Protein analysis method and sample analyzer

Abstract

The invention relates to a protein analysis method and a sample analyzer, a first test solution is prepared from a to-be-detected sample and an indicating reagent, and the indicating reagent is used for indicating the concentration of protein in the to-be-detected sample; detecting the first test solution to obtain an indication signal of protein in the to-be-detected sample; selecting a to-be-executed detection mode from a plurality of detection modes according to the indication signal; according to the to-be-executed detection mode, preparing a second test solution by adopting the to-be-detected sample and a detection reagent for detecting the concentration of the protein in the to-be-detected sample, and detecting the second test solution to obtain the concentration value of the protein in the to-be-detected sample. Therefore, the number of times of re-detection of the sample can be reduced or even avoided as much as possible, so that the detection efficiency is improved, and the reagent cost is saved.

Description

Technical Field

[0001] The present application relates to the field of in vitro diagnosis, and in particular to a protein analysis method and a sample analyzer. Background Art

[0002] During sample testing, the sample test results may exceed the effective detection range of the testing instrument, which will cause abnormal sample test results.

[0003] In existing solutions, after obtaining the measurement result of a sample, it is usually determined whether the measurement result of the sample exceeds the effective measurement range. If it exceeds the effective measurement range, the sample will be re-measured. However, frequent re-measurements lead to reduced detection efficiency and increased costs.

[0004] For example, microalbumin (mALB) in urine is a common clinical marker for early diagnosis of renal function damage, disease progression monitoring, and patient risk stratification. The clinical detection of microalbumin requires high sensitivity at low values ​​and no false results at high values. Currently, immune scattering turbidimetry and immune transmission turbidimetry are commonly used to detect microalbumin mALB in urine. The clinical concentration distribution of mALB is very wide, and the highest clinically visible concentration exceeds 60,000 mg / L, far exceeding the effective detection range of the analyzer. When the albumin concentration in urine is too high, an excess of antigen may cause a false negative (hook effect).

[0005] In the prior art, in order to ensure the test results, a detection system with the ability to detect excess antigen is usually selected. Whether it is nephelometry or transmission turbidimetry, the sample to be tested needs to be repeatedly diluted, and the reporting range after dilution must meet clinical needs. According to statistics, the retest rate of microalbumin mALB can be as high as 35%, which leads to high reagent costs on the one hand and TAT delays on the other.

[0006] In addition, when using turbidimetry to detect trace albumin in urine, the cross-linking reaction of antigen and antibody has a "hook effect" that may lead to inaccurate test results. That is, when the antigen concentration is low, the cross-linking degree after the antigen-antibody reaction is low (the turbidity is small) and as the antigen concentration increases, the cross-linking degree also increases (the turbidity becomes larger). When the concentration ratio of the antigen and antibody reaches a suitable ratio, the cross-linking degree after the antigen-antibody reaction reaches the maximum (the turbidity is maximum). If the antigen concentration continues to increase, the cross-linking degree after the antigen-antibody reaction begins to decrease (the turbidity becomes smaller). Using the antigen concentration in the reaction system as the x-axis and the cross-linking signal (turbidity signal) generated after the antigen-antibody reaction as the y-axis, a "dose-signal" curve will be drawn, and a bell-shaped curve will be presented. This phenomenon is called the "hook effect."

[0007] The existing solutions to the "hook effect" are as follows: 1. Dilute the sample to be tested and retest it to reduce the concentration of antigen (or antibody) in the reaction system and reduce the probability of excess antigen. However, this method will increase the detection steps, prolong the detection time, and make it impossible to detect the sample with low antigen (or antibody) concentration normally; 2. Increase the concentration of antibody (or antigen) in the detection reagent to make it less likely for the antigen to be in excess, but this method will greatly increase the reagent cost; 3. Re-add the reagent (antibody) or the sample to be tested (antigen) in the later stage of the test, and observe whether the cross-linking signal (turbidity signal) generated after the antigen-antibody reaction increases, so as to determine whether the "hook effect" occurs. Although this method can basically avoid misjudgment, it greatly increases the detection cost and time. Summary of the invention

[0008] Therefore, in order to at least partially eliminate the shortcomings of the prior art, one task of the present application is to provide a protein analysis method and a corresponding sample analyzer, which can minimize or even avoid sample retesting, increase the detection range of a single protein test, thereby improving detection efficiency and saving reagent costs.

[0009] Another task of the present application is to provide a protein analysis method and a corresponding sample analyzer, which can improve the accuracy of protein detection.

[0010] In order to achieve the above-mentioned task of the present application, the present application proposes a sample analyzer in a first aspect, comprising:

[0011] A sample preparation device, used to prepare a first test solution using a sample to be tested and an indicator reagent, wherein the indicator reagent is used to indicate the concentration of a protein in the sample to be tested;

[0012] A first detection device, used to detect the first test solution to obtain an indication signal of the protein in the sample to be tested;

[0013] A second detection device, used to obtain the concentration value of the protein in the sample to be tested;

[0014] The controller is used to select a detection mode to be executed from a plurality of detection modes according to the indication signal, and control the sample preparation device to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to the detection mode to be executed, and control the second detection device to detect the second test solution to obtain the concentration value of the protein in the sample to be tested.

[0015] Therefore, before preparing the second test solution that is ultimately used to detect the protein concentration in the sample to be tested, a first test solution for predicting the protein concentration in the sample to be tested can be prepared based on the indicator reagent and the sample to be tested. Based on the indicator signal of the protein in the sample to be tested obtained by testing the first test solution, a detection mode suitable for the current sample to be tested is selected, so that a second test solution suitable for the current sample to be tested can be prepared based on the selected detection mode. A more accurate detection result can be obtained through a single detection, thereby avoiding sample retesting, thereby improving sample detection efficiency and saving reagent costs.

[0016] A second aspect of the present application provides a sample analyzer, comprising:

[0017] A sample preparation device, used to prepare a first test solution using a sample to be tested and an indicator reagent, wherein the indicator reagent is used to indicate the concentration of a protein in the sample to be tested;

[0018] A first detection device, used to detect the first test solution to obtain an indication signal of the protein in the sample to be tested;

[0019] A second detection device, used to obtain the concentration value of the protein in the sample to be tested;

[0020] Controller for:

[0021] When the indication signal is lower than a preset threshold, the sample preparation device is controlled to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of a protein in the sample to be tested according to a first detection mode, and the second detection device is controlled to detect the second test solution to obtain and output a concentration value of the protein in the sample to be tested, and

[0022] When the indication signal is not lower than the threshold value, an alarm is outputted, and / or the sample preparation device is controlled to prepare a third test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to a second detection mode different from the first detection mode, and the second detection device detects the third test solution to obtain the concentration value of the protein in the sample to be tested.

[0023] Therefore, it is possible to choose whether to output an alarm prompt and / or change the detection mode according to the estimated protein concentration of the sample to be tested, so as to improve the accuracy of the detection result.

[0024] The third aspect of the present application provides a sample analyzer, comprising:

[0025] A sample preparation device, used to prepare a first test solution using a sample to be tested and an indicator reagent, wherein the indicator reagent is used to indicate the concentration of a protein in the sample to be tested;

[0026] A first detection device, used to detect the first test solution to obtain an indication signal of the protein in the sample to be tested;

[0027] A second detection device, used to obtain the concentration value of the protein in the sample to be tested;

[0028] Controller for:

[0029] According to the first detection mode, the sample preparation device is controlled to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested, and the second detection device is controlled to detect the second test solution to obtain a first concentration value of the protein in the sample to be tested.

[0030] When the indication signal is lower than a preset threshold, a first concentration value is output, and

[0031] When the indication signal is not lower than the preset threshold, an alarm prompt is outputted, and / or, the sample preparation device is controlled to prepare a third test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to a second detection mode different from the first detection mode, and the second detection device is controlled to detect the third test solution to obtain and output a second concentration value of the protein in the sample to be tested.

[0032] Therefore, when it is predicted that the protein concentration of the sample to be tested is low, the protein concentration value detected according to the first detection mode can be directly outputted; and when it is predicted that the protein concentration of the sample to be tested is high, an alarm can be outputted to prompt that the result detected according to the first detection mode may be wrong and / or to switch to another detection mode (i.e., the second detection mode) for retesting and confirmation, thereby obtaining a more accurate protein value concentration test result.

[0033] In a fourth aspect, the present application provides a protein analysis method for a sample analyzer, wherein the sample analyzer includes a sample preparation device, a first detection device, a second detection device, and a controller. The protein analysis method includes:

[0034] The controller controls the sample preparation device to prepare a first test solution using the sample to be tested and an indicator reagent, wherein the indicator reagent is used to indicate the concentration of the protein in the sample to be tested;

[0035] The controller controls the first detection device to detect the first test solution to obtain an indication signal of protein in the sample to be tested;

[0036] The controller selects a detection mode to be executed from a plurality of detection modes according to the indication signal;

[0037] The controller controls the sample preparation device to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to the detection mode to be executed, and controls the second detection device to detect the second test solution to obtain the concentration value of the protein in the sample to be tested.

[0038] In a fifth aspect, the present application provides a protein analysis method for a sample analyzer, wherein the sample analyzer includes a sample preparation device, a first detection device, a second detection device, and a controller. The protein analysis method includes:

[0039] The controller controls the sample preparation device to prepare a first test solution using the sample to be tested and an indicator reagent, wherein the indicator reagent is used to indicate the concentration of the protein in the sample to be tested;

[0040] The controller controls the first detection device to detect the first test solution to obtain an indication signal of protein in the sample to be tested;

[0041] When the indication signal is lower than a preset threshold, the controller controls the sample preparation device to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of a protein in the sample to be tested according to a first detection mode, and controls the second detection device to detect the second test solution to obtain and output a concentration value of the protein in the sample to be tested;

[0042] When the indication signal is not lower than the preset threshold value, the controller outputs an alarm prompt, and / or the controller controls the sample preparation device to prepare a third test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to a second detection mode different from the first detection mode, and controls the second detection device to detect the third test solution to obtain and output the concentration value of the protein in the sample to be tested.

[0043] In a sixth aspect, the present application provides a protein analysis method for a sample analyzer, wherein the sample analyzer includes a sample preparation device, a first detection device, a second detection device, and a controller. The protein analysis method includes:

[0044] The controller controls the sample preparation device to prepare a first test solution using the sample to be tested and an indicator reagent, wherein the indicator reagent is used to indicate the concentration of protein in the urine sample to be tested;

[0045] The controller controls the first detection device to detect the first test solution to obtain an indication signal of protein in the sample to be tested;

[0046] The controller controls the sample preparation device to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of a protein in the sample to be tested according to a first detection mode, and controls the second detection device to detect the second test solution to obtain a first concentration value of the protein in the sample to be tested;

[0047] When the indication signal is lower than a preset threshold, the controller outputs a first concentration value;

[0048] When the indication signal is not lower than the preset threshold value, the controller outputs an alarm prompt, and / or the controller controls the sample preparation device to prepare a third test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to a second detection mode different from the first detection mode, and controls the second detection device to detect the third test solution to obtain and output a second concentration value of the protein in the sample to be tested. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Figure 1 is a schematic block diagram of a sample analyzer according to an embodiment of the present application;

[0050] Figure 2 for Figure 1 A schematic structural diagram of a sample analyzer in FIG.

[0051] Figure 3 is a schematic structural diagram of a first detection device according to an embodiment of the present application;

[0052] Figure 4 A schematic flow chart of protein concentration detection according to an embodiment of the present application;

[0053] Figure 5 Another schematic flow chart of protein concentration detection according to an embodiment of the present application;

[0054] Figure 6 is a reaction curve diagram of a low concentration sample according to an embodiment of the present application;

[0055] Figure 7 is a reaction curve diagram of a high concentration sample according to an embodiment of the present application;

[0056] Figure 8 is a schematic flow chart of a protein analysis method according to the first embodiment of the present application;

[0057] Fig. 9is a schematic flow chart of a protein analysis method according to the second embodiment of the present application; and

[0058] Fig.10 It is a schematic flow chart of the protein analysis method according to the third embodiment of the present application. DETAILED DESCRIPTION

[0059] The embodiments of the present application will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present application.

[0060] It should be noted that the terms "first\second\third" involved in the embodiments of the present application are merely used to distinguish similar objects and do not represent a specific ordering of the objects. It can be understood that "first\second\third" can be interchanged in a specific order or sequence where permitted.

[0061] Figure 1 A schematic block diagram of a sample analyzer 100 according to an embodiment of the present application is shown. The sample analyzer 100 includes a sample preparation device 110 , a first detection device 120 , a second detection device 130 , and a controller 140 .

[0062] The sample preparation device 110 is used to prepare a first test solution using a sample to be tested and an indicator reagent, wherein the indicator reagent is used to indicate the concentration of a protein in the sample to be tested.

[0063] The first detection device 120 is used to detect the first test solution to obtain an indication signal of the protein in the sample to be tested.

[0064] The second detection device 130 is used to obtain the concentration value of the protein in the sample to be tested.

[0065] The controller 140 is used to implement various method steps proposed according to the embodiments of the present application, as will be described below.

[0066] In a specific embodiment, Figure 2 As shown, the sample analyzer 100 is configured as a biochemical analyzer. Figure 2 In the illustrated embodiment, the sample preparation device 110 includes a sample carrying component 111 , a sample dispensing mechanism 112 , a reagent carrying component 113 , a reagent dispensing mechanism 114 and a reaction component 115 .

[0067] The sample carrying component 111 is used to carry the sample to be tested. For example, the sample carrying component 111 can be constructed as a sample tray, which includes a plurality of sample positions where the container 10 can be placed, and the sample tray can dispatch the container containing the sample to be tested to a corresponding position by rotation, for example, to a position for the sample dispensing mechanism 112 to absorb the sample to be tested. The sample dispensing mechanism 112 is used to absorb the sample to be tested from the container 10 and discharge it into a reaction cup to be loaded with the sample. For example, the sample dispensing mechanism 112 can include a sample needle, which can perform two-dimensional or three-dimensional movement in space through a two-dimensional or three-dimensional driving mechanism, so that the sample needle can move to the position to absorb the sample to be tested and to the reaction cup to be loaded with the sample, and discharge the absorbed sample to be tested into the reaction cup.

[0068] The reagent carrying component 113 is used to carry reagents, including indicator reagents and detection reagents.

[0069] In some embodiments, the reagent carrying component 113 can be constructed as a reagent disk with a disc-shaped structure, and the reagent disk has a plurality of positions for carrying reagent containers. The reagent carrying component 113 can rotate and drive the reagent container it carries to rotate, so as to rotate the reagent container to a specific position, such as a position where the reagent is sucked by the reagent dispensing mechanism 114. The number of reagent carrying components 113 can be one or more. The reagent dispensing mechanism 114 is used to absorb the reagent and discharge it into a reaction cup to be added with the reagent. For example, the reagent dispensing mechanism 114 can include a reagent needle, and the reagent needle can perform two-dimensional or three-dimensional movement in space through a two-dimensional or three-dimensional driving mechanism, so that the reagent needle can move to the position to absorb the reagent and to the reaction cup to be added with the reagent, and discharge the absorbed reagent to the reaction cup.

[0070] The reaction component 115 has at least one placement position, and the placement position is used to place a reaction cup and incubate the test solution in the reaction cup, such as the pre-treatment test solution and the sample solution to be tested. For example, the reaction component 115 can be constructed as a reaction disk with a disc-shaped structure, and the reaction disk has one or more placement positions for placing the reaction cups. The reaction disk can rotate and drive the reaction cups in the placement positions to move, so as to arrange the reaction cups in the reaction disk and incubate the test solution in the reaction cups.

[0071] The first detection device 120 is used to detect the first test solution mixed with the test sample and the indicator reagent in the reaction component 115 to obtain the indicator signal of the protein in the test sample. The first detection device 120 is, for example, arranged outside the reaction component 115, and the reaction component 115 rotates to drive the container containing the first test solution to move to the first detection device 120 for detection.

[0072] The second detection device 130 is, for example, also disposed outside the reaction component 115 . The reaction component 115 rotates to drive the container containing the liquid to be tested to move to the second detection device 130 for detection.

[0073] Further, in Figure 2 In the illustrated embodiment, the sample preparation device 110 may further include a test solution transfer unit (not shown) for transferring the first test solution to the corresponding reaction cup. In some embodiments, the sample dispensing mechanism 112 may be used as the test solution transfer unit.

[0074] In some embodiments, Figure 3 As shown, the first detection device 120 can be further used to irradiate the first test liquid with light of at least one wavelength, and obtain the optical signal generated by the first test liquid after being irradiated with the light, so as to obtain the indication signal based on the optical signal. Figure 3 In the illustrated embodiment, the first detection device 120 includes a light source 121 and a light detector 122. The light source 121 is used to illuminate the first test liquid with light of at least one wavelength, and the light detector 122 is used to detect the optical signal (transmitted light and / or scattered light) emitted by the light source 121 and passing through the first test liquid, thereby obtaining an indication signal based on the optical signal.

[0075] In some embodiments, the first detection device 120 and the second detection device 130 may be the same detection device to further reduce costs. Figure 3 The optical detection device shown.

[0076] In some embodiments, the sample analyzer 100 may further include a stirring device (not shown) to mix the liquid in the reaction cup.

[0077] according to Figure 1 In the first embodiment of the sample analyzer 100 shown, the controller 140 is used to:

[0078] selecting a detection mode to be executed from a plurality of detection modes according to the indication signal;

[0079] According to the detection mode to be executed, the sample preparation device 110 is controlled to prepare a second test solution using the test sample and a detection reagent for detecting the concentration of protein in the test sample; and the second detection device 130 is controlled to detect the second test solution to obtain the concentration value of the protein in the test sample.

[0080] In this first embodiment, before preparing the second test solution that is ultimately used to detect the protein concentration in the sample to be tested, a first test solution for predicting the protein concentration in the sample to be tested can be prepared based on the indicator reagent and the sample to be tested, and based on the indicator signal of the protein in the sample to be tested obtained by testing the first test solution, a detection mode suitable for the current sample to be tested is selected, so that the second test solution suitable for the current sample to be tested can be prepared based on the selected detection mode, and a more accurate detection result can be obtained through a single test, thereby reducing the number of retests of the sample, thereby improving the detection efficiency of the sample and saving reagent costs.

[0081] In the embodiment of the present application, after the detection mode to be executed is selected based on the indication signal, the second test solution can be prepared in the following ways.

[0082] In the first method of preparing the second test solution, the sample preparation device 110 can be further used to: mix a portion of the sample to be tested with an indicator reagent to prepare a first test solution; and mix at least a portion of the first test solution with a detection reagent to prepare a second test solution. In this way, not only the overall detection efficiency of the sample analyzer can be improved, but also the overall detection cost can be reduced.

[0083] by Figure 2 The biochemical analyzer shown in the figure is used as an example to describe the first method of preparing the sample solution to be tested. The controller 140 controls the reagent dispensing mechanism 114 to absorb the indicator reagent from the reagent carrying part 113 and add it to the first reaction cup located in the reaction part 115, and then the controller 140 controls the sample dispensing mechanism 112 to absorb a portion of the sample to be tested from the container 10 and add it to the first reaction cup to which the indicator reagent has been added, so as to obtain the first test solution. The controller 140 controls the first detection device 130 to detect the first test solution in the first reaction cup to obtain an indication signal. The controller 140 selects a detection mode to be executed according to the indication signal. Then, the controller 140 controls the reagent dispensing mechanism 114 to absorb the detection reagent from the reagent carrying part 113 and add it to the second reaction cup located in the reaction part 115 according to the detection mode to be executed, and controls the test solution transfer part to transfer at least a portion of the first test solution in the first reaction cup to the second reaction cup to which the detection reagent has been added, so as to prepare the second test solution. Then, the controller 140 controls the second detection device 130 to detect the second test solution in the second reaction cup.

[0084] In the second method of preparing the second test solution, the sample preparation device 110 can be further used to: mix at least a portion of the sample to be tested with an indicator reagent to prepare the first test solution; and mix at least another portion of the sample to be tested with a detection reagent to prepare the second test solution. In other words, the sample preparation device 110 does not use the first test solution, but uses another portion of the sample to be tested to prepare the second test solution.

[0085] Likewise Figure 2 The biochemical analyzer shown in the figure is used as an example to describe the second method of preparing the second test solution. The controller 140 controls the reagent dispensing mechanism 114 to draw the indicator reagent from the reagent carrying part 113 and add it to the first reaction cup located in the reaction part 115. Then the controller 140 controls the sample dispensing mechanism 112 to draw a part of the sample to be tested from the container 10 and add it to the first reaction cup to which the indicator reagent has been added, so as to obtain the first test solution. The controller 140 controls the first detection device 130 to detect the first test solution in the first reaction cup to obtain an indication signal. The controller 140 selects a detection mode to be executed according to the indication signal. Then, the controller 140 controls the reagent dispensing mechanism 114 to draw the detection reagent from the reagent carrying part 113 and add it to the second reaction cup located in the reaction part 115 according to the detection mode to be executed. Then, the controller 140 controls the sample dispensing mechanism 112 to draw another part of the sample to be tested from the container 10 again or draw a part of the sample to be tested from another container containing the sample to be tested of the same subject and add it to the second reaction cup to which the detection reagent has been added, so as to obtain the second test solution. Afterwards, the controller 140 controls the second detection device 130 to detect the second test solution in the second reaction cup.

[0086] In some embodiments, the multiple detection modes differ in at least one of the following aspects:

[0087] The dilution factor of the sample to be tested when preparing the test solution; and

[0088] The type of detection reagent.

[0089] As some implementations, the multiple detection modes differ in the dilution multiples of diluting the sample to be tested when preparing the test solution, that is, the dilution multiples of diluting the sample to be tested when preparing the test solution in different detection modes are different.

[0090] In one example, the controller 140 may be further configured to:

[0091] When the indication signal is lower than the preset threshold, the first detection mode is selected, and the sample preparation device 110 is controlled to prepare the second test solution by using the test sample and the antibody reagent as the detection reagent at a first dilution factor according to the first detection mode, and the second detection device 130 is controlled to detect the second test solution by turbidimetry; and

[0092] When the indication signal is not lower than the preset threshold, the second detection mode is selected, and the sample preparation device 110 is controlled to prepare the second test solution using the sample to be tested and the antibody reagent at a second dilution factor according to the second detection mode, and the second detection device 130 is controlled to detect the second test solution using the turbidimetry method.

[0093] Here, the first dilution factor is smaller than the second dilution factor. For example, the dilution factor for preparing the second test solution can be increased by increasing the amount of diluent (eg, saline).

[0094] That is to say, both the first detection mode and the second detection mode use immunoturbidimetry to perform protein detection (that is, the types of detection reagents used are the same, both are antibody reagents), but when the indicator signal indicates that the protein concentration of the sample to be tested is high, a larger dilution factor will be used to dilute the sample used to prepare the second test solution to obtain more accurate test results.

[0095] It should be understood that the plurality of detection modes may include a plurality of other detection modes with different dilution factors in addition to the first detection mode and the second detection mode.

[0096] Figure 4 A schematic flow chart of a specific protein concentration detection is shown. In step S210, the sample preparation device 110 mixes the sample to be tested with the indicator reagent to obtain a first test solution. In step S220, the first detection device 120 detects the light signal generated after the protein in the sample to be tested reacts with the indicator reagent as an indicator signal, so as to estimate the protein concentration of the sample to be tested based on the light signal. In step S230, the controller 140 determines whether the light signal exceeds a preset threshold value (for example, determines whether the estimated protein concentration in the sample to be tested exceeds the effective detection range of the sample analyzer). When the light signal is lower than the preset threshold value (for example, the estimated protein concentration does not exceed the effective detection range), step S240 is executed: the sample preparation device 110 prepares a second test solution with a first dilution factor based on the first detection mode. When the light signal is not lower than the preset threshold value (for example, the estimated protein concentration exceeds the effective detection range), step S250 is executed: the sample preparation device 110 prepares a second test solution with a second dilution factor greater than the first dilution factor based on the second detection mode. In step S260 , the second detection device 130 performs protein detection on the second test solution.

[0097] In the above embodiment, the protein concentration of the sample to be tested is estimated based on the indicator signal (such as a light signal) obtained by detecting the first test solution, and then a detection mode with a dilution factor corresponding to the estimated protein concentration is selected according to the estimated protein concentration to prepare the second test solution, so that a more accurate test result can be obtained through a single test, reducing the reagent cost caused by repeated dilution and improving the detection efficiency of the sample.

[0098] In addition, since the highest concentration of urine microalbumin in clinical practice exceeds 60,000 mg / L, which is far beyond the effective measurement range of the instrument, when the concentration of urine microalbumin in the urine sample is too high, there may be an excess of antigen in the urine sample, resulting in a false negative. In this case, dilution is required to avoid an excess of antigen in the urine sample. However, in the current sample analyzer, a single dilution is limited by the maximum sample volume and reagent volume, so the dilution multiple that can be achieved for a single dilution of the same sample is limited.

[0099] Thus, in some embodiments, the controller 140 may be further configured to:

[0100] When the dilution factor corresponding to the detection mode to be executed is greater than the preset factor, the sample preparation device 110 is controlled to dilute the sample to be tested for preparing the second test solution multiple times to prepare the second test solution that meets the dilution factor corresponding to the detection mode to be executed.

[0101] That is to say, when the dilution factor corresponding to the detection mode to be executed exceeds the maximum dilution factor of the sample analyzer, the same sample can be diluted multiple times to broaden the coverage of the dilution factor of the detection mode and improve the reporting range of the sample detection, thereby better meeting the measurement requirements.

[0102] Combine the following Figure 2 The biochemical analyzer shown describes an exemplary detection process of using the embodiment of the present application to detect albumin mALB in urine. In this example, the reagent carrying component 113 carries an indicator reagent (such as sulfosalicylic acid), mALB immunoturbidimetric detection reagent and a diluent (such as normal saline).

[0103] First, the controller 140 controls the reagent dispensing mechanism 114 to absorb the indicator reagent from the reagent carrying component 113 (e.g., a reagent disk) and add it to the first reaction cup located in the reaction component 115; then, the controller 140 controls the sample dispensing mechanism 112 to absorb a portion of the urine sample to be tested from the container 10 containing the urine sample to be tested of the subject and add it to the first reaction cup to which the indicator reagent has been added; then, the controller 140 controls the stirring device to stir the mixed liquid in the first reaction cup to obtain the first test solution after mixing. Finally, the controller 140 controls the first detection device 120 (here, the photometric device) to detect the absorbance of the first test solution after mixing in the first reaction cup, and records it as A1.

[0104] Subsequently, the controller 140 compares the absorbance A1 of the first test solution with the threshold values Q1, Q2, and Q3. If A1 < Q1, the first detection mode is selected for subsequent albumin detection; if Q1 < A1 < Q2, the second detection mode is selected for subsequent albumin detection; if Q2 < A1 < Q3, the third detection mode is selected for subsequent albumin detection; if Q3 < A1, the fourth detection mode is selected for subsequent albumin detection. The detection processes of each detection mode are as follows.

[0105] First detection mode: Since A1 < Q1, it is determined that the protein concentration in the urine sample to be tested is relatively low, and the test can be carried out according to the conventional sample volume, that is, the urine sample to be tested is not diluted. In this first detection mode, the controller 140 controls the reagent dispensing mechanism 114 to aspirate the detection reagent from the reagent carrier component 113 and add it to the second reaction cup located in the reaction component 115; then, the controller 140 controls the sample dispensing mechanism 112 to aspirate a part of the urine sample to be tested from the container 10 and add it to the second reaction cup that has already been added with the detection reagent; then, the controller 140 controls the stirring device to mix the mixed liquid in the second reaction cup to obtain the second test solution after mixing; finally, the controller 140 controls the second detection device 130 (which is the same photometric device as the first detection device here) to detect the absorbance of the second test solution after mixing in the second reaction cup to obtain and output the albumin concentration of the urine sample to be tested.

[0106] Second detection mode: Since Q1 < A1 < Q2, it is determined that the protein concentration in the urine sample to be tested is relatively high, and the urine sample to be tested needs to be diluted 10 times before detection. In this second detection mode, the controller 140 controls the reagent dispensing mechanism 114 to aspirate 90 uL of sample diluent from the reagent carrier component 113 and add it to the second reaction cup; then, the controller 140 controls the sample dispensing mechanism 112 to aspirate 10 uL of the urine sample to be tested from the container 10 and add it to the second reaction cup that has already been added with the sample diluent; then, the controller 140 controls the stirring device to mix the mixed liquid in the second reaction cup to obtain the test solution diluted 10 times for standby. In addition, the controller 140 controls the reagent dispensing mechanism 114 to aspirate the detection reagent from the reagent carrier component 113 and add it to the third reaction cup, and controls the sample dispensing mechanism 112 to aspirate a part of the test solution diluted 10 times from the second reaction cup and add it to the third reaction cup; then, the controller 140 controls the stirring device to mix the mixed liquid in the third reaction cup to obtain the second test solution after mixing; finally, the controller 140 controls the second detection device 130 (which is the same photometric device as the first detection device here) to detect the absorbance of the second test solution after mixing in the third reaction cup to obtain and output the albumin concentration of the urine sample to be tested.

[0107] Third detection mode: Since Q2 < A1 < Q3, it is determined that the protein concentration in the urine sample to be tested is relatively high, and the urine sample to be tested needs to be diluted 50 times before detection. In this third detection mode, the controller 140 controls the reagent dispensing mechanism 114 to aspirate 196 uL of sample diluent from the reagent carrier component 113 and add it to the second reaction cup; then, the controller 140 controls the sample dispensing mechanism 112 to aspirate 4 uL of the urine sample to be tested from the container 10 and add it to the second reaction cup that has already been added with the sample diluent; then, the controller 140 controls the stirring device to mix the mixed liquid in the second reaction cup to obtain a test solution diluted 50 times for standby. In addition, the controller 140 controls the reagent dispensing mechanism 114 to aspirate the detection reagent from the reagent carrier component 113 and add it to the third reaction cup, and controls the sample dispensing mechanism 112 to aspirate a part of the test solution diluted 50 times from the second reaction cup and add it to the third reaction cup; thereafter, the controller 140 controls the stirring device to mix the mixed liquid in the third reaction cup to obtain a second mixed test solution; finally, the controller 140 controls the second detection device 130 (which is the same photometric device as the first detection device here) to detect the absorbance of the second mixed test solution in the third reaction cup after mixing, so as to obtain and output the albumin concentration of the urine sample to be tested.

[0108] Fourth Detection Mode: Since Q3 < A1, it is determined that the protein concentration in the urine sample to be tested is relatively high, and the urine sample to be tested needs to be diluted 200 times before testing. However, the single dilution multiple that this biochemical analyzer can achieve is less than 200 times, so it is necessary to perform secondary dilution on this urine sample to be tested. First Dilution: The controller 140 controls the reagent dispensing mechanism 114 to aspirate 90 uL of sample diluent from the reagent carrying component 113 and add it to the second reaction cup; then, the controller 140 controls the sample dispensing mechanism 112 to aspirate 10 uL of the urine sample to be tested from the container 10 and add it to the second reaction cup that has already been added with the sample diluent; then, the controller 140 controls the stirring device to mix the mixed liquid in the second reaction cup to obtain a test solution diluted 10 times for standby. Second Dilution: The controller 140 controls the reagent dispensing mechanism 114 to aspirate 190 uL of sample diluent from the reagent carrying component 113 and add it to the third reaction cup; then, the controller 140 controls the sample dispensing mechanism 112 to aspirate 10 uL of the test solution diluted 10 times from the second reaction cup and add it to the third reaction cup; then, the controller 140 controls the stirring device to mix the mixed liquid in the third reaction cup to obtain a test solution diluted 200 times for standby. After that, the controller 140 controls the reagent dispensing mechanism 114 to aspirate the detection reagent from the reagent carrying component 113 and add it to the fourth reaction cup, and controls the sample dispensing mechanism 112 to aspirate a part of the test solution diluted 200 times from the third reaction cup and add it to the fourth reaction cup; then, the controller 140 controls the stirring device to mix the mixed liquid in the fourth reaction cup to obtain the second mixed test solution; finally, the controller 140 controls the second detection device 130 (which is the same photometric device as the first detection device here) to detect the absorbance of the second mixed test solution in the fourth reaction cup to obtain and output the albumin concentration of the urine sample to be tested.

[0109] It can be understood that the order of adding reagents and samples above can also be adjusted according to the structure of the biochemical analyzer to add samples first and then reagents.

[0110] As other implementation manners, the multiple detection modes are different in terms of the type of detection reagent, that is, the types of detection reagents corresponding to different detection modes are different. For example, the detection reagent can be a pigment reagent or an antibody reagent.

[0111] In one example, the controller 140 can further be used for:

[0112] When the indication signal is lower than the preset threshold, select the first detection mode, control the sample preparation device 110 to prepare the second test solution using the sample to be tested and the antibody reagent as the detection reagent according to the first detection mode, and control the second detection device 130 to detect the second test solution by turbidimetry;

[0113] When the indication signal is not lower than the preset threshold, the second detection mode is selected, and the sample preparation device 110 is controlled to prepare the second test solution using the sample to be tested and the pigment reagent as the detection reagent according to the second detection mode, and the second detection device 130 is controlled to detect the second test solution using colorimetry.

[0114] In the embodiment of the present application, the principle of immunoturbidimetry is to make the antibody (or antigen) in the detection reagent react with the antigen (or antibody) in the sample to be tested, and the complex cross-linked structure formed after the reaction of the antigen and the antibody will lead to a change in absorbance (turbidity), thereby forming a reactivity, based on which the concentration of protein, especially albumin, in the sample to be tested can be determined. The principle of colorimetry is to compare or measure the depth of the color presented by the test liquid after the addition of the pigment reagent to determine the concentration of protein in the test liquid.

[0115] Pigments are low-sensitivity reaction substances that do not produce reaction signals or produce low reaction signals when the antigen concentration is low, but produce obvious reaction signals when the antigen concentration is high. Therefore, when the immunoturbidimetric method may cause the hook effect due to the high concentration of protein in the sample to be tested, the colorimetric method can obtain a more accurate protein concentration.

[0116] Figure 5 A specific protein concentration detection process is shown. In step S310, the sample preparation device 110 mixes the sample to be tested with the indicator reagent to obtain a first test solution. In step S320, the first detection device 120 detects the optical signal generated after the protein in the sample to be tested reacts with the indicator reagent, so as to estimate the concentration of the protein in the sample to be tested based on the optical signal. In step S330, the controller 140 determines whether the optical signal exceeds a preset threshold value (i.e., determines whether the estimated protein concentration in the sample to be tested exceeds the effective detection range). When the optical signal is lower than the preset threshold value (i.e., the estimated protein concentration in the sample to be tested does not exceed the effective detection range), step S340 is executed: the sample preparation device 110 uses the antibody reagent as the detection reagent to prepare the second test solution based on the first detection mode. When the optical signal is not lower than the preset threshold value (i.e., the estimated protein concentration in the sample to be tested exceeds the effective detection range), step S350 is executed: the sample preparation device 110 uses the pigment reagent as the detection reagent to prepare the second test solution based on the second detection mode. In step S360 , the second detection device 130 performs protein detection on the second test solution.

[0117] As some other implementations, the multiple detection modes can be different in terms of the type of detection reagents and the dilution multiples of the test samples when preparing the test solution, so as to increase the effective measurement range of a protein detection without increasing costs as much as possible and obtain more accurate detection results.

[0118] In some embodiments, the indicator reagent used to prepare the first test solution may include a pigment. That is, a colorimetric method may be used to detect the concentration of protein in the sample to be tested, especially albumin in a urine sample, and the detection mode to be performed is selected based on the protein concentration detected by the colorimetric method.

[0119] In some examples, the pigment can be an acid-base indicator. For example, the pigment reagent can be selected from one of pentamethoxy red, methylquinoline red and bromocresol green. For another example, the pigment reagent can be selected from azo compounds (compounds with nitrogen-nitrogen double swords, such as methyl orange), sulfonphthalein compounds (compounds with phenol sulfonyl and phenolic hydroxyl groups, such as bromocresol green), phenolphthalein compounds (phenolphthalein and its derivatives, such as phenolphthalein, thymol blue, α-naphtholphthalein), anthraquinone compounds (anthraquinone compounds with carbonyl groups at C9 and C10, such as alizarin red), nitrophenol compounds (compounds with phenol nitro and phenolic hydroxyl groups, such as p-nitrophenol) and any combination thereof (such as Evans blue, i.e., azo + sulfonphthalein) The group consisting of.

[0120] In other embodiments, the indicator reagent used to prepare the first test solution may include a precipitation reagent, which can react with proteins in the sample to be tested, especially total proteins in the urine sample to form a precipitate. Here, the indicator signal of the protein in the sample to be tested obtained by detecting the first test solution can be a light signal generated after the indicator reagent reacts with the protein in the sample to be tested. That is to say, turbidimetry is used here to detect the concentration of protein in the sample to be tested, and the detection mode to be executed is selected based on the protein concentration prediction result obtained by turbidimetry detection. For example, the absorbance data generated after the precipitation reagent reacts with the protein in the sample to be tested can be obtained, and the concentration of the protein in the sample to be tested can be estimated based on the absorbance data obtained, and then the detection mode to be executed with an effective detection range suitable for the sample to be tested is selected from a plurality of different detection modes, so as to avoid the final detection result exceeding the effective detection range, thereby achieving accurate detection of protein in the sample to be tested through one detection.

[0121] In some examples, the precipitation reagent can be selected from the group consisting of salicylic acid, oxalic acid, trichloroacetic acid, and any combination thereof. For example, the precipitation reagent can be sulfosalicylic acid, and under acidic conditions, the sulfonate ions of sulfosalicylic acid combine with protein amino acid cations to form insoluble protein salt precipitates, wherein the degree of precipitate generation can reflect the protein content.

[0122] In some embodiments, the protein in the sample to be tested may be one of albumin and total protein. Preferably, the protein is albumin.

[0123] In some embodiments, the sample to be tested may be one of urine, serum and cerebrospinal fluid. Preferably, the sample to be tested is urine.

[0124] In some preferred embodiments, the sample to be tested is urine, and the protein is albumin (or microalbumin).

[0125] In some embodiments, before waiting for the detection result of the reaction between the indicator and the sample to be tested to come out, the sample to be tested can be in a variety of processing states. For example, the sample to be tested can stay on the sample supporting component or the transport track, waiting for the predicted result based on the indication signal to come out before performing the sample addition action; or, the sample to be tested can be added to the reaction cup without dilution, waiting for the predicted result based on the indication signal to come out before performing the subsequent sample addition or dilution action; or, the sample to be tested and a certain amount of water are first added to the reaction cup, the sample to be tested is first diluted a certain number of times, and then the subsequent sample addition or dilution action is performed after waiting for the predicted result based on the indication signal to come out.

[0126] Alternatively to the first embodiment described above, according to Figure 1 In the second embodiment of the sample analyzer 100 shown, the controller 140 is used to:

[0127] When the indication signal is lower than the preset threshold, the sample preparation device 110 is controlled to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of the protein in the sample to be tested according to the first detection mode, and the second detection device 130 is controlled to detect the second test solution to obtain and output the concentration value of the protein in the sample to be tested, and

[0128] When the indication signal is not lower than the preset threshold, an alarm prompt is output, and / or the sample preparation device 110 is controlled to prepare a third test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to a second detection mode different from the first detection mode, and the second detection device 130 is controlled to detect the third test solution to obtain the concentration value of the protein in the sample to be tested.

[0129] In the second embodiment, a low-sensitivity reaction substance, i.e., an indicator, is introduced. The reaction substance does not generate a signal or generates a low signal when the protein concentration is low, but generates an obvious reaction signal when the protein concentration is high. Thus, before the detection reagent, such as an antibody reagent, reacts with the sample to be tested, the approximate information of the protein concentration can be obtained in advance based on the indicator signal. If the indicator signal indicates that the sample to be tested is a sample with a high protein concentration, it indicates that the result may be wrong and needs to be diluted and re-tested for confirmation, or the sample analyzer directly changes the mode for re-testing to improve the accuracy of the test result.

[0130] In a specific example, Figure 2 The biochemical analyzer shown is used as an example to describe an exemplary process for detecting albumin in urine according to an embodiment of the present application. A pigment reagent is used as an indicator reagent, and an immunoturbidimetric reagent is used as a detection reagent. Among them, bromocresol green is used as a pigment reagent and is combined with the immunoturbidimetric reagent. The immunoturbidimetric reagent includes a first reagent R1 and a second reagent R2, wherein the first reagent R1 includes PEG6000, bromocresol green (i.e., a pigment reagent) and BRIJ35, and the second reagent includes ALB antiserum and Tris buffer. An exemplary process for detecting albumin in urine is as follows: the controller 140 controls the reagent dispensing mechanism 114 to draw 100uL of the first reagent R1 from the reagent carrying component 113 and add it to the reaction cup located in the reaction component 115, and controls the photometric device (the first detection device 120 and the second detection device 130 are the same photometric device) to obtain the absorbance S0 at a wavelength of 605nm; then, the controller 140 controls the sample dispensing mechanism 112 to draw 6uL of the urine sample to be tested from the container 10 containing the urine sample to be tested and add it to the reaction cup to which the first reagent has been added to obtain a first test solution, and then controls the photometric device to obtain the absorbance S1H at a wavelength of 605nm and the absorbance S1L at a wavelength of 340nm; then Then, the signal value (indicator signal) SH=S1H-S0×100 / (100+6) is calculated. If the signal value SH is outside the preset range, for example, greater than the preset threshold value (for example, 5000), an alarm prompt is output and subsequent tests are terminated; if the signal value SH is within the preset range, for example, less than or equal to ≤ the preset threshold value, the controller 140 controls the reagent dispensing mechanism 114 to absorb 30uL of the second reagent R2 from the reagent carrying component 113 and add it to the above-mentioned reaction cup loaded with the first test solution to prepare the second test solution, and then controls the photometric device to obtain the absorbance S2 at a wavelength of 340; finally, the signal value SL=S2-S1L×(100+6) / (100+6+30) is calculated, and the corresponding albumin concentration value is calculated based on the signal value SL.

[0131] In some embodiments, the controller 140 may be further configured to:

[0132] Controlling the sample preparation device 110 to prepare a second test solution using the test sample and an antibody reagent as a detection reagent at a first dilution factor according to the first detection mode, and controlling the second detection device 130 to detect the second test solution using turbidimetry; and

[0133] Control the sample preparation device 110 to prepare a third test solution using the test sample and an antibody reagent as a detection reagent at a second dilution factor according to the second detection mode, and control the second detection device 130 to detect the third test solution using turbidimetry;

[0134] The first dilution factor is smaller than the second dilution factor.

[0135] In some other embodiments, the controller 140 may be further configured to:

[0136] Controlling the sample preparation device 110 to prepare a second test solution using the sample to be tested and an antibody reagent as a detection reagent according to the first detection mode, and controlling the second detection device 130 to detect the second test solution using turbidimetry; and

[0137] The sample preparation device 110 is controlled to prepare a third test solution using the sample to be tested and a pigment reagent as a detection reagent according to a second detection mode different from the first detection mode, and the second detection device 130 is controlled to detect the third test solution using a colorimetric method.

[0138] In some embodiments, the third test solution is prepared in a manner similar to the above-described preparation of the second test solution.

[0139] For other features and advantages of the sample analyzer according to the second embodiment of the present application, reference may be made to the various embodiments and advantages of the sample analyzer according to the first embodiment of the present application described above.

[0140] Alternatively to the first and second embodiments described above, according to Figure 1 In the third embodiment of the sample analyzer 100 shown, the controller 140 is used to:

[0141] According to the first detection mode, the sample preparation device 110 is controlled to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of the protein in the sample to be tested, and the second detection device 130 is controlled to detect the second test solution to obtain a first concentration value of the protein in the sample to be tested.

[0142] When the indication signal is lower than a preset threshold, a first concentration value is output, and

[0143] When the indication signal is not lower than the preset threshold, an alarm prompt is output, and / or the sample preparation device 110 is controlled to prepare a third test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to a second detection mode different from the first detection mode, and the second detection device 120 is controlled to detect the third test solution to obtain and output a second concentration value of the protein in the sample to be tested.

[0144] In the third embodiment, a low-sensitivity reaction substance, i.e., an indicator, is introduced. This reaction substance does not generate a signal or generates a low signal when the protein concentration is low, but generates an obvious reaction signal when the protein concentration is high. Thus, before the detection reagent, such as an antibody reagent, reacts with the sample to be tested, the approximate information of the protein concentration can be obtained in advance based on the indicator signal. If the indicator signal indicates that the protein concentration of the sample to be tested is low, the protein concentration value detected according to the first detection mode can be directly output. If the indicator signal indicates that the protein concentration of the sample to be tested is high, an alarm can be output to indicate that the result may be wrong (i.e., the first concentration value is unreliable) and / or a detection mode (i.e., the second detection mode) can be changed for retesting and confirmation, so that a more accurate protein value concentration detection result can be obtained.

[0145] In a specific example, Figure 2The biochemical analyzer shown is used as an example to describe an exemplary process for detecting albumin in urine according to an embodiment of the present application. A pigment reagent is used as an indicator reagent, and an immunoturbidimetric reagent is used as a detection reagent. Among them, bromocresol green is used as a pigment reagent and is combined with the immunoturbidimetric reagent. The immunoturbidimetric reagent includes a first reagent R1 and a second reagent R2, wherein the first reagent R1 includes PEG6000, bromocresol green (i.e., a pigment reagent) and BRIJ35, and the second reagent includes ALB antiserum and Tris buffer. An exemplary process for detecting albumin in urine is as follows: the controller 140 controls the reagent dispensing mechanism 114 to draw 100uL of the first reagent R1 from the reagent carrying component 113 and add it to the reaction cup located in the reaction component 115, and controls the photometric device (the first detection device 120 and the second detection device 130 are the same photometric device) to obtain the absorbance S0 at a wavelength of 605nm; then, the controller 140 controls the sample dispensing mechanism 112 to draw 6uL of the urine sample to be tested from the container 10 containing the urine sample to be tested and add it to the reaction cup to which the first reagent has been added to obtain the first test solution, and then controls the photometric device to obtain the absorbance S1H at a wavelength of 605nm and the absorbance S1L at a wavelength of 340nm; then, the signal value (indicator signal) SH=S1H-S0×100 / (10 0+6); then, the controller 140 controls the reagent dispensing mechanism 114 to absorb 30uL of the second reagent R2 from the reagent carrying component 113 and add it to the above-mentioned reaction cup loaded with the first test solution to prepare the second test solution, and then controls the photometric device to obtain the absorbance S2 at a wavelength of 340; then calculates the signal value SL=S2-S1L×(100+6) / (100+6+30), and then calculates the corresponding albumin concentration value based on the signal value SL; then determines whether the albumin concentration value is credible. If the signal value SH is outside the preset range, for example, greater than a preset threshold value (for example, 5000), it indicates that the albumin concentration value is unreliable and an alarm prompt is output, or it can automatically switch to the second detection mode for re-testing; if the signal value SH is within the preset range, for example, less than or equal to ≤ the preset threshold value, it indicates that the albumin concentration value is credible and it is output.

[0146] Here, the signal value SH can be used to determine whether the "hook effect" occurs, and further determine whether the albumin concentration value is a reliable result. For example, if SH>5000, it is determined that the "hook effect" exists, and further determines that the albumin concentration value is unreliable, and you can choose to switch to the second detection mode to prepare a third test solution for dilution and retesting.

[0147] The above exemplary process is used to test two urine samples with known albumin concentrations. The albumin concentration of one urine sample is 287 mg / L (low concentration sample). The reaction curve is as follows: Figure 6As shown, the albumin concentration of another urine sample is 36776 mg / L (high concentration sample), and its reaction curve is as follows Figure 7 shown.

[0148] like Figure 6 As shown, based on the reaction curve, the albumin concentration value C = 287 mg / L of the low-concentration sample can be calculated. Since the signal value SH = S1H-S0×100 / (100+6) < 5000, the sample analyzer determines that there is no hook effect, and the albumin concentration value C = 287 mg / L is a reliable result.

[0149] like Figure 7 As shown, based on the reaction curve, the albumin concentration value C = 281 mg / L of the high-concentration sample can be calculated. Since the signal value SH = S1H-S0100 / (100+6)>5000, the sample analyzer determines that a hook effect occurs, and the albumin concentration value C = 281 mg / L is an unreliable result and needs to be diluted and retested.

[0150] It can be seen that the sample analyzer proposed in the embodiment of the present application can avoid the misjudgment of results caused by the "hook effect".

[0151] In some embodiments, the controller 140 may be further configured to:

[0152] Controlling the sample preparation device 110 to prepare a second test solution using the test sample and an antibody reagent as a detection reagent at a first dilution factor according to the first detection mode, and controlling the second detection device 130 to detect the second test solution using turbidimetry; and

[0153] Control the sample preparation device 110 to prepare a third test solution using the test sample and the antibody reagent at a second dilution factor according to the second detection mode, and control the second detection device 130 to detect the third test solution using the turbidimetry method;

[0154] The first dilution factor is smaller than the second dilution factor.

[0155] In some other embodiments, the controller 140 may be further configured to:

[0156] Controlling the sample preparation device 110 to prepare a second test solution using the sample to be tested and an antibody reagent as a detection reagent according to the first detection mode, and controlling the second detection device 130 to detect the second test solution using turbidimetry; and

[0157] The sample preparation device 110 is controlled to prepare a third test solution using the sample to be tested and a pigment reagent as a detection reagent according to a second detection mode different from the first detection mode, and the second detection device 130 is controlled to detect the third test solution using a colorimetric method.

[0158] In some embodiments, the third test solution is prepared in a manner similar to the above-described preparation of the second test solution.

[0159] For other features and advantages of the sample analyzer according to the third embodiment of the present application, reference may be made to the various embodiments and advantages of the sample analyzer according to the first and second embodiments of the present application.

[0160] Figure 8 A protein analysis method 600 according to the first embodiment of the present application is shown, which is used in a sample analyzer, especially the sample analyzer 100 described above, wherein the sample analyzer includes a sample preparation device, a first detection device, a second detection device, and a controller. Figure 8 As shown, method 600 includes steps S610 to S640.

[0161] In step S610, the controller controls the sample preparation device to prepare a first test solution using the sample to be tested and the indicator reagent. Here, the indicator reagent is used to indicate the concentration of the protein in the sample to be tested.

[0162] In step S620, the controller controls the first detection device to detect the first test solution to obtain an indication signal of the protein in the sample to be tested.

[0163] In step S630, the controller selects a detection mode to be executed from a plurality of detection modes according to the indication signal.

[0164] In step S640, the controller controls the sample preparation device to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to the detection mode to be executed, and controls the second detection device to detect the second test solution to obtain the concentration value of the protein in the sample to be tested.

[0165] In some embodiments, the protein in the sample to be tested may be one of albumin and total protein. Preferably, the protein is albumin.

[0166] In some embodiments, the sample to be tested may be one of urine, serum and cerebrospinal fluid. Preferably, the sample to be tested is urine.

[0167] In some preferred embodiments, the sample to be tested is urine, and the protein is albumin (eg, urine microalbumin).

[0168] In some embodiments, the indicator reagent used to prepare the first test solution may include a pigment. That is, a colorimetric method may be used to detect the concentration of protein in the sample to be tested, especially albumin in a urine sample, and the detection mode to be performed is selected based on the protein concentration detected by the colorimetric method.

[0169] In other embodiments, the indicator reagent used to prepare the first test solution may include a precipitation reagent, which can react with proteins in the sample to be tested, especially total proteins in the urine sample to form a precipitate. Here, the indicator signal of the protein in the sample to be tested obtained by detecting the first test solution can be a light signal generated after the indicator reagent reacts with the protein in the sample to be tested.

[0170] In some embodiments, in step S610, the sample preparation device using the sample to be tested and the indicator reagent to prepare a first test solution may include: the sample preparation device mixing at least a portion of the sample to be tested with the indicator reagent to prepare the first test solution; and in step S640, the sample preparation device using the sample to be tested and the detection reagent to prepare a second test solution may include: the sample preparation device mixing at least a portion of the first test solution with the detection reagent to prepare the second test solution.

[0171] In other embodiments, in step S610, the sample preparation device using the sample to be tested and the indicator reagent to prepare the first test solution may include: the sample preparation device mixing at least a portion of the sample to be tested with the indicator reagent to prepare the first test solution; and in step S640, the sample preparation device using the sample to be tested and the detection reagent to prepare the second test solution may include: the sample preparation device mixing at least another portion of the sample to be tested with the detection reagent to prepare the second test solution. For example, the sample to be tested may be re-absorbed and added to the reaction cup, and the sample to be tested and the detection reagent may be mixed to prepare the second test solution after the predicted result of the detection of the first test solution is obtained.

[0172] In some embodiments, the multiple detection modes differ in at least one of the following aspects:

[0173] The dilution factor by which the sample to be tested is diluted when preparing the test solution; and

[0174] Type of test reagent.

[0175] In some embodiments, the multiple detection modes differ in the type of detection reagent, that is, the type of detection reagent is different in different detection modes. For example, the detection reagent can be a pigment reagent or an antibody reagent.

[0176] In one example, the controller selects a detection mode to be executed from a plurality of detection modes according to the indication signal, and controls the sample preparation device to prepare a second test solution and controls the second detection device to detect the second test solution according to the detection mode to be executed. Steps S630 and S640 may include: the controller

[0177] When the indication signal is lower than a preset threshold, the first detection mode is selected, the sample preparation device is controlled to prepare the second test solution using the sample to be tested and the antibody reagent as the detection reagent according to the first detection mode, and the second detection device is controlled to detect the second test solution using turbidimetry;

[0178] When the indication signal is not lower than the preset threshold, a second detection mode is selected, and according to the second detection mode, the sample preparation device is controlled to prepare the second test solution using the sample to be tested and the pigment reagent as the detection reagent, and the second detection device is controlled to detect the second test solution using a colorimetric method.

[0179] Here, the types of detection reagents used in the first detection mode and the second detection mode are different. Turbidimetry is used for detection in the first detection mode, while colorimetry is used for detection in the second detection mode.

[0180] In other embodiments, the multiple detection modes have different dilution multiples for diluting the sample to be tested when preparing the test solution, that is, the dilution multiples for diluting the sample to be tested when preparing the test solution in different detection modes are different.

[0181] In one example, the controller selects a detection mode to be executed from a plurality of detection modes according to the indication signal, and controls the sample preparation device to prepare a second test solution according to the detection mode to be executed and controls the second detection device to detect the second test solution in steps S630 and S640, which may include: the controller

[0182] When the indication signal is lower than a preset threshold, a first detection mode is selected, and according to the first detection mode, a sample preparation device is controlled to prepare the second test solution by using the sample to be tested and the antibody reagent as the detection reagent at a first dilution multiple, and a second detection device is controlled to detect the second test solution by turbidimetry;

[0183] When the indication signal is not lower than the preset threshold, a second detection mode is selected, and the second test solution is prepared by using the sample to be tested and the antibody reagent at a second dilution factor according to the second detection mode, and the second detection device is controlled to detect the second test solution by using the turbidimetry; wherein the first dilution factor is less than the second dilution factor.

[0184] Here, both the first detection mode and the second detection mode adopt turbidimetry for detection, but the first detection mode and the second detection mode have different dilution multiples for diluting the sample to be detected when preparing the test solution.

[0185] In some embodiments, in step S640, the sample preparation device preparing the second test solution according to the detection mode to be performed may include: when the dilution multiple corresponding to the detection mode to be performed is greater than a preset multiple, the sample preparation device dilutes the sample to be tested used to prepare the second test solution multiple times to prepare the second test solution that meets the dilution multiple corresponding to the detection mode to be performed. For example, the preset multiple may be the maximum multiple that can be achieved by a single dilution.

[0186] For other features and advantages of the protein analysis method 600 according to the first embodiment of the present application, reference may be made to the various embodiments and advantages of the sample analyzer 100 according to the present application described above.

[0187] Fig. 9 A protein analysis method 700 according to the second embodiment of the present application is shown, which is used in a sample analyzer, especially the sample analyzer 100 described above, wherein the sample analyzer includes a sample preparation device, a first detection device, a second detection device, and a controller. Fig. 9 As shown, method 700 includes steps S710 to S740.

[0188] In step S710, the controller controls the sample preparation device to prepare a first test solution using the sample to be tested and the indicator reagent. Here, the indicator reagent is used to indicate the concentration of the protein in the sample to be tested.

[0189] In step S720, the controller controls the first detection device to detect the first test solution to obtain an indication signal of the protein in the sample to be tested.

[0190] In step S730, when the indication signal is lower than a preset threshold value, the controller controls the sample preparation device to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested in accordance with the first detection mode, and controls the second detection device to detect the second test solution to obtain and output the concentration value of the protein in the sample to be tested.

[0191] In step S740, when the indication signal is not lower than the preset threshold value, the controller outputs an alarm prompt, and / or the controller controls the sample preparation device to prepare a third test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to a second detection mode different from the first detection mode, and controls the second detection device to detect the third test solution to obtain and output the concentration value of the protein in the sample to be tested.

[0192] Fig.10A protein analysis method 800 according to the third embodiment of the present application is shown, which is used in a sample analyzer, especially the sample analyzer 100 described above, wherein the sample analyzer includes a sample preparation device, a first detection device, a second detection device, and a controller. Fig.10 As shown, method 800 includes steps S810 to S850.

[0193] In step S810, the controller controls the sample preparation device to prepare a first test solution using the sample to be tested and an indicator reagent, wherein the indicator reagent is used to indicate the concentration of protein in the urine sample to be tested.

[0194] In step S820, the controller controls the first detection device to detect the first test solution to obtain an indication signal of the protein in the sample to be tested.

[0195] In step S830, the controller controls the sample preparation device to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to the first detection mode, and controls the second detection device to detect the second test solution to obtain a first concentration value of the protein in the sample to be tested;

[0196] In step S840, when the indication signal is lower than a preset threshold, the controller outputs a first concentration value;

[0197] In step S850, when the indication signal is not lower than the preset threshold value, the controller outputs an alarm prompt, and / or the controller controls the sample preparation device to prepare a third test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to a second detection mode different from the first detection mode, and controls the second detection device to detect the third test solution to obtain and output a second concentration value of the protein in the sample to be tested.

[0198] In some embodiments, in step S730 or S830, the controller controls the sample preparation device to prepare a second test solution according to a first detection mode and controls the second detection device to detect the second test solution, including: the controller controls the sample preparation device to prepare the second test solution using the sample to be tested and the antibody reagent as the detection reagent at a first dilution factor according to the first detection mode, and controls the second detection device to detect the second test solution using turbidimetry; and in step S740 or S850, the controller controls the sample preparation device to prepare a third test solution according to a second detection mode different from the first detection mode and controls the second detection device to detect the third test solution, including: the controller controls the sample preparation device to prepare the third test solution using the sample to be tested and the antibody reagent at a second dilution factor according to the second detection mode, and controls the second detection device to detect the third test solution using turbidimetry. Here, the first dilution factor is less than the second dilution factor.

[0199] In some embodiments, in step S730 or S830, the controller controls the sample preparation device to prepare a second test solution according to a first detection mode and controls the second detection device to detect the second test solution, including: the controller controls the sample preparation device to prepare the second test solution using the sample to be tested and the antibody reagent as the detection reagent according to the first detection mode, and controls the second detection device to detect the second test solution using turbidimetry; and, in step S740 or S850, the controller controls the sample preparation device to prepare a third test solution according to a second detection mode different from the first detection mode and controls the second detection device to detect the third test solution, including: the controller controls the sample preparation device to prepare the third test solution using the sample to be tested and the pigment reagent as the detection reagent according to the second detection mode, and controls the second detection device to detect the third test solution using colorimetry.

[0200] For other features and advantages of the protein analysis method 700 according to the second embodiment of the present application and the protein analysis method 800 according to the third embodiment of the present application, reference may be made to the various embodiments and advantages of the above-mentioned sample analyzer 100 or protein analysis method 600 .

[0201] It can be understood that, although this article mainly describes the relevant embodiments by taking the sample to be tested as urine and the protein as urine microalbumin as an example, the relevant embodiments described in this article are also applicable to other situations such as the sample to be tested is serum or cerebrospinal fluid, the protein is total protein, etc.

[0202] The features or feature combinations mentioned in the specification, drawings and claims above, as long as they are meaningful within the scope of the present application and do not contradict each other, can be used in any combination or alone. The advantages and features described for the sample analyzer provided in the present application are applicable to the protein analysis method provided in the present application in a corresponding manner, and vice versa.

[0203] The above description is only a preferred embodiment of the present application, and does not limit the patent scope of the present application. All equivalent transformations made by using the contents of the present application specification and drawings under the inventive concept of the present application, or direct / indirect application in other related technical fields are included in the patent protection scope of the present application.

Claims

1. A sample analyzer, comprising: A sample preparation device, used to prepare a first test solution using a sample to be tested and an indicator reagent, wherein the indicator reagent is used to indicate the concentration of a protein in the sample to be tested; A first detection device, used to detect the first test solution to obtain an indication signal of the protein in the sample to be tested; A second detection device, used to obtain the concentration value of the protein in the sample to be tested; The controller is used to select a detection mode to be executed from a plurality of detection modes according to the indication signal, and control the sample preparation device to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to the detection mode to be executed, and control the second detection device to detect the second test solution to obtain the concentration value of the protein in the sample to be tested.

2. The sample analyzer according to claim 1, characterized in that: The multiple detection modes differ in at least one of the following aspects: The dilution factor of the sample to be tested when preparing the test solution; and The type of detection reagent.

3. The sample analyzer according to claim 2, characterized in that: The controller is further configured to: When the indication signal is lower than a preset threshold, a first detection mode is selected, and according to the first detection mode, the sample preparation device is controlled to prepare the second test solution by using the sample to be tested and the antibody reagent as the detection reagent at a first dilution multiple, and the second detection device is controlled to detect the second test solution by turbidimetry; In the case where the indication signal is not lower than the preset threshold, selecting a second detection mode, controlling the sample preparation device to prepare the second test solution using the sample to be tested and the antibody reagent at a second dilution factor according to the second detection mode, and controlling the second detection device to detect the second test solution using the turbidimetry method; Wherein, the first dilution factor is smaller than the second dilution factor.

4. The sample analyzer according to claim 2, characterized in that: The controller is further configured to: When the indication signal is lower than a preset threshold, a first detection mode is selected, and the sample preparation device is controlled to prepare the second test solution using the sample to be tested and the antibody reagent as the detection reagent according to the first detection mode, and the second detection device is controlled to detect the second test solution using turbidimetry; When the indication signal is not lower than the preset threshold, the second detection mode is selected, and the sample preparation device is controlled according to the second detection mode to prepare the second test solution using the sample to be tested and the pigment reagent as the detection reagent, and the second detection device is controlled to detect the second test solution using a colorimetric method.

5. The sample analyzer according to any one of claims 1 to 4, characterized in that: The sample preparation device is further used for: Mixing at least a portion of the sample to be tested with the indicator reagent to prepare the first test solution; as well as At least a portion of the first test solution is mixed with the detection reagent to prepare the second test solution, or at least another portion of the sample to be tested is mixed with the detection reagent to prepare the second test solution.

6. The sample analyzer according to any one of claims 1 to 5, characterized in that: The controller is further configured to: When the dilution factor corresponding to the detection mode to be executed is greater than the preset factor, the sample preparation device is controlled to dilute the sample to be tested for preparing the second test solution multiple times to prepare the second test solution that meets the dilution factor corresponding to the detection mode to be executed.

7. The sample analyzer according to any one of claims 1 to 6, characterized in that: The indicator reagent includes a pigment.

8. The sample analyzer according to any one of claims 1 to 6, characterized in that: The indicator reagent includes a precipitation reagent, and the precipitation reagent can react with proteins in the sample to be tested to form a precipitate.

9. The sample analyzer according to claim 8, characterized in that: The precipitation reagent is selected from the group consisting of salicylic acid, oxalic acid, trichloroacetic acid and any combination thereof.

10. The sample analyzer according to any one of claims 1 to 9, characterized in that: The protein is one of albumin and total protein, preferably the protein is albumin; and / or the sample to be tested is one of urine, serum and cerebrospinal fluid, preferably the sample to be tested is urine; Preferably, the sample to be tested is urine, and the protein is albumin.

11. A sample analyzer, comprising: A sample preparation device, used to prepare a first test solution using a sample to be tested and an indicator reagent, wherein the indicator reagent is used to indicate the concentration of a protein in the sample to be tested; A first detection device, used to detect the first test solution to obtain an indication signal of the protein in the sample to be tested; A second detection device, used to obtain the concentration value of the protein in the sample to be tested; Controller for: When the indication signal is lower than a preset threshold, the sample preparation device is controlled to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of a protein in the sample to be tested according to a first detection mode, and the second detection device is controlled to detect the second test solution to obtain and output a concentration value of the protein in the sample to be tested, and When the indication signal is not lower than the threshold value, an alarm is outputted, and / or the sample preparation device is controlled to prepare a third test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to a second detection mode different from the first detection mode, and the second detection device detects the third test solution to obtain the concentration value of the protein in the sample to be tested.

12. A sample analyzer, comprising: A sample preparation device, used to prepare a first test solution using a sample to be tested and an indicator reagent, wherein the indicator reagent is used to indicate the concentration of a protein in the sample to be tested; A first detection device, used to detect the first test solution to obtain an indication signal of the protein in the sample to be tested; A second detection device, used to obtain the concentration value of the protein in the sample to be tested; Controller for: According to the first detection mode, the sample preparation device is controlled to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested, and the second detection device is controlled to detect the second test solution to obtain a first concentration value of the protein in the sample to be tested. When the indication signal is lower than a preset threshold, a first concentration value is output, and When the indication signal is not lower than the preset threshold, an alarm prompt is outputted, and / or, the sample preparation device is controlled to prepare a third test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to a second detection mode different from the first detection mode, and the second detection device is controlled to detect the third test solution to obtain and output a second concentration value of the protein in the sample to be tested.

13. The sample analyzer according to claim 11 or 12, characterized in that: The controller is further configured to: Control the sample preparation device to prepare the second test solution using the sample to be tested and the antibody reagent as the detection reagent at a first dilution factor according to the first detection mode, and control the second detection device to detect the second test solution using turbidimetry; as well as Controlling the sample preparation device to prepare the third test solution using the sample to be tested and the antibody reagent at a second dilution factor according to a second test mode different from the first test mode, and controlling the second test device to detect the third test solution using the turbidimetry method; Wherein, the first dilution factor is smaller than the second dilution factor.

14. The sample analyzer according to claim 11 or 12, characterized in that: The controller is further configured to: Control the sample preparation device to prepare the second test solution using the sample to be tested and the antibody reagent as the detection reagent according to the first detection mode, and control the second detection device to detect the second test solution using turbidimetry; as well as The sample preparation device is controlled to prepare the third test solution using the sample to be tested and the pigment reagent as the detection reagent according to a second detection mode different from the first detection mode, and the second detection device is controlled to detect the third test solution using colorimetry.

15. A protein analysis method, used in a sample analyzer, the sample analyzer comprising a sample preparation device, a first detection device, a second detection device and a controller, the protein analysis method comprising: The controller controls the sample preparation device to prepare a first test solution using the sample to be tested and an indicator reagent, wherein the indicator reagent is used to indicate the concentration of the protein in the sample to be tested; The controller controls the first detection device to detect the first test solution to obtain an indication signal of protein in the sample to be tested; The controller selects a detection mode to be executed from a plurality of detection modes according to the indication signal; The controller controls the sample preparation device to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to the detection mode to be executed, and controls the second detection device to detect the second test solution to obtain the concentration value of the protein in the sample to be tested.

16. The method according to claim 15, characterized in that The multiple detection modes differ in at least one of the following aspects: The dilution factor of the sample to be tested when preparing the test solution; and The type of detection reagent.

17. The method according to claim 16, characterized in that The controller selects a detection mode to be executed from a plurality of detection modes according to the indication signal, and controls the sample preparation device to prepare a second test solution and controls the second detection device to detect the second test solution according to the detection mode to be executed, including: the controller When the indication signal is lower than a preset threshold, a first detection mode is selected, and according to the first detection mode, the sample preparation device is controlled to prepare the second test solution by using the sample to be tested and the antibody reagent as the detection reagent at a first dilution multiple, and the second detection device is controlled to detect the second test solution by turbidimetry; In the case where the indication signal is not lower than the preset threshold, selecting a second detection mode, controlling the sample preparation device to prepare the second test solution using the sample to be tested and the antibody reagent at a second dilution factor according to the second detection mode, and controlling the second detection device to detect the second test solution using the turbidimetry method; Wherein, the first dilution factor is smaller than the second dilution factor.

18. The method according to claim 16, characterized in that The controller selects a detection mode to be executed from a plurality of detection modes according to the indication signal, and controls the sample preparation device to prepare a second test solution and controls the second detection device to detect the second test solution according to the detection mode to be executed, including: When the indication signal is lower than a preset threshold, a first detection mode is selected, and the sample preparation device is controlled to prepare the second test solution using the sample to be tested and the antibody reagent as the detection reagent according to the first detection mode, and the second detection device is controlled to detect the second test solution using turbidimetry; When the indication signal is not lower than the preset threshold, the second detection mode is selected, and the sample preparation device is controlled according to the second detection mode to prepare the second test solution using the sample to be tested and the pigment reagent as the detection reagent, and the second detection device is controlled to detect the second test solution using a colorimetric method.

19. The method according to any one of claims 15 to 18, characterized in that The sample preparation device uses the sample to be tested and the indicator reagent to prepare the first test solution, including: the sample preparation device mixes at least a portion of the sample to be tested with the indicator reagent to prepare the first test solution; and The sample preparation device uses the sample to be tested and the detection reagent to prepare the second test solution, including: the sample preparation device mixes at least a portion of the first test solution with the detection reagent to prepare the second test solution; or the sample preparation device mixes at least another portion of the sample to be tested with the detection reagent to prepare the second test solution.

20. The method according to any one of claims 15 to 19, characterized in that Preparing a second test solution according to the detection mode to be performed includes: When the dilution factor corresponding to the detection mode to be executed is greater than a preset factor, the sample to be tested used to prepare the second test solution is diluted multiple times to prepare the second test solution that meets the dilution factor corresponding to the detection mode to be executed.

21. The method according to any one of claims 15 to 20, characterized in that The protein is one of albumin and total protein, preferably the protein is albumin; and / or the sample to be tested is one of urine, serum and cerebrospinal fluid, preferably the sample to be tested is urine; Preferably, the sample to be tested is urine, and the protein is albumin.

22. A protein analysis method, used in a sample analyzer, the sample analyzer comprising a sample preparation device, a first detection device, a second detection device and a controller, the protein analysis method comprising: The controller controls the sample preparation device to prepare a first test solution using the sample to be tested and an indicator reagent, wherein the indicator reagent is used to indicate the concentration of the protein in the sample to be tested; The controller controls the first detection device to detect the first test solution to obtain an indication signal of protein in the sample to be tested; When the indication signal is lower than a preset threshold, the controller controls the sample preparation device to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of a protein in the sample to be tested according to a first detection mode, and controls the second detection device to detect the second test solution to obtain and output a concentration value of the protein in the sample to be tested; When the indication signal is not lower than the preset threshold value, the controller outputs an alarm prompt, and / or the controller controls the sample preparation device to prepare a third test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to a second detection mode different from the first detection mode, and controls the second detection device to detect the third test solution to obtain and output the concentration value of the protein in the sample to be tested.

23. A protein analysis method, used in a sample analyzer, the sample analyzer comprising a sample preparation device, a first detection device, a second detection device and a controller, the protein analysis method comprising: The controller controls the sample preparation device to prepare a first test solution using the sample to be tested and an indicator reagent, wherein the indicator reagent is used to indicate the concentration of protein in the urine sample to be tested; The controller controls the first detection device to detect the first test solution to obtain an indication signal of protein in the sample to be tested; The controller controls the sample preparation device to prepare a second test solution using the sample to be tested and a detection reagent for detecting the concentration of a protein in the sample to be tested according to a first detection mode, and controls the second detection device to detect the second test solution to obtain a first concentration value of the protein in the sample to be tested; When the indication signal is lower than a preset threshold, the controller outputs a first concentration value; When the indication signal is not lower than the preset threshold value, the controller outputs an alarm prompt, and / or the controller controls the sample preparation device to prepare a third test solution using the sample to be tested and a detection reagent for detecting the concentration of protein in the sample to be tested according to a second detection mode different from the first detection mode, and controls the second detection device to detect the third test solution to obtain and output a second concentration value of the protein in the sample to be tested.

24. The method according to claim 22 or 23, characterized in that The controller controls the sample preparation device to prepare a second test solution according to a first detection mode and controls the second detection device to detect the second test solution, including: the controller controls the sample preparation device to prepare the second test solution with a first dilution factor using the sample to be tested and the antibody reagent as the detection reagent according to the first detection mode, and controls the second detection device to detect the second test solution using turbidimetry; and The controller controls the sample preparation device to prepare a third test solution according to a second detection mode different from the first detection mode and controls the second detection device to detect the third test solution, including: the controller controls the sample preparation device to prepare the third test solution using the sample to be tested and the antibody reagent at a second dilution factor according to the second detection mode, and controls the second detection device to detect the third test solution using the turbidimetry method; Wherein, the first dilution factor is smaller than the second dilution factor.

25. The method according to claim 22 or 23, characterized in that The controller controls the sample preparation device to prepare a second test solution according to a first detection mode and controls the second detection device to detect the second test solution, including: the controller controls the sample preparation device to prepare the second test solution using the sample to be tested and the antibody reagent as the detection reagent according to the first detection mode, and controls the second detection device to detect the second test solution using turbidimetry; and The controller controls the sample preparation device to prepare a third test solution and controls the second detection device to detect the third test solution according to a second detection mode different from the first detection mode, including: the controller controls the sample preparation device to prepare the third test solution using the sample to be tested and a pigment reagent as the detection reagent according to the second detection mode, and controls the second detection device to detect the third test solution using a colorimetric method.

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