Method for measuring an analyte based on nephelometry, sample analyzer and storage medium

Abstract

The embodiment of the present application discloses a method for measuring an analyte based on a turbidimetry method, which comprises the following steps: acquiring at least one prediction time period within a maximum measurement duration and a calibration curve corresponding to the at least one prediction time period; obtaining an estimated concentration value of the analyte according to a reaction degree of the analyte in the at least one prediction time period and the calibration curve corresponding to the at least one prediction time period; determining a final measurement time of the analyte according to the estimated concentration value and a preset corresponding relationship between an analyte concentration value and a measurement time; and determining an actual concentration value of the analyte when the final measurement time is reached. The present application also relates to a measuring device for measuring an analyte based on a turbidimetry method, a sample analyzer for measuring an analyte based on a turbidimetry method and a computer readable storage medium.

Description

Technical Field

[0001] This invention relates to the field of in vitro detection technology, and in particular to a method, measuring device, sample analyzer, and storage medium for measuring analytes based on turbidimetry. Background Technology

[0002] C-reactive protein (CRP) is an acute-phase reactive protein. After the body is infected by bacteria or viruses, the concentration of CRP will rise to hundreds or even thousands of times the normal value. After the disease is cured, the concentration of CRP will drop rapidly and return to normal. Therefore, CRP concentration is usually used as the first choice indicator for identifying bacterial or viral infections. Specifically, it can be used for the diagnosis and monitoring of autoimmune and infectious diseases, as well as for observing the efficacy of antibiotics.

[0003] In existing technologies, latex immunoturbidimetry is known for determining C-reactive protein (CRP) concentration. This method utilizes the characteristic that antigens or antibodies on insoluble materials bind to corresponding antibodies or antigens on the sample to form agglutinations. The agglutinations are irradiated with light waves with wavelengths between 600 nm and 2400 nm, and the antigen parameters are obtained by analyzing the degree of light absorption or scattering. This method measures serum. In practical applications, it is often necessary to measure both complete blood count (CBC) and CRP simultaneously. However, since CBC requires measuring anticoagulated whole blood, while CRP requires measuring serum, two tubes of blood need to be drawn simultaneously, increasing the burden on the patient. Furthermore, in certain special cases, such as testing children, it is almost impossible to draw large amounts of blood. Therefore, a method for measuring whole blood CRP is also known. Serum CRP testing requires the addition of reagents for antigen-antibody reaction. However, blood cells in whole blood may affect light scattering or absorption. Therefore, to remove the interference of blood cells in CRP measurement, reagents are added to dissolve the blood cells to eliminate interference. Simultaneously, measuring CRP also requires the addition of reagents to induce an antigen-antibody reaction. Both hemolytic reactions and antigen-antibody reactions require a certain reaction time, which means that measuring the CRP concentration of a blood sample usually takes 2 minutes, resulting in low measurement efficiency. Summary of the Invention

[0004] To address the aforementioned technical problems, embodiments of the present invention aim to provide a method, measuring device, sample analyzer, and storage medium for measuring analytes based on turbidimetry. Within the maximum measurement duration, the concentration of the analyte is estimated for certain time periods, and the measurement end time is determined based on the estimated analyte concentration. This eliminates the need for each sample to undergo the maximum measurement duration to obtain detection results, thereby improving overall measurement efficiency.

[0005] To achieve the above objectives, the technical solution of this invention is implemented as follows:

[0006] The first aspect of this invention provides a method for measuring analytes based on turbidimetry, the method comprising:

[0007] Obtain at least one predicted time period within the maximum measurement duration and the calibration curve corresponding to the at least one predicted time period;

[0008] Based on the reactivity of the analyte in at least one predicted time period and its corresponding calibration curve, the estimated concentration value of the analyte is determined.

[0009] Based on the estimated concentration value and the preset correspondence between the analyte concentration value and the measurement time, the final measurement time of the analyte is determined;

[0010] At the final measurement time, the actual concentration value of the analyte is determined.

[0011] In the above scheme, the step of determining the estimated concentration value of the analyte may include:

[0012] Based on the reactivity of the analyte in each of the predicted time periods and its corresponding calibration curve, the concentration value of the analyte in each of the predicted time periods is determined;

[0013] The estimated concentration of the analyte is obtained based on the concentration values ​​of the analyte in each of the predicted time periods.

[0014] In the above scheme, the step of calculating the estimated concentration value of the analyte based on the concentration values ​​of the analyte in each of the predicted time periods may include:

[0015] The estimated concentration value is determined by the average or weighted average of the concentration values ​​of the analyte in each of the predicted time periods; or

[0016] The concentration value of the analyte in each of the predicted time periods is determined as the estimated concentration value, preferably the concentration value corresponding to the last time period in each of the predicted time periods is determined as the estimated concentration value.

[0017] In the above scheme, the step of determining the final measurement time of the analyte based on the estimated concentration value and the preset correspondence between the analyte concentration value and the measurement time may include:

[0018] When the estimated concentration value is outside the preset threshold range, any time between the current time and the end time of the maximum measurement duration will be determined as the final measurement time.

[0019] When the estimated concentration value is within the preset threshold range, the end time of the maximum measurement duration is determined as the final measurement time.

[0020] Optionally, the preset threshold range can be adjusted according to a reference range. Preferably, the preset threshold range can be 5 mg / L to 50 mg / L, or 10 mg / L to 50 mg / L, 20 mg / L to 50 mg / L, 5 mg / L to 80 mg / L, 10 mg / L to 80 mg / L, or 20 mg / L to 80 mg / L.

[0021] In the above scheme, the step of determining the actual concentration value of the analyte at the final measurement time may include:

[0022] Obtain at least one measurement time period prior to the final measurement time and the calibration curve corresponding to the at least one measurement time period;

[0023] Based on the reactivity of the analyte in each measurement time period and its corresponding calibration curve, the concentration value of the analyte in each measurement time period is determined;

[0024] The actual concentration of the analyte is determined based on its concentration values ​​during each of the measurement time periods.

[0025] Optionally, the step of determining the actual concentration value of the analyte based on its concentration values ​​during each of the measurement time periods may include:

[0026] The actual concentration value is determined by the average or weighted average of the concentration values ​​of the analyte over each of the measurement time periods; or

[0027] The concentration value of the analyte in each of the measurement time periods is determined as the actual concentration value. Preferably, the concentration value corresponding to the measurement time period whose end time is closest to the final measurement time is determined as the actual concentration value.

[0028] Optionally, the step of determining the actual concentration value of the analyte at the final measurement time may include:

[0029] Obtain multiple measurement time periods prior to the final measurement time and the corresponding calibration curves for the multiple measurement time periods;

[0030] Based on the reactivity of the analyte in each measurement time period and its corresponding calibration curve, the concentration value of the analyte in each measurement time period is determined;

[0031] Concentration values ​​from two of the multiple measurement time periods are selected for comparison;

[0032] When the concentration values ​​of the analyte differ by a certain threshold between the two measurement time periods, an error message indicating an anomaly in the measurement process will be output.

[0033] Optionally, the method may further include:

[0034] When the estimated concentration value is within the preset threshold range, compare the estimated concentration value with the actual concentration value;

[0035] When the estimated concentration value differs from the actual concentration value by a certain threshold, an error message indicating an anomaly in the measurement process will be output.

[0036] Optionally, the method may further include:

[0037] Display the final measurement time of the analyte; and / or

[0038] If the final measurement time is less than the end time of the maximum measurement duration, a prompt indicating that the maximum measurement duration has not been reached will be output.

[0039] Optionally, the analyte can be a blood component, such as C-reactive protein or a specific protein.

[0040] A second aspect of the present invention provides a method for measuring analytes based on turbidimetry, the method comprising:

[0041] Set the measurement mode;

[0042] When the measurement mode is the first mode, the maximum measurement duration and the calibration curve corresponding to the maximum measurement duration are obtained, and the concentration value of the analyte is calculated based on the reactivity of the analyte within the maximum measurement duration and its corresponding calibration curve.

[0043] When the measurement mode is the second mode, the method according to the first aspect of the present invention is implemented.

[0044] A third aspect of the present invention provides a measuring device for measuring analytes based on turbidimetry, the measuring device comprising:

[0045] The data acquisition module is used to acquire at least one predicted time period within the maximum measurement duration and the calibration curve corresponding to the at least one predicted time period;

[0046] The concentration prediction module is used to obtain the predicted concentration value of the analyte based on the reactivity of the analyte in the at least one prediction time period and its corresponding calibration curve.

[0047] The final measurement time determination module is used to determine the final measurement time of the analyte based on the estimated concentration value and the preset correspondence between the analyte concentration value and the measurement time.

[0048] The actual concentration determination module is used to determine the actual concentration value of the analyte when the final measurement time is reached.

[0049] In the above-mentioned measuring device, the concentration prediction module can specifically be used for:

[0050] Based on the reactivity of the analyte in each of the predicted time periods and its corresponding calibration curve, the concentration value of the analyte in each of the predicted time periods is determined;

[0051] The estimated concentration of the analyte is obtained based on the concentration values ​​of the analyte in each of the predicted time periods.

[0052] In the above-mentioned measuring device, the concentration prediction module can specifically be used for:

[0053] The estimated concentration value is determined by the average or weighted average of the concentration values ​​of the analyte in each of the predicted time periods; or

[0054] The concentration value of the analyte in each of the predicted time periods is determined as the estimated concentration value, preferably the concentration value corresponding to the last time period in each of the predicted time periods is determined as the estimated concentration value.

[0055] In the above-mentioned measuring device, the final measurement time determination module can specifically be used for:

[0056] When the estimated concentration value is outside the preset threshold range, any time between the current time and the end time of the maximum measurement duration will be determined as the final measurement time.

[0057] When the estimated concentration value is within the preset threshold range, the end time of the maximum measurement duration is determined as the final measurement time.

[0058] Optionally, the preset threshold range can be adjusted according to a reference range. Preferably, the preset threshold range can be 5 mg / L to 50 mg / L, or 10 mg / L to 50 mg / L, 20 mg / L to 50 mg / L, 5 mg / L to 80 mg / L, 10 mg / L to 80 mg / L, or 20 mg / L to 80 mg / L.

[0059] In the above-mentioned measuring device, the actual concentration determination module can specifically be used for:

[0060] Obtain at least one measurement time period prior to the final measurement time and the calibration curve corresponding to the at least one measurement time period;

[0061] Based on the reactivity of the analyte in each measurement time period and its corresponding calibration curve, the concentration value of the analyte in each measurement time period is determined;

[0062] The actual concentration of the analyte is determined based on its concentration values ​​during each of the measurement time periods.

[0063] In the above-mentioned measuring device, the actual concentration determination module can specifically be used for:

[0064] The actual concentration value is determined by the average or weighted average of the concentration values ​​of the analyte over each of the measurement time periods; or

[0065] The actual concentration value is determined by one of the concentration values ​​of the analyte in each of the measurement time periods, preferably by the concentration value corresponding to the measurement time period whose end time is closest to the final measurement time.

[0066] In the above-mentioned measuring device, the measuring device may further include a prompting module, which is used to compare the estimated concentration value with the actual concentration value when the estimated concentration value is within the preset threshold range; and to output a prompt that there is an abnormality in the measurement process when the estimated concentration value and the actual concentration value differ from a certain threshold.

[0067] In the above-mentioned measuring device, the measuring device may further include a display module for displaying the final measurement time of the analyte; and / or the measuring device may further include a prompt module for outputting a prompt that the maximum measurement time has not been reached when the final measurement time is less than the end time of the maximum measurement time.

[0068] In the above-mentioned measuring device, the analyte can be a blood component, such as C-reactive protein or a specific protein.

[0069] A fourth aspect of the present invention provides a sample analyzer for measuring analytes based on turbidimetry, the sample analyzer comprising:

[0070] A reaction chamber is a reaction area designed to provide samples and reagents.

[0071] A photometer is used to illuminate the analytes in a sample in order to obtain the absorbance of the analytes at different time points.

[0072] The processor is configured to execute the method for measuring analytes based on turbidimetry as described above.

[0073] An output device for outputting the actual concentration value of the analyte.

[0074] The fifth aspect of the present invention provides a computer-readable storage medium storing one or more programs that can be executed by a processor to implement the above-described method for measuring analytes based on turbidimetry. Attached Figure Description

[0075] Figure 1 A schematic diagram of a process for measuring analytes based on turbidimetry is provided in an embodiment of the present invention;

[0076] Figure 2 An exemplary reaction rate variation curve is provided for an embodiment of the present invention;

[0077] Figure 3 This is a schematic diagram of another process for measuring analytes based on turbidimetry, provided in an embodiment of the present invention.

[0078] Figure 4 This is a schematic diagram of a measuring device for measuring analytes based on turbidimetry, provided in an embodiment of the present invention.

[0079] Figure 5 This is a schematic diagram of a sample analyzer for measuring analytes based on turbidimetry, provided as an embodiment of the present invention. Detailed Implementation

[0080] To gain a more detailed understanding of the features and technical content of the embodiments of the present invention, the implementation of the embodiments of the present invention will be described in detail below with reference to the accompanying drawings. The accompanying drawings are for reference and illustration only and are not intended to limit the embodiments of the present invention.

[0081] The first aspect of the present invention provides a method for measuring analytes based on turbidimetry, which is applied to a sample analyzer for measuring analytes based on turbidimetry. Figure 1 This is a schematic diagram of a process for measuring analytes based on turbidimetry, provided as an embodiment of the present invention. Figure 1 As shown, the method includes the following steps:

[0082] S101. Obtain at least one predicted time period within the maximum measurement duration and the calibration curve corresponding to the at least one predicted time period.

[0083] In an embodiment of the present invention, a sample analyzer based on turbidimetric measurement of analytes can first obtain at least one predicted time period within the maximum measurement duration and a calibration curve (standard curve) corresponding to the at least one predicted time period.

[0084] It should be noted that, in the embodiments of the present invention, a maximum measurement time is typically preset, for example, 2 minutes for C-reactive protein, to limit the longest measurement time for analytes in samples based on turbidimetric methods. Essentially, all analytes and corresponding reagents in all samples can react substantially completely within the maximum measurement time. Then, the operator can set at least one fixed time period within the maximum measurement time according to actual measurement needs and input it into the sample analyzer. The concentration of the analyte can be measured separately within each fixed time period. Furthermore, a calibration curve for the analyte corresponding to the at least one fixed time period can be input simultaneously. The specific maximum measurement time, fixed time periods, and calibration curve for the analyte are not limited in the embodiments of the present invention.

[0085] It should be noted that, in the embodiments of the present invention, at least one predicted time period within the maximum measurement duration specifically refers to at least one time period selected from the at least one fixed time period. This can be specified by the operator sending relevant instructions to the sample analyzer, or it can be selected according to certain preset rules or randomly. Since the calibration curve of the analyte corresponding to the at least one fixed time period is simultaneously input into the measuring device, the sample analyzer can directly obtain the calibration curve corresponding to the at least one predicted time period, i.e., the calibration curve corresponding to each predicted time period. The specific at least one preset time period is not limited in the embodiments of the present invention.

[0086] For example, in an embodiment of the present invention, a maximum measurement duration T is preset in the sample analyzer. The operator determines N fixed time periods within the maximum measurement duration, where N is a natural number greater than or equal to 1. These N fixed time periods and their corresponding calibration curves for the N analytes are input into the sample analyzer. Furthermore, the operator can instruct M time periods within these N fixed time periods to be set as predicted time periods. That is, the sample analyzer can obtain M predicted time periods, where M is a natural number greater than or equal to 1 and less than or equal to N. Accordingly, the calibration curves corresponding to each time period in the M predicted time periods can be obtained from the N calibration curves.

[0087] S102. Based on the reactivity of the analyte in at least one predicted time period and its corresponding calibration curve, determine the estimated concentration value of the analyte.

[0088] In an embodiment of the present invention, after the sample analyzer acquires at least one prediction time period and the calibration curve corresponding to the at least one prediction time period, it calculates the estimated concentration value of the analyte based on the reactivity of the analyte in the at least one prediction time period and the corresponding calibration curve.

[0089] It should be noted that, in the embodiments of the present invention, the analyte can be a blood component, such as C-reactive protein or a specific protein. Of course, it can also be other components suitable for turbidimetric measurement. The specific analyte is not limited in the embodiments of the present invention.

[0090] Specifically, in embodiments of the present invention, the sample analyzer calculates the estimated concentration value of the analyte based on the reactivity of the analyte in at least one predicted time period and its corresponding calibration curve. This may include: calculating the concentration value of the analyte in each predicted time period based on the reactivity of the analyte in each predicted time period and its corresponding calibration curve; and calculating the estimated concentration value of the analyte based on the concentration value of the analyte in each predicted time period.

[0091] It should be noted that, in the embodiments of the present invention, reactivity refers to the difference between the absorbance measured at the beginning and the end of a fixed time period. For each prediction time period within at least one prediction time period, the sample analyzer can measure the corresponding absorbance at the beginning and end of each prediction time period, thereby calculating the reactivity of each prediction time period.

[0092] It should be noted that, in the embodiments of the present invention, the sample containing the analyte, such as a blood sample, needs to be reacted with the corresponding reagents, and then the analyte in the sample is irradiated with light. The sample analyzer can then obtain the difference in absorbance of the analyte at various prediction time periods, i.e., the reactivity. As the reaction time progresses, the degree of reaction also changes; therefore, the reactivity varies at different prediction time periods.

[0093] Figure 2 An exemplary absorbance variation curve is provided for an embodiment of the present invention. For example... Figure 2 As shown, the absorbance at the beginning of a certain prediction time period is T1, which is A1, and the absorbance at the end of the prediction time period is T2. Therefore, the reactivity of the analyte during this prediction time period can be calculated as A2-A1.

[0094] It should be noted that, in the embodiments of the present invention, after obtaining the reactivity of each prediction time period in the at least one prediction time period, the sample analyzer calculates the concentration value of the analyte for each prediction time period based on the calibration curve corresponding to each prediction time period.

[0095] It should be noted that, in the embodiments of the present invention, the sample analyzer calculates the concentration value of the analyte in each predicted time period based on the reactivity of the analyte in each predicted time period and its corresponding calibration curve. In fact, it finds the corresponding analyte concentration value in the corresponding calibration curve based on the reactivity of each predicted time period. Those skilled in the art know that the specific calculation process is prior art and will not be described in detail here.

[0096] Specifically, in embodiments of the present invention, after the sample analyzer obtains the concentration values ​​of the analyte in each predicted time period, the step of obtaining the estimated concentration value of the analyte based on the concentration values ​​of the analyte in each predicted time period may include: determining the average or weighted average of the concentration values ​​of the analyte in each predicted time period as the estimated concentration value; or determining one of the concentration values ​​of the analyte in each predicted time period as the estimated concentration value, preferably determining the concentration value corresponding to the last time period in each predicted time period as the estimated concentration value.

[0097] It should be noted that, in the embodiments of the present invention, the sample analyzer can calculate the average or weighted average of the concentration values ​​of the analyte in each predicted time period, and thus determine the obtained average or weighted average as the estimated concentration value. In calculating the weighted average, the operator can estimate the accuracy or importance of the concentration values ​​in each predicted time period, pre-set the weights corresponding to the concentration values ​​in each predicted time period, and input them into the measuring device. After obtaining the concentration values ​​of the analyte in each predicted time period, the measuring device can directly substitute the corresponding weights to perform weighted average calculation and obtain the weighted average. The specific weights are not limited in the embodiments of the present invention.

[0098] It should be noted that, in the embodiments of the present invention, the sample analyzer can also determine any one of the concentration values ​​of the analyte in each predicted time period as the estimated concentration value. Of course, as time goes by, the later the time period, the more stable the reaction between the analyte and the reagent in the sample usually becomes, i.e., the more accurate the concentration value. Therefore, the sample analyzer can also preferentially determine the concentration value of the last predicted time period, i.e. the predicted time period closest to the end of the maximum measurement duration, as the estimated concentration value.

[0099] It should be noted that, in the embodiments of the present invention, the operator may also pre-set other rules for determining the estimated concentration in the sample analyzer, such as determining the concentration value corresponding to the middle time period in each prediction time period as the estimated concentration value. The embodiments of the present invention do not make specific limitations.

[0100] S103. Determine the final measurement time of the analyte based on the estimated concentration value and the preset correspondence between the analyte concentration value and the measurement time.

[0101] In an embodiment of the present invention, after obtaining the estimated concentration value of the analyte, the sample analyzer can determine the final measurement time of the analyte based on the estimated concentration value and the preset correspondence between the analyte concentration value and the measurement time.

[0102] Specifically, such as Figure 3 As shown, in an embodiment of the present invention, step S103, in which the sample analyzer determines the final measurement time of the analyte based on the estimated concentration value and the preset correspondence between the analyte concentration value and the predicted time, may include: S103a, when the estimated concentration value is outside the preset threshold range, determining any time between the current time and the end time of the maximum measurement duration as the final measurement time, particularly preferably determining the current time as the final measurement time, i.e., immediately stopping the measurement of the current sample; S103b, when the estimated concentration value is within the preset threshold range, determining the end time of the maximum measurement duration as the final measurement time. Furthermore, when the estimated concentration value differs from the actual concentration value by a certain threshold, a prompt indicating an abnormality in the measurement process (sample abnormality or reaction abnormality) may be output.

[0103] It should be noted that, in the embodiments of the present invention, the operator can set the correspondence between the analyte concentration value and the measurement time according to practical experience and specific measurement requirements. This correspondence can be a function or other type, and can be pre-input into the sample analyzer. After the sample analyzer calculates the estimated concentration value of the analyte, it looks up the actual measurement time corresponding to the estimated concentration value from the correspondence and determines this actual measurement time as the final measurement time of the analyte. The specific correspondence between the analyte concentration value and the measurement time is not limited in the embodiments of the present invention.

[0104] It should be noted that, in the embodiments of the present invention, the preset threshold range may optionally be adjusted according to a reference range. In the context of the present invention, the reference range refers to medical clinical reference values ​​or normal values, which are the content of various components of an analyte (e.g., blood, body fluids) in a normal human body or its response values ​​to various human experiments. Since the reference ranges may differ between hospitals, users can set the preset threshold range according to their actual situation. Preferably, the preset threshold range can be 5 mg / L to 50 mg / L, or 10 mg / L to 50 mg / L, 20 mg / L to 50 mg / L, 5 mg / L to 80 mg / L, 10 mg / L to 80 mg / L, or 20 mg / L to 80 mg / L.

[0105] It should be noted that, in the embodiments of the present invention, for samples with low concentrations of analytes, such as C-reactive protein, the analyte and reagents will reach a reaction (antigen-antibody reaction) equilibrium in a short time. Even if the reaction time is increased further, the impact on the detection results is small, so a long measurement time is not required. For samples with high concentrations of analytes, such as C-reactive protein, a rapid reaction (antigen-antibody reaction) will occur between the analyte and reagents in a short time. At this time, the change in absorbance is large, which is sufficient to support the change in light information required to calculate the concentration of the analyte, such as C-reactive protein, so a long measurement time is also not required. Therefore, for cases where the estimated concentration value is small or large, i.e., the estimated concentration value is outside the preset threshold range, the measurement can be stopped earlier. For example, the sample analyzer can determine any time between the current time and the end time of the maximum measurement duration as the final measurement time. However, for cases where the estimated concentration value is moderate, i.e., the estimated concentration value is within the preset threshold range, it is difficult to determine the degree of reaction between the sample and the reagents. For example, the analysis device can determine the end time of the maximum measurement duration as the final measurement time, i.e., the measurement of the analyte has undergone the maximum measurement duration.

[0106] It is understood that, in the embodiments of the present invention, when the estimated concentration value of the analyte is outside the preset threshold range, the measurement time of the analyte can be shortened, thereby saving measurement time and improving the overall measurement efficiency of the sample while ensuring the accuracy of the measurement results.

[0107] For example, in an embodiment of the present invention, the analyte is CRP (C-reactive protein), the maximum measurement time is 120s, the estimated concentration value is denoted as CRP_est, and the preset correspondence between the analyte concentration value and the measurement time, F(CRP_est), is shown in the following formula (1):

[0108]

[0109] As shown in formula (1), the preset threshold range is greater than or equal to 5.0 mg / L and less than 50.0 mg / L. If the CRP_est obtained by the sample analyzer is less than 5.0 mg / L or greater than or equal to 50.0 mg / L, that is, outside the preset threshold range, the final measurement time is determined to be 80s, that is, the measurement ends at the 80s. If the CRP_est obtained by the sample analyzer is greater than or equal to 5.0 mg / L and less than 50.0 mg / L, that is, within the preset threshold range, the final measurement time is determined to be 120s, that is, the measurement ends at the 120s.

[0110] It should be noted that, in the embodiments of the present invention, the above formula (1) is only an exemplary correspondence, and the embodiments of the present invention are not specifically limited. S104. When the final measurement time is reached, determine the actual concentration value of the analyte.

[0111] In an embodiment of the present invention, after determining the final measurement time of the analyte, the sample analyzer determines the actual concentration value of the analyte when the final measurement time is reached.

[0112] Specifically, in embodiments of the present invention, the step of determining the actual concentration value of the analyte when the sample analyzer reaches the final measurement time may include: acquiring at least one measurement time period before the final measurement time and a calibration curve corresponding to the at least one measurement time period; calculating the concentration value of the analyte in each measurement time period based on the reactivity of the analyte in each measurement time period and its corresponding calibration curve; and calculating the actual concentration value of the analyte based on the concentration value of the analyte in each measurement time period. Further, when multiple measurement time periods are selected, the method may also include: selecting two measurement time periods from the multiple measurement time periods for comparison of concentration values; and outputting a prompt indicating an abnormality in the measurement process (sample abnormality or reaction abnormality) when the concentration values ​​of the analyte in the two measurement time periods differ by a certain threshold.

[0113] It should be noted that, in the embodiments of the present invention, as described in step S101, the at least one prediction time period is selected from the at least one fixed time period, and the sample analyzer calculates the estimated concentration value of the analyte based on the concentration values ​​of the analyte in each prediction time period. In the actual measurement process, the sample analyzer calculates the corresponding concentration value for each fixed time period before the final measurement time. Therefore, the sample analyzer can obtain all fixed time periods before the final measurement time from the at least one fixed time period, including the at least one prediction time period. Therefore, in step S104, one or more of these fixed time periods are determined as the measurement time period, that is, the sample analyzer obtains at least one measurement time period, and correspondingly, it can also obtain the calibration curve corresponding to the at least one measurement time period.

[0114] It should be noted that, in the embodiments of the present invention, similar to the method for determining the concentration value of the analyte in each predicted time period, the sample analyzer can also determine the concentration value of the analyte in each measurement time period based on the reactivity of the analyte in each measurement time period and its corresponding calibration curve. The specific process will not be elaborated here.

[0115] For example, in an embodiment of the present invention, N fixed time periods are input into the sample analyzer, of which M time periods are prediction time periods. The sample analyzer determines the final measurement time T based on the M prediction time periods and the M calibration curves corresponding to the M prediction time periods. e Therefore, it is possible to select from N fixed time periods, in time T e Select one or more time periods before the specified time as the measurement time period to obtain at least one measurement time period.

[0116] Specifically, in embodiments of the present invention, the step of the sample analyzer determining the actual concentration value of the analyte based on the concentration values ​​of the analyte in each measurement time period may include: determining the average or weighted average of the concentration values ​​of the analyte in each measurement time period as the actual concentration value; or determining one of the concentration values ​​of the analyte in each measurement time period as the actual concentration value, preferably determining the concentration value corresponding to the measurement time period whose end time is closest to the final measurement time in each predicted time period as the actual concentration value.

[0117] It should be noted that, in the embodiments of the present invention, the sample analyzer can calculate the average or weighted average of the concentration values ​​of the analyte in each measurement time period, thereby determining the obtained average or weighted average as the actual concentration value. In calculating the weighted average, the operator can estimate the accuracy or importance of the concentration values ​​in each measurement time period, pre-set the weights corresponding to the concentration values ​​in each measurement time period, and input them into the sample analyzer. After obtaining the concentration values ​​of the analyte in each measurement time period, the sample analyzer can directly substitute the corresponding weights to perform weighted average calculation and obtain the weighted average. The specific weights are not limited in the embodiments of the present invention.

[0118] It is understood that, in the embodiments of the present invention, the sample analyzer can determine any one of the concentration values ​​of the analyte in each measurement time period as the actual concentration value. Of course, since the reaction degree of the analyte and the corresponding reagent is usually more stable as the time is closer to the final measurement time, the measurement result is usually more accurate. Therefore, the concentration value of the measurement time period with the end time closest to the final measurement time can be selected as the actual concentration value.

[0119] It should be noted that, in the embodiments of the present invention, in addition to the above-described method for determining the actual concentration value, other determination methods can be set according to actual measurement needs, and the embodiments of the present invention do not impose specific limitations.

[0120] In addition, the method may also include: displaying the final measurement time of the analyte; and / or outputting a prompt that the maximum measurement time has not been reached when the final measurement time is less than the end time of the maximum measurement duration.

[0121] In one embodiment, blood samples from 10 patients were randomly selected for C-reactive protein testing. The C-reactive protein of each sample was measured using existing measurement methods with a maximum measurement time of 120 seconds. The C-reactive protein test results of the 10 samples are shown in Table 1 below:

[0122] Table 1

[0123]

[0124]

[0125] According to the measurement method of the present invention, the measurement is performed at the final measurement time determined according to the correspondence shown in formula (1), and the measurement time and measurement results are shown in Table 2:

[0126] Table 2

[0127] sample C-reactive protein measurement time (seconds) C-reactive protein test results (mg / L) Sample 1 80 0.98 Sample 2 120 12.3 Sample 3 80 2.35 Sample 4 80 69.6 Sample 5 80 0.15 Sample 6 80 3.43 Sample 7 120 19.1 Sample 8 80 0.86 Sample 9 80 2.01 Sample 10 120 6.83

[0128] According to the results shown in Table 2, the average measurement time for 10 samples using the measurement method of the present invention is 92 seconds, which is significantly shorter than the maximum measurement time of 120 seconds for each sample as shown in Table 1. Furthermore, the average C-reactive protein measurement result in Table 2 is 11.76 mg / L, while the average C-reactive protein measurement result in Table 1 is 11.63 mg / L. It can be seen that the measurement method of the present invention improves the overall measurement speed without affecting the measurement results.

[0129] A second aspect of the present invention provides a method for measuring analytes based on turbidimetry, applied to a sample analyzer for measuring analytes based on turbidimetry, the method comprising the following steps:

[0130] Set the measurement mode;

[0131] When the measurement mode is the first mode, the maximum measurement duration and the calibration curve corresponding to the maximum measurement duration are obtained, and the concentration value of the analyte is calculated based on the reactivity of the analyte within the maximum measurement duration and its corresponding calibration curve.

[0132] When the measurement mode is the second mode, the method according to the first aspect of the present invention is implemented.

[0133] A third aspect of the present invention also provides a measuring device for measuring analytes based on turbidimetry, which is applied to a sample analyzer for measuring analytes based on turbidimetry. Figure 4 This is a schematic diagram of a measuring device for measuring analytes based on turbidimetry, provided as an embodiment of the present invention. Figure 4 As shown, the measuring device includes:

[0134] Data acquisition module 301 is used to acquire at least one predicted time period within the maximum measurement duration and a calibration curve corresponding to the at least one predicted time period;

[0135] The concentration prediction module 302 is used to obtain the predicted concentration value of the analyte based on the reactivity of the analyte in the at least one prediction time period and its corresponding calibration curve.

[0136] The final measurement time determination module 303 is used to determine the final measurement time of the analyte based on the estimated concentration value and the preset correspondence between the analyte concentration value and the measurement time.

[0137] The actual concentration determination module 304 is used to determine the actual concentration value of the analyte when the final measurement time is reached.

[0138] Optionally, the concentration prediction module 302 can be specifically used for:

[0139] Based on the reactivity of the analyte in each of the predicted time periods and its corresponding calibration curve, the concentration value of the analyte in each of the predicted time periods is determined;

[0140] The estimated concentration of the analyte is obtained based on the concentration values ​​of the analyte in each of the predicted time periods.

[0141] Optionally, the concentration prediction module 302 can be specifically used for:

[0142] The estimated concentration value is determined by the average or weighted average of the concentration values ​​of the analyte in each of the predicted time periods; or

[0143] The concentration value of the analyte in each of the predicted time periods is determined as the estimated concentration value, preferably the concentration value corresponding to the last time period in each of the predicted time periods is determined as the estimated concentration value.

[0144] Optionally, the final measurement time determination module 303 can be specifically used for:

[0145] When the estimated concentration value is outside the preset threshold range, any time between the current time and the end time of the maximum measurement duration will be determined as the final measurement time.

[0146] When the estimated concentration value is within the preset threshold range, the end time of the maximum measurement duration is determined as the final measurement time.

[0147] Optionally, the actual concentration determination module 304 can be specifically used for:

[0148] Obtain at least one measurement time period prior to the final measurement time and the calibration curve corresponding to the at least one measurement time period;

[0149] Based on the reactivity of the analyte in each measurement time period and its corresponding calibration curve, the concentration value of the analyte in each measurement time period is determined;

[0150] The actual concentration of the analyte is determined based on its concentration values ​​during each of the measurement time periods.

[0151] Optionally, the actual concentration determination module 304 can be specifically used for:

[0152] The actual concentration value is determined by the average or weighted average of the concentration values ​​of the analyte over each of the measurement time periods; or

[0153] The concentration value of the analyte in each of the measurement time periods is determined as the actual concentration value. Preferably, the concentration value corresponding to the measurement time period whose end time is closest to the final measurement time is determined as the actual concentration value.

[0154] Optionally, the measuring device may further include a prompting module (not shown), used to compare the estimated concentration value with the actual concentration value when the estimated concentration value is within the preset threshold range; and to output a prompt indicating that there is an abnormality in the measurement process when the estimated concentration value differs from the actual concentration value by a certain threshold.

[0155] Optionally, the measuring device may further include a display module (not shown) for displaying the final measurement time of the analyte; and / or the measuring device may further include a prompt module (not shown) for outputting a prompt that the maximum measurement time has not been reached when the final measurement time is less than the end time of the maximum measurement time.

[0156] Optionally, the analyte can be a blood component, such as C-reactive protein or a specific protein.

[0157] A fourth aspect of the present invention also provides a sample analyzer based on turbidimetric measurement of analytes. Figure 5 A schematic diagram of a sample analyzer for measuring analytes based on turbidimetry is provided as an embodiment of the present invention, as shown below. Figure 5 As shown, the sample analyzer includes: a reaction cell 401, which is set up as a reaction site for providing samples and reagents; a photometer 402, which is set up to irradiate the analytes in the sample with light so as to obtain the absorbance of the analytes at different time periods; a processor 403, which is set up to execute the above-mentioned method for measuring analytes based on turbidimetry; and an output device 404, which is used to output the actual concentration value of the analytes.

[0158] Preferably, reaction chamber 401 may be provided as a site for providing agglutination reaction for hemolyzed blood samples to be tested, such as whole blood samples, and latex reagents loaded with anti-CRP antibodies.

[0159] Preferably, the photometer 402 includes a light source (not shown), and if the light source is non-monochromatic, it may also include a spectroscopic element (not shown). The spectroscopic element may be, for example, a prism, a filter wheel, and / or a grating. A suitable spectroscopic element can be selected according to actual needs. The photometer 402 can be used to irradiate the product of a sample and reagent reaction (agglutination reaction) with light, and to determine the C-reactive protein concentration in the sample based on the change in absorbance of the product at different time periods. Generally, the photometer 402 may also include a calculator for determining the concentration value; the function of this calculator can also be integrated into the processor 403.

[0160] A fifth aspect of the present invention also provides a computer-readable storage medium storing one or more programs that can be executed by a processor to implement the above-described method for measuring analytes based on turbidimetry.

[0161] The processor in this embodiment of the invention can be a Central Processing Unit (CPU), or other general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. The general-purpose processor can be a microprocessor or any conventional processor.

[0162] The computer-readable storage medium in embodiments of the present invention may be volatile memory, such as random-access memory (RAM); or non-volatile memory, such as read-only memory (ROM), flash memory, hard disk drive (HDD), or solid-state drive (SSD); or it may be a device that includes one or any combination of the above-mentioned memories, such as a mobile phone, computer, tablet device, personal digital assistant, etc.

[0163] Those skilled in the art will understand that embodiments of the present invention can be provided as methods, systems, or computer program products. Therefore, the present invention can take the form of hardware embodiments, software embodiments, or embodiments combining software and hardware aspects. Furthermore, the present invention can take the form of a computer program product embodied on one or more computer-usable storage media (including, but not limited to, disk storage and optical storage) containing computer-usable program code.

[0164] This invention is described with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, special-purpose computer, embedded processor, or other programmable signal processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable signal processing apparatus, generate instructions for implementing the flowchart illustrations and / or block diagrams. Figure 1 One or more processes and / or boxes Figure 1 A device that provides the functions specified in one or more boxes.

[0165] These computer program instructions may also be stored in a computer-readable storage medium that can direct a computer or other programmable signal processing device to operate in a particular manner, such that the instructions stored in the computer-readable storage medium produce an article of manufacture including instruction means, which are implemented in a process Figure 1 One or more processes and / or boxes Figure 1 The function specified in one or more boxes.

[0166] These computer program instructions can also be loaded onto a computer or other programmable signal processing device to cause a series of operational steps to be performed on the computer or other programmable device to produce a computer-implemented process, thereby providing instructions that execute on the computer or other programmable device for implementing the process. Figure 1 One or more processes and / or boxes Figure 1 The steps of the function specified in one or more boxes.

[0167] The features mentioned above, as long as they are meaningful within the scope of this invention, can be arbitrarily combined with each other. The advantages and features described with respect to the method for measuring analytes based on turbidimetry are applied accordingly to the measuring device and the sample analyzer for measuring analytes based on turbidimetry, and vice versa.

[0168] While specific embodiments of the present invention have been described above, those skilled in the art should understand that these specific embodiments are merely illustrative. Those skilled in the art can make various changes or modifications to these specific embodiments without departing from the principles of the present invention, and all such changes and modifications fall within the protection scope of the present invention.

Claims

1. A method for measuring analytes based on turbidimetry, characterized in that, The method includes: Obtain at least one predicted time period within the maximum measurement duration and a calibration curve of the analyte corresponding to the at least one predicted time period; Based on the reactivity of the analyte in at least one predicted time period and its corresponding calibration curve, the estimated concentration value of the analyte is determined. Based on the estimated concentration value and the preset correspondence between analyte concentration value and measurement time, the final measurement time of the analyte is determined; wherein, in the preset correspondence between analyte concentration value and measurement time, different analyte concentration values ​​correspond to different measurement times, and the final measurement time is not greater than the end time of the maximum measurement duration. At the final measurement time, the actual concentration value of the analyte is determined.

2. The method according to claim 1, characterized in that, The step of determining the estimated concentration value of the analyte includes: Based on the reactivity of the analyte in each of the predicted time periods and its corresponding calibration curve, the concentration value of the analyte in each of the predicted time periods is determined; The estimated concentration of the analyte is obtained based on the concentration values ​​of the analyte in each of the predicted time periods.

3. The method according to claim 2, characterized in that, The step of calculating the estimated concentration value of the analyte based on its concentration values ​​in each of the predicted time periods includes: The estimated concentration value is determined by the average or weighted average of the concentration values ​​of the analyte in each of the predicted time periods; or The estimated concentration value is determined as one of the concentration values ​​of the analyte in each of the predicted time periods.

4. The method according to claim 3, characterized in that, The concentration value corresponding to the last time period in each of the predicted time periods is determined as the estimated concentration value.

5. The method according to any one of claims 1 to 4, characterized in that, The step of determining the final measurement time of the analyte based on the estimated concentration value and the preset correspondence between the analyte concentration value and the measurement time includes: When the estimated concentration value is outside the preset threshold range, any time between the current time and the end time of the maximum measurement duration will be determined as the final measurement time. When the estimated concentration value is within the preset threshold range, the end time of the maximum measurement duration is determined as the final measurement time.

6. The method according to claim 5, characterized in that, The preset threshold range can be adjusted according to the reference range.

7. The method according to claim 6, characterized in that, The preset threshold range is 5 mg / L to 50 mg / L, or 10 mg / L to 50 mg / L, 20 mg / L to 50 mg / L, 5 mg / L to 80 mg / L, 10 mg / L to 80 mg / L, or 20 mg / L to 80 mg / L.

8. The method according to any one of claims 1 to 4, characterized in that, The step of determining the final measurement time of the analyte based on the estimated concentration value and the preset correspondence between the analyte concentration value and the measurement time includes: Based on practical experience and specific measurement requirements, a correspondence between analyte concentration values ​​and measurement times is established. The actual measurement time corresponding to the estimated concentration value is found from the correspondence, and this actual measurement time is determined as the final measurement time of the analyte.

9. The method according to claim 1, characterized in that, The step of determining the actual concentration value of the analyte at the final measurement time includes: Obtain at least one measurement time period prior to the final measurement time and the calibration curve corresponding to the at least one measurement time period; Based on the reactivity of the analyte in each measurement time period and its corresponding calibration curve, the concentration value of the analyte in each measurement time period is determined; The actual concentration of the analyte is determined based on its concentration values ​​during each of the measurement time periods.

10. The method according to claim 9, characterized in that, The step of determining the actual concentration value of the analyte based on its concentration values ​​during each of the measurement time periods includes: The actual concentration value is determined by the average or weighted average of the concentration values ​​of the analyte over each of the measurement time periods; or The concentration value of the analyte during each of the measurement time periods is determined as the actual concentration value.

11. The method according to claim 10, characterized in that, The concentration value corresponding to the measurement time period whose end time is closest to the final measurement time is determined as the actual concentration value.

12. The method according to claim 9, characterized in that, The step of determining the actual concentration value of the analyte at the final measurement time includes: Obtain multiple measurement time periods prior to the final measurement time and the corresponding calibration curves for the multiple measurement time periods; Based on the reactivity of the analyte in each measurement time period and its corresponding calibration curve, the concentration value of the analyte in each measurement time period is determined; Concentration values ​​from two of the multiple measurement time periods are selected for comparison; When the concentration values ​​of the analyte differ by a certain threshold between the two measurement time periods, an error message indicating an anomaly in the measurement process will be output.

13. The method according to claim 5, characterized in that, The method further includes: When the estimated concentration value is within the preset threshold range, the estimated concentration value is compared with the actual concentration value. When the estimated concentration value differs from the actual concentration value by a certain threshold, an error message indicating an anomaly in the measurement process will be output.

14. The method according to claim 1, characterized in that, The method further includes: Display the final measurement time of the analyte; and / or If the final measurement time is less than the end time of the maximum measurement duration, a prompt indicating that the maximum measurement duration has not been reached will be output.

15. The method according to claim 1, characterized in that, The analyte is a blood component.

16. The method according to claim 15, characterized in that, The blood components are specific proteins.

17. The method according to claim 16, characterized in that, The blood component was C-reactive protein.

18. A method for measuring analytes based on turbidimetry, characterized in that, The method includes: Set the measurement mode; When the measurement mode is the first mode, the maximum measurement duration and the calibration curve corresponding to the maximum measurement duration are obtained, and the concentration value of the analyte is calculated based on the reactivity of the analyte within the maximum measurement duration and its corresponding calibration curve. When the measurement mode is the second mode, the method of any one of claims 1 to 17 is implemented.

19. A measuring device for measuring analytes based on turbidimetry, characterized in that, The measuring device includes: The data acquisition module is used to acquire at least one predicted time period within the maximum measurement duration and the calibration curve of the analyte corresponding to the at least one predicted time period; The concentration prediction module is used to obtain the predicted concentration value of the analyte based on the reactivity of the analyte in at least one prediction time period and its corresponding calibration curve. The final measurement time determination module is used to determine the final measurement time of the analyte based on the estimated concentration value and the preset correspondence between the analyte concentration value and the measurement time; wherein, in the preset correspondence between the analyte concentration value and the measurement time, different analyte concentration values ​​correspond to different measurement times, and the final measurement time is not greater than the end time of the maximum measurement time. The actual concentration determination module is used to determine the actual concentration value of the analyte when the final measurement time is reached.

20. The measuring device according to claim 19, characterized in that, The concentration prediction module is specifically used for: Based on the reactivity of the analyte in each of the predicted time periods and its corresponding calibration curve, the concentration value of the analyte in each of the predicted time periods is determined; The estimated concentration of the analyte is obtained based on the concentration values ​​of the analyte in each of the predicted time periods.

21. The measuring device according to claim 19, characterized in that, The concentration prediction module is specifically used for: The estimated concentration value is determined by the average or weighted average of the concentration values ​​of the analyte in each of the predicted time periods; or The estimated concentration value is determined as one of the concentration values ​​of the analyte in each of the predicted time periods.

22. The measuring device according to claim 21, characterized in that, The concentration value corresponding to the last time period in each of the predicted time periods is determined as the estimated concentration value.

23. The measuring device according to any one of claims 19 to 22, characterized in that, The final measurement time determination module is specifically used for: When the estimated concentration value is outside the preset threshold range, any time between the current time and the end time of the maximum measurement duration will be determined as the final measurement time. When the estimated concentration value is within the preset threshold range, the end time of the maximum measurement duration is determined as the final measurement time.

24. The measuring device according to claim 23, characterized in that, The preset threshold range can be adjusted according to the reference range.

25. The measuring device according to claim 24, characterized in that, The preset threshold range is 5 mg / L to 50 mg / L, or 10 mg / L to 50 mg / L, 20 mg / L to 50 mg / L, 5 mg / L to 80 mg / L, 10 mg / L to 80 mg / L, or 20 mg / L to 80 mg / L.

26. The measuring device according to any one of claims 19 to 22, characterized in that, The step of determining the final measurement time of the analyte based on the estimated concentration value and the preset correspondence between the analyte concentration value and the measurement time includes: Based on practical experience and specific measurement requirements, a correspondence between analyte concentration values ​​and measurement times is established. The actual measurement time corresponding to the estimated concentration value is found from the correspondence, and this actual measurement time is determined as the final measurement time of the analyte.

27. The measuring device according to claim 19, characterized in that, The actual concentration determination module is specifically used for: Obtain at least one measurement time period prior to the final measurement time and the calibration curve corresponding to the at least one measurement time period; Based on the reactivity of the analyte in each measurement time period and its corresponding calibration curve, the concentration value of the analyte in each measurement time period is determined; The actual concentration of the analyte is determined based on its concentration values ​​during each of the measurement time periods.

28. The measuring device according to claim 27, characterized in that, The actual concentration determination module is specifically used for: The actual concentration value is determined by the average or weighted average of the concentration values ​​of the analyte over each of the measurement time periods; or The concentration value of the analyte during each of the measurement time periods is determined as the actual concentration value.

29. The measuring device according to claim 28, characterized in that, The concentration value corresponding to the measurement time period whose end time is closest to the final measurement time is determined as the actual concentration value.

30. The measuring device according to claim 19, characterized in that, The measuring device also includes a prompting module, which is used to compare the estimated concentration value with the actual concentration value when the estimated concentration value is within a preset threshold range; and to output a prompt indicating that there is an abnormality in the measurement process when the estimated concentration value differs from the actual concentration value by a certain threshold.

31. The measuring device according to claim 19, characterized in that, The measuring device further includes a display module for displaying the final measurement time of the analyte; and / or The measuring device also includes a prompting module, which outputs a prompt that the maximum measurement duration has not been reached when the final measurement time is less than the end time of the maximum measurement duration.

32. The measuring device according to claim 19, characterized in that, The analyte is a blood component.

33. The measuring device according to claim 32, characterized in that, The blood components are specific proteins.

34. The measuring device according to claim 33, characterized in that, The blood component was C-reactive protein.

35. A sample analyzer for measuring analytes based on turbidimetric methods, characterized in that, The sample analyzer includes: A reaction chamber is a reaction area designed to provide samples and reagents. A photometer is used to illuminate the analytes in a sample in order to obtain the absorbance of the analytes at different time points. A processor configured to perform a method for measuring an analyte based on turbidimetry according to any one of claims 1 to 18; An output device for outputting the actual concentration value of the analyte.

36. A computer-readable storage medium, characterized in that, The computer-readable storage medium stores one or more programs, which are executed by a processor to implement the method for measuring analytes based on turbidimetry as described in any one of claims 1 to 18.

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