Method and apparatus for detecting prozone phenomena in a sample to be detected based on the length of the reaction 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 length of the reaction curve. The method for detecting the prozone phenomenon of a sample to be detected based on the length 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 time-dependent reaction curve of absorbance, selecting a preset start time and a preset end time on the time-dependent reaction curve of absorbance, calculating the length of the time-dependent reaction curve of absorbance between the preset start time and the preset end time, and comparing the calculated length with a reference length, and determining that the sample to be detected has a prozone phenomenon if the calculated length is greater than the reference length. By comparing the length of the reaction curve with the reference length, 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 device for detecting the prozone phenomenon in a sample to be detected based on the length of the reaction 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 an excess of antigens or antibodies to be detected during use, and the resulting situation is called the prozone phenomenon, and such specimens are called samples with the prozone phenomenon. When detecting a sample with the prozone phenomenon, the device will use some judgment methods to prompt the operator 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 device 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 device for detecting the prozone phenomenon of a sample to be detected based on the length 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 length of the reaction curve with a reference length, 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 a prozone phenomenon in a sample to be detected based on the length of the reaction curve, the method including the steps of: acquiring a sample to be detected; processing original signal reaction data of the sample to be detected to acquire a time-dependent reaction curve of absorbance; selecting a preset start time point and a preset end time point on the time-dependent reaction curve of absorbance, and calculating a length of the time-dependent reaction curve of absorbance between the preset start time point and the preset end time point; comparing the calculated length with a reference length, and determining that the sample to be detected has a prozone phenomenon if the calculated length is greater than the reference length.

[0007] Furthermore, the reference length is determined by utilizing the length of the time-dependent response curve of the absorbance of a normal sample between a preset start time point and a preset end time point.

[0008] Furthermore, the sampling length is determined by the following formula:

number

number

[0009] Furthermore, the original signal response data of the sample to be detected is time-dependent data of transmitted light intensity collected by the optical detection system during the reaction of the sample to be detected, and the reaction curve of the sample to be detected is determined by converting the original signal response data of the sample to be detected into time-dependent data of absorbance.

[0010] Additionally, the method further includes issuing a prompt if it is determined that the sample to be detected is present with a prozone phenomenon.

[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 length of the reaction curve, the apparatus comprising: an acquisition module configured to acquire a sample to be detected; a processing module configured to process original signal reaction data of the sample to be detected and acquire an absorbance time-dependent reaction curve; a calculation module configured to select a preset start time point and a preset end time point on the absorbance time-dependent reaction curve and calculate a length of the absorbance time-dependent reaction curve between the preset start time point and the preset end time point; and a comparison module configured to compare the calculated length with a reference length and determine that the sample to be detected has a prozone phenomenon if the calculated length is greater than the reference length.

[0012] Furthermore, the reference length is determined by utilizing the length of the time-dependent response curve of the absorbance of a normal sample between a preset start time point and a preset end time point.

[0013] Furthermore, the sampling length is determined by the following formula:

number

number

[0014] Furthermore, 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.

[0015] Additionally, the apparatus includes a prompt module configured to issue a prompt if the apparatus determines that a prozone phenomenon is present in the sample to be detected.

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

[0017] Exemplary embodiments of the invention will now be described in more detail with reference to the drawings, in which, for the sake of clarity, identical elements in different drawings are designated by the same reference numerals. As an illustration, 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 length 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 length of a reaction 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 in a sample to be detected based on the length of a reaction 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 response curve length according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

[0020] 1 is a flow chart showing a method for detecting the prozone phenomenon of a sample to be detected based on the length 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 length 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 original signal reaction data of the sample to be detected to acquire a time-dependent reaction curve of absorbance in step S200; selecting a preset start time and a preset end time on the time-dependent reaction curve of absorbance in step S300; and comparing the calculated length with a reference length and determining that the sample to be detected has a prozone phenomenon if the calculated length is greater than the reference length 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 component, 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 therefore, the concentration of the antigen, which is an analyte component in the system, may be derived according to the Lambert-Beer law (which expresses 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 antigen concentration in the sample is high, but the antigen is apparently determined to be absent or low, resulting in a false negative result of the antigen being absent or the measured concentration of the antigen being low.

[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 the prozone phenomenon exists, the antigen is in excess, so there are more binding and dissociation processes between the antigen and the antibody, which will manifest its peculiarities on the reaction curve, specifically, it will manifest as more fluctuations, and as a result, the overall length of the reaction curve will be longer. 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 length of a reaction 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 T and a preset end time T' on the time-dependent absorbance response curve, the length L of the time-dependent absorbance response curve MM' between the preset start time T and the preset end time T' is calculated. For example, the formula

number

[0030] After calculating the length L of the time-dependent reaction curve of absorbance between a preset start time T and a preset end time T' in step S300, the calculated length L is compared with a reference length L0 in step S400, and if the calculated length L is greater than the reference length L0, it is determined that the sample to be detected has a prozone phenomenon.

[0031] According to an embodiment of the present invention, the reference length L0 is determined by using the length of the time-dependent response curve of the absorbance of a normal sample between a preset start time point and a preset end time point. The determination of the reference length L0 is described in detail below.

[0032] According to an embodiment of the present invention, the reference length is determined by the following formula:

number

[0033] where L0 is the reference length,

number

[0034] 3 is a schematic diagram showing the actual measurement data of a normal sample in a method for detecting the prozone phenomenon of a sample to be detected based on the length of the reaction curve according to an embodiment of the present invention. As shown in FIG. 3, the preset start time is selected as 11 s, and the preset end time is selected as 27 s. The length NN' of the reaction curve of the absorbance over time of the normal sample shown in FIG. 3 between the preset start time and the preset end time is 0.0505.

[0035] Table 1 shows the response curve lengths of seven normal samples between the preset start and end time points.

[0036] [Table 1]

[0037] Accordingly,

number

number

[0038] Furthermore, C is a coefficient, and the value of the coefficient C may be in the range of 0.8 to 1.2.

[0039] therefore,

number

[0040] According to an exemplary embodiment of the present invention, the calculated length of the sample to be detected is L=0.2182, and the value range of the reference length L0 is 0.0477-0.0715, and L>L0, 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.

[0041] Conversely, if the calculated length L of the sample to be detected is within the range of values ​​of the reference length L0, it can be determined that the sample to be detected is free of the prozone phenomenon.

[0042] According to an embodiment of the present invention, if a prozone phenomenon is determined to be present in a sample to be detected, a prompt is issued.

[0043] FIG. 4 is a block diagram showing an apparatus for detecting a prozone phenomenon in a sample to be detected based on the length of a reaction curve according to an embodiment of the present invention. As shown in FIG. 4, the apparatus for detecting a prozone phenomenon in a sample to be detected based on the length of a reaction 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 original signal reaction data of the sample to be detected to obtain a time-dependent reaction curve of absorbance. The calculation module can select a preset start time point and a preset end time point on the time-dependent reaction curve of absorbance, and calculate the length of the time-dependent reaction curve of absorbance between the preset start time point and the preset end time point. The comparison module can compare the calculated length with a reference length, and determine that the sample to be detected has a prozone phenomenon if the calculated length is greater than the reference length. The apparatus for detecting a prozone phenomenon in a sample to be detected based on the length of a reaction curve according to an embodiment of the present invention may further include a prompt module that can issue a prompt when it is determined that the sample to be detected has a prozone phenomenon.

[0044] 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.

[0045] According to an embodiment of the present invention, the reference length is determined by using the length of the time-dependent response curve of the absorbance of a normal sample between a preset start time point and a preset end time point. Specifically, the reference length is determined by the following formula:

number

number

[0046] Advantages of the method and apparatus for detecting the prozone phenomenon in a sample to be detected based on the length of the reaction curve according to the embodiment of the present invention are as follows.

[0047] 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 length of the reaction curve with the reference length, 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.

[0048] 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.

[0049] 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 a length of a reaction 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; Selecting a preset start time point and a preset end time point on the time-dependent response curve of absorbance, and calculating the length of the time-dependent response curve of absorbance between the preset start time point and the preset end time point; comparing the calculated length with a reference length, and determining that the sample to be detected has a prozone phenomenon if the calculated length is greater than the reference length.

2. 2. The method for detecting a prozone phenomenon in a sample to be detected based on the length of a reaction curve according to claim 1, wherein the reference length is determined using the length of a time-dependent reaction curve of absorbance of a normal sample between a preset start point and a preset end point.

3. The reference length is determined by the following formula: [0010] In the formula, L0 is the reference length, [0025] 2. The method for detecting the prozone phenomenon of a sample to be detected based on the length of the reaction curve as described in claim 1, characterized in that: C is the average value of the length of the reaction curve over time of the absorbance of multiple normal samples between a preset start time point and a preset end time point, and C is a coefficient.

4. the original signal response data of the sample to be detected is data of transmitted light intensity over time collected by the optical detection system during the reaction of the sample to be detected; A method for detecting the prozone phenomenon of a sample to be detected based on the length of the reaction curve, as described in claim 1, characterized in that the reaction curve of the sample to be detected is determined by converting the original signal reaction data of the sample to be detected into time-dependent absorbance data.

5. 2. The method for detecting a prozone phenomenon in a sample to be detected based on the length of the reaction curve as described in claim 1, further comprising the step of issuing a prompt when it is determined that the sample to be detected has a prozone phenomenon.

6. 1. An apparatus for detecting prozone phenomena in a sample to be detected based on the length of a reaction 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 the absorbance time-dependent response curve, and calculate a length 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 length with a reference length and determine that the sample to be detected has a prozone phenomenon if the calculated length is greater than the reference length.

7. 7. The apparatus for detecting the prozone phenomenon of a sample to be detected based on the length of a reaction curve as claimed in claim 6, wherein the reference length is determined using the length of a time-dependent reaction curve of absorbance of a normal sample between a preset start point and a preset end point.

8. The reference length is determined by the following formula: [0030] In the formula, L0 is the reference length, [0045] 7. The apparatus for detecting the prozone phenomenon of a sample to be detected based on the length of the reaction curve as described in claim 6, characterized in that: is an average value of the length of the reaction curve over time of the absorbance of a plurality of normal samples between a preset start time point and a preset end time point, and C is a coefficient.

9. The processing module includes: the original signal response data of the sample to be detected is data of transmitted light intensity over time collected by the optical detection system during a reaction of the sample to be detected; The apparatus for detecting the prozone phenomenon of a sample to be detected based on the length of the reaction curve, as described in claim 6, characterized in that it is configured to determine a reaction curve of the sample to be detected by converting the original signal reaction data of the sample to be detected into time-dependent absorbance data.

10. The apparatus for detecting a prozone phenomenon in a sample to be detected based on the length of the reaction curve, as described in claim 6, further comprising a prompt module configured to issue a prompt when it is determined that the sample to be detected has a prozone phenomenon.

Images