Detection method and application of electronic detection pen

By introducing the quality control area data and adopting specific data processing steps, the error problem caused by uncontrollable factors during the electronic detection pen detection process is solved, and the stability and accuracy of the detection results are improved.

CN119845933APending Publication Date: 2025-04-18GUANGZHOU DECHENG BIOTECHNOLOGY CO LTD
View PDF 0 Cites 0 Cited by

Patent Information

Application Number
CN202311343115.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2023-10-17
Publication Date
2025-04-18

AI Technical Summary

Technical Problem

There are various uncontrollable factors during the detection process of the electronic detection pen, which leads to problems with the reagent release, the color rendering consistency of the detection area and the quality control area, and the error increases, which in turn affects the stability and accuracy of the detection results.

Method used

By introducing the data in the quality control area as a reference to the judgment of the detection result, specific data processing steps are adopted, including collecting data in the initial sampling stage and the end detection stage, and reducing the errors of the chromatography and reagent card through initial value replacement and data quotient processing, and improving the stability of the detection result.

Benefits of technology

It effectively reduces the calculation result error caused by chromatography and reagent card errors, solves the problem of unstable detection results, and improves the detection accuracy and reliability of the electronic detection pen.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure BDA0004497883880000072
    Figure BDA0004497883880000072
  • Figure BDA0004497883880000081
    Figure BDA0004497883880000081
  • Figure BDA0004497883880000092
    Figure BDA0004497883880000092
Patent Text Reader

Abstract

The invention discloses a detection method and application of an electronic detection pen, and the method comprises the steps: carrying out the value selection of a detection line and a reference line within the total time of sampling detection, and obtaining N groups of data after the value selection of the detection line and the reference line is completed each time; in the time of the initial sampling stage, comparing the Mth group of data with the (M-1) th group of data to obtain initial value data T0 and C0; obtaining final value data Tn corresponding to the detection line and final value data Cn corresponding to the reference line within the time of the detection ending stage; and processing the final value data to obtain T final and C final, carrying out quotient on the C final and the T final in the same group to obtain a group of quotient values, then carrying out data processing, and comparing an obtained result judgment numerical value with a preset threshold value to obtain a detection result. According to the invention, the data of the quality control area is used as reference to be introduced into the judgment of the detection result, so that the calculation result error caused by the error of chromatography and reagent cards is effectively reduced, and the problem of misjudgment easily caused by the unstable detection result in the mass production process is solved.
Need to check novelty before this filing date? Find Prior Art

Description

Technical Field

[0001] The invention belongs to the technical field of electronic detection pens, and in particular relates to a detection method and application of an electronic detection pen. Background Art

[0002] The application field of electronic test pens is getting bigger and bigger. For example, in the field of early pregnancy and ovulation detection, electronic test pens are widely used for detection. The electronic test pen contains a reagent strip, and its detection is based on immunochromatography, such as the immunogold labeling assay principle and the double antigen sandwich assay principle. The judgment principle of the electronic test pen is to use a single-wavelength LED light to illuminate the detection area (T line) and the quality control area (C line), and then use the photoelectric conversion principle to convert the reflected light into an electrical signal, and then quantify the electrical signal. Finally, the algorithm is used to obtain the color of the detection area and the quality control area, and the corresponding judgment result is given. Generally speaking, the role of the quality control area is only to determine whether the reagent strip is still valid. As long as its color change is detected, the color development result of the detection area is more concerned. However, there are various uncontrollable factors in the detection process that may affect the final test results. For example, improper sample addition methods and techniques may lead to problems in the release of reagents, poor color consistency in the detection area and the quality control area, and increased errors; or in the production process of the reagent strip, errors in the color of the detection area and the quality control area due to the production process; or errors in the production process of the monochromatic LED light may lead to large errors in the photoelectric conversion process. Therefore, it is necessary to propose a new detection method for electronic detection pens. Summary of the invention

[0003] In order to solve the above technical problems, the purpose of the present invention is to provide a detection method and application of an electronic detection pen, introduce the data of the quality control area as a reference into the judgment of the test results, effectively reduce the calculation result error caused by the errors of chromatography and reagent cards, and solve the problem of misjudgment caused by unstable test results during mass production.

[0004] In order to achieve the above-mentioned invention object, the technical solution adopted by the present invention is as follows:

[0005] In a first aspect of the present invention, the present invention provides a detection method for an electronic detection pen, comprising the following steps:

[0006] S1. During the total sampling and testing time, the test line and the reference line are valued. After the test line and the reference line are valued each time, the value is recorded as a set of data, and a total of N sets of data are obtained, where N ≥ 2;

[0007] S2. During the initial sampling period, the data of the Mth group is compared with the data of the M-1th group. If the result meets the preset initial value condition, the data of the Mth group is used to replace the data of the M-1th group as the initial value data T0 and C0 of the detection line and the reference line, where M≥1 and M<N;

[0008] S3, the Nmth group, the N-(m-1)th group, ... to the m+1th group of data in the end stage of the detection are used as the final calculated data, where m<N and m≥1, to obtain a set of detection final value data T corresponding to the detection line n The detection final value data C corresponding to a set of reference lines n , n≥Nm and n≤N;

[0009] S4, process T based on T0 n The final value data of T 终 , taking C0 as the benchmark to process C n The final value data of C 终 , the same group of C 终 With T 终 After taking the quotient, a set of quotient values ​​is obtained, data processing is performed on this set of quotient values ​​to obtain a result judgment value, and the result judgment value is compared with a preset threshold to obtain a corresponding test result.

[0010] Preferably, in step S2, the initial condition is to set the data T of the Mth group M , C M With the data T of group M-1 M-1 , C M-1 By comparison, when 0.98<(C M / C M-1 ) / (T M / T M-1 )<1.02, and C M / C0≤1.25 and T M When / T0≤1.25, the data of group M replaces the data of group M-1 as the initial value data T0 and C0 of the detection line and the reference line, otherwise the data of group M does not replace the data of group M-1;

[0011] When C M / C0>1.25 or T M When / T0>1.25, the data of the Mth group does not replace the data of the M-1th group.

[0012] Preferably, in step S3, the value of m is 5 to 11, and 6 to 12 groups of continuous data are obtained in the end stage of detection.

[0013] Preferably, in step S4, C 终 With T终 After taking the quotient, a group of quotient values ​​are obtained, and the group of quotient values ​​are summed to obtain a result judgment value, and the result judgment value is compared with a preset threshold to obtain a corresponding detection result.

[0014] More preferably, in step S4, the calculation formula of the result judgment value is: Among them, f(T,C) is the result judgment value, T0 is the initial value data of the detection line, T n is the nth group of data of the test line used in the end stage of the test, C0 is the initial value data of the reference line, C n It is the nth group of data of the reference line used in the end stage of detection. A is a constant for easy calculation. For example, A is 1. Preferably, A is 1000.

[0015] More preferably, in step S4, the calculation formula of the result judgment value is: Among them, f(T,C) is the result judgment value, T0 is the initial value data of the detection line, T n is the nth group of data of the test line used in the end stage of the test, C0 is the initial value data of the reference line, C n is the nth set of data of the reference line used in the end stage of detection, and A is a constant.

[0016] More preferably, when the result judgment value is less than or equal to the preset threshold, the electronic detection pen displays the test result as positive, and when the result judgment value is greater than the preset threshold, the electronic detection pen displays the test result as negative; or, when the result judgment value is greater than or equal to the preset threshold, the electronic detection pen displays the test result as positive, and when the result judgment value is less than the preset threshold, the electronic detection pen displays the test result as negative.

[0017] Preferably, in step S1, values ​​of the detection line and the reference line are taken at equal time intervals to obtain N groups of data.

[0018] Preferably, the preset threshold value is set by: according to the lower limit of the positive result detected, within the total sampling detection time, using an effective electronic detection pen to detect the standard sample with the lowest detection concentration, obtaining N groups of test line and reference line data, and obtaining m+1 groups of data in the end stage of the detection, and obtaining C 终 With T 终 After obtaining the quotient value, the quotient value is processed to obtain a preset threshold value corresponding to the detection lower limit.

[0019] In a second aspect of the present invention, the present invention provides an application of a detection method for an electronic detection pen, wherein the above detection method is applied to the electronic detection pen.

[0020] Beneficial effects:

[0021] The present invention detects the color change of the quality control area, and introduces the data of the quality control area as a reference in the judgment of the test result, effectively reducing the calculation result error caused by the error of the chromatography and the reagent card, and solving the problem of misjudgment caused by unstable test results in the mass production process, which has great application value and promotion significance. DETAILED DESCRIPTION

[0022] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the specific implementation of the present invention will be described below. Obviously, for ordinary technicians in the field, other implementations can be obtained without creative work.

[0023] The present invention provides a detection method for an electronic detection pen, which introduces a quality control area (i.e., C line) that is currently not taken seriously as a reference line. The reference line is used to refer to the C line of the present invention. The present invention pays attention to both the detection line (i.e., T line) and the reference line, and uses the reference line as a basis for auxiliary judgment, and then combines the photoelectric conversion data of the detection line to obtain the corresponding detection result. It is easy to understand that in the present invention, the preparation of the reagent strip is no different from the prior art. The present invention proposes a new detection method to reduce errors and improve detection accuracy.

[0024] The detection method of the present invention comprises the following steps:

[0025] S1. During the total sampling and testing time, the test line and the reference line are valued. After the test line and the reference line are valued each time, the value is recorded as a set of data, and a total of N sets of data are obtained, where N ≥ 2;

[0026] S2. During the initial sampling period, the data of the Mth group is compared with the data of the M-1th group. If the result meets the preset initial value condition, the data of the Mth group is used to replace the data of the M-1th group as the initial value data T0 and C0 of the detection line and the reference line, where M≥1 and M<N;

[0027] S3, the Nmth group, the N-(m-1)th group, ... to the m+1th group of data in the end stage of the detection are used as the final calculated data, where m<N and m≥1, to obtain a set of detection final value data T corresponding to the detection line n The detection final value data C corresponding to a set of reference lines n , n≥Nm and n≤N;

[0028] S4, process T based on T0 n The final value data of T 终 , taking C0 as the benchmark to process C n The final value data of C 终 , the same group of C终 With T 终 After taking the quotient, a set of quotient values ​​is obtained, data processing is performed on this set of quotient values ​​to obtain a result judgment value, and the result judgment value is compared with a preset threshold to obtain a corresponding test result.

[0029] It is easy to understand that the sampling initial stage of step S2 does not overlap with the detection end stage of step S3, and the sum of the time of the sampling initial stage and the detection end stage should be less than or equal to the total time of the sampling detection. That is, according to the time axis, the sampling initial stage and the detection end stage are equivalent to the front and back ends of the sampling detection. Therefore, the data used in step S2 will not overlap with the data used in step S3, and the data used in step S3 is after the data used in step S2.

[0030] In steps S1 and S2, the present invention jointly determines the initial value data with the detection data of the detection area and the quality control area to ensure the stability of the detection results. In the prior art, generally, in the initial stage of sampling, only the sampling data of the detection line is concerned, and the data of the quality control line is not included in the sampling operation. As long as the color change of the quality control line is finally detected, it is sufficient. This is generally determined by comparing the changes in the quantitative data of its electrical signal. However, the detection data of the electronic detection pen is affected by many factors. For example, due to the error in the color development of the detection area and the quality control area introduced by the production process, or the error introduced by the production process of the monochrome LED lamp, it may cause a large error in the photoelectric conversion process. The situation where the sample does not flow to the quality control line or the quality control line fails may be mistakenly judged as a valid test result. For example, even if the sample only flows to the detection line area and stops, and the normal chromatography process is not completed, if the electronic detection pen finally determines that the quality control line data is valid, then an incorrect test result will be output.

[0031] The present invention simultaneously collects the data of the detection line and the reference line during the initial stage of sampling. Only when the data of the detection line and the reference line are valid at the same time can they be used as initial value data. In addition, in the initial stage of sampling, the subsequent valid data replaces the previous valid data as the initial value, which is beneficial to the accuracy of data processing in subsequent steps.

[0032] The total time of the sampling test in step S1 is generally determined, which depends on the specific test items. The present invention is not limited to this. For example, the detection time of an electronic test pen used to detect whether a woman is pregnant is generally 3-5 minutes. The present invention takes values ​​of the test line and the reference line at equal time intervals (such as 3 seconds) within the total time of the sampling test to obtain N groups of data. The number of data groups is related to the sampling time interval. The larger the sampling time interval, the fewer the data groups. On the contrary, the smaller the sampling time interval, the more the data groups. N represents the sequence number of the detection sampling points arranged in chronological order.

[0033] The initial value condition of the present invention refers to a pre-set condition. Specifically, during the initial sampling period, the data T of the Mth group is M , C M With the data T of group M-1 M-1 , C M-1 By comparison, when 0.98<(C M / C M-1 ) / (T M / T M-1 )<1.02 and C M / C0≤1.25 and T M When / T0≤1.25, the data of group M will replace the data of group M-1 as the initial value data T0 and C0 of the detection line and reference line. Otherwise, no replacement will be made. When C M / C0>1.25 or T M When / T0>1.25, the data of the Mth group does not replace the data of the M-1th group.

[0034] It should be noted that when the first set of data is obtained, the set of data is used as T0 and C0. When other sets of data are replaced later, the values ​​of T0 and C0 are updated.

[0035] It is easy to understand that compared with the total time of sampling detection, the time of the initial sampling stage is shorter. In the present invention, when C M / C0>1.25 and T M When / T0>1.25, the initial sampling phase ends.

[0036] In step S3, the time of the end stage of the detection refers to the time period of the last stage of the total sampling detection time. During this time period, the results of the detection line tend to be stable, and it is feasible to use the data of this stage as the basis for calculation and judgment.

[0037] Multiple groups of data including the last group of data are continuously taken during the time period. It is easy to understand that the more data sampled in the end stage of detection, the better. In order to take into account both detection efficiency and detection quality, preferably, the value of m is 5 to 11, that is, 6 to 12 groups of continuous data are taken in the end stage of detection. For example, when 6 groups of data are taken, the data of the N-5th group, the N-4th group, the N-3rd group, the N-2nd group, the N-1st group and the Nth group are taken respectively; when 12 groups of data are taken, the data of the N-11th group, the N-10th group, the N-9th group, ..., the Nth group are taken respectively.

[0038] In step S4, the present invention adopts a processing idea different from the prior art. In the prior art, the main difference between the reagent strip and the test line (test area) when testing negative and positive samples is determined by the color depth of the test line. Therefore, the T value (i.e., the value of the test line) will change significantly before and after the sample is added. The prior art method is to make a difference between the final value and the initial value of the T value to make a judgment. If the difference exceeds the preset value, it means that the color change of the test line is large, and if the difference is lower than the preset value, it means that the color change of the test line is small. However, the detection method of the prior art cannot remove the errors introduced by various electronic components and circuit board processing in the photoelectric conversion process, resulting in poor stability of the final result interpretation.

[0039] The present invention pays attention to the fact that the errors introduced by various electronic components and circuit board processing in the photoelectric conversion process will also be reflected in the color change of the quality control line. In an effective electronic detection pen, the color change of the quality control line is small and can be regarded as stable. Therefore, the present invention introduces the quality control line into the judgment of the test result, and processes T0 as the reference. n The data is processed based on C0 n Data is processed through proportional relationship C 终 and T 终 , most of the error factors of the electronic detection pen are removed, so that the change results of the detection line are displayed more clearly and accurately. The error of the reagent strip and the instability of the sample addition are easy to cause the phenomenon of secondary release, and the abnormality of the electronic circuit is easy to cause the abnormality of the single point result. When calculating the final result, the present invention adopts a method of multi-point sampling processing and then performs data processing on the quotient value to reduce the adverse effects of single point abnormality and reagent secondary release.

[0040] It is easy to understand that the preset threshold can be determined by the same processing method through the standard experiment, that is, according to the upper or lower limit of the positive result detected, the standard samples of different concentrations are detected by multiple effective electronic detection pens to obtain N groups of data, and the m+1 groups of data are obtained at the end of the detection stage, so as to obtain C 终 With T 终 After the quotient is calculated, data processing is performed on the quotient value to determine the preset threshold value.

[0041] Furthermore, for C 终 and T 终 There are also various ways to process the quotient value. For example, the quotient value can be summed to obtain the result judgment data. According to the C obtained from the m+1 group of data at the end of the detection 终 With T 终 After taking the quotient, the sum is calculated, and the sum value is related to the number of data groups used. When the number of groups increases, the sum value increases, and the preset threshold value also changes accordingly.

[0042] Since C is the denominator 终It is relatively stable. The more obvious the color of the test line is, the higher the T value of the data used in the end stage of the test. n The larger the T 终 The larger the C 终 With T 终 The smaller the quotient is, the smaller the calculation result of the sum of multiple groups of quotient values ​​is compared to the calculation result when the test line color is not obvious. When the test line color represents a positive, when the sum is less than or equal to the preset threshold, the test result is displayed as "positive", and when the sum is greater than the preset threshold, the test result is displayed as "negative". Similarly, when the test line color represents a negative, when the sum is less than or equal to the preset threshold, the test result is displayed as "negative", and when the sum is greater than the preset threshold, the test result is displayed as "positive".

[0043] Alternatively, the T obtained from the m+1 group of data at the end of the detection can be 终 With C 终 The sum is related to the number of data sets used. When the number of sets increases, the sum becomes larger, and the preset threshold also changes accordingly. It is easy to understand that when T 终 The larger the T 终 With C 终 The larger the quotient value, the larger the calculation result of the sum of multiple groups of quotient values ​​is compared to the calculation result when the test line color is not obvious. When the test line color represents a positive, when the sum value is greater than or equal to the preset threshold, the test result is displayed as "positive", and when the sum value is less than the preset threshold, the test result is displayed as "negative". Similarly, when the test line color represents a negative, when the sum value is greater than or equal to the preset threshold, the test result is displayed as "negative", and when the sum value is less than the preset threshold, the test result is displayed as "positive".

[0044] In step S4, T n and C n There are various ways to process data. It should be noted that for T n The data processing method and C n The data processing method should be consistent. For example, the m+1 groups of test line data and reference line data used in the end stage of the test are subtracted from the initial value data, and then the two are summed up. That is, It is easy to understand that in the present invention, T n and C n The data processing method for the data of the quotient value can also be other methods, such as common data statistical processing methods such as standard deviation and variance. The present invention innovatively introduces the quality control line data as the data processing of the detection line to reduce the adverse effects of data errors on the results.

[0045] Preferably, the present invention calculates the quotient of m+1 groups of detection line data and reference line data with the initial value data, and then sums the quotients of the two, that is, Among them, f(T,C) is the result judgment value, T0 is the initial value data of the detection line, T n is the nth group of data of the test line used in the end stage of the test, C0 is the initial value data of the reference line, C n It is the nth group of data of the reference line used in the end stage of the detection. A is a positive integer constant, such as A is 1. Preferably, A is 1000. The final value of T value is divided by the initial value of T value. This can effectively avoid errors introduced by electronic components and circuit board processing, and effectively improve the stability of the detection results.

[0046] Preferably, the present invention may also process m+1 groups of detection line data and reference line data in the following manner: Among them, f(T,C) is the result judgment value, T0 is the initial value data of the detection line, T n is the nth group of data of the test line used in the end stage of the test, C0 is the initial value data of the reference line, C n is the nth group of reference line data used in the end stage of detection, A is a constant, which can be a positive integer, such as A is 1, preferably, A is 1000. Since the reference line data does not change much in general, C n Using / C0 as the denominator can more intuitively determine the changes in the test line data.

[0047] The present invention also provides conditions for judging whether the electronic detection pen is valid. In the total sampling detection time, if multiple groups of data in N groups of data meet the following conditions, the data of the electronic detection pen is valid: C a / C0>1.25,T b / T0>1.25,C a Refers to the reference line data of the ath group of data, 1≤a≤N, T b Refers to the detection line data of the bth group of data, 1≤b≤N, a and b can be the same or different, otherwise, the data of the electronic detection pen is invalid.

[0048] It should be noted that in the present invention, the "stability" of the electronic detection pen refers to the stability of the final detection results during industrial mass production, that is, the electronic detection pen can stably and effectively obtain detection results between different products in the same batch or between different products in different batches.

[0049] The technical solution of the present invention is described in detail below with specific embodiments.

[0050] The detection method of the present invention is adopted and an effective electronic detection pen is used to detect negative samples and positive samples.

[0051] Example 1

[0052] The test item is human chorionic gonadotropin (HCG), the detection time is 100s, and an electronic detection pen is used to test three groups of negative samples with the same concentration and three groups of positive samples with the same concentration. Each sample obtains 59 sets of data within the total sampling and detection time. T0 and C0 are obtained during the initial sampling stage, and the last 6 sets of data are obtained during the end of the detection stage. The data obtained are shown in Tables 1 and 3 below. The calculation formula is Wherein, A=1000, the data processing results are shown in Tables 2 and 4 below, the preset threshold is 5300, the result greater than 5300 is negative, and the result less than or equal to 5300 is positive.

[0053] Table 1 Human chorionic gonadotropin (HCG) negative sample test data

[0054]

[0055]

[0056] Table 2 Processing results of negative sample test data of human chorionic gonadotropin (HCG)

[0057] 1 2 3 <![CDATA[(C 54 / C0) / (T 54 / T0)]]> 1.026 1.029 1.019 <![CDATA[(C 55 / C0) / (T 55 / T0)]]> 1.023 1.029 1.024 <![CDATA[(C 56 / C0) / (T 56 / T0)]]> 1.026 1.026 1.021 <![CDATA[(C 57 / C0) / (T 57 / T0)]]> 1.025 1.028 1.018 <![CDATA[(C 58 / C0) / (T 58 / T0)]]> 1.022 1.029 1.024 <![CDATA[(C 59 / C0) / (T 59 / T0)]]> 1.025 1.028 1.020 Calculation results 6147 6169 6126

[0058] Table 3 Human chorionic gonadotropin (HCG) positive sample test data

[0059] 4 5 6 <![CDATA[T0]]> 1785 2020 1485 <![CDATA[C0]]> 2062 1680 1575 <![CDATA[T 54 ]]> 3024 3420 2475 <![CDATA[C 54 ]]> 2399 1961 1842 <![CDATA[T 55 ]]> 3030 3424 2479 <![CDATA[C 55 ]]> 2395 1958 1846 <![CDATA[T 56 ]]> 3030 3429 2480 <![CDATA[C 56 ]]> 2392 1956 1839 <![CDATA[T 57 ]]> 3027 3429 2472 <![CDATA[C 57 ]]> 2388 1950 1837 <![CDATA[T 58 ]]> 3033 3426 2476 <![CDATA[C 58 ]]> 2383 1951 1836 <![CDATA[T 59 ]]> 3036 3428 2477 <![CDATA[C 59 ]]> 2383 1947 1836

[0060] Table 4 Processing results of positive sample test data of human chorionic gonadotropin (HCG)

[0061] 4 5 6 <![CDATA[(C 54 / C0) / (T 54 / T0)]]> 0.687 0.689 0.702 <![CDATA[(C 55 / C0) / (T 55 / T0)]]> 0.684 0.688 0.702 <![CDATA[(C 56 / C0) / (T 56 / T0)]]> 0.683 0.686 0.699 <![CDATA[(C 57 / C0) / (T 57 / T0)]]> 0.683 0.684 0.701 <![CDATA[(C 58 / C0) / (T 58 / T0)]]> 0.680 0.685 0.699 <![CDATA[(C 59 / C0) / (T 59 / T0)]]> 0.679 0.683 0.699 Calculation results 4096 4115 4202

[0062] According to the comparison of the original data in Tables 1 and 3, even for the same batch of electronic detection pens, there are differences in the data obtained when testing samples. After the calculation of the present invention, the factors affecting the test results can be eliminated to obtain more accurate test result data, as shown in Tables 2 and 4.

[0063] In this test item, the color of the test line represents a positive result. Based on the calculation formula, when the sum is less than the preset threshold, the test result is displayed as "positive", and when the sum is greater than or equal to the preset threshold, the test result is displayed as "negative". It can be seen that the test results of the present invention are in line with the actual situation.

[0064] Example 2

[0065] The test item is luteinizing hormone (LH), the detection time is 180s, and an electronic detection pen is used to test three groups of negative samples with the same concentration and three groups of positive samples with the same concentration. Each sample obtains 59 sets of data within the total sampling and detection time. T0 and C0 are obtained during the initial sampling stage, and the last 6 sets of data are obtained during the end of the detection stage. The data obtained are shown in Tables 5 and 7 below. The calculation formula is Wherein, A=1000, the data processing results are shown in Tables 6 and 8 below, the preset threshold is 5500, the result greater than 5500 is positive, and the result less than or equal to 5500 is negative.

[0066] Table 5 Negative sample test data of luteinizing hormone (LH)

[0067]

[0068]

[0069] Table 6 Processing results of luteinizing hormone (LH) negative sample test data

[0070] 1 2 3 <![CDATA[(C 55 / C0) / (T 55 / T0)]]> 0.673 0.678 0.685 <![CDATA[(C 56 / C0) / (T 56 / T0)]]> 0.669 0.677 0.685 <![CDATA[(C 57 / C0) / (T 57 / T0)]]> 0.671 0.675 0.682 <![CDATA[(C 58 / C0) / (T 58 / T0)]]> 0.667 0.676 0.683 <![CDATA[(C 59 / C0) / (T 59 / T0)]]> 0.667 0.674 0.681 <![CDATA[(C 60 / C0) / (T 60 / T0)]]> 0.667 0.673 0.680 Calculation results 4014 4053 4096

[0071] Table 7 Luteinizing hormone (LH) positive sample test data

[0072]

[0073]

[0074] Table 8 Processing results of luteinizing hormone (LH) positive sample test data

[0075] 4 5 6 <![CDATA[(C 55 / C0) / (T 55 / T0)]]> 1.027 1.016 1.038 <![CDATA[(C 56 / C0) / (T 56 / T0)]]> 1.029 1.016 1.037 <![CDATA[(C 57 / C0) / (T 57 / T0)]]> 1.029 1.019 1.035 <![CDATA[(C 58 / C0) / (T 58 / T0)]]> 1.027 1.016 1.035 <![CDATA[(C 59 / C0) / (T 59 / T0)]]> 1.025 1.017 1.036 <![CDATA[(C 60 / C0) / (T 60 / T0)]]> 1.029 1.014 1.036 Calculation results 6166 6098 6217

[0076] According to the comparison of the original data in Tables 5 and 7, even for the same batch of electronic detection pens, there are differences in the data obtained when testing samples. After the calculation of the present invention, the factors affecting the test results can be eliminated to obtain more accurate test result data, as shown in Tables 6 and 8.

[0077] In this test item, the color of the test line represents negative. Based on the calculation formula, when the sum is greater than the preset threshold, the test result is displayed as "positive", and when the sum is less than or equal to the preset threshold, the test result is displayed as "negative". It can be seen that the test results of the present invention are consistent with the actual situation.

[0078] According to the data of Examples 1 and 2, the present invention can obtain correct test results and effectively reduce the calculation result errors caused by errors in chromatography and reagent cards, solving the problem of misjudgment caused by unstable test results in mass production, so it has great application value.

[0079] The embodiments provided by the present invention are described in detail above. Specific examples are used herein to describe the principles and implementation methods of the present invention, and the description of the above embodiments is only used to help understand the core idea of ​​the present invention. It should be pointed out that for ordinary technicians in this technical field, without departing from the principles of the present invention, the present invention can also be improved and modified in a number of ways, and these improvements and modifications also fall within the scope of protection of the claims of the present invention.

Claims

1. A detection method for an electronic detection pen, characterized in that: The following steps are involved: S1. During the total sampling and testing time, the test line and the reference line are valued. After the test line and the reference line are valued each time, the value is recorded as a set of data, and a total of N sets of data are obtained, where N ≥ 2; S2. During the initial sampling period, the data of the Mth group is compared with the data of the M-1th group. If the result meets the preset initial value condition, the data of the Mth group is used to replace the data of the M-1th group as the initial value data T0 and C0 of the detection line and the reference line, where M≥1 and M<N; S3. During the end of the detection phase, the Nmth group, the N-(m-1)th group, ... to the Nth group of data m+1 groups of data are used as the final calculated data, where m<N and m≥1, to obtain a set of detection final value data T corresponding to the detection line n The detection final value data C corresponding to a set of reference lines n , n≥Nm and n≤N; S4, process T based on T0 n The final value data of T 终 , taking C0 as the benchmark to process C n The final value data of C 终 , the same group of C 终 With T 终 After taking the quotient, a set of quotient values ​​is obtained, data processing is performed on this set of quotient values ​​to obtain a result judgment value, and the result judgment value is compared with a preset threshold to obtain a corresponding test result.

2. The detection method according to claim 1, characterized in that: In step S2, the initial condition is to set the data T of the Mth group M , C M With the data T of group M-1 M-1 , C M-1 By comparison, when 0.98<(C M / C M-1 ) / (T M / T M-1 )<1.02, and C M / C0≤1.25 and T M When / T0≤1.25, the data of the Mth group replaces the data of the M-1th group and serves as the initial value data T0 and C0 of the detection line and the reference line.

3. The detection method according to claim 1, characterized in that: In step S3, the value of m is 5 to 11, and 6 to 12 groups of continuous data are obtained in the detection end stage.

4. The detection method according to claim 1, characterized in that: In step S4, the C 终 With T 终 After taking the quotient, a group of quotient values ​​are obtained, and the group of quotient values ​​are summed to obtain a result judgment value, and the result judgment value is compared with a preset threshold to obtain a corresponding detection result.

5. The detection method according to claim 4, characterized in that: In step S4, the calculation formula of the result judgment value is: Among them, f(T,C) is the result judgment value, T0 is the initial value data of the detection line, T n is the nth group of data of the test line used in the end stage of the test, C0 is the initial value data of the reference line, C n is the nth set of data of the reference line used in the end stage of detection, and A is a constant.

6. The detection method according to claim 4, characterized in that: In step S4, the calculation formula of the result judgment value is: Among them, f(T,C) is the result judgment value, T0 is the initial value data of the detection line, T n is the nth group of data of the test line used in the end stage of the test, C0 is the initial value data of the reference line, C n is the nth set of data of the reference line used in the end stage of detection, and A is a constant.

7. The detection method according to any one of claims 1 to 6, characterized in that: When the result judgment value is less than or equal to the preset threshold, the electronic detection pen displays the test result as positive; when the result judgment value is greater than the preset threshold, the electronic detection pen displays the test result as negative; Or, when the result judgment value is greater than or equal to the preset threshold, the electronic detection pen displays the test result as positive; when the result judgment value is less than the preset threshold, the electronic detection pen displays the test result as negative.

8. The detection method according to claim 1, characterized in that: In step S1, values ​​of the detection line and the reference line are taken at equal time intervals to obtain N groups of data.

9. The detection method according to claim 1, characterized in that: The preset threshold is set by: according to the lower limit of the positive result detected, within the total sampling time, using an effective electronic detection pen to detect the standard sample with the lowest detection concentration, obtaining N sets of test line and reference line data, and obtaining m+1 sets of data at the end of the detection phase, and obtaining T 终 With C 终 After obtaining the quotient value, the quotient value is processed to obtain a preset threshold value corresponding to the detection lower limit.

10. An application of a detection method for an electronic detection pen, characterized in that: The detection method according to any one of claims 1 to 9 is applied to an electronic detection pen.