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

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 the prozone phenomenon 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 biochemical analyzers and fully automated blood coagulation measuring devices, but this method may cause a phenomenon in which the antigen or antibody to be detected becomes excessive during use, and the resulting situation is called the prozone phenomenon, and such a specimen is called a sample with the prozone phenomenon. When detecting a sample with the prozone phenomenon, the instrument will prompt the operator to use several judgment methods to dilute the sample with the prozone phenomenon before detecting it to obtain the correct concentration value.

[0003] The prozone sample determination method used in the current equipment is based on the change in the slope of the reaction curve (i.e., the first derivative), and selects two time intervals, an unstable interval and a linear interval, on the time axis representing the abscissa, and identifies samples with prozone phenomenon according to the ratio of the slope of the linear interval of the prozone sample to the slope of the unstable interval being greater than the slope ratio of the normal sample, and can further give the system prompts the operator to dilute the sample with prozone phenomenon and give the correct sample concentration information. The method used in the fully automatic biochemical analyzer differs from the above method in details, but both are methods based on comparing the change in the slope of the front and rear segments of the reaction curve. However, the above process based on the first derivative analysis depends on the selection of the time interval, but is complicated and prone to errors because the selection of the interval is related to multiple factors such as the specific nature of the reaction curve, the components of the reagent, etc. And this method requires the determination of many parameters, but the calculation is complicated.

[0004] The above description of the background art is only intended to facilitate a deeper understanding of the technical solutions of the present invention (including the technical means used, the technical problems solved, and the technical effects produced), and should not be deemed to be 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 the 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 the prozone phenomenon by comparing the curvature of the reaction curve with a reference curvature, and can improve the reliability of the detection result by using it 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 the prozone phenomenon in a sample to be detected based on the curvature of the response curve, the method including the steps of obtaining 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 a 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 functional 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 corresponding to the three preset points on each 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 an 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 a curvature of the response curve, the apparatus including: an acquisition module configured to acquire a sample to be detected; a processing module configured to process original signal response data of the sample to be detected and acquire an absorbance time-dependent response curve; a calculation module configured to select a preset start time point and a preset end time point on the absorbance time-dependent response curve and calculate a curvature of the absorbance time-dependent response curve between the preset start time point and the preset end time point; and a comparison module configured to compare the calculated curvature with a reference curvature and determine that the prozone phenomenon exists in the sample to be detected if the calculated curvature is greater than the reference curvature.

[0012] Furthermore, the calculation module is configured, when calculating the curvature of the response curve of absorbance over time between the preset start point and the preset end point, to fit data within the section between the preset start point and the preset end point according to a preset functional 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] Further, 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 set 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 arc curve, divide the fitted arc curve into at least two segments, select three preset time points on each segment of the fitted arc curve, calculate a radius of each segment of the fitted arc curve based on coordinates of points corresponding to the three preset time points on each segment of the fitted arc curve, take the reciprocal of the radius as the curvature of each segment of the fitted arc curve, and take an average value of the curvatures of each segment of the fitted arc curve as the curvature of the fitted 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 reaction curve of the absorbance of the sample to be detected, and can simply and effectively determine whether the sample has the prozone phenomenon by comparing the curvature of the reaction curve with the reference curvature, and has the beneficial effect of improving the reliability of the detection result by combining with other prozone sample prediction methods.

[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. As an illustrative example, the drawings are only schematic and are not necessarily drawn to scale. These drawings are as follows: [Brief description of the drawings]

[0018] [Figure 1] 1 is a flow chart illustrating a method for detecting a prozone phenomenon in a sample to be detected based on the curvature of a response curve according to an embodiment of the present invention. [Diagram 2] 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; [Diagram 3] FIG. 2 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; [Figure 4] FIG. 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 PREFERRED EMBODIMENTS

[0019] The following describes in detail an embodiment of the present invention. The embodiment is implemented on the premise of the technical solution of the present invention, and a detailed implementation manner and specific operation process are given, but the protection scope of the present invention is not limited to the following embodiment.

[0020] 1 is a flow chart showing a method for detecting the prozone phenomenon of 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. 1, the method for detecting the prozone phenomenon of a sample to be detected based on the curvature of a reaction curve according to an embodiment of the present invention includes the steps of: acquiring a sample to be detected in step S100; processing the original signal reaction data of the sample to be detected to acquire a reaction curve of absorbance over time in step S200; selecting a preset start time and a preset end time on the reaction curve of absorbance over time in step S300; calculating the curvature of the reaction curve of absorbance over time between the preset start time and the preset end time in step S400; 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 in step S400.

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

[0022] However, there may be an excess of antigen in the sample to be detected according to the embodiment of the present invention. If the sample to be detected is a high-concentration antigen sample with prozone phenomenon, the actual concentration of antigen in the sample is high, but the antigen is apparently absent or low, resulting in a false negative result of no antigen or low measured concentration of antigen.

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

[0024] Specifically, the original signal response data of the sample to be detected is the time-dependent data of the 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 analysis instrument, the light emitted from the light source is irradiated onto the analysis instrument, the sample to be detected that is undergoing a reaction is placed in the analysis instrument, the light transmitted through the analysis instrument is irradiated onto the receiver, and the amount of light received by the signal collection circuit in the receiver is converted into the transmitted light intensity, thereby collecting the time-dependent data of the 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 absorbance data over time to determine a response curve of the sample to be detected over time.

[0026] When there is a prozone phenomenon, there is an excess of antigen, so there are more binding and dissociation processes between antigen and antibody, which will manifest its peculiarities on the reaction curve, specifically, it will manifest as more fluctuations, resulting in a larger curvature of the whole reaction curve. It is this characteristic that is utilized in step S300 according to the 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 reaction curve of absorbance. As shown in FIG. 2, for example, the preset start time T selected is 11s, and the preset end time T' selected is 27s. Because the absorbance data in the initial time interval (e.g., 0s to 10s) changes rapidly due to physical vibrations when the sample to be detected and the test reagent are mixed, the data after a certain period (e.g., 11s and thereafter) is caused by the actual biochemical reaction. Therefore, in the embodiment 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. The embodiment of the present invention is simpler and less prone to errors because it does not involve multiple factors such as the specific properties of the reaction curve and the components of the reagent as in the prior art.

[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 that can fit data of a time-dependent response curve of absorbance to an arc curve among prestored function models. 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 above, the selected first preset time T1 may be close to T and in 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 in 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] Therefore, as an example, as shown in Figure 2, the selected preset start time T is 11s, the selected preset end time T' is 27s, and the selected first preset time T1, second preset time T2 and third preset time T3 are T1 = 12, T2 = 19 and T3 = 25, respectively. The selection method of T1, T2 and T3 may be adjusted slightly, and as long as the reaction curves of different concentrations of the same reagent are kept consistent by the selection method of T1, T2 and T3, the regularity of the curvature distribution of the reaction 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 Fig. 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), 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 inverse of the calculated radius R is the curvature of the fitted circular arc curve, 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 a preset start point M and a 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, that is, 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, three preset time points can be selected on each segment by the above formula. Based on the coordinates of the points corresponding to the three preset time points on each segment of the fitted arc curve, the radius of each segment of the fitted arc curve is calculated, and the reciprocal of this radius is taken as the curvature of each segment of the fitted arc curve. Finally, the average value of the curvature 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 of the fitted arc curve) is taken as the curvature of the fitted arc curve.

[0039] Step S300 of calculating the curvature of the absorbance over time response curve between the preset start point and the preset end point may further include the steps of selecting several points on the absorbance over time response curve 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 setting this average curvature as the curvature of the absorbance over time response curve between the preset start point and the preset end point.

[0040] In step S300, the curvature K of the time-dependent reaction curve of absorbance between a preset start time T and a preset end time T' is calculated, and 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 has a 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 the prozone phenomenon of 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 11s and a preset end time 27s are selected, and the data in the section between the preset start time and the preset end time are fitted according to a preset function model to obtain an arc curve of absorbance versus time. A first preset time 12s, a second preset time 19s, and a third preset time 25s 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. 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 reaction 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, and K>K0, so it can be determined that the sample to be detected has the prozone phenomenon. Subsequent detection shows that the sample to be detected has the prozone phenomenon, the theoretical concentration is 9000 mg / L, and the actual concentration is 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 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. As shown in FIG. 4, the 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 includes an acquisition module, a processing module, a calculation module, and a comparison module. The acquisition module can acquire a 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 response curve of absorbance. The calculation module can select a preset start time point and a preset end time point on the time-dependent response curve of absorbance, and calculate the curvature of the time-dependent response curve of absorbance between the preset start time point and the preset end time point. The comparison module can compare the calculated curvature with a reference curvature, and determine that there is a prozone phenomenon in the sample to be detected if the calculated curvature is greater than the reference curvature.

[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 reaction 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 functional 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 reaction 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 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 preset points in time may be selected on each segment of the fitted arc curve, a 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 preset points in time, the reciprocal of the radius may be set as the curvature of each segment of the fitted arc curve, and an average value of the curvatures of each segment of the fitted arc curve may be set as the curvature of the fitted arc curve.

[0057] Advantages of the method and apparatus for detecting the prozone phenomenon in 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 reaction curve of the absorbance of a sample to be detected can be obtained, and by comparing the curvature of the reaction curve with a reference curvature, it is possible to simply and effectively determine whether the sample has the prozone phenomenon, and by using it 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 description given in the above exemplary embodiments is only for illustrating the technical solutions of the present invention, and is not intended to be exhaustive, nor is it intended to limit the present invention to the precise form described. Obviously, those skilled in the art can make many modifications and variations according to the above teachings. The exemplary embodiments are selected and described to illustrate the specific principles of the present invention and its practical application, and to enable other 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 a prozone phenomenon in a sample to be detected based on the curvature of a response curve, comprising: obtaining a detection pending sample; Processing the original signal response data of the sample to be detected to obtain a response curve of absorbance over time; A step of selecting a preset start time point and a preset end time point on the time-dependent response curve of absorbance, and calculating a 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.

2. The step of calculating the curvature of the reaction curve over time of absorbance between a preset start time point and a preset end time point includes: fitting the data within the interval between the preset start time point and the preset end time point according to a preset function model to obtain an arc curve relating to absorbance versus time; 2. A method for detecting the prozone phenomenon in a sample to be detected based on the curvature of a reaction curve as described in claim 1, characterized in that it includes a step of calculating the curvature of the fitted circular arc curve and setting the curvature as the curvature of a time-dependent reaction curve of absorbance between a preset start time point and a preset end time point.

3. The step of calculating the curvature of the fitted circular arc curve includes: selecting a first preset time point, a second preset time point, and a third preset time point on the fitted circular arc curve; The method for detecting the prozone phenomenon of a sample to be detected based on the curvature of a reaction curve as described in claim 2, further comprising: calculating a radius of the fitted arc curve based on coordinates of 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, and taking the reciprocal of the radius as the curvature of the fitted arc curve.

4. 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 preset 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 three preset 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; A method for detecting a prozone phenomenon in a sample to be detected based on the curvature of a response curve as described in claim 2, further comprising a step of determining the average value of the curvatures of each segment of the fitted circular arc curve as the curvature of the fitted circular arc curve.

5. The reference curvature is determined by the following formula: [0010] where K0 is the reference curvature, [0025] 2. The method for detecting the prozone phenomenon of a sample to be detected based on the curvature of the reaction curve as described in claim 1, characterized in that: m is the average value of the curvature of the reaction curve of the absorbance of multiple normal samples over time between a preset start time point and a preset end time point, and C is a coefficient.

6. 1. An apparatus for detecting the prozone phenomenon in a sample to be detected based on the curvature of a response curve, comprising: an acquisition module configured to acquire the detection-waiting 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 preset start time point and a preset end time point on a time-dependent response curve of absorbance, and calculate a curvature of the time-dependent response curve of absorbance between the preset start time point and the preset 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.

7. The computing module includes:

7. The apparatus for detecting a prozone phenomenon in a sample to be detected based on the curvature of a reaction curve as described in claim 6, characterized in that, when calculating the curvature of a reaction curve of absorbance over time between a preset start point and a preset end point, the apparatus is configured to fit data within a section between the preset start point and the preset end point according to a preset functional 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 reaction curve of absorbance over time between the preset start point and the preset end point.

8. The computing module includes:

8. The apparatus for detecting the prozone phenomenon of a sample to be detected based on the curvature of a reaction curve according to claim 7, characterized in that, when calculating the curvature of the fitted arc curve, a first preset time point, a second preset time point, and a third preset time point are selected on the fitted arc curve, a radius of the fitted arc curve is calculated based on coordinates of 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, and the reciprocal of the radius is set as the curvature of the fitted arc curve.

9. The computing module includes:

8. The device for detecting the prozone phenomenon of a sample to be detected based on the curvature of a reaction curve as claimed in claim 7, characterized in that, when calculating the curvature of the fitted arc curve, the device is configured to divide the fitted arc curve into at least two segments, select three preset time points on each segment of the fitted arc curve, calculate a radius of each segment of the fitted arc curve based on the coordinates of points corresponding to the three preset time points on each segment of the fitted arc curve, and set the reciprocal of the radius as the curvature of each segment of the fitted arc curve, and set the average value of the curvatures of each segment of the fitted arc curve as the curvature of the fitted arc curve.

10. The reference curvature is determined by the following formula: [0030] where K0 is the reference curvature, [0045] 7. The apparatus for detecting the prozone phenomenon of a sample to be detected based on the curvature of the reaction curve as described in claim 6, characterized in that: Λ is the average value of the curvature of the reaction curve of the absorbance of a plurality of normal samples over time between a preset start time point and a preset end time point, and C is a coefficient.

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