A sample analysis device and method

Abstract

A sample analysis device and method, which obtains detection data of a test sample prepared by a sample and a reagent, generates a reaction curve according to the detection data, calculates a first concentration of an analyte in the sample according to the reaction curve, obtains a reference curve corresponding to the analyte at the first concentration, and corrects the first concentration according to the reaction curve and the reference curve to obtain a second corrected concentration. The present application provides a scheme for correcting the measurement result of a sample with a hook effect.

Description

Technical Field

[0001] This invention relates to a sample analysis apparatus and method. Background Technology

[0002] In the field of blood testing, with the expansion of clinical needs, more and more blood parameters need to be tested. This has evolved from the initial three-part differential blood test to five-part differential, and later to combined blood tests with specific protein detection. Specific proteins refer to certain special types of proteins present in human plasma, including C-reactive protein, serum amyloid, procalcitonin, interleukin-6, human chorionic gonadotropin (hCG), growth hormone, luteinizing hormone (LH), alpha-fetoprotein (AFP), and carcinoembryonic antigen (CEA), among others. These specific proteins can reflect the body's inflammatory status and postoperative recovery, thus having significant clinical importance.

[0003] The concentration of specific proteins in blood can be detected using immunoturbidimetric inhibition immunoassay. Specifically, immunoturbidimetry is a method for dynamically measuring antigen-antibody binding; it is divided into immunotransmission turbidimetry and immunoscattering turbidimetry. Antibody-antigen complexes scatter and block light. Therefore, the amount of antibody-antigen complexes is proportional to the change in the intensity of transmitted or scattered light. When the antibody amount is constant, the change in light intensity is also proportional to the antigen content. Therefore, under certain conditions, the antigen content in a sample can be determined by detecting changes in the intensity of transmitted or scattered light.

[0004] Let's explain the detection process for specific proteins in a sample.

[0005] Please refer to Figure 1 The sample and hemolysin are added to the reaction chamber. After the sample dissolves and incubates, a latex reagent containing a specific protein is added. This latex reagent is a suspension composed of nanoscale latex particles (antibodies). Under certain conditions, these latex particles can bind to surrounding specific proteins (antigens), forming larger microclusters. As the latex particles continuously bind to the specific protein, the volume of the resulting microclusters increases. When irradiated with light of a specific wavelength, the scattering signal gradually increases, while the transmission signal gradually decreases. By monitoring the rate of change in the scattering or transmission signal and through certain calculations, the content of the specific protein in the original sample can be obtained.

[0006] In the above immunoturbidimetric assay for detecting the concentration of a specific protein in a sample, the rate of change of the scattering (or transmission) signal is related to the concentration of the specific protein and latex particles in the sample cell. Please refer to... Figure 2Generally speaking, when the concentration of latex particles is constant, within a certain range, the rate of change of the scattering (transmission) signal increases with the increase of the concentration of a specific protein. The concentration range in which the rate of change of the signal increases with the increase of the concentration of the specific protein is called the non-HOOK range. When the concentration of the specific protein in the sample exceeds the non-HOOK range, the rate of change of the signal no longer increases with the increase of the concentration, and may even weaken with the increase of the concentration. This phenomenon is called the HOOK effect.

[0007] The levels of specific proteins vary in blood samples from different patients, ranging from orders of magnitude of 10. -3 mg / L to 10 3 The concentration varies by mg / L. Taking C-reactive protein and serum amyloid (SAA) as examples, clinical samples can be broadly divided into two categories based on their content or concentration:

[0008] One category is ordinary samples, which include low-value samples, medium-value samples, and high-value samples, with specific protein concentrations below 10 mg / L, 10~100 mg / L, and 100~1000 mg / L, respectively; the other category is ultra-high-value samples, with specific protein concentrations generally above 1000 mg / L.

[0009] Generally, samples with high concentrations of specific proteins (such as samples with extremely high values) are prone to the hook effect during detection, which leads to a large deviation between the instrument measurement value of the specific protein and the true value of the sample, resulting in unreliable detection results. Summary of the Invention

[0010] To address the above problems, this invention proposes a sample analysis device and method, which are described in detail below.

[0011] According to a first aspect, one embodiment provides a sample analysis apparatus, including a sampling unit, a reagent supply unit, a reaction unit, a detection unit, and a processor;

[0012] The sampling unit is used to acquire a sample and transport the acquired sample to the reaction unit;

[0013] The reagent supply unit is used to store reagents and supply reagents to the reaction unit;

[0014] The reaction section is used to mix the sample and reagents to prepare the sample;

[0015] The detection unit is used to detect the sample and output detection data;

[0016] in:

[0017] The processor acquires the detection data output by the detection unit when detecting the sample, in order to generate a reaction curve;

[0018] The processor calculates the first concentration of the analyte in the sample based on the reaction curve;

[0019] The processor acquires the reference curve corresponding to the analyte at the first concentration, and corrects the first concentration based on the reaction curve and the reference curve to obtain the corrected second concentration.

[0020] In one embodiment, the reaction curve includes one or more of the following: a reaction measurement curve showing the change of a measured value over time, a reaction rate curve showing the change of a reaction rate over time, or a reaction acceleration curve showing the change of a reaction acceleration over time.

[0021] In one embodiment, the processor corrects the first concentration based on the reaction curve and the reference curve, including:

[0022] The processor corrects the first concentration based on the difference between the reaction curve and the reference curve.

[0023] In one embodiment, the processor corrects the first concentration based on the difference between the reaction curve and the reference curve, including:

[0024] The values ​​corresponding to the same reaction time point on the reaction curve and the reference curve are selected, and the correction factor Coef is calculated based on the values ​​corresponding to the same reaction time point; in one embodiment, the correction factor Coef is calculated using the following formula:

[0025] ;

[0026] Where A i and B i These are the values ​​corresponding to the same reaction time points on the reaction curve and the reference curve, respectively; k1, k2, m, b1, and b2 are constants; min represents the operation of taking the minimum of the two;

[0027] The second concentration is obtained by multiplying the first concentration by the correction factor.

[0028] In one embodiment, the processor corrects the first concentration based on the difference between the reaction curve and the reference curve, including:

[0029] Values ​​corresponding to multiple identical reaction time points on the reaction curve and the reference curve are selected, and a correction factor Coef is calculated based on these values. In one embodiment, the correction factor Coef is calculated using the following formula:

[0030] ;

[0031] Where i ranges from 1 to N, and N is an integer greater than or equal to 1, A i and B i These are the values ​​corresponding to the same reaction time points on the reaction curve and the reference curve, respectively; k1, k2, m, b1, and b2 are constants; min represents the operation of taking the minimum of the two;

[0032] The second concentration is obtained by multiplying the first concentration by the correction factor.

[0033] In one embodiment, the processor further determines whether the second concentration is within a preset measurable range of the analyte;

[0034] If so, the processor outputs the second concentration as the detection result of the analyte;

[0035] If not, the processor outputs information indicating that the concentration of the analyte exceeds the measurable range, or the processor controls the reagent supply unit to provide reagents to increase the dilution factor of the sample for retesting.

[0036] In one embodiment, before the processor acquires the reference curve corresponding to the analyte at the first concentration and corrects the first concentration based on the reaction curve and the reference curve, the processor first determines whether the sample has a hook effect based on the reaction curve. If it is determined that the sample has a hook effect, the processor then corrects the first concentration based on the reaction curve and the reference curve.

[0037] The processor determines whether the sample exhibits a hook effect based on the reaction curve, including:

[0038] The processor compares the reaction curve with the reference curve to determine whether the sample exhibits a hook effect.

[0039] or,

[0040] The processor determines whether the sample exhibits a hook effect based on the shape of the reaction curve itself.

[0041] In one embodiment, the processor compares the response curve with the reference curve to determine whether the sample exhibits a hook effect, including:

[0042] The processor compares the values ​​corresponding to the same reaction time point on the reaction curve and the reference curve; when the difference between the value on the reaction curve and the value corresponding to the same time point on the reference curve exceeds a preset percentage, it is determined that the sample has a HOOK effect.

[0043] or,

[0044] The processor compares the average values ​​of the reaction curve and the reference curve for the same time period; when the difference between the average values ​​of the reaction curve and the reference curve for the same time period exceeds a preset percentage, it determines that the sample has a hook effect.

[0045] In one embodiment, the processor determines whether the sample exhibits a hook effect based on the shape of the reaction curve itself, including:

[0046] When the reaction rate curve shows a decreasing trend over time, it is determined that the sample exhibits a hook effect.

[0047] or,

[0048] When the reaction acceleration curve shows an increasing trend over time, it is determined that the sample exhibits the HOOK effect.

[0049] In one embodiment, the processor acquires the detection data output by the detection unit when detecting the sample, in order to generate a reaction curve, including:

[0050] The processor acquires the detection unit data from T1 to T2 after the reaction begins. n The output detection data within the specified time period; where Tn is less than or equal to the time T when the reaction has proceeded to 90% of the total reaction time. 90 The preferred time is less than or equal to the time T when the reaction has proceeded to 70% of the total reaction time. 70 More preferably, the time T is less than or equal to 50% of the total reaction time. 50 More preferably, the time T is less than or equal to 40% of the total reaction time. 40 More preferably, the time T is less than or equal to 30% of the total reaction time. 30 More preferably, the time T is less than or equal to 20% of the total reaction time. 20 More preferably, the time T is less than or equal to 10% of the total reaction time. 10 ;

[0051] The processor according to T1~T n The reaction curve is generated from the detection data within the specified time period.

[0052] In one embodiment, the reaction unit includes a routine blood test reaction unit and a specific protein reaction unit, and the detection unit includes a routine blood test detection unit and a specific protein detection unit;

[0053] The processor controls the sampling unit to deliver the sample to the specific protein reaction unit, and controls the reagent supply unit to supply hemolysing agent and latex reagent to the specific protein reaction unit to prepare a specific protein sample; the specific protein detection unit is used to detect the specific protein sample and output the detection data of the specific protein; the processor acquires the detection data of the specific protein to calculate the concentration of the specific protein in the sample; the analyte is the specific protein;

[0054] The processor controls the sampling unit to deliver the sample to the blood routine reaction unit, and controls the reagent supply unit to supply at least one hemolytic agent to the blood routine reaction unit to prepare a blood routine sample; the blood routine detection unit is used to detect the blood routine sample and output the blood routine detection data, and the processor acquires the blood routine detection data to calculate the blood routine information in the sample.

[0055] In one embodiment, the complete blood count (CBC) unit includes one or more of the following: a BASO unit, a DIFF unit, an HGB unit, an RBC unit, a RET unit, and an NRBC unit. The BASO unit is used to detect white blood cell count and basophil differential, the DIFF unit is used to detect four-part white blood cell differential, the HGB unit is used to detect hemoglobin concentration, the RBC unit is used to detect red blood cell count and / or platelet count, the RET unit is used to detect reticulocyte count, and the NRBC unit is used to detect nucleated red blood cell count, white blood cell count, and basophil count.

[0056] In one embodiment, the specific protein includes one or more of the following: C-reactive protein, serum amyloid protein, procalcitonin, interleukin-6, human chorionic gonadotropin, growth hormone, luteinizing hormone, alpha-fetoprotein, and carcinoembryonic antigen.

[0057] According to a second aspect, one embodiment provides a sample analysis device, including a sampling unit, a reagent supply unit, a reaction unit, a detection unit, and a processor;

[0058] The sampling unit is used to acquire a sample and transport the acquired sample to the reaction unit;

[0059] The reagent supply unit is used to store reagents and supply reagents to the reaction unit;

[0060] The reaction section is used to mix the sample and reagents to prepare the sample;

[0061] The detection unit is used to detect the sample and output detection data;

[0062] in:

[0063] The sample analysis device has a first anomaly handling mode and a second anomaly handling mode;

[0064] The processor controls the sampling unit and the reagent supply unit to add the sample and reagent to the reaction unit respectively, in order to prepare a sample with a first dilution factor;

[0065] The processor acquires the detection data output by the detection unit when detecting the sample with the first dilution factor, in order to generate a reaction curve;

[0066] The processor determines whether the sample exhibits the HOOK effect based on the reaction curve.

[0067] For samples exhibiting the HOOK effect, in the first anomaly handling mode: the processor calculates the first concentration of the analyte in the sample based on the reaction curve; the processor obtains the reference curve corresponding to the analyte at the first concentration, and corrects the first concentration based on the reaction curve and the reference curve to obtain the corrected second concentration;

[0068] For samples exhibiting the HOOK effect, in the second anomaly handling mode: the processor controls the reagent supply unit to provide reagents to prepare a sample with a second dilution factor for retesting, wherein the second dilution factor is greater than the first dilution factor.

[0069] In one embodiment, the reaction unit includes a routine blood test reaction unit and a specific protein reaction unit, and the detection unit includes a routine blood test detection unit and a specific protein detection unit;

[0070] The processor controls the sampling unit to deliver the sample to the specific protein reaction unit, and controls the reagent supply unit to supply hemolysin and latex reagent to the specific protein reaction unit to prepare a specific protein sample; the specific protein detection unit is used to detect the specific protein sample and output the detection data of the specific protein; the processor acquires the detection data of the specific protein to calculate the concentration of the specific protein in the sample; the analyte is the specific protein;

[0071] The processor controls the sampling unit to deliver the sample to the blood routine reaction unit, and controls the reagent supply unit to supply at least one hemolytic agent to the blood routine reaction unit to prepare a blood routine sample; the blood routine detection unit is used to detect the blood routine sample and output the blood routine detection data, and the processor acquires the blood routine detection data to calculate the blood routine information in the sample.

[0072] In one embodiment, the sample analysis device further includes an operation unit for responding to a user-inputted exception handling mode selection command and selecting either the first exception handling mode or the second exception handling mode as the current mode.

[0073] In one embodiment, for a sample exhibiting a hook effect, the processor activates an anomaly processing first mode to obtain the second concentration; the processor further determines whether the second concentration is within the preset measurable range of the analyte, and if not, for the sample exhibiting a hook effect, the processor activates an anomaly processing second mode to retest.

[0074] According to a third aspect, one embodiment provides a sample analysis method, comprising:

[0075] To obtain test data for a sample, which is prepared from a sample and reagents;

[0076] A reaction curve is generated based on the detection data;

[0077] Calculate the first concentration of the analyte in the sample based on the reaction curve;

[0078] Determine whether the HOOK effect exists in the sample based on the reaction curve;

[0079] When it is determined that the sample exhibits a HOOK effect, a reference curve corresponding to the analyte at the first concentration is obtained, and the first concentration is corrected based on the reaction curve and the reference curve to obtain the corrected second concentration.

[0080] In one embodiment, the reaction curve includes one or more of the following: a reaction measurement curve showing the change of a measured value over time, a reaction rate curve showing the change of a reaction rate over time, or a reaction acceleration curve showing the change of a reaction acceleration over time.

[0081] In one embodiment, correcting the first concentration based on the reaction curve and the reference curve includes:

[0082] The first concentration is corrected based on the difference between the reaction curve and the reference curve.

[0083] In one embodiment, correcting the first concentration based on the difference between the reaction curve and the reference curve includes:

[0084] The values ​​corresponding to the same reaction time point on the reaction curve and the reference curve are selected, and the correction factor Coef is calculated based on the values ​​corresponding to the same reaction time point; in one embodiment, the correction factor Coef is calculated using the following formula:

[0085] ;

[0086] Where A i and B iThese are the values ​​corresponding to the same reaction time points on the reaction curve and the reference curve, respectively; k1, k2, m, b1, and b2 are constants; min represents the operation of taking the minimum of the two;

[0087] The second concentration is obtained by multiplying the first concentration by the correction factor.

[0088] In one embodiment, correcting the first concentration based on the difference between the reaction curve and the reference curve includes:

[0089] Values ​​corresponding to multiple identical reaction time points on the reaction curve and the reference curve are selected, and a correction coefficient Coef is calculated based on these values. In one embodiment, the correction coefficient Coef is calculated using the following formula:

[0090] ;

[0091] Where i ranges from 1 to N, and N is an integer greater than or equal to 1, A i and B i These are the values ​​corresponding to the same reaction time points on the reaction curve and the reference curve, respectively; k1, k2, m, b1, and b2 are constants; min represents the operation of taking the minimum of the two;

[0092] The second concentration is obtained by multiplying the first concentration by the correction factor.

[0093] In one embodiment, the sample analysis method further includes:

[0094] Determine whether the second concentration is within the preset measurable range of the analyte;

[0095] If so, the second concentration is output as the detection result of the analyte;

[0096] If not, output information that the concentration of the analyte exceeds the measurable range, or increase the dilution factor of the sample with reagents for retesting.

[0097] According to the fourth aspect, one embodiment provides a sample analysis method, the sample analysis method having a first anomaly handling mode and a second anomaly handling mode, the method comprising the following steps:

[0098] The sample was treated with reagents to prepare a sample with a first dilution factor;

[0099] Obtain the detection data of the sample with the first dilution factor;

[0100] A reaction curve is generated based on the detection data;

[0101] Determine whether the HOOK effect exists in the sample based on the reaction curve;

[0102] For samples exhibiting the hook effect, in the first anomaly handling mode:

[0103] Calculate the first concentration of the analyte in the sample based on the reaction curve;

[0104] Obtain the reference curve corresponding to the analyte at the first concentration;

[0105] The first concentration is corrected based on the reaction curve and the reference curve to obtain the corrected second concentration;

[0106] For samples exhibiting the hook effect, in the second anomaly handling mode:

[0107] The sample is treated with reagents to prepare a sample with a second dilution factor, wherein the second dilution factor is greater than the first dilution factor;

[0108] The sample with the second dilution factor was retested.

[0109] In one embodiment:

[0110] Responding to the user's input command to select an exception handling mode, the user can choose either exception handling mode 1 or exception handling mode 2 as the current mode; or...

[0111] For samples exhibiting the HOOK effect, the first anomaly handling mode is activated to obtain the second concentration; it is also determined whether the second concentration is within the preset measurable range of the analyte. If not, the second anomaly handling mode is activated for the sample exhibiting the HOOK effect to perform a retest.

[0112] In one embodiment, the analyte includes one or more of the following: C-reactive protein, serum amyloid protein, procalcitonin, interleukin-6, human chorionic gonadotropin, growth hormone, luteinizing hormone, alpha-fetoprotein, and carcinoembryonic antigen.

[0113] According to a fifth aspect, one embodiment provides a computer-readable storage medium storing a program that can be executed by a processor to perform the methods as described in any of the embodiments herein.

[0114] Based on the sample analysis apparatus, method, and computer-readable storage medium of the above embodiments, a scheme for correcting the measurement results of samples exhibiting the HOOK effect is proposed. Attached Figure Description

[0115] Figure 1A schematic diagram of the hardware structure corresponding to a specific protein detection process in one embodiment;

[0116] Figure 2 An illustration of the HOOK effect in one embodiment.

[0117] Figure 3 This is a schematic diagram of the structure of a sample analysis device according to one embodiment;

[0118] Figure 4 This is a schematic diagram of the structure of a sample analysis device according to one embodiment;

[0119] Figure 5 This is a schematic diagram of the structure of a sample analysis device according to one embodiment;

[0120] Figure 6 This is a schematic diagram of the reaction curve of a specific protein in one embodiment;

[0121] Figure 7 This is a schematic diagram of the reaction curve (thick solid line in the figure) corresponding to the presence of the HOOK effect in one embodiment and the corresponding reference curve (thin solid line in the figure);

[0122] Figure 8 This is a schematic diagram of the reaction curve (thick solid line in the figure) corresponding to the presence of the HOOK effect in one embodiment and the corresponding reference curve (thin solid line in the figure);

[0123] Figure 9 This is a schematic diagram of the reaction curve (thick solid line in the figure) corresponding to the presence of the HOOK effect in one embodiment and the corresponding reference curve (thin solid line in the figure);

[0124] Figure 10 This is a schematic diagram of the structure of a sample analysis device according to one embodiment;

[0125] Figure 11 This is a schematic diagram of the structure of the exception storage unit in one embodiment;

[0126] Figure 12 This is a schematic diagram of the structure of the exception storage unit in one embodiment;

[0127] Figure 13 A schematic diagram of the structure of a secondary sample preparation tube according to one embodiment;

[0128] Figure 14 A schematic diagram of the structure of a secondary sample preparation tube according to one embodiment;

[0129] Figure 15 A schematic diagram of the first calibration curve of a specific protein in one embodiment;

[0130] Figure 16 This is a schematic diagram of the structure of a sample analysis device according to one embodiment;

[0131] Figure 17 A flowchart of a sample analysis method according to one embodiment;

[0132] Figure 18 A flowchart of a sample analysis method according to one embodiment;

[0133] Figure 19 A flowchart of a sample analysis method according to one embodiment;

[0134] Figure 20 A flowchart of a sample analysis method according to one embodiment;

[0135] Figure 21 A flowchart of a sample analysis method according to one embodiment;

[0136] Figure 22 A flowchart of a sample analysis method according to one embodiment;

[0137] Figure 23 This is a flowchart of a sample analysis method according to one embodiment. Detailed Implementation

[0138] The present invention will now be described in further detail with reference to specific embodiments and accompanying drawings. Similar elements in different embodiments are referred to by associated similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of this application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to this application are not shown or described in the specification. This is to avoid obscuring the core parts of this application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0139] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for the clear description of a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0140] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include both direct and indirect connections (linkages).

[0141] As mentioned in the background section, turbidimetric measurements of reactive proteins in blood samples typically employ antigen-antibody reactions, with the protein concentration determined by measuring changes in transmitted or scattered light intensity. However, when there is an excess of antigen in the blood sample, the limited number of antibodies leads to an uneven reaction, affecting the measurement results of high-value samples, which are generally lower than expected—a phenomenon known as the hook effect. This invention proposes a scheme to correct the measurement results for samples exhibiting the hook effect.

[0142] Please refer to Figure 3 and Figure 4 This invention discloses a sample analysis device in some embodiments, which may include a housing, a sampling unit 10, a reagent supply unit 20, a reaction unit 30, a detection unit 40, and a processor 50. In some embodiments, a scheduling unit 60 may also be included. Any one or more of the reagent supply unit 20, reaction unit 30, detection unit 40, and processor 50 may be disposed within the housing; for example, the reagent supply unit 20, reaction unit 30, detection unit 40, and processor 50 may all be disposed within the housing, or, for another example, the reagent supply unit 20, reaction unit 30, and detection unit 40 may all be disposed within the housing. The components are described in detail below.

[0143] The sampling unit 10 is used to acquire samples and transport the acquired samples to the reaction unit 30. For example, the sampling unit 10 may include a sampling needle for drawing samples from a sample tube located at the sampling position, so as to transport the drawn samples to the reaction unit 30. The sample tube is used to carry the samples, and the sample tube can be scheduled by the scheduling unit 60, that is, the scheduling unit 60 can schedule the sample tube to different positions to cooperate with the corresponding test procedures.

[0144] In this invention, the term "sample" generally refers to a blood sample, particularly a whole blood sample. In this document, the sample is typically derived from peripheral or venous blood samples from mammals, particularly from human blood samples. The sample has undergone necessary processing prior to the immune response, including but not limited to anticoagulation treatment.

[0145] The reagent supply unit 20 is used to store reagents and supply reagents to the reaction unit 30. For example, the reagent supply unit 20 can supply the reaction unit 30 with a first reagent, a second reagent, and a third reagent, etc., wherein the first reagent and the third reagent can be the same or different types of hemolytic agents, and the second reagent can be a latex reagent, such as polyethylene glycol.

[0146] The reaction section 30 is used to mix samples and reagents to prepare test samples, such as routine blood test samples and specific protein test samples, as described in detail below.

[0147] From a structural perspective, the reaction unit 30 may include one or more reaction chambers for receiving samples and reagents delivered by the sampling unit 10 and the reagent supply unit 20 to prepare corresponding samples. For example, at least one reaction chamber is used to receive a sample delivered by the sampling needle and at least a first reagent—such as a first reagent and a second reagent—supplied by the reagent supply unit 20 to prepare a specific protein sample; and at least one reaction chamber is used to receive a sample delivered by the sampling needle and at least a third reagent (e.g., may also include a fourth reagent, i.e., a fluorescent agent) supplied by the reagent supply unit 20 to prepare a complete blood count sample.

[0148] From a functional perspective, please refer to Figure 5 The reaction unit 30 includes a routine blood test reaction unit 31 and a specific protein reaction unit 32. In some embodiments, the routine blood test reaction unit 31 may include one or more reaction chambers, and the specific protein reaction unit 32 may include one or more reaction chambers. In a specific embodiment, the routine blood test reaction unit 31 is used to receive a sample delivered by the sampling unit 10, such as a sampling needle, and reagents supplied by the reagent supply unit 20, such as at least a third reagent (and may also include a fourth reagent, i.e., a fluorescent agent), to prepare a routine blood test sample; the specific protein reaction unit 32 is used to receive a sample delivered by the sampling unit 10, such as a sampling needle, and reagents supplied by the reagent supply unit 20, such as at least a first reagent—specifically, it may be a first reagent and a second reagent—to prepare a specific protein sample.

[0149] The detection unit 40 is used to detect samples and output detection data. For example, the detection unit 40 detects a blood routine sample and outputs blood routine detection data, and the detection unit 40 detects a specific protein sample and outputs specific protein detection data. Therefore, in some embodiments, the detection unit 40 may include a blood routine detection unit 41 and a specific protein detection unit 43, which will be described in detail below.

[0150] The complete blood count (CBC) testing unit 41 is used to test the CBC sample and output the CBC test data. The processor 50 acquires the CBC test data to calculate the CBC information in the sample. For example, the CBC information may include, but is not limited to, one or more of the following: white blood cell count, white blood cell differential (three-part, four-part, or five-part), red blood cell count, reticulocyte count, nucleated red blood cell count, platelet count, and hemoglobin concentration. Therefore, in some embodiments, the CBC testing unit 41 may include one or more of the following: a BASO testing unit, a DIFF testing unit, an HGB testing unit, an RBC testing unit, a RET testing unit, and an NRBC testing unit; wherein the BASO testing unit is used to detect the white blood cell count and basophil differential, the DIFF testing unit is used to detect the four-part white blood cell differential, the HGB testing unit is used to detect the hemoglobin concentration, the RBC testing unit is used to detect the red blood cell count and / or platelet count; the RET testing unit is used to detect the reticulocyte count, and the NRBC testing unit is used to detect the nucleated red blood cell count, white blood cell count, and basophil count.

[0151] The specific protein detection unit 42 is used to detect a specific protein sample and output the detection data of the specific protein. The processor 50 acquires the detection data of the specific protein to calculate the concentration of the specific protein in the sample. In some embodiments, the specific protein detection unit 42 may include a photometer, specifically a turbidimeter and / or a turbidimeter.

[0152] In some embodiments, the processor 50 acquires the detection data output by the detection unit 40 upon detecting the sample to generate a reaction curve. For example, the sample here may be a specific protein sample. Accordingly, the processor 50 acquires the detection data of the specific protein output by the detection unit 40, such as the specific protein detection unit 42, upon detecting the specific protein sample to generate a reaction curve. In some embodiments, the reaction curve is used to calculate measurement results and also to determine whether the sample exhibits a hook effect, as will be explained in detail below.

[0153] In some embodiments, the processor 50 calculates a first concentration of the analyte in the sample based on the reaction curve. As mentioned above, the sample can be a specific protein sample, so the first concentration of the analyte in the sample calculated by the processor 50 based on the reaction curve is the first concentration of the specific protein in the sample; that is, the analyte involved here can be a specific protein. In some embodiments, the specific protein includes one or more of C-reactive protein, serum amyloid, procalcitonin, interleukin-6, human chorionic gonadotropin, growth hormone, luteinizing hormone, alpha-fetoprotein, and carcinoembryonic antigen.

[0154] In some embodiments, the processor 50 acquires a reference curve corresponding to the analyte at the first concentration, and corrects the first concentration based on the reaction curve and the reference curve to obtain a corrected second concentration.

[0155] In other embodiments, before correcting the first concentration, it can be determined whether the sample exhibits a hook effect. Specifically, the processor 50 also determines whether the sample exhibits a hook effect based on the reaction curve. If it is determined that the sample does not exhibit a hook effect, it indicates that the first concentration calculated by the processor 50 based on the reaction curve is reliable and accurate, and therefore can be output as the detection result. If it is determined that the sample exhibits a hook effect, it indicates that there is a deviation between the first concentration calculated by the processor 50 based on the reaction curve and the true value. In this case, the processor 50 will correct the first concentration. Specifically, when it is determined that the sample exhibits a hook effect, the processor 50 obtains the reference curve corresponding to the analyte at the first concentration, and corrects the first concentration based on the reaction curve and the reference curve to obtain the corrected second concentration.

[0156] A "reference curve" is a response curve of a specific protein in a normal sample without hook effect at a calculated concentration, corresponding to the concentration of a specific protein calculated from response measurements over a predetermined time period.

[0157] In some embodiments, the reaction curve includes one or more of the following: a reaction measurement curve showing the change of a measured value over time, a reaction rate curve showing the change of reaction rate over time, or a reaction acceleration curve showing the change of reaction acceleration over time. The reaction rate curve can be obtained by taking the first derivative of the reaction measurement curve, and the reaction acceleration curve can be obtained by taking the second derivative of the reaction measurement curve.

[0158] The above process involves two steps: first, identifying whether the sample has a hook effect; and second, correcting the first concentration calculated for samples with a hook effect. These two steps are explained in detail below.

[0159] The first question is how to identify whether a sample exhibits a hook effect.

[0160] When there is an excess of antigen in the sample (e.g., high concentration of a specific protein) and the number of antibodies is fixed, the intensity of transmitted or scattered light is monitored in real time when the antigen and antibody begin to react. By analyzing the changes in light intensity and reaction rate during the measurement process, samples with the HOOK effect can be identified.

[0161] Let's take serum amyloid (SAA) as an example. Figure 6 Let its reaction curve be represented by the x-axis as time and the y-axis as the measured value, such as absorbance. Each point on the curve is a detection point. Let's define the i-th time point in the reaction curve as T. i The absorbance is A iLet i = 1, 2, ..., N; where N is an integer greater than or equal to 1. Then the coordinates of the i-th detection point are (T... i A i Generally, N is greater than 1, meaning there are multiple detection points on the reaction curve. The reaction intensity, or reactivity, is calculated from the reaction curve. It is defined as the difference between the absorbance at the end of a fixed testing period and the absorbance at the beginning of the period. Based on the reaction intensity and the corresponding calibration curve of SAA, the first concentration of a specific protein, such as SAA, can be calculated.

[0162] Next, the calculated first concentration can be used to obtain the reaction curve of a specific protein at the first concentration under normal reaction conditions, i.e., the reference curve mentioned above. Then, the difference between the two can be compared to determine whether the sample has a hook effect.

[0163] Please refer to Figure 7 The diagram illustrates the reaction curve (thick solid line) and the corresponding reference curve (thin solid line) for the presence of the hook effect. A specific time point, such as T1 or T2, can be selected to compare the absorbance difference between the reaction curve and the reference curve at that same time point. At point T1, the absorbance of the reaction curve exhibiting the hook effect is 3334, while the absorbance of the reference curve is 2803. The absorbance of the reaction curve exhibiting the hook effect is 18.9% higher, indicating the presence of a hook effect. Alternatively, a time interval can be selected and the average absorbance difference over that period calculated. For example, considering the time interval T1 to T2, the average absorbance of the reaction curve exhibiting the hook effect is 4578, while the average absorbance of the reference curve is 3935. The absorbance of the reaction curve exhibiting the hook effect is 16.3% higher, also indicating the presence of a hook effect.

[0164] Figure 7 This is an example of a reaction curve where the measured value changes over time. Figure 8 The reaction curve is a reaction rate curve that shows the change of reaction rate over time, with the horizontal axis representing time and the vertical axis representing the reaction rate.

[0165] Figure 8 The study analyzes the difference in reaction rates between the reaction curve exhibiting the hook effect (thick solid line in the figure) and the reference curve (thin solid line in the figure) at time points T1 or T2. Taking T1 as an example, Figure 8The ordinate value of the reaction curve exhibiting the hook effect, representing the reaction rate, is 88.77, while the reference curve's is 63.92. The reaction rate of the curve exhibiting the hook effect is 38.9% higher, a significant difference, thus indicating the presence of a hook effect. Similarly, the difference in average reaction rates over a period of time can be analyzed. For example, the average reaction rate of the curve exhibiting the hook effect over the time interval T1-T2 is 85.81, while the average reaction rate of the reference curve during the same period is 73.24. The average reaction rate of the curve exhibiting the hook effect is 17.2% higher, a significant difference, also indicating the presence of a hook effect. In other examples, it can also be determined by... Figure 8 The shape or trend of the reaction curve itself is used to determine whether the sample has a HOOK effect. Analyzing the reaction curve with a HOOK effect in the graph, the value of its vertical axis, i.e., the reaction rate, shows a trend of decreasing continuously over time, while the reference curve shows a trend of first increasing and then decreasing over time. Therefore, when the sample's reaction curve is specifically a reaction rate curve and the curve itself shows a trend of decreasing continuously over time, it is determined that the sample has a HOOK effect.

[0166] Figure 9 This is an example where the reaction curve is a reaction acceleration curve that shows the reaction acceleration changing over time. Figure 8 Similarly, the presence of a hook effect can be determined by analyzing the difference between the reaction acceleration curve (thick solid line in the figure) and the corresponding reference curve (thin solid line in the figure) at a single point or over a period of time. For example, analyzing the difference in the ordinate values ​​(i.e., reaction acceleration) of the reaction acceleration curve and the corresponding reference curve at the same moment, if the difference is large, it can be concluded that the sample has a hook effect. Another example is analyzing the difference in the average reaction acceleration of the reaction acceleration curve and the corresponding reference curve over the same period of time; if the difference is large, it can be concluded that the sample has a hook effect. Preferably, the selected time point or time period can be located in the early stage of the reaction, such as the first 50% of the total reaction time; more preferably, the first 30% of the total reaction time; more preferably, the first 20% of the total reaction time; more preferably, the first 15% of the total reaction time; more preferably, the first 10% of the total reaction time; more preferably, the first 5% of the total reaction time. In other examples, it can also be determined by... Figure 9 The shape or trend of the reaction curve itself is used to determine whether the sample has a HOOK effect. Analyzing the reaction curve with a HOOK effect in the graph, the value of its vertical axis, i.e., the reaction acceleration, shows a trend of increasing with time, while the reference curve shows a trend of decreasing with time. Therefore, when the sample's reaction curve is specifically a reaction acceleration curve and the curve itself shows a trend of increasing with time, it is determined that the sample has a HOOK effect.

[0167] Based on the above analysis, it can be seen that in some embodiments, the processor 50 determines whether a sample exhibits a hooking effect based on the reaction curve in at least one or more of the following ways:

[0168] In one method, the processor 50 compares the response curve with the reference curve to determine whether the sample exhibits a hook effect. For example, the processor 50 compares the values ​​corresponding to the same response time point on the response curve and the reference curve; if the difference between the value on the response curve and the value corresponding to the same time point on the reference curve exceeds a preset percentage, then the sample is determined to exhibit a hook effect. Specifically, when the response curve is a response measurement curve, "if the difference between the value on the response curve and the value corresponding to the same time point on the reference curve exceeds a preset percentage, then the sample is determined to exhibit a hook effect" can include "if the value on the response curve is greater than the value corresponding to the same time point on the reference curve by a preset percentage, then the sample is determined to exhibit a hook effect."

[0169] For example, the processor 50 compares the average values ​​of the response curve and the reference curve for the same time period; when the difference between the average values ​​of the response curve and the reference curve for the same time period exceeds a preset percentage, it is determined that the sample has a hook effect.

[0170] Method Two: The processor 50 determines whether the sample exhibits a hook effect based on the shape of the reaction curve itself. For example, if the reaction rate curve shows a decreasing trend over time, the sample is judged to exhibit a hook effect. Similarly, if the reaction acceleration curve shows an increasing trend over time, the sample is judged to exhibit a hook effect.

[0171] The above explains how to identify whether a sample has a hook effect. The following explains how to correct the initial concentration of the analyte.

[0172] In some embodiments, when a hook effect is determined to exist in the sample, the processor 50 acquires the reference curve corresponding to the analyte at the first concentration, and corrects the first concentration based on the reaction curve and the reference curve to obtain a corrected second concentration. In some specific embodiments, the processor 50 corrects the first concentration based on the difference between the reaction curve and the reference curve. Specifically, there are two methods.

[0173] Method 1:

[0174] The processor 50 selects the value corresponding to the same reaction time point on the reaction curve and the reference curve, and calculates the correction factor Coef based on the value corresponding to the same reaction time point; in one embodiment, the correction factor Coef is calculated using the following formula:

[0175] ;

[0176] Where A i and B i These are the values ​​corresponding to the same reaction time points on the reaction curve and the reference curve, respectively; k1, k2, m, b1, and b2 are constants; min represents the operation of taking the minimum of the two;

[0177] The processor 50 then multiplies the first concentration by the correction factor Coef to obtain the second concentration.

[0178] Method 2:

[0179] The processor 50 selects values ​​corresponding to multiple identical reaction time points on the reaction curve and the reference curve, and calculates the correction coefficient Coef based on the values ​​corresponding to the multiple identical reaction time points; in one embodiment, the correction coefficient Coef is calculated using the following formula:

[0180] ;

[0181] Where i ranges from 1 to N, and N is an integer greater than or equal to 1, A i and B i These are the values ​​corresponding to the same reaction time points on the reaction curve and the reference curve, respectively; k1, k2, m, b1, and b2 are constants; min represents the operation of taking the minimum of the two;

[0182] The processor 50 multiplies the first concentration by the correction factor to obtain the second concentration.

[0183] As described above, the reaction curve includes one or more of the following: a reaction measurement curve of the measured value changing over time, a reaction rate curve of the reaction rate changing over time, or a reaction acceleration curve of the reaction acceleration changing over time. Therefore, those skilled in the art will understand that the reaction curve used to identify the HOOK effect and the reaction curve used to correct the first concentration can be the same or different. For example, one case is that the reaction curve used to identify the HOOK effect is a reaction measurement curve, and the reaction curve used to correct the first concentration is also a reaction measurement curve; another example is that the reaction curve used to identify the HOOK effect is a reaction rate curve, and the reaction curve used to correct the first concentration is a reaction measurement curve.

[0184] To expedite testing and measurement, some embodiments of the present invention may utilize only the detection data from the initial stage of the reaction to generate the reaction curve and identify and subsequently correct the hook effect. Therefore, in some embodiments, the processor 50 acquires data from the detection unit at times T1~T1 after the reaction begins. n The output detection data within the specified time period; where Tn is less than or equal to the time T when the reaction has proceeded to 90% of the total reaction time. 90 The preferred time is less than or equal to the time T when the reaction has proceeded to 70% of the total reaction time. 70 More preferably, the time T is less than or equal to 50% of the total reaction time. 50 More preferably, the time T is less than or equal to 40% of the total reaction time. 40 More preferably, the time T is less than or equal to 30% of the total reaction time. 30 More preferably, the time T is less than or equal to 20% of the total reaction time. 20 More preferably, the time T is less than or equal to 10% of the total reaction time. 10 Processor 50 according to T1~T n The detection data within the specified time period are used to generate a reaction curve.

[0185] The above explains how the second concentration is obtained by correcting the first concentration.

[0186] As mentioned above, samples with high concentrations of specific proteins (e.g., extremely high concentrations) are prone to the hook effect during detection. This leads to a significant deviation between the instrument's measured value of the specific protein and the true value of the sample, resulting in unreliable detection results. Therefore, the non-hooked range is generally the instrument's detectable range or measurable range. In some examples, if the corrected second concentration exceeds a measurable range, the second concentration may not be output as a result; instead, dilution and retesting may be performed. Therefore, in some embodiments, the processor 50 further determines whether the second concentration is within the preset measurable range of the analyte. If so, the processor 50 outputs the second concentration as the detection result of the analyte; if not, the processor 50 outputs information indicating that the concentration of the analyte exceeds the measurable range, or the processor 50 controls the reagent supply unit 20 to provide reagents to increase the dilution factor of the sample for retesting.

[0187] The following explains how to increase the dilution factor of a sample for retesting. Specifically, when a HOOK effect is determined to exist in a sample, the processor 50 controls the reagent supply unit 20 to provide reagents, such as the first reagent described above, to increase the dilution factor of the sample for retesting. Let's take the retesting of a specific protein as an example for illustration.

[0188] Please refer to Figure 10 In some embodiments, the sample analysis apparatus may incorporate an anomaly storage unit 70 for storing samples drawn by the sampling unit 10, such as a sampling needle. In some embodiments, the anomaly storage unit 70 is disposed within the housing.

[0189] When a hook effect is detected in a sample, the sample from the abnormal storage unit 70 is transferred to the specific protein reaction unit 32 (e.g., a reaction chamber), and the processor 50 controls the reagent supply unit 20 to supply reagents, such as a first reagent and a second reagent, to the specific protein reaction unit 32 to prepare a specific protein sample with a higher dilution factor. A specific detection procedure could be as follows:

[0190] The processor 50 controls the sampling needle to draw a sample from the sample tube located at the sampling position;

[0191] The processor 50 controls the sampling needle to deliver the sample to the specific protein reaction section 32, and controls the reagent supply section 20 to supply reagents, such as the first reagent and the second reagent, to the specific protein reaction section to prepare a specific protein sample with a first dilution factor.

[0192] The processor 50 controls the specific protein detection unit 42 to detect the specific protein sample with the first dilution factor to obtain the detection data of the specific protein and determine whether the sample has a hook effect.

[0193] When a HOOK effect is detected in a sample, and retesting is required (e.g., the current anomaly handling mode 2 is activated, or the corrected second concentration is outside the preset measurable range of the analyte), the sample in the anomaly storage unit 70 will be transferred to the specific protein reaction unit 32, and the processor 50 will control the reagent supply unit 20 to supply reagents to the specific protein reaction unit 32 to prepare a specific protein sample with a second dilution factor. It is understood that the specific protein reaction unit 32 used for preparing a specific protein sample with a first dilution factor can be emptied before preparing a specific protein sample with a second dilution factor, or the specific protein sample with a second dilution factor can be prepared in another specific protein reaction unit 32.

[0194] The processor 50 controls the specific protein detection unit 42 to detect the specific protein sample having a second dilution factor. In some embodiments, the second dilution factor is greater than the first dilution factor.

[0195] In the above detection process, in addition to detecting specific proteins, routine blood tests can also be performed. For example, after the processor 50 controls the sampling needle to draw a sample from the sample tube located at the sampling position, the processor 50 not only controls the sampling needle to dispense or deliver the sample to the specific protein reaction section 32, but also controls the sampling needle to deliver the sample drawn to the routine blood test section 31, and controls the reagent supply section 20 to supply reagents to the routine blood test section 31 to prepare a routine blood test sample. Then, the processor 50 controls the routine blood test section to test the routine blood test sample to obtain routine blood test data. Based on the routine blood test data, the processor 50 calculates the routine blood test information in the sample.

[0196] There are several ways to implement the exception storage unit 70. Here are a few examples.

[0197] In some embodiments, the sampling unit 10 is used as an abnormal storage unit 70; after the processor 50 controls the sampling unit 10 to aspirate a sample, a portion of the aspirated sample is transported to the reaction unit 30, such as the specific protein reaction unit 32, and a portion is stored in the sampling unit 10. In a more specific embodiment, the sampling needle is used as the abnormal storage unit 70; after the processor 50 controls the sampling needle to aspirate a sample from the sample tube located at the aspiration position, the sampling needle transports a portion of the aspirated sample to the reaction unit 30, such as the specific protein reaction unit 32, and a portion is stored in the sampling needle. When it is determined that the sample has a hook effect, the processor 50 controls the transport of the sample stored in the sampling unit 10, such as the sampling needle, to the specific protein reaction unit 32, and controls the reagent supply unit 20 to supply reagents to the specific protein reaction unit 32 to prepare a specific protein sample with a second dilution factor. In embodiments where the sampling needle is used as the abnormal storage unit 70, further, at least when the sampling needle discharges a sample to the reaction unit 30, the sampling needle is inside the housing.

[0198] In some embodiments, an abnormality storage unit 70 is provided inside the sample analysis device, and the abnormality storage unit 70 is used to receive samples delivered by the sampling unit 10, such as a sampling needle.

[0199] For more specific embodiments, please refer to Figure 11 The abnormal storage unit 70 has an abnormal storage position 71, which can hold a container for storing samples—such as a sample tube or a reaction cup; after the processor 50 controls the sampling needle to draw a sample from the sample tube located at the sampling position, the sampling needle delivers part of the drawn sample to the reaction unit 30, such as the specific protein reaction unit 32, and part to the container located at the abnormal storage position 71; when it is determined that the sample has a hook effect, the processor 50 can control the sampling needle to draw a sample from the container to deliver the sample to the reaction unit 30, such as the specific protein reaction unit 32.

[0200] In other embodiments, please refer to Figure 12 The abnormal storage unit 70 has a space 72 for storing samples. This space 72 is connected to the reaction unit 30, such as the specific protein reaction unit 32, via a conduit 74 connected to a power source 73. After the processor 50 controls the sampling needle to draw a sample from the sample tube located at the sampling position, the sampling needle delivers part of the drawn sample to the reaction unit 30, such as the specific protein reaction unit 32, and part to the space 72 of the abnormal storage unit 70. When it is determined that the sample has a hook effect, the processor 50 can control the power source 73 to deliver the sample stored in the space 72 to the reaction unit 30, such as the specific protein reaction unit 32, via the conduit 74.

[0201] By introducing the abnormal storage unit 70 and coordinating it with the corresponding process, not only is the detectable range of the sample analysis device for specific proteins improved, but the entire process is also faster and more efficient when preparing specific protein samples with a second dilution factor for retesting.

[0202] Please refer to Figure 13 In some embodiments, the sample analysis device may incorporate a secondary sample preparation line 80, which is connected to a power source 81. The secondary sample preparation line 80 is also connected to a reaction section 30, such as a specific protein reaction section 32. Alternatively, the secondary sample preparation line 80 may be connected to a reaction cell in the reaction section 30. A specific detection process may be as follows:

[0203] The processor 50 controls the sampling unit 10, for example, the sampling needle draws a sample from the sample tube located at the sampling position;

[0204] The processor 50 controls the sampling needle and the reagent supply unit 20 to deliver the sample and supply the first reagent, such as a hemolysin, to the reaction cell, respectively.

[0205] The processor 50 controls the power source 81 to draw a portion of the sample that has been treated with the first reagent into the secondary sample preparation pipeline 80 connected to the reaction cell.

[0206] The processor 50 controls the reagent supply unit 20 to add a second reagent, such as a latex reagent, to the reaction chamber to prepare a specific protein sample with a first dilution factor;

[0207] The processor 50 controls the specific protein detection unit 42 to detect the specific protein sample with the first dilution factor to obtain the detection data of the specific protein and determine whether the sample has a hook effect.

[0208] When it is determined that the sample has a HOOK effect, if a retest is required (e.g., the current abnormal handling second mode is activated, or the corrected second concentration is not within the preset measurable range of the analyte), then the processor 50 controls the reaction cell to empty the specific protein sample and controls the power source 81 to push the sample treated with the first reagent in the secondary sample preparation pipeline 80 into the reaction cell; understandably, the reaction cell generally has a discharge port, and the discharge port may also have a controllable solenoid valve. The processor 50 controls the solenoid valve to open, so that the liquid in the reaction cell can be discharged through the discharge port;

[0209] The processor 50 controls the reagent supply unit 20 to add a first reagent and a second reagent, such as a hemolysin and a latex reagent, to the reaction chamber to prepare a specific protein sample having a second dilution factor; in some embodiments, the second dilution factor is greater than the first dilution factor;

[0210] The processor 50 controls the specific protein detection unit 42 to detect the aforementioned specific protein sample having a second dilution factor;

[0211] The above describes the situation where the sample is determined to have a hook effect. When it is determined that the sample does not have a hook effect, the processor 50 can control the power source 81 to push the sample in the secondary sample preparation pipeline 80 into the reaction cell, and control the reaction cell to be emptied.

[0212] Please refer to Figure 14 In some embodiments, the reagent supply unit 20 includes a first reagent supply unit 21, which includes a first reagent storage unit 22 and a first reagent line 23. The first reagent storage unit 22 is connected to the reaction cell via the first reagent line 23. The first reagent line 23 is also used as the secondary sample preparation line 80 described above. As mentioned above, the first reagent can be a hemolysin, therefore the secondary sample preparation line 80 can reuse the hemolysin line.

[0213] By introducing a secondary sample preparation line 80, the detectable range of a sample analysis device for a specific protein can be increased without slowing down the measurement of ordinary samples. Furthermore, since the secondary detection uses the first sample treated with the first reagent, such as a hemolysin, this approach does not require additional sample consumption.

[0214] Some of the above embodiments involve a power source, and the power source in this invention includes, but is not limited to, a syringe, a metering pump, or other devices for precise metering.

[0215] The above solutions address the hook effect in samples by introducing an abnormal storage unit 70 or a secondary sample preparation pipeline 80. In other embodiments, the sample analysis device can also address the hook effect by using a backtracking retest, which will be explained in detail below.

[0216] A testing process could be as follows:

[0217] The processor 50 controls the scheduling unit 60 to schedule the sample tube to the first detection position, such as the sampling position;

[0218] The processor 50 controls the sampling unit 10, for example, the sampling needle, to obtain a sample from the sample tube located at the first detection position, and dispenses the sample into the blood routine reaction unit 31 and the specific protein reaction unit 32 respectively;

[0219] The processor 50 controls the reagent supply unit 20 to add reagents to the blood routine reaction unit 31 and the specific protein reaction unit 32 respectively to prepare blood routine samples and specific protein samples with a first dilution factor; in some embodiments, the processor 50 controls the reagent supply unit 20 to add at least a first reagent to the specific protein reaction unit 32 to prepare specific protein samples with a first dilution factor; the processor 50 controls the reagent supply unit 20 to add at least a third reagent to the blood routine reaction unit 31 to prepare blood routine samples;

[0220] The processor 50 controls the blood routine detection unit 41 to detect the blood routine sample to obtain blood routine detection data; the processor 50 calculates the blood routine information in the sample based on the blood routine detection data.

[0221] The processor 50 controls the specific protein detection unit 42 to detect the specific protein sample with the first dilution factor to obtain the detection data of the specific protein; the processor 50 determines whether the sample has a hook effect;

[0222] When it is determined that a sample has a HOOK effect, if a retest is required later (for example, the current abnormal handling second mode is enabled, or the second concentration obtained after correction is not within the preset measurable range of the analyte), then the processor 50 obtains the position information of the sample tube corresponding to the sample with the HOOK effect and controls the scheduling unit 60 to schedule the sample tube to the second detection position, such as the sampling position or the retest position mentioned above.

[0223] The processor 50 controls the sampling unit 10 to acquire a sample from the sample tube located at the second detection position and dispense the sample into the specific protein reaction unit 32;

[0224] The processor 50 controls the reagent supply unit 20 to add reagents, such as at least a first reagent, to the specific protein reaction unit 32 to prepare a specific protein sample having a second dilution factor; in some embodiments, the second dilution factor is greater than the first dilution factor;

[0225] The processor 50 controls the specific protein detection unit 42 to detect the specific protein sample with the second dilution factor to obtain the detection data of the specific protein, and calculates the concentration of the specific protein based on the detection data.

[0226] When calculating the concentration of a specific protein, it can be done based on a calibration curve, or correction curve. Specifically, a specific protein sample with a first dilution factor and a specific protein sample with a second dilution factor correspond to a first calibration curve and a second calibration curve, respectively. In some embodiments, the second calibration curve of the specific protein is obtained by correcting the first calibration curve. A specific protein sample with a first dilution factor represents the specific protein sample before retesting or a normal specific protein sample, while a specific protein sample with a first dilution factor represents the specific protein sample at the time of retesting or a specific protein sample with a higher value. Please refer to... Figure 15 The figure shows an example of a first calibration curve for a specific protein. The horizontal axis represents the concentration of the specific protein, and the vertical axis represents the reaction intensity or reactivity, which means the difference between the absorbance measured at the end of a fixed testing period and the absorbance measured at the beginning of the period. The curve has five calibration points A, B, C, D, and E, with coordinates (A1, A2), (B1, B2), (C1, C2), (D1, D2), and (E1, E2), respectively. A second calibration curve can be obtained by taking several calibration points, such as C, D, and E, and correcting them to (C1, C2'), (D1, D2'), and (E1, E2'), where C2' = k1 * C2, D2' = k2 * D2, and E2' = k3 * E2, where k1, k2, and k3 are the same or different coefficients. This is an example of keeping the concentration constant and correcting the reaction intensity; alternatively, the reaction intensity could be kept constant and the concentration corrected to obtain the second calibration curve.

[0227] For a specific protein sample with a first dilution factor: the processor 50 acquires a first calibration curve for the specific protein and calculates the concentration of the specific protein in the sample based on the first calibration curve and the detection data of the specific protein at the first dilution factor. For a specific protein sample with a second dilution factor: the processor 50 acquires a second calibration curve for the specific protein and calculates the concentration of the specific protein in the sample based on the second calibration curve and the detection data of the specific protein at the second dilution factor.

[0228] As can be seen, before the retest, the sample was tested for blood routine and specific proteins. During the retest, the sample was tested for specific proteins. In some embodiments, the processor 50 also obtains the blood routine information obtained before the sample was retested and corrects the concentration of specific proteins calculated after the sample was retested based on the blood routine information in the sample.

[0229] To obtain more accurate concentrations of specific proteins, in some embodiments, the sample is retested not only for the specific protein but also for a complete blood count. The concentration of the specific protein after retesting is then corrected using the information from the retested complete blood count.

[0230] The above involves using blood routine information to correct the concentration of a specific protein. In some specific embodiments, the blood routine information includes hematocrit, and the processor 50 corrects the concentration of the specific protein based on the hematocrit; or, the blood routine information includes whole blood hematocrit, and the processor 50 corrects the concentration of the specific protein based on the whole blood hematocrit.

[0231] In some embodiments, the processor 50 also corrects the concentration of a specific protein after retesting based on the dilution factor of the specific protein sample.

[0232] In some embodiments, during the retesting process, the amount of sample obtained by the sampling unit 10 from the sample tube located at the second detection position is less than the amount of sample obtained by the sampling unit from the sample tube located at the first detection position when the sample detection is performed before the retest.

[0233] The above process involves the preparation of a specific protein sample at a second dilution factor. In some embodiments, when preparing a specific protein sample at a second dilution factor in the reaction chamber or the specific protein reaction section 32, to prevent the sample from overflowing due to an excessively high dilution factor, multiple dilutions can be used. For example, a hemolysin and sample are added to the reaction chamber, and a portion of the sample treated with the hemolysin is aspirated using a sampling needle, or a portion of the sample treated with the hemolysin is discharged from the reaction chamber, leaving a portion of the sample treated with the hemolysin in the reaction chamber. Then, the remaining sample is added to the reaction chamber to complete the dilution. Another example is adding a hemolysin and sample to the reaction chamber, aspirating a portion of the sample treated with the hemolysin using a sampling needle, and then using the hemolysin in the original reaction chamber (which has now been emptied) or a new reaction chamber to complete the dilution.

[0234] In some embodiments, specific protein samples with a second dilution factor can be diluted and prepared in the following way:

[0235] The processor 50 controls the sampling unit 10 and the reagent supply unit 20 to add the sample and the first reagent to the specific protein reaction unit 31, respectively.

[0236] The processor 50 controls the sampling unit 10 to draw a portion of the sample treated with the first reagent from the specific protein reaction unit 31, or the processor 50 controls the specific protein reaction unit 31 to discharge a portion of the sample treated with the first reagent.

[0237] The processor 50 controls the reagent supply unit 20 to add the first reagent and the second reagent to the specific protein reaction unit 31 to prepare the specific protein sample having the second dilution factor.

[0238] In other embodiments, specific protein samples with a second dilution factor can be diluted and prepared in the following manner:

[0239] The processor 50 controls the sampling unit 10 and the reagent supply unit 20 to add the sample and the first reagent to the specific protein reaction unit 31, respectively.

[0240] The processor 50 controls the sampling unit 10 to draw a portion of the sample treated with the first reagent from the specific protein reaction unit 31;

[0241] The processor 50 controls the specific protein reaction unit 31 to empty the remaining sample after treatment with the first reagent, then controls the sampling unit 10 to add the sampled portion to the specific protein reaction unit 31, and controls the reagent supply unit 20 to add the first reagent and the second reagent to the specific protein reaction unit 31 to prepare the specific protein sample with the second dilution factor.

[0242] In other embodiments, specific protein samples with a second dilution factor can be diluted and prepared in the following manner:

[0243] The processor 50 controls the sampling unit 10 and the reagent supply unit 20 to add the sample and the first reagent to the specific protein reaction unit 31, respectively.

[0244] The processor 50 controls the sampling unit 10 to draw a portion of the sample treated with the first reagent from the specific protein reaction unit 31;

[0245] The processor 50 controls the sampling unit 10 to add the sampled portion to another specific protein reaction unit 31, and controls the reagent supply unit 20 to add a first reagent and a second reagent to the other specific protein reaction unit 31 to prepare the specific protein sample with a second dilution factor.

[0246] As can be seen, when a HOOK effect is identified in a sample, some embodiments of the present invention propose two processing schemes, which may be referred to as the first abnormal processing mode and the second abnormal processing mode. Therefore, in some embodiments, the sample analysis device may have the first abnormal processing mode and the second abnormal processing mode. For samples exhibiting a HOOK effect, in the first abnormal processing mode: the processor 50 calculates the first concentration of the analyte in the sample based on the reaction curve; the processor 50 obtains the reference curve corresponding to the analyte at the first concentration, and corrects the first concentration based on the reaction curve and the reference curve to obtain the corrected second concentration. For samples exhibiting a HOOK effect, in the second abnormal processing mode: the processor 50 controls the reagent supply unit 20 to provide reagents to increase the dilution factor of the sample for retesting.

[0247] There are several options for selecting the current mode for a sample analysis device.

[0248] In some embodiments, for samples exhibiting a hook effect, the processor 50 enables an anomaly processing first mode to obtain the second concentration; the processor 50 also determines whether the second concentration is within the preset measurable range of the analyte, and if not, for the samples exhibiting a hook effect, the processor 50 enables an anomaly processing second mode to retest.

[0249] In other embodiments, please refer to Figure 16 The sample analysis device may also include an operation unit 90, which is used to respond to a user-inputted exception handling mode selection command and select either exception handling first mode or exception handling second mode as the current mode. The operation unit 90 may be an input tool such as a keyboard, mouse, or touch screen.

[0250] The above is a description of the sample analysis device.

[0251] Please refer to Figure 17 Some embodiments of the present invention also disclose a sample analysis method, comprising the following steps:

[0252] Step 100: Controlled treatment of the sample using a first reagent and a second reagent to prepare a specific protein sample. In some embodiments, the first reagent includes a hemolysin and the second reagent includes a latex reagent.

[0253] Step 110: Obtain detection data for specific protein samples.

[0254] Step 120: Determine whether the HOOK effect exists in the sample based on the detection data;

[0255] Step 130: When it is determined that the sample has a HOOK effect, control the use of the first reagent to increase the dilution factor of the sample for retesting.

[0256] Please refer to Figure 18 Some embodiments of the present invention also disclose a sample analysis method, comprising the following steps:

[0257] Step 200: Control the sampling needle to draw a sample from the sample tube located at the aspiration position;

[0258] Step 210: Control the sampling needle to transport part of the sample to the reaction cell and store part of it in the abnormal storage section.

[0259] The exception storage unit involved in step 210 can be found in the description of exception storage unit 70 above, and will not be repeated here.

[0260] Step 220: Add reagents to the reaction vessel to prepare a specific protein sample with a first dilution factor;

[0261] Step 230: Obtain the detection data of the specific protein sample;

[0262] Step 240: Determine whether the sample exhibits the HOOK effect.

[0263] For step 240, how to determine whether the sample has a HOOK effect, please refer to the explanation of HOOK effect determination in the sample analysis device above, which will not be repeated here.

[0264] Step 250: When it is determined that the sample exhibits a HOOK effect, the sample from the abnormal storage unit is transferred to the reaction chamber, and reagents are added to the reaction chamber to prepare a specific protein sample with a second dilution factor. In some embodiments, the second dilution factor is greater than the first dilution factor.

[0265] Step 260: Detect the specific protein sample with the second dilution factor.

[0266] Please refer to Figure 19 Some embodiments of the present invention also disclose a sample analysis method, comprising the following steps:

[0267] Step 300: Add the sample and the first reagent to the reaction cell, which is connected to a secondary sample preparation pipeline.

[0268] The secondary sample preparation pipeline involved in step 300 can be found in the description of the secondary sample preparation pipeline 80 above, and will not be repeated here.

[0269] Step 310: Aspirate a portion of the sample treated with the first reagent in the reaction cell into a secondary sample preparation pipeline connected to the reaction cell;

[0270] Step 320: Add a second reagent to the reaction vessel to prepare a specific protein sample with a first dilution factor;

[0271] Step 330: Obtain the detection data of the specific protein sample;

[0272] Step 340: Determine whether the sample has a HOOK effect; For how to determine whether the sample has a HOOK effect in step 340, please refer to the explanation of the HOOK effect determination in the sample analysis device above, which will not be repeated here.

[0273] Step 350: When it is determined that the sample has a HOOK effect, the specific protein sample in the reaction cell is emptied, and the sample treated with the first reagent in the secondary sample preparation pipeline is pushed into the reaction cell.

[0274] Step 360: Add the first reagent and the second reagent to the reaction vessel to prepare a specific protein sample with a second dilution factor; in some embodiments, the second dilution factor is greater than the first dilution factor.

[0275] Step 370: Detect the specific protein sample with the second dilution factor.

[0276] Please refer to Figure 20 Some embodiments of the present invention also disclose a sample analysis method, comprising the following steps:

[0277] Step 400: Move the sample tube containing the sample to the first detection position;

[0278] Step 410: Obtain a sample from the sample tube located at the first detection position and dispense it to prepare a routine blood sample and a specific protein sample with a first dilution factor, respectively.

[0279] Step 420: Detect the blood routine sample to obtain the blood routine test data, and calculate the blood routine information in the sample based on the blood routine test data;

[0280] Step 430: Detect the specific protein sample with the first dilution factor to obtain detection data for the specific protein, and determine whether the sample exhibits a hook effect based on the detection data. For details on how to determine whether a sample exhibits a hook effect in Step 430, please refer to the explanation of hook effect determination in the sample analysis device section above; it will not be repeated here.

[0281] Step 440: When it is determined that the sample has a HOOK effect, the position information of the sample tube corresponding to the sample with the HOOK effect is obtained, and the sample tube is scheduled to the second detection position;

[0282] Step 460: Obtain a sample from the sample tube located at the second detection position to prepare a specific protein sample with a second dilution factor; in some embodiments, the second dilution factor is greater than the first dilution factor.

[0283] Step 470: Detect the specific protein sample with the second dilution factor to obtain detection data of the specific protein, and calculate the concentration of the specific protein based on the detection data.

[0284] Some embodiments of the present invention also disclose a sample analysis method, which has an anomaly handling first mode and an anomaly handling second mode. In some embodiments, in response to a user-input anomaly handling mode selection command, the anomaly handling first mode or the anomaly handling second mode is selected as the current mode. In some embodiments, for samples with a HOOK effect, the anomaly handling first mode is enabled to obtain the second concentration. It is also determined whether the second concentration is within the preset measurable range of the analyte. If not, for the samples with a HOOK effect, the anomaly handling second mode is enabled for retesting.

[0285] Please refer to Figure 21 In some embodiments, the sample analysis method may include the following steps:

[0286] Step 500: Treat the sample with a reagent to prepare a sample with a first dilution factor, such as a specific protein sample;

[0287] Step 510: Obtain the detection data of the sample with the first dilution factor;

[0288] Step 520: Generate a reaction curve based on the detection data; in some embodiments, the reaction curve includes one or more of the following: a reaction measurement curve of the measured value changing over time, a reaction rate curve of the reaction rate changing over time, or a reaction acceleration curve of the reaction acceleration changing over time.

[0289] Step 530: Determine whether the HOOK effect exists in the sample based on the reaction curve; Step 530, determining whether the HOOK effect exists in the sample based on the reaction curve, can be found in the explanation of the HOOK effect determination in the sample analysis device above, and will not be repeated here.

[0290] For samples exhibiting the hook effect, in the first anomaly handling mode:

[0291] Step 540: Calculate the first concentration of the analyte in the sample based on the reaction curve;

[0292] Step 541: Obtain the reference curve corresponding to the analyte at the first concentration;

[0293] Step 542: Correct the first concentration based on the reaction curve and the reference curve to obtain the corrected second concentration;

[0294] For samples exhibiting the hook effect, in the second anomaly handling mode:

[0295] Step 550: Treat the sample with reagents to prepare a sample with a second dilution factor; wherein the second dilution factor is greater than the first dilution factor; how to use reagents to treat the sample to prepare a sample with a second dilution factor in step 550 can be found in the relevant instructions on dilution and retesting of the sample analysis device above, and will not be repeated here.

[0296] Step 551: Retest the sample with the second dilution factor.

[0297] Please refer to Figure 22 In some embodiments, the sample analysis method may include the following steps:

[0298] Step 600: Obtain detection data for the sample, which is prepared from a sample and reagents. For example, the sample may be a specific protein sample.

[0299] Step 610: Generate a reaction curve based on the detection data; in some embodiments, the reaction curve includes one or more of the following: a reaction measurement curve of the measured value changing over time, a reaction rate curve of the reaction rate changing over time, or a reaction acceleration curve of the reaction acceleration changing over time.

[0300] Step 620: Calculate the first concentration of the analyte in the sample based on the reaction curve;

[0301] Step 630: Determine whether the HOOK effect exists in the sample based on the reaction curve; Step 630, determining whether the HOOK effect exists in the sample based on the reaction curve, can be found in the explanation of the HOOK effect determination in the sample analysis device section above, and will not be repeated here.

[0302] Step 640: When it is determined that the sample has a HOOK effect, obtain the reference curve corresponding to the analyte at the first concentration, and correct the first concentration according to the reaction curve and the reference curve to obtain the corrected second concentration.

[0303] For step 640, how to correct the first concentration to obtain the second concentration, please refer to the explanation above on how the sample analysis device corrects the first concentration to obtain the second concentration, which will not be repeated here.

[0304] Please refer to Figure 23 In some embodiments, in Figure 22 Based on the sample analysis method shown, the sample analysis method may also include the following steps:

[0305] Step 650: Determine whether the second concentration is within the preset measurable range of the analyte;

[0306] Step 660: If yes, output the second concentration as the detection result of the analyte;

[0307] Step 670: If not, output information that the concentration of the analyte exceeds the measurable range, or increase the dilution factor of the sample with reagents for retesting.

[0308] This document describes various exemplary embodiments with reference to them. However, those skilled in the art will recognize that changes and modifications can be made to the exemplary embodiments without departing from the scope of this document. For example, various operational steps and components for performing operational steps can be implemented in different ways depending on the specific application or considering any number of cost functions associated with the operation of the system (e.g., one or more steps can be deleted, modified, or combined with other steps).

[0309] In the above embodiments, implementation can be achieved, in whole or in part, by software, hardware, firmware, or any combination thereof. Furthermore, as those skilled in the art will understand, the principles herein can be reflected in a computer program product on a computer-readable storage medium pre-loaded with computer-readable program code. Any tangible, non-transitory computer-readable storage medium may be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-ROMs, DVDs, Blu-ray discs, etc.), flash memory, and / or the like. These computer program instructions can be loaded onto a general-purpose computer, special-purpose computer, or other programmable data processing apparatus to form a machine, such that instructions executing on the computer or other programmable data processing apparatus can generate means for performing a specified function. These computer program instructions can also be stored in a computer-readable storage medium that can instruct the computer or other programmable data processing apparatus to operate in a particular manner, such that instructions stored in the computer-readable storage medium can form an article of manufacture, including means for implementing the specified function. The computer program instructions can also be loaded onto a computer or other programmable data processing apparatus to perform a series of operational steps on the computer or other programmable apparatus to produce a computer-implemented process, such that instructions executing on the computer or other programmable apparatus can provide steps for implementing the specified function.

[0310] While the principles herein have been illustrated in various embodiments, numerous modifications to the structure, arrangement, proportions, elements, materials, and components, particularly suited to specific environmental and operational requirements, may be used without departing from the principles and scope of this disclosure. These modifications and other alterations or alterations will be included within the scope of this document.

[0311] The foregoing specific descriptions have been described with reference to various embodiments. However, those skilled in the art will recognize that various modifications and changes can be made without departing from the scope of this disclosure. Therefore, considerations for this disclosure are to be illustrative rather than restrictive, and all such modifications are to be included within its scope. Similarly, advantages, other advantages, and solutions to problems with respect to various embodiments have been described above. However, benefits, advantages, solutions to problems, and any elements that produce these, or make them more explicit, should not be construed as critical, essential, or necessary. The term “comprising” and any other variations thereof as used herein are non-exclusive inclusion, meaning that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not expressly listed or not part of the process, method, system, article, or apparatus. Furthermore, the term “coupled” and any other variations thereof as used herein refer to physical connections, electrical connections, magnetic connections, optical connections, communication connections, functional connections, and / or any other connections.

[0312] Those skilled in the art will recognize that many changes can be made to the details of the above embodiments without departing from the basic principles of the invention. Therefore, the scope of the invention should be determined only by the claims.

Claims

1. A sample analysis device, characterized in that, It includes a sampling unit, a reagent supply unit, a reaction unit, a detection unit, and a processor; The sampling unit is used to acquire a sample and transport the acquired sample to the reaction unit; The reagent supply unit is used to store reagents and supply reagents to the reaction unit; The reaction section is used to mix the sample and reagents to prepare the sample; The detection unit is used to detect the sample and output detection data; in: The processor acquires the detection data output by the detection unit when detecting the sample, in order to generate a reaction curve; The processor calculates the first concentration of the analyte in the sample based on the reaction curve; The processor obtains a reference curve corresponding to the first concentration of the analyte based on the calculated first concentration, and corrects the first concentration based on the reaction curve and the reference curve to obtain a corrected second concentration. The correction of the first concentration based on the reaction curve and the reference curve includes: the processor correcting the first concentration based on the difference between the reaction curve and the reference curve; the correction of the first concentration based on the difference between the reaction curve and the reference curve includes: selecting a value corresponding to the same reaction time point on the reaction curve and the reference curve, and calculating a correction coefficient based on the value corresponding to the same reaction time point; or, selecting values ​​corresponding to multiple identical reaction time points on the reaction curve and the reference curve, and calculating a correction coefficient based on the values ​​corresponding to the multiple identical reaction time points; and obtaining the second concentration based on the first concentration and the correction coefficient.

2. The sample analysis apparatus as described in claim 1, characterized in that, The reaction curve includes one or more of the following: a reaction measurement curve showing the change of measured values ​​over time, a reaction rate curve showing the change of reaction rate over time, or a reaction acceleration curve showing the change of reaction acceleration over time.

3. The sample analysis apparatus as described in claim 1, characterized in that, The step of obtaining the second concentration based on the first concentration and the correction coefficient includes: multiplying the first concentration by the correction coefficient to obtain the second concentration.

4. The sample analysis apparatus according to any one of claims 1 to 3, characterized in that, The processor also determines whether the second concentration is within the preset measurable range of the analyte; If so, the processor outputs the second concentration as the detection result of the analyte; If not, the processor outputs information indicating that the concentration of the analyte exceeds the measurable range, or the processor controls the reagent supply unit to provide reagents to increase the dilution factor of the sample for retesting.

5. The sample analysis apparatus as described in claim 1 or 2, characterized in that, Before the processor acquires the reference curve corresponding to the analyte at the first concentration and corrects the first concentration based on the reaction curve and the reference curve, the processor first determines whether the sample has a hook effect based on the reaction curve. If the processor determines that the sample has a hook effect, then the processor corrects the first concentration based on the reaction curve and the reference curve. The processor determines whether the sample exhibits a hook effect based on the reaction curve, including: The processor compares the reaction curve with the reference curve to determine whether the sample exhibits a hook effect. or, The processor determines whether the sample exhibits a hook effect based on the shape of the reaction curve itself.

6. The sample analysis apparatus as described in claim 5, characterized in that, The processor compares the reaction curve with the reference curve to determine whether the sample exhibits a hook effect, including: The processor compares the values ​​corresponding to the same reaction time point on the reaction curve and the reference curve; when the difference between the value on the reaction curve and the value corresponding to the same time point on the reference curve exceeds a preset percentage, it is determined that the sample has a HOOK effect. or, The processor compares the average values ​​of the reaction curve and the reference curve for the same time period; when the difference between the average values ​​of the reaction curve and the reference curve for the same time period exceeds a preset percentage, it determines that the sample has a hook effect.

7. The sample analysis apparatus as described in claim 5, characterized in that, The processor determines whether the sample exhibits a hook effect based on the shape of the reaction curve itself, including: When the reaction rate curve shows a decreasing trend over time, it is determined that the sample exhibits a hook effect. or, When the reaction acceleration curve shows an increasing trend over time, it is determined that the sample exhibits the HOOK effect.

8. The sample analysis apparatus as described in claim 1, characterized in that, The processor acquires the detection data output by the detection unit when detecting the sample, and generates a reaction curve, including: The processor acquires the detection unit data from T1 to T2 after the reaction begins. n The output detection data within the specified time period; where Tn is less than or equal to the time T when the reaction has proceeded to 90% of the total reaction time. 90 ; The processor according to T1~T n The reaction curve is generated from the detection data within the specified time period.

9. The sample analysis apparatus as described in claim 8, characterized in that, in, Tn is less than or equal to the time T when the reaction has proceeded to 70% of its total reaction time. 70 .

10. The sample analysis apparatus as described in claim 8, characterized in that, in, Tn is less than or equal to the time T when the reaction has proceeded to 50% of its total reaction time. 50 .

11. The sample analysis apparatus as described in claim 8, characterized in that, in, Tn is less than or equal to the time T when the reaction has proceeded to 40% of its total reaction time. 40 .

12. The sample analysis apparatus as described in claim 8, characterized in that, in, Tn is less than or equal to the time T when the reaction has proceeded to 30% of the total reaction time. 30 .

13. The sample analysis apparatus as described in claim 8, characterized in that, in, Tn is less than or equal to the time T when the reaction has proceeded to 20% of the total reaction time. 20 .

14. The sample analysis apparatus as described in claim 8, characterized in that, in, Tn is less than or equal to the time T when the reaction has proceeded to 10% of the total reaction time. 10 .

15. The sample analysis apparatus as described in claim 1, characterized in that, The reaction section includes a routine blood test reaction section and a specific protein reaction section, and the detection section includes a routine blood test detection section and a specific protein detection section; The processor controls the sampling unit to deliver the sample to the specific protein reaction unit, and controls the reagent supply unit to supply hemolysing agent and latex reagent to the specific protein reaction unit to prepare a specific protein sample; the specific protein detection unit is used to detect the specific protein sample and output the detection data of the specific protein; the processor acquires the detection data of the specific protein to calculate the concentration of the specific protein in the sample; the analyte is the specific protein; The processor controls the sampling unit to deliver the sample to the blood routine reaction unit, and controls the reagent supply unit to supply at least one hemolytic agent to the blood routine reaction unit to prepare a blood routine sample; the blood routine detection unit is used to detect the blood routine sample and output the blood routine detection data, and the processor acquires the blood routine detection data to calculate the blood routine information in the sample.

16. The sample analysis apparatus as described in claim 15, characterized in that, The complete blood count (CBC) unit includes one or more of the following: a DIFF unit, an RBC unit, an HGB unit, an NRBC unit, and a RET unit. The DIFF unit is used to detect the four differential white blood cell counts; the HGB unit is used to detect hemoglobin concentration; the RBC unit is used to detect red blood cell count and / or platelet count; the RET unit is used to detect reticulocyte count; and the NRBC unit is used to detect nucleated red blood cell count, white blood cell count, and basophil count.

17. The sample analysis apparatus as described in claim 15, characterized in that, The specific proteins include one or more of the following: C-reactive protein, serum amyloid, procalcitonin, interleukin-6, human chorionic gonadotropin, growth hormone, luteinizing hormone, alpha-fetoprotein, and carcinoembryonic antigen.

18. A sample analysis device, characterized in that, It includes a sampling unit, a reagent supply unit, a reaction unit, a detection unit, and a processor; The sampling unit is used to acquire a sample and transport the acquired sample to the reaction unit; The reagent supply unit is used to store reagents and supply reagents to the reaction unit; The reaction section is used to mix the sample and reagents to prepare the sample; The detection unit is used to detect the sample and output detection data; in: The sample analysis device has a first anomaly handling mode and a second anomaly handling mode; The processor controls the sampling unit and the reagent supply unit to add the sample and reagent to the reaction unit respectively, in order to prepare a sample with a first dilution factor; The processor acquires the detection data output by the detection unit when detecting the sample with the first dilution factor, in order to generate a reaction curve; The processor determines whether the sample exhibits the HOOK effect based on the reaction curve. For samples exhibiting the HOOK effect, in the first anomaly handling mode: the processor calculates a first concentration of the analyte in the sample based on the reaction curve; the processor obtains a reference curve corresponding to the analyte at the first concentration based on the calculated first concentration, and corrects the first concentration based on the reaction curve and the reference curve to obtain a corrected second concentration; wherein, the processor correcting the first concentration based on the reaction curve and the reference curve includes: the processor correcting the first concentration based on the difference between the reaction curve and the reference curve; the processor correcting the first concentration based on the difference between the reaction curve and the reference curve includes: selecting a value corresponding to the same reaction time point on the reaction curve and the reference curve, and calculating a correction coefficient based on the value corresponding to the same reaction time point; or, selecting values ​​corresponding to multiple identical reaction time points on the reaction curve and the reference curve, and calculating a correction coefficient based on the values ​​corresponding to the multiple identical reaction time points; the second concentration is obtained based on the first concentration and the correction coefficient. For samples exhibiting the HOOK effect, in the second anomaly handling mode: the processor controls the reagent supply unit to provide reagents to prepare a sample with a second dilution factor for retesting, wherein the second dilution factor is greater than the first dilution factor.

19. The sample analysis apparatus as described in claim 18, characterized in that, The reaction section includes a routine blood test reaction section and a specific protein reaction section, and the detection section includes a routine blood test detection section and a specific protein detection section; The processor controls the sampling unit to deliver the sample to the specific protein reaction unit, and controls the reagent supply unit to supply hemolysin and latex reagent to the specific protein reaction unit to prepare a specific protein sample; the specific protein detection unit is used to detect the specific protein sample and output the detection data of the specific protein; the processor acquires the detection data of the specific protein to calculate the concentration of the specific protein in the sample; the analyte is the specific protein; The processor controls the sampling unit to deliver the sample to the blood routine reaction unit, and controls the reagent supply unit to supply at least one hemolytic agent to the blood routine reaction unit to prepare a blood routine sample; the blood routine detection unit is used to detect the blood routine sample and output the blood routine detection data, and the processor acquires the blood routine detection data to calculate the blood routine information in the sample.

20. The sample analysis apparatus as described in claim 18 or 19, characterized in that, It also includes an operation unit for responding to user input of an exception handling mode selection command, and selecting either exception handling mode one or exception handling mode two as the current mode.

21. The sample analysis apparatus as described in claim 18 or 19, characterized in that, For samples exhibiting a hook effect, the processor activates an anomaly processing first mode to obtain the second concentration; the processor also determines whether the second concentration is within the preset measurable range of the analyte. If not, for the samples exhibiting a hook effect, the processor activates an anomaly processing second mode to retest.

22. A sample analysis method, characterized in that, include: To obtain test data for a sample, which is prepared from a sample and reagents; A reaction curve is generated based on the detection data; Calculate the first concentration of the analyte in the sample based on the reaction curve; Determine whether the HOOK effect exists in the sample based on the reaction curve; When it is determined that the sample exhibits a HOOK effect, a reference curve corresponding to the first concentration of the analyte is obtained based on the calculated first concentration. The first concentration is then corrected based on the reaction curve and the reference curve to obtain a corrected second concentration. The correction of the first concentration based on the reaction curve and the reference curve includes: correcting the first concentration based on the difference between the reaction curve and the reference curve. This correction includes: selecting a value corresponding to the same reaction time point on both the reaction curve and the reference curve, and calculating a correction coefficient based on that value; or, selecting multiple values ​​corresponding to the same reaction time points on both the reaction curve and the reference curve, and calculating a correction coefficient based on those values. The second concentration is then obtained based on the first concentration and the correction coefficient.

23. The sample analysis method as described in claim 22, characterized in that, Also includes: Determine whether the second concentration is within the preset measurable range of the analyte; If so, the second concentration is output as the detection result of the analyte; If not, output information that the concentration of the analyte exceeds the measurable range, or increase the dilution factor of the sample with reagents for retesting.

24. A computer-readable storage medium, characterized in that, The computer-readable storage medium stores a program that can be executed by a processor to implement the method as described in claim 22 or 23.

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