Measurement operation method of detection item and application thereof

Abstract

The invention relates to a determination operation method of a detection item and application thereof. The method comprises the following steps: determining a detection sequence according to the concentration of detection molecules in a detection reagent corresponding to a to-be-executed detection item; wherein the detection sequence comprises the following steps: detecting a detection item corresponding to a detection molecule in the low-concentration detection reagent, and then detecting a detection item corresponding to a detection molecule in the high-concentration detection reagent; and executing the detection of each to-be-executed detection item according to the detection sequence. According to the scheme provided by the invention, the detection sequence of the detection items can be automatically adjusted, the risk of cross interference is reduced, the influence of residual reagents on subsequent item detection is reduced, the accuracy of a detection result is improved, and meanwhile, manpower is saved.

Description

Technical Field

[0001] The present application relates to the technical field of sample analysis, and in particular to a method for measuring and operating a detection item and its application. Background Art

[0002] Sample analyzers, such as chemiluminescence analyzers, are mainly used to detect specific markers in body fluids (such as blood). The detection of samples requires cooperation with specific reagents. By detecting the mixture formed by the sample and the reagent, the concentration of the specific marker can be obtained.

[0003] Sample analyzers generally use the pipette needle of the pipette to absorb the reagent and add the reagent to the sample to achieve detection. Between the execution of different test items, the pipette needle will be cleaned after adding the reagent. However, this cleaning is difficult to guarantee 100% cleanliness, and some residual reagents will be carried, such as 10PPM residue. This carryover interference will cause the residue of the previous item to affect the repeatability and accuracy of the next item, especially for low-value samples. The impact may be more serious.

[0004] When there may be cross-interference between items, a common operation method is to manually separate the related inspection items that may cause cross-interference when entering the inspection item information. Although this method avoids cross-interference, it requires a lot of manpower when there are a large number of inspection items. Summary of the invention

[0005] In order to solve or partially solve the problems existing in the related art, the present application provides a measurement operation method for detection items and its application, which can reduce the risk of cross interference by automatically adjusting the detection order of detection items in a simple manner, reduce the impact of residual reagents on subsequent item detection, improve the accuracy of detection results, and save manpower.

[0006] The first aspect of the present application provides a method for measuring and operating a detection item, comprising:

[0007] Determine the detection order according to the concentration of the detection molecule in the detection reagent corresponding to the detection item to be performed; wherein the detection order includes first performing the detection of the detection item corresponding to the detection molecule in the detection reagent with a low concentration, and then performing the detection of the detection item corresponding to the detection molecule in the detection reagent with a high concentration;

[0008] Execute the detection of each of the detection items to be executed according to the detection sequence.

[0009] In some embodiments of the present application, determining the detection order according to the concentration of the detection molecule in the detection reagent corresponding to the detection item to be performed includes:

[0010] Determine whether there is cross-interference between any two of the to-be-executed detection items;

[0011] Determining that the two to-be-performed detection items with cross-interference are a detection item pair;

[0012] The detection order is determined according to the detection molecule concentration in the detection reagent corresponding to the detection items.

[0013] In some embodiments of the present application, the determining whether any two of the to-be-performed detection items have cross-interference includes:

[0014] Determine whether the target molecules specifically bound by the detection molecules in the detection reagents corresponding to any two detection items to be executed have partially identical molecular structures.

[0015] In some embodiments of the present application, the two detection items to be performed with cross interference include:

[0016] The detection molecule in the detection reagent corresponding to one of the detection items to be performed will bind to the target molecule of another detection item to be performed.

[0017] In some embodiments of the present application, the concentration of the detection molecule in the detection reagent corresponding to the detection item to be performed and the determination of the detection order include:

[0018] The detection order is determined according to the concentration of the detection molecules in the detection reagent corresponding to the parts with different molecular structures in the target molecules of the detection item to be executed.

[0019] In some embodiments of the present application, the detection principle of the test item to be performed is the sandwich method.

[0020] In some embodiments of the present application, when the test items to be performed include any two or three of FSH antigen detection, LH antigen detection, and β-hCG antigen detection, the detection order is:

[0021] FSH antigen test > LH antigen test > β-hCG antigen test;

[0022] Among them, > means that the priority of the preceding test item is higher than that of the succeeding test item.

[0023] The second aspect of the present application provides a readable storage medium having a computer program stored thereon. When the computer program is executed, the steps of the determination and operation method of the detection item as described in the first aspect of the present application are performed.

[0024] A third aspect of the present application provides a sample analyzer, comprising:

[0025] A reagent unit, including a reagent compartment for storing the detection reagent and a pipette for aspirating the detection reagent;

[0026] A sample unit, comprising a sample chamber for storing samples and a sample loading arm for aspirating samples;

[0027] An analysis unit, used for analyzing a mixture of a sample and a detection reagent;

[0028] A control device, used to control the operation of the reagent unit, the sample unit and the analysis unit;

[0029] The control device also includes a readable storage medium as described in the second aspect of the present application, which is used to execute the steps of the measurement operation method of the detection item as described in the third aspect of the present application.

[0030] The fourth aspect of the present application provides an application of the measurement operation method of the detection item as described in the first aspect of the present application in reducing cross-interference of detection reagents.

[0031] The technical solution provided by the present application may include the following beneficial effects: adjusting the detection order of the detection items by adjusting the concentration of the detection molecule in the detection reagent corresponding to the detection item to be executed, giving priority to the detection of the items corresponding to the detection molecule in the low-concentration detection reagent, and then detecting the items corresponding to the detection molecule in the high-concentration detection reagent, and adjusting the order of adding the detection reagent by utilizing the characteristic that the concentration of the detection molecule in the detection reagent of different detection items is different, and then adjusting the detection order of the detection items. Even if the instrument has carryover interference, the probability of the low-concentration detection molecule remaining in the instrument combining with the molecule to be detected is much lower than the probability of the high-concentration detection molecule combining with the molecule to be detected, reducing the impact of the residual reagent on the detection of subsequent items, reducing the impact of cross-interference on the accuracy of the detection results, and improving the accuracy of the detection results of the detection items.

[0032] The technical solution provided in the present application can adjust the detection order of detection items such as FSH, LH, β-hCG, etc. by adjusting the sample addition order, thereby achieving the purpose of measuring markers with partially identical and partially different structures of target molecules in the detection items, reducing the interference of the residual molecules to be detected in the detection reagent of the previous detection item on the detection result of the next detection item, and ensuring the accuracy of the detection results of the detection items.

[0033] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The above and other objects, features and advantages of the present application will become more apparent by describing in more detail exemplary embodiments of the present application in conjunction with the accompanying drawings, wherein the same reference numerals generally represent the same components in the exemplary embodiments of the present application.

[0035] Figure 1It is a flow chart of a method for measuring and operating a detection item shown in an embodiment of the present application;

[0036] Figure 2 It is a structural schematic diagram of a measuring and operating device for a detection item shown in an embodiment of the present application;

[0037] Figure 3 It is a schematic diagram of the structure of a sample analyzer shown in an embodiment of the present application. DETAILED DESCRIPTION

[0038] The embodiments of the present application will be described in more detail below with reference to the accompanying drawings. Although the embodiments of the present application are shown in the accompanying drawings, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided to make the present application more thorough and complete, and to fully convey the scope of the present application to those skilled in the art.

[0039] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The singular forms of "a", "said" and "the" used in this application and the appended claims are also intended to include plural forms unless the context clearly indicates other meanings. It should also be understood that the term "and / or" used herein refers to and includes any or all possible combinations of one or more associated listed items.

[0040] It should be understood that although the terms "first", "second", "third", etc. may be used in this application to describe various information, this information should not be limited to these terms. These terms are only used to distinguish the same type of information from each other. For example, without departing from the scope of this application, the first information may also be referred to as the second information, and similarly, the second information may also be referred to as the first information. Thus, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "multiple" is two or more, unless otherwise clearly and specifically defined.

[0041] When there may be cross-interference between items, a common operation method is to manually separate the related inspection items that may cause cross-interference when entering the inspection item information. Although this method avoids cross-interference, it requires a lot of manpower when there are a large number of inspection items.

[0042] In response to the above problems, the embodiments of the present application provide a method for operating a measurement of detection items and its application, which can reduce the risk of cross-interference by automatically adjusting the detection order of the detection items in a simple manner, reduce the impact of residual reagents on subsequent item detection, improve the accuracy of the detection results, and save manpower.

[0043] It should be noted that the method of the embodiment of the present application is applicable to the corresponding detection kit designed based on photochemiluminescence and using photochemiluminescence. Photochemiluminescence is a homogeneous chemiluminescence method, which detects the concentration of the substance to be tested in the sample to be tested based on the interaction between biological molecules. The detection kit of the photochemiluminescence method includes a variety of reagents, which respectively include photosensitive microspheres and luminescent microspheres. Usually, the antigen or antibody used to mark the substance to be tested is coated with luminescent microspheres to prepare reagent 1 containing luminescent microspheres. The surface of the photosensitive microspheres is coated with avidin to prepare reagent 2. During the detection process, reagents 1 and 2 containing luminescent microspheres are combined with the sample to be tested in turn. When the sample contains the substance to be tested, the photosensitive microspheres and the luminescent microspheres are combined within a certain range through the biotin-avidin reaction system, generating the transfer of ion oxygen energy and emitting light signals, thereby detecting the sample to be tested. Among them, the photosensitive microspheres are filled with photosensitive compounds, and the luminescent microspheres are filled with luminescent compounds and lanthanide elements. Under the excitation of red laser (600-700nm), the photosensitive microspheres release high-energy singlet oxygen ions (4μS), which propagate about 200nm. When the distance between the photosensitive microspheres and the luminescent microspheres is close enough, the singlet oxygen ions released by the photosensitive microspheres can reach the luminescent microspheres and, through a series of chemical reactions, emit high-energy light of 520-620nm, which is detected by the instrument's detection unit. When the sample does not contain the substance to be tested, immune complexes cannot be formed between the two microspheres, the distance between the two microspheres exceeds the propagation range of ion oxygen, and the ion oxygen is rapidly quenched in the liquid phase, so no high-energy red light is generated during detection.

[0044] The size of the microspheres of the photochemiluminescence detection reagent is at the nanometer level, so they have a large specific surface area after coating, which can effectively avoid the steric hindrance effect and improve the detection sensitivity.

[0045] Although the present application takes a photochemiluminescence analyzer and a photochemiluminescence detection reagent as an example, the present application is not limited thereto, but can be run on any sample analyzer that uses a detection reagent to analyze a sample.

[0046] The technical solution of the embodiments of the present application is described in detail below with reference to the accompanying drawings.

[0047] Figure 1 It is a flow chart of the determination operation method of the detection item shown in the embodiment of the present application. The determination operation method can be run on any sample analyzer that uses a detection reagent to analyze the sample. For example, the sample analyzer can be a biochemical analyzer, a chemiluminescence analyzer, etc. Further, the sample analyzer can be a sample analyzer based on different detection methods, such as a biochemical analyzer based on latex turbidimetric detection, a chemiluminescence analyzer based on enzyme-linked immunosorbent assay, and a chemiluminescence analyzer based on photoinduced chemiluminescence.

[0048] See also Figure 1 , the method may include:

[0049] S110: Determine the detection order according to the concentration of the detection molecule in the detection reagent corresponding to the detection item to be executed; wherein the detection order includes first executing the detection of the detection item corresponding to the detection molecule in the low concentration detection reagent, and then executing the detection of the detection item corresponding to the detection molecule in the high concentration detection reagent.

[0050] S120: Execute the detection of each to-be-executed detection item according to the detection sequence.

[0051] Through the above steps, the detection order can be adjusted according to the concentration of the detection molecules in the detection reagents corresponding to the detection items to be executed. The detection of the detection items to be executed corresponding to the detection molecules in the low-concentration detection reagents is performed first, and then the detection of the detection items to be executed corresponding to the detection molecules in the high-concentration detection reagents is performed, thereby reducing the impact of residual reagents on the detection of subsequent items and improving the accuracy of the detection results.

[0052] When adjusting the detection order, it can be for detection items with cross-interference or for detection items without cross-interference. Therefore, the method of adjusting the detection order according to the detection molecule concentration in the detection reagent corresponding to the detection item to be executed can effectively reduce or eliminate the influence of cross-interference; at the same time, there is no need to manually judge whether there is cross-interference in the detection items one by one, and there is no need to spend a lot of time manually separating the related items that may have cross-interference for detection, which greatly saves labor.

[0053] Step S110 further includes: determining whether there is cross interference between any two detection items to be executed, determining the two detection items to be executed with cross interference as a detection item pair, and determining the detection order according to the detection molecule concentration in the detection reagent corresponding to the detection item pair.

[0054] It is judged whether there is cross interference between any two detection items to be executed, specifically whether the target molecule specifically bound by the detection molecule in the detection reagent corresponding to any two detection items to be executed has a partially identical molecular structure. When there is a partially identical molecular structure in the target molecules of any two detection items to be executed, the detection molecule in the detection reagent corresponding to one of the detection items to be executed can be combined with or react with the target molecules of the two detection items to be executed. Therefore, the detection item pair described in the present application, that is, the two detection items to be executed that have cross interference can be: the detection molecule in the detection reagent corresponding to one of the detection items to be executed can be combined with the target molecule of another detection item to be executed.

[0055] Therefore, for two detection items to be executed with cross-interference, when the residual reagents of the current detection item and the detection reagents of the subsequent detection item exist at the same time, the residual reagents of the former detection item and the detection reagents of the subsequent detection item will both combine with or react with the molecules to be detected in the subsequent detection item. At this time, the residual detection reagents of the former detection item will interfere with the detection results of the subsequent detection item, affecting the accuracy and repeatability of the detection results.

[0056] Step 110 also includes: determining the detection order according to the concentration of the detection molecules in the detection reagent corresponding to the parts with different molecular structures in the target molecules of the detection project to be executed.

[0057] The target molecule of the detection item to be performed may be an antigen or an antibody, and the detection molecule of the detection reagent includes an antibody or an antigen that can specifically bind to the target molecule of the detection item to be performed.

[0058] The detection principle of the detection items to be performed described in this application is the sandwich method.

[0059] Specifically, the test item to be detected is detected using reagent 1 and reagent 2, wherein reagent 1 includes luminescent microspheres coated with antigens / antibodies that can specifically bind to the target molecules of the test item to be detected, and can react with singlet oxygen to emit detectable light signals; reagent 2 includes photosensitive microspheres coated with antigens / antibodies that can specifically bind to the target molecules of the test item to be detected, and can release singlet oxygen under the action of excitation light. When performing the detection of the test item, reagent 1 and reagent 2 can respectively bind to different sites of the target molecules of the test item to be detected.

[0060] For two detection items to be performed with cross-interference, the two target molecules have parts with the same molecular structure and parts with different molecular structures. When the parts with the same molecular structure and the parts with different molecular structures are both used as the binding sites of the target molecule, the parts with the same molecular structure can be called α binding sites, and the parts with different molecular structures can be called β binding sites. One of the detection reagents in reagent 1 and reagent 2 can specifically bind to the α binding site, and the other detection reagent can specifically bind to the β binding site. When performing the detection of the detection items, the α binding site of the target molecule is used as the basis for judging whether there is cross-interference between the two detection items, and the detection order is determined by the concentration of the detection molecule in the detection reagent corresponding to the β binding site of the target molecule. For example, reagent 1 can specifically bind to the α binding site, and reagent 2 can specifically bind to the β binding site, then the detection order is determined according to the concentration of the detection molecule (antigen / antibody) in reagent 2.

[0061] Generally speaking, the components of one detection reagent will not react with the components of another detection reagent. However, the applicant found that the α subunit of hFSH (follicle stimulating hormone) has the same structure as the α subunit of the glycoprotein hCG (human chorionic gonadotropin) and hLH (luteinizing hormone), but the difference is the β subunit, which makes the immune and physiological specificity different. The detection principle of the hFSH, hCG, and hLH kits is the double antibody sandwich method. The luminescent reagent (reagent 1) is diluted by the α subunit antibody coated with luminescent particles, and the labeling reagent (reagent 2) is diluted by the β subunit antibody labeled with biotin. When there is a group of projects for experiment, the steps of adding samples on the chemiluminescence analyzer are: add all samples / calibrators → add reagent 1 of the first project → wash the needle → add reagent 2 of the first project → add reagent 1 of the second project → add reagent 2 of the second project... add samples in this mode, so that the reagent 2 remaining in the pipette needle of the previous project will be mixed with the reagent 1 of the next project. Everyone has different concentrations of hFSH, hCG, and hLH in their bodies, so the three projects with the same α subunit structure antibodies may interfere with each other's test results, which are called test projects with cross-interference.

[0062] For the detection items to be executed, the detection items corresponding to the low-concentration detection molecules in the detection reagent are detected first, and then the detection items corresponding to the high-concentration detection molecules in the detection reagent are detected. Even if there is interference with instruments such as pipette needles, the probability of the residual low-concentration detection molecules combining with the target molecules of the next detection item is much smaller than that of the high-concentration detection molecules, thereby reducing the impact of residual reagents on the detection of subsequent items.

[0063] When the test items to be performed include any two or three of the FSH antigen test, LH antigen test, and β-hCG antigen test, the test order is: FSH antigen test>LH antigen test>β-hCG antigen test; among which, > means that the priority of the former test item is higher than that of the latter test item.

[0064] Specifically, when the test items to be performed include any two of FSH antigen test, LH antigen test, and β-hCG antigen test, the test sequence includes: first performing FSH antigen test or LH antigen test, and then performing LH antigen test or β-hCG antigen test.

[0065] When the test items to be performed include FSH antigen test, LH antigen test, and β-hCG antigen test, the test sequence includes: first perform FSH antigen test, then perform LH antigen test, and then perform β-hCG antigen test.

[0066] Among them, in FSH antigen detection, LH antigen detection, and β-hCG antigen detection, reagent 1 can target the same site of the three, and reagent 2 can target different sites of the three. The antibody concentration in reagent 2 is used as a parameter to adjust the detection order, so that during the detection process, the residual reagent concentration of the previous project is extremely low, and will not affect the detection of subsequent projects, thereby improving the accuracy of the detection results of each project.

[0067] Step 110 may include: sorting the detection items to be executed in order of detection molecule concentration from low to high according to the detection molecule concentration in the detection reagent corresponding to the detection item to be executed, and determining the detection order.

[0068] In the embodiment of the present application, the sample analyzer can adjust the order of adding the detection reagents according to the principle of increasing the concentration of the detection molecules in the detection reagents corresponding to the detection items to be executed as the detection order for executing the detection items to be executed.

[0069] The assay operation method for the detection items described in the embodiments of the present application can be applied to reduce cross-interference of detection reagents.

[0070] The effect of the technical solution of the present application is explained below based on specific experiments.

[0071] Example

[0072] In the embodiments of the present application, the determination of sex hormones (including FSH, β-hCG, and LH) is described in detail. Of course, the present application is not limited thereto, but can be applied to any detection analysis of detection items with cross-interference, as long as the molecules to be detected have partially the same structure and the concentrations of the detected molecules are different.

[0073] For the three test items of FSH, β-hCG, and LH, the α subunit structure is the same, and the β subunit is the same, so the three are molecules to be tested with the same partial structure. In the FSH, β-hCG, and LH test kits, reagent 1 is diluted by the α subunit antibody coated with luminescent microparticles, so no matter whether it is reagent 1 of any test item of FSH, β-hCG, and LH, it can be combined with the α subunit part of the other two test items; reagent 2 is diluted by the β subunit antibody labeled with biotin, and the antibody concentration of reagent 2 of the three test items of FSH, β-hCG, and LH is different, as shown in the table below.

[0074] Table 1 FSH, β-hCG, LH detection reagents

[0075] project Antibody sites in reagent 1 Antibody sites in reagent 2 Antibody concentration in reagent 2 FSH α subunit β subunit 1.5 to 3.5 μg / mL LH α subunit β subunit 10.5-15.5 μg / mL β-hCG α subunit β subunit 30~50ug / mL

[0076] When performing the test items, when the test items corresponding to the high-concentration antibodies in reagent 2 are tested first, the residual antibodies are likely to affect the subsequent test items. For example, when adding β-hCG reagent first and then FSH reagent, the β-hCG reagent 2 and FSH reagent 1 remaining in the pipette needle are added to the reaction well at the same time. Since hFSH and β-hCG exist in every human body at the same time, the reaction well will form: β-hCG reagent 2 antibody remaining in the pipette needle-β-hCG antigen in the sample-FSH reagent 1 antibody complex, FSH reagent 2 antibody-FSH antigen in the sample-FSH reagent 1 antibody complex, these two complexes can produce luminescence values ​​after adding the universal solution, thereby affecting the FSH measurement value.

[0077] To verify that running the antibody concentration from low to high can reduce carryover interference, the following two test orders are used to test the test items:

[0078] 1. Overall experimental method or overall experimental design idea

[0079] 1) Run the project with high antibody concentration first and then the project with low antibody concentration, that is, the detection order is:

[0080] Example 1: β-hCG→LH;

[0081] Example 2: β-hCG→FSH;

[0082] Example 3: LH→FSH;

[0083] 2) Run the project with low antibody concentration first and then the project with high antibody concentration, that is, the detection order is:

[0084] Example 4: FSH→LH;

[0085] Example 5: LH→β-hCG;

[0086] Example 6: FSH→β-hCG;

[0087] Finally, the results of the two operating methods (method ① and method ②) are analyzed and compared.

[0088] 2. Main experimental materials and equipment

[0089] 1) Reagents: Reagent 1 includes luminescent microspheres coated with antibodies and a diluent; Reagent 2 includes biotin-labeled antibodies and a diluent; Reagent 1 and Reagent 2 can respectively bind to the molecules to be tested in the sample to form a double antibody sandwich.

[0090] 2) Samples: For each marker (test item), select 5 samples of different concentrations, for a total of 15 samples.

[0091] 3) Instrument selection 800 fully automatic chemiluminescence immunoassay system.

[0092] 3. Experimental Procedure

[0093] 1) Turn on LiCA800 for maintenance.

[0094] 2) Repeat the test 10 times for each of the LH, FSH and β-hCG samples, take the average value to obtain the theoretical concentration of the sample and record it in Table 2.

[0095] 3) Edit a worksheet: Submit the samples for testing in the order of Example 1.

[0096] 4) Click Submit to run, and query the experimental results after the run is completed.

[0097] 5) Re-execute steps 3) and 4) for 5 times, remove the highest value and the lowest value, and record the sample experimental results in Table 3.

[0098] 6) Repeat steps 3) and 4) and conduct experiments on the samples according to the detection sequence of Examples 2-6. The experimental results are recorded in Tables 4-8 respectively.

[0099] 7) Exit the host computer software after the experiment.

[0100] 4. Statistical analysis:

[0101] 1) Calculate the standard deviation (SD) and the ratio of the standard deviation to the mean (CV) of the three sample results. The CV is required to be no higher than 8%.

[0102] 2) Calculate the percentage deviation between the mean of the three sample results and the theoretical value, and the percentage deviation is required to be no higher than 10%.

[0103] 5. Experimental Data

[0104] 1) Theoretical concentrations of 5 samples in 3 items.

[0105] Table 2 Theoretical concentration of samples

[0106]

[0107] 2) Experimental results where samples were submitted in the order of Example 1 (β-hCG→LH).

[0108] Table 3 β-hCG→LH experimental results

[0109]

[0110] 3) Experimental results of samples submitted in the order of Example 2 (β-hCG→FSH).

[0111] Table 4β-hCG→FSH experimental results

[0112]

[0113] 4) Experimental results of samples submitted in the order of Example 3 (LH→FSH).

[0114] Table 5 LH→FSH experimental results

[0115]

[0116] 5) Experimental results of samples submitted in the order of Example 4 (FSH→LH).

[0117] Table 6 FSH→LH experimental results

[0118]

[0119] 5) Experimental results where samples were submitted in the order of Example 5 (LH→β-hCG).

[0120] Table 7 LH→β-hCG experimental results

[0121]

[0122]

[0123] 6) Experimental results of samples submitted in the order of Example 6 (FSH→β-hCG).

[0124] Table 8 FSH→β-hCG experimental results

[0125]

[0126] 6. Experimental data interpretation and analysis

[0127] The experimental results show that: when β-hCG is run first, it will affect the measured values ​​of LH and FSH that are run later; when LH is run first, it will affect the FSH that is run later. It can be seen that when using method ①, high-concentration antibody residues will affect the detection of low-concentration antibody items. After running the items with low reagent 2 antibody concentration first and then running the items with high reagent 2 antibody concentration, the test results are close to the theoretical values. It can be seen that method ② can avoid the impact of residual reagents on the test results.

[0128] 7. Experimental Conclusion

[0129] Therefore, running the project in the order of FSH→LH→β-hCG can solve the problem of reagent carryover interference and ensure the repeatability and accuracy of the test results.

[0130] Corresponding to the aforementioned application function realization method embodiment, the present application also provides a measurement operation device for a detection item, which is applied to a sample analyzer.

[0131] Figure 2 It is a schematic diagram of the structure of a measuring and operating device for a detection item shown in an embodiment of the present application.

[0132] See also Figure 2 The device 200 includes an adjustment module 210 and a detection module 220 .

[0133] The adjustment module 220 is used to determine the detection order according to the concentration of the detection molecules in the detection reagent corresponding to the detection item to be executed; wherein the detection order includes first executing the detection of the detection items corresponding to the detection molecules in the low-concentration detection reagent, and then executing the detection of the detection items corresponding to the detection molecules in the high-concentration detection reagent.

[0134] The detection module 200 is used to perform detection of each to-be-executed detection item according to the detection sequence determined by the adjustment module 220 .

[0135] The measurement and operation device 200 for the detection items of this embodiment may also include a processor and a memory, the memory is used to store the executable code of the above-mentioned adjustment module and the detection module, and the processor is used to execute the above-mentioned various program modules stored in the memory to realize the measurement and operation of the detection items and control each detection item to be executed according to the obtained detection order.

[0136] It should be noted that, although several units / modules or subunits / modules of the determination operation device 200 of the detection item are mentioned in the detailed description above, this division is merely exemplary and not mandatory. In fact, according to an embodiment of the present invention, the features and functions of two or more units / modules described above can be embodied in one unit / module. Conversely, the features and functions of one unit / module described above can also be further divided into multiple units / modules to be embodied.

[0137] In addition, the method according to the present application may also be implemented as a computer program or a computer program product, which includes computer program code instructions for executing some or all of the steps in the above method of the present application.

[0138] Alternatively, the present application can also be implemented as a computer-readable storage medium (or non-temporary machine-readable storage medium or machine-readable storage medium) on which a computer program (or executable code or computer instruction code) is stored. When the computer program (or executable code or computer instruction code) is executed by a processor of a measurement operation device for the detection item, the processor executes part or all of the steps of the above-mentioned method according to the present application.

[0139] The processor may be a central processing unit (CPU), or other general-purpose processors, digital signal processors (DSP), application-specific integrated circuits (ASIC), field-programmable gate arrays (FPGA) or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. A general-purpose processor may be a microprocessor or any conventional processor, etc.

[0140] The memory may include various types of storage units, such as system memory, read-only memory (ROM), and permanent storage. Among them, ROM may store static data or instructions required by the processor or other modules of the computer. The permanent storage may be a readable and writable storage device. The permanent storage may be a non-volatile storage device that does not lose the stored instructions and data even after the computer is powered off. In some embodiments, the permanent storage device uses a large-capacity storage device (such as a magnetic or optical disk, flash memory) as a permanent storage device. In other embodiments, the permanent storage device may be a removable storage device (such as a floppy disk, an optical drive). The system memory may be a readable and writable storage device or a volatile readable and writable storage device, such as a dynamic random access memory. The system memory may store some or all instructions and data required by the processor at run time. In addition, the memory may include any combination of computer-readable storage media, including various types of semiconductor memory chips (such as DRAM, SRAM, SDRAM, flash memory, programmable read-only memory), and disks and / or optical disks may also be used. In some embodiments, the memory may include a readable and / or writable removable storage device, such as a laser disc (CD), a read-only digital versatile disc (e.g., DVD-ROM, double-layer DVD-ROM), a read-only Blu-ray disc, an ultra-density optical disc, a flash memory card (e.g., SD card, mini SD card, Micro-SD card, etc.), a magnetic floppy disk, etc. The computer-readable storage medium does not include carrier waves and transient electronic signals transmitted wirelessly or wired.

[0141] Figure 3 It is a schematic diagram of the structure of a sample analyzer shown in an embodiment of the present application.

[0142] See also Figure 3 This embodiment also provides a sample analyzer 300 , including a reagent unit 310 , a sample unit 320 , an analysis unit 330 and a control device 340 .

[0143] The reagent unit 30 includes a reagent chamber for storing detection reagents and a pipette for aspirating the detection reagents; the detection reagents are, for example, reagents 1 and 2 for detecting FSH, LH, and β-hCG.

[0144] The sample unit 320 includes a sample chamber for storing samples and a sample loading arm for drawing samples; a sample refers to a mixture that may contain molecules to be tested, such as blood, plasma, serum, urine, semen, saliva, etc. When the sample analyzer 300 is used to detect FSH, LH, β-hCG items, the sample may be a blood sample containing FSH, LH, β-hCG. A scanner for reading sample codes is provided in the sample chamber.

[0145] The analysis unit 330 is used to analyze the mixture of the sample and the reagent. The analysis unit 330 includes an incubation tray, which is used to carry the reaction cups required for the detection and provide the temperature required for the reaction, such as heating the reactor by a heating plate. The analysis unit 330 also includes a detection device, which is used to detect the signal generated by the reaction liquid in the reaction cup. The analysis unit 330 also includes a cup organizer, which is used to store the reaction cups required for the detection and analysis and transfer the reaction cups to the incubation tray.

[0146] The control device 340 is used to control the operation of the reagent unit 310, the sample unit 320 and the analysis unit 330. The control device 340 obtains the sample code from the sample bin. The sample code is a specific identifier used to identify the sample. After obtaining the sample code, the control device 340 obtains the test items of the sample to be tested according to the sample code. The user can input the test items corresponding to the sample code into the sample analyzer in advance. The test items can also be obtained by the control device 340 from the superior information management system (such as the laboratory information management system LIS, or the hospital information management system HIS) connected to the sample analyzer. The samples to be tested are usually put into the sample bin in batches, for example, five or ten at a time. In addition, each sample to be tested may correspond to multiple items to be tested, for example, a blood sample needs to detect FSH, LH, β-hCG3 items. Therefore, the test items obtained by the control device 340 are usually in the form of an execution list, and the execution list includes the sample codes of all samples to be tested and the corresponding detection reagents corresponding to each test item. In the execution list, the test items can be arranged in units of samples, that is, all the test items of a sample are executed first, and then all the test items of the next sample are executed.

[0147] The control device 340 also includes the readable storage medium of the present application or the measurement operation device 200 of the present application, which is used to execute the steps of the detection operation method of the detection items as described above, that is, the control device 340 can determine the final execution order of each detection item and control the various components of the sample analyzer to perform corresponding actions.

[0148] After being equipped with a disposable pipette tip in the pipette tip bin, the pipette arm sucks the sample to be tested from the sample bin and transfers the sample to an empty reaction cup on the incubation tray. The pipette sucks the required test reagent from the reagent bin according to the execution list and transfers the reagent to the reaction cup on the incubation tray to which the sample has been added. Each time the pipette sucks and transfers a test reagent, it is cleaned with the conventional washing solution provided by the liquid path module. After cleaning, the pipette sucks and transfers the next required test reagent.

[0149] For example, when performing a group of tests on FSH, LH, and β-hCG items, the sample loading arm first transfers the blood sample to be tested to the empty reaction cup on the incubation tray, and then draws the corresponding reagents from the reagent compartment in sequence according to the loading order determined in the execution list and adds them to the reaction cup on the incubation tray to which the blood sample has been added: add FSH reagent 1 → wash needle → add FSH reagent 2 → wash needle → add LH reagent 1 → wash needle → add LH reagent 2 → wash needle → add β-hCG reagent 1 → wash needle → add β-hCG reagent 2 → wash needle → add universal solution, and the injection is completed.

[0150] The embodiments of the present application have been described above, and the above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and changes will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The selection of terms used herein is intended to best explain the principles of the embodiments, practical applications, or improvements to the technology in the market, or to enable other persons of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

1. A method for measuring and operating a test item, It is characterized in that include: Determine the detection order according to the concentration of the detection molecule in the detection reagent corresponding to the detection item to be performed; wherein the detection order includes first performing the detection of the detection item corresponding to the detection molecule in the detection reagent with a low concentration, and then performing the detection of the detection item corresponding to the detection molecule in the detection reagent with a high concentration; Execute the detection of each of the detection items to be executed according to the detection sequence.

2. The method according to claim 1, It is characterized in that The step of determining the detection sequence according to the concentration of the detection molecules in the detection reagent corresponding to the detection item to be performed includes: Determine whether there is cross-interference between any two of the to-be-executed detection items; Determining that the two to-be-performed detection items with cross-interference are a detection item pair; The detection order is determined according to the detection molecule concentration in the detection reagent corresponding to the detection items.

3. The method according to claim 2, It is characterized in that The determining whether there is cross interference between any two of the to-be-executed detection items includes: Determine whether the target molecules specifically bound by the detection molecules in the detection reagents corresponding to any two detection items to be executed have partially identical molecular structures.

4. The method according to any one of claims 2 or 3, It is characterized in that The two detection items to be performed with cross interference include: The detection molecule in the detection reagent corresponding to one of the detection items to be performed will bind to the target molecule of another detection item to be performed.

5. The method according to any one of claims 1 to 3, It is characterized in that The concentration of the detection molecule in the detection reagent corresponding to the detection item to be performed, and the determination of the detection order, include: The detection order is determined according to the concentration of the detection molecules in the detection reagent corresponding to the parts with different molecular structures in the target molecules of the detection item to be executed.

6. The method according to claim 1, It is characterized in that The detection principle of the test item to be performed is the sandwich method.

7. The method according to claim 1, It is characterized in that When the test items to be performed include any two or three of the FSH antigen test, the LH antigen test, and the β-hCG antigen test, the test sequence is: FSH antigen test > LH antigen test > β-hCG antigen test; Among them, > means that the priority of the preceding test item is higher than that of the succeeding test item.

8. A readable storage medium having a computer program stored thereon, which, when executed, executes the steps of the method for measuring and operating a detection item according to any one of claims 1 to 7.

9. A sample analyzer, It is characterized in that include: A reagent unit, including a reagent compartment for storing the detection reagent and a pipette for aspirating the detection reagent; A sample unit, comprising a sample chamber for storing samples and a sample loading arm for aspirating samples; An analysis unit, used for analyzing a mixture of a sample and a detection reagent; A control device, used to control the operation of the reagent unit, the sample unit and the analysis unit; The control device further comprises a readable storage medium as claimed in claim 8, which is used to execute the steps of the measurement operation method of the detection item as claimed in any one of claims 1 to 7.

10. Use of the assay method of any one of claims 1 to 7 for reducing cross-interference of detection reagents.

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