A self-priming in vitro diagnostic reagent card

Abstract

The present invention discloses a self-priming in vitro diagnostic reagent card, which belongs to the field of reagent cards, and includes a main body and a shell for installing the main body. The main body includes a sample area for contacting and detecting a sample, a binding area for combining with a sample marker, and a detection area for displaying aggregated precipitation. The shell also includes a supporting component, which accelerates the sample to combine and react through an internally arranged air pressure mechanism. The self-priming in vitro diagnostic reagent card adopts a new type of negative pressure self-priming acceleration design, and can achieve effective negative pressure environment creation through a simple pressing operation, thereby effectively improving the detection efficiency without affecting the binding of the sample with the antigen.

Description

Technical Field

[0001] The present invention relates to the technical field of reagent cards, and in particular, to testing materials by means of measuring the chemical properties of the materials, specifically, a self-aspirating in vitro diagnostic reagent card. Background Art

[0002] Taking a coronavirus reagent card as an example, as one of the important means of in vitro diagnosis, the sample solution capillary flows in the sample layer to the binding area, and the characteristics of the combination of coronavirus and its antigen are used to conveniently use the detection line in the detection area for color development. For example, a reagent card disclosed in the prior art with the publication number CN114324753A includes: a main body; a sample area for communicating with a container containing a sample to be tested; a first reagent area in which a first reagent for mixing with the sample to be tested is provided, the first reagent area having a first liquid inlet and a first liquid outlet, and the first liquid inlet is communicated with the sample area through a first liquid channel; a second reagent area in which a stirring device is provided, the second reagent area is communicated with the first liquid outlet of the first reagent area through a second liquid channel, and a first cut-off valve is provided on the second liquid channel; a first gas channel, the first end of the first gas channel is communicated with the first reagent area, and the second end of the first gas channel is a first negative pressure end; a second gas channel, the first end of the second gas channel is communicated with the second reagent area, and the second end of the first gas channel is a second negative pressure end. Applying the technical solution of the present invention can effectively solve the problem of poor mixing effect between the reagent and the liquid sample in the related art.

[0003] Another example is an in vitro diagnostic analyzer and a reagent card disclosed in the prior art with the publication number CN111257548B. The reagent card includes a reagent card body and an installation body. The installation body includes an installation hole for sleeving a sample tube, a hollow needle provided in the installation hole, a sealing part provided in the installation hole, and an air inlet channel. One end of the hollow needle can be inserted into the sample tube, the sealing part is sealingly matched with the outer wall of the sample tube, and the air inlet channel includes an air outlet hole, an air inlet hole provided on the surface of the reagent card body, and a first flow-stop structure provided between the air outlet hole and the air inlet hole. The air outlet hole is used to communicate with the sample tube installed on the installation hole; the reagent card body includes a sample injection channel communicated with the liquid outlet end of the hollow needle, a detection chamber, and an air receiving end. The sample injection channel and the air receiving end are communicated with the detection chamber. The reagent card adopts a new on-off control scheme for the sample liquid, which can solve the hidden dangers of sample liquid leakage and inability to extract. When the in vitro diagnostic analyzer is used, it is beneficial to improve the reliability of detection.

[0004] The above-mentioned existing technologies have all made important technical improvements in improving the accuracy and reliability of detection, and some contents have high reference value in practical applications. However, some sample liquids cannot increase the detection efficiency by further dilution. In the case of high concentration, the fluidity will be poor, affecting the detection efficiency. Therefore, this type of reagent card needs to be further improved in design. Summary of the Invention

[0005] The purpose of the present invention is to provide a self-aspirating in vitro diagnostic reagent card to solve the problem that some sample liquids cannot increase the detection efficiency by further dilution as mentioned in the above background technology. In the case of high concentration, the fluidity will be poor, affecting the detection efficiency.

[0006] To achieve the above purpose, the present invention provides the following technical solution: A self-aspirating in vitro diagnostic reagent card includes a main body and a housing for installing the main body. At the same time, the main body contains a sample area for contacting the detection sample, a binding area for binding with the sample label, and a detection area for aggregating and precipitating for display. The housing also contains a support component, and this support component simultaneously accelerates the combination and reaction of the sample through a pneumatic mechanism arranged inside.

[0007] Furthermore, the support component includes a cross bar for fixing the main body in the housing from below the main body and cooperating with the upper wall of the housing.

[0008] Furthermore, the pneumatic mechanism includes air holes opened on the surface of the cross bar, and these air holes are inclined or perpendicular to the surface of the main body. At the same time, the air holes are connected to an air cavity opened inside the cross bar.

[0009] Furthermore, the air cavity is connected to a negative pressure mechanism, and the negative pressure mechanism is arranged inside the housing and generates a pneumatic change effect through the sliding of an external handle.

[0010] Furthermore, the negative pressure mechanism includes a sliding plate connected to the handle through a sliding rod. The outer surface of the sliding plate is connected to a first airbag in the negative pressure mechanism, and the inner surface of the sliding plate is also connected to a second airbag.

[0011] Furthermore, the first airbag is connected to the air cavity through a first air pipe.

[0012] Furthermore, the second airbag generates deformation synchronously with the movement of the sliding plate, and the deformation direction is opposite to that of the first airbag.

[0013] Furthermore, the second airbag is connected to a second air pipe, and the second air pipe is connected to the air cavity inside the cross bar located above the main body in the housing.

[0014] Further, the horizontal bar above the detection area is discontinuously arranged, and the air cavity incision exposed at the discontinuous part is distributed in an inclined, vertical or horizontal direction towards the upper surface of the detection area.

[0015] The beneficial effects of the present invention are as follows: This self-priming in vitro diagnostic reagent card adopts a novel negative pressure self-priming acceleration design, which can create an effective negative pressure environment through simple pressing operations, thereby effectively improving the detection efficiency without affecting the binding of the sample and the antigen. Specifically, it is shown as follows.

[0016] 1. The structural design of the horizontal bar below the body can, on the one hand, stably support and limit the reagent card, and on the other hand, it can cooperate with the air cavity generating a negative pressure effect inside it and the suction effect generated by the air holes on its surface to accelerate the downward infiltration of the sample solution from below the reagent card, thereby improving the speed and comprehensiveness of its reaction with the antigen, and further cooperating with the capillary action to improve the overall detection efficiency of the reagent card for the sample.

[0017] 2. The structural design of the sliding plate cooperating with the sliding rod and the handle outside the housing enables the user to achieve the effect of providing a negative pressure environment through simple pressing and releasing operations: through the movement of the sliding plate and the deformation of the airbag it guides, the suction holes below the body can be in a negative pressure state during the static waiting for the reaction, without using other solutions with complex principles, with low cost and excellent effects;

[0018] Further, the use of the second airbag enables the movement of the sliding plate to synchronously drive the deformation of the second airbag and generate a pressure adjustment effect completely opposite to that of the first airbag in the same stroke, so that during the reaction of the sample solution, the self-priming below the body and the pressurization above can be used simultaneously to produce better acceleration and accuracy improvement effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a schematic diagram of the overall structure of the present invention;

[0020] Figure 2 It is a schematic diagram of the internal structure of Embodiment 1 of the present invention;

[0021] Figure 3 It is a schematic diagram of the distribution structure of the body of the present invention;

[0022] Figure 4 It is a schematic diagram of the internal structure of the horizontal bar of the present invention;

[0023] Figure 5 It is a schematic diagram of the distribution structure of the horizontal bar at the binding area of the present invention;

[0024] Figure 6 It is a schematic diagram of the distribution structure of the horizontal bar at the detection area of the present invention;

[0025] Figure 7 It is a schematic diagram of the overall structure of the second embodiment of the present invention;

[0026] Figure 8 For the present invention Figure 7 Internal structure schematic diagram.

[0027] In the figure: 1, main body; 2, outer shell; 3, sample area; 4, binding area; 5, detection area; 6, cross bar; 7, air cavity; 8, air hole; 9, handle; 10, sliding rod; 11, sliding plate; 12, first airbag; 13, first air pipe; 14, second airbag; 15, second air pipe. Specific embodiments

[0028] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0029] Please refer to Figures 1-8 , the present invention provides the following technical solutions:

[0030] Embodiment 1: The solution disclosed in this embodiment is to solve the problems existing in the prior art and effectively improve the speed of sample-antibody binding while improving the accuracy. The specific solution is to provide a negative pressure environment from below the main body 1, thereby generating an acceleration of the capillary reaction and the infiltration speed of the sample liquid in different functional areas, thereby improving the binding speed. Specifically, such as Figures 1-4As shown, it includes a main body 1 and a housing 2 for installing the main body 1. The main body 1 contains a sample area 3 for contacting and detecting samples, a binding area 4 for binding with sample markers, and a detection area 5 for aggregating and precipitating for display. The housing 2 also contains a support member, and this support member uses an internal air pressure mechanism to accelerate the combination and reaction of the samples. The support member includes a cross bar 6 that is located below the main body 1 and cooperates with the upper wall of the housing 2 to fix the main body 1 in the housing 2. The air pressure mechanism includes air holes 8 opened on the surface of the cross bar 6, and these air holes 8 are inclined or vertically distributed towards the surface of the main body 1. At the same time, the air holes 8 are connected to an air cavity 7 opened inside the cross bar 6. The function of the support member, that is, the cross bar 6 itself, is to support the main body 1 from below and, in combination with the upper housing 2, stably install the main body 1 in the housing 2. After setting the corresponding air pressure mechanism in the cross bar 6, through the negative pressure effect generated by the air holes 8 below the main body 1, when the main body 1 is close to or adjacent to the lower air holes 8, the sample solution in the corresponding functional area can fully react under the condition of accelerated downward infiltration and achieve the corresponding functions. At the same time, it cooperates with the capillary adsorption effect originally possessed by the main body 1 to accelerate the overall function of the reagent card.

[0031] Embodiment 2: In this embodiment, the following specific scheme is disclosed. As Figures 4-8 shown, the air cavity 7 is connected to a negative pressure mechanism. The negative pressure mechanism is arranged inside the housing 2 and generates an air pressure change effect through the sliding of an external handle 9. The negative pressure mechanism includes a sliding plate 11 connected to the handle 9 through a sliding rod 10. The outer surface of the sliding plate 11 is connected to a first airbag 12 in the negative pressure mechanism, and the inner surface of the sliding plate 11 is also connected to a second airbag 14. The first airbag 12 is connected to the air cavity 7 through a first air tube 13. When the user drops the sample liquid, one hand can press the handle 9. During the pressing process, the handle 9 drives the sliding plate 11 to slide inside the housing 2 through the sliding rod 10. In this sliding direction, the first airbag 12 is in a compressed state. Therefore, after releasing the handle 9, the slow or rapid rebound of the first airbag 12 will make the first air tube 13 in a negative pressure state. At the same time, under the connection effect of the first air tube 13 and the air cavity 7, the air cavity 7 and the connected air holes 8 will simultaneously be in a continuous negative pressure state, thus realizing the self-priming and rapid reaction function of the sample liquid in the main body 1 and the corresponding functional areas on the main body 1. At the same time, because both the two-way output inlets of the first airbag 12 in this scheme are connected to the first air tube 13, before dropping the sample liquid, the user can also repeatedly press the handle 9 to make the first airbag 12 deform repeatedly and generate positive and negative pressure effects repeatedly, thereby performing auxiliary pre-cleaning on the reagent card itself, and thus avoiding the situation of false positives of the sample caused by possible impurities on the surface of the reagent card.

[0032] The solution disclosed in this embodiment is to cooperate with the self-priming effect to further accelerate the reaction speed in the reagent card. The specific form is as follows Figures 4-8 As shown, the second airbag 14 deforms synchronously with the movement of the slide plate 11, and the deformation direction is opposite to that of the first airbag 12. The second airbag 14 is connected to the second trachea 15, and at the same time, the second trachea 15 is connected to the internal air cavity 7 of the cross bar 6 located above the body 1 in the housing 2. The cross bar 6 above the detection area 5 is provided with a break, and the exposed air cavity 7 cut at the break is distributed in an inclined, vertical or horizontal direction towards the upper surface of the detection area 5. When the slide plate 11 is moving, it will also synchronously pull the second airbag 14 to deform. When the airbag deforms, the air pressure in the internal air cavity 7 of the cross bar 6 above the body 1 will be adjusted through the connection of the second trachea 15, and the adjustment direction is opposite to that of the first airbag 12. That is to say, when the user presses and releases the handle 9, the slow or fast movement of the slide plate 11 will cause the first airbag 12 to stretch and deform to produce a negative pressure effect, while the second airbag 14 will be synchronously squeezed and deformed to produce a positive pressure conveying effect of the air flow. That is to say, the lower part of the body 1 is in a negative pressure state and the upper part is in a state of being blown by a positive pressure air flow. Therefore, the functions of different functional areas in the body 1 will be exerted more quickly, and at the same time, the rapid horizontal flow of the sample solution and the occurrence of false results in the detection area 5 due to untimely reaction are avoided.

[0033] Although the embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A self-priming in vitro diagnostic reagent card, comprising a body (1) and a housing (2) for mounting the body (1), wherein the body (1) comprises a sample area (3) for contacting a test sample, a binding area (4) for binding with a sample marker, and a detection area (5) for displaying aggregated precipitation, characterized in that: The housing (2) also includes a support component, which accelerates the binding and reaction of the sample through an internally arranged air pressure mechanism; The supporting component comprises a horizontal bar (6) for fixing the body (1) in the shell (2) from below the body (1) and in cooperation with the upper wall of the shell (2); The air pressure mechanism comprises air holes (8) formed on the surface of the horizontal bar (6), and the air holes (8) are inclined or vertically distributed toward the surface of the body (1), and the air holes (8) are connected to the air cavity (7) formed inside the horizontal bar (6); The air cavity (7) is connected to a negative pressure mechanism, wherein the negative pressure mechanism is arranged inside the housing (2) and generates an air pressure change effect through the sliding of an external handle (9).

2. A self-priming in vitro diagnostic reagent card according to claim 1, characterized in that: The negative pressure mechanism comprises a slide plate (11) connected to a handle (9) via a slide rod (10), wherein an outer surface of the slide plate (11) is connected to a first air bag (12) in the negative pressure mechanism, and an inner surface of the slide plate (11) is also connected to a second air bag (14).

3. A self-priming in vitro diagnostic reagent card according to claim 2, characterized in that: The first air bag (12) is connected to the air cavity (7) via the first air tube (13).

4. A self-priming in vitro diagnostic reagent card according to claim 2, characterized in that: The second airbag (14) deforms synchronously with the movement of the slide plate (11), and the deformation direction is opposite to that of the first airbag (12).

5. A self-priming in vitro diagnostic reagent card according to claim 4, characterized in that: The second air bag (14) is connected to the second air pipe (15), and the second air pipe (15) is connected to the air cavity (7) inside the horizontal bar (6) located above the main body (1) in the outer shell (2).

6. A self-priming in vitro diagnostic reagent card according to claim 5, characterized in that: The horizontal strip (6) above the detection area (5) is disconnected, and the cutout of the air cavity (7) exposed at the disconnection position is distributed in an inclined, vertical or horizontal direction toward the upper surface of the detection area (5).

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