Hook effect identification method and related device

Abstract

Embodiments of the present invention disclose a hook effect identification method and related devices. In the embodiments of the present invention, by obtaining the degree of curve bending of the antigen-antibody reaction curve of a sample, or by obtaining the change time of the antigen-antibody reaction curve of the sample; the reaction curve is the original sampling curve or the fitted curve of the optical detection value of the sample changing with time, and the change time is the time length corresponding to the change from the first preset optical detection value to the second preset optical detection value in the reaction curve; when the degree of curve bending meets the preset conditions, or when the change time is less than the change time threshold, it is determined that the sample has a hook effect. The method of the embodiments of the present invention does not need to consider the selection of time periods like the rate judgment method, but uses the degree of curve bending or the change time to judge the hook effect. Therefore, the identification accuracy is high and the specificity is strong.

Description

Technical Field

[0001] The present invention relates to the field of detection technologies, and in particular, to a hook effect identification method and related devices. Background Art

[0002] The hook effect, namely the HOOK effect or the zone effect, refers to the phenomenon of false negatives in the antigen-antibody reaction due to inappropriate antigen-antibody ratios. Among them, antibody excess is called the prozone effect; antigen excess is called the postzone effect. The false negative caused by antigen excess will make the measured value of the antigen-antibody reaction significantly low, seriously affecting clinical judgment and posing a great clinical risk. Therefore, it is necessary to identify the hook effect.

[0003] In the prior art, the rate judgment method is used to identify whether the hook effect appears. After obtaining the curve of the optical detection value (light flux or absorbance) of the antigen-antibody reaction changing with the detection time, the ratio of the curve rates at two different time periods is used to determine whether the hook effect exists. This method has relatively strict requirements for the selection of time periods. If the selection is not good, it may not be able to accurately judge the existence of the hook effect. Therefore, it is necessary to improve the method for identifying the hook effect. Summary of the Invention

[0004] Embodiments of the present invention provide a hook effect identification method and related devices, which can improve the identification accuracy of the hook effect.

[0005] In a first aspect, embodiments of the present invention provide a hook effect identification method, including:

[0006] Obtaining the degree of curve bending of the antigen-antibody reaction curve of a sample, or obtaining the change time of the antigen-antibody reaction curve of the sample; the reaction curve is the original sampling curve or the fitting curve of the optical detection value of the sample changing with time, and the change time is the time length corresponding to the change from the first preset optical detection value to the second preset optical detection value in the reaction curve;

[0007] When the degree of curve bending meets the preset conditions, or when the change time is less than the change time threshold, it is determined that the sample has the hook effect.

[0008] Optionally, the obtaining the degree of curve bending of the antigen-antibody reaction curve of the sample includes:

[0009] Normalizing the optical detection value according to the initial optical detection value corresponding to the reaction start point of the reaction curve to obtain a normalized reaction curve;

[0010] Determining the connection line between the reaction start point and the reaction end point in the normalized reaction curve;

[0011] Determine the maximum vertical distance from the normalized reaction curve to the connecting line, and use the maximum vertical distance as the degree of curve bending.

[0012] Optionally, the determining the maximum vertical distance from the normalized reaction curve to the connecting line includes:

[0013] Determine the vertical distances from the points on the normalized reaction curve to the connecting line;

[0014] Use the maximum value of the vertical distances as the maximum vertical distance.

[0015] Optionally, the obtaining the degree of curve bending of the antigen-antibody reaction curve of the sample includes:

[0016] Normalize the optical detection values according to the initial optical detection value corresponding to the reaction starting point of the reaction curve to obtain a normalized reaction curve;

[0017] Determine the connecting line between the reaction starting point and the reaction ending point in the normalized reaction curve;

[0018] Determine the area of the region enclosed by the connecting line and the normalized reaction curve, and use the area as the degree of curve bending.

[0019] Optionally, when the degree of curve bending meets a preset condition, determining that the sample has a hook effect includes:

[0020] When the degree of curve bending is greater than the bending degree threshold, determine that the sample has a hook effect.

[0021] Optionally, the obtaining the degree of curve bending of the antigen-antibody reaction curve of the sample includes:

[0022] Normalize the optical detection values according to the initial optical detection value corresponding to the reaction starting point of the reaction curve to obtain a normalized reaction curve;

[0023] Determine the radius of curvature of the normalized reaction curve, and use the radius of curvature as the degree of curve bending.

[0024] Optionally, when the degree of curve bending meets a preset condition, determining that the sample has a hook effect includes:

[0025] When the degree of curve bending is less than the bending degree threshold, determine that the sample has a hook effect.

[0026] Optionally, the second preset optical detection value is at least 30% of the first preset optical detection value.

[0027] Optionally, the first preset optical detection value is the initial optical detection value corresponding to the reaction start point of the reaction curve.

[0028] Optionally, the optical detection value includes luminous flux or absorbance.

[0029] Optionally, before obtaining the degree of curve bending or the change time, the method further includes:

[0030] Obtaining relevant parameters of the fitting curve;

[0031] When it is determined that the relevant parameters are greater than the relevant parameter threshold, execute the step of obtaining the degree of curve bending or the change time.

[0032] In a second aspect, an embodiment of the present invention provides a sample analyzer, including a sample delivery module for delivering a sample, a dispensing module for aspirating and discharging the sample or reagent, a reagent storage module for storing the reagent, a sample detection module for detecting the sample to obtain an optical detection value of the sample, a memory, and a processor; the processor is connected to the memory, wherein the memory is used for storing program codes, and the processor is used for calling the program codes to execute the following steps:

[0033] Obtaining the degree of curve bending of the antigen-antibody reaction curve of the sample, or obtaining the change time of the antigen-antibody reaction curve of the sample; the reaction curve is the original sampling curve or the fitting curve of the optical detection value of the sample changing with time, and the change time is the time length corresponding to the change from the first preset optical detection value to the second preset optical detection value in the reaction curve;

[0034] When the degree of curve bending meets a preset condition, or when the change time is less than the change time threshold, it is determined that the sample has a hook effect.

[0035] In a third aspect, an embodiment of the present invention provides a computer storage medium, characterized in that the computer storage medium stores a computer program, the computer program includes program instructions, and when the program instructions are executed by a processor, the hook effect recognition method described in the first aspect is executed.

[0036] In an embodiment of the present invention, by obtaining the degree of curve bending of the antigen-antibody reaction curve of a sample, or by obtaining the change time of the antigen-antibody reaction curve of the sample; the reaction curve is the original sampling curve or the fitting curve of the optical detection value of the sample changing with time, and the change time is the time length corresponding to the change from the first preset optical detection value to the second preset optical detection value in the reaction curve; when the degree of curve bending meets the preset condition, or when the change time is less than the change time threshold, it is determined that the sample has a hook effect. The method of the embodiment of the present invention does not need to consider the selection of time periods like the rate judgment method, but uses the degree of curve bending or the change time to judge the hook effect, so the recognition accuracy is high and the specificity is strong. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the description of the embodiments will be briefly introduced below. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0038] Figure 1 is a schematic structural diagram of a sample analyzer provided by an embodiment of the present invention;

[0039] Figure 2 is a perspective view of a sample analyzer provided by an embodiment of the present invention as viewed from one direction;

[0040] Figure 3 is Figure 2 a perspective view of the sample analyzer shown as viewed from another direction;

[0041] Figure 4 is Figure 2 a top view of the sample analyzer shown;

[0042] Figure 5 is a schematic flowchart of a hook effect recognition method provided by an embodiment of the present invention;

[0043] Figure 6a 、 Figure 6b is a schematic diagram of a reaction curve of a hook effect recognition method provided by an embodiment of the present invention;

[0044] Figure 7 is a schematic diagram of a comparison of light flux curves provided by an embodiment of the present invention;

[0045] Figure 8 is a schematic diagram of a comparison of light flux curves of different concentrations provided by an embodiment of the present invention;

[0046] Figure 9It is a schematic diagram for comparing the light flux curves at different concentrations provided by an embodiment of the present invention. Detailed implementation manners

[0047] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention.

[0048] It should be understood that the terms "first", "second", etc. in the specification, claims and drawings of this application are used to distinguish different objects, rather than to describe a specific order. In addition, the terms "include" and "have" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, system, product or device that includes a series of steps or units is not limited to the listed steps or units, but optionally further includes steps or units not listed, or optionally further includes other steps or units inherent to these processes, methods, products or devices.

[0049] Referring to "embodiment" in the present invention means that the specific features, structures or characteristics described in conjunction with the embodiment can be included in at least one embodiment of the present invention. The appearance of this phrase at various positions in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment mutually exclusive with other embodiments. Those skilled in the art explicitly and implicitly understand that the embodiments described in the present invention can be combined with other embodiments.

[0050] Refer to Figure 1 , Figure 1 It is a schematic structural diagram of a sample analyzer provided by an embodiment of the present invention; the sample analyzer 100 includes a sample delivery module 105 for delivering blood samples, a dispensing module 102 for aspirating and discharging samples or reagents, a reagent storage module 107 for storing reagents, a sample detection module 106 for detecting blood samples to obtain optical detection values of the samples, a memory 104, and a processor 101; the above-mentioned various modules communicate with each other through a communication bus 103, wherein the memory 104 is used to store program codes, and the processor 101 is used to call the above program codes to execute the steps of the hook effect recognition method provided in any of the following embodiments.

[0051] In one embodiment, the sample analyzer further includes at least one of a sample incubation module for incubating samples, a transfer module for transferring reaction cups, and a display screen for inputting information and outputting information. For example, a doctor can set the working parameters of the analyzer through the display screen, and the display screen can output information such as characteristic parameters.

[0052] In one embodiment, refer to Figure 2 , Figure 3 and Figure 4 , Figure 2A perspective view of a sample blood analyzer provided by an embodiment of the present invention from one direction. Figure 3 is Figure 2 A perspective view of the sample analyzer shown from another direction. Figure 4 is Figure 2 A top view of the sample analyzer shown. The sample analyzer 1 includes a sample delivery module 11, a cuvette loading module 12, a dispensing module 13, a sample incubation module 14, a reagent storage module 15, a transfer module 16, and a sample detection module 17. The sample delivery module 11 is used to deliver blood samples to achieve the automated delivery of blood samples, improve the sample injection efficiency, and thus improve the working efficiency of the sample analyzer 1. The cuvette loading module 12 is used to deliver reaction cuvettes to achieve the automatic delivery of empty reaction cuvettes and improve the delivery efficiency. The dispensing module 13 is used to aspirate and discharge samples or reagents to add samples or reagents to the corresponding reaction cuvettes. The sample incubation module 14 is used to (heat) incubate samples to enable the samples to reach the optimal reaction conditions, facilitating the detection of sample parameters. The reagent storage module 15 is used to store reagents, which can store various reagents required for sample detection, facilitating the selection of required reagents and improving the efficiency of aspirating reagents. The transfer module 16 is used to transfer reaction cuvettes so that the reaction cuvettes can move to various positions of the sample analyzer 1 to achieve the automatic analysis and detection of samples and improve the operation efficiency. The sample detection module 17 is used to detect samples to obtain the corresponding parameters of the samples. In this embodiment, the sample detection module 17 is used to detect blood samples to obtain their optical detection values.

[0053] In one embodiment, referring to Figure 2 and Figure 4 , the reagent storage module 15 is arranged in a disk-shaped structure and is rotatable. The reagent storage module 15 can store a variety of reagents and can also achieve the refrigeration and automatic barcode recognition of a variety of reagents. It should be noted that the reagent storage module 15 has a refrigeration function for storing low-temperature reagents to achieve the preservation of reagents.

[0054] In one embodiment, referring to Figure 2 and Figure 3 , the dispensing module 13 includes a puncture needle mechanism 131, a comprehensive needle mechanism 132, and a reagent needle mechanism 133. That is to say, in this embodiment, the sample analyzer 1 is a three-needle mechanism, and the transfer of samples and reagents is jointly achieved through the puncture needle mechanism 131, the comprehensive needle mechanism 132, and the reagent needle mechanism 133, and then the detection of samples is realized. The puncture needle mechanism 131 is used to aspirate and discharge samples, the comprehensive needle mechanism 132 is used to aspirate and discharge samples or reagents, and the reagent needle mechanism 133 is used to aspirate and discharge reagents.

[0055] In one embodiment, referring to Figure 2 , Figure 3 and Figure 4, in order to improve the transfer efficiency of the reaction cups, the transfer module 16 of the sample analyzer 1 of the present invention includes a first transfer mechanism 161 and a second transfer mechanism 162. The empty reaction cups are transferred by the first transfer mechanism 161, and the reaction cups added with reagents and samples are transferred by the second transfer mechanism 162, so that the first transfer mechanism 161 and the second transfer mechanism 162 each have their corresponding functions, improving the working efficiency of the sample analyzer 1.

[0056] In one embodiment, referring to Figure 2 and Figure 4 , the sample detection module 17 can complete the data acquisition and result output of various parameter measurements. The sample detection module 17 of this embodiment can support the measurement of the coagulation method, immunoturbidimetry method, and substrate method for the samples. Specifically, the sample detection module 17 includes a magnetic bead method detection mechanism 171 and an optical method detection mechanism. The magnetic bead method detection mechanism 171 performs magnetic bead method detection on the samples, and the optical method detection mechanism performs optical method detection on the samples. The magnetic bead method detection mechanism 171 and the optical method detection mechanism are arranged side by side, which can facilitate the transfer of the reaction cups. It should be noted that the magnetic bead method detection mechanism 171 and the optical method detection mechanism can detect the samples by adding different reagents, with a wide range of applications. In this embodiment, the optical method detection mechanism includes a first optical method detection mechanism 172 and a second optical method detection mechanism 173, and the magnetic bead method detection mechanism 171, the second optical method detection mechanism 173, and the first optical method detection mechanism 172 are arranged in sequence.

[0057] In one embodiment, when the optical method detection mechanism performs optical method detection on a blood sample, its optical detection value can be obtained. The optical detection value can be the light flux or absorbance. For example, when detecting the coagulation item by the optical method, usually, the reaction cup solution is irradiated with collimated light and the scattered or transmitted light is analyzed to obtain the light flux or absorbance of the solution, so as to obtain the coagulation time or the concentration of the analyte.

[0058] In the prior art, the amount of antibody added during the antigen-antibody reaction process is fixed. When the antigen in the plasma sample is in excess, it is easy to cause the turbidity to decrease, the absorbance difference to decrease, and finally the measured value to be significantly low, that is, the false low value situation appears, indicating that the sample has a hook effect, seriously affecting the clinical judgment and posing a greater clinical risk. Currently, the accuracy of identifying the hook effect by the rate judgment method is low. Therefore, the embodiment of the present invention also provides a hook effect identification method to improve the identification accuracy of the hook effect.

[0059] Please refer to Figure 5 , Figure 5 which is a schematic flowchart of a hook effect identification method provided by the embodiment of the present invention. The hook effect identification method includes:

[0060] Step 501: Obtain the degree of curve bending of the antigen-antibody reaction curve of the sample, or obtain the change time of the antigen-antibody reaction curve of the sample; the reaction curve is the original sampling curve or the fitting curve of the optical detection value of the sample changing with time, and the change time is the time length corresponding to the change from the first preset optical detection value to the second preset optical detection value in the reaction curve;

[0061] Specifically, the antigen-antibody reaction curve of the blood sample is the original sampling curve or the fitting curve of the optical detection value of the sample changing with time, and the fitting curve is obtained by fitting the original optical detection value and time. Among them, the optical detection value includes the light flux or absorbance. Refer to Figure 6a and Figure 6b , Figure 6a 、 Figure 6b are schematic diagrams of the reaction curves of a hook effect recognition method provided by an embodiment of the present invention. Taking the detection of D-dimer in a blood sample as an example, where the abscissa is in seconds, representing the real reaction time, and the ordinate is the light flux or absorbance.

[0062] The specific values of the first preset optical detection value and the second preset optical detection value can be set according to actual needs. When identifying whether a blood sample has a hook effect, first obtain the degree of curve bending of the reaction curve, or first obtain the change time of the reaction curve. The change time refers to the length of time experienced from the first preset optical detection value to the second preset optical detection value in the reaction curve.

[0063] Step 502: When the degree of curve bending meets the preset condition, or when the change time is less than the change time threshold, determine that the sample has a hook effect.

[0064] Specifically, the preset condition is the range of the degree of curve bending that meets the hook effect characteristics. The specific range values can be determined based on multiple real experiments combined with clinical judgment. On this basis, the specific set range values can also be further selected according to actual needs. Similarly, the specific value of the change time threshold can be determined based on multiple real experiments combined with clinical judgment. On this basis, the specific set change time threshold value can also be further selected according to actual needs. When the degree of curve bending obtained in step 501 meets the preset condition set in advance, it can be determined that the blood sample has a hook effect. Or, when the change time obtained in step 501 is less than the change time threshold, it can be determined that the blood sample has a hook effect.

[0065] The method of the embodiment of the present invention does not need to consider the selection of time periods like the rate judgment method, but uses the degree of curve bending or the change time to judge the hook effect. Therefore, the recognition accuracy is high, the specificity is strong, and the recognition method is simple and efficient.

[0066] Specifically, the specific magnitudes of the preset conditions or the change time thresholds for identifying the hook effect are independent of the samples, and are only related to the reagents added in the antigen-antibody reaction. One reagent corresponds to one preset condition and one change time threshold. Among them, the reagent is an antigen reagent or an antibody reagent.

[0067] In a possible embodiment, taking the optical detection value as the light flux for example, refer to Figure 7 , Figure 7 which is a schematic diagram of the comparison of light flux curves provided by an embodiment of the present invention; Figure 7 is a comparison diagram of light flux curves at low and high concentration values. Among them, the reaction trend of the curve at low concentration (solid line) is relatively gentle and the curve is relatively straight, while the reaction trend of the curve at high concentration (dashed line) is relatively steep and the curve is relatively curved. It can be seen that the higher the concentration of the analyte in the sample, the steeper the reaction curve trend and the more curved the curve. Based on this characteristic, by setting the degree of curve bending for judging the existence of the hook effect as the threshold, when the reaction curve bends to a certain extent, it is considered that the sample has the hook effect.

[0068] In step 501, obtaining the degree of curve bending of the antigen-antibody reaction curve of the sample includes:

[0069] Step 11, normalizing the optical detection value according to the initial optical detection value corresponding to the reaction start point of the reaction curve to obtain a normalized reaction curve;

[0070] Specifically, taking the optical detection value as the light flux for example, using the initial light flux as the unit "1", dividing all light flux values by the initial light flux, thereby obtaining the normalized light flux of all reaction points. Refer to Figure 8 , Figure 8 which is a schematic diagram of the comparison of light flux curves of different concentrations provided by an embodiment of the present invention; normalizing the light flux curves of different samples to obtain Figure 8 the normalized light flux curve shown in.

[0071] Step 12, determining the connection line between the reaction start point and the reaction end point in the normalized reaction curve;

[0072] Specifically, refer to Figure 7 , connecting the reaction start point and the reaction end point in the normalized reaction curve to obtain the connection line.

[0073] Step 13, determining the maximum vertical distance from the normalized reaction curve to the connection line, and taking the maximum vertical distance as the degree of curve bending.

[0074] Specifically, refer to Figure 7 and Figure 8, determine the maximum vertical distance from the normalized reaction curve to the connecting line, and use this maximum vertical distance as the curve bending degree σ of the sample for reference Figure 8 , the higher the bending degree (the higher the concentration of the analyte), the larger its σ value.

[0075] Furthermore, in step 13, determining the maximum vertical distance from the normalized reaction curve to the connecting line includes:

[0076] Step 131, determine the vertical distance from each point on the normalized reaction curve to the connecting line;

[0077] Specifically, calculate the vertical distance from each point on the normalized reaction curve to the connecting line.

[0078] Step 132, use the maximum value of the vertical distances as the maximum vertical distance.

[0079] Specifically, use the maximum value among the multiple vertical distances obtained in step 131 as the maximum vertical distance, that is, the curve bending degree.

[0080] In another possible embodiment, in step 501, obtaining the curve bending degree of the antigen-antibody reaction curve of the sample includes:

[0081] Step 21, normalize the optical detection values according to the initial optical detection value corresponding to the reaction start point of the reaction curve to obtain a normalized reaction curve;

[0082] Specifically, refer to step 11, which will not be elaborated here.

[0083] Step 22, determine the connecting line between the reaction start point and the reaction end point in the normalized reaction curve;

[0084] Specifically, refer to step 12, which will not be elaborated here.

[0085] Step 23, determine the area of the region enclosed by the connecting line and the normalized reaction curve, and use the area as the curve bending degree.

[0086] Specifically, refer to Figure 7 , calculate the area of the region enclosed by the connecting line and the normalized reaction curve, and use this area as the curve bending degree of the sample. The larger the area, the greater the curve bending degree.

[0087] Furthermore, in step 502, when the curve bending degree meets the preset conditions, determining that the sample has a hook effect includes:

[0088] When the curve bending degree is greater than the bending degree threshold, determine that the sample has a hook effect.

[0089] Specifically, the specific value of the bending degree threshold can be set according to actual needs. When the curve bending degree is the maximum vertical distance, or the area of the region enclosed by the connection line and the normalized reaction curve, when the curve bending degree is greater than the bending degree threshold, it can be determined that the sample has a hook effect.

[0090] In another possible embodiment, in step 501, obtaining the curve bending degree of the antigen-antibody reaction curve of the sample includes:

[0091] Step 31, normalizing the optical detection value according to the initial optical detection value corresponding to the reaction start point of the reaction curve to obtain a normalized reaction curve;

[0092] Specifically, referring to step 11, it will not be elaborated here.

[0093] Step 32, determining the radius of curvature of the normalized reaction curve and taking the radius of curvature as the curve bending degree.

[0094] Specifically, calculate the radius of curvature of the normalized reaction curve and take the radius of curvature as the curve bending degree of the sample. The smaller the radius of curvature, the greater the curve bending degree of the sample.

[0095] Further, in step 502, when the curve bending degree meets the preset condition, determining that the sample has a hook effect includes:

[0096] When the curve bending degree is less than the bending degree threshold, it is determined that the sample has a hook effect.

[0097] Specifically, the specific value of the bending degree threshold can be set according to actual needs. When the curve bending degree is the radius of curvature of the normalized reaction curve, when the curve bending degree is less than the bending degree threshold, it can be determined that the sample has a hook effect.

[0098] In a possible embodiment, in step 501, the second preset optical detection value is at least 30% of the first preset optical detection value, which can avoid too short a change time obtained, resulting in inability to make a comparison and judgment. For example, the second preset optical detection value can be 40%, 50%, 60%, etc. of the first preset optical detection value. Further, the first preset optical detection value is the initial optical detection value corresponding to the reaction start point of the reaction curve to prevent the reaction speed from being too fast to determine whether there is a hook effect.

[0099] Taking the first preset optical detection value as the initial optical detection value corresponding to the reaction start point of the reaction curve and the second preset optical detection value as 50% of the first preset optical detection value as an example, the change time at this time is the half-life time ω. Refer to Figure 9 , Figure 9It is a schematic diagram for comparing the light flux curves of different concentrations provided by an embodiment of the present invention; it can be seen that the higher the concentration of the analyte in the sample, the shorter the half-life time ω.

[0100] In a possible embodiment, before obtaining the degree of curve bending or the change time, it is possible to first determine the effectiveness of the antigen-antibody reaction curve of the sample, determine whether the fitting curve is well-fitted, or determine whether there are outliers in the original curve. When the fitting is good or there are no outliers in the curve, the reaction curve can be used for hook effect identification. Specifically, the hook effect identification method further includes:

[0101] Obtain the relevant parameters of the fitting curve;

[0102] Specifically, obtain the fitting curve of the original optical detection value of the sample changing with time, and calculate the relevant parameters of the fitting curve. These relevant parameters are used to evaluate the effectiveness of the antigen-antibody reaction curve of the sample. Further, the relevant parameter can be r 2 or r.

[0103] When it is determined that the relevant parameter is greater than the relevant parameter threshold, perform the step of obtaining the degree of curve bending or the change time.

[0104] Specifically, the relevant parameter threshold can be set as needed. When the relevant parameter is greater than the relevant parameter threshold, it indicates that the antigen-antibody reaction curve of the sample is well-fitted or there are no large fluctuations, and the step of obtaining the degree of curve bending or the change time can be performed, that is, the reaction curve can be used for hook effect identification. For example, r 2 or r < 0.98, it can be considered that the reaction curve is poorly fitted or there are bubbles, jumps, steps, etc. At this time, it is not suitable to use this reaction curve to identify whether there is a hook effect, to prevent the large fluctuations of the curve caused by bubbles, vibrations, etc. in the reaction from affecting the detection of the hook effect, and effectively guarantee the identification accuracy of the hook effect.

[0105] In addition, it should be pointed out here that: an embodiment of the present invention also provides a computer storage medium, and the computer storage medium stores a computer program, and the computer program includes program instructions. When the processor executes the program instructions, it can execute the description of the hook effect identification method described above. Therefore, it will not be elaborated here. In addition, the description of the beneficial effects of using the same method will not be elaborated either. For the technical details not disclosed in the embodiment of the computer storage medium involved in the present invention, please refer to the description of the method embodiment of the present invention.

[0106] Those of ordinary skill in the art can understand that all or part of the processes in the methods of the above embodiments can be completed by instructing relevant hardware through a computer program. The program can be stored in a computer-readable storage medium. When the program is executed, it can include the processes of the embodiments of the above various methods. Among them, the storage medium can be a magnetic disk, an optical disk, a read-only memory (ROM), or a random access memory (RAM), etc.

[0107] The above-disclosed are only the preferred embodiments of the present invention. Of course, the scope of the rights of the present invention cannot be limited thereby. Therefore, equivalent changes made according to the claims of the present invention still fall within the scope covered by the present invention.

Claims

1. A hook effect recognition method, characterized in that, Including: Obtaining the degree of curve bending of the antigen-antibody reaction curve of the sample, or obtaining the change time of the antigen-antibody reaction curve of the sample; The reaction curve is the original sampling curve or the fitting curve of the optical detection value of the sample changing with time, and the change time is the time length corresponding to the change from the first preset optical detection value to the second preset optical detection value in the reaction curve; When the degree of curve bending meets the preset condition, or when the change time is less than the change time threshold, it is determined that the sample has a hook effect; Wherein, obtaining the degree of curve bending of the antigen-antibody reaction curve of the sample includes: Normalizing the optical detection value according to the initial optical detection value corresponding to the reaction starting point of the reaction curve to obtain a normalized reaction curve; determining the connection line between the reaction starting point and the reaction ending point in the normalized reaction curve; determining the maximum vertical distance from the normalized reaction curve to the connection line, and taking the maximum vertical distance as the degree of curve bending; Or, normalizing the optical detection value according to the initial optical detection value corresponding to the reaction starting point of the reaction curve to obtain a normalized reaction curve; determining the connection line between the reaction starting point and the reaction ending point in the normalized reaction curve; determining the area of the region enclosed by the connection line and the normalized reaction curve, and taking the area as the degree of curve bending; Or, normalizing the optical detection value according to the initial optical detection value corresponding to the reaction starting point of the reaction curve to obtain a normalized reaction curve; determining the radius of curvature of the normalized reaction curve, and taking the radius of curvature as the degree of curve bending.

2. The method according to claim 1, characterized in that The determining the maximum vertical distance from the normalized reaction curve to the connection line includes: Determining the vertical distance from each point on the normalized reaction curve to the connection line; Taking the maximum value of the vertical distance as the maximum vertical distance.

3. The method according to claim 1, wherein When taking the maximum vertical distance as the degree of curve bending or taking the area as the degree of curve bending, when the degree of curve bending meets the preset condition, determining that the sample has a hook effect includes: When the degree of curve bending is greater than the bending degree threshold, it is determined that the sample has a hook effect.

4. The method according to claim 1, wherein When taking the radius of curvature as the degree of curve bending, when the degree of curve bending meets the preset condition, determining that the sample has a hook effect includes: When the degree of curve bending is less than the bending degree threshold, it is determined that the sample has a hook effect.

5. The method according to claim 1, characterized in that, The second preset optical detection value is at least 30% of the first preset optical detection value.

6. The method according to claim 1, wherein The first preset optical detection value is the initial optical detection value corresponding to the reaction starting point of the reaction curve.

7. The method according to any one of claims 1-4, characterized in that, The optical detection value includes luminous flux or absorbance.

8. The method according to any one of claims 1-4, characterized in that Before obtaining the degree of curve bending or the change time, the method further includes: Obtaining the relevant parameters of the fitting curve; When it is determined that the relevant parameters are greater than the relevant parameter threshold, performing the step of obtaining the degree of curve bending or the change time.

9. A sample analyzer, characterized in that, It includes a sample conveyance module for conveying a sample, a dispensing module for aspirating and discharging the sample or a reagent, a reagent storage module for storing the reagent, a sample detection module for detecting the sample to obtain an optical detection value of the sample, a memory, and a processor; the processor is connected to the memory, wherein the memory is used for storing program codes, and the processor is used for calling the program codes to execute the following steps: Obtaining the degree of curve bending of the antigen-antibody reaction curve of the sample, or obtaining the change time of the antigen-antibody reaction curve of the sample; the reaction curve is an original sampling curve or a fitting curve of the optical detection value of the sample changing with time, and the change time is the time length corresponding to the change from a first preset optical detection value to a second preset optical detection value in the reaction curve; When the degree of curve bending meets a preset condition, or when the change time is less than a change time threshold, determining that the sample has a hook effect; Wherein, the obtaining the degree of curve bending of the antigen-antibody reaction curve of the sample includes: Normalizing the optical detection value according to the initial optical detection value corresponding to the reaction starting point of the reaction curve to obtain a normalized reaction curve; determining the connection line between the reaction starting point and the reaction ending point in the normalized reaction curve; determining the maximum vertical distance from the normalized reaction curve to the connection line, and taking the maximum vertical distance as the degree of curve bending; Or, normalizing the optical detection value according to the initial optical detection value corresponding to the reaction starting point of the reaction curve to obtain a normalized reaction curve; determining the connection line between the reaction starting point and the reaction ending point in the normalized reaction curve; determining the area of the region enclosed by the connection line and the normalized reaction curve, and taking the area as the degree of curve bending; Or, normalizing the optical detection value according to the initial optical detection value corresponding to the reaction starting point of the reaction curve to obtain a normalized reaction curve; determining the radius of curvature of the normalized reaction curve, and taking the radius of curvature as the degree of curve bending.

10. A computer storage medium, characterized in that, The computer storage medium stores a computer program, the computer program includes program instructions, and when the program instructions are executed by the processor, the hook effect recognition method according to any one of claims 1-8 is executed.

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