Method and apparatus for detecting prozone phenomena in a sample to be detected based on the curvature of the response curve

Abstract

The present invention relates to a method and apparatus for detecting the prozone phenomenon of a sample to be detected based on the curvature of the reaction curve. The method for detecting the prozone phenomenon of a sample to be detected based on the curvature of the reaction curve includes the steps of obtaining a sample to be detected, processing the original signal reaction data of the sample to be detected to obtain a reaction curve of absorbance over time, selecting a preset start time and a preset end time on the reaction curve of absorbance over time, calculating the curvature of the reaction curve of absorbance over time between the preset start time and the preset end time, and comparing the calculated curvature with a reference curvature, and determining that the sample to be detected has a prozone phenomenon if the calculated curvature is greater than the reference curvature. By comparing the curvature of the reaction curve with the reference curvature, it is possible to simply and effectively determine whether the sample has a prozone phenomenon, and by using it in combination with other prozone sample prediction methods, the reliability of the detection result is improved.

Description

[Technical Field]

[0001] The present invention relates to the field of detection technology, and in particular to a method and apparatus for detecting prozone phenomena in a sample to be detected based on the curvature of the response curve. [Background technology]

[0002] Immunoturbidimetry is a conventional detection method used in fully automated biochemistry analyzers and fully automated blood coagulation measuring devices. However, this method can cause an excess of the antigen or antibody to be detected during use. This phenomenon is called the prozone phenomenon, and such specimens are called samples with the prozone phenomenon. When detecting a sample with the prozone phenomenon, the instrument prompts the operator using several determination methods to dilute the sample with the prozone phenomenon before detecting it and obtaining the correct concentration value.

[0003] The prozone sample identification method used in current instruments is based on the change in the slope (i.e., first derivative) of the reaction curve. Two time intervals, an unstable interval and a linear interval, are selected on the time axis representing the abscissa. The ratio of the slope of the linear interval of the prozone sample to the slope of the unstable interval is greater than that of the normal sample. The system then identifies the sample with prozone phenomenon and prompts the operator to dilute the prozone sample, providing accurate sample concentration information. The method used in fully automated biochemistry analyzers differs in some details, but both are based on comparing the change in slope between the preceding and following segments of the reaction curve. However, the first derivative analysis process relies on the selection of a time interval, which is complex and prone to error because the interval selection depends on multiple factors, such as the specific characteristics of the reaction curve and the composition of the reagents. Furthermore, this method requires the determination of many parameters, resulting in complex computations.

[0004] The above explanation of the background art is only intended to facilitate a deeper understanding of the technical solutions of the present invention (such as the technical means used, the technical problems solved, and the technical effects produced), and should not be considered as an admission or in any way suggestion that this message constitutes prior art already known to those skilled in the art. Summary of the Invention [Problem to be solved by the invention]

[0005] The present invention aims to provide a method and apparatus for detecting prozone phenomenon in a sample to be detected based on the curvature of the reaction curve, which can obtain a time-dependent reaction curve of absorbance, and can simply and effectively determine whether the sample has prozone phenomenon by comparing the curvature of the reaction curve with a reference curvature. The reliability of the detection results can be improved by using the method and apparatus in combination with other prozone sample prediction methods. [Means for solving the problem]

[0006] According to an embodiment of the present invention, there is provided a method for detecting a prozone phenomenon in a sample to be detected based on the curvature of the response curve, the method including the steps of: acquiring a sample to be detected; processing original signal response data of the sample to be detected to obtain a time-dependent response curve of absorbance; selecting a preset start time point and a preset end time point on the time-dependent response curve of absorbance; calculating the curvature of the time-dependent response curve of absorbance between the preset start time point and the preset end time point; comparing the calculated curvature with a reference curvature; and determining that the sample to be detected has a prozone phenomenon if the calculated curvature is greater than the reference curvature.

[0007] Furthermore, the step of calculating the curvature of the reaction curve of absorbance over time between the preset start point and the preset end point includes the steps of fitting data within the section between the preset start point and the preset end point according to a preset function model to obtain an arc curve relating to absorbance versus time, and calculating the curvature of the fitted arc curve, and setting the curvature as the curvature of the reaction curve of absorbance over time between the preset start point and the preset end point.

[0008] Furthermore, the step of calculating the curvature of the fitted arc curve includes the steps of selecting a first preset point in time, a second preset point in time, and a third preset point in time on the fitted arc curve, and calculating a radius of the fitted arc curve based on coordinates of points on the fitted arc curve corresponding to the first preset point in time, the second preset point in time, and the third preset point in time, respectively, and setting the reciprocal of the radius as the curvature of the fitted arc curve.

[0009] Furthermore, the step of calculating the curvature of the fitted arc curve includes the steps of: dividing the fitted arc curve into at least two segments and selecting three preset points on each segment of the fitted arc curve; calculating a radius of each segment of the fitted arc curve based on coordinates of points on each segment of the fitted arc curve corresponding to the three preset points on the segment of the fitted arc curve and setting the reciprocal of the radius as the curvature of each segment of the fitted arc curve; and setting the average value of the curvatures of each segment of the fitted arc curve as the curvature of the fitted arc curve.

[0010] Furthermore, the reference curvature is determined by the following formula:

number

number

[0011] According to another embodiment of the present invention, there is provided an apparatus for detecting a prozone phenomenon in a sample to be detected based on the curvature of the response curve, the apparatus including: an acquisition module configured to acquire the sample to be detected; a processing module configured to process original signal response data of the sample to be detected and acquire a time-dependent response curve of absorbance; a calculation module configured to select a predetermined start time point and a predetermined end time point on the time-dependent response curve of absorbance and calculate a curvature of the time-dependent response curve of absorbance between the predetermined start time point and the predetermined end time point; and a comparison module configured to compare the calculated curvature with a reference curvature and determine that the sample to be detected has a prozone phenomenon if the calculated curvature is greater than the reference curvature.

[0012] Furthermore, when calculating the curvature of the response curve of absorbance over time between the preset start point and the preset end point, the calculation module is configured to fit data within the section between the preset start point and the preset end point according to a preset function model to obtain an arc curve relating to absorbance versus time, calculate the curvature of the fitted arc curve, and set the curvature as the curvature of the response curve of absorbance over time between the preset start point and the preset end point.

[0013] Furthermore, the calculation module is configured, when calculating the curvature of the fitted circular arc curve, to select a first preset time point, a second preset time point, and a third preset time point on the fitted circular arc curve, calculate a radius of the fitted circular arc curve based on coordinates of points on the fitted circular arc curve corresponding to the first preset time point, the second preset time point, and the third preset time point, respectively, and use the reciprocal of the radius as the curvature of the fitted circular arc curve.

[0014] Further, the calculation module is configured to, when calculating the curvature of the fitted circular arc curve, divide the fitted circular arc curve into at least two segments, select three preset points on each segment of the fitted circular arc curve, calculate a radius of each segment of the fitted circular arc curve based on coordinates of points on each segment of the fitted circular arc curve corresponding to the three preset points, and set the reciprocal of the radius as the curvature of each segment of the fitted circular arc curve, and set the average value of the curvatures of each segment of the fitted circular arc curve as the curvature of the fitted circular arc curve.

[0015] Furthermore, the reference curvature is determined by the following formula:

number

number

[0016] The present invention adopts the above technical solution, which can obtain the time-dependent response curve of the absorbance of the sample to be detected, and by comparing the curvature of the response curve with the reference curvature, it can simply and effectively determine whether the sample has prozone phenomenon, and when used in combination with other prozone sample prediction methods, it has the beneficial effect of improving the reliability of the detection results.

[0017] Exemplary embodiments of the present invention will be described in more detail below in conjunction with the drawings. For clarity, the same elements in different drawings are designated by the same reference numerals. For illustrative purposes, the drawings are merely schematic and are not necessarily drawn to scale. These drawings are as follows: [Brief explanation of the drawings]

[0018] [Figure 1] 1 is a flowchart illustrating a method for detecting prozone phenomena in a sample to be detected based on the curvature of a response curve according to an embodiment of the present invention. [Figure 2] 1 is a schematic diagram showing actual measurement data of a sample to be detected in a method for detecting a prozone phenomenon of a sample to be detected based on the curvature of a response curve according to an embodiment of the present invention; FIG. [Figure 3] 1 is a schematic diagram showing actual measurement data of a normal sample in a method for detecting the prozone phenomenon of a sample to be detected based on the curvature of a response curve according to an embodiment of the present invention; FIG. [Figure 4] 1 is a block diagram illustrating an apparatus for detecting prozone phenomena in a sample to be detected based on the curvature of a response curve according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0019] The following describes in detail the embodiments of the present invention, which are implemented on the premise of the technical solutions of the present invention, and provide detailed implementation methods and specific operation processes, but the protection scope of the present invention is not limited to the following embodiments.

[0020] 1 is a flowchart illustrating a method for detecting prozone phenomenon in a sample to be detected based on the curvature of a response curve according to an embodiment of the present invention. As shown in FIG. 1, the method for detecting prozone phenomenon in a sample to be detected based on the curvature of a response curve according to an embodiment of the present invention includes the steps of: acquiring a sample to be detected (S100); processing original signal response data of the sample to be detected to acquire a time-dependent absorbance response curve (S200); selecting a predetermined start point and a predetermined end point on the time-dependent absorbance response curve; calculating the curvature of the time-dependent absorbance response curve between the predetermined start point and the predetermined end point (S300); and comparing the calculated curvature with a reference curvature (S400). If the calculated curvature is greater than the reference curvature, the sample to be detected has a prozone phenomenon.

[0021] In step S100, a sample to be detected is acquired. According to an embodiment of the present invention, an antigen, which is a target component to be detected, may be present in the sample to be detected. For example, the principle of measuring the concentration of the target antigen in a sample using an immunological method may be such that, when the antigen binds to a specific antibody in the system, the turbidity of the system increases due to an increase in particles, resulting in an increase in absorbance. Therefore, the concentration of the antigen, which is a target component to be detected in the system, may be derived according to the Beer-Lambert law (which indicates a direct proportional relationship between absorbance and concentration).

[0022] However, there is a possibility that the antigen in the sample to be detected according to the embodiment of the present invention may be excessive. If the sample to be detected is a high-concentration antigen sample with prozone phenomenon, the actual antigen concentration in the sample may be high, but the antigen may be judged to be absent or at a low concentration, resulting in a false negative result in which the antigen is not present or the measured antigen concentration is low.

[0023] In step S200, the original signal response data of the sample to be detected is processed to obtain a response curve of absorbance over time.

[0024] Specifically, the original signal response data of the sample to be detected is time-lapse data of transmitted light intensity collected by the optical detection system during the reaction of the sample to be detected. In one exemplary embodiment, the optical detection system is composed of a light source, a lens, a filter, and an optical fiber, the light source system is located on one side of the analytical instrument, the light emitted from the light source is irradiated onto the analytical instrument, the sample to be detected that is undergoing a reaction is placed in the analytical instrument, the light that has passed through the analytical instrument is irradiated onto the receiver, and the signal collection circuit in the receiver converts the amount of light received into transmitted light intensity, thereby collecting time-lapse data of transmitted light intensity and forming the original signal response data.

[0025] Next, the original signal response data of the sample to be detected is converted into time-dependent absorbance data, thereby determining a time-dependent response curve of the sample to be detected.

[0026] When the prozone phenomenon occurs, the antigen is in excess, so the binding and dissociation processes between the antigen and the antibody are more frequent, which manifests itself as a particularity in the reaction curve. Specifically, it manifests as more fluctuations, resulting in a larger curvature of the entire reaction curve. It is this characteristic that is utilized in step S300 according to an embodiment of the present invention.

[0027] FIG. 2 is a schematic diagram showing actual measurement data of a sample to be detected in a method for detecting the prozone phenomenon of a sample to be detected based on the curvature of a response curve according to an embodiment of the present invention.

[0028] In step S300, a preset start time T and a preset end time T' are selected on the time-dependent absorbance curve. As shown in FIG. 2, for example, the selected preset start time T is 11 s and the selected end time T' is 27 s. Because physical vibrations during mixing of the sample to be detected and the test reagent cause rapid changes in absorbance data in the initial time interval (e.g., 0 s to 10 s), data after a certain period (e.g., 11 s and thereafter) is caused by the actual biochemical reaction. Therefore, in embodiments of the present invention, a time interval is selected, but two time intervals (i.e., an unstable interval and a linear interval) are not selected as in the prior art. Because embodiments of the present invention do not depend on multiple factors, such as the specific characteristics of the reaction curve and the components of the reagent, as in the prior art, the process is simpler and less prone to errors.

[0029] After selecting a preset start time point and a preset end time point on the time-dependent response curve of absorbance, the curvature of the time-dependent response curve of absorbance between the preset start time point and the preset end time point is calculated.

[0030] The process of calculating the curvature of the absorbance response curve over time between a preset start point and a preset end point in step S300 will now be described in detail.

[0031] In step S300, data within the interval between a preset start time T and a preset end time T' (i.e., data between a preset start point M corresponding to the preset start time T and a preset end point M' corresponding to the preset end time T') is fitted according to a preset function model to obtain an arc curve relating to absorbance versus time. The preset function model is a function model among pre-stored function models that can fit data of a time-dependent response curve of absorbance to an arc curve. The fitted arc curve is shown in FIG. 2.

[0032] According to one embodiment of the present invention, a first preset time T1, a second preset time T2, and a third preset time T3 are selected on the fitted arc curve. When the actual biochemical reaction period [T, T'] is selected as described above, the selected first preset time T1 may be close to T and within the period [T, T'], the second preset time T2 may be the middle value of the period [T, T'], and the third preset time T3 may be close to T' and within the period [T, T']. Specifically, the first preset time T1, the second preset time T2, and the third preset time T3 may be selected according to the following formula: T1=T+1, T2=int(T'-T) / 2+T, where int(T'-T) denotes an integer less than or equal to (T'-T), T3 = T' - 2.

[0033] 2, the selected preset start time T is 11 s, the selected preset end time T' is 27 s, and the selected first, second, and third preset time T1, T2, and T3 are T1 = 12, T2 = 19, and T3 = 25, respectively. The selection method for T1, T2, and T3 may be slightly adjusted, and as long as the response curves of different concentrations of the same reagent are kept consistent by the selection method for T1, T2, and T3, the regularity of the curvature distribution of the response curves of each concentration can also be kept consistent.

[0034] Next, the radius of the fitted arc curve is calculated based on the coordinates of a point M1 on the fitted arc curve corresponding to the first preset time T1, the coordinates of a point M2 on the fitted arc curve corresponding to the second preset time T2, and the coordinates of a point M3 on the fitted arc curve corresponding to the third preset time T3.

[0035] For example, as shown in Figure 2, the coordinates of M1, M2, and M3 corresponding to the selected first preset time T1, second preset time T2, and third preset time T3 are M1 (12.000, 1.2514), M2 (19.000, 1.4000), and M3 (25, 1.4199), respectively. Therefore, based on the coordinates of these three points, the radius of the fitted circular arc curve can be calculated as R ≈ 0.3577.

[0036] If the reciprocal of the calculated radius R is the curvature of the fitted circular arc curve, then the curvature of the fitted circular arc curve is K = 1 / R. The calculated curvature K of the fitted circular arc curve is the curvature between the preset start point M and the preset end point M'.

[0037] Using Figure 2 as an example, K = 1 / 0.3577 ≒ 2.7956.

[0038] According to another embodiment of the present invention, the fitted arc curve can be divided into at least two segments. For example, the fitted arc curve can be divided into three segments on average, i.e., the fitted arc curve can be divided into three segments on average by the period [T, T']. Three preset time points are selected on each segment of the fitted arc curve, specifically, the three preset time points on each segment can be selected according to the above formula. The radius of each segment of the fitted arc curve is calculated based on the coordinates of points corresponding to the three preset time points on each segment of the fitted arc curve, and the reciprocal of this radius is used as the curvature of each segment of the fitted arc curve. Finally, the average value of the curvatures of each segment of the fitted arc curve (i.e., the sum of the curvatures of each segment of the fitted arc curve divided by the number of segments into which the fitted arc curve is divided) is used as the curvature of the fitted arc curve.

[0039] Step S300 of calculating the curvature of the absorbance response curve over time between a preset start point and a preset end point may further include the steps of selecting several points on the absorbance response curve over time between the preset start point and the preset end point, calculating the curvature of each of the several points according to a curvature calculation formula, dividing the sum of the curvatures of each point in the section between the preset start point and the preset end point by the number of points to obtain an average curvature, and using this average curvature as the curvature of the absorbance response curve over time between the preset start point and the preset end point.

[0040] In step S300, the curvature K of the absorbance response curve over time between a preset start time T and a preset end time T' is calculated. Then, in step S400, the calculated curvature K is compared with a reference curvature K0. If the calculated curvature K is greater than the reference curvature K0, it is determined that the sample to be detected contains the prozone phenomenon.

[0041] The determination of the reference curvature K0 will be described in detail below.

[0042] According to an embodiment of the present invention, the reference curvature is determined by the following formula:

number

[0043] where K0 is the reference curvature,

number

[0044] 3 is a schematic diagram showing actual measurement data of a normal sample in a method for detecting prozone phenomenon in a sample to be detected based on the curvature of a reaction curve according to an embodiment of the present invention. As shown in FIG. 3, a preset start time of 11 s and a preset end time of 27 s are selected, and data within the interval between the preset start time and the preset end time are fitted according to a preset function model to obtain an arc curve relating absorbance to time. A first preset time of 12 s, a second preset time of 19 s, and a third preset time of 25 s are selected on the fitted arc curve. Based on the coordinates (12.000, 1.0761), (19.000, 1.0798), and (25.000, 1.0824) of the points on the fitted arc curve corresponding to the first preset time point, the second preset time point, and the third preset time point, respectively, the radius of the fitted arc curve is calculated to be 86.7060. If the reciprocal of the calculated radius is taken as the curvature of the fitted arc curve, the curvature of the fitted arc curve is 0.0115. That is, the curvature of the time-dependent response curve of the absorbance of the normal sample shown in FIG. 3 between the preset start time point and the preset end time point is 0.0115.

[0045] Table 1 shows the curvature of the response curves of seven normal samples between the preset start and end time points.

[0046] [Table 1] Accordingly,

number

number

[0047] Furthermore, C is a coefficient, and the value of the coefficient C may be in the range of 0.8 to 1.2.

[0048] therefore,

number

[0049] According to an exemplary embodiment of the present invention, the calculated curvature of the sample to be detected is K≈2.7956, and the value range of the reference curvature K0 is 0.1077~0.1615, where K>K0, so it can be determined that the sample to be detected has prozone phenomenon. Subsequent detection reveals that the sample to be detected has prozone phenomenon, with a theoretical concentration of 9000 mg / L and an actual measured concentration of 87.64 mg / L.

[0050] Conversely, if the calculated curvature K of the sample to be detected is within the range of values ​​of the reference curvature K0, it can be determined that the sample to be detected is free of the prozone phenomenon.

[0051] FIG. 4 is a block diagram of an apparatus for detecting prozone phenomenon in a sample to be detected based on the curvature of a response curve according to an embodiment of the present invention. As shown in FIG. 4, the apparatus for detecting prozone phenomenon in a sample to be detected based on the curvature of a response curve according to an embodiment of the present invention includes an acquisition module, a processing module, a calculation module, and a comparison module. The acquisition module can acquire the sample to be detected. The processing module can process the original signal response data of the sample to be detected to obtain a time-dependent absorbance response curve. The calculation module can select a predetermined start point and a predetermined end point on the time-dependent absorbance response curve and calculate the curvature of the time-dependent absorbance response curve between the predetermined start point and the predetermined end point. The comparison module compares the calculated curvature with a reference curvature. If the calculated curvature is greater than the reference curvature, it can be determined that the sample to be detected has a prozone phenomenon.

[0052] The processing module is configured to determine a reaction curve of the sample to be detected by converting the original signal response data of the sample to be detected, which is time-dependent data of transmitted light intensity collected by the optical detection system during the reaction of the sample to be detected, into time-dependent data of absorbance.

[0053] According to an embodiment of the present invention, the reference curvature is determined by the following formula:

number

number

[0054] Specifically, when calculating the curvature of the response curve of absorbance over time between a preset start point and a preset end point, the calculation module is configured to fit data within the section between the preset start point and the preset end point according to a preset function model to obtain an arc curve relating to absorbance versus time, calculate the curvature of the fitted arc curve, and set this curvature as the curvature of the response curve of absorbance over time between the preset start point and the preset end point.

[0055] When calculating the curvature of the fitted circular arc curve, a first preset time point, a second preset time point, and a third preset time point are selected on the fitted circular arc curve, and a radius of the fitted circular arc curve is calculated based on the coordinates of points on the fitted circular arc curve corresponding to the first preset time point, the second preset time point, and the third preset time point, respectively, and the reciprocal of this radius is taken as the curvature of the fitted circular arc curve.

[0056] Alternatively, the fitted arc curve may be divided into at least two segments, three predetermined points in time may be selected on each segment of the fitted arc curve, the radius of each segment of the fitted arc curve may be calculated based on the coordinates of points on each segment of the fitted arc curve corresponding to the three predetermined points in time, the reciprocal of the radius may be set as the curvature of each segment of the fitted arc curve, and the average of the curvatures of each segment of the fitted arc curve may be set as the curvature of the fitted arc curve.

[0057] The advantages of the method and apparatus for detecting the prozone phenomenon of a sample to be detected based on the curvature of a response curve according to an embodiment of the present invention are as follows.

[0058] According to an embodiment of the present invention, a time-dependent response curve of the absorbance of a sample to be detected can be obtained, and by comparing the curvature of the response curve with a reference curvature, it is possible to simply and effectively determine whether the sample has prozone phenomenon. When used in combination with other prozone sample prediction methods, the reliability of the detection results can be improved.

[0059] The various embodiments of the present invention are intended to describe representative aspects of the present invention, rather than an exhaustive list of all possible combinations, and the contents described in the various embodiments may be applied independently or in combination of two or more.

[0060] The descriptions set forth in the above exemplary embodiments are only intended to illustrate the technical solutions of the present invention and are not intended to be exhaustive or to limit the present invention to the precise form described. Obviously, those skilled in the art can make many modifications and variations in accordance with the above teachings. The exemplary embodiments are selected and described to illustrate the specific principles of the present invention and its practical applications, and to enable others skilled in the art to easily understand, implement, and utilize various exemplary embodiments of the present invention and various alternatives and modifications thereof. The protection scope of the present invention is intended to be limited by the appended claims and their equivalents.

Claims

1. 1. A method for detecting prozone phenomena in a sample to be detected based on the curvature of a response curve, comprising: Processing the collected original signal response data of the sample to be detected to obtain a time-dependent response curve of absorbance; selecting a start time point and an end time point on the absorbance response curve over time, and calculating the curvature of the absorbance response curve over time between the selected start time point and end time point; comparing the calculated curvature with a reference curvature, and determining that the sample to be detected has a prozone phenomenon if the calculated curvature is greater than the reference curvature; Furthermore, the step of selecting a start time point and an end time point on the response curve of absorbance over time and calculating the curvature of the response curve of absorbance over time between the selected start time point and end time point includes: fitting the data within the interval between the selected start and end time points according to a preset function model to obtain an arc-shaped curve relating absorbance to time; Calculating the curvature of the fitted arc-shaped curve and setting the curvature as the curvature of the absorbance response curve over time between the selected start and end time points; Furthermore, the step of calculating the curvature of the fitted circular arc curve includes: selecting a first time point, a second time point, and a third time point on the fitted arc-shaped curve; a step of calculating the radius of the fitted arc-shaped curve based on the coordinates of points on the fitted arc-shaped curve corresponding to the first, second, and third time points, and setting the reciprocal of the radius as the curvature of the fitted arc-shaped curve.

2. The step of calculating the curvature of the fitted circular arc curve includes: Dividing the fitted circular arc curve into at least two segments and selecting three time points on each segment of the fitted circular arc curve; calculating a radius of each segment of the fitted circular arc curve based on coordinates of points corresponding to the three time points on each segment of the fitted circular arc curve, and setting the reciprocal of the radius as the curvature of each segment of the fitted circular arc curve; 2. The method for detecting a prozone phenomenon in a sample to be detected based on the curvature of a response curve according to claim 1, further comprising the step of: determining the average value of the curvatures of each segment of the fitted arc-shaped curve as the curvature of the fitted arc-shaped curve.

3. The reference curvature is determined by the following formula: [Equation 1] where K0 is the reference curvature, [Equation 2] 2. The method for detecting prozone phenomenon in a sample to be detected based on the curvature of the reaction curve according to claim 1, characterized in that ∂C∂ is the average value of the curvature of the reaction curve of the absorbance of multiple normal samples over time between the start time point and the end time point, and C∂ is a coefficient.

4. 1. An apparatus for detecting prozone phenomena in a sample to be detected based on the curvature of a response curve, comprising: an acquisition module configured to acquire the collected detection-awaiting samples; a processing module configured to process the original signal response data of the sample to be detected and obtain a response curve of absorbance over time; a calculation module configured to select a start time point and an end time point on the absorbance response curve over time and calculate the curvature of the absorbance response curve over time between the selected start time point and end time point; a comparison module configured to compare the calculated curvature with a reference curvature and determine that the sample to be detected has a prozone phenomenon if the calculated curvature is greater than the reference curvature; Furthermore, the calculation module When calculating the curvature of the response curve of absorbance over time between the selected start time point and end time point, the method is configured to fit data within the interval between the selected start time point and end time point according to a preset function model to obtain an arc-shaped curve relating to absorbance versus time, calculate the curvature of the fitted arc-shaped curve, and set the curvature as the curvature of the response curve of absorbance over time between the start time point and end time point; An apparatus for detecting a prozone phenomenon in a sample to be detected based on the curvature of a reaction curve, characterized in that, when calculating the curvature of the fitted arc-shaped curve, a first time point, a second time point, and a third time point are selected on the fitted arc-shaped curve, a radius of the fitted arc-shaped curve is calculated based on the coordinates of points on the fitted arc-shaped curve corresponding to the first time point, the second time point, and the third time point, and the reciprocal of the radius is set as the curvature of the fitted arc-shaped curve.

5. The computing module:

5. The apparatus for detecting prozone phenomenon in a sample to be detected based on the curvature of a reaction curve as claimed in claim 4, wherein when calculating the curvature of the fitted arc-shaped curve, the apparatus is configured to divide the fitted arc-shaped curve into at least two segments, select three time points on each segment of the fitted arc-shaped curve, calculate the radius of each segment of the fitted arc-shaped curve based on the coordinates of points corresponding to the three time points on each segment of the fitted arc-shaped curve, determine the reciprocal of the radius as the curvature of each segment of the fitted arc-shaped curve, and determine the average value of the curvatures of each segment of the fitted arc-shaped curve as the curvature of the fitted arc-shaped curve.

6. The reference curvature is determined by the following formula: [Equation 3] where K0 is the reference curvature, [Equation 4] 5. The apparatus for detecting prozone phenomenon in a sample to be detected based on the curvature of the reaction curve as described in claim 4, characterized in that ∂C∂ is the average value of the curvature of the reaction curve of the absorbance of multiple normal samples over time between the selected start and end points, and C is a coefficient.

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