequent first sample solution to be tested. When the estimated hemoglobin concentration is between the preset upper limit and the preset lower limit of hemoglobin measurement, selecting a first detection mode and preparing a first sample liquid to be detected by adopting 6 mu l of a first pretreatment sample liquid; when the estimated hemoglobin concentration is greater than the preset upper hemoglobin measurement limit, a second detection mode is selected and 4 μl of the first pretreatment liquid is used to prepare a first sample liquid to be tested. Here, in the first detection mode and the second detection mode, the amount of the detection reagent used for preparing the first sample liquid to be detected is the same. After determining the amount of the first pretreatment liquid, mixing the determined first pretreatment liquid with a first detection reagent containing a glycosylated hemoglobin specific antibody to obtain an intermediate sample liquid to be measured, and simultaneously performing optical measurement on the intermediate sample liquid to obtain the hemoglobin concentration of the blood sample to be measured. Then, a second detection reagent containing a plurality of clusters of single antigens carrying a plurality of glycosylated hemoglobin antigenic determinants is added into the middle sample liquid to be detected to obtain a first sample liquid to be detected, the clusters of single antigens react with excessive antibodies in the first sample liquid to form insoluble complexes, and if the glycosylated hemoglobin concentration in the first sample liquid to be detected is increased, the formation of immune complexes is reduced and turbidity is reduced, so that the glycosylated hemoglobin concentration in the first sample liquid to be detected can be detected. And finally, obtaining a glycosylated hemoglobin detection result based on the hemoglobin concentration and the glycosylated hemoglobin concentration.
Another example of the present application will be described with reference to enzymatic detection of glycosylated hemoglobin. First, the hemoglobin measurement range of the enzymatic method is determined to be 70g/L to 400g/L by a plurality of samples having gradient hemoglobin concentrations, wherein the upper limit of measurement is 400g/L and the lower limit is 70g/L. In a specific detection process, a whole blood sample to be detected is first subjected to cracking treatment with a hemolytic agent (i.e., a pretreatment reagent) according to a certain proportion, for example, a proportion of 1:23, so as to obtain a first pretreatment test solution, wherein the hemolytic agent contains nitrite and other components capable of oxidizing hemoglobin into methemoglobin. The first pretreatment test solution is used as a test solution for preparing a blood sample to be tested later. When the hemolytic agent is mixed with the whole blood sample to be measured, the hemoglobin is oxidized into methemoglobin, and the estimated hemoglobin concentration of the first pretreatment liquid can be obtained by measuring the absorbance of the first pretreatment liquid at the wavelength of 630 nm. And then comparing the estimated hemoglobin concentration with preset upper and lower limits of hemoglobin measurement and determining the dosage of the first pretreatment test solution which participates in the preparation of the subsequent first sample solution to be tested. When the predicted hemoglobin concentration is between the preset upper limit and the preset lower limit of hemoglobin measurement, selecting a first detection mode, and preparing a first sample liquid to be detected by adopting 5 mu l of a first pretreatment test liquid, 90ul of a first detection reagent containing proteolytic enzyme and 30ul of a second detection reagent containing specific oxidase; when the predicted hemoglobin concentration is greater than the preset upper hemoglobin measurement limit, selecting a second detection mode and preparing a first sample liquid to be detected by adopting 5 mu l of a first pretreatment test liquid, 120ul of a first detection reagent containing proteolytic enzyme and 40ul of a second detection reagent containing specific oxidase; when the estimated hemoglobin concentration is less than the preset lower hemoglobin measurement limit, a third test mode is selected and a first sample solution to be tested is prepared using 5 μl of the first pretreatment reagent, 60ul of the first detection reagent containing proteolytic enzyme, and 20ul of the second detection reagent containing specific oxidase. The relative adjustment of the first pretreatment reagent is achieved by adjusting the amount of the detection reagent used.
In other examples, the ratio of the amount of the first pretreatment reagent to the amount of the detection reagent may also be adjusted based on the intermediate detection information.
In some embodiments, in the case of detecting glycosylated hemoglobin based on ion exchange chromatography, the amount of pretreatment solution entering the ion column chromatography may be adjusted based on intermediate detection information.
In other embodiments, in the case of detecting glycosylated hemoglobin based on affinity chromatography, the amount of pretreatment solution entering the affinity chromatography column may be adjusted based on intermediate detection information.
In some alternative or additional embodiments, the following steps may be performed in the second assay procedure:
when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is greater than a first preset threshold value, selecting a fourth sub-detection mode as a detection mode to be executed; and is also provided with
And when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is smaller than or equal to a first preset threshold value, selecting a fifth sub-detection mode as a detection mode to be executed, wherein the first sample liquid to be tested is prepared based on a glycosylated hemoglobin enzyme method in a fourth sub-detection mode, and the first sample liquid to be tested is prepared based on a glycosylated hemoglobin immunonephelometry in the fifth sub-detection mode.
FIG. 8 shows a specific glycosylated hemoglobin measurement flow. In step S310, the sample preparation device 110 mixes the blood sample to be tested with the hemolysis agent to obtain a first pretreatment solution. In step S320, the first detecting device 120 detects an optical signal during the reaction of the blood sample to be tested and the hemolysis agent, so as to obtain the estimated hemoglobin concentration of the first pretreatment solution based on the optical signal. In step S330, the controller 140 determines whether the estimated hemoglobin concentration is higher than a first preset threshold. When the estimated hemoglobin concentration is higher than the first preset threshold, step S340 is performed: the sample preparation device 110 prepares a first sample liquid to be tested based on the fourth detection mode. When the estimated hemoglobin concentration is lower than the first preset threshold, step S350 is executed: the sample preparation device 110 prepares a first sample liquid to be tested based on the fifth detection mode. In step S360, the second detecting device 130 performs glycosylated hemoglobin detection on the first sample fluid to be detected.
In a specific example, first, an enzymatic hemoglobin measurement range of 90g/L to 400g/L is determined by a plurality of samples having gradient hemoglobin concentrations, wherein the upper measurement limit is 400g/L and the lower measurement limit is 90g/L. In addition, the measurement range of the immune turbidimetric hemoglobin is also determined to be 40g/L to 400g/L by a plurality of samples with gradient hemoglobin concentration, wherein the upper limit of measurement is 400g/L and the lower limit is 40g/L. In a specific detection process, a whole blood sample to be detected and a hemolytic agent (i.e. a pretreatment reagent) are subjected to cracking treatment according to a certain proportion to obtain a first pretreatment test solution, wherein the hemolytic agent contains nitrite and other components capable of oxidizing hemoglobin into methemoglobin. When the hemolytic agent is mixed with the whole blood sample to be measured, the hemoglobin is oxidized into methemoglobin, and the estimated hemoglobin concentration of the first pretreatment sample can be obtained by measuring the absorbance of the first pretreatment sample at the wavelength of 540nm or 570 nm. And then comparing the estimated hemoglobin concentration with the upper limit and the lower limit of the hemoglobin measurement of the enzymatic method and determining the type of the detection reagent involved in the preparation of the subsequent first sample liquid to be detected. When the estimated hemoglobin concentration is between the upper limit and the lower limit of the hemoglobin measurement of the enzymatic method, selecting a detection reagent based on the enzymatic method to prepare a first sample liquid to be detected; when the estimated hemoglobin concentration is lower than the lower limit of hemoglobin measurement by an enzyme method, selecting a detection reagent based on an immunoturbidimetry to prepare a first sample liquid to be detected.
Although the measurement lower limit of the glycosylated hemoglobin enzyme method is higher than the measurement lower limit of the glycosylated hemoglobin immunoturbidimetry, the single test cost of the glycosylated hemoglobin enzyme method is lower than the single test cost of the glycosylated hemoglobin immunoturbidimetry. By selecting the corresponding detection reagent by means of the detection value of the first pretreatment liquid in relation to the hemoglobin concentration and/or the hematocrit, a wider effective measurement range can be provided without increasing the costs as much as possible.
In some alternative or additional embodiments, in the second assay procedure:
the intermediate detection information comprises detection values related to interference objects interfering with the detection of glycosylated hemoglobin in the first pretreatment liquid;
when the detection value related to the interferent of the first pretreatment test solution exceeds a second preset threshold value, selecting a sixth sub-detection mode as a detection mode to be executed, re-sucking the blood sample of the subject according to the sixth sub-detection mode when preparing the first sample solution to be tested, preparing a new pretreatment test solution according to the re-sucked blood sample and a new pretreatment reagent, and preparing the first sample solution to be tested by adopting the new pretreatment test solution and a glycosylated hemoglobin detection reagent, wherein the new pretreatment reagent contains an anti-interference reagent for eliminating the interferent; and is also provided with
And when the detection value related to the interfering object of the first pretreatment liquid does not exceed a second preset threshold value, selecting a seventh sub-detection mode as a detection mode to be executed, and adopting the first pretreatment liquid as the second pretreatment liquid and a glycosylated hemoglobin detection reagent to prepare a first sample liquid to be tested according to the seventh sub-detection mode when preparing the first sample liquid to be tested.
That is, when it is judged that an interfering substance, such as lipid interference, interfering with the detection of glycosylated hemoglobin exists in the blood sample to be measured based on the detection value related to the interfering substance of the first pretreatment liquid, an anti-interference agent for eliminating the interfering substance is added at the time of the subsequent preparation of the first sample liquid to be measured, ensuring that an accurate glycosylated hemoglobin detection result can be obtained.
The detection value associated with the interfering substance of the first pretreatment liquid includes, in particular, a lipid blood concentration or a bilirubin concentration.
Another example of the present application will be described with reference to enzymatic detection of glycosylated hemoglobin. Firstly, a whole blood sample to be tested and a hemolytic agent (i.e. a pretreatment reagent) are subjected to pyrolysis treatment according to a certain proportion to obtain a first pretreatment test solution, wherein the hemolytic agent contains nitrite and other components capable of oxidizing hemoglobin into methemoglobin. When the hemolytic agent is mixed with the whole blood sample to be measured, the hemoglobin is oxidized to methemoglobin, and the estimated lipid concentration of the first pretreatment liquid can be obtained by measuring the absorbance of the first pretreatment liquid at a wavelength of more than 600 nm. And then comparing the estimated lipid concentration with a preset threshold value and determining whether the lipid-lowering component is added when the first sample liquid to be tested is prepared later. And when the lipid blood concentration is larger than the set threshold value, re-sucking the whole blood sample to be tested, and mixing the re-sucked whole blood sample to be tested with the hemolytic agent added with the lipid-removing component to prepare a second pretreatment test solution. Mixing at least a portion of the second pretreatment sample solution with a first detection reagent comprising a proteolytic enzyme that reacts with glycosylated hemoglobin in the sample solution to produce glycosylated peptides or glycosylated amino acids, and simultaneously measuring absorbance of the intermediate sample solution at a wavelength of 480nm and determining a hemoglobin concentration of the blood sample based on the absorbance and a calibration curve. Then, a second detection reagent containing a specific oxidase is added into the intermediate sample liquid to be detected to obtain a first sample liquid to be detected, the specific oxidase reacts with the glycosylated peptide or amino acid to generate a detectable product (such as hydrogen peroxide), the hydrogen peroxide reacts with sodium 10- (carboxymethyl aminocarbonyl) -3, 7-bis (dimethylamino) phenothiazine (color-developing agent) to generate color-development reaction, and the glycosylated hemoglobin concentration is obtained by measuring the absorbance. And finally, obtaining a glycosylated hemoglobin detection result based on the hemoglobin concentration and the glycosylated hemoglobin concentration.
Alternatively or additionally, provision may be made in the second assay flow for:
the intermediate detection information comprises detection values related to interference objects interfering with the detection of glycosylated hemoglobin in the first pretreatment liquid; and is also provided with
And when the detection value related to the interferent of the first pretreatment test solution exceeds a third preset threshold value, preparing the first sample solution to be tested based on the glycosylated hemoglobin immunoturbidimetry.
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 first 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 first pretreatment test solution at a first wavelength and a second wavelength is measured, wherein the first wavelength is any wavelength within 450-500nm, the second wavelength is any wavelength within 500-600nm, the hemoglobin and the bilirubin have characteristic absorption at the first wavelength, the bilirubin has no absorption at the second wavelength, and the hemoglobin has characteristic absorption at the second wavelength. Subtracting the absorbance of the hemoglobin at the first wavelength from the absorbance of the first pretreatment solution at the first wavelength to obtain the absorbance of bilirubin at the first wavelength; the concentration value of bilirubin in a sample may be obtained by dividing the absorbance of bilirubin at a first wavelength by the extinction coefficient of bilirubin at that wavelength. When the bilirubin concentration is larger than a preset threshold value, selecting a detection reagent based on an immunoturbidimetry to prepare a first sample liquid to be detected.
In some embodiments, the second assay procedure may further comprise: and when the intermediate detection information exceeds a second preset range, terminating the second measurement flow and outputting an alarm prompt. Here, the intermediate detection information exceeding the second preset range indicates that the currently measured glycosylated hemoglobin concentration of the blood sample exceeds the effective detection range of the sample analyzer, and thus, an accurate glycosylated hemoglobin concentration cannot be obtained even if the detection is continued. The early termination of the measurement process can further avoid reagent waste and improve the detection efficiency.
Fig. 9 shows a schematic flow chart of a sample detection method according to an embodiment of the present application.
As shown in fig. 9, the sample detection method 800 includes the following method steps:
s810, selecting a first glycosylated hemoglobin detection mode or a second glycosylated hemoglobin detection mode;
s820 executing a first measurement flow when the first glycosylated hemoglobin detection mode is selected; and
s830, when the second glycosylated hemoglobin detection mode is selected, executing a second measurement flow including: preparing a first pretreatment test solution by adopting a blood sample of a subject and a pretreatment reagent, detecting the first pretreatment test solution to obtain intermediate detection information, preparing a first sample solution to be detected by adopting a second pretreatment test solution and a glycosylated hemoglobin detection reagent according to the intermediate detection information, and detecting the first sample solution to be detected to obtain a glycosylated hemoglobin detection result, wherein the second pretreatment solution is prepared by adopting the blood sample to be detected of the subject and the pretreatment reagent, and the first measurement flow and the second measurement flow are at least partially different.
In some embodiments, the first test procedure may include:
preparing a second sample liquid to be detected by adopting a blood sample of a subject, a pretreatment reagent and a glycosylated hemoglobin detection reagent, and detecting the second sample liquid to be detected to obtain a glycosylated hemoglobin detection result;
when the glycosylated hemoglobin detection result is abnormal, preparing a third sample liquid to be detected by adopting the blood sample of the subject, the pretreatment reagent and the glycosylated hemoglobin detection reagent, and detecting glycosylated hemoglobin of the third sample liquid to be detected;
wherein, the dosage or proportion of at least one of the blood sample, pretreatment reagent and glycosylated hemoglobin detection reagent of the third sample liquid to be tested and the second sample liquid to be tested is different; or preparing a third sample liquid to be tested and a second sample liquid to be tested, wherein the components, the formulas or the dosage of the pretreatment reagent are different; alternatively, the types or amounts of the glycosylated hemoglobin detection reagents for preparing the third sample liquid to be measured and the second sample liquid to be measured are different.
In some embodiments, in step S810, selecting the first glycosylated hemoglobin detection mode or the second glycosylated hemoglobin detection mode comprises:
selecting a first glycosylated hemoglobin detection mode or a second glycosylated hemoglobin detection mode according to red blood cell related information of the subject.
In some embodiments, in the second assay procedure, preparing the first test sample fluid result using the second pretreatment test fluid and the glycosylated hemoglobin detection reagent according to the intermediate detection information comprises:
selecting a detection mode to be executed from a plurality of different glycosylated hemoglobin sub-detection modes according to the intermediate detection information; and
and preparing the first sample liquid to be tested by adopting the second pretreatment test liquid and the glycosylated hemoglobin detection reagent according to the detection mode to be executed.
In some alternative embodiments, the following steps may be performed in the second assay procedure:
preparing pretreatment test solutions corresponding to respective glycosylated hemoglobin sub-detection modes in a plurality of different glycosylated hemoglobin sub-detection modes by using a blood sample of the subject and a pretreatment reagent;
detecting at least one pretreatment liquid serving as the first pretreatment liquid in the pretreatment liquid to obtain intermediate detection information of the first pretreatment liquid;
selecting a detection mode to be executed from the plurality of different glycosylated hemoglobin sub-detection modes according to the intermediate detection information; and
and selecting a pretreatment test solution corresponding to the detection mode to be executed from the pretreatment test solutions according to the detection mode to be executed as the second pretreatment test solution, and preparing the first sample solution to be tested by adopting the selected pretreatment test solution and the glycosylated hemoglobin detection reagent.
In yet other alternative embodiments, in the second assay procedure, preparing the first sample fluid to be tested using the second pretreatment test fluid and the glycosylated hemoglobin detection reagent according to the intermediate detection information may include:
preparing a first sample liquid to be tested corresponding to each glycosylated hemoglobin detection mode in a plurality of different glycosylated hemoglobin detection modes by adopting a blood sample of the subject, a pretreatment reagent and a glycosylated hemoglobin detection reagent;
respectively detecting the first to-be-detected sample liquid corresponding to the detection modes of the respective glycosylated hemoglobin to obtain a plurality of glycosylated hemoglobin detection results; and
and selecting and outputting at least one glycosylated hemoglobin detection result from the plurality of glycosylated hemoglobin detection results according to the intermediate information.
In some embodiments, the plurality of different glycosylated hemoglobin sub-detection patterns may be different in at least one of the following:
the amount of at least one of the blood sample, the pretreatment reagent, the glycosylated hemoglobin detection reagent used for preparing the first sample liquid to be tested or the ratio of at least one of the blood sample to be tested, the pretreatment reagent, the glycosylated hemoglobin detection reagent used for preparing the first sample liquid to be tested in the first sample liquid to be tested;
The components, the formula or the dosage of the pretreatment reagent for preparing the first sample liquid to be tested; and
the type or amount of glycosylated hemoglobin detection reagent used to prepare the first sample fluid to be tested.
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 intermediate detection information includes a detection value related to a hemoglobin concentration of the first pretreatment reagent.
Alternatively, the pretreatment reagent may include a diluent for diluting the blood sample to detect the hematocrit, and the intermediate detection information includes a detection value related to the hematocrit of the first pretreatment reagent.
In some embodiments, the following steps may be performed in the second assay procedure:
when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is within a first preset range, selecting a first sub-detection mode as a detection mode to be performed, and
when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is higher than the upper limit of the first preset range, selecting a second sub-detection mode as the detection mode to be performed, wherein the ratio of the blood sample for preparing the first sample liquid to be tested or the second pretreatment liquid to the first sample liquid to be tested in the first sub-detection mode is larger than the ratio of the blood sample for preparing the first sample liquid to be tested or the second pretreatment liquid to the first sample liquid to be tested in the second sub-detection mode, and/or,
When the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is lower than the lower limit of the first preset range, a third sub-detection mode is selected as the detection mode to be executed, wherein the ratio of the blood sample for preparing the first sample liquid to be tested or the second pretreatment liquid to the first sample liquid in the first sub-detection mode is smaller than the ratio of the blood sample for preparing the first sample liquid to be tested or the second pretreatment liquid to the first sample liquid in the third sub-detection mode.
Alternatively or additionally, the following steps may be performed in the second assay procedure:
when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is greater than the first preset threshold, selecting the fourth sub-detection mode as the detection mode to be performed, and
when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is less than or equal to a first preset threshold value, a fifth sub-detection mode is selected as a detection mode to be executed, wherein the first sample liquid to be tested is prepared based on a glycosylated hemoglobin enzymatic method in the fourth sub-detection mode, and the first sample liquid to be tested is prepared based on a glycosylated hemoglobin immunoturbidimetry in the fifth sub-detection mode.
Alternatively or additionally, the intermediate detection information comprises detection values related to interferents in the first pretreatment test solution that interfere with the detection of glycosylated hemoglobin, and the following steps may be performed in the second assay procedure:
when the detection value related to the interferent of the first pretreatment test solution exceeds a second preset threshold value, selecting a sixth sub-detection mode as a detection mode to be executed, re-sucking the blood sample of the subject according to the sixth sub-detection mode when preparing the first sample solution to be tested, preparing a new pretreatment test solution according to the re-sucked blood sample and a new pretreatment reagent, and preparing the first sample solution to be tested by adopting the new pretreatment test solution and a glycosylated hemoglobin detection reagent, wherein the new pretreatment reagent contains an anti-interference reagent for eliminating the interferent; and is also provided with
And when the detection value related to the interfering object of the first pretreatment liquid does not exceed a second preset threshold value, selecting a seventh sub-detection mode as a detection mode to be executed, and adopting the first pretreatment liquid as the second pretreatment liquid and a glycosylated hemoglobin detection reagent to prepare a first sample liquid to be tested according to the seventh sub-detection mode when preparing the first sample liquid to be tested.
In some embodiments, the second assay procedure may further comprise: and when the intermediate detection information exceeds a third preset range, terminating the second measurement flow and outputting an alarm prompt.
Other features and advantages of the sample detection method 800 provided according to the embodiments of the present application may refer to the various embodiments of the sample analyzer and their advantages described above, and are not described herein.
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 detection method provided by the embodiments of the present application, and vice versa.
The foregoing description is only of the preferred embodiments of the present application, and is not intended to limit the scope of the application, but the equivalent transformation schemes made by the description and the drawings of the present application or the direct/indirect application in other related technical fields are included in the scope of the application.
Claims (26)
1. A sample analyzer, comprising:
A glycosylated hemoglobin measurement unit for obtaining a glycosylated hemoglobin measurement result of a blood sample of a subject;
a mode selection unit for selecting the first glycosylated hemoglobin measurement mode or the second glycosylated hemoglobin measurement mode; and
a controller configured to control the operation of the device,
receiving a mode selection of the mode selection section,
when the mode selection section selects the first glycosylated hemoglobin measurement mode, controlling the glycosylated hemoglobin measurement section to execute a first measurement flow, and
when the mode selection unit selects the second glycosylated hemoglobin measurement mode, controlling the glycosylated hemoglobin measurement unit to execute a second measurement flow including: preparing a first pretreatment test solution by adopting a blood sample of the subject and a pretreatment reagent, detecting the first pretreatment test solution to obtain intermediate detection information, preparing a first sample solution to be detected by adopting a second pretreatment test solution and a glycosylated hemoglobin detection reagent according to the intermediate detection information, and detecting the first sample solution to be detected to obtain a glycosylated hemoglobin detection result, wherein the second pretreatment solution is prepared by adopting the blood sample of the subject and the pretreatment reagent, and the first measurement flow and the second measurement flow are at least partially different.
2. The sample analyzer of claim 1, wherein the first assay procedure comprises:
preparing a second sample liquid to be detected by adopting a blood sample of the subject, a pretreatment reagent and a glycosylated hemoglobin detection reagent, and detecting the second sample liquid to be detected to obtain a glycosylated hemoglobin detection result;
when the glycosylated hemoglobin detection result is abnormal, preparing a third sample liquid to be detected by adopting the blood sample of the subject, the pretreatment reagent and the glycosylated hemoglobin detection reagent again, and detecting glycosylated hemoglobin of the third sample liquid to be detected;
wherein, the dosage or proportion of at least one of the blood sample, pretreatment reagent and glycosylated hemoglobin detection reagent of the third sample liquid to be tested and the second sample liquid to be tested is different; or preparing the third sample liquid to be tested and the second sample liquid to be tested, wherein the components, the formulas or the dosage of the pretreatment reagent are different; alternatively, the types or amounts of the glycosylated hemoglobin detection reagents for preparing the third sample liquid to be measured and the second sample liquid to be measured are different.
3. The sample analyzer according to claim 1 or 2, wherein the mode selection section is further configured to select a first glycosylated hemoglobin detection mode or a second glycosylated hemoglobin detection mode based on red blood cell-related information of the subject.
4. The sample analyzer according to claim 1 or 2, wherein the mode selection section is further configured to select the first glycosylated hemoglobin detection mode or the second glycosylated hemoglobin detection mode based on a user input.
5. The sample analyzer of claim 4, wherein the mode selection section includes a user interaction interface for displaying a control for selecting the glycosylated hemoglobin detection mode and receiving an operation of the control to select the first glycosylated hemoglobin detection mode or the second glycosylated hemoglobin detection mode.
6. The sample analyzer according to any one of claims 1 to 5, wherein in the second measurement flow, preparing a first sample liquid to be measured from the intermediate detection information using a second pretreatment reagent and a glycosylated hemoglobin detection reagent includes:
selecting a detection mode to be executed from a plurality of different glycosylated hemoglobin sub-detection modes according to the intermediate detection information; and
and preparing the first sample liquid to be tested by adopting the second pretreatment test liquid and the glycosylated hemoglobin detection reagent according to the detection mode to be executed.
7. The sample analyzer of any one of claims 1 to 5, wherein in the second assay flow path:
Preparing pretreatment test solutions corresponding to each glycosylated hemoglobin detection mode by adopting a blood sample of the subject and a pretreatment reagent;
detecting at least one of the pretreatment test solutions as the first pretreatment test solution to obtain intermediate detection information of the first pretreatment test solution;
selecting a detection mode to be executed from the plurality of different glycosylated hemoglobin sub-detection modes according to the intermediate detection information; and
and selecting a pretreatment test solution corresponding to the detection mode to be executed from the pretreatment test solutions according to the detection mode to be executed as the second pretreatment test solution, and preparing the first sample solution to be tested by adopting the selected pretreatment test solution and the glycosylated hemoglobin detection reagent.
8. The sample analyzer according to any one of claims 1 to 5, wherein in the second measurement flow, preparing a first sample liquid to be measured from the intermediate detection information using a second pretreatment reagent and a glycosylated hemoglobin detection reagent includes:
preparing a first sample liquid to be tested corresponding to each glycosylated hemoglobin detection mode in a plurality of different glycosylated hemoglobin detection modes by adopting a blood sample of the subject, a pretreatment reagent and a glycosylated hemoglobin detection reagent;
Respectively detecting the first to-be-detected sample liquid corresponding to the detection modes of the respective glycosylated hemoglobin to obtain a plurality of glycosylated hemoglobin detection results; and
and selecting and outputting at least one glycosylated hemoglobin detection result from the plurality of glycosylated hemoglobin detection results according to the intermediate information.
9. The sample analyzer of any of claims 6-8, wherein the plurality of different glycosylated hemoglobin sub-detection modes comprises at least two sub-detection modes, the effective detection ranges of the at least two sub-detection modes being at least partially misaligned.
10. The sample analyzer of any of claims 6-9, wherein the plurality of different glycosylated hemoglobin sub-detection patterns are different in at least one of the following:
the amount of at least one of the blood sample, the pretreatment reagent, the glycosylated hemoglobin detection reagent used for preparing the first sample liquid to be tested or the ratio of at least one of the blood sample to be tested, the pretreatment reagent, the glycosylated hemoglobin detection reagent used for preparing the first sample liquid to be tested in the first sample liquid to be tested;
The components, the formula or the dosage of the pretreatment reagent for preparing the first sample liquid to be tested; and
the type or amount of glycosylated hemoglobin detection reagent used to prepare the first sample fluid to be tested.
11. The sample analyzer of any one of claims 1-10, wherein in the second assay procedure, detecting the first pre-treatment sample to obtain intermediate detection information further comprises:
illuminating the first pretreatment liquid with light of at least one wavelength, and acquiring an optical signal generated by the first pretreatment liquid after being illuminated by the light so as to obtain the intermediate detection information based on the optical signal; or alternatively
A pulse measurement signal is detected when the first pretreatment liquid passes through a resistance measurement device, so that the intermediate detection information is obtained based on the pulse measurement signal.
12. The sample analyzer of any one of claims 1 to 11, wherein the pretreatment reagent includes a hemolyzing agent for lysing red blood cells in a blood sample to release hemoglobin, and the intermediate detection information includes a detection value related to a hemoglobin concentration of the first pretreatment reagent; alternatively, the pretreatment reagent includes a diluent for diluting the blood sample to detect the hematocrit, and the intermediate detection information includes a detection value related to the hematocrit of the first pretreatment reagent.
13. The sample analyzer of claim 12, wherein in the second assay flow path:
when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is within a first preset range, selecting a first sub-detection mode as a detection mode to be performed, and
when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is higher than the upper limit of the first preset range, selecting a second sub-detection mode as a detection mode to be performed, wherein the ratio of the blood sample for preparing the first sample liquid to be tested or the second pretreatment liquid to the first sample liquid in the first sub-detection mode is larger than the ratio of the blood sample for preparing the first sample liquid to be tested or the second pretreatment liquid to the first sample liquid in the second sub-detection mode, and/or,
and when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is lower than the lower limit of the first preset range, selecting a third sub-detection mode as a detection mode to be executed, wherein the proportion of the blood sample or the second pretreatment liquid used for preparing the first sample liquid to be tested in the first sub-detection mode to the first sample liquid to be tested is smaller than the proportion of the blood sample or the second pretreatment liquid used for preparing the first sample liquid to be tested in the third sub-detection mode to the first sample liquid to be tested.
14. The sample analyzer of claim 12 or 13, wherein in the second assay procedure:
when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is greater than a first preset threshold value, selecting a fourth sub-detection mode as a detection mode to be executed, and
and when the detection value related to the hemoglobin concentration and/or the hematocrit of the first pretreatment liquid is smaller than or equal to a first preset threshold value, selecting a fifth sub-detection mode as a detection mode to be executed, wherein the first sample liquid to be tested is prepared based on a glycosylated hemoglobin enzyme method in a fourth sub-detection mode, and the first sample liquid to be tested is prepared based on a glycosylated hemoglobin immunonephelometry in the fifth sub-detection mode.
15. The sample analyzer of any one of claims 12 to 14, wherein in the second assay flow path:
the intermediate detection information includes a detection value related to an interfering substance that interferes with the detection of glycosylated hemoglobin in the first pretreatment liquid;
when the detection value related to the interferent of the first pretreatment test solution exceeds a second preset threshold value, selecting a sixth sub-detection mode as a detection mode to be executed, re-sucking the blood sample of the subject according to the sixth sub-detection mode when preparing the first sample solution to be tested, preparing a new pretreatment test solution according to the re-sucked blood sample and a new pretreatment reagent, and preparing the first sample solution to be tested by adopting the new pretreatment test solution and a glycosylated hemoglobin detection reagent, wherein the new pretreatment reagent contains an anti-interference reagent for eliminating the interferent; and is also provided with
And when the detection value related to the interfering object of the first pretreatment liquid does not exceed a second preset threshold value, selecting a seventh sub-detection mode as a detection mode to be executed, and adopting the first pretreatment liquid as the second pretreatment liquid and a glycosylated hemoglobin detection reagent to prepare a first sample liquid to be tested according to the seventh sub-detection mode when preparing the first sample liquid to be tested.
16. The sample analyzer of any one of claims 1 to 15, wherein the second assay procedure further comprises:
and when the intermediate detection information exceeds a second preset range, terminating the second measurement flow and outputting an alarm prompt.
17. A sample analyzer, comprising:
a glycosylated hemoglobin measurement unit for obtaining a glycosylated hemoglobin measurement result of a blood sample of a subject;
a mode selection unit for selecting the first glycosylated hemoglobin measurement mode or the second glycosylated hemoglobin measurement mode; and
a controller configured to control the operation of the device,
receiving a mode selection of the mode selection section,
when the mode selection section selects the first glycosylated hemoglobin measurement mode, controlling the glycosylated hemoglobin measurement section to execute a first measurement flow, and
Controlling the glycosylated hemoglobin measurement section to execute a second measurement flow when the mode selection section selects the second glycosylated hemoglobin measurement mode; the effective detection range of the first measurement procedure for the primary glycosylated hemoglobin detection of the blood sample is smaller than the effective detection range of the second measurement procedure for the primary glycosylated hemoglobin detection of the blood sample.
18. A method of sample detection comprising:
selecting a first glycosylated hemoglobin measurement mode or a second glycosylated hemoglobin measurement mode;
executing a first measurement flow when the first glycosylated hemoglobin measurement mode is selected; and
when the second glycated hemoglobin measurement mode is selected, performing a second measurement procedure, the second measurement procedure including: preparing a first pretreatment test solution by adopting a blood sample of a subject and a pretreatment reagent, detecting the first pretreatment test solution to obtain intermediate detection information, preparing a first sample solution to be detected by adopting a second pretreatment test solution and a glycosylated hemoglobin detection reagent according to the intermediate detection information, and detecting the first sample solution to be detected to obtain a glycosylated hemoglobin detection result, wherein the second pretreatment solution is prepared by adopting the blood sample to be detected of the subject and the pretreatment reagent, and the first measurement flow and the second measurement flow are at least partially different.
19. The method of claim 18, wherein the first assay procedure comprises:
preparing a second sample liquid to be detected by adopting a blood sample of the subject, a pretreatment reagent and a glycosylated hemoglobin detection reagent, detecting the second sample liquid to be detected to obtain a glycosylated hemoglobin detection result, preparing a third sample liquid to be detected by adopting the blood sample of the subject, the pretreatment reagent and the glycosylated hemoglobin detection reagent again when the glycosylated hemoglobin detection result is abnormal, and detecting glycosylated hemoglobin of the third sample liquid to be detected;
wherein, the dosage or proportion of at least one of the blood sample, pretreatment reagent and glycosylated hemoglobin detection reagent of the third sample liquid to be tested and the second sample liquid to be tested is different; or preparing the third sample liquid to be tested and the second sample liquid to be tested, wherein the components, the formulas or the dosage of the pretreatment reagent are different; alternatively, the types or amounts of the glycosylated hemoglobin detection reagents for preparing the third sample liquid to be measured and the second sample liquid to be measured are different.
20. The method of claim 18 or 19, wherein selecting the first glycosylated hemoglobin detection mode or the second glycosylated hemoglobin detection mode comprises:
Selecting a first glycosylated hemoglobin detection mode or a second glycosylated hemoglobin detection mode according to red blood cell related information of the subject.
21. The method according to any one of claims 18 to 20, wherein in the second measurement flow, preparing a first sample liquid result to be measured using a second pretreatment reagent and a glycosylated hemoglobin detection reagent based on the intermediate detection information comprises:
selecting a detection mode to be executed from a plurality of different glycosylated hemoglobin sub-detection modes according to the intermediate detection information; and
and preparing the first sample liquid to be tested by adopting the second pretreatment test liquid and the glycosylated hemoglobin detection reagent according to the detection mode to be executed.
22. The sample detection method according to any one of claims 18 to 20, wherein in the second assay procedure:
preparing pretreatment test solutions corresponding to respective glycosylated hemoglobin sub-detection modes in a plurality of different glycosylated hemoglobin sub-detection modes by using a blood sample of the subject and a pretreatment reagent;
detecting at least one pretreatment liquid serving as the first pretreatment liquid in the pretreatment liquid to obtain intermediate detection information of the first pretreatment liquid;
Selecting a detection mode to be executed from the plurality of different glycosylated hemoglobin sub-detection modes according to the intermediate detection information; and
and selecting a pretreatment test solution corresponding to the detection mode to be executed from the pretreatment test solutions according to the detection mode to be executed as the second pretreatment test solution, and preparing the first sample solution to be tested by adopting the selected pretreatment test solution and the glycosylated hemoglobin detection reagent.
23. The method according to any one of claims 18 to 20, wherein preparing a first sample liquid to be measured using a second pretreatment reagent and a glycosylated hemoglobin detection reagent according to the intermediate detection information in the second measurement flow includes:
preparing a first sample liquid to be tested corresponding to each glycosylated hemoglobin detection mode in a plurality of different glycosylated hemoglobin detection modes by adopting a blood sample of the subject, a pretreatment reagent and a glycosylated hemoglobin detection reagent;
respectively detecting the first to-be-detected sample liquid corresponding to the detection modes of the respective glycosylated hemoglobin to obtain a plurality of glycosylated hemoglobin detection results; and
and selecting and outputting at least one glycosylated hemoglobin detection result from the plurality of glycosylated hemoglobin detection results according to the intermediate information.
24. The sample detection method according to any one of claims 21 to 23, wherein the plurality of different glycosylated hemoglobin sub-detection patterns are different in at least one of the following:
the amount of at least one of the blood sample, the pretreatment reagent, the glycosylated hemoglobin detection reagent used for preparing the first sample liquid to be tested or the ratio of at least one of the blood sample to be tested, the pretreatment reagent, the glycosylated hemoglobin detection reagent used for preparing the first sample liquid to be tested in the first sample liquid to be tested;
the components, the formula or the dosage of the pretreatment reagent for preparing the first sample liquid to be tested; and
the type or amount of glycosylated hemoglobin detection reagent used to prepare the first sample fluid to be tested.
25. The method according to any one of claims 18 to 23, wherein the pretreatment reagent includes a hemolyzing agent for lysing erythrocytes in a blood sample to release hemoglobin, and the intermediate detection information includes a detection value related to a hemoglobin concentration of the first pretreatment liquid; alternatively, the pretreatment reagent includes a diluent for diluting the blood sample to detect the hematocrit, and the intermediate detection information includes a detection value related to the hematocrit of the first pretreatment reagent.
26. A method of sample detection comprising:
selecting a first glycosylated hemoglobin measurement mode or a second glycosylated hemoglobin measurement mode;
executing a first measurement flow when the first glycosylated hemoglobin measurement mode is selected; and
executing a second measurement flow when the second glycosylated hemoglobin measurement mode is selected; the effective detection range of the first measurement procedure for the primary glycosylated hemoglobin detection of the blood sample is smaller than the effective detection range of the second measurement procedure for the primary glycosylated hemoglobin detection of the blood sample.
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