An integrated sample test card

Abstract

This invention relates to the field of clinical testing technology and discloses an integrated sample testing card, including a housing with a test strip disposed within it. The card is characterized by further comprising: a linear pipette with an inlet and a slit in its wall communicating with an internal cavity; and an elastic support structure connecting the housing and the linear pipette. The elastic support structure is configured to give the linear pipette an initial position and a working position. In the initial position, there is a gap between the slit and the surface of the sample application area of ​​the test strip. When subjected to an external actuating force, the elastic support structure deforms, driving the linear pipette to move to the working position, causing the slit to contact the surface of the sample application area for linear sample application via capillary action. This solves the problems of complex structure, cumbersome operation, need for regular cleaning and maintenance, and susceptibility to cross-contamination in existing testing instruments.

Description

Technical Field

[0001] This invention relates to the field of clinical testing technology, and in particular to an integrated sample testing card. Background Technology

[0002] In the field of in vitro diagnostics, especially point-of-care testing (POCT), simplifying and integrating the entire process from sample collection to test result output is key to improving user experience and product accessibility.

[0003] Existing technologies, such as the integrated glycated hemoglobin and blood glucose test instrument disclosed in patent document CN206497128U, fix the sample dispensing guidance structure (such as an elastic arm and a sampler guide groove) and the reaction solution dispensing function (liquid dispensing tank) on the instrument panel. This technology has a relatively complex instrument structure, many operation steps, and the instrument's sample dispensing tank requires regular cleaning and maintenance.

[0004] To address the problems existing in the aforementioned integrated glycated hemoglobin and blood glucose testing machines, a device is provided that integrates sample collection, transfer, and sample loading functions into a disposable test card. This simplifies the structure of external testing instruments, avoids instrument contamination and operational complexity caused by manual sample loading, and improves the repeatability and accuracy of sample loading. Summary of the Invention

[0005] The purpose of this invention is to provide an integrated sample detection card that solves the problems of complex structure, cumbersome operation steps, need for regular cleaning and maintenance, and easy cross-contamination of existing detection instruments.

[0006] To achieve the above objectives, the present invention provides an integrated sample detection card, comprising a housing, wherein a test strip is disposed within the housing, characterized in that it further comprises: a linear sampler with a sample inlet and a slit in its tube wall communicating with an internal cavity; an elastic support structure connecting the housing and the linear sampler; the elastic support structure is configured to give the linear sampler an initial position and a working position; in the initial position, there is a gap between the slit and the surface of the sample application area of ​​the test strip; when subjected to an external actuating force, the elastic support structure deforms, driving the linear sampler to move to the working position, so that the slit contacts the surface of the sample application area, thereby performing linear sample application through capillary action.

[0007] The elastic support structure is further configured to drive the linear sampler from the working position back to a position separated from the surface of the sample application area when the external actuation force is removed.

[0008] The housing has a recessed structure corresponding to the inlet area of ​​the linear sampler.

[0009] The housing also integrates at least one liquid storage chamber, which is in fluid communication with the test strip.

[0010] The linear sampler and the elastic support structure are integrated on the housing and integrally injection molded.

[0011] The lower shell of the housing has a detection hole, which corresponds to the reaction area of ​​the test strip and is used for optical signal acquisition by external instruments.

[0012] The present invention discloses an integrated sample testing card that integrates key functional components such as a linear sampler, an elastic support structure, and a liquid storage chamber into a disposable testing card. It utilizes an external actuation force to drive the elastic support structure to make the linear sampler contact the test strip to complete automatic capillary sampling. Moreover, the testing card is disposable after use, eliminating the need for instrument intervention in sample contact and cleaning maintenance. This solves the problems of complex structure, cumbersome operation steps, the need for regular cleaning and maintenance, and the susceptibility to cross-contamination in existing testing instruments. Attached Figure Description

[0013] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below.

[0014] Figure 1 This is a schematic diagram of the overall structure of the integrated sample detection card of the present invention.

[0015] Figure 2 This is a three-dimensional exploded view of the integrated sample detection card of the present invention.

[0016] Figure 3 This is the present invention. Figure 1 A sectional view after assembly, in its initial position.

[0017] Figure 4 This is a cross-sectional view of the present invention in its working position under external actuation force.

[0018] Figure 5 This is a partial three-dimensional view of the linear sampler and elastic support structure in this invention.

[0019] Figure 6 This is a schematic diagram of the arc-shaped notch of the present invention.

[0020] Figure 7 This is a partial cross-sectional view of the liquid storage chamber of the present invention.

[0021] In the diagram: 101-shell, 102-lower shell, 103-sample suction upper shell, 104-liquid storage upper shell, 105-test strip, 106-linear sampler, 107-sample inlet, 108-cavity, 109-slit, 110-elastic support structure, 111-sample application area, 112-external limiting actuator, 113-recessed structure, 114-liquid storage cavity, 115-detection hole, 116-sample application port. Detailed Implementation

[0022] The embodiments of the present invention are described in detail below. Examples of the embodiments are shown in the accompanying drawings. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, but should not be construed as limiting the present invention.

[0023] The embodiment of this application is as follows:

[0024] Please refer to Figures 1-7 , Figure 1 This is a three-dimensional exploded view of the integrated sample detection card of the present invention. Figure 2 This is the present invention. Figure 1 A sectional view after assembly, in its initial position. Figure 3 This is a cross-sectional view of the present invention in its working position under external actuation force. Figure 4 These are cross-sectional views of the present invention from different perspectives when it is in its working position under external actuation force. Figure 5 This is a partial perspective view of the linear sampler 106 and the elastic support structure 110 in this invention. Figure 6 This is a schematic diagram of the arc-shaped notch structure of the present invention. Figure 7 This is a partial cross-sectional view of the liquid storage chamber 114 of the present invention.

[0025] The integrated sample detection card of the present invention includes a housing 101, a lower housing 102, a sample suction upper housing 103, a liquid storage upper housing 104, a test strip 105, a linear sampler 106, a sample inlet 107, a cavity 108, a slit 109, an elastic support structure 110, a sample application area 111, an external limiting actuator 112, a recessed structure 113, a liquid storage chamber 114, a detection hole 115, and a sample application port 116. This solves the problems of complex structure, cumbersome operation steps, the need for regular cleaning and maintenance, and the susceptibility to cross-contamination in existing detection instruments. It is understood that the aforementioned solution can also be used to improve convenience and sample application quality.

[0026] In this embodiment, the housing 101 is formed by fastening together a lower housing 102, a sample suction upper housing 103, and a liquid storage upper housing 104. The test strip 105 is a prior art material, fixedly installed inside the housing 101, used to carry the sample and undergo a specific reaction. The signal change in its reaction zone indicates whether the target analyte is present in the sample, thereby achieving qualitative or detection of the target analyte in the sample. The elastic support structure 110 is a cantilever beam integrally formed with the inner wall of the sample suction upper housing 103, and its free end is fixedly connected to the linear sampler 106. The linear sampler 106 is a capillary tube with an axial slit 109 in its tube wall (its shape can be V-shaped, trapezoidal, etc., which is prior art; refer to the inventor's patent application for a linear sampler siphon). In its natural state, the elastic support structure 110 keeps the linear sampler 106 in its raised initial position, and the slit 109 is spaced approximately 0.3 mm from the membrane material of the test strip 105. The linear pipette 106 is used to quantitatively aspirate liquid samples and uniformly and linearly transfer the samples to the sample application area 111 of the test strip 105, achieving precise and controllable sample application. The elastic support structure 110 is used to connect the housing 101 and the linear pipette 106, providing the ability to switch between the initial position and the working position. Under the action of external actuation force, the linear pipette 106 is driven to move down to contact the test strip 105 to complete the sample application, and automatically resets after the external force is removed, so that the linear pipette 106 and the test strip 105 are in contact. The test strip 105 is separated to prevent contamination and overfilling. By integrating key functional components such as the linear pipette 106, the elastic support structure 110, and the liquid storage chamber 114 into a disposable test card, the linear pipette 106 is brought into contact with the test strip 105 by an external actuation force driven by the elastic support structure 110 to complete automatic capillary sampling. The test card is disposable after use, eliminating the need for instrument intervention in sample contact and cleaning maintenance. This solves the problems of complex structure, cumbersome operation steps, need for regular cleaning and maintenance, and easy cross-contamination of existing testing instruments.

[0027] Furthermore, when the external actuation force is removed, the linear feeder 106 can be driven to return from the working position to a position separated from the surface of the sample application area 111. After the external thrust is removed, the elastic support structure 110 will automatically bounce the feeder back to its original position, allowing the slit 109 at the bottom of the linear feeder 106 to leave the surface of the test strip 105 and no longer contact it. This can prevent the liquid from being drawn back or too much sample from being applied, and can also avoid cross-contamination.

[0028] Furthermore, the housing 101 is provided with a recessed structure 113 corresponding to the inlet 107 area of ​​the linear sampler 106. The inlet 107 is used to allow liquid samples to be added into the cavity 108 inside the linear sampler 106. The recessed structure 113 is equivalent to a "waistline" design, which is used to protect the suction tube, reduce the sample volume, and optimize the user experience. Through the inlet 107 and the recessed structure 113, the convenience and accuracy of sampling are improved.

[0029] Furthermore, at least one liquid storage chamber 114 is integrated on the housing 101. The liquid storage chamber 114 is in fluid communication with the test strip 105. The liquid storage chamber 114 is integrally formed with the liquid storage upper shell 104, and a sample addition port 116 is provided at its bottom. The sample addition port 116 is in communication with the test strip 105. After the blood sample is automatically added, the user can manually add the required reaction solution to the liquid storage chamber 114 for subsequent testing steps.

[0030] Furthermore, the linear feeder 106 and the elastic support structure 110 are integrated onto the housing 101 by injection molding. This integral injection molding process combines the linear feeder 106, the elastic support structure 110, and the sample suction shell 103 into a single component, thereby improving the relative positional accuracy and connection reliability of the three components, reducing the number of parts and assembly steps, lowering production costs, and ensuring the consistency of the mechanical properties of the elastic support structure 110 during mass production. This also ensures that the linear feeder 106 operates smoothly between its initial and working positions. The linear feeder 106 and the elastic support structure 110 can also be integrated into an independent pre-assembled module, which facilitates independent assembly, testing and replacement on the production line, thereby improving production efficiency and yield. At the same time, this modular design allows the same housing 101 to be adapted to feeders of different specifications or types, enhancing the flexibility and maintainability of the product, and reducing the mold complexity and manufacturing cost of the main housing 101.

[0031] Furthermore, the lower shell 102 of the housing 101 is provided with a detection hole 115, which corresponds to the reaction area of ​​the test strip 105 and is used for optical signal acquisition by external instruments. The detection hole 115, which corresponds to the reaction area of ​​the test strip 105, is provided in the lower shell 102 of the housing 101 to provide an unobstructed light path for the acquisition of optical signals by external instruments, so that the instruments can accurately and stably read the colorimetric, fluorescent or reflected light signals of the reaction area of ​​the test strip, thereby realizing the quantitative or qualitative detection of the target analyte in the sample.

[0032] In this embodiment, during use, the user first aligns the inlet 107 of the linear sampler 106 with the liquid sample via the recessed structure 113 on the housing 101, allowing the sample to be automatically drawn into the cavity 108 of the linear sampler 106 for quantitative aspiration. Then, the entire test card is placed into an external testing instrument. An actuator within the instrument applies external actuation force to the elastic support structure 110, causing it to deform and drive the linear sampler 106 downwards from its initial position to its working position. At this time, the sample within the slit 109 is uniformly transferred to the sample application area 111 of the test strip 105 under capillary action, completing linear sample application. Subsequently, the user can manually add the required reaction solution to the storage chamber 114 to support multi-step detection processes. After the test is completed, the test card is removed and discarded; the instrument does not require cleaning. This application integrates key functional components such as the linear pipette 106, the elastic support structure 110, and the liquid storage chamber 114 into a disposable test card. An external actuation force drives the elastic support structure 110 to make the linear pipette 106 contact the test strip 105 to complete automatic capillary sampling. The test card is disposable after use, eliminating the need for instrument intervention in sample contact and cleaning maintenance. This solves the problems of complex structure, cumbersome operation steps, need for regular cleaning and maintenance, and easy cross-contamination of existing detection instruments.

[0033] The above-disclosed embodiments are merely one or more preferred embodiments of this application and should not be construed as limiting the scope of this application. Those skilled in the art can understand that all or part of the processes for implementing the above embodiments and equivalent changes made in accordance with the claims of this application still fall within the scope of this application.

Claims

1. An integrated sample detection card, comprising a housing, wherein a test strip is disposed within the housing, characterized in that, Also includes: A linear sampler is provided with an inlet, and a slit is opened on its tube wall to communicate with the internal cavity. An elastic support structure connects the housing to the linear sampler; The elastic support structure is configured to give the linear sampler an initial position and a working position; At the initial position, there is a gap between the slit and the sample application area surface of the test strip; when subjected to external actuation force, the elastic support structure deforms, driving the linear sampler to move to the working position, so that the slit contacts the sample application area surface, so as to perform linear sample application through capillary action.

2. The integrated sample detection card as described in claim 1, characterized in that, The elastic support structure is also configured to drive the linear sampler from the working position back to a position separated from the surface of the sample application area when the external actuation force is removed.

3. The integrated sample detection card as described in claim 1, characterized in that, The housing has a recessed structure corresponding to the inlet area of ​​the linear sampler.

4. The integrated sample detection card as described in claim 1, characterized in that, The housing also integrates at least one liquid storage chamber, which is in fluid communication with the test strip.

5. The integrated sample detection card as described in claim 1, characterized in that, The linear feeder and the elastic support structure are integrated on the housing and integrally injection molded.

6. The integrated sample detection card as described in claim 1, characterized in that, The lower shell of the housing has a detection hole, which corresponds to the reaction area of ​​the test strip and is used for optical signal acquisition by external instruments.

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