CN212433190U - Methodology evaluation system for medical examination - Google Patents
Methodology evaluation system for medical examination Download PDFInfo
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- CN212433190U CN212433190U CN202020750107.9U CN202020750107U CN212433190U CN 212433190 U CN212433190 U CN 212433190U CN 202020750107 U CN202020750107 U CN 202020750107U CN 212433190 U CN212433190 U CN 212433190U
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- 238000000034 method Methods 0.000 title claims abstract description 49
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- 238000012384 transportation and delivery Methods 0.000 description 2
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Abstract
本实用新型公开了一种用于医学检验的方法学评估系统，包括把手和外壳，外壳左右两端表面通过螺丝固定设有把手，外壳上端表面左右两侧螺丝镶嵌固定设有USB接口和网络插口，外壳前端表面上方镶嵌设有显示屏，显示屏下方通过螺丝固定设有开关，外壳内下方底部通过螺丝固定设有蓄电池，蓄电池上方设有防护板并左右两端通过螺丝固定在外壳内壁上，防护板上端通过螺丝固定设有驱动主板，驱动主板上端表面左上方通过螺丝固定设有采集模块，采集模块下方设有检测模块通过螺丝固定在驱动主板上，驱动主板上端表面中间通过螺丝固定设有控制器；本实用新型具备了检测精度好、方案明确清晰和数据统计精确的优点。
The utility model discloses a methodology evaluation system for medical inspection, comprising a handle and a casing. The left and right ends of the casing are fixed with handles by screws, and the left and right sides of the upper surface of the casing are inlaid and fixed with screws and are provided with a USB interface and a network socket , a display screen is inlaid above the front surface of the casing, a switch is fixed under the display screen by screws, a battery is fixed by screws at the bottom of the inner bottom of the casing, a protective plate is arranged above the battery, and the left and right ends are fixed on the inner wall of the casing by screws. The upper part of the protective plate is fixed with screws, and a driving main board is fixed. The upper left side of the upper surface of the driving main board is fixed with a collection module. A detection module is fixed on the driving main board by screws. The controller; the utility model has the advantages of good detection accuracy, clear and clear scheme and accurate data statistics.
Description
Technical Field
The utility model relates to a hospital inspection technical field, concretely relates to is a methodology evaluation system for medical science inspection.
Background
When a new inspection method is established in a clinical laboratory, the basic performance of the method is evaluated so as to grasp the characteristics of the method and judge whether the method can meet the use requirements, the methodological evaluation is taken as a means for ensuring the quality of a detection system in the clinical laboratory, is a necessary activity before the application of an inspection project to the clinic, and is confirmed aiming at the detection quality of a non-standard method and a standard method in the laboratory, the current research on the methodological evaluation mainly focuses on the implementation and effect comparison of various evaluation methods, the research on the data management of the process design and the construction of related information platforms is lacked, and the existing problems are mainly embodied as follows: 1. the criteria are to be clarified, the protocol selection is not yet clear: the methodological evaluation relates to a plurality of experiments, and the experimental types, the sample numbers, the concentrations, the batches and the repetition times are different, for example, the accuracy evaluation can use a plurality of methods such as comparison, alternative comparison, preliminary evaluation of EP10, accuracy evaluation and the like of EP9, in addition, whether a detection system is developed by a laboratory, and also determines the difference of experimental schemes, for example, linear evaluation is used, the former uses 7-11 samples according to a linear EP6-A evaluation scheme, and the latter uses 5-7 samples, in daily work, technicians select the schemes by mistake and omission, or although the schemes are correct, the parameter selection is not good or even the number or the concentration of the detection samples is reduced, so that the situation of insufficient statistical efficiency is generated; 2. the data utilization rate is to be promoted: 1) part of indexes need to be evaluated regularly, if CAP requires that two-point calibration projects need to be subjected to linear verification twice a year, the result updating frequency is high, the evaluation results are put on the wall in a display board mode in the prior art, and the utilization rate is low due to the fact that data updating and using are inconvenient; 2) when the performance of the same reagent brand is evaluated, the data of a plurality of laboratories can provide more objective conclusions than the data of a single laboratory, but the data of the same item cannot be shared among the laboratories at present; 3) result application separation, data of linear evaluation is not applied to a patient result report in time; 3. the work management control ability is weak: the traditional methodology evaluation excessively emphasizes technical details, neglects the connection with upstream and downstream work, should be used as the category of project development, should also include reagent equipment and management departments of a sample library, and in addition, the conclusion of the evaluation cannot be controlled by an LIS platform to release a report, so that a clinical result is released and the evaluation data is not approved; a methodology evaluation system for medical testing is needed.
SUMMERY OF THE UTILITY MODEL
An object of the utility model is to provide a methodology evaluation system for medical science inspection, possessed and detected that the precision is good, the clear and clear advantage accurate with the data statistics of scheme, solved prior art's problem.
In order to achieve the above object, the utility model provides a following technical scheme: a methodology evaluation system for medical examination comprises a handle and a shell, wherein the left end surface and the right end surface of the shell are fixedly provided with the handle through screws, the left side and the right side of the upper end surface of the shell are fixedly embedded with a USB interface and a network socket, a display screen is embedded above the front end surface of the shell, a switch is fixedly arranged below the display screen through screws, a storage battery is fixedly arranged at the bottom below the inside of the shell through screws, a protection plate is arranged above the storage battery, the left end and the right end of the protection plate are fixedly arranged on the inner wall of the shell through screws, the upper end of the protection plate is fixedly provided with a driving mainboard through screws, an acquisition module is fixedly arranged above the upper left end surface of the driving mainboard through screws, a detection module is arranged below the acquisition module and is fixedly arranged on the driving mainboard through screws, a controller is fixedly, the controller right side below is equipped with storage module and passes through the screw fixation on the drive mainboard, storage module right side top loops through the screw fixation and is equipped with plan making module and transport module.
Preferably, the storage module is internally provided with audited detection items, detection systems and methodology parameters.
Preferably, the USB interface and the network socket are connected to the driving main board, the acquisition module, the detection module, the controller, the storage module, the touch display screen, the plan making module and the conveying module through cables.
Compared with the prior art, the beneficial effects of the utility model are as follows:
1. a methodology evaluation system for medical examination, which is characterized in that random errors of candidate methods are inspected through a repeatability test, the method of the repeatability test is to divide a same material into a plurality of test samples, to perform a plurality of times of analysis and measurement, to make the samples of the repeatability test, to apply a standard solution, a control solution, a patient sample or mixed serum, to make batch repeatability tests according to the application, to obtain various concentrations by using the standard solution, to be simple and convenient, to represent the best repeatability performance, to indicate that the operation of the method is suitable, to further perform measurement by using other samples, to perform the day-to-day repeatability test, to use freeze-dried quality control serum better due to stability and convenience, other samples are tested, and the freeze-dried quality control serum is better when the day repeatability test is carried out, because the freeze-dried quality control serum is stable and convenient and has accurate data statistics.
2. A methodology evaluation system for medical examination makes an evaluation plan to be audited in a module for setting up a post, a detection project, a detection method, an equipment model, a reagent combination and a plan through a detection module, and includes that corresponding basic information, a detection system, an audit index and specific parameters are input by taking a plan name as a unit, so that the detection precision is good, and the scheme is clear and clear.
3. A methodology assessment system for medical testing transmits a planned plan through a network jack connection network via a transport module and facilitates review by a worker over a touch screen display.
Drawings
FIG. 1 is an overall flow system diagram of a methodology evaluation system for medical testing of the present invention;
FIG. 2 is an overall block diagram of a methodology evaluation system for medical testing of the present invention;
FIG. 3 is a cross-sectional view of a housing of a methodology evaluation system for medical testing of the present invention;
fig. 4 is a driving board structure diagram of a methodology evaluation system for medical examination of the present invention.
The figures are labeled as follows: 1. a housing; 2. a handle; 3. a USB interface; 4. a network socket; 5. a touch display screen; 6. a switch; 7. a storage battery; 8. a protection plate; 9. driving the main board; 10. an acquisition module; 11. A detection module; 12. a controller; 13. a storage module; 14. a plan making module; 15. and a conveying module.
Detailed Description
The technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, rather than all embodiments, and all other embodiments obtained by a person of ordinary skill in the art without creative work belong to the protection scope of the present invention based on the embodiments of the present invention.
Referring to fig. 1, a methodology evaluation system for medical examination, a storage module 13, a pre-evaluation, a preliminary evaluation, a final evaluation, a repeatability test, a detection module 11, a planning module 14 and a delivery module 15; comprises the following steps: acquiring medical examination information from the storage module 13, establishing and storing a single index and a combined index, wherein the single index stores corresponding basic parameters by taking an index name as a unit, and the basic parameters comprise an experiment step; the combined index corresponds to at least two single indexes by taking the combined name as a unit; through pre-evaluation, preliminary evaluation and final evaluation, the pre-evaluation comprises reagent concentration, buffer solution types, ionic strength PH value, volume ratio of samples and reagents, reaction temperature and time, absorption curve and wavelength selection, linear range and the like, the preliminary evaluation uses standard solution to carry out linear and batch repeated tests, uses serum to carry out batch and day repeated realization, carries out recovery tests and interference tests, and the final evaluation uses day repeated tests, method comparison tests, method acceptability judgment and clinical relevant research, repeatability tests, (1) batch repeatability tests: the same specimen can be used for repeated measurement for a plurality of times (generally 20 times) in a relatively stable condition according to a specified operation method in a relatively short time, X, S of the specimen is calculated to have different requirements on the CV percent value from the analysis of the different properties of the CV percent and is generally less than 5 percent, the precision analysis or the repeated measurement requires less than 2 percent, and (2) the repeated test in days: repeated measurements of one or several samples are performed in batches during a day, other conditions being the same as in the batch, but since repeated measurements of several batches during a day are affected more than in the batch, the resulting CV% values may be greater than in the batch, (3) the day repeat test: randomly inserting the same specimen into a conventional specimen once a day for determination, and continuously performing determination for 20 working days, wherein the CV% value obtained by the determination is larger than that in the batch and the day, and can reflect the actual working condition, (4) performing parallel duplicate determination on patient specimens: if a stable sample containing a suitable matrix is not easily available (such as a sample for repeated measurement of blood pH), a patient sample can be subjected to double measurement to replace a repeated test, and a batch of patient samples (20-100) is selected, wherein the concentration of the substance to be measured is within the analysis range of the experimental method and has high or low; the characteristics of the recorded specimen, such as a certain drug, turbidity, hemolysis or uremia, can affect the accuracy, can be analyzed in one or more batches, but each sample is parallelly made into two samples, the difference (d) of the two-sample analysis result is used for calculating S (Zd/2N) as an index of imprecision, a plan making module 14 is used for making an evaluation plan to be checked, which comprises the steps of inputting corresponding basic information, a detection system, a check index and specific parameters by taking a plan name as a unit, the basic information comprises evaluation opportunity which comprises periodic verification, new project development, detection system change and equipment fault repair, wherein the detection system corresponds to a post, a detection project, a detection method, an equipment model and a reagent combination, a single index or a combined index corresponding to the detection system is selected from the index storage module 13 as an audit index, and specific parameters are set in a range limited by basic parameters; the plan making module 14 also displays the made evaluation plan to be audited completely in one page, the evaluation plan to be entered is formed after the approval of the authority owner is passed, the evaluation plan to be entered is used as an execution frame of sample detection, and the detection results and the methodological parameters corresponding to the single indexes are entered in the conveying module 15 according to the made evaluation plan to be entered to form the evaluation plan to be approved; the evaluation plan to be approved forms a feasible evaluation plan after being approved by the authority owner, when the evaluation time of the feasible evaluation plan is periodic verification, the corresponding methodology parameters are output to the detection module 11, when the evaluation time of the feasible evaluation plan is new project development, the corresponding project name, detection system and methodology parameters are output to the detection module 11, when the evaluation time of the feasible evaluation plan is detection system change, the corresponding detection system and methodology parameters are output to the detection module 11, and when the evaluation time of the feasible evaluation plan is equipment fault repair, the corresponding methodology parameters are output to the detection module 11.
The working principle is as follows: a methodology evaluation system for medical examination is connected to a driving main board 9, an acquisition module 10, a detection module 11, a controller 12, a storage module 13, a touch display screen 5, a plan making module 14 and a conveying module 15 through a USB interface 3 and a network socket 4 through cables, the equipment is electrified, handles 2 at two ends of a shell 1 are convenient for taking the equipment, a storage battery 7 is used as power of the equipment, a protection plate 8 effectively reduces heat energy generated by the storage battery 7, a switch 6 is turned on, the equipment is electrified to operate, the driving main board 9 is electrified to operate, the detection module 11, a storage 13, the plan making module 14 and the conveying module 15 are controlled to operate with the controller 12, the acquisition module 10 carries out pre-evaluation, preliminary evaluation and final evaluation on information in the storage module 13, and detection items, detection systems and methodology parameters of examination and examination are set in the acquisition module 10, the pre-evaluation comprises reagent concentration, buffer solution type, ionic strength PH value, volume ratio of sample to reagent, reaction temperature and time, absorption curve and wavelength selection and linear range, etc., the preliminary evaluation uses standard solution to do linear and batch repeat test, uses serum to do batch and day repeat realization, carries out recovery test and interference test, and finally evaluates day repeat test, method comparison test, acceptability of judgment method and clinical relevant research to evaluate detection information, the repeat test is to examine random error of candidate method, the repeat test method is to divide the same material into several test samples, carry out multiple analysis and determination to make samples of repeat test, the application of standard solution, control solution, patient sample or mixed serum can be determined according to the application, and batch repeat test can be made, various concentrations can be obtained by the standard solution, the method is simple and convenient, represents the best repeatability performance, if the result is good, the operation of the method is suitable, then other samples are further used for measurement, when the day-to-day repeatability test is carried out, the freeze-dried quality control serum is better used, because the freeze-dried quality control serum is stable and convenient, other samples are used for measurement, when the day-to-day repeatability test is carried out, the freeze-dried quality control serum is better used, because the freeze-dried quality control serum is stable and convenient and the data statistics is accurate, the detection module 11 detects the test data information for comparison processing, the stability and the accuracy are determined, the plan making module 14 makes an evaluation plan to be checked, which comprises the corresponding basic information, the detection system, the check index and the specific parameter which are recorded by taking the plan name as a unit, the basic information comprises the evaluation time which comprises periodic verification, new project development, detection system change and equipment fault repair, and the detection system corresponds, Detecting items, detecting methods, equipment models and reagent combinations, selecting a single index or a combined index corresponding to a detecting system from the index storage module 13 as an auditing index, and setting specific parameters within a range limited by basic parameters; the plan making module 14 also displays the made evaluation plan to be audited completely in one page, the evaluation plan to be entered is formed after the approval of the authority owner is passed, the evaluation plan to be entered is used as an execution frame of sample detection, and finally, the conveying module 15 enters the detection results and the methodological parameters corresponding to the single indexes according to the made evaluation plan to be entered, so as to form the evaluation plan to be approved; the evaluation plan to be approved is approved by the authority owner to form a feasible evaluation plan, when the evaluation time of the feasible evaluation plan is periodic verification, the corresponding methodology parameters are output to the detection module 11, when the evaluation time of the feasible evaluation plan is new project development, the corresponding project names, detection systems and methodology parameters are output to the detection module 11, when the evaluation time of the feasible evaluation plan is detection system change, the corresponding detection systems and methodology parameters are output to the detection module 11, when the evaluation time of the feasible evaluation plan is equipment fault repair, the corresponding methodology parameters are output to the detection module 11 for detection, the delivery module 15 is convenient for calculating the plan set in the plan formulation module 14, sending the plan to an external control end for judging the implementation of the plan, and displaying the plan on the touch display screen 5, the observation of staff is convenient.
Having shown and described the basic principles and principal features of the invention and advantages thereof, it will be apparent to those skilled in the art that the invention is not limited to the details of the foregoing exemplary embodiments, but is capable of other specific forms without departing from the spirit or essential characteristics thereof; the present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein, and any reference signs in the claims are not intended to be construed as limiting the claim concerned.
Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description is for clarity only, and those skilled in the art should integrate the description, and the embodiments may be combined as appropriate to form other embodiments understood by those skilled in the art.
Claims (3)
1. A methodology evaluation system for medical testing characterized by: the portable intelligent monitoring device comprises a handle (2) and a shell (1), wherein the left and right surfaces of the shell (1) are provided with the handle (2) through screw fixation, the left and right surfaces of the upper end surface of the shell (1) are provided with a USB interface (3) and a network socket (4) through screw embedding fixation, a display screen (5) is embedded above the front end surface of the shell (1), a switch (6) is arranged below the display screen (5) through screw fixation, the bottom of the inner lower part of the shell (1) is provided with a storage battery (7) through screw fixation, a protection plate (8) is arranged above the storage battery (7) and the left and right ends of the protection plate are fixed on the inner wall of the shell (1) through screws, the upper end of the protection plate (8) is provided with a driving mainboard (9) through screw fixation, the left upper part of the upper end surface of the driving mainboard (9) is provided with an acquisition module (10) through screw fixation, a detection module, drive mainboard (9) upper end surface is middle to be equipped with controller (12) through the screw fixation, controller (12) right side below is equipped with storage module (13) and passes through the screw fixation on drive mainboard (9), storage module (13) right side top loops through the screw fixation and is equipped with plan making module (14) and transport module (15).
2. A methodology assessment system for medical testing according to claim 1, characterized by: the storage module (13) is internally provided with checked detection items, a detection system and methodology parameters.
3. A methodology assessment system for medical testing according to claim 1, characterized by: the USB interface (3) and the network socket (4) are connected to the driving main board (9), the acquisition module (10), the detection module (11), the controller (12), the touch display screen (5), the storage module (13), the plan making module (14) and the conveying module (15) through cables.
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| CN202020750107.9U CN212433190U (en) | 2020-05-08 | 2020-05-08 | Methodology evaluation system for medical examination |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117529648A (en) * | 2021-12-31 | 2024-02-06 | 深圳迈瑞动物医疗科技股份有限公司 | Sample analysis device and sample analysis method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117529648A (en) * | 2021-12-31 | 2024-02-06 | 深圳迈瑞动物医疗科技股份有限公司 | Sample analysis device and sample analysis method |
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