Sample sampling detection device and sample sampling detection method

Abstract

The invention provides a sample sampling detection device and a sample sampling detection method.The device comprises a shell assembly and a detection test strip, an elution hole is defined in the shell assembly, an insertion opening and a release opening are formed in the positions, on the two opposite sides of the shell assembly, of the elution hole respectively, and a liquid containing groove is formed in the side, provided with the insertion opening, of the shell assembly; the insertion opening is located in the liquid containing groove and used for allowing the sampling end of the swab to be inserted therein, and the liquid containing groove is used for receiving sample diluent; the detection test strip shields at least part of the release opening. According to a conventional kit, a swab needs to be rinsed with excessive diluent. According to the invention, the sample swab only needs to be inserted into the elution hole, and a small amount of sample diluent is dropwise added, so that the elution and detection of the swab can be completed, the complex operation of rinsing the swab and the sample pollution risk and the biological safety risk brought by the complex operation are avoided, and higher detection sensitivity is brought by a smaller use amount of the sample diluent; and the detection efficiency is improved and the detection time is shortened due to simpler steps.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a sample sampling and detecting device and a sample sampling and detecting method. BACKGROUND

[0002] This part provides only background information related to the present disclosure, which is not necessarily prior art.

[0003] At present, related in vitro diagnostic products represented by immunochromatography technology have been widely used due to their convenient operation, low price, short reaction time and other advantages, especially in the field of home self-testing, which has great market prospects. As an important branch of in vitro diagnosis, colloidal gold technology has been popularized and its characteristics are to detect the measured substance by using antigen-antibody immunological reaction. This detection technology is based on the principle of chromatography and can detect whether the specific antigen or antibody required for detection is contained in the measured sample. Immunochromatography technology can quickly and conveniently provide reliable detection results for samples, and is very suitable for primary medical institutions and home self-testing scenarios.

[0004] Swabs are often used to collect biological samples from nasopharynx, oropharynx and other parts. By detecting the measured substance in the swab sample, physicians and patients can be provided with auxiliary diagnostic information. The most common way of detecting swab samples is to use a plastic card shell. First, the swab containing the biological sample is washed with diluent to elute the sample into the diluent. Then, the sample-containing diluent is dropped into the sample well of the plastic card shell to complete the chromatography sampling. After waiting for a certain period of time, the detection result is read. Some products integrate the swab, diluent and chromatography test strip into a device to realize integrated sampling. However, in the common detection method, the swab sample needs to be washed with excess diluent before detection. During the sample washing process, the sample is exposed for a long time and there is a certain biological safety risk in the sample transfer process. If the sample contains pathogenic bacteria or viruses, it is easy to cause secondary pollution to the detection personnel. The steps of elution and detection are relatively complex, which is not friendly to non-professionals. It needs to be mastered after certain professional training. Non-standard operation can affect the accuracy of the result. In addition, the excess diluent will dilute the measured substance, thereby reducing the accuracy of the detection result. In some integrated sampling schemes, the swab and diluent are integrated into the device for elution and sampling inside the device. Compared with the conventional scheme, the safety is improved, but the accuracy and operation steps are not optimized. In addition, the sealing and production and processing requirements are high, and the cost is much higher than that of the conventional scheme, which is difficult to popularize and use on a large scale. SUMMARY

[0005] The application aims to at least solve the technical problem of biological safety risk of the existing swab sample detection device.

[0006] The first aspect of the application provides a sample sampling and detection device, comprising:

[0007] The housing assembly defines an elution hole inside, and the elution hole forms an insertion port and a release port on opposite sides of the housing assembly, respectively. One side of the housing assembly provided with the insertion port is provided with a liquid containing groove. The insertion port is located in the liquid containing groove and is used for inserting the sampling end of the swab. The liquid containing groove is used for receiving the sample diluent.

[0008] The detection test strip has a sample section that blocks at least part of the release port.

[0009] The sample sampling and detection device provided by the application does not need to perform the rinsing step of the sampling swab with an excessive amount of sample diluent as in the conventional card shell type kit. When used, the swab collecting a biological sample is inserted into the elution hole, and a small amount of sample diluent is added, so that the elution and detection of the swab sample can be completed, avoiding the complex operation of rinsing the swab and the biological safety risk and sample pollution risk caused thereby. The use of a smaller amount of sample diluent brings higher detection sensitivity, and the simpler steps bring higher detection efficiency, thereby shortening the time required for detection.

[0010] In addition, the sample sampling and detection device according to the application can have the following additional technical features:

[0011] In some embodiments of the application, along the height direction of the housing assembly, the elution hole forms the insertion port and the release port at the top end and the bottom end of the housing assembly, respectively, and the axis of the elution hole is arranged at an angle relative to the height direction of the housing assembly.

[0012] In some embodiments of the application, along the height direction of the housing assembly, the top end of the liquid containing groove forms a notch, the bottom end of the liquid containing groove coincides with part of the insertion port, and the liquid containing groove is configured to be folded from the top end to the bottom end along the height direction of the housing assembly.

[0013] In some embodiments of the application, the liquid containing groove includes a first groove wall and a second groove wall. Along the height direction of the housing assembly, the top end of the first groove wall and the top end of the second groove wall define the notch, the bottom end of the first groove wall and the bottom end of the second groove wall are connected, the insertion port is arranged on the first groove wall, and the bottom end of the insertion port is connected with the bottom end of the second groove wall.

[0014] In some embodiments of the present application, the shell assembly comprises:

[0015] a first plate body;

[0016] a second plate body, edges of the second plate body being connected with edges of the first plate body, the second plate body being arranged in a stack with the first plate body, the second plate body being provided with a window and a relief hole;

[0017] a box body, the box body being connected with the first plate body and penetrating the relief hole, the liquid containing groove being arranged on a side of the box body away from the first plate body, the release port being arranged on a side of the box body facing the first plate body, the sample segment being arranged between the box body and the first plate body, the test strip further having an interpretation segment for displaying a detection result, along a height direction of the box body, the interpretation segment and the window have a coincident area in a projection on a same plane.

[0018] In some embodiments of the present application, the shell assembly further comprises a third plate body, edges of opposite sides of the second plate body being connected with edges of the first plate body and the third plate body respectively, the third plate body being capable of rotating relative to the second plate body, the third plate body having a position arranged in a stack with the second plate body and shielding the window and the relief hole in a process of rotation of the third plate body.

[0019] In some embodiments of the present application, the shell assembly further comprises at least one fixing sheet, the fixing sheet being connected with the box body and clamped between the first plate body and the second plate body, the first plate body and the fixing sheet and the second plate body and the fixing sheet being filled with adhesive.

[0020] In some embodiments of the present application, the sample sampling and detection device further comprises at least one ridge arranged in the elution hole, the ridge being located at an end of the elution hole provided with the release port and used for extruding the sampling end.

[0021] In some embodiments of the present application, the sample sampling and detection device further comprises a swab, the swab having a sampling end, the elution hole being interference-connected with the sampling end.

[0022] A second aspect of the present application provides a sample sampling and detection method, which is implemented according to the sample sampling and detection device of the first aspect of the present application, and comprises the following steps:

[0023] inserting the swab after collecting a biological sample into the elution hole;

[0024] adding a diluent into the liquid containing groove;

[0025] controlling the diluent to flow into the elution hole to elute the swab;

[0026] the sample in the swab is automatically contacted with the test strip through the release hole after being eluted by the diluent;

[0027] observe the detection result shown by the test strip.

[0028] The sample sampling and detection method provided by the application does not need to perform the step of separately rinsing the sampling swab with an excessive amount of sample diluent as in the use of a conventional cassette type kit. When used, only the swab collecting a biological sample is inserted into the elution hole, and a small amount of sample diluent is added, so that the elution and detection of the swab sample can be completed, avoiding the complex operation of rinsing the swab and the sample pollution risk and biological safety risk brought by the rinsing of the swab. The use of a smaller amount of sample diluent brings higher detection sensitivity, and the simpler steps bring higher detection efficiency, shortening the time required for detection. BRIEF DESCRIPTION OF DRAWINGS

[0029] Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The accompanying drawings are included to provide a better understanding of the preferred embodiments, and are not to be considered as limitations on the present application. Moreover, in the drawings, like reference numerals refer to similar components throughout the several views. In the drawings:

[0030] Figure 1 a structure schematic view of a first perspective of a sample sampling and detection device according to an embodiment of the application is schematically shown;

[0031] Figure 2 structure schematic views of first to third plates according to an embodiment of the application are schematically shown;

[0032] Figure 3 a structure schematic view of a sample sampling and detection device according to an embodiment of the application when the second plate and the third plate are unfolded is schematically shown;

[0033] Figure 4 a structure schematic view of a box according to an embodiment of the application is schematically shown;

[0034] Figure 5 a cross-sectional structure schematic view of a box according to an embodiment of the application is schematically shown;

[0035] Figure 6 a cross-sectional structure schematic view of a box when a swab is inserted according to an embodiment of the application is schematically shown;

[0036] Figure 7A structure schematic view of a swab according to an embodiment of the present application is shown schematically;

[0037] Figure 8 A partial sectional structure schematic view of a cartridge body according to an embodiment of the present application is shown schematically when a swab is inserted;

[0038] Figure 9 A structure schematic view of a sample sampling and detecting device according to an embodiment of the present application is shown schematically from a first perspective when a diluent is added dropwise;

[0039] Figure 10 A structure schematic view of a sample sampling and detecting device according to an embodiment of the present application is shown schematically from a second perspective;

[0040] Figure 11 A structure schematic view of a sample sampling and detecting device according to an embodiment of the present application is shown schematically from a second perspective when a diluent is added dropwise;

[0041] Figure 12 A structure schematic view of a sample sampling and detecting device according to an embodiment of the present application is shown schematically when a swab is inserted;

[0042] Reference signs are as follows:

[0043] 100, sample sampling and detecting device; 101, housing assembly;

[0044] 10, cartridge body; 11, elution hole; 111, insertion port; 112, limiting surface; 113, release port; 114, ridge; 12, liquid containing groove; 121, first groove wall; 122, second groove wall; 13, fixing sheet;

[0045] 20, test strip; 21, PVC base plate; 22, sample pad; 23, conjugate pad; 24, nitrocellulose membrane; 25, absorbent paper; 26, interpretation section;

[0046] 31, first plate body; 32, second plate body; 321, window; 322, avoiding hole; 33, third plate body;

[0047] 40, swab; 41, sampling end;

[0048] 50, diluent tube (containing sample diluent). DETAILED DESCRIPTION

[0049] Exemplary embodiments of the present disclosure will be described more fully hereinafter with reference to the accompanying drawings. While example embodiments of the present disclosure are shown in the drawings, it is understood that the present disclosure can be embodied in many forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present disclosure to those skilled in the art.

[0050] It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises", "comprising", "includes", "including" and the like are to be construed to be inclusive (i.e., to include both instances of open ended terms and instances of terms limiting to a specific number) unless otherwise indicated as otherwise limited by context. The methods described herein can be implemented as a method, an apparatus, a system, a computer program product, computer-readable medium, computer program, or a combination thereof.

[0051] Although the terms first, second, third, and the like can be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can be only used to differentiate one element, component, region, layer or section from another region, layer or section. Terms such as "first", "second", and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

[0052] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0053] like Figures 1 to 12 As shown in the accompanying drawings, the Y direction in the specification indicates the height direction of the housing assembly 101 and the box body 10. A first aspect of the invention provides a sample sampling and detection device 100, including a housing assembly 101 and a test strip 20. The housing assembly 101 internally defines an elution port 11. The elution port 11 forms an insertion port 111 and a release port 113 on opposite sides of the housing assembly 101, respectively. A liquid receiving tank 12 is provided on the side of the housing assembly 101 with the insertion port 111. The insertion port 111 is located within the liquid receiving tank 12 and is used for inserting the sampling end 41 of a swab 40. The liquid receiving tank 12 is used to receive sample diluent. The test strip 20 has a sample segment that at least partially obstructs the release port 113.

[0054] As can be seen, the sample sampling and detection device 100 proposed in this invention does not require the step of rinsing the sampling swab 40 separately with an excessive amount of sample diluent 50, as is required with conventional cartridge-type reagent kits. In use, simply insert the swab 40 containing the biological sample into the elution well 11, and then add a small amount of sample diluent 50 to complete the elution and detection of the swab 40 sample. This avoids the complex operation of rinsing the swab 40 and the associated risks of sample contamination and biosafety. The smaller amount of sample diluent used results in higher detection sensitivity, and the simpler steps lead to higher detection efficiency and shorten the time required for detection.

[0055] Exemplarily, the shell assembly 101 can be a box-shaped or a plate-shaped structure with a certain thickness. An elution hole 11 is formed on the shell assembly 101, and the elution hole 11 forms an insertion port 111 and a release port 113 on opposite sides of the shell assembly 101, respectively. The elution hole 11 can extend along the thickness direction of the shell assembly 101, and the aperture of the elution hole 11 can be less than or equal to the diameter of the sampling end 41 of the swab 40, so that the elution hole 11 can extrude the swab 40, thereby accelerating the mixing of the diluent 50 and the swab 40, and flowing out of the release port 113. The side of the shell assembly 101 where the insertion port 111 is arranged can be partially recessed to form a liquid containing groove 12. The liquid containing groove 12 can be circular, drop-shaped or wedge-shaped, and the insertion port 111 is arranged at the bottom end of the liquid containing groove 12 along the depth direction of the liquid containing groove 12, so that the liquid containing groove 12 can converge the diluent 50 dropped by the user into the insertion port 111, and make it contact with the biological sample on the swab 40. The test strip 20 can be arranged at the release port 113, so that the liquid flowing out of the elution hole 11 can flow onto the sample section of the test strip 20 to complete the sample detection. In order to reduce the risk of exposure of the biological sample, the shell assembly 101 can be arranged as a sealed structure, and the side of the shell assembly 101 where the release port 113 is arranged can be arranged as a closed structure to seal the connection between the test strip 20 and the release port 113, and to seal the test strip 20 except for the part showing the detection result.

[0056] In some embodiments of the present application, along the height direction of the shell assembly 101, the elution hole 11 forms the insertion port 111 and the release port 113 at the top end and the bottom end of the shell assembly 101, respectively, and the axis of the elution hole 11 is arranged at an angle relative to the height direction of the shell assembly 101.

[0057] It can be seen that by arranging the axis of the elution hole 11 at an angle relative to the height direction of the shell assembly 101, i.e. inclined arrangement, it is convenient for the user to insert the swab 40 into the elution hole 11, and it is convenient for the diluent 50 to flow to the test strip 20 after elution, and at the same time, the thickness of the shell assembly 101 can be reduced.

[0058] Exemplarily, the elution hole 11 is a straight hole structure, and an angle between an axis of the elution hole 11 and a height direction of the shell assembly 101 can be between 45° and 60°, so that, after the shell assembly 101 is placed flat, an angle between the axis of the elution hole 11 and a horizontal direction is between 30° and 45°, and a user can hold the shell assembly 101 with one hand and insert the swab 40 into the elution hole 11 with the other hand, and the insertion action is more comfortable. In addition, the release port 113 is located on a side of an end of the elution hole 11 away from the liquid containing groove 12, the end of the elution hole 11 away from the liquid containing groove 12 is in a closed state, and an end face of the end of the elution hole 11 away from the liquid containing groove 12 can serve as a limiting face 112 to limit the insertion of the swab 40, and the swab 40 can abut against the limiting face 112 after being inserted into the elution hole 11, and the user can confirm that the swab 40 is inserted in place.

[0059] In some embodiments of the present application, along the height direction of the shell assembly 101, a top end of the liquid containing groove 12 forms a groove opening, and a bottom end of the liquid containing groove 12 coincides with part of the insertion port 111, and the liquid containing groove 12 is configured to be tapered from the top end to the bottom end along the height direction of the shell assembly 101.

[0060] It can be seen that, by configuring the liquid containing groove 12 to be tapered from the top end to the bottom end along the height direction of the shell assembly 101, the liquid containing groove 12 can converge the flowing dilution liquid 50, and by coinciding the bottom end of the liquid containing groove 12 with part of the insertion port 111, the insertion port 111 is located at the lowest part of the liquid containing groove 12, so that the liquid containing groove does not store the dilution liquid 50, and there is no liquid dead angle.

[0061] Exemplarily, the groove opening of the liquid containing groove 12 can be circular, drop-shaped, trapezoidal or wedge-shaped, etc., and the groove opening is located on a top side of the shell assembly 101, and the liquid containing groove 12 can be configured to have a shape of a trapezoid, a triangle, a semicircle, etc. in a vertical cross section, so as to make the side wall of the liquid containing groove 12 inclined downward, thereby being able to converge the dilution liquid 50 to the bottom end of the liquid containing groove 12 and flow into the elution hole 11 from the insertion port 111.

[0062] In some embodiments of the present application, the liquid containing groove 12 includes a first groove wall 121 and a second groove wall 122, and along the height direction of the shell assembly 101, a top end of the first groove wall 121 and a top end of the second groove wall 122 define a groove opening therebetween, a bottom end of the first groove wall 121 and a bottom end of the second groove wall 122 are connected, and the insertion port 111 is arranged on the first groove wall 121, and a bottom end of the insertion port 111 is connected with the bottom end of the second groove wall 122.

[0063] It can be seen that, by defining the liquid containing groove 12 by the first groove wall 121 and the second groove wall 122, the diluent 50 dripped by the user can flow downward along the first groove wall 121 and the second groove wall 122 to the insertion port 111, thereby entering the elution hole 11, and the first groove wall 121 and the second groove wall 122 are both arranged downwardly inclined, achieving the function of converging the elution liquid to the groove bottom. And the first groove wall 121 and the second groove wall 122 can be designed as an arc surface or other shape of a concave surface according to actual needs to guide the flow of the elution liquid, improving the efficiency of converging the elution liquid.

[0064] Exemplarily, the first groove wall 121 can be an arc concave surface, facilitating the diluent 50 to flow downward along the first groove wall 121 and converge, the second groove wall 122 is a downwardly inclined plane, the insertion port 111 is opened at the bottom end of the first groove wall 121, and the bottom end of the insertion port 111 coincides with the bottom end of the first groove wall 121, so that there is no accumulation of diluent 50 in the liquid containing groove 12, and there is no dead angle. The first groove wall 121 can also be a downwardly inclined inclined surface like the second groove wall 122, and the first groove wall 121 and the second groove wall 122 are connected by a side groove wall, so that the vertical cross section of the liquid containing groove 12 is a triangle, and the horizontal cross section is a rectangle. Also can play the effect of converging the diluent 50.

[0065] In some embodiments of the present application, the shell assembly 101 comprises:

[0066] a first plate body 31;

[0067] a second plate body 32, the edge of the second plate body 32 is connected with the edge of the first plate body 31, the second plate body 32 is arranged in a stack with the first plate body 31, and the second plate body 32 is provided with a window 321 and a relief hole 322;

[0068] a box body 10, the box body 10 is connected with the first plate body 31 and is arranged through the relief hole 322, the liquid containing groove 12 is arranged on the side of the box body 10 away from the first plate body 31, the release port 113 is arranged on the side of the box body 10 facing the first plate body 31, the sample segment is arranged between the box body 10 and the first plate body 31, the test strip 20 further has a judgment segment 26 for displaying the detection result, and the projection of the judgment segment 26 and the window 321 in the same plane has an overlapping area along the height direction of the box body 10.

[0069] It can be seen that, by fixing the box body 10 and the test strip 20 by the first plate body 31 and the second plate body 32, the user is facilitated to operate during detection, and the space between the first plate body 31 and the second plate body 32 can also seal the release port 113 and the test strip 20 in a closed space, improving the installation reliability of the test strip 20, and avoiding safety risks caused by exposure of biological samples.

[0070] Exemplarily, the laminated connection structure of the first plate body 31 and the second plate body 32 can be formed by bending a piece of paperboard, or formed by laminating and connecting two plastic plates through adhesion, clamping or hinging. The second plate body 32 can be provided with a relief hole 322 for embedding the box body 10, the relief hole 322 is shaped to be adapted to the box body 10, and can be rectangular or circular. A window 321 can be provided on the second plate body 32 for the user to observe the detection result of the test strip 20 through the second plate body 32, and the window 321 has an overlapping area with the interpretation section 26 of the test strip 20 in the through direction of the window 321. The box body 10 can be cuboid or disc-shaped, and can be formed by splicing plastic pieces or integrally formed. One side of the box body 10 in the height direction can be connected to the plate surface of the first plate body 31 facing the second plate body 32 through adhesion or clamping, and the other side of the box body 10 in the height direction is provided with a liquid containing groove 12 and penetrates the relief hole 322 of the second plate body 32. The box body 10 and the second plate body 32 can be interference connected to improve the reliability of the connection, or adhesively engaged with the hole wall of the relief hole 322. The test strip 20 is long strip-shaped and is pasted on the side of the first plate body 31 facing the box body 10. The sample pad 22 of the test strip 20 can be clamped between the box body 10 and the first plate body 31 and coincides with the release port 113, so that the diluent 50 flowing out of the release port 113 can contact the test strip 20, and the interpretation section 26 of the test strip 20 coincides with the window 321 in the height direction for easy observation.

[0071] In some embodiments of the present application, the shell assembly 101 further comprises a third plate body 33, the edges of the opposite sides of the second plate body 32 are respectively connected to the edges of the first plate body 31 and the third plate body 33, and the third plate body 33 can rotate relative to the second plate body 32. During the rotation of the third plate body 33, the third plate body 33 has a position laminated with the second plate body 32 and shielding the window 321 and the relief hole 322.

[0072] It can be seen that by providing the third plate body 33, the third plate body 33 can cover and shield the window 321 and the relief hole 322, thereby protecting the window 321 and the box body 10 protruding from the relief hole 322, and improving the durability of the sample sampling and detection device 100.

[0073] Exemplarily, the third plate body 33 can be a paper plate integrally arranged with the first plate body 31 and the second plate body 32, that is, the third plate body 33 is connected with the edge of the second plate body 32, and the third plate body 33 can be folded about the connected part as a pivot, so that when the third plate body 33 is folded to be parallel with the second plate body 32, the third plate body 33 covers the part of the box body 10 protruding in the window 321 and the avoiding hole 322, thereby achieving the protection of the window 321 and the protruding part of the box body 10. The third plate body 33 can also be separately connected with the second plate body 32 by adhesion or the like, or connected by a hinged structure. Similarly, the third plate body 33 can also be made of a plastic plate to improve durability. In addition, the plate surface of the third plate body 33 can also be provided with instructions, trademarks and the like to improve the user experience.

[0074] In some embodiments of the present application, the shell assembly 101 further comprises at least one fixing sheet 13, the fixing sheet 13 is connected with the box body 10 and clamped between the first plate body 31 and the second plate body 32, and the first plate body 31 and the fixing sheet 13 and the second plate body 32 and the fixing sheet 13 are both filled with adhesive.

[0075] It can be seen that by arranging the fixing sheet 13 on the box body 10, the box body 10 can be clamped between the first plate body 31 and the second plate body 32 through the fixing sheet 13, thereby increasing the area of the connection between the box body 10 and the first plate body 31 and the second plate body 32, and further improving the reliability of the connection between the box body 10 and the first plate body 31 and the second plate body 32, so that the box body 10 is not easy to fall off.

[0076] Exemplarily, the fixing sheet 13 can be rectangular, semicircular or trapezoidal, the edge of the fixing sheet 13 can be integrally formed with the box body 10 or connected through a fastener such as a buckle bolt, the fixing sheet 13 is arranged in parallel with the bottom side of the box body 10, that is, the side of the box body 10 on which the test strip 20 is installed, and is clamped and fixed between the first plate body 31 and the second plate body 32 by adhesion. After the box body 10 is connected with the first plate body 31 and the second plate body 32 through the fixing sheet 13, the installation is stable and reliable, and the box body 10 is not easy to be separated from the first plate body 31 and the second plate body 32, thereby improving the durability of the sample sampling and detection device 100. Specifically, the fixing sheet 13 can be provided with two or more, and arranged at intervals in the direction around the box body 10, for example, when the box body 10 is in the shape of a cuboid, one fixing sheet 13 can be arranged on each of the opposite sides of the box body 10, thereby achieving reliable connection between the box body 10 and the first plate body 31 and the second plate body 32.

[0077] In some embodiments of the present application, the sample sampling and detection device 100 further comprises at least one ridge 114 arranged in the elution hole 11, the ridge 114 is located at one end of the elution hole 11 provided with the release port 113, and is used for extruding the sampling end 41.

[0078] It can be seen that by arranging the ridge 114 in the elution hole 11, after the user drops the diluent 50 into the liquid containing groove, the swab 40 can be rotated, and the sampling end 41 of the swab 40 is pressed and scraped under the action of the ridge 114 in the elution hole 11, so that the biological sample on the sampling end 41 is fully mixed with the diluent 50, and is separated from the sampling end 41 under the pressing action, and contacts the test strip 20 through the release port 113.

[0079] Exemplarily, the ridge 114 can extend along the axial direction of the elution hole 11, and at least one is arranged along the circumferential direction of the elution hole 11, so that when the swab 40 is rotated, the ridge 114 can apply pressure to the sampling end 41 of the swab 40 for scraping, thereby accelerating the mixing of the biological sample of the sampling end 41 with the diluent 50, and enabling the eluted diluent 50 to flow along the ridge 114 to the release port 113, thereby playing a certain flow guiding role. The ridge 114 can also be a protruding point structure, and a plurality of ridges are arranged along the circumferential direction of the elution hole 11 and a plurality of ridges are arranged along the axial direction of the elution hole 11, which can also play a role of applying pressure to the sampling end 41 and improving the elution efficiency.

[0080] In some embodiments of the present application, the sample sampling and detection device 100 further comprises a swab 40, and the swab 40 has a sampling end 41, and the elution hole 11 is in interference connection with the sampling end 41.

[0081] It can be seen that by interference connecting the elution hole 11 with the sampling end 41 of the swab 40, the sampling end 41 of the swab 40 can be pressed by the elution hole 11, and after the user drops the diluent 50 into the liquid containing groove, the swab 40 can be rotated, and the sampling end 41 of the swab 40 is fully mixed with the diluent 50 under the pressing of the hole wall of the elution hole 11, so as to accelerate the elution efficiency of the biological sample of the sampling end 41 by the diluent 50, and the connection between the swab 40 and the elution hole 11 is tight, reducing the safety risk of the exposed biological sample.

[0082] Exemplarily, the axial length and the hole diameter of the elution hole 11 can be designed according to the specifications of the conventional swab 40, for example, the axial length of the elution hole 11 is designed to be greater than the length of the sampling end 41 of the conventional swab 40, and the hole diameter of the elution hole 11 is designed to be smaller than the diameter of the sampling end 41, so that the two can be interference connected.

[0083] The second aspect of the present application proposes a sample sampling and detection method, which is implemented according to the sample sampling and detection device 100 of the first aspect of the present application, and the sample sampling and detection method comprises the following steps:

[0084] Inserting the swab 40 after collecting the biological sample into the elution hole 11;

[0085] Adding the diluent 50 into the liquid containing groove;

[0086] The diluent 50 is controlled to flow into the elution hole 11 to elute the swab 40;

[0087] The sample in the swab 40 is automatically contacted with the test strip 20 through the release hole 113 after being eluted by the diluent 50;

[0088] The detection result shown by the test strip 20 is observed.

[0089] The sample sampling and detection method provided by the present application does not need to separately rinse the sampling swab 40 with an excessive amount of sample diluent 50 as in the conventional card shell type kit. When used, only the swab 40 collecting the biological sample is inserted into the elution hole 11, and a small amount of sample diluent 50 is added, so that the elution and detection of the sample of the swab 40 can be completed, avoiding the complex operation of rinsing the swab 40 and the sample pollution risk and biological safety risk brought by the operation. The use of a smaller amount of sample diluent brings higher detection sensitivity, and the simpler steps bring higher detection efficiency, shortening the time required for detection.

[0090] Embodiment one, the sample sampling and detection device 100 provided by the present application can be used as a respiratory syncytial virus antigen detection device.

[0091] 1. The preparation method of the respiratory syncytial virus antigen detection colloidal gold test strip 20 is as follows:

[0092] Step 1: Preparation of colloidal gold, 1L of ultrapure water is heated to boiling under stirring, 40mL of 1% concentration of chloroauric acid is added, the solution is boiled again, 25mL of 2% concentration of trisodium citrate is quickly added, heating is continued for 10 minutes, after the color is stable, the heating is turned off, and the natural cooling is carried out to room temperature, and the constant temperature preservation is carried out.

[0093] Step 2: Preparation of the conjugate pad 23: take 1mL of colloidal gold solution, adjust the pH to 6.5-7.5, mix for 10min, add 10-50ug of respiratory syncytial virus antibody, mix and oscillate for 15min, add BSA with a final concentration of 0.2%, mix and oscillate for 25min after mixing. Centrifugation, remove the supernatant, and redissolve with the diluent 50 to obtain the respiratory syncytial virus antibody-colloidal gold complex. The respiratory syncytial virus antibody-colloidal gold complex is uniformly coated on the glass fiber, dried at 50℃ for 24 hours, and cut to obtain the conjugate pad.

[0094] Step 3: Preparation of the nitrocellulose membrane 24, the respiratory syncytial virus antibody and the goat anti-mouse IgG are diluted to 0.5-2mg / mL and 0.5-2mg / mL respectively with the coating diluent 50, and coated on the corresponding positions of the nitrocellulose membrane 24 by a membrane coating machine, dried at 50℃ for 48 hours, to obtain the nitrocellulose membrane 24.

[0095] Step 4: Preparation of sample pad 22, sample pad treatment solution is evenly applied to the glass fiber, dried at 50℃ for 24 hours, and then cut to obtain the sample pad.

[0096] Step 5: Sample pad 22, coupling pad 23, nitrocellulose membrane 24, and water absorption paper 25 are sequentially pasted on PVC bottom plate 21, and then cut into 3.5mm wide test strip by cutting machine to obtain respiratory syncytial virus antigen detection test strip 20.

[0097] 2, Respiratory syncytial virus antigen detection test strip 20 is first fixed on the back of first plate body 31 by double-sided tape, and first plate body 31 and second plate body 32 are folded towards the back to clamp and fix the detection test strip 20 and the box body 10. The avoidance hole on the second plate body 32 corresponds to the position of the box body 10, and the box body 10 is fixed and exposed by the fixed piece 13 to expose the elution hole 11. The window 321 on the second plate body 32 corresponds to the result judgment area on the nitrocellulose membrane 24. The third plate body 33 is folded to protect the window 321 and the notch on the box body 10.

[0098] 3, During detection, open the third plate body 33, insert the cotton head (sampling end 41) of the sampling swab 40 collecting biological samples into the elution hole 11, and then add the diluent 50 into the liquid containing groove 12. The liquid can flow into the elution hole 11 through the insertion port 111, elute the biological sample on the cotton head, enter the sample pad 22 through the release port 113, and perform chromatography on the detection test strip 20. The detection result can be displayed on the nitrocellulose membrane 24, and can be seen by the user through the window 321.

[0099] Example 2: The sample sampling and detection device 100 provided by the application can be used as an influenza A / B virus antigen detection device.

[0100] 1. Preparation of colloidal gold influenza A / B virus antigen detection test strip

[0101] Step 1: Preparation of colloidal gold, 1L ultrapure water is heated to boiling under stirring, 40mL of 1% concentration of chloroauric acid is added, the solution is boiled again, 25mL of 2% concentration of trisodium citrate is quickly added, heating is continued for 10 minutes, and after the color is stable, the heating is turned off and naturally cooled to room temperature. Store at room temperature.

[0102] Step 2: Preparation of the conjugate pad 23: ① Take 1 mL of colloidal gold solution, adjust the pH to 6.5-7.5, mix for 10 min, add 10-50 ug of influenza A virus antibody, mix and oscillate for 15 min, add BSA with a final concentration of 0.2%, mix and oscillate for 25 min. Centrifuge, remove the supernatant, and resuspend with diluent 50 to obtain the influenza A virus antibody-colloidal gold complex. ② Take 1 mL of colloidal gold solution, adjust the pH to 6.5-7.5, mix for 10 min, add 10-50 ug of influenza B virus antibody, mix and oscillate for 15 min, add BSA with a final concentration of 0.2%, mix and oscillate for 25 min. Centrifuge, remove the supernatant, and resuspend with diluent 50 to obtain the influenza B virus antibody-colloidal gold complex. Mix the influenza A virus antibody-colloidal gold complex and the influenza B virus antibody-colloidal gold complex uniformly, uniformly coat them on glass fiber, dry at 50°C for 24 hours, and cut to obtain the conjugate pad.

[0103] Step 3: Preparation of the nitrocellulose membrane 24, dilute the influenza A virus antibody, the influenza B virus antibody, and the goat anti-mouse IgG to 0.5-2 mg / mL, 0.5-2 mg / mL, and 0.5-2 mg / mL respectively with the coating diluent 50, coat them on the corresponding positions of the nitrocellulose membrane 24 by using a membrane coating machine, dry at 50°C for 48 hours, and obtain the nitrocellulose membrane 24.

[0104] Step 4: Preparation of the sample pad 22, uniformly apply the sample pad treatment solution to glass fiber, dry at 50°C for 24 hours, and cut to obtain the sample pad.

[0105] Step 5: Paste the sample pad, the conjugate pad, the nitrocellulose membrane 24, and the water absorption paper 25 on the PVC base plate 21 in sequence, cut into 3.5 mm wide test strip by using a cutting machine, and obtain the influenza A / B virus antigen test strip 20.

[0106] 2, The influenza A / B virus antigen test strip 20 is first fixed on the back of the first plate body 31 by double-sided tape, the first plate body 31 and the second plate body 32 are folded towards the back to sandwich and fix the test strip 20 and the box body 10, the relief hole on the second plate body 32 corresponds to the position of the box body 10, the box body 10 is fixed and exposed by the fixing piece 13, the window 321 on the second plate body 32 corresponds to the result interpretation area on the nitrocellulose membrane 24. The third plate body 33 is folded to protect the window 321 and the notch on the box body 10.

[0107] 3. During testing, open the third plate 33, insert the cotton head (sampling end 41) of the sampling swab 40 containing the biological sample into the elution well 11, and then add the diluent 50 to the liquid container 12. The liquid can flow into the elution well 11 through the insertion port 111. After eluting the biological sample on the cotton head, it enters the sample pad 22 through the release port 113 and is subjected to chromatography on the test strip 20. The test results can be displayed on the nitrocellulose membrane 24 and can be seen by the user through the viewing window 321.

[0108] A comparison of the detection methods (influenza A / B virus antigen) of nucleic acid detection, conventional antigen detection, and the antigen detection device of the present invention is presented in the following table, which summarizes the detection results of the above-mentioned nucleic acid detection reagents, conventional antigen detection reagents, and the sample sampling and detection device 100 of the present invention:

[0109]

[0110]

[0111] As shown in the table above, when detecting influenza A virus, the positive concordance rate of conventional antigen test reagents and nucleic acid test reagents was 90.9%, the negative concordance rate was 100%, and the overall concordance rate was 96.0%.

[0112]

[0113] As can be seen from the table above, when detecting influenza A virus, the positive concordance rate of the sample sampling and detection device 100 of the present invention with the nucleic acid detection reagent is 100%, the negative concordance rate is 100%, and the total concordance rate is 100%.

[0114]

[0115] As shown in the table above, when detecting influenza B virus, the positive concordance rate of conventional antigen detection reagents and nucleic acid detection reagents was 80.0%, the negative concordance rate was 100%, and the overall concordance rate was 96.0%.

[0116]

[0117] As shown in the table above, when detecting influenza B virus, the positive concordance rate of the sample sampling and detection device 100 of the present invention with the nucleic acid detection reagent is 90%, the negative concordance rate is 100%, and the overall concordance rate is 98%.

[0118] The following table summarizes the detection process and total detection time of the above-mentioned nucleic acid reagent detection method, conventional card antigen detection method, and the sample sampling and detection device 100 of the present invention:

[0119]

[0120] From the above data, it can be seen that when detecting influenza A / B virus in oropharyngeal swab sample, the positive coincidence rate of the conventional cassette antigen detection reagent and the nucleic acid detection reagent is only 90.9% for influenza A and 80% for influenza B, the positive coincidence rate of the sample sampling and detecting device 100 of the present application and the nucleic acid detection reagent is 100% for influenza A and 90% for influenza B, and the sensitivity is superior to that of the conventional cassette antigen detection reagent. In terms of operation steps, the nucleic acid reagent detection method needs 5 steps, and the total time is 420 minutes; the conventional cassette detection method needs 3 steps, and the total time is 150 minutes; and the sample sampling and detecting device 100 of the present application only needs 2 steps, and the total time is only 75 minutes, which is simpler in operation and far lower in time than the nucleic acid detection method, and is only half of the conventional cassette detection method.

[0121] The above merely describes preferred specific embodiments of the present application, but the protection scope of the present application is not limited thereto, and any person skilled in the art can easily think of changes or replacements within the technical range disclosed by the present application, which should be covered in the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. A sample sampling detection device, characterized by, The sample sampling and detecting device comprises: a shell assembly, which internally defines an elution hole, the elution hole forms an insertion port and a release port at opposite sides of the shell assembly respectively, one side of the shell assembly provided with the insertion port is provided with a liquid containing groove, the insertion port is located in the liquid containing groove and used for inserting a sampling end of a swab, and the liquid containing groove is used for receiving a sample diluent; a test strip, which has a sample section, the sample section shields at least part of the release port.

2. The sample sampling detection apparatus according to claim 1, characterized by, Along the height direction of the shell assembly, the elution hole forms the insertion port and the release port at the top end and the bottom end of the shell assembly respectively, and the axis of the elution hole is arranged at an angle relative to the height direction of the shell assembly.

3. The sample sampling detection apparatus according to claim 2, characterized by, Along the height direction of the shell assembly, the top end of the liquid containing groove forms a notch, the bottom end of the liquid containing groove coincides with part of the insertion port, and the liquid containing groove is configured in a structure that is tapered from the top end to the bottom end along the height direction of the shell assembly.

4. The sample sampling detection apparatus according to claim 3, characterized by The liquid containing groove comprises a first groove wall and a second groove wall, along the height direction of the shell assembly, the top end of the first groove wall and the top end of the second groove wall define the notch, the bottom end of the first groove wall and the bottom end of the second groove wall are connected, the insertion port is arranged on the first groove wall, and the bottom end of the insertion port is connected with the bottom end of the second groove wall.

5. The sample sampling detection apparatus according to claim 1, characterized by, The shell assembly comprises: a first plate body; a second plate body, the edges of the second plate body are connected with the edges of the first plate body, the second plate body is arranged in a stack with the first plate body, the second plate body is provided with a window and a relief hole; a box body, the box body is connected with the first plate body and penetrates through the relief hole, the liquid containing groove is arranged on the side of the box body away from the first plate body, the release port is arranged on the side of the box body facing the first plate body, the sample section is arranged between the box body and the first plate body, and the test strip further has an interpretation section for displaying a detection result, along the height direction of the box body, the projection of the interpretation section and the window in the same plane has an overlapping area.

6. The sample sampling detection apparatus according to claim 5, wherein The shell assembly further comprises a third plate body, the edges of the opposite sides of the second plate body are connected with the edges of the first plate body and the edges of the third plate body respectively, the third plate body can rotate relative to the second plate body, and the third plate body has a position arranged in a stack with the second plate body and shielding the window and the relief hole in the process of rotation of the third plate body.

7. The sample sampling detection apparatus according to claim 5, wherein The shell assembly further comprises at least one fixing sheet, the fixing sheet is connected with the box body and clamped between the first plate body and the second plate body, and the first plate body and the fixing sheet and the second plate body and the fixing sheet are both filled with adhesive.

8. The sample sampling detection device according to any one of claims 1 to 7, characterized in that, The sample sampling and detecting device further comprises at least one ridge arranged in the elution hole, the ridge is located at one end of the elution hole provided with the release port and used for extruding the sampling end.

9. The sample sampling detection device according to any one of claims 1 to 7, characterized in that, The sample sampling and detecting device further comprises a swab, the swab has a sampling end, and the elution hole is connected with the sampling end in an interference fit.

10. A sample sampling detection method, implemented by the sample sampling detection device according to any one of claims 1 to 9, characterized in that, The sample sampling detection method comprises the following steps: inserting the swab after collecting the biological sample into the elution hole; adding diluent into the liquid containing groove; controlling the diluent to flow into the elution hole to elute the swab; after the sample in the swab is eluted by the diluent, the sample is automatically contacted with the test strip through the release port; observing the detection result displayed by the test strip.

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