Calibration method applied to human body trace element analyzer

Abstract

The invention provides a calibration method of a human body trace element analyzer, which comprises the following steps: checking the appearance and normality of a to-be-detected analyzer, configuring a measuring range corresponding to the to-be-detected analyzer, and preparing a standard solution according to a preset proportion; carrying out first preset times of measurement by adopting at least three standard solutions with different preset proportions so as to calibrate the concentration indication error of the to-be-detected analyzer; a standard solution with the concentration being 50% of the measuring range of the to-be-detected analyzer is adopted for measurement for a second preset number of times, so that the measurement repeatability of the to-be-detected analyzer is calibrated; and according to the measurement principle of the to-be-detected analyzer, performing continuous measurement for a third preset number of times by adopting a standard solution with a preset concentration so as to calibrate the detection limit of the to-be-detected analyzer.

Description

Technical Field

[0001] At least one embodiment of this disclosure relates to the field of calibration technology for human trace element analyzers, and more particularly to a calibration method for human trace element analyzers. Background Technology

[0002] Human trace element analyzers are widely used in medical, scientific research, and other fields to detect the content of trace elements in human blood, serum, and other samples. The accuracy of human trace element analyzers directly affects the reliability of diagnostic results. Current technology typically involves relatively simple calibration of these analyzers, or focuses only on a single performance indicator (such as indication error), lacking a systematic and comprehensive calibration scheme to simultaneously evaluate the accuracy, precision, and sensitivity of human trace element analyzers.

[0003] Therefore, how to provide a calibration method has become an urgent technical problem to be solved. Summary of the Invention

[0004] To address at least one of the aforementioned and other technical problems in the prior art, this disclosure provides a calibration method for a human trace element analyzer.

[0005] This disclosure provides a calibration method for a human trace element analyzer, comprising: inspecting the appearance and normality of the analyzer under test, and preparing a standard solution according to a preset ratio corresponding to the range of the analyzer under test; performing a first preset number of measurements using at least three different preset ratios of the standard solution to calibrate the concentration indication error of the analyzer under test; performing a second preset number of measurements using the standard solution with a concentration of 50% of the range of the analyzer under test to calibrate the measurement repeatability of the analyzer under test; and performing a third preset number of continuous measurements using the standard solution of a preset concentration according to the measurement principle of the analyzer under test to calibrate the detection limit of the analyzer under test.

[0006] According to embodiments of this disclosure, the above configuration corresponds to the range of the analyzer under test, and the standard solution is prepared according to a preset ratio, including: for the analyzer under test whose measurement principle is leaching, cadmium is used as a standard substance to prepare the standard solution; and / or, for the analyzer under test whose measurement principle is polarography, zinc is used as a standard substance to prepare the standard solution.

[0007] According to embodiments of this disclosure, the aforementioned standard material further includes at least one of iron, calcium, magnesium, manganese, lead, and copper.

[0008] According to embodiments of this disclosure, the above configuration, corresponding to the range of the analyzer under test, is configured with a standard solution according to a preset ratio, and further includes: using pure water to prepare a standard solution with a concentration of 20% of the range of the analyzer under test; and / or, using pure water to prepare a standard solution with a concentration of 50% of the range of the analyzer under test; and / or, using pure water to prepare a standard solution with a concentration of 80% of the range of the analyzer under test.

[0009] According to embodiments of this disclosure, the above-mentioned measurement using at least three different preset proportions of the above-mentioned standard solutions for a first preset number of measurements to calibrate the concentration indication error of the analyzer under test includes: calculating the concentration indication error of the analyzer under test using Equation 1.

[0010] Formula 1;

[0011] In Equation 1, Characterized as concentration indication error, Characterized by the concentration value of the standard solution, The average concentration of the standard solution is represented by i measurements, where i represents the first preset number of measurements.

[0012] According to embodiments of this disclosure, the above-mentioned measurement of the standard solution with a concentration of 50% of the range of the analyzer under test for a second preset number of measurements to calibrate the measurement repeatability of the analyzer under test includes:

[0013] The measurement repeatability of the above-mentioned analyzer under test is calculated using Equation 2.

[0014] Formula 2;

[0015] In Equation 2, represents the measurement repeatability, represents the concentration value of the i-th measurement, represents the average of the concentration values ​​of the n-th measurement, represents the average of the concentration values ​​of the n-th measurement, and n represents the second preset number of times.

[0016] According to embodiments of this disclosure, the above-mentioned calibration of the detection limit of the analyzer under test, based on the measurement principle of the analyzer under test, involves performing a third preset number of continuous measurements using a standard solution of a preset concentration. This includes calculating the standard deviation value of the analyzer under test using Equation 3.

[0017] Formula 3;

[0018] In Equation 3, Characterized by the standard deviation value; The concentration value is represented by the i-th measurement. The value is represented by the average of m concentration measurements; m represents the third preset number of measurements.

[0019] According to embodiments of this disclosure, the above-mentioned calibration of the detection limit of the analyzer under test by performing a third preset number of continuous measurements using a standard solution of a preset concentration based on the measurement principle of the analyzer under test, further includes: calculating the detection limit of the analyzer under test using Equation 4.

[0020] Equation 4;

[0021] In Equation 3, Characterized by the limit of detection; It is represented by the standard deviation value.

[0022] According to an embodiment of this disclosure, the above-mentioned continuous measurement of the above-mentioned standard solution of a preset concentration for a third preset number of times based on the measurement principle of the above-mentioned analyzer to calibrate the detection limit of the above-mentioned analyzer further includes: for the above-mentioned analyzer to be based on the leaching method, using cadmium as a standard substance and the above-mentioned standard solution with a concentration of 2.0 μg / L.

[0023] According to an embodiment of this disclosure, the above-mentioned continuous measurement of the above-mentioned standard solution of a preset concentration for a third preset number of times based on the measurement principle of the above-mentioned analyzer to calibrate the detection limit of the above-mentioned analyzer further includes: for the above-mentioned analyzer to be based on the polarographic method, using zinc element as a standard substance and the above-mentioned standard solution with a concentration of 20 μg / L.

[0024] According to the calibration method provided in the illustrative embodiments of this disclosure, a complete calibration procedure is provided for a human trace element analyzer, which comprehensively calibrates the indication error, repeatability, and detection limit of the human trace element analyzer in one go. In this way, the accuracy, precision, and sensitivity of the human trace element analyzer can be comprehensively evaluated, thus enabling a complete calibration. Attached Figure Description

[0025] Figure 1 A flowchart illustrating a calibration method according to an illustrative embodiment of the present disclosure is shown. Detailed Implementation

[0026] To make the objectives, technical solutions, and advantages of this disclosure clearer, the following detailed description is provided in conjunction with specific embodiments and the accompanying drawings.

[0027] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit this disclosure. The terms “comprising,” “including,” etc., as used herein indicate the presence of the stated features, steps, operations, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, or components.

[0028] All terms used herein, including technical and scientific terms, have the meanings commonly understood by those skilled in the art, unless otherwise defined. It should be noted that the terms used herein are to be interpreted in a manner consistent with the context of this specification, and not in an idealized or overly rigid way.

[0029] When using expressions such as "at least one of A, B, and C," the meaning should generally be interpreted according to the understanding of someone skilled in the art. For example, "a system having at least one of A, B, and C" should include, but is not limited to, systems having A alone, having B alone, having C alone, having A and B, having A and C, having B and C, and / or having A, B, and C. Similarly, when using expressions such as "at least one of A, B, or C," the meaning should generally be interpreted according to the understanding of someone skilled in the art. For example, "a system having at least one of A, B, or C" should include, but is not limited to, systems having A alone, having B alone, having C alone, having A and B, having A and C, having B and C, and / or having A, B, and C.

[0030] Human trace element analyzers are widely used in medical, scientific research, and other fields to detect the content of trace elements in human blood, serum, and other samples. The accuracy of human trace element analyzers directly affects the reliability of diagnostic results. Current technology typically involves relatively simple calibration of these analyzers, or focuses only on a single performance indicator (such as indication error), lacking a systematic and comprehensive calibration scheme to simultaneously evaluate the accuracy, precision, and sensitivity of human trace element analyzers.

[0031] Furthermore, for trace element analyzers that employ different measurement principles (such as dissolution and polarography), the calibration focus and selection of standard substances vary, and existing calibration methods often fail to make clear distinctions, potentially leading to inaccurate calibration results. There is also a lack of unified and detailed guidance regarding the standardization of operating procedures and the requirements for preparing standard solutions, affecting the efficiency and reliability of calibration work.

[0032] Therefore, how to provide a calibration method has become an urgent technical problem to be solved.

[0033] Figure 1 A flowchart illustrating a calibration method according to an illustrative embodiment of the present disclosure is shown.

[0034] This disclosure provides a calibration method for a trace element analyzer for human use, including:

[0035] Step S100: Check the appearance and normality of the analyzer under test, and configure the standard solution according to the preset ratio based on the range corresponding to the analyzer under test;

[0036] Step S110: Perform a first preset number of measurements using at least three standard solutions with different preset ratios to calibrate the concentration indication error of the analyzer under test;

[0037] Step S120: Use a standard solution with a concentration of 50% of the range of the analyzer under test to perform a second preset number of measurements in order to calibrate the measurement repeatability of the analyzer under test;

[0038] Step S130: Based on the measurement principle of the analyzer under test, a third preset number of continuous measurements are performed using a standard solution of preset concentration to calibrate the detection limit of the analyzer under test.

[0039] According to embodiments of this disclosure, the standard solution is configured according to a preset ratio based on the range of the analyzer to be tested, including: for analyzers to be tested using the leaching method as the measurement principle, using cadmium as the standard substance to prepare the standard solution; and / or, for analyzers to be tested using the polarographic method as the measurement principle, using zinc as the standard substance to prepare the standard solution.

[0040] According to embodiments of this disclosure, the standard substance also includes at least one of iron, calcium, magnesium, manganese, lead, and copper.

[0041] In some illustrative embodiments, step S100 specifically includes performing an appearance and operational check on the analyzer to ensure that the human trace element analyzer is in good condition. Subsequently, based on the measurement principle of the human trace element analyzer (dissolution method or polarography) and the user's requirements for the matrix (whole blood or serum), suitable standard substances are selected, and at least three standard solutions with different preset ratios are precisely prepared using high-purity water.

[0042] According to embodiments of this disclosure, configuring a standard solution corresponding to the range of the analyzer under test according to a preset ratio further includes: using pure water to prepare a standard solution with a concentration of 20% of the analyzer's range; and / or, using pure water to prepare a standard solution with a concentration of 50% of the analyzer's range; and / or, using pure water to prepare a standard solution with a concentration of 80% of the analyzer's range. The preset ratio includes, but is not limited to, using standard solutions with concentrations of 20%, 50%, and 80% of the range of the human trace element analyzer. That is, when the range of the human trace element analyzer is 0-100 μg / L, standard solutions with concentrations of 20 μg / L, 50 μg / L, and 80 μg / L can be prepared. This allows for a gradient detection from low to high concentrations.

[0043] In this implementation, a standard solution with a concentration of 20% of the range of the human trace element analyzer can be considered a low-concentration point, used to evaluate the performance of the human trace element analyzer in the region close to the detection limit. The signal in this region is weak and easily affected by baseline noise and background interference. Checking the indication error at this point can verify the accurate response capability of the human trace element analyzer to low-concentration samples.

[0044] Furthermore, a standard solution with a concentration of 50% of the range of a human trace element analyzer can be considered the medium concentration point, which is the most commonly used and representative operating range of the human trace element analyzer. Assessing the accuracy and precision (repeatability) at this point is crucial, as it directly relates to the reliability of the test results for the vast majority of routine samples.

[0045] Furthermore, a standard solution with a concentration of 80% of the range of the human trace element analyzer can be considered a high-concentration point and can be used to evaluate the performance of the human trace element analyzer near the upper limit of its range. Check for issues such as signal saturation, nonlinear response, or decreased sensitivity at this point to ensure that high-concentration samples can also be measured accurately.

[0046] In this implementation, the three concentration points effectively cover the entire range (i.e., operating range) of the human trace element analyzer, thus providing a linear sample. If the indication errors at all three concentration points are within the allowable range, the analyzer under test can be considered accurate and reliable throughout the entire range. Therefore, compared to calibration at a single concentration point, the calibration of the human trace element analyzer can be more comprehensive. It should be understood that the embodiments of this disclosure are not limited thereto.

[0047] For example, the concentration of the above standard solution can also be configured to 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% of the range of the human trace element analyzer, and any other concentration.

[0048] According to an embodiment of this disclosure, step S110: performing a first preset number of measurements using at least three standard solutions with different preset ratios to calibrate the concentration indication error of the analyzer under test, including:

[0049] The concentration indication error of the analyzer under test is calculated using Equation 1.

[0050] Formula 1;

[0051] In Equation 1, Characterized as concentration indication error, Characterized by the concentration value of the standard solution, The average concentration of the standard solution is represented by i measurements, where i represents the first preset number of measurements.

[0052] The first preset number of times includes, but is not limited to, being configured as 3 times.

[0053] In this implementation, setting the first preset number of measurements to three is to prevent random errors (such as operational fluctuations or sample inhomogeneity) from being included in a single measurement. Measuring three times allows for the calculation of a more stable and reliable average value than a single measurement, effectively smoothing out random fluctuations. It should be understood that the embodiments of this disclosure are not limited thereto.

[0054] For example, it could be 4, 5, 6, 7, 8, or any other number of measurements. While more measurements can reduce random errors, the detection needs to cover three different concentration points (i.e., standard solutions at 20%, 50%, and 80% of the range of the human trace element analyzer). Therefore, too many measurements (e.g., 8) would result in an excessive total number of measurements (e.g., 24), leading to wasted time and materials. Therefore, the specific number of measurements should strike a good balance between ensuring data reliability and operational efficiency.

[0055] According to an embodiment of this disclosure, step S120: performing a second preset number of measurements using a standard solution with a concentration of 50% of the range of the analyzer under test, in order to calibrate the measurement repeatability of the analyzer under test, includes:

[0056] The measurement repeatability of the analyzer under test is calculated using Equation 2.

[0057] Formula 2;

[0058] In Equation 2, represents the measurement repeatability, represents the concentration value of the i-th measurement, represents the average of the concentration values ​​of the n-th measurement, represents the average of the concentration values ​​of the n-th measurement, and n represents the second preset number of times.

[0059] The second preset number of times includes, but is not limited to, being configured as 7 times.

[0060] In this implementation, the denominator (n-1) in Equation 2 can be understood as the degrees of freedom. The larger the degrees of freedom, the more representative the calculated standard deviation is of the true dispersion of the population, and the more reliable the estimate is. Therefore, when n=7, the degrees of freedom are 6. According to the t-distribution (i.e., the Student's t-distribution), the t-value is relatively stable at a 95% confidence level. This makes the precision calculated based on 7 measurements have a high statistical confidence level and can more robustly reflect the random error of the human trace element analyzer.

[0061] According to an illustrative embodiment of this disclosure, based on the measurement principle of the analyzer under test, a third preset number of continuous measurements are performed using a standard solution of a preset concentration to calibrate the detection limit of the analyzer under test. The method further includes: for the analyzer under test whose measurement principle is leaching, using cadmium as a standard substance and a standard solution with a concentration of 2.0 μg / L.

[0062] According to another illustrative embodiment of this disclosure, based on the measurement principle of the analyzer under test, a third preset number of continuous measurements are performed using a standard solution of a preset concentration to calibrate the detection limit of the analyzer under test. The method further includes: for the analyzer under test whose measurement principle is polarography, using zinc as a standard substance and a standard solution with a concentration of 20 μg / L.

[0063] In this implementation, different testing conditions were used for the analyzers employing the leaching method and polarography, respectively. The leaching method itself has high sensitivity, therefore a lower concentration of cadmium (Cd) is used (e.g., 2.0 μg / L as mentioned above). The polarography method has relatively lower sensitivity for zinc (Zn), therefore a higher concentration (e.g., 20 μg / L as mentioned above) is used. This ensures that the detection limit test based on the above steps is both challenging (i.e., the concentration of the standard solution is low enough to reflect the detection sensitivity) and within its linear range (i.e., it reflects the direct proportionality between the signal response value and the concentration), thus avoiding misjudgments due to inappropriate selection of testing conditions.

[0064] According to an embodiment of this disclosure, step S130: Based on the measurement principle of the analyzer under test, a third preset number of continuous measurements are performed using a standard solution of a preset concentration to calibrate the detection limit of the analyzer under test, including: calculating the standard deviation value of the analyzer under test using Equation 3.

[0065] Formula 3;

[0066] In Equation 3, Characterized by the standard deviation value; The concentration value is represented by the i-th measurement. The value is represented by the average of m concentration measurements; m represents the third preset number of measurements.

[0067] According to embodiments of this disclosure, based on the measurement principle of the analyzer under test, a third preset number of continuous measurements are performed using a standard solution of a preset concentration to calibrate the detection limit of the analyzer under test. The method further includes: calculating the detection limit of the analyzer under test using Equation 4.

[0068] Equation 4;

[0069] In Equation 3, Characterized by the limit of detection; It is represented by the standard deviation value.

[0070] In some exemplary embodiments, the third preset number of times can be configured to 11 times in order to accurately assess the detection limit of the human trace element analyzer.

[0071] Specifically, for a trace element analyzer that uses the leaching method, 11 consecutive measurements were performed using a cadmium standard solution with a concentration of approximately 2.0 μg / L. Based on the results of this series of measurements, the standard deviation was first calculated using Equation 3, and then multiplied by 3 using Equation 4 to finally determine the detection limit of the trace element analyzer for cadmium.

[0072] Similarly, for human trace element analyzers that use the polarographic principle, a zinc standard solution with a concentration of approximately 20 μg / L can be used to perform the same measurement and calculation procedures to obtain the detection limit for zinc, which will not be elaborated further.

[0073] In this implementation, the calibration method described above is based on the "3 times signal-to-noise ratio" criterion, defining the concentration value corresponding to 3 times the measurement noise level as the detection limit of the human trace element analyzer. This indicator can reliably reflect the lowest concentration that the human trace element analyzer can detect under optimal operating conditions, thereby scientifically determining whether its sensitivity meets the detection requirements of practical applications.

[0074] It should also be noted that the directional terms mentioned in the embodiments, such as "up," "down," "front," "back," "left," and "right," are only for reference in the accompanying drawings and are not intended to limit the scope of protection of this disclosure. Throughout the drawings, the same elements are identified by the same or similar reference numerals. Conventional structures or constructions will be omitted where they may cause confusion in understanding this disclosure.

[0075] The embodiments of this disclosure have been described above. However, these embodiments are for illustrative purposes only and are not intended to limit the scope of this disclosure. Although various embodiments have been described above, this does not mean that the measures in the various embodiments cannot be used advantageously in combination. The scope of this disclosure is defined by the appended claims and their equivalents. Various substitutions and modifications can be made by those skilled in the art without departing from the scope of this disclosure, and all such substitutions and modifications should fall within the scope of this disclosure.

Claims

1. A calibration method for a human trace element analyzer, characterized in that, include: Check the appearance and normal function of the analyzer under test, and prepare a standard solution according to a preset ratio corresponding to the range of the analyzer under test; The concentration indication error of the analyzer under test is calibrated by performing a first preset number of measurements using at least three different preset ratios of the standard solution. The standard solution with a concentration of 50% of the range of the analyzer under test is used to perform a second preset number of measurements in order to calibrate the measurement repeatability of the analyzer under test. Based on the measurement principle of the analyzer under test, a third preset number of continuous measurements are performed using the standard solution of a preset concentration to calibrate the detection limit of the analyzer under test.

2. The calibration method according to claim 1, characterized in that, The configuration corresponds to the range of the analyzer under test, and the standard solution is prepared according to a preset ratio, including: For the analyzer under test that uses the dissolution method as its measurement principle, cadmium is used as a standard substance to prepare the standard solution. And / or, for the analyzer under test whose measurement principle is polarography, zinc element is used as a standard substance to prepare the standard solution.

3. The calibration method according to claim 2, characterized in that, The standard material also includes at least one of iron, calcium, magnesium, manganese, lead, and copper.

4. The calibration method according to claim 2, characterized in that, The configuration, corresponding to the range of the analyzer under test, includes a standard solution prepared according to a preset ratio, and further includes: The standard solution with a concentration of 20% of the range of the analyzer under test was prepared using pure water; And / or, prepare the standard solution with a concentration of 50% of the range of the analyzer under test using pure water; And / or, prepare the standard solution with a concentration of 80% of the range of the analyzer under test using pure water.

5. The calibration method according to claim 1, characterized in that, The step of performing a first preset number of measurements using at least three standard solutions in at least three different preset proportions to calibrate the concentration indication error of the analyzer under test includes: The concentration indication error of the analyzer under test is calculated using Equation 1. Formula 1; In Equation 1, Characterized as concentration indication error, Characterized by the concentration value of the standard solution, The average concentration of the standard solution is represented by i measurements, where i represents the first preset number of measurements.

6. The calibration method according to claim 1, characterized in that, The step of performing a second preset number of measurements using a standard solution with a concentration of 50% of the range of the analyzer under test to calibrate the measurement repeatability of the analyzer under test includes: The measurement repeatability of the analyzer under test is calculated using Equation 2. Formula 2; In Equation 2, represents the measurement repeatability, represents the concentration value of the i-th measurement, represents the average of the concentration values ​​of the n-th measurement, represents the average of the concentration values ​​of the n-th measurement, and n represents the second preset number of times.

7. The calibration method according to claim 1, characterized in that, The step of calibrating the detection limit of the analyzer under test by performing a third preset number of continuous measurements using a standard solution of a preset concentration, based on the measurement principle of the analyzer under test, includes: The standard deviation of the analyzer under test is calculated using Equation 3. Formula 3; In Equation 3, Characterized by the standard deviation value; This is represented by the concentration value from the i-th measurement; The value is represented by the average of m concentration measurements; m represents the third preset number of measurements.

8. The calibration method according to claim 7, characterized in that, The step of calibrating the detection limit of the analyzer by performing a third preset number of continuous measurements using a standard solution of a preset concentration, based on the measurement principle of the analyzer under test, further includes: The detection limit of the analyzer under test is calculated using Equation 4. Equation 4; In Equation 3, Characterized by the limit of detection; It is represented by the standard deviation value.

9. The calibration method according to claim 8, characterized in that, The step of calibrating the detection limit of the analyzer by performing a third preset number of continuous measurements using a standard solution of a preset concentration, based on the measurement principle of the analyzer under test, further includes: For the analyzer under test, which uses the leaching method as its measurement principle, cadmium is used as the standard substance, and the standard solution has a concentration of 2.0 μg / L.

10. The calibration method according to claim 8, characterized in that, The step of calibrating the detection limit of the analyzer by performing a third preset number of continuous measurements using a standard solution of a preset concentration, based on the measurement principle of the analyzer under test, further includes: For the analyzer under test, which uses polarography as its measurement principle, zinc is used as the standard substance, and the standard solution has a concentration of 20 μg / L.

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