Method and device for detecting a fronting phenomenon of a sample to be detected

Abstract

The present application relates to a method and device for detecting the front band phenomenon of a sample to be detected. The method for detecting the front band phenomenon of a sample to be detected comprises: obtaining the sample to be detected; processing the original signal reaction data of the sample to be detected to obtain a reaction curve of absorbance changing with time; obtaining the inflection point of the reaction curve of the sample to be detected by taking the second derivative of the reaction curve; and comparing the time of occurrence of the inflection point of the reaction curve of the sample to be detected with a predetermined threshold to determine whether the front band phenomenon exists in the sample to be detected. The method and device of the present application can obtain a reaction curve of absorbance changing with time, and determine whether the front band phenomenon exists in the sample by comparing the time of occurrence of the point (i.e. the inflection point) at which the second derivative of the reaction curve is zero, thereby improving the reliability of the detection result without depending on the selection of the time interval on the reaction curve, and improving the reliability of the detection result when combined with other methods for predicting the front band sample.

Description

Technical Field

[0001] This invention relates to the field of detection technology, and in particular to a method and apparatus for detecting the frontal zone phenomenon of a sample to be tested. Background Technology

[0002] When measuring the concentration of antigens and antibodies in a sample using immunoassay methods, antigen overload often occurs, a condition known as the prozone phenomenon. In immunoassays, absorbance increases with increasing antigen concentration, but when the antigen concentration exceeds a certain level, absorbance decreases instead of increasing. For example, absorbance X may be detected at an antigen concentration Z1, but at a high concentration Z2, due to the prozone phenomenon, only absorbance of the same level as or even lower than absorbance X may be detected. Therefore, although the actual antigen concentration in the sample is high, it may appear to be absent or low. This prozone phenomenon often produces false negative results with underestimating antigen concentration, significantly interfering with the measurement.

[0003] In biochemical analyzers and coagulation analyzers, alarm processing is employed to overcome interference from the prozone phenomenon. The basic principle of this alarm system is that samples exhibiting the prozone phenomenon will show an abnormal slope in the reaction curve. By analyzing the properties of the first derivative of the reaction curve, samples with the prozone phenomenon can be identified, prompting the system to provide a warning, allowing for dilution and providing accurate sample concentration information. However, the results of this first derivative-based processing depend on the selection of the time interval, which involves various factors such as the specific properties of the reaction curve and the composition of the reagents, making it complex and prone to errors. Therefore, effectively detecting whether a sample is a high-concentration antigen sample exhibiting the prozone phenomenon is particularly important.

[0004] The above description of the background technology is only for the purpose of facilitating a deeper understanding of the technical solution of the present invention (the technical means used, the technical problems solved, and the technical effects produced, etc.), and should not be regarded as an admission or in any form an implication that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0005] The purpose of this invention is to provide a method and apparatus for detecting the pre-band phenomenon in a sample. It can obtain a reaction curve of absorbance changing over time. By comparing the time when the second derivative of the reaction curve is zero (i.e., the inflection point), it can determine whether the pre-band phenomenon exists in the sample. It does not depend on the selection of the time interval on the reaction curve. When used in combination with other methods for predicting pre-band samples, it improves the reliability of the detection results.

[0006] According to an embodiment of the present invention, a method for detecting a front-band phenomenon in a sample to be tested is provided, comprising: acquiring the sample to be tested; processing the original signal response data of the sample to be tested to obtain a response curve of absorbance changing with time; calculating the second derivative of the response curve to obtain an inflection point of the response curve of the sample to be tested at a point where the second derivative of the response curve is equal to zero; and comparing the occurrence time of the inflection point of the obtained response curve of the sample to be tested with a predetermined threshold to determine whether a front-band phenomenon exists in the sample to be tested.

[0007] Furthermore, the predetermined threshold is determined using the inflection point occurrence time of the reaction curve of a normal sample; when the inflection point occurrence time of the sample to be tested is less than the predetermined threshold, it is determined that a front-band phenomenon exists in the sample to be tested.

[0008] Furthermore, the predetermined threshold is determined by the following equation: A = T × C, where A is the predetermined threshold, T is the average time T of the inflection point of the response curves of multiple normal samples, and C is a coefficient, the value of which ranges from 0.8 to 1.2.

[0009] Furthermore, the original signal response data of the sample to be tested is the data on the change of transmitted light intensity over time, which is collected by an optical detection system during the reaction process of the sample to be tested; the original signal response data of the sample to be tested is converted into data on the change of absorbance over time, thereby determining the reaction curve of the sample to be tested.

[0010] Furthermore, the method further includes issuing an alarm when a pre-band phenomenon is determined to be present in the sample to be tested.

[0011] According to an embodiment of the present invention, an apparatus for detecting a front-band phenomenon in a sample to be tested includes: an acquisition module configured to acquire the sample to be tested; a processing module configured to process the raw signal response data of the sample to be tested to obtain a response curve of absorbance changing over time; a calculation module configured to calculate the second derivative of the response curve and obtain the inflection point of the response curve of the sample to be tested at the point where the second derivative of the response curve is equal to zero; and a comparison module configured to compare the occurrence time of the inflection point of the obtained response curve of the sample to be tested with a predetermined threshold to determine whether a front-band phenomenon exists in the sample to be tested.

[0012] Furthermore, the predetermined threshold is determined using the inflection point occurrence time of the reaction curve of a normal sample; the comparison module is further configured to determine that a front-band phenomenon exists in the sample to be detected when the inflection point occurrence time of the sample to be detected is less than the predetermined threshold.

[0013] Furthermore, the predetermined threshold is determined by the following equation: A = T × C, where A is the predetermined threshold, T is the average time T of the inflection point of the response curves of multiple normal samples, and C is a coefficient, the value of which ranges from 0.8 to 1.2.

[0014] Furthermore, the original signal response data of the sample to be tested is the data of the change of transmitted light intensity over time collected by the optical detection system during the reaction process of the sample to be tested. The processing module is further configured to convert the original signal response data of the sample to be tested into data of absorbance change over time, thereby determining the reaction curve of the sample to be tested.

[0015] Furthermore, the device further includes an alarm module configured to issue an alarm when a frontal band phenomenon is detected in the sample to be tested.

[0016] The present invention adopts the above technical solution and has the following beneficial effects: it can obtain the reaction curve of the absorbance of the sample to be tested changing with time, and by comparing the time when the second derivative of the reaction curve is zero (i.e., the inflection point), it can determine whether there is a front-band phenomenon in the sample. It does not depend on the selection of the time interval on the reaction curve. When used in combination with other methods for predicting front-band samples, it improves the reliability of the detection results. Attached Figure Description

[0017] The exemplary embodiments of the present invention will now be described in more detail with reference to the accompanying drawings. For clarity, the same components in different drawings are shown with the same reference numerals. It should be noted that the drawings are for illustrative purposes only and are not necessarily drawn to scale. In these drawings:

[0018] Figure 1 This is a flowchart illustrating a method for detecting the front-band phenomenon of a sample to be tested according to an embodiment of the present invention.

[0019] Figure 2 It is a schematic diagram showing the reaction curve of a normal sample, the first derivative curve of the reaction curve, the second derivative curve of the reaction curve, and the inflection point.

[0020] Figure 3 It is a schematic diagram showing the reaction curve of the sample to be tested, the first derivative curve of the reaction curve, the second derivative curve of the reaction curve, and the inflection point.

[0021] Figure 4 This is a block diagram illustrating the configuration of an apparatus for detecting the frontal zone phenomenon of a sample according to an embodiment of the present invention. Detailed Implementation

[0022] The following provides a detailed description of the embodiments of the present invention. These embodiments are implemented based on the technical solution of the present invention, and provide detailed implementation methods and specific operation processes. However, the scope of protection of the present invention is not limited to the following embodiments.

[0023] Figure 1 This is a flowchart illustrating a method for detecting the front-band phenomenon in a sample according to an embodiment of the present invention. Figure 1 As shown, the method for detecting the front-band phenomenon in a sample according to an embodiment of the present invention includes: step S100, acquiring the sample to be tested; step S200, processing the original signal response data of the sample to be tested to obtain a response curve of absorbance changing with time; step S300, calculating the second derivative of the response curve, and obtaining the inflection point of the response curve of the sample to be tested where the second derivative of the response curve is equal to zero; step S400, comparing the occurrence time of the inflection point of the obtained response curve of the sample to be tested with a predetermined threshold to determine whether the front-band phenomenon exists in the sample to be tested.

[0024] In step S100, a sample to be tested is obtained. According to an embodiment of the present invention, the sample to be tested may contain an antigen as the analyte. As an example, the detection principle for measuring the concentration of the antigen in a sample using an immunoassay method can be that when the antigen binds to a specific antibody in the system, the particle size increases, leading to increased turbidity and absorbance. Therefore, the concentration of the antigen as the analyte in the system can be derived using the Lambert-Beer law (which describes the direct proportionality between absorbance and concentration).

[0025] However, according to embodiments of the present invention, the antigen in the sample to be tested may be excessive. In the case of a high-concentration antigen sample exhibiting prozone phenomenon, although the actual antigen concentration in the sample is high, it may be perceived as absent or low, thus producing false negative results indicating that the antigen is absent or the measured antigen concentration is too low.

[0026] In step S200, the raw signal response data of the sample to be tested is processed to obtain the response curve of absorbance changing with time.

[0027] Specifically, the raw signal response data of the sample to be tested is the data on the change of transmitted light intensity over time, collected by an optical detection system during the reaction process of the sample to be tested. In an exemplary embodiment, an optical detection system consists of a light source, a lens, a filter, and an optical fiber. The light source system is located on one side of the analysis apparatus, and the light emitted by the light source illuminates the analysis apparatus. The sample to be tested, which is undergoing a reaction, is placed inside the analysis apparatus. The light passing through the analysis apparatus illuminates a receiver, and the signal acquisition circuit in the receiver converts the received light quantity into transmitted light intensity, thereby collecting data on the change of transmitted light intensity over time, thus forming the raw signal response data.

[0028] Subsequently, the original signal response data of the sample to be tested is converted into absorbance data as a function of time, thereby determining the response curve of the sample to be tested over time.

[0029] In step S300, the second derivative of the reaction curve is calculated, and the inflection point of the reaction curve for the sample to be tested is obtained where the second derivative of the reaction curve equals zero. When a sample exhibiting a prozone phenomenon reacts with antibodies in the reagent, the immune response is more intense than that of a normal sample (i.e., a sample without a prozone phenomenon) due to the excess antigen. This results in the point where the second derivative of the reaction curve reaches zero (i.e., the inflection point) occurring earlier during this period. The embodiments of the present invention utilize this characteristic.

[0030] In step S400, the inflection point time of the obtained reaction curve of the sample to be tested is compared with a predetermined threshold to determine whether a pre-band phenomenon exists in the sample. The predetermined threshold is determined using the inflection point time of the reaction curve of a normal sample, which occurs relatively late. When the inflection point time of the sample to be tested is less than the predetermined threshold, it is determined that a pre-band phenomenon exists in the sample.

[0031] As an example, according to an embodiment of the present invention, normal samples and samples to be tested are acquired respectively, and the raw signal response data of the normal samples and samples to be tested are processed. Specifically, the raw signal response data of the samples to be tested are converted into absorbance data as a function of time. Table 1 below shows the measured data of the absorbance response curves of normal samples and samples to be tested as a function of time.

[0032] Table 1

[0033] 0 0.0094 0.0069 1 0.0025 0.0027 2 0.0027 0.0028 3 0.0027 0.0027 4 0.0027 0.0026 5 0.0025 0.0026 6 0.0026 0.0026 7 0.0026 0.0026 8 0.0026 0.0026 9 0.0025 0.0025 10 0.0025 0.0025 11 1.3051 1.3341 12 1.3116 1.3814 13 1.3215 1.4308 14 1.3336 1.4723 15 1.3476 1.5048 16 1.3626 1.5293 17 1.3788 1.5479 18 1.3959 1.5614 19 1.4133 1.5712 20 1.4308 1.5776 21 1.4487 1.5822 22 1.4664 1.5842 23 1.4833 1.5851 24 1.4994 1.5848 25 1.5145 1.584 26 1.5288 1.5833 27 1.5423 1.5822

[0034] After processing the above data, the response curves and inflection points of normal samples and samples to be tested were obtained respectively. Figure 2 It is a schematic diagram showing the reaction curve of a normal sample, the first derivative curve of the reaction curve, the second derivative curve of the reaction curve, and the inflection point. Figure 3It is a schematic diagram showing the reaction curve of the sample to be tested, the first derivative curve of the reaction curve, the second derivative curve of the reaction curve, and the inflection point.

[0035] like Figure 2 , Figure 3 As shown, ti refers to the position of the inflection point on the time axis. For normal samples, the inflection point on the time axis is (20.47, 0). For the sample to be tested, the inflection point on the time axis is (11.53, 0).

[0036] The predetermined threshold of 20.47 was determined using the inflection point time of the reaction curve of the normal sample. Since the inflection point time of the reaction curve of the sample to be tested was 11.53 s, which was less than the predetermined threshold of 20.47 s, it was determined that a pre-band phenomenon existed in the sample to be tested. According to subsequent tests, the theoretical concentration of the normal sample was 100 mg / L, and the measured concentration was 98.58 mg / L. The sample to be tested, which also exhibited a pre-band phenomenon, had a theoretical concentration of 1500 mg / L, and the measured concentration was 124.06 mg / L.

[0037] The predetermined threshold is determined by the inflection point time of the reaction curve of a normal sample. To enhance the accuracy of the determined predetermined threshold and thus improve the reliability of the detection results, the predetermined threshold can also be determined by the inflection point times of the reaction curves of multiple normal samples (e.g., 20 normal samples), allowing for an appropriate difference between the inflection point time of the reaction curve of the sample to be tested and the predetermined threshold. Therefore, preferably, the predetermined threshold can be determined by the following equation:

[0038] A = T × C

[0039] Where A is the predetermined threshold, T is the average time T of the inflection point of the reaction curves of multiple normal samples, and C is the coefficient, which ranges from 0.8 to 1.2. The specific value of the coefficient C is determined by the reagent characteristics as an input parameter.

[0040] Figure 4 This is a block diagram illustrating the configuration of an apparatus for detecting the front-band phenomenon of a sample according to an embodiment of the present invention. Figure 4 As shown, the apparatus for detecting the front-band phenomenon in a sample includes an acquisition module, a processing module, a calculation module, and a comparison module. The acquisition module is configured to acquire the sample to be tested; the processing module is configured to process the raw signal response data of the sample to obtain a response curve showing the change in absorbance over time; the calculation module is configured to calculate the second derivative of the response curve and obtain the inflection point of the response curve of the sample to be tested where the second derivative equals zero; the comparison module is configured to compare the inflection point occurrence time of the obtained response curve of the sample to be tested with a predetermined threshold to determine whether a front-band phenomenon exists in the sample to be tested.

[0041] The predetermined threshold is determined using the inflection point occurrence time of the response curve of a normal sample; the comparison module is further configured to determine that a front-band phenomenon exists in the sample to be detected when the inflection point occurrence time of the sample to be detected is less than the predetermined threshold.

[0042] Preferably, the predetermined threshold is determined by the following equation:

[0043] A = T × C

[0044] Where A is the predetermined threshold, T is the average time T of the inflection point of the response curves of multiple normal samples, and C is the coefficient, which ranges from 0.8 to 1.2.

[0045] The original signal response data of the sample to be tested is the data of the change of transmitted light intensity over time collected by the optical detection system during the reaction process of the sample to be tested; the processing module is further configured to convert the original signal response data of the sample to be tested into data of absorbance change over time, thereby determining the reaction curve of the sample to be tested.

[0046] The apparatus for detecting the front-band phenomenon in a sample to be tested further includes an alarm module configured to issue an alarm when it is determined that the front-band phenomenon exists in the sample to be tested.

[0047] According to an embodiment of the present invention, a method and apparatus for detecting the front-band phenomenon in a sample to be tested can obtain a reaction curve of absorbance changing over time. By comparing the time when the second derivative of the reaction curve is zero (i.e., the inflection point), the presence of the front-band phenomenon in the sample can be determined. This method is independent of the selection of the time interval on the reaction curve and, when used in combination with other methods for predicting front-band samples, improves the reliability of the detection results.

[0048] The various embodiments of the present invention are not an exhaustive list of all possible combinations, but are intended to describe representative aspects of the invention, and the contents described in the various embodiments can be applied independently or in two or more combinations.

[0049] The description of the exemplary embodiments presented above is merely illustrative of the technical solutions of the present invention and is not intended to be exhaustive, nor is it intended to limit the invention to the precise forms described. Obviously, those skilled in the art can make many changes and variations based on the above teachings. The exemplary embodiments were chosen and described to explain the specific principles of the invention and its practical applications, thereby enabling others skilled in the art to understand, implement, and utilize the various exemplary embodiments of the invention and their various alternatives and modifications. The scope of protection of the present invention is intended to be defined by the appended claims and their equivalents.

Claims

1. A method for detecting the pre-band phenomenon in a sample to be tested, wherein the pre-band phenomenon refers to a situation arising from antigen overload when measuring the concentration of the antigen-antibody in the sample using an immunoassay method, characterized in that... The method includes: Obtain the sample to be tested; The raw signal response data of the sample to be tested are processed to obtain the response curve of absorbance changing over time; The inflection point of the reaction curve is obtained by taking the second derivative of the reaction curve and finding that the second derivative of the reaction curve is equal to zero. The inflection point time of the obtained reaction curve of the sample to be tested is compared with a predetermined threshold. When the inflection point of the reaction curve of the sample to be tested occurs less than a predetermined threshold, it is determined that the sample to be tested has a front-band phenomenon. The predetermined threshold is determined using the inflection point time of the response curve of normal samples, and is further determined by the following equation: A = T × C Where A is the predetermined threshold, T is the average time T of the inflection point of the response curves of multiple normal samples, and C is the coefficient, which ranges from 0.8 to 1.

2.

2. The method for detecting the front-band phenomenon of a sample to be tested according to claim 1, characterized in that, The raw signal response data of the sample to be tested is the data on the change of transmitted light intensity over time, which is collected by an optical detection system during the reaction process of the sample to be tested. The original signal response data of the sample to be tested is converted into absorbance data as a function of time, thereby determining the response curve of the sample to be tested.

3. The method for detecting the front-band phenomenon of a sample according to claim 1, characterized in that, Further includes: An alarm is issued when a pre-band phenomenon is detected in the sample to be tested.

4. An apparatus for detecting the pre-band phenomenon in a sample to be tested, wherein the pre-band phenomenon refers to a situation arising from antigen overload when measuring the concentration of the antigen-antibody in the sample using an immunoassay method, characterized in that... The device includes: The acquisition module is configured to acquire the sample to be detected. The processing module is configured to process the raw signal response data of the sample to be tested to obtain the response curve of absorbance changing over time. The calculation module is configured to calculate the second derivative of the reaction curve and obtain the inflection point of the reaction curve of the sample to be tested when the second derivative of the reaction curve is equal to zero. The comparison module is configured to compare the inflection point occurrence time of the obtained reaction curve of the sample to be tested with a predetermined threshold. When the inflection point occurrence time of the reaction curve of the sample to be tested is less than the predetermined threshold, it is determined that there is a front-band phenomenon in the sample to be tested. The predetermined threshold is determined using the inflection point time of the response curve of normal samples, and is further determined by the following equation: A = T × C Where A is the predetermined threshold, T is the average time T of the inflection point of the response curves of multiple normal samples, and C is the coefficient, which ranges from 0.8 to 1.

2.

5. The apparatus for detecting the front-band phenomenon of a sample to be tested according to claim 4, characterized in that, The raw signal response data of the sample to be tested is the data on the change of transmitted light intensity over time, which is collected by an optical detection system during the reaction process of the sample to be tested. The processing module is further configured to convert the original signal response data of the sample to be tested into data on the change of absorbance over time, thereby determining the response curve of the sample to be tested.

6. The apparatus for detecting the front-band phenomenon of a sample according to claim 4, characterized in that, Further includes: The alarm module is configured to issue an alarm when a frontal band phenomenon is detected in the sample to be tested.

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