A storage tube for quality control analytes

By designing a gradually thinning tube port and a storage tube with upper and lower double cavity structures, the quality problems of the storage tube when sealing and uncovering the membrane multiple times in the quality control process are solved, and higher detection accuracy and yield are achieved.

CN110631886BActive Publication Date: 2025-03-11BEIJING SIGHTNOVO MEDICAL TECH CO LTD
View PDF 3 Cites 0 Cited by

Patent Information

Application Number
CN201910834452.2
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-06-26
Filing Date
2019-09-05
Publication Date
2025-03-11
Estimated Expiration
2039-09-05

AI Technical Summary

Technical Problem

In the existing biochemical detection assembly line, storage tubes are prone to residual sealing or unclear film removal when sealing and unplugging the film multiple times in the quality control process, resulting in unstable detection quality.

Method used

A storage tube for quality-controlled analytes was designed. The tube mouth part was gradually thinned, and the inside was a double cavity structure with upper and lower cavity structure. Magnetic force could be mixed with beads and reinforcement ribs to improve the durability of the tube mouth and the reliability of the sealing film.

Benefits of technology

Through the gradually thinning tube port design, the contact area during the sealing film is reduced and the film residue is avoided; the double-cavity structure improves the processing yield and is suitable for frequent quality control processes.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN110631886B_ABST
    Figure CN110631886B_ABST
Patent Text Reader

Abstract

The present invention provides a storage tube for quality control analytes, comprising a tube mouth 1, an upper tube body 2 and a lower base 4 which are sequentially connected from top to bottom; the tube mouth 1 is surrounded by a tube wall, and the thickness of the tube wall gradually becomes thinner from the upper tube body 2 to the tube mouth 1; the upper tube body 2 is surrounded by a tube wall, and a middle cavity 3 is formed inside the upper tube body 2, the upper part of the middle cavity 3 is communicated with the outside, and the lower part of the middle cavity 3 is in contact with the lower base 4, and the middle cavity 3 is used to store quality control products; the lower base 4 is a truncated cone structure with a wide top and a narrow bottom on the outside, and a cylindrical bottom cavity 5 is inside; the upper end of the bottom cavity 5 is in contact with the outer wall of the lower base 4, and the lower end of the bottom cavity 5 is communicated with the outside.
Need to check novelty before this filing date? Find Prior Art

Description

Technical Field

[0001] The present invention relates to the field of biochemical detection technology, and in particular to a storage tube used for quality control analytes. Background Art

[0002] At present, there is no reference literature and information for automatic quality control, and it has been in the exploratory stage. ISO15189 and CLSI do not clearly provide personalized control rules based on a certain project. There is only a relatively simple requirement, which states: quality control should be run at least once a day for each project, and each project should have no less than two levels.

[0003] The structure of the existing biochemical testing line: host machine - storage box - mechanical arm on the conveyor belt, sampler, analyzer, capper - refrigerator, etc. The purpose of the line itself is to perform biochemical analysis, that is, to automatically perform various tests on a large number of patients' blood samples. The whole process is automated. Currently, many manufacturers such as Abbott have biochemical testing lines.

[0004] Specifically, the process of biochemical detection is as follows:

[0005] On the assembly line, the robotic arm grabs the storage tube from the refrigerator (the storage tube is initially covered and contains the patient's blood), then enters the uncapping module to complete the uncapping; the next step is to enter the analysis unit, i.e. the biochemical analyzer, to complete the sample suction; the next step is to enter the capping module to complete the capping; the next step is to enter the refrigerator. After the storage tube enters the refrigerator, wait for 10 to 15 minutes to complete the biochemical analysis.

[0006] The material of the patient blood sample storage tube is a mixture of plastic and fiberglass (the tube used by the hospital to store blood after drawing blood from patients). There is a cap on the tube mouth, which is usually a screw-tight cap at the beginning. The cap will be unscrewed when the assembly line takes samples for the first time. After the sampling is completed, a film is sealed on the tube mouth. The material of the film is generally soft metal materials such as aluminum foil, and there is glue on the surface. The assembly line relies on downward pressure to stick the film to the tube mouth. The film needs to be peeled off when sampling next time. For patient sample testing, sealing and peeling the film generally only need to be done once or twice, and then the sample storage tube will be discarded.

[0007] According to the structure of the pipeline, it is found that the pipeline can be used for quality control of biochemical testing, that is, automatic quality control. Only a set of automatic quality control software programs are needed to change some processes of the pipeline to perform quality control.

[0008] The main difference between quality control and patient sample testing is that quality control needs to be performed periodically, that is, the above process needs to be performed several times a week or even several times a day. Therefore, the storage tubes will be frequently sealed and unsealed. The existing storage tube design is not suitable for multiple sealing and unsealing.

[0009] CN305142959S provides a peripheral blood sample tube, which is used for the collection, transportation and storage of peripheral blood samples in medical institutions, and can also be used for the transfer, transportation and storage of other collected blood samples. The wall thickness of the storage tube, that is, the width of the tube mouth section, is relatively large. Therefore, the contact area with the film is relatively large, and it is easy to stick to the film when sealing, but it may not be able to be peeled off when peeling off the film, especially when the film is peeled off multiple times, it is more likely to be unable to be peeled off (not peeled off cleanly), which will cause problems when sealing the film.

[0010] Therefore, it is a technical problem to be solved urgently to provide a storage tube for quality control analytes in the field of biochemical detection technology. Summary of the invention

[0011] The object of the present invention is to provide a storage tube for quality control analytes, which can realize multiple film-sticking packaging of the storage tube to solve the shortcomings of traditional blood sample tubes in the quality control process.

[0012] To achieve the above-mentioned purpose, the solution of the present invention is to provide a storage tube for quality control analytes, comprising a tube mouth (1), an upper tube body (2) and a lower base (4) connected in sequence from top to bottom;

[0013] The pipe opening (1) is surrounded by a pipe wall, and the thickness of the pipe wall gradually becomes thinner from the upper pipe body (2) to the pipe opening (1);

[0014] The upper tube body (2) is surrounded by a tube wall, and a middle cavity (3) is formed inside the upper tube body (2). The upper part of the middle cavity (3) is communicated with the outside, and the lower part of the middle cavity (3) is in contact with the lower base (4). The middle cavity (3) is used to store quality control products;

[0015] The lower base (4) is externally a truncated cone-shaped structure that is wide at the top and narrow at the bottom, and internally a cylindrical bottom cavity (5); the upper end of the bottom cavity (5) is in contact with the outer wall of the lower base (4), and the lower end of the bottom cavity (5) is in communication with the outside.

[0016] Optionally, a plurality of reinforcing ribs (6) are evenly distributed on the inner wall of the pipe opening (1) for reinforcing the pipe opening (1).

[0017] Optionally, the tube body material of the storage tube contains glass fiber.

[0018] Optionally, a cover or a membrane is added to the upper part of the nozzle (1).

[0019] Optionally, magnetic mixing beads are arranged in the middle cavity (3) for stirring and mixing the quality control product therein.

[0020] Optionally, a plurality of reinforcing ribs (6) are evenly distributed on the outer wall of the pipe mouth (1), and the outer wall of the pipe mouth (1) gradually shrinks inward from bottom to top, so that the position where the reinforcing ribs (6) are arranged is kept consistent with the middle diameter of the upper pipe body (2).

[0021] Optionally, a filling body (7) is provided in the bottom cavity (5) for cooperating with a thimble of a base on which the storage tube is placed on an assembly line to lift the storage tube out of the base.

[0022] Optionally, the filling body (7) is a short column, the upper part of the short column is connected to the upper end center of the bottom cavity (5), and the radius of the short column is smaller than the radius of the bottom cavity (5).

[0023] Optionally, the filling body (7) includes a motor, a battery and an electromagnetic switch, and the electromagnetic switch is used to respond to a start signal on the assembly line, and when the start signal is received, the motor moves, thereby driving the storage tube to move to mix the quality control product therein.

[0024] Optionally, the lower base (4) and the upper tube body (2) are detachably connected.

[0025] The present invention has the following advantages:

[0026] 1. The existing storage tube has the same thickness as the tube body, so when the tube mouth is sealed, it is easy to produce residue when it is removed again. The present invention makes improvements at the tube mouth, and the tube mouth is designed to be a gradually thinner structure. This makes the present invention easy to operate in actual use, and no residue will be produced, because the contact area between the tube mouth and the sealing film is small, and it is more suitable for quality control processes;

[0027] 2. Existing storage tubes are all single-cavity. This structure, because the bottom is solid, will cause the tube body to deform during processing, resulting in a high defective rate. The present invention designs the storage tube to have an upper and lower double-cavity structure to cope with the limitation of the assembly line on the storage tube specifications, and the bottom cavity can improve the processing yield rate. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 This is a front view of a storage tube for quality control analytes provided by the present invention;

[0029] Figure 2 is a top view of a storage tube for a quality control analyte provided by the present invention;

[0030] Figure 3 It is a partial schematic diagram of the nozzle provided by the present invention;

[0031] Figure 4 It is a schematic diagram of a preferred solution of a storage tube for quality control analytes provided by the present invention;

[0032] Figure 5 A schematic diagram showing the structure of a clinical medical body fluid detection system according to an embodiment of the present invention is shown;

[0033] Figure 6 A schematic diagram showing a clinical medical body fluid detection quality control method according to an embodiment of the present invention;

[0034] 1- pipe mouth, 2- upper pipe body, 3- middle cavity, 4- lower base, 5- bottom cavity, 6- reinforcing rib, 7- filling body. Example

[0035] To make the purpose, technical solution and advantages of the embodiments of the present invention more clear, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0036] like Figure 1 and Figure 2 As shown, a storage tube for quality control analytes comprises a tube mouth 1, an upper tube body 2 and a lower base 4 connected in sequence from top to bottom; the tube mouth 1, the upper tube body 2 and the lower base 4; the tube mouth 1 is surrounded by a tube wall, and the thickness of the tube wall gradually becomes thinner from the upper tube body 2 to the tube mouth 1. Preferably, the tube wall thickness at the connection between the upper tube body 2 and the tube mouth 1 and the upper tube body 2 is 0.8mm, the tube wall thickness at the top of the tube mouth 1 is 0.1mm, the length of the tube mouth 1 is 6mm, the radius of the tube mouth 1 is 12mm, and a cover or film can be added to the upper part of the tube mouth 1 so that it meets the requirements of the medical field for a sterile environment when leaving the factory.

[0037] The upper tube body 2 is surrounded by a tube wall, and a middle cavity 3 is formed inside the upper tube body 2. The upper part of the middle cavity 3 is connected to the outside world, and the lower part of the middle cavity 3 is in contact with the lower base 4. The middle cavity 3 is used to store quality control products. Preferably, one or more magnetic mixing beads are added inside the middle cavity 3 so that magnetic mixing can be performed on the assembly line; the tube wall thickness of the upper tube body 2 is 0.8mm, and the length of the upper tube body 2 is 75mm or 100mm. The lower base 4 is a truncated cone structure that is wide at the top and narrow at the bottom, and a cylindrical bottom cavity 5 is inside; the upper end of the bottom cavity 5 is in contact with the outer wall of the lower base 4, and the lower end of the bottom cavity 5 is connected to the outside world.

[0038] like Figure 3As shown, the inner wall of the nozzle 1 is evenly distributed with four reinforcing ribs 6, so that the nozzle 1 is not easily damaged. Specifically, a downward pressure will be applied to the nozzle 1 when the film is sealed on the assembly line. Since the nozzle 1 in this embodiment is very thin, it may be deformed or broken when subjected to the downward pressure. In order to reinforce the nozzle 1 so that it is not damaged by the film sealing device of the assembly line, a number of reinforcing ribs can be provided at the nozzle 1. In other embodiments, the reinforcing ribs can also be provided on the outer wall of the nozzle 1. Because in some application scenarios, the storage tube has a lid, the reinforcing ribs 6 on the inner wall will result in an inability to add a plug or a poor seal, so the reinforcing ribs are preferably provided on the outer wall.

[0039] Furthermore, the material of the storage tube contains glass fiber, which can make the tube body hard and not easy to deform when subjected to downward pressure.

[0040] Figure 4 Meanwhile, three preferred schemes are provided. A filling body 7 is provided in the bottom cavity 5. The base for placing the storage tube on the assembly line of some brands needs to lift the storage tube from the base during the inspection process. If the bottom cavity 5 is hollow, the ejector pin on the base cannot lift the storage tube. Therefore, the filling body 7 needs to be provided in the bottom cavity 5 so that the ejector pin of the base can lift the entire storage tube.

[0041] In a first optional solution, the filling body 7 is a short column, the upper part of the short column is connected to the upper center of the bottom cavity 5, the radius of the short column is smaller than the radius of the bottom cavity 5, and the purpose of the short column is to cooperate with an automatic biochemical detection line.

[0042] The second optional solution is that the filling body 7 is composed of a battery, an electromagnetic switch and a motor. This setting is to enable the storage tube to vibrate or shake, so as to mix the quality control analyte in the storage tube. Specifically, a corresponding magnetic switch is set on the assembly line. When the storage tube passes through the switch (which can respond to the signal sent by the magnetic switch of the assembly line), the electromagnetic switch in the filling body 7 is triggered, so that the motor runs briefly, and the storage tube vibrates briefly, thereby achieving a mixing operation. Optionally, the bottom cavity 5 and the middle cavity 3 are separately arranged, and the lower base 4 and the upper tube body 2 are detachably connected by plug-in or threaded connection, so that the lower base 4 with the motor can be reused, and the upper tube body 2 can be discarded after use.

[0043] In a third optional solution, the outer wall of the pipe mouth 1 gradually shrinks inward from bottom to top, so that the place where the reinforcing ribs 6 are arranged is kept consistent with the middle diameter of the upper pipe body 2.

[0044] Specific implementation process: the storage tube enters the assembly line from the refrigerator, and a corresponding magnetic switch is set on the assembly line. When the storage tube passes through the magnetic switch, the electromagnetic switch in the filling body 7 is triggered, so that the motor runs briefly, and the storage tube vibrates briefly, thereby achieving a mixing operation; then it enters the lid opening module, the pipe mouth 1 has a lid, which is initially a threaded lid, and the lid will be unscrewed when the assembly line takes samples for the first time; then it enters the analysis module, and the ejector pin on the assembly line base pushes into the bottom cavity 5 and contacts the filling body 7, and lifts the storage tube, and the sampling needle extends into the middle cavity 3 for the analyzer to perform quality control analysis; after the sampling is completed, it enters the film sealing module, and a film is sealed on the pipe mouth 1. The material of the film is generally soft metal material such as aluminum foil, and there is glue on the surface. The assembly line sticks the film to the pipe mouth 1 by downward pressure; finally, the sealed storage tube returns to the refrigerator.

[0045] Quality control needs to be performed periodically, that is, the above process needs to be performed several times a week, or even several times a day. Therefore, the storage tube will be frequently sealed and peeled off. The top wall thickness of the tube mouth 1 is only 0.1 mm, so the contact area with the film is small, and the sealing film will not be unable to be peeled off during frequent operations.

[0046] In order to clearly explain the purpose of the storage tube, the embodiment of the present invention introduces a clinical medical body fluid detection quality control method, which automatically performs quality control operations based on a clinical medical body fluid detection system. Figure 5 As shown, the clinical medical body fluid detection system (equivalent to the assembly line in the above embodiment) includes a detection system 10 and a data management system 20, and the data management system can be a computer or a server. The detection system 10 includes a track transmission module 111 and a sampling module 11, a recognition module 12, a centrifugal module 13, a capping module 14, a membrane removal module 15, at least one analytical instrument 16, a sealing module 17, a capping module 18, a sample output module 19, and a storage module 112 connected to the track transmission module 111 in sequence. The magnetic switch on the assembly line described in the above embodiment can be set at any module before the analytical instrument 16, so that the storage tube is mixed before reaching the analytical instrument 16.

[0047] The data management system 20 is connected and communicated with the detection system 10 . Management system software is installed in the data management system 20 . The management system software in the data management system 20 is used to control and operate the detection system.

[0048] The sampling module 11 sends the body fluid sample into the orbital transmission module 111, and the orbital transmission module 111 transfers the body fluid sample to the analyzer. The analyzer performs sampling detection on the body fluid sample. The analyzer is connected to the data management system 20. The analyzer transmits the collected data to the data management system 20, and the data management system 20 analyzes and processes the data collected by the analyzer.

[0049] The detection system comprises at least one sample injection module 11 and at least one sample output module 19. The sample injection module 11 and the sample output module 19 are configured to load and unload body fluid sample tubes on a track transport module. The sample injection module 11 and the sample output module 19 can be manipulators or other devices for loading and unloading body fluid samples.

[0050] The centrifugal module 13 can automatically centrifuge the body fluid sample, the cap removal module 14 can disassemble the plastic screw cap and pressure seal of the main sample tube, the membrane removal module can remove the sealing film of the sample tube sealed by the membrane sealing module 17, and the cup separation module can generate auxiliary sample tubes through the existing main sample tube.

[0051] The film sealing module 17 seals the test tubes using a sealing door. The sealing film is cut and then heat-sealed to each plastic sample test tube. The capping module can place screw caps on the auxiliary sample test tubes produced by the cupping module. The storage module stores the sealed sample test tubes in a temperature-controlled environment, which can include a storage workbench and an automatic freezer.

[0052] The working process of the clinical medical detection system will be described below in combination with each module of the clinical medical body fluid detection system. The body fluid sample is placed in a test tube, and a label for marking the body fluid sample information is provided on the test tube. Specifically, the label can be an identification code such as a QR code or an electronic label. First, when the body fluid sample is detected, the sample injection module 11 places the body fluid sample on the track transmission module 111, and the identification module 12 identifies the label on the test tube. After the identification is completed, if centrifugation is required, it enters the centrifugation module 13 for automatic centrifugation, and then enters the capping module 14 or the membrane removal module 15. Specifically, it can be selected according to the seal on the test tube. After the capping or membrane removal is completed, the track transmission module 111 transports the sample to the analyzer, and the analyzer can identify the body fluid sample information through the label on the test tube. The analyzer aspirates and analyzes the sample, and then enters the sealing module 17 for sealing. After the sealing is completed, the track transmission module 111 transfers the body fluid sample to the storage module 112, and the sample output module 19 puts the body fluid sample back to the storage module for storage.

[0053] based on Figure 5 The clinical medical body fluid detection system shown in the figure, the clinical medical body fluid detection quality control method provided by the embodiment of the present invention is as follows Figure 6 As shown, the quality control method may include the following steps:

[0054] S10, obtaining test data of at least one test item of the body fluid sample. In this embodiment, the body fluid sample may include blood, urine, and tissue fluid. The test items may include the detection of various enzymes in the body fluid. For example, alanine aminotransferase, alanine transferase, etc., and the detection of various ions, such as potassium, calcium, sodium ions. Or other test items, such as albumin, globulin and other test items. Exemplary so-called test data are the test results of the patient's test items.

[0055] S20, calculating the moving average of the detection data to obtain the moving average of the detection items. As an exemplary embodiment, the calculation of the moving average can be carried out in the following way:

[0056] (x1, x2, x3, ..., x n ), take all the arithmetic mean values ​​of a certain number of them in order. For example A moving average value can be obtained. Of course, in this embodiment, two data can also be taken in sequence as an average value. As an exemplary embodiment, in this embodiment, a single moving average method or a double moving average method can be used.

[0057] S30, judging whether the moving average of the test item exceeds a preset threshold. As an exemplary embodiment, the preset threshold can be determined according to the test results of the hospital test samples. In this embodiment, the preset threshold can be changed at any time according to the test data obtained by the test, and the moving average can be plotted in chronological order according to the test moving average. When the moving average point falls within the preset threshold, it is considered that the test data of the test item is normal. When the moving average point falls outside the preset threshold, it is considered that there may be problems with the test result of the test item.

[0058] In order to avoid random phenomena, for example, when the analyzer draws bubbles when drawing body fluid samples in a test tube, which causes a large drift in the detection data, in an exemplary embodiment, when confirming whether the moving mean exceeds the preset threshold, it is possible to continuously detect whether multiple moving means all exceed the preset threshold, or continuously detect whether there are multiple moving means exceeding the preset threshold among multiple preset thresholds, that is, multiple moving means exceeding the preset threshold appear intermittently in a relatively short period of time.

[0059] Specifically, it is determined whether the number of moving averages of the detection items in multiple consecutive body fluid samples that exceeds the preset threshold is greater than the preset number; when the number of moving averages in multiple consecutive body fluid samples that exceeds the preset threshold is greater than the preset number, it is confirmed whether the moving average exceeds the preset threshold. As an exemplary explanation, when the moving average exceeds the preset threshold, in order to avoid random situations, starting from the first moving average that exceeds the preset threshold, it is possible to continuously observe whether the subsequent two or three moving averages all exceed the preset threshold. If two or three moving averages exceed the preset threshold in succession starting from the first moving average that exceeds the preset threshold, it can be confirmed that the moving average of the current detection item exceeds the standard, and a prompt message is output. For example, it can be displayed on the operation screen of clinical medical body fluid detection that there may be some problems with the detection of a certain item, or a voice prompt can be output.

[0060] As another optional embodiment, starting from the first moving average that exceeds the preset threshold, continuously observe whether there are more than two moving averages that exceed the preset threshold among the subsequent five moving averages. When there are more than two, confirm that the moving average of the current detection item exceeds the standard and output a prompt message. Those skilled in the art should understand that the number of moving averages in the above embodiment is only an example for the convenience of explanation, and other numbers of moving averages are also within the protection scope of this embodiment. When the moving average of the detection item exceeds the preset threshold, enter step S40, and when the moving average of the detection item is within the preset range, return to step S10.

[0061] S40, control the clinical medical body fluid detection system to perform quality control on the detection items. Specifically, quality control products (quality control analytes) are placed in the storage module of the clinical medical body fluid detection system in advance. After the moving average of the detection item exceeds the preset threshold, the sample output module 19 is controlled to take out the quality control products from the storage module, put them on the track transmission module 111 to enter the analyzer, and perform quality control analysis on the corresponding detection items whose moving average exceeds the preset threshold.

[0062] As an exemplary embodiment, Figure 5 As shown, the track transmission module 111 may include an emergency channel 113. When the moving mean of the detection item exceeds a preset threshold, the quality control product can be controlled to enter the emergency channel 113 and enter the analyzer for quality control first, so as to complete the quality control of the current detection item in the shortest time.

[0063] As an exemplary embodiment, when the moving average of the detection item exceeds the preset threshold, the body fluid sample continues to be tested, and the subsequent body fluid samples with the detection item when the moving average is confirmed to be out of control are marked with a to-be-checked label. Specifically, the to-be-checked label can be associated with the identification label of the body fluid sample. Since it cannot be completely confirmed that the detection item is out of control when the moving average exceeds the preset threshold, the sample can continue to be tested normally to avoid affecting the detection efficiency.

[0064] As another exemplary embodiment, when the moving average of the test item exceeds a preset threshold, the clinical medical body fluid detection system is controlled to take the test item offline, and the so-called offline of the test item can be to stop the current analyzer from injecting samples. Specifically, the body fluid sample with the test item can be stopped from entering the current analyzer. In this embodiment, after stopping entering the current analyzer, the body fluid sample with the test item is transported to other online analyzers to continue the sample suction test.

[0065] As an exemplary embodiment, when the moving average of a certain test item exceeds a preset threshold, after the quality control product enters the analyzer corresponding to the test item through the emergency channel 113, the control analysis instrument 16 collects the indoor quality control data corresponding to the test item in the quality control product according to the preset quality control rules, and analyzes the indoor quality control data. Specifically, the quality control rules corresponding to different test items can select at least one rule in the Six Sigma Sigma rules for quality control according to actual conditions, wherein the quality control rules may include: 13s, 22s, 232s, r4s, 6x, 8x, 9x, 10x, 15s, etc.

[0066] Taking the control rule of 13s as an example, when the indoor quality control data exceeds the quality control rule of 13s, the quality control result is judged to be out of control. When the quality control result is out of control, the body fluid sample of the current test item is re-tested. Specifically, if the analyzer continues to inject samples for testing when the moving mean of the test item exceeds the preset threshold, the body fluid sample with the label to be checked can be re-tested. Because when the moving mean exceeds the preset threshold for the first time, in order to prevent random events, the subsequent samples are marked only when the number of moving means in multiple consecutive body fluid samples that exceed the preset threshold is greater than the preset number. Therefore, only re-testing the body fluid samples with the label to be checked may result in omissions, so it is also necessary to re-test several samples before the body fluid sample with the moving mean exceeding the preset threshold. Specifically, all samples between the sample when the moving mean exceeds the preset threshold for the first time and the quality control obtained by using quality control products and the quality control result is out of control are re-tested.

[0067] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. A storage tube for quality control analytes, characterized in that: It comprises a pipe mouth (1), an upper pipe body (2) and a lower base (4) which are connected in sequence from top to bottom; The pipe mouth (1) is surrounded by a pipe wall. The thickness of the pipe wall gradually decreases from the upper pipe body (2) to the pipe mouth (1). The pipe wall thickness at the top of the pipe mouth (1) is 0.1 mm. The outer wall of the pipe mouth (1) is evenly distributed with a plurality of reinforcing ribs (6) for reinforcing the pipe mouth. The pipe body material of the storage pipe contains glass fiber. A film is added to the upper part of the pipe mouth (1). There is glue on the surface of the film. The production line adheres the film to the pipe mouth (1) by downward pressure. Quality control needs to be performed periodically, and the storage pipe needs to be sealed and peeled off frequently. The upper tube body (2) is surrounded by a tube wall, and a middle cavity (3) is formed inside the upper tube body (2). The upper part of the middle cavity (3) is communicated with the outside, and the lower part of the middle cavity (3) is in contact with the lower base (4). The middle cavity (3) is used to store quality control products; The outer wall of the pipe mouth (1) gradually shrinks inward from bottom to top, so that the position where the reinforcing rib (6) is arranged is consistent with the middle diameter of the upper pipe body (2); the outer part of the lower base (4) is a truncated cone structure that is wide at the top and narrow at the bottom, and the inner part is a cylindrical bottom cavity (5); a filling body (7) is arranged in the bottom cavity (5) for cooperating with a thimble on the base of the storage tube on the production line to lift the storage tube from the base; the upper end of the bottom cavity (5) contacts the outer wall of the lower base (4), and the lower end of the bottom cavity (5) is connected to the outside.

2. The storage tube according to claim 1, characterized in that: The middle cavity (3) is provided with magnetic mixing beads for stirring and mixing the quality control product therein.

3. The storage tube according to claim 1, characterized in that: The filling body (7) is a short column, the upper portion of the short column is connected to the upper center of the bottom cavity (5), and the radius of the short column is smaller than the radius of the bottom cavity (5).

4. The storage tube according to claim 1, characterized in that: The filling body (7) comprises a motor, a battery and an electromagnetic switch, wherein the electromagnetic switch is used to respond to a start signal on the assembly line and to move the motor when receiving the start signal, thereby driving the storage tube to move so as to mix the quality control product therein.

5. The storage tube according to claim 1, characterized in that: The lower base (4) and the upper tube body (2) are detachably connected.

Citation Information

Patent Citations

  • Devices, systems and methods for the collection, stimulation, stabilization, and analysis of a biological sample

    CN101896276A

  • Collection assembly

    CN1791534A

  • A storage tube for quality control analyte

    CN211292270U