WO2017012168A1 - Procédé de détection biochimique optimisée approprié pour un examen médical - Google Patents

Procédé de détection biochimique optimisée approprié pour un examen médical Download PDF

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WO2017012168A1
WO2017012168A1 PCT/CN2015/088075 CN2015088075W WO2017012168A1 WO 2017012168 A1 WO2017012168 A1 WO 2017012168A1 CN 2015088075 W CN2015088075 W CN 2015088075W WO 2017012168 A1 WO2017012168 A1 WO 2017012168A1
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detection
absorbance
time
item
standard
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PCT/CN2015/088075
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English (en)
Chinese (zh)
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张陆军
曹宁
徐新
詹小勇
周强
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江苏英诺华医疗技术有限公司
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Publication of WO2017012168A1 publication Critical patent/WO2017012168A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor

Definitions

  • the invention relates to the technical field of medical examination, in particular to an optimized biochemical detection method suitable for medical examination.
  • Biochemical analyzer is a very commonly used testing instrument in clinical medical testing. It is also an important tool in clinical diagnosis. With the progress of related research and the popularization and application of biochemical detection technology, biochemical testing projects are increasing rapidly, so the biochemical testing is automated. The level of intelligence and the accuracy and reliability of the test results put forward higher requirements. However, there are some shortcomings in the existing design of such instruments, which cannot meet the actual needs well. These problems are mainly manifested in the following two aspects:
  • the setting of the biochemical detection parameters includes some simple fixed parameters: such as the name of the project, the type of detection method, the content and unit of the standard, the detection wavelength, etc. These parameters are relatively easy to set in the fixed parameters determined when the kit is designed.
  • the detection time condition of each item is “variable parameter”, and adjustments and modifications must be made due to various conditions and factors to obtain correct detection results. For example, when using the same brand and model biochemical analyzer for the same project test, if the reagents used come from different production plants or even different batch numbers, the setup time conditions required for the test are often different.
  • the biochemical detection time range is also affected by some uncontrollable factors such as reagent storage conditions (even different states of the same batch of reagents), environmental temperature and humidity. . Therefore, it has many changes and it is difficult to set up.
  • the detection time parameters of each item of the existing biochemical analyzer are generally set or modified by the operator or the engineer.
  • the work is mainly based on the operator's experience to select and set, but due to the operator's experience and Different levels, it is often difficult to ensure the best detection time conditions for each test item, and it is often necessary to test, analyze and optimize the test time conditions of different test items. All relying on manual operation is not only a very difficult task. It is also a very tedious job. In the use of biochemical analyzers, it is often impossible for the operator to set reasonable detection time conditions according to the actual conditions of the instruments, reagents and environment used, resulting in failure to obtain satisfactory biochemical test results in daily work, and even leading to false detection results. .
  • the quality evaluation of the test results by the existing biochemical analyzer is mainly based on the test results of the applied quality control products to evaluate the correct level of the test results of the instrument and the reagent system.
  • the general evaluation method is that if the quality control test result is within the acceptable range of the target value of the quality control product, the instrument and reagent test conditions are recognized, and all test results obtained under the instrument, reagent and test conditions are considered to be "trustworthy”. Or correct.”
  • the instrument is tested and calibrated by applying the standard or calibrator.
  • the principle of calibration is mainly through simple mathematical difference.
  • the proportional relationship calculates and calibrates the difference between the detection result and the theoretical target value, so that the detection result satisfies the quality control or standard product detection requirements.
  • calibration does not correct the lack of setting parameters of the detection method.
  • the existing biochemical testing quality control system does not judge whether a single individual sample test result is erroneous. That is, the existing biochemical instruments generally consider that the quality control test results meet the range of the target value, and all the test results obtained by detecting the instrument and the reagent system are considered to be "qualified and credible". In fact, even if the instruments and reagents are in a normal state, it is difficult to ensure that each test result is correct in the actual work of biochemical tests.
  • the technical problem to be solved by the present invention is to provide an optimized biochemical detection method suitable for medical examination for the technical deficiencies of the existing biochemical analyzer.
  • the present invention discloses an optimized biochemical detection method suitable for medical examination, and the method of the invention comprises: applying a biochemical analyzer and a reagent to a standard for detecting a concentration in a linear range in the reagent and the biochemical analyzer Performing the specified project detection automatically obtains the detection time condition parameters of the project without the need for manual setting.
  • the item to be detected is the end point method
  • the standard product is first tested, and the reagent blank value, the absorbance change of the reagent and the standard mixed reactant in the whole detection process are recorded during the detection process, and The time zone that satisfies the following conditions during the detection process is used as the optimal detection time condition T1 of the endpoint method item:
  • the time zone range is used as a suitable detection time zone range for performing the end point detection of the item under the biochemical analyzer and the reagent condition, and finally the time range is all or part of the time range.
  • the segment selection is the end point method optimal detection time condition T1 of the item, and the time range of T1 is not less than 10 seconds.
  • the calculation result of the method is calculated by using the average value of the absorbance in the optimal detection time T1 selected by the method as the detection result, or the difference between the average value of the absorbance in the T1 and the reagent blank value, and the sample blank value. The value is calculated as the calculation result of the test result to obtain the final test result.
  • the item to be detected is a multi-standard end point method
  • two or more different concentration standards are separately tested, recorded and analyzed, and all the standards of the different concentrations are respectively in their respective whole detection processes.
  • the absorbance value is used as a suitable detection time region for performing the detection of the item under the condition of the biochemical analyzer and the reagent, and the suitable detection time is then used. All or part of the area is used as the optimal detection time condition T2 for the multi-standard end point detection of the item under the condition of the biochemical analyzer and the reagent; the suitable detection time area detected by the item and the determination method of the optimal detection time condition T2 as follows:
  • the respective reactants formed by the mixing are continuously subjected to absorbance detection, and the average value of the absorbance detected by each reactant in each of the reactants is in the same time zone and the respective reactants at the time.
  • the difference between the absorbance values measured in each of the multiple times in the region is less than 0.0030 OD; and the time region is greater than or equal to 10 seconds, and part or all of the time range of the region is selected as the optimal detection of the multi-standard endpoint method.
  • the time range of time T2, T2 is not shorter than 10 seconds.
  • the calculation result of the method is calculated by using the average value of the absorbance in the optimal detection time T2 selected by the method as the calculation result, or the difference between the average value of the absorbance in the T2 and the reagent blank value, and the sample blank value.
  • the value is calculated as a basis for calculation to obtain the final test result.
  • the biochemical analyzer when the item to be detected is the rate method, the biochemical analyzer continuously detects the absorbance value and the change rate of the absorbance formed by mixing the reagent and the standard product, and the time when the following conditions are met during the detection process
  • the area serves as a suitable detection time area for the project; the biochemical analyzer automatically selects part or all of the time in the time zone as the optimal detection time condition T3 of the item, and automatically sets the detection time as the biochemical analyzer for the item.
  • Condition; the suitable detection time area of the project and the method for judging the optimal detection time condition T3 and the calculation result are as follows:
  • the absorbance is continuously increased or decreased.
  • a change in the direction of the direction in which the rate of change of absorbance in a continuous region is not less than 0.0020 OD/10 sec; and the linear regression coefficient of the absorbance value measured in the time region is not less than 0.85, and the length of time in the region is not shorter than For 30 seconds, the time zone is selected as the appropriate detection time zone for the item.
  • the absorbance change rate in the T3 region is not less than 0.0020 OD/10 sec; measured in the T3 time region
  • the linear regression coefficient of the absorbance value is not less than 0.85, and the time length of the T3 region is not shorter than 30 seconds.
  • the detection result is calculated using the absorbance change rate of the T3 time range.
  • the linear regression coefficient of the absorbance value measured when the sample is in the set overall T3 time region is less than 0.85
  • the linear regression coefficient of the absorbance value measured in a part of the continuous time region is not less than 0.85
  • the absorbance value is linear. If the time segment with a regression coefficient of not less than 0.85 is not shorter than 30 seconds, the instrument automatically calculates the detection result according to the rate of change of the absorbance value of the portion of the T3 region obtained by the sample detection, instead of the absorbance value of all T3 regions. Calculate the test results.
  • the detection method of the standard product is a two-point rate method
  • the corresponding reagent and the standard product are used for detection
  • the biochemical analyzer continuously detects the absorbance value and the change rate of the absorbance of the reactant formed by mixing the reagent with the standard product
  • the time zone satisfying the following conditions is taken as the suitable detection time zone and the optimal detection time condition T4 of the item in the detection process, and T4 is automatically set as the time condition for detecting the item, and the suitable detection time zone of the item
  • T4 judgment method and the calculation result of the test result are as follows:
  • the absorbance in the time zone is continuously increasing steadily or continuously decreasing unidirectionally, and the rate of change of absorbance is not less than 0.0020 OD/10 sec; suitable for the project
  • the linear regression coefficient of the absorbance value measured in the detection time region should be not less than 0.75, and the time length of the region is not shorter than 30 seconds, then the time region is selected as the suitable detection time region of the project; Select some or all of them as the optimal detection time condition T4 of the project, T4 should also satisfy: the absorbance change rate in the T4 time range is not less than 0.0020 OD/10 sec; the absorbance value measured in the T4 time zone
  • the linear regression coefficient is not less than 0.75, and the time length of T4 is not shorter than 30 seconds.
  • the detection result is calculated using the absorbance change rate of the T4 time range.
  • the linear regression coefficient of the absorbance value measured in the set overall T4 time region is less than 0.75
  • the linear regression coefficient of the absorbance value measured in a part of the continuous time region is not less than 0.75
  • the time period is not If it is shorter than 30 seconds, the instrument automatically calculates the detection result according to the rate of change of the absorbance value of the time period in the T4 region, instead of calculating the detection result according to the total absorbance change rate of all the T4 regions.
  • the reagent blank value can be detected in advance, and each time the sample is detected.
  • the absorbance is measured for the sample and reagent mixture initially entering the flow cell and compared with the reagent blank absorbance value; before the optimal detection time condition T3 (rate method) or T4 (two-point rate method) of the item.
  • T3 rate method
  • T4 two-point rate method
  • the method for judging the quality of the test results by the method of the present invention is as follows:
  • the range of the optimal detection time T1 or T2 is set.
  • the data of the difference between the absorbance detection values of the sample and the average absorbance value in the time zone is greater than 0.0030 OD, and the data is determined to be unqualified;
  • any absorbance data within the set optimal detection time T1 or T2 reaches the biochemical analyzer detection absorbance limit value ⁇ 0.0050 OD, that is, the detection result is unqualified.
  • the detection result is also considered to be too high, and needs to be diluted and re-detected.
  • the detection result that is judged to be unqualified is one of the following conditions:
  • the linear regression coefficient of the absorbance value obtained by the detection is less than 0.75; and there is no linear regression coefficient that can satisfy the absorbance value for more than 30 seconds.
  • the detection method is the rate method for detecting the sample
  • the linear regression coefficient of the absorbance value obtained by the detection is less than 0.85, and there is no linearity that can satisfy the absorbance value for more than 30 seconds. a continuous segment having a regression coefficient greater than or equal to 0.85;
  • the method of the invention can automatically obtain the reasonable detection time region for performing the detection items of the instruments and reagents of any specific condition by detecting the standard product (or the quality control product) at any time, so that the instrument and the reagent can be better adapted. Even changes in environmental conditions.
  • the instrument designed by the method of the invention can easily and conveniently obtain the correct optimal detection time condition for performing the detection of any item according to the method of the invention, and automatically complete the optimal detection time condition for the item. Settings or modifications.
  • the method of the invention also provides a method for automatically evaluating the quality of each test result of each different item one by one, screening out the unqualified test result, and reducing the error rate of the instrument test result.
  • the method of the invention and the living analyzer designed according to the method of the invention can automatically obtain the optimized detection time conditions for obtaining different method items for the biochemical analyzer according to the steps, the flow and the method of the method of the invention, and can also automatically set the instrument to the instrument.
  • FIG. 1 is a view showing an absorbance curve obtained by performing end point method standard detection according to the present invention, and a selection method for selecting a suitable detection time region and an optimum detection time T1 therein.
  • FIG. 2 is a graph showing the absorbance curves of five different concentration standards obtained by detecting five different concentration standards according to the multi-standard end point method according to the present invention, and the selection of the suitable detection time region and the optimal detection time T2.
  • Figure 3 is a graph showing the correlation between a multi-standard concentration and absorbance obtained after performing multi-standard endpoint detection of five different concentrations of standards according to the method of the present invention.
  • Figure 4a is a graphical representation of the absorbance curve obtained for the detection of a rate method item standard in accordance with the present invention, and the selection of a suitable detection time region and optimal detection time condition T3 therein.
  • Figure 4b illustrates a particular rate method sample detection application in accordance with the present invention.
  • Figure 5 is a diagram showing the selection of an absorbance curve obtained by detecting a two-point rate method item standard, and a selection of a suitable detection time zone and an optimum detection time T4 condition, in accordance with the present invention.
  • Fig. 6a is a graph showing the absorbance curve obtained by the reaction rate standard of a reaction absorbance-decreasing type, and the selection of a suitable detection time region and an optimum detection time T3 therein.
  • Figure 6b shows one of the application methods for the detection of a specific sample with a reaction absorbance as a descending rate method.
  • Fig. 7 is a graph showing the absorbance curve obtained by the detection of the end point method standard for the reaction absorbance as a descending type, and the selection of the suitable detection time region and the optimum detection time T1 therein.
  • the implementation process of the biochemical analyzer and method of the present invention comprises the following steps:
  • Step 1 Pre-set the fixed detection parameters required for the test on the biochemical analyzer: project name, project detection method, standard target value (or quality control product) and its unit, reagent dosage, sample dosage and wavelength.
  • the input method may be input through a keyboard, or may be directly input through an electronic version of the reagent manual, a standard product manual, or input through a network; or the operation of the first step may be omitted, and the reagent barcode and standard product of the reagent bottle are passed. Bar code scanning and other methods automatically input the required fixed detection parameter information;
  • Step 2 Put the reagents and standard products into the corresponding designated positions of the instrument, start the instrument to perform the standard product test of the project, and the detected object is a standard product (or quality control product) with a known value, and the concentration of the applied standard product. (Content) should be within the linear range of detection of the instruments and reagents used.
  • Step 3 analyzing the absorbance data during the detection process of the project to obtain a “suitable detection time zone” for the detection of the project under the specified laboratory conditions, and according to the obtained “suitable The detection time zone is automatically set (in whole or in part) to the optimal detection time condition parameter of the project.
  • This parameter is combined with other parameter conditions to form a complete and appropriate project under the instrument, reagent and environmental conditions.
  • the test conditions of the biochemical test of the project, the instrument then automatically applies the condition to perform sample test.
  • Step 4 the instrument detects the parameter conditions of the item detected by the standard product (or quality control item), and tests each sample to calculate the test result of each sample, and the instrument is automatically designed according to the method of the present invention.
  • the quality evaluation method analyzes the quality of each test result, judges whether each test result is qualified, and prompts (alarm), re-detects, re-detects after dilution, etc. Processing, reducing and avoiding detection errors.
  • the method of the present invention and the designed biochemical analyzer are in the third step of the implementation process, and the selection and setting of the suitable detection time region and the optimal detection time condition for each different detection item are completed as follows:
  • the instrument tests the item standard (or quality control item), and records the reagent blank value, the reagent and the standard product (or quality control product) mixture in the detection process.
  • 1 is a view showing an absorbance curve obtained by performing end point method standard detection according to the present invention, and a selection method for selecting a suitable detection time region and an optimum detection time T1 therein.
  • 1 is the time point when the standard product is added to the test cup during the detection of the end point method; between 1 and 2 o'clock, the absorbance changes significantly during the reaction between the reagent and the standard in the project, and the absorbance changes significantly after 1
  • the absorbance change is significantly reduced after 2 o'clock, and the difference between the absorbance values of each time in the time zone between 2 o'clock and 3 o'clock and the average value of the absorbance values obtained in each test of the region is less than 0.0030 OD, and the segment The duration is greater than 3 minutes (satisfying the requirement of more than 10 seconds).
  • the area is selected as the suitable detection time area of the project, and the area between 4 and 3 points is selected as the most of the item because the detection absorbance is more stable or because the detection time is more convenient for the instrument to perform detection.
  • the time zone of the excellent detection time T1 and T1 also satisfies the requirement of not less than 10 seconds.
  • the optimal detection time condition of the project may be the entire time range between 2 o'clock and 3 o'clock, or may be part of the time between 2 o'clock and 3 o'clock, or other satisfaction: the absorbance value obtained by each test in the region and The difference between the average values of the absorbance values obtained in each test in this region is less than 0.0030 OD; and the region whose time length is not shorter than 10 seconds can be used as the optimal detection time condition T1 of the project.
  • the instrument automatically sets the optimal detection time T1 of the item end point method under the instrument and reagent conditions according to the above-mentioned selected detection time condition according to the absorbance curve detected above. Then the instrument applies the optimal detection time T1 to the other samples for the item detection, and the average value of the absorbance of the time region is used as the basis for the calculation of the detection result.
  • the instrument can automatically extend the test time, or take Dilution reduces the concentration of the standard, and the diluted standard is tested to obtain a suitable detection time region and an optimal detection time T1 that satisfy the above requirements.
  • the method is also applicable to the end point method test in which the absorbance of the reactant is decreased.
  • the selection judgment criterion of the suitable detection time zone and the optimal detection time condition is the same as the end point method of the absorbance increase type.
  • Fig. 7 is a graph showing the absorbance curve obtained by the detection of the end point method standard for the reaction absorbance as a descending type, and the selection of the suitable detection time region and the optimum detection time T1 therein.
  • 7-1 is the time point when the standard product is added to the test cup when the end point method of the absorbance is decreased; between 7-1 and 7-2, the absorbance of the reagent and the standard is significantly decreased during the reaction.
  • the changed segment; 7-2 to 7-3 is a stable absorbance region, and the absorbance values of each test in the segment are less than 0.0030 OD of the average absorbance obtained in each test of the region, and the The time of the segment reaches more than 10 seconds, so the region is selected as the suitable detection time region for the project, and the region of 7-4 points 7-3 points is more stable due to the detection of absorbance, or at the same time due to the detection time.
  • Convenient instrument execution detection is selected as the optimal detection time condition T1 for the project. T1 The time must not be shorter than 10 seconds.
  • the time range of T1 may also be the total or time zone of the suitable detection time zone, but the length of time is not shorter than 10 seconds.
  • the reagent blank detection and the sample blank detection can also be added, and the corresponding deduction is performed in the calculation result to improve the accuracy of the detection result.
  • the biochemical analyzer has two or more different concentration standards (or quality control) for the project.
  • Product separately test, record and analyze the absorbance changes of each standard of different concentrations in their respective detection processes.
  • the absorbance change of each standard of the project after mixing with the reagent should be the same increase or decrease.
  • Trend but the degree of change in absorbance obtained when the standards of different concentrations are different, and finally the different standards reach the maximum change value of the absorbance and tend to be stable, and the "suitable detection time area" obtained in each standard product is detected.
  • the difference between the absorbance value obtained by each test and the average value of the absorbance detection in the "suitable test time zone" should be less than 0.0030 OD, and the time of each of the standards for each of the "suitable test time zones" detected by each standard is greater than 10 second. Then, the instrument automatically compares the time ranges of the “suitable detection time zones” obtained by each standard product detection, and selects the “appropriate detection time zone” obtained by each different standard test of the project, and the common absorbance is stable, and is not short. In the 10 second time zone as the "suitable detection time zone" of the project, the instrument selects all or part of the zone as the optimal detection time condition T2 of the project in the zone, and automatically sets it in the instrument, and then applies the Conditions are tested on the sample.
  • FIG. 2 is a schematic diagram showing the selection of five different concentration standard absorbance curves and the optimal detection time region obtained by the five standard test of the multi-standard end point method according to the present invention.
  • 2-1 to 2-5 are the absorbance curves obtained by the five different concentration standards in the respective detection processes; in the figure, 2A, 2B, 2C, 2D, and 2E respectively measure the absorbance of the five different concentration standards. Beginning a transition point from a zone of significant change in absorbance to a stable zone;
  • the absorbances obtained by the detection of the five standards are in a stable state, that is, the average value of the absorbance obtained by each test of each concentration standard in the region and the standard.
  • the difference in absorbance values of each test in this region is less than 0.0030 OD, which is the suitable detection time region of the project, and the optimal detection time T2 of the project is set within the range of 2-8 to 2-7. Interval.
  • the optimal detection time T2 may be all or part of the 2-6 to 2-7 time zone.
  • the method automatically cancels the high concentration and the concentration is more than this. Data points for high standards.
  • the effective standard curve of the multi-standard endpoint method of this project is obtained by only counting the detection points of the remaining concentration standards.
  • the method is also applicable to a multi-standard endpoint method in which the reactant absorbance is a reduced reaction, and the selection of the optimal detection time condition T2 also follows the same standards and methods.
  • Fig. 3 is a graph showing the correlation between the absorbance value measured by the T2 region of each standard and the standard concentration obtained after the detection of each standard of the multi-standard endpoint method.
  • 3-1, 3-2, 3-3, 3-4, 3-5 are the absorbance values detected by five different concentration standards of the project. But in the project standard test The difference between the absorbance value of 3-5 points and the maximum detection limit value of the instrument is less than 0.0050 OD, so 3-5 points are canceled.
  • the effective standard curve of this item is the concentration of 0 to 3-4 standard.
  • the absorbance values of the four standards of 3-1, 3-2, 3-3, and 3-4 are “effective standard” absorbance values, and 3-5 are due to their absorbance values and instrument detection limits.
  • the difference of 3-6 is less than 0.0050 OD and is considered as an invalid standard. It is not used in the calculation of the standard curve and detection of this project.
  • the test results of the standard products, quality control products and samples to be tested are calculated according to the standard calculation formula of the existing multi-standard end point method.
  • the reagent blank detection and the sample blank detection can also be added, and the corresponding deduction is performed in the calculation result to improve the accuracy of the detection result.
  • the instrument continuously detects the absorbance of the reactant formed by mixing the reagent, the reagent and the standard product (or the quality control product), wherein the instrument automatically excludes the standard product addition, the reagent and the standard product.
  • Mixing, or the stirring device of the instrument can cause short-term fluctuations of short-time absorbance due to factors such as adding samples, or adding reagents, or stirring.
  • the fluctuation of the absorbance is limited to the addition of samples (standard During the operation of any one of the reagents, the reagents, and the stirring of the reactants, and within 10 seconds after the completion, the absorbance of the reactants appears to be continuously changed after a certain period of time (may be a continuous increase, or may be continuous) Reduced), but the rate of change in absorbance at different times of reaction after mixing the same standard with the reagent is different.
  • the instrument finds out that the rate of change of absorbance is satisfied by analysis and comparison: the linear regression coefficient of the absorbance value measured within the selected detection time range should be not less than 0.85 And the time period is not shorter than 30 seconds.
  • This section is used as the "suitable detection time zone" of the item rate method, and a period of time not shorter than 30 seconds is selected as the optimal detection time condition T3 of the item.
  • the selection principle of the optimal detection time T3 is generally a partial area of the "suitable detection time zone", or all sections, and is not shorter than 30 seconds.
  • the instrument then automatically sets the time period T3 as the time condition for the instrument's rate method detection for the item to be used for optimal detection time conditions for all samples of the item.
  • the detection can be started when the reagent is simply added to the test cup (the blank value of the reagent is obtained), or the reagent can be mixed with the standard and added to the test cup to start the detection (no reagent blank value).
  • the method selects the optimal detection time condition T3 of the rate method, which is not only suitable for the item of the increase of the absorbance of the reactant after the standard product and the reagent are mixed, but also for the change of the absorbance of the reactant after the mixing of the standard product and the reagent is reduced.
  • the rate method detects the item. The conditions and manner of judgment are the same.
  • the reagent blank detection and the sample blank detection can also be added, and the corresponding deduction is performed in the calculation result to improve the accuracy of the detection result.
  • 4a is a schematic diagram showing the absorbance curve obtained by detecting a rate method item standard (or quality control item) according to the method and apparatus of the present invention, and selecting a suitable detection time area and an optimum detection time T3.
  • 4-1 is the sample addition point.
  • the previous absorbance value is the absorbance value of the reagent, and then the absorbance of the reagent after the sample is added becomes a significant increase section, that is, the time is 0 to 4-1 in the graph curve.
  • the point is the reagent blank value detection area, and the 4-1 point is the standard addition point.
  • the absorbance change between 4-2 and 4-3 in the figure is a stable and stable one.
  • the absorbance increases the change zone, the absorbance change of the region is greater than 0.0020 OD/10 sec, the time of the region is greater than 30 seconds, and the "suitable detection time region" obtained by the standard test of the project between 4-2 and 4-3 points ", the absorbance change rate after 4-3 in the figure is significantly reduced, and the absorbance change rate of the segment between 4-2 and 4-3 is inconsistent, or in other words, the absorbance measured after 4-3 and before 4-3.
  • the resulting absorbance values are combined in a calculated linear regression coefficient of less than 0.85. .
  • the absorbance change rate of sections 4-4 and 4-5 in the figure is stable, and is in the central section of the suitable detection time zone of the project, which can be selected as the optimal detection time T3 of the project.
  • the suitable detection time area of the item is not shorter than 30 seconds
  • the optimal detection time condition T3 of the item is not shorter than 30 seconds.
  • the calculation of the standard product, the quality control product and the sample to be tested is based on the change value of the absorbance between 4-4 points and 4-5 points.
  • the calculation formula is the calculation formula of the current standard rate method result.
  • the method of the present invention also allows the calculation of the rate method detection result to calculate the detection result of the sample based on the detection of the absorbance value of the inner portion of the "optimal detection time" at the time of sample detection.
  • Figure 4b is a flow rate specific sample detection application method for increasing the absorbance of a reaction according to the present invention.
  • the horizontally extending dashed line in the figure represents the absorbance data during the sample detection.
  • the absorbance curve obtained by the sample detection does not have a good linearity in all the optimal detection time T3 of the item.
  • the absorbance value between 4-4 and 4-6 in the T3 segment is a good linearity
  • the linear regression coefficient of the absorbance measured in the range between 4-4 and 4-6 is ⁇ 0.85
  • the time between 4-4 points and 4-6 points is not shorter than 30 seconds
  • the result of the sample can be used to calculate the detection result of the sample by the absorbance change rate between 4-4 points and 4-6 points.
  • the time period of the linear regression coefficient of the absorbance value measured in the range of 4-4 to 4-5 is less than 30 seconds, it is judged that the detection result is wrong, and the instrument will automatically prompt or re-detect the sample. .
  • Fig. 6a is a graph showing the absorbance value curve of the absorbance at different time points during the detection of the rate-measured sample with a decreasing absorbance, and the time-selection of the absorbance data for the calculation of the test result in the region of the optimal detection time T3.
  • 6-1 is the sample addition point.
  • the previous absorbance value is the absorbance value of the reagent, and then the change section of the reagent reaction absorbance is significantly reduced after the sample is added.
  • the change in absorbance between 6-2 and 6-3 in the figure is a continuous stable change in absorbance drop, and the change in absorbance reduction in this region is greater than 0.0020 OD/10 sec; and the segment after 6-3 in the figure
  • the rate of change in absorbance was significantly slowed down, and the rate of change in absorbance between the two points between 6-2 and 6-3 was significantly inconsistent, or in other words, the absorbance measured after 6-3 was combined with the absorbance value measured before 6-3.
  • the calculated linear regression coefficient is less than 0.85. Therefore, the time zone between 6-2 and 6-3 in the figure is the suitable detection time zone for this project.
  • the absorbance change rate of the 6-4 and 6-5 segments is stable, and the linear regression coefficient of the measured absorbance value is ⁇ 0.85, and is in the central segment of the suitable detection time zone of the project, which can be selected as the project.
  • the time of T3 is not shorter than 30 seconds, and the suitable detection time area of this item is not shorter than 30 seconds.
  • Figure 6b shows one of the application methods for sample detection of a reaction absorbance-decreasing rate method.
  • the horizontally extending dashed lines in the figure represent absorbance data at different points in time during the sample detection.
  • the absorbance curve obtained by the sample detection does not have a good linearity in all the optimal detection time T3 of the item.
  • the absorbance values in the T3 segment, that is, between 6-4 and 6-6, the sample detection time are in good linearity, measured in the range between 6-4 and 6-6.
  • the linear regression coefficient of the absorbance value is ⁇ 0.85; and the time between 6-4 points and 6-6 points is not shorter than 30 seconds, the result of the sample is the absorbance between 6-4 points and 6-6 points.
  • Rate of change meter Calculate the test results of the sample.
  • the linear regression coefficient of the absorbance value measured in any range of 6-4 to 6-5 is less than 30 seconds for less than 30 seconds, the detection result is wrong, the instrument automatically prompts, or automatically The sample is retested.
  • the corresponding reagents and standards are used for detection.
  • the instrument continuously detects the absorbance of the reactants formed by mixing the reagents, reagents and standards, wherein the instrument automatically excludes the addition of the standard, the reagent and the standard are mixed, or the instrument stirring device can be short-lived after stirring the reactants.
  • the fluctuation of the short-term absorbance caused by the addition of the sample (standard), or the addition of reagents, or stirring, etc. generally the fluctuation of the absorbance is limited to the addition of the sample (standard), the addition of the reagent, the stirring of the reactants, etc.
  • the absorbance of the reactants should be continuously changed (either as an increase or a decrease), but the absorbance at different times of the reaction after mixing the same standard with the reagent The rate of change is different.
  • the instrument finds out that the rate of change of absorbance is satisfied by analysis and comparison: the linear regression coefficient of the absorbance value measured within the selected detection time range is not less than 0.75, and the time period is not shorter than 30 seconds period. This time period is used as the "suitable detection time zone" of the two-point rate method of the project. Then the instrument automatically selects the optimal detection time condition T4 in the "suitable detection time zone" obtained by analyzing the absorbance, and the selected T4 time zone.
  • the optimal detection time condition T4 is then automatically set to the time condition that the instrument detects the two-point rate method of the item for detecting the sample to be inspected for the item.
  • 5 is an absorbance curve obtained by detecting a two-point rate method item standard (or quality control item) according to the method and apparatus of the present invention, and a suitable detection time area and most for the two-point rate method detection item.
  • 0 to 5-1 points is the reagent blank value detection area
  • 5-1 points is the standard product addition point
  • between 5-2 points and 5-3 points is the area where the standard product detects stable growth of absorbance.
  • selected as the "suitable detection time zone" for this project, and the rate of change of absorbance detected within 5-4 points and 5-5 points is more stable, and is located in the center of the suitable detection time zone of the project, this time
  • the segment is selected as the optimal detection time T4 of the project.
  • T4 Used to perform the inspection of the sample of the project.
  • T4 is not shorter than 30 seconds, and the suitable detection time area of this project is not shorter than 30 seconds.
  • the instrument calculates the results of the standard, quality control and sample test results of the project according to the absorbance values obtained in the range of 5-4 points and 5-5 points (T4) at the time of detection. The calculation of the results is still based on the current standard two-point rate method.
  • the suitable detection time zone and the optimal detection time condition set by the method and the instrument of the present invention for each different method are not lower than the time range specified by the above items.
  • the following analysis schemes are used to analyze and test the detection results of various types of detection items, and the unqualified test results are screened out.
  • the quality of the test result is automatically analyzed, evaluated, and processed in the fourth step of the method of the present invention as follows.
  • the instrument automatically records all the absorbance information of all the sample detection processes, and automatically analyzes the detection data, and judges the detection result when the following situation is encountered. Failed and automatically processed as described below.
  • the difference between the absorbance value measured each time in the range of the optimal detection time condition T1 set by the instrument item and the average value of the absorbance of the region is greater than 0.0030 OD, the data of the time range is more than 5% of the total data.
  • the test result is judged as unqualified, the instrument automatically reports that the quality of the test result is unqualified, and the automatic prompt requires attention or automatic re-detection; when the "suitable detection time zone" of the sample to be tested is detected to move forward more than 10 seconds As a result, it will also be considered as a result of unqualified, the instrument will automatically re-test the sample after dilution; when the sample to be tested is mixed with the reagent, the absorbance value of the data is 2% or more in the optimal detection time T1 region or the data reaches If the instrument detects the absorbance limit value within ⁇ 0.0050 OD, the test result should also be judged as unqualified. In this case, the instrument automatically retests the sample.
  • the instrument and method designed by the present invention automatically analyze and evaluate the quality of the test result of each sample according to the following manner when the test sample is tested. And processing.
  • the specific evaluation and processing methods are as follows: 1) The data of each sample measured in the optimal detection time T2 region and the average value of the total absorbance data measured in the region exceeds ⁇ 0.0030 OD, and the data exceeds the time. If the range of the total data is 5%, the obtained test result is judged as unqualified; 2) when the "suitable test time zone" range of the sample test is moved forward by more than 10 seconds and above, the instrument automatically judges that the result is unqualified.
  • the sample is diluted and retested; 3) when the sample is detected, the detection result of the absorbance exceeding the maximum absorbance value set by the multi-standard end point method is detected in the optimal detection time region, and the instrument automatically takes the sample as a non-conforming result. Re-detection or alarm prompt; 4) When the sample is detected within 2% of the absorbance detection data within the optimal detection time T2 or the time zone reaches the instrument detection absorbance limit value of 0.0050 OD, the test result is unqualified. The instrument automatically re-tests the sample after dilution, or performs alarm prompt processing.
  • the instrument test item method is the normal rate method
  • the instrument automatically analyzes, evaluates and processes the quality of the test results as follows.
  • the measured absorbance in the T3 segment is not linear when the sample is detected, and the absorbance value of only a part of the continuous time period is in good linearity, and the linear regression coefficient of the absorbance value measured in the partial time range is ⁇ 0.85; and the time If the segment is not shorter than 30 seconds, the result of the sample can be used to calculate the detection result of the sample by the absorbance change rate of the local detection time period satisfying the two conditions within the range of the optimal detection time T3.
  • the instrument automatically analyzes, evaluates and processes the quality of the test results as follows.
  • B) When the sample is actually detected, the linear regression coefficient of the absorbance value measured within the optimal detection time T4 selected by the item is less than 0.75, and When the time period of the linear regression coefficient ⁇ 0.75 that continuously satisfies the absorbance value in the range of T4 is less than 30 seconds, the instrument judges that the test result is unqualified, and automatically re-detects the sample or automatically prompts the operator to pay attention.
  • the result of the sample can be used in the range of the optimal detection time T4.
  • the change rate of the absorbance of the detection period is used to calculate the detection result of the sample.
  • the biochemical analyzer of the method and design of the present invention may be a discrete automatic biochemical analyzer.
  • the absorbance detection information can be obtained from the instrument after each test is added to the test cup from any reagent or sample (including quality control or standard) until the end of the test. Therefore, when the method of the present invention is applied to the detection time selection of the discrete biochemical analyzer, the reagent may be added to the detection cup, or the reagent may be mixed with the quality control product (or standard product), and the instrument may be used throughout the process.
  • the detection obtains the information of all the absorbance values of the whole detection process, so that the screening of the "suitable detection time zone and the optimal detection time condition" can be conveniently completed, and the sample and the reagent can be mixed after the sample is detected. Detecting all the absorbance information, and performing the analysis and selection of the "suitable detection time zone” and the optimal detection time condition of the required test items according to the method designed by the present invention, and selecting each sample (including standard product, quality control) The quality of the test results is analyzed and processed.
  • a typical discrete biochemical analyzer has a detection time of 10 minutes for a single sample, and the design according to the present invention can extend the detection time if necessary.
  • the detection time for different items is also obtained by data analysis of the standard or control product detection, the principle of which is to satisfy the selection condition of the "suitable detection time zone" of each item and the optimal detection time of the method of the invention.
  • short-term absorbance fluctuations may occur due to reagent addition, sample addition, and agitation, but the fluctuation of the absorbance generally disappears about 10 seconds after the end of the corresponding action. Therefore, the fluctuation of the absorbance of the segment at the time of detection is automatically excluded by the design instrument.
  • the instrument may also add a reagent in the test cup, or a mixture of the reagent 1 and the sample, or use a mixture of water and the sample to be tested to detect the reagent blank, the reagent 1 + the blank of the sample to be tested, and the blank of the water and the sample to be inspected, by adding Various blank reference information is used to make a more accurate analysis for each sample.
  • the method of the invention can also be adapted to flow cell biochemical analyzers.
  • the method of the present invention can confirm the "suitable detection time region and optimal detection time condition" of different items by using a flow cell biochemical analyzer, and then inhaling the flow cell after mixing the standard product (or quality control product) with the reagent and The sample is continuously observed until a satisfactory time condition is obtained.
  • the simple reagent used can also be directly sucked into the flow cell, and the blank absorbance value of the simple reagent can be detected for the detection of the standard and Used as a reference for sample detection.
  • the "suitable detection time zone" of various items and the optimum detection time condition can also be determined in the manner of Embodiment 1.
  • the instrument can mix the reagent with the sample into the instrument cuvette and then inhale the reactant into the flow cell for detection before the reaction reaches the detection time. Immediately after the end of the detection time, the reactant is self-flowing. Excluded, this can shorten the time of the reactants in the flow cell and fully improve the utilization of the flow cell.
  • the reagent, the reagent, the sample to be tested, the water, the sample to be tested, etc. can be obtained by separately detecting the mixture of the reagent, the reagent 1+ the sample mixture to be tested, and the water to be tested separately. The blank absorbance value is used to more accurately analyze the test results.
  • the method of the present invention can also be applied to a flow cell biochemical analyzer for analyzing and evaluating the detection result, and the implementation method thereof is the same as that of the first embodiment.
  • the apparatus of the present invention can also mix the absorbance by automatically comparing the reagent blank with the reagent + sample to be inspected when the flow cell is just aspirated. The total change value is compared with the rate of change in absorbance over the optimal detection time range.
  • the absorbance change rate before the optimal detection time condition T4 (two-point rate method) or T3 (rate method) is greater than the absorbance change rate within the optimal detection time range of the item, the sample concentration is judged to be too high, and the detection result is If it is unqualified, it should be diluted and retested.
  • the rate method is performed in the flow cell, the linear regression coefficient of the absorbance value measured in the region of the optimal detection time T3 at the time of the rate detection is less than 0.85, and the result is wrong and should be re-detected.
  • the linear regression coefficient of the absorbance value of the partial region may be greater than or equal to 0.85, and the time segment is not shorter than 30 seconds, and the instrument automatically follows the rate of change of absorbance of the local time segment. Calculate the test results.
  • the linear regression coefficient of the absorbance value measured in the region of the optimal detection time T4 at the time of the two-point rate detection is less than 0.75, and the result is wrong and should be re-detected.
  • only the linear regression coefficient of the absorbance value of the partial region may be greater than or equal to 0.75, and the time segment is not shorter than 30 seconds, and the instrument automatically follows the rate of change of absorbance of the local time segment. Calculate the test results.
  • the present invention provides an optimized biochemical detection method suitable for medical examination.
  • the above description is only a preferred embodiment of the present invention, and it should be pointed out that one of ordinary skill in the art In the meantime, several modifications and refinements can be made without departing from the principles of the invention, and such modifications and refinements are also considered to be within the scope of the invention.
  • the components that are not clear in this embodiment can be implemented by the prior art.

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Abstract

L'invention concerne un procédé de détection biochimique optimisée approprié pour un examen médical, comprenant les étapes consistant : à analyser des informations de capacité d'absorption obtenues par application d'un analyseur biochimique et d'un produit standard de réactif de détection ou d'un produit de contrôle de qualité pour obtenir des régions de temps de détection appropriées et des conditions de temps de détection optimales de différents procédés de détection pour différents projets sous la condition d'avoir des facteurs, tels qu'un instrument désigné et un réactif ; et à configurer automatiquement les conditions de temps de détection de l'instrument pour le procédé de détection de projet désigné, le processus étant automatiquement achevé par l'instrument. Par adoption du procédé, un utilisateur peut automatiquement obtenir des conditions de temps de détection raisonnables et précises lors de l'utilisation de réactifs avec d'autres marques de manière très pratique et les conditions de temps de détection optimales et un résultat de détection précis peuvent être obtenus lorsque les réactifs et l'instrument sont remplacés ou sont dans d'autres conditions. Parallèlement, la qualité de chaque résultat de détection des différents projets est analysée une par une et des résultats non qualifiés sont analysés, de telle sorte que le taux d'erreur d'un résultat de détection d'instrument est réduit.
PCT/CN2015/088075 2015-07-22 2015-08-26 Procédé de détection biochimique optimisée approprié pour un examen médical WO2017012168A1 (fr)

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CN112345778A (zh) * 2019-08-06 2021-02-09 深圳迈瑞生物医疗电子股份有限公司 级联的样本分析系统、装置和质控项目失控的处理方法
CN112946304A (zh) * 2019-11-26 2021-06-11 深圳市帝迈生物技术有限公司 样本检测的插入方法、样本检测设备以及存储介质
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CN112946304B (zh) * 2019-11-26 2024-06-07 深圳市帝迈生物技术有限公司 样本检测的插入方法、样本检测设备以及存储介质
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CN113970644A (zh) * 2021-12-24 2022-01-25 天德瑞(北京)生物科技有限公司 基于hrp标记蛋白的工作浓度检测方法
CN115757722A (zh) * 2022-11-10 2023-03-07 吉林金域医学检验所有限公司 样本检测结果的处理方法、装置、设备及介质
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