CN110542661B - High-concentration sample identification method, device and detection system - Google Patents

High-concentration sample identification method, device and detection system Download PDF

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CN110542661B
CN110542661B CN201910933947.0A CN201910933947A CN110542661B CN 110542661 B CN110542661 B CN 110542661B CN 201910933947 A CN201910933947 A CN 201910933947A CN 110542661 B CN110542661 B CN 110542661B
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王准
赵清楠
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Maccura Medical Electronics Co Ltd
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Abstract

The invention relates to a high-concentration sample identification method, a high-concentration sample identification device and a high-concentration sample detection system, wherein the high-concentration sample identification method comprises the following steps: processing the original signal reaction data of the sample to obtain an absorbance change curve; determining a first curve segment and a second curve segment according to a preset time point, wherein the length of a data sequence corresponding to the first curve segment is equal to the length of a data sequence corresponding to the second curve segment; calculating a first parameter value capable of reflecting the difference of the bending degrees between the first curve segment and the second curve segment through the absorbance data sequence corresponding to the first curve segment and the absorbance data sequence corresponding to the second curve segment; by comparing the first parameter value with the determination threshold value R, it is determined whether or not the sample is a high concentration sample. The method can eliminate the influence of abnormal points with large partial fluctuation, and the identification result of the high-concentration sample is more accurate.

Description

High-concentration sample identification method, device and detection system
Technical Field
The invention relates to the technical field of detection, in particular to a high-concentration sample identification method, a high-concentration sample identification device and a high-concentration sample detection system.
Background
In the field of medical examination, transmission turbidimetry is generally used for detecting items such as DD and FDP in the blood coagulation items.
The detection principle of the transmission turbidimetry is as follows: a sample to be measured, such as plasma, is added to a cuvette and subjected to an antigen-antibody reaction with a reagent, and the cuvette is irradiated at one end with light generated by a light source and at the other end with a receiver to receive the transmitted light and convert it into a signal value. In the detection process, an antigen-antibody compound is formed along with the combination of a detected substance (antigen) in blood plasma and a corresponding antibody, the light intensity of received transmitted light can be changed to a certain extent, then the variation of absorbance in unit time is calculated according to the transmitted light intensity, and then the content of the substance to be detected is calculated according to a standard curve.
Most chemical reactions can increase with increasing concentration. However, when the concentration of the sample is too high, an antigen excess effect, which is also called a prozone effect, tends to occur. The prozone effect is shown by the fact that when different concentrations of antigen are added to a constant dose of antibody solution, the absorbance increases with the increase in the sample concentration, and when the peak is reached, the absorbance decreases with the increase in the sample concentration, resulting in a bell-like curve, and the unique phenomenon of antigen-antibody reaction can be represented by the well-known "Heidelberg curve" (see FIG. 1). If the sample concentration is too high, a prozone effect occurs, which has a large influence on the analysis result of the sample, and the obtained result has a large error from the actual sample amount, so how to effectively detect whether the sample is a high-concentration sample with the prozone effect is important.
The existing means judges whether there is an excess of antigen (excessive sample concentration) in a sample by comparing a ratio value R of reaction rates in two time periods before and after calculation with a predetermined limit value. However, this method directly uses two points to directly determine the slope in the time period, and if the filtering effect of the original curve is not good, there is a high possibility that the signal error at a certain point is large, which may cause the generated reaction rate error to be also large, thereby deviating from the actual reaction rate. As shown in fig. 2, when the filtering effect is not good, V-shaped fluctuation may still occur, and if the time point of obtaining the slope is exactly on the fluctuation point, the error of the calculated reaction rate is very large, and the reaction rate value obtained according to the two points deviates from the true value of the actual reaction rate.
Disclosure of Invention
In order to solve the above-mentioned problems, a first aspect of the present invention discloses a method for identifying a high-concentration sample, so as to accurately and efficiently detect whether the sample is a high-concentration sample having a prozone effect, and improve the reliability of an analysis result.
A second aspect of the present invention is to disclose an apparatus capable of implementing the above-described high-concentration sample identification method.
A third aspect of the present invention is to disclose a detection system using the method for identifying a high concentration sample.
The method for identifying a high-concentration sample disclosed by the first aspect of the present invention comprises the steps of:
processing the original signal reaction data of the sample to obtain an absorbance change curve;
intercepting a first curve segment corresponding to the absorbance change curve according to a preset first starting time and a preset first ending time, and intercepting a second curve segment corresponding to the absorbance change curve according to a preset second starting time and a preset second ending time, wherein the length of a data sequence corresponding to the first curve segment is equal to that of a data sequence corresponding to the second curve segment;
calculating a first parameter value capable of reflecting the difference of the bending degrees between the first curve segment and the second curve segment through the absorbance data sequence corresponding to the first curve segment and the absorbance data sequence corresponding to the second curve segment;
and judging whether the sample is a high-concentration sample or not by comparing the first parameter value with a judgment threshold value R.
Further, the first parameter value is a variance/standard deviation of a difference between a data sequence corresponding to the second curve segment and an absorbance data sequence corresponding to the first curve segment.
Further, the first parameter value is a variance/standard deviation of a quotient of the absorbance data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment.
Further, the step of processing the raw signal reaction data of the sample to obtain the absorbance change curve includes the following steps:
determining a starting point A of the stable reaction of the sample and an end point B of the reaction of the sample according to the absorbance change curve,
and fitting the data between the starting point A and the end point B by adopting a preset function model to obtain a new absorbance change curve.
Further, the first start time is a time point corresponding to a start point a of the sample stabilization reaction, and the second end time is a time point corresponding to an end point B of the sample reaction.
Further, if the first parameter value is larger than the determination threshold value R, it is determined that the sample is a high concentration sample.
In a high concentration sample discrimination apparatus disclosed in a second aspect of the present invention,
the data processing module is used for processing the original signal reaction data of the sample to obtain an absorbance change curve;
a curve segment intercepting module, configured to intercept a first curve segment corresponding to the absorbance change curve according to a preset first start time and a preset first end time, and intercept a second curve segment on the absorbance change curve according to a preset second start time and a preset second end time, where a data sequence length corresponding to the first curve segment is equal to a data sequence length corresponding to the second curve segment;
the calculation module is used for calculating a first parameter value capable of reflecting the difference of the bending degrees between the first curve segment and the second curve segment through the absorbance data sequence corresponding to the first curve segment and the absorbance data sequence corresponding to the second curve segment;
and the comparison and judgment module is used for judging whether the sample is a high-concentration sample or not by comparing the first parameter value with a judgment threshold value R.
Further, it also includes
The stable reaction time determining module is used for determining a starting point A of the stable reaction of the sample and an end point B of the reaction end of the sample according to the absorbance change curve;
and the fitting module is used for fitting the data between the starting point A and the end point B by adopting a preset function model to obtain a new absorbance change curve.
Further, the comparison determination module determines that the sample is a high concentration sample when the first parameter value is larger than the determination threshold value R.
A detection system disclosed in a third aspect of the present invention includes a light source subsystem for irradiating a cuvette, a receiver for receiving transmitted light transmitted through the cuvette, and a processor connected to the receiver, wherein the processor performs the following operations in detecting absorbance of a sample reaction:
processing the original signal reaction data of the sample to obtain an absorbance change curve;
intercepting a first curve segment corresponding to the absorbance change curve according to a preset first starting time and a preset first ending time, and intercepting a second curve segment corresponding to the absorbance change curve according to a preset second starting time and a preset second ending time, wherein the length of a data sequence corresponding to the first curve segment is equal to that of a data sequence corresponding to the second curve segment;
calculating a first parameter value capable of reflecting the difference of the bending degrees between the first curve segment and the second curve segment through the absorbance data sequence corresponding to the first curve segment and the absorbance data sequence corresponding to the second curve segment;
and judging whether the sample is a high-concentration sample or not by comparing the first parameter value with a judgment threshold value R.
Compared with the prior art, the method has the advantages that the first parameter value which can reflect the difference of the bending degrees between the two preset curve segments on the absorbance change curve is calculated, and is compared with the judgment threshold value, so that whether the sample is the high-concentration sample or not is judged; by calculating the data corresponding to the curve segment, the influence of abnormal points with large partial fluctuation can be eliminated, and the identification result of the high-concentration sample is more accurate. Because the reaction kinetics depends on the concentration of an analyte, the absorbance of a low-concentration sample is gradually enhanced and the speed is uniform, the absorbance signal of a high-concentration sample is enhanced quickly when the reaction starts, and the absorbance signal is enhanced slowly at the later stage of the reaction, so that the bending degrees of reaction curves in different setting intervals are different, and therefore, whether the sample is the high-concentration sample or not can be accurately and effectively identified by calculating the first parameter values of different preset curve sections and comparing the first parameter values with a judgment threshold value, and the reliability of an analysis result is improved.
Drawings
FIG. 1 is a schematic diagram of a Heidelberg curve;
FIG. 2 is a schematic diagram showing the influence of V-shaped fluctuation on the slope method for determining the absorbance change rate;
FIG. 3 is a schematic diagram of an absorbance change curve according to an embodiment of the disclosure;
FIG. 4 is a schematic illustration of a first curve segment and a second curve segment selected according to an embodiment of the present disclosure;
FIG. 5 is a schematic flow chart illustrating a method for identifying a high concentration sample according to an embodiment of the present invention;
FIG. 6 is a schematic flow chart illustrating a method for identifying a high concentration sample according to another embodiment of the present invention;
FIG. 7 is a data diagram illustrating first parameters calculated using the high concentration sample identification method disclosed in an embodiment of the present invention;
FIG. 8 is a schematic structural diagram of a detection system disclosed in an embodiment of the present invention;
wherein 1 is a light source, 2 is a lens, 3 is a filter, 4 is an optical fiber, 5 is a reaction cup, and 6 is a receiver.
Detailed Description
In view of the problems of the prior art, the present inventors have used a reaction kinetics method to verify the presence of an antigen excess (i.e., a high concentration sample) by analyzing kinetic data obtained during the measurement of the sample. In most cases, the reaction kinetics depend on the analyte concentration: the present inventors have determined whether a sample is a high concentration sample by calculating a parameter value that reflects a difference in degree of curvature between two curve segments using absorbance data sequences corresponding to different curve segments and comparing the parameter value with a determination threshold value, based on this characteristic.
The high concentration sample identification method, the high concentration sample identification apparatus, the high concentration sample detection system, and the time point determination method applied to the high concentration sample identification method according to the present invention will be described in detail below with reference to the detailed description and the accompanying drawings.
Referring first to fig. 5, the method for identifying a high concentration sample disclosed in the present invention comprises the steps of:
s1: processing the original signal reaction data of the sample to obtain an absorbance change curve;
s2: intercepting a corresponding first curve segment on the absorbance change curve according to a preset first starting time (such as StartTime1 in FIG. 4) and a first ending time (such as EndTime1 in FIG. 4), and intercepting a second curve segment on the absorbance change curve according to a preset second starting time (such as StartTime2 in FIG. 4) and a second ending time (such as EndTime2 in FIG. 4), wherein the data sequence length corresponding to the first curve segment is equal to the data sequence length corresponding to the second curve segment; namely, after the absorbance change curve is discretized, the number of data points corresponding to the first curve segment is the same as the number of data points corresponding to the second curve segment;
s3: calculating a first parameter value capable of reflecting the difference of the bending degrees between the first curve segment and the second curve segment through the absorbance data sequence corresponding to the first curve segment and the absorbance data sequence corresponding to the second curve segment;
s4: and judging whether the sample is a high-concentration sample or not by comparing the first parameter value with a judgment threshold value R.
Compared with the prior art, the embodiment of the disclosure calculates the first parameter value of the two preset curve segments on the absorbance change curve, which can reflect the difference of the bending degrees between the first curve segment and the second curve segment, and compares the first parameter value with the judgment threshold value, so as to judge whether the sample is a high-concentration sample, and by using the method, the influence of the abnormal point with large partial fluctuation on the result can be eliminated, and the accuracy of the identification result can be improved; because the reaction kinetics depends on the concentration of the analyte, the low-concentration sample can display the increasing signal of the absorbance, and the high-concentration sample can display the faster signal increase at the beginning of the reaction and the slow signal increase at the end of the reaction, so that the bending degrees of the reaction curves in different setting intervals are different, and whether the sample is the high-concentration sample or not can be accurately and effectively identified by calculating the first parameter values of different preset curve segments and comparing the first parameter values with the judgment threshold value, and the reliability of the analysis result is improved.
The method for identifying a high concentration sample according to one aspect of the present disclosure will be described in detail below with reference to specific embodiments.
Referring to fig. 6, in the present embodiment, the method for identifying a high concentration sample includes the following steps:
s11: signal data points are collected at a fixed frequency to form raw signal response data.
The step is specifically carried out in a signal value-time coordinate system (also called a two-dimensional coordinate system), which represents a signal value collected after light penetrates through the reaction cup, the abscissa is time, the ordinate is a signal value, namely transmission light intensity data, the means for acquiring the transmission light intensity data is a conventional means, and the following briefly describes the acquisition mode of the transmission light intensity data:
referring to fig. 8, fig. 8 is an optical detection system, a light source system composed of a light source 1, a lens 2, a filter 3 and an optical fiber 4 is located at one side of a reaction cup, light emitted by the light source is irradiated on the reaction cup 5, a sample to be detected which is undergoing a reaction is placed in the reaction cup 5, the light after passing through the reaction cup is irradiated on a receiver 6, and a signal acquisition circuit in the receiver 6 converts the received light quantity into transmission light intensity; in the actual detection process, the time interval between two adjacent acquisition moments is t (e.g. 0.1s), and after a period of acquisition (e.g. 140s), a plurality of data points (i.e. time series data points) can be formed in the signal value-time coordinate system to form the raw signal reaction data.
S12: and processing the original signal reaction data by using the Lambert beer law, and converting the original signal reaction data into an absorbance change curve.
The step is specifically that the original signal reaction data obtained in the step is obtained according to Lambert-Beer (Lambert-Beer) law:
Figure BDA0002221098340000081
calculating the absorbance at each acquisition time, wherein I0Representing the intensity of incident light, ItRepresents the emergent light intensity at the time t, and A represents the absorbance. Thus, an absorbance change curve can be obtained, and as shown in fig. 3, the abscissa of the absorbance change curve represents time and the ordinate represents absorbance.
S13: and determining a starting point A of the stable reaction of the sample and an end point B of the reaction termination of the sample according to the absorbance change curve.
S14: and fitting the data between the starting point A and the end point B by adopting a preset function model to obtain a new absorbance change curve.
In the step S13, a curve between the starting point a of the stable reaction period of the sample reaction and the end point B of the reaction is selected as a fitting interval on the absorbance change curve, and the starting point a and the end point B of the stable reaction period are obtained empirically. Then, in step S14, the data of the fitting interval is fitted using a pre-stored function model, and a function y ═ f (x) capable of expressing an absorbance change curve is obtained. It can be understood that, a person skilled in the art can perform filtering processing on the fitted function y ═ f (x) according to actual conditions, so as to filter out outliers, and make an analysis result more accurate; and the used function model is the function model which can reflect the absorbance change curve most in the prestored function models.
S15: and intercepting a first curve segment corresponding to the absorbance change curve according to a preset first starting time and a preset first ending time, and intercepting a second curve segment on the absorbance change curve according to a preset second starting time and a preset second ending time, wherein the length of a data sequence corresponding to the first curve segment is equal to that of a data sequence corresponding to the second curve segment.
As shown in fig. 4, the step is to select two curves with equal length on the absorbance change curve of the stable reaction region: a first curve segment and a second curve segment. It will be appreciated that the first start time and the first end time for determining the first curve segment and the second start time and the second end time for determining the second curve segment are time parameters pre-stored in the program that maximize the difference in the degree of curvature between the first curve segment and the second curve segment.
S16: and calculating a first parameter value capable of reflecting the difference of the bending degrees between the first curve segment and the second curve segment through the absorbance data sequence corresponding to the first curve segment and the absorbance data sequence corresponding to the second curve segment.
Since the reaction kinetics depend on the analyte concentration, a low concentration sample may show an increasing signal of absorbance, while a high concentration sample may show a faster signal increase at the beginning of the reaction and a slower signal increase at the end of the reaction, resulting in different degrees of curvature of the reaction curves for different set intervals, and thus a first parameter value capable of reflecting the difference in the degree of curvature between a first curve segment and a second curve segment may be calculated from the absorbance data sequence corresponding to the first curve segment and the absorbance data sequence corresponding to the second curve segment.
The first parameter value may be a variance/standard deviation of a difference between the data series corresponding to the second curve segment and the absorbance data series corresponding to the first curve segment, or may be a variance/standard deviation of a quotient between the absorbance data series corresponding to the second curve segment and the absorbance data series corresponding to the first curve segment.
The calculation formula of the variance of the difference between the data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment is as follows:
Figure BDA0002221098340000101
in the formula, yiIs the absorbance, y, of each point in the first curve segmentiiIs the absorbance of each point in the second curve segment, n is the data sequence length corresponding to the first/second curve segment, μ1Is the average value of the absorbance difference between the corresponding point in the second curve segment and the corresponding point in the first curve segment, and the calculation formula is as follows:
Figure BDA0002221098340000102
in the formula, the object of multiplying by 10000 is to increase V1Of course, other numbers, such as 10, 100, 1000, etc., may be multiplied depending on the actual situation.
The calculation formula of the standard deviation of the difference between the data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment is as follows:
Figure BDA0002221098340000103
in the formula, the object of multiplying by 10000 is to increase V2Of course, other numbers, such as 10, 100, 1000, etc., may be multiplied depending on the actual situation.
The calculation formula of the variance of the quotient of the data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment is as follows:
Figure BDA0002221098340000104
in the formula, yiIs the absorbance, y, of each point in the first curve segmentiiIs the absorbance of each point in the second curve segment, n is the data sequence length corresponding to the first/second curve segment, μ2Is the average value of the quotient of the absorbance of the corresponding point in the second curve segment and the corresponding point in the first curve segment, and the calculation formula is as follows:
Figure BDA0002221098340000105
in the formula, the object of multiplying by 10000 is to increase V3Of course, other numbers, such as 10, 100, 1000, etc., may be multiplied depending on the actual situation.
The calculation formula of the standard deviation of the quotient of the data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment is as follows:
Figure BDA0002221098340000111
in the formula, the object of multiplying by 10000 is to increase V4Of course, other numbers, such as 10, 100, 1000, etc., may be multiplied depending on the actual situation.
S17: and judging whether the sample is a high-concentration sample or not by comparing the first parameter value with a judgment threshold value R.
This step specifically shows a step of comparing the first parameter value with the determination threshold value R to determine whether or not the sample is a high-concentration sample. It is understood that the decision threshold R is pre-stored data, which is mainly determined by the detection item, the upper limit of the linear range of the reagent, and the selected first curve segment and the second curve segment, and can be understood as an empirical value.
Determining that the threshold value R corresponds to the selected first parameter value, and when the first parameter value is the variance of the difference between the data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment, determining that the threshold value R is the threshold value of the variance of the difference between the data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment; when the first parameter value is the standard deviation of the difference between the data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment, determining that the threshold value R is the threshold value of the standard deviation of the difference between the data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment; when the first parameter value is the variance of the quotient of the data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment, determining that the threshold value R is the threshold value of the variance of the quotient of the data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment; and when the first parameter value is the standard deviation of the quotient of the data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment, determining that the threshold value R is the threshold value of the standard deviation of the quotient of the data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment. That is, the calculation rule of the first parameter value is different, and the corresponding determination threshold value R is also different.
Since the reaction kinetics depend on the analyte concentration, low concentration samples may show an increasing signal of absorbance, while high concentration samples have a faster signal increase at the beginning of the reaction and a slower signal increase at the end of the reaction, and thus the degree of curve of the reaction curve varies more for different time periods. When the difference is larger than a certain threshold, the sample can be judged to be a high concentration sample. Judging whether the sample is a high-concentration sample or not by judging the size of the first parameter value and a prestored judging threshold value R.
If the first parameter value is larger than R, the sample is a high-concentration sample, and the high-concentration sample is marked on the detection sample; if the first parameter value is not greater than R, the sample is a non-high concentration sample, and the detection result can be normally analyzed.
Referring to fig. 7, the results of actual detection using the high concentration sample identification method disclosed in the above embodiment are shown, and the distribution of the first parameter values obtained in the case of different concentrations is shown by setting a reasonable determination threshold R (i.e., V in fig. 7)cutoff) It is possible to effectively identify a high concentration sample (i.e., an excessive amount of antigen in fig. 7), that is, a high concentration sample when the first parameter value is greater than the determination threshold R, and a non-high concentration sample when the first parameter value is not greater than the determination threshold R.
As can be understood by those skilled in the art, in the high-concentration sample identification method disclosed in the above embodiments, when the sample concentration is low, the overall bending degree of the corresponding absorbance change curve is small, and the probability of occurrence of the prozone effect is low; when the concentration of the sample is higher, the playing degree of the corresponding absorbance change curve is large, the bending degree is changed greatly, and the probability of the occurrence of the prozone effect is relatively higher; according to the high-concentration sample identification method disclosed by the embodiment, the first parameter values among different curve segments are calculated and compared with the judgment threshold value, so that the high-concentration sample can be effectively identified, and the reliability of an analysis result is improved.
Preferably, in order to make the difference between the bending degrees of the selected first curve segment and the second curve segment larger, the preset first starting time is a time point corresponding to a starting point a of the sample stable reaction, and the preset second ending time is a time point corresponding to an ending point B of the sample reaction. When a preset first starting time, a preset first ending time, a preset second starting time and a preset second ending time are selected, the difference of the bending degrees between the corresponding first curve section and the corresponding second curve section is required to be as large as possible; the high-concentration sample reacts violently at the initial stage of the stable reaction, the bending degree of the corresponding absorbance change curve segment is maximum, the bending degree of the absorbance change curve gradually becomes smaller along with the progress of the reaction, and the bending degree of the corresponding absorbance change curve is minimum at the end stage of the stable reaction of the high-concentration sample, so that the difference of the bending degrees between the first curve segment and the second curve segment can be larger by the preset first initial time and the second end time, and the judgment result is more accurate.
In addition, in order to implement the above identification method, an embodiment of the present invention further discloses a high-concentration sample identification device, including:
the data processing module is used for processing the original signal reaction data of the sample to obtain an absorbance change curve;
a curve segment intercepting module, configured to intercept a first curve segment corresponding to the absorbance change curve according to a preset first start time and a preset first end time, and intercept a second curve segment on the absorbance change curve according to a preset second start time and a preset second end time, where a data sequence length corresponding to the first curve segment is equal to a data sequence length corresponding to the second curve segment;
the calculation module is used for calculating a first parameter value capable of reflecting the difference of the bending degrees between the first curve segment and the second curve segment through the absorbance data sequence corresponding to the first curve segment and the absorbance data sequence corresponding to the second curve segment;
and the comparison and judgment module is used for judging whether the sample is a high-concentration sample or not by comparing the first parameter value with a judgment threshold value R.
In the high-concentration sample identification device, the first parameter value capable of reflecting the difference of the bending degrees between the first curve segment and the second curve segment is calculated by utilizing the absorbance data sequence corresponding to the first curve segment and the absorbance data sequence corresponding to the second curve segment, and the first parameter value is compared with the judgment threshold value, so that whether the prozone effect exists in the sample reaction can be effectively identified, and the reliability of the analysis result is improved.
Specifically, the data processing module processes the original signal reaction data by using the lambert beer law, and converts the original signal reaction data into an absorbance change curve.
Preferably, in order to improve the identification accuracy, the high concentration sample identification device disclosed in this embodiment further includes
The stable reaction time determining module is used for determining a starting point A of the stable reaction of the sample and an end point B of the reaction end of the sample according to the absorbance change curve;
and the fitting module is used for fitting the data between the starting point A and the end point B by adopting a preset function model to obtain a new absorbance change curve.
The stable reaction time can accurately reflect the actual condition of the reaction of the sample and the reagent; the fitted curve more closely approximates the reality of the sample reacting with the reagent. And the fitted curve is easier to filter, and abnormal data points can be eliminated.
Specifically, in order to determine whether or not the prozone effect is present in the sample reaction, in the high concentration sample discrimination device according to the present embodiment, the comparison determination module determines that the sample is a high concentration sample when the first parameter value is larger than the determination threshold R. When the sample is determined to be a high concentration sample, the detection sample is labeled with an excessive amount of antigen.
The embodiment of the invention also discloses a detection system, as shown in fig. 8, which comprises a light source system composed of a light source 1, a lens 2, a filter 3 and an optical fiber 4, wherein the light source system is located at one side of a reaction cup 5, light emitted by the light source is irradiated on the reaction cup 5, a sample to be detected which is undergoing reaction is placed in the reaction cup 5, a receiver 6 is arranged at the other side of the reaction cup 5 opposite to the light source system, the receiver 6 is used for receiving transmitted light which penetrates through the reaction cup 5, a signal acquisition circuit in the receiver 6 converts the received transmitted light into transmitted light, and a processor connected with the receiver 6 executes the following operations when detection is carried out:
processing the original signal reaction data of the sample to obtain an absorbance change curve;
intercepting a first curve segment corresponding to the absorbance change curve according to a preset first starting time and a preset first ending time, and intercepting a second curve segment corresponding to the absorbance change curve according to a preset second starting time and a preset second ending time, wherein the length of a data sequence corresponding to the first curve segment is equal to that of a data sequence corresponding to the second curve segment;
calculating a first parameter value capable of reflecting the difference of the bending degrees between the first curve segment and the second curve segment through the absorbance data sequence corresponding to the first curve segment and the absorbance data sequence corresponding to the second curve segment;
and judging whether the sample is a high-concentration sample or not by comparing the first parameter value with a judgment threshold value R.
After the receiver 6 receives the transmitted light signal, the detection system executes the high-concentration sample identification method through the processor, so that the detection system disclosed in this embodiment has the technical advantages corresponding to the high-concentration sample identification method, which is not described herein again.
The method, apparatus and detection system for identifying a high concentration sample disclosed in the present invention are described in detail above. The principles and embodiments of the present invention are explained herein using specific examples, which are presented only to assist in understanding the method and its core concepts. It should be noted that, for those skilled in the art, it is possible to make various improvements and modifications to the present invention without departing from the principle of the present invention, and those improvements and modifications also fall within the scope of the claims of the present invention.

Claims (6)

1. A high-concentration sample identification method is characterized by comprising the following steps:
processing the original signal reaction data of the sample to obtain an absorbance change curve;
intercepting a first curve segment corresponding to the absorbance change curve according to a preset first starting time and a preset first ending time, and intercepting a second curve segment which is equal to the data sequence length corresponding to the first curve segment and is positioned on the absorbance change curve according to a preset second starting time and a preset second ending time;
calculating a first parameter value capable of reflecting the difference of the bending degree between the first curve segment and the second curve segment according to the difference/quotient of the absorbance data sequence corresponding to the first curve segment and the absorbance data sequence corresponding to the second curve segment;
the first parameter value is the variance/standard deviation of the difference between the absorbance data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment, or
The first parameter value is the variance/standard deviation of the quotient of the absorbance data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment;
and if the first parameter value is larger than a judgment threshold value R, judging that the sample is a high-concentration sample.
2. The method of claim 1, wherein: the step of processing the original signal reaction curve of the sample to obtain the absorbance change curve comprises the following steps:
determining a starting point A of the stable reaction of the sample and an end point B of the reaction end of the sample according to the absorbance change curve;
and fitting the data between the starting point A and the end point B by adopting a preset function model to obtain a new absorbance change curve.
3. The method of claim 2, wherein: the first starting time is a time point corresponding to a starting point A of the sample stable reaction, and the second ending time is a time point corresponding to an ending point B of the sample reaction.
4. A high concentration sample discrimination apparatus, comprising:
the data processing module is used for processing the original signal reaction curve of the sample to obtain an absorbance change curve;
a curve segment intercepting module, configured to intercept a first curve segment corresponding to the absorbance change curve according to a preset first start time and a preset first end time, and intercept a second curve segment, which is equal to a data sequence length corresponding to the first curve segment, on the absorbance change curve according to a preset second start time and a second end time;
the calculation module is used for calculating a first parameter value capable of reflecting the difference of the bending degrees between the first curve segment and the second curve segment according to the difference/quotient of the absorbance data sequence corresponding to the first curve segment and the absorbance data sequence corresponding to the second curve segment; the first parameter value is a variance/standard deviation of a difference between the absorbance data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment, or the first parameter value is a variance/standard deviation of a quotient between the absorbance data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment;
the comparison and judgment module is used for judging whether the sample is a high-concentration sample or not by comparing the first parameter value with a judgment threshold value R;
the comparison determination module determines that the sample is a high concentration sample when the first parameter value is greater than the determination threshold value R.
5. The apparatus of claim 4, wherein: also comprises
The stable reaction time determining module is used for determining a starting point A of the stable reaction of the sample and an end point B of the reaction end of the sample according to the absorbance change curve;
and the fitting module is used for fitting the data between the starting point A and the end point B by adopting a preset function model to obtain a new absorbance change curve.
6. A detection system comprising a light source subsystem for illuminating a cuvette, a receiver for receiving transmitted light transmitted through the cuvette, and a processor coupled to the receiver, wherein the processor performs the following operations in performing a sample reaction absorbance detection:
processing an original signal reaction curve of the sample to obtain an absorbance change curve;
intercepting a first curve segment corresponding to the absorbance change curve according to a preset first starting time and a preset first ending time, and intercepting a second curve segment which is equal to the data sequence length corresponding to the first curve segment and is positioned on the absorbance change curve according to a preset second starting time and a preset second ending time;
calculating a first parameter value capable of reflecting the difference of the bending degree between the first curve segment and the second curve segment according to the difference/quotient of the absorbance data sequence corresponding to the first curve segment and the absorbance data sequence corresponding to the second curve segment;
the first parameter value is the variance/standard deviation of the difference between the absorbance data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment, or
The first parameter value is the variance/standard deviation of the quotient of the absorbance data sequence corresponding to the second curve segment and the absorbance data sequence corresponding to the first curve segment;
and if the first parameter value is larger than a judgment threshold value R, judging that the sample is a high-concentration sample.
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