WO2023056621A1 - Sample access tube - Google Patents

Abstract

The present application provides a sample access tube, comprising a tube body, an adapting body, and a cover body. The tube body is provided with a deformable part, and the adapting body is provided with a liquid dripping part. When the tube body is in closed disconnection to the adapting body, the cover body is in closed connection to the adapting body, the tube body is inverted, and no external force acts on the deformable part of the tube body, a sample preservation liquid in the tube body cannot be automatically discharged from a liquid dripping outlet of the adapting body; and when the deformable part of the tube body deforms under the action of external force, the sample preservation liquid in the tube body is dripped out of the liquid dripping outlet of the adapting body. Optionally, when the deformable part of the tube body has a maximum allowable deformation, the set number of droplets are dripped out of the liquid dripping outlet of the adapting body, and each droplet has a set volume value or range.

Description

A sample access tube technical field

The application relates to the field of medical devices, in particular to a sample access tube.

Background technique

The current preservation solution used to preserve viral nucleic acid samples is usually composed of a buffer supplemented with protein denaturants such as guanidine isothiocyanate, which has better preservation performance. Specific DNA and RNA of the virus can be detected after the sample is collected and preserved in a sample preservation solution, providing an important template for virus detection.

When using the preservation tubes currently on the market to preserve viral nucleic acid samples, the flocked swab head after repeatedly scratching the subject's nose and pharynx is immersed in the sample preservation solution. This provides a convenient, fast, safe and effective method for preserving viral nucleic acid on nasopharyngeal swabs, providing a reliable guarantee for high-quality nucleic acid templates required for detection and diagnosis, and can meet various molecular detection, diagnosis, and analysis Experimental requirements.

However, the current preservation tubes have certain defects, that is, a pipette needs to be used to transfer the sample preservation solution from the preservation tube to the nucleic acid extraction tube when performing molecular detection, diagnosis and analysis experiments. Specifically, the caps of the preservation tubes need to be opened prior to transfer. Moreover, the nozzle opening of the preservation tube is required to be sufficient to accommodate the insertion of the pipette tip into the preservation tube to absorb the sample preservation solution. This highly open sampling operation can easily cause sample contamination. In addition, when using a preservation tube to store the sample preservation solution and using a pipette to transfer the sample preservation solution, usually a maximum of 60 sample preservation solutions are processed per hour, which has problems such as low efficiency and complicated operation.

Contents of the invention

The purpose of the present application is to provide a sample access tube suitable for storing swab samples (which contain potential pathogens such as fungi, bacteria and viruses) collected from the nose and throat of subjects (such as people). Pick. When using the sample access tube of the present application, the operation of transferring the sample preservation solution is convenient and fast, and the sample contamination can also be avoided or reduced.

In order to achieve the above purpose, the application provides a sample access tube (such as drop type), which includes a tube body, an adapter and a cover, wherein the tube body has a deformable (including but not limited to elastic deformation and flexible deformation) part, and wherein the aptamer has a droplet part. When the airtight connection between the tube body and the adapter body is closed, the airtight connection between the cover body and the adapter body is opened, and the tube body is turned upside down, when no external force acts on the deformable part of the tube body, the The sample preservation solution will not be discharged from the drip outlet of the aptamer by itself; when the deformable part of the tube is deformed under the action of external force, the sample preservation solution in the tube will drip out from the drip outlet of the aptamer. Optionally, when the deformable part of the tube body undergoes the maximum allowable deformation, a set number of liquid droplets drip out from the liquid drop outlet of the adapter, and each liquid droplet has a set volume value or range.

In one aspect, the present application provides a sample access tube (such as a drip type), which includes a tube body, an adapter and a cap, wherein the tube body has a deformable part and the adapter has a drip part. In one embodiment, there is a hermetic connection between the tube body and the adapter. In one embodiment, there is a hermetic connection between the cap and the aptamer. In one embodiment, the airtight connection is a threaded connection. In one embodiment, the inner diameter of the drip outlet, drip channel and/or drip inlet of the drip portion is less than about 5.0, 4.9, 4.8, 4.7, 4.6, 4.5, 4.4, 4.3, 4.2, 4.1, 4.0, 3.9 , 3.8, 3.7, 3.6, 3.5, 3.4, 3.3, 3.2, 3.1, 3.0, 2.9, 2.8, 2.7, 2.6, 2.5, 2.4, 2.3, 2.2, 2.1, 2.0, 1.9, 1.8, 1.7, 1.6, 1.5, 1.4 , 1.3, 1.2, 1.1 or 1.0 mm, ±0.01, 0.02, 0.03, 0.04 or 0.05 mm. In one embodiment, the length of the drip channel of the drip portion is greater than about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 , 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42 , 43, 44, 45, 46, 47, 48, 49 or 50 mm, ±0.1, 0.2, 0.3, 0.4 or 0.5 mm. In one embodiment, a single maximum allowable deformation of the deformable portion results in about 1-600, 5-500, 10-400, 15-300, 20-200 or 25-100 microliters, such as about 1, 10, 20 ,30,40,50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270 ,280,290,300,310,320,330,340,350,360,370,380,390,400,410,420,430,440,450,460,470,480,490,500,510,520 , 530, 540, 550, 560, 570, 580, 590 or 600 microliters, ±1, 2, 3, 4 or 5 microliters of tube volume difference. In one embodiment, when the airtight connection between the tube body and the adapter body is closed, the airtight connection between the cover body and the adapter body is opened, and the tube body is inverted, when no external force acts on the deformable body of the tube body Partially, the sample preservation liquid in the tube body will not be discharged from the drip outlet of the adapter body; The outlet drips out. In one embodiment, a single maximum allowable deformation of the deformable portion of the tube body is sufficient to cause N drops of the sample preservation solution to drip from the dripping portion of the aptamer but not enough to cause N+1 drops of the sample preservation solution to emerge from the aptamer Part of the dripping liquid drops out, optionally, N is an integer of 1 to 10, such as 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10, optional 3 to 5, such as 3, 4 or 5. In one embodiment, the sample preservation solution in the tube is dripped from the drip outlet of the aptamer in a volume of about 1-100, 10-90, 20-80, 30-70 or 40-60 microliters , for example about 1, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 microliters, ±1, 2, 3, 4 or 5 microliters.

In one embodiment, (1) two sets of thread directions are the same, or, two sets of thread directions are the same and opposite; and/or (2) the number of threads between the pipe body and the fitting body is greater than that between the cap body and the fitting body number of threads; and/or (3) the thread density between the pipe body and the fitting body is greater than the thread density between the cover body and the fitting body; and/or (4) the thread density between the pipe body and the fitting body The screwing resistance is greater than the thread screwing resistance between the cover body and the adapter; and/or (5) the thread between the pipe body and the adapter is a safety thread. In one embodiment, the sample access tube of the present application further comprises (1) hanging skirt; and/or (2) standing skirt; and/or (3) sealing pad; and/or (4) sealing protrusion; and/or (5) sealing ring; and/or (6) sealing skirt; and/or (7) arresting protrusion; and/or (8) wiping protrusion; and/or (9) connecting strip; and/or ( 10) Anti-slip structure. In one embodiment, the sample access tubes of the present application have the following characteristics: (1) capable of holding 1-10 swab heads and optionally a portion or the entire swab shaft; and/or (2) having about 0.5 - 3.0 cm inside diameter of the tube; and/or (3) having a tube body height of about 3-15 cm; and/or (4) having a tube body volume of about 1-50 ml; and/or (5) tube body The airtight connection with the adapter cannot be opened after being closed; and/or (6) the airtight connection between the cover and the adapter can be opened and closed repeatedly; and/or (7) the tube body is partially or completely transparent or translucent.

In another aspect, the present application provides a method for using the sample access tube of the present application (such as a drip type) (such as accessing a swab sample), which includes one or more of the following steps:

(1) Preparation: close the airtight connection between the cap and the aptamer, dispense the sample storage buffer into the tube, and close the airtight connection between the tube and the aptamer (together with the cap);

(2) Sample storage: without opening the airtight connection between the cover and the adapter, open the airtight connection between the tube and the adapter (together with the cover), and store the swab sample after sampling. Insert the tube body; optionally, repeat the sample storage step, so that one sample access tube saves multiple swab samples; after the sample storage ends, restore the airtight connection between the tube body and the adapter (together with the cover); and

(3) Sampling: Without opening the airtight connection between the adapter body and the tube body, open the airtight connection between the cover body and the adapter body (together with the tube body), and turn it upside down above the sample collection container (vertical or Tilt, such as about 30, 40, 45, 50 or 60 degrees relative to the horizontal or vertical) sample access tube, squeeze the deformable part of the tube body to deform it (at this time, the sample preservation solution is discharged as a droplet, falling into the sample collection container or its compartment); after sampling, restore the airtight connection between the cap and the adapter (together with the tubing).

Compared with related technologies, the effect of the present application is at least that: without using a pipette, only by squeezing the deformable part of the tube body, the sample preservation solution stored in the sample access tube can be transferred quickly and effectively; Volume (depending on several factors, such as the inner diameter and shape of the drip outlet and the inclination angle of the drip channel) of sample preservation liquid; by controlling extrusion, a set number of droplets can be obtained; copies can be set; mixed samples can be set ; By limiting the exposure of the sample preservation solution to the outside world, the sample preservation solution can be safely transferred (this not only avoids or reduces the contamination of the sample preservation solution from the outside, but also avoids or reduces the spread of pathogens that may exist in the sample preservation solution to the outside world). This application also provides the possibility for the automation of the whole process of sample detection.

Description of drawings

FIG. 1 is an embodiment of the sample access tube of the present application. A: Exploded view of the sample access tube; B: Schematic diagram of the assembled sample access tube;

Fig. 2 is an embodiment (i.e. embodiment 1) of the sample access tube of the present application. A: Exploded view of the sample access tube; B: Schematic diagram of the assembled sample access tube; C: Schematic diagram of the outlet channel;

FIG. 3 is a schematic structural view of various embodiments of the tube body of the sample access tube of the present application;

Fig. 4 is a structural schematic diagram of various embodiments of the adapter (and liquid outlet channel) of the sample access tube of the present application;

FIG. 5 is a schematic structural view of various embodiments of the cover of the sample access tube of the present application;

Fig. 6 is a structural schematic diagram of various embodiments of the drip outlet and part of the drip channel of the adapter of the sample access tube of the present application;

Fig. 7 is a schematic diagram of an embodiment of the aptamer of the sample access tube of the present application;

8A is a schematic diagram of an embodiment of the tube body of the sample access tube of the present application;

Fig. 8B is a schematic diagram of an embodiment of the adapter of the sample access tube of the present application;

FIG. 8C is a schematic diagram of an embodiment of the cover of the sample access tube of the present application;

Figure 9 shows a schematic diagram of the measurement method for the drop inlet.

Reference signs:

1. Tube body; 11. Lower section of tube body; 12. Upper section of tube body; 13. Middle section of tube body; 14. Horizontal skirt; 15. Vertical skirt; 16. Deformable part;

2. Aptamer; 21. The lower part of the aptamer; 22. The upper part of the aptamer; 23. The middle part of the aptamer; 24. The junction between the lower part of the aptamer 21 and the middle part of the aptamer 23; 25. Adaptation The connecting part between the upper part of the adapter body 22 and the middle part of the adapter body 23; 26, the blocking protrusion;

3. Cover body; 31. Cover body main body; 32. Topping of cover body body; 33. Cover body lower section; 34. Joint between cover body main body 31 and cover body lower section 33.

Detailed ways

In order to make the technical solutions and technical effects of the present application clearer, the implementation of the present application will be clearly and completely described below in conjunction with the embodiments of the present application and the accompanying drawings. The described embodiments are some, but not all, embodiments of the application. The components of the embodiments of the application generally described and illustrated in the figures herein may be arranged and designed in a variety of different configurations.

Accordingly, the following detailed description of the embodiments of the application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely represents selected embodiments of the application. Based on the embodiments in this application, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of this application.

It should be noted that like numerals and letters denote similar items in the following figures, therefore, once an item is defined in one figure, it does not require further definition and explanation in subsequent figures.

In the description of this application, it should be noted that, unless otherwise stated, the terms "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" The orientation or positional relationship indicated is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship that is usually placed when the product is used, and it is only for the convenience of describing the application and simplifying the description, rather than indicating or implying References to devices or elements must have a particular orientation, be constructed, and operate in a particular orientation and therefore should not be construed as limiting the application. In addition, the terms "first", "second", "third", etc. are only used for distinguishing descriptions, and should not be construed as indicating or implying relative importance. In the description of the present application, unless otherwise specified, "plurality" means two or more.

In the description of this application, it should also be noted that, unless otherwise clearly stipulated and limited, the terms "setting" and "connection" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection, or Connected integrally; either mechanically or electrically. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application in specific situations.

In this application, unless otherwise expressly specified and limited, a first feature being "on" or "under" a second feature may include direct contact between the first and second features, and may also include the first and second features Not in direct contact but through another characteristic contact between them. Moreover, "above", "above" and "above" the first feature on the second feature include that the first feature is directly above and obliquely above the second feature, or simply means that the first feature is horizontally higher than the second feature. "Below", "beneath" and "under" the first feature to the second feature include that the first feature is directly below and obliquely below the second feature, or simply means that the first feature has a lower level than the second feature.

sample access tube

In one aspect, the present application provides a sample access tube (such as a drip type), which includes a tube body, an adapter and a cap, wherein the tube body has a deformable (including but not limited to elastic deformation and flexible deformation) portion , and wherein the aptamer has a droplet portion. When the airtight connection between the tube body and the adapter body is closed, the airtight connection between the cover body and the adapter body is opened, and the tube body is turned upside down, when no external force acts on the deformable part of the tube body, the The sample preservation solution will not be discharged from the drip outlet of the aptamer by itself; when the deformable part of the tube is deformed under the action of external force, the sample preservation solution in the tube will drip out from the drip outlet of the aptamer. Optionally, when the deformable part of the tube body undergoes the maximum allowable deformation, a set number of liquid droplets drip out from the liquid drop outlet of the adapter, and each liquid droplet has a set volume value or range.

Tube

One end of the pipe body is closed and the other end is open. The closed end is the bottom of the pipe, the open end is the mouth of the pipe, and the space between the bottom of the pipe and the mouth of the pipe is the pipe body. In other words, the tube body includes a tube wall and a lumen surrounded by the tube wall.

The nozzle can be in any shape, such as circular, oval, square, rectangular, etc., circular is optional. The bottom of the tube can be in any shape, such as flat bottom (can be any shape, such as circular, oval, square, rectangular, etc.), arc bottom (such as spherical bottom), pointed bottom (such as cone bottom) and the like. The cross-section of the tube body can be in any shape, such as circular, oval, square, rectangular, shuttle-shaped, etc., and circular is optional. In one embodiment, the cross-sectional shape at different positions of the tube body is the same. In one embodiment, the cross-sectional shape of the tube body is different at different positions, such as a combination of a circle and a rectangle. In one embodiment, the cross-sectional shapes at different positions of the pipe body are the same but different in size, for example, they are all circular, the top is large and the bottom is small, the top is small and the bottom is large, the middle is small and both ends are large, the middle is large and both ends are small, etc. In one embodiment, the body is segmented (eg, 2, 3 or more segments), wherein each segment independently has the characteristics described above. In one embodiment, the change in cross-section is gradual. In one embodiment, the change in cross-section is abrupt. In mutational embodiments, there is a junction between the two segments involved in the mutation.

The size of the nozzle allows the swab to be inserted into the body of the tube. In one embodiment, the inner diameter of the nozzle is less than or equal to 3.0, 2.9, 2.8, 2.7, 2.6, 2.5, 2.4, 2.3, 2.2, 2.1, 2.0, 1.9, 1.8, 1.7, 1.6, 1.5, 1.4, 1.3, 1.2 , 1.1, 1.0, 0.9, 0.8, 0.7, 0.6, 0.5, 04, 0.3, 0.2, or 0.1 cm, and/or, greater than or equal to 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0 , 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9 or 3.0 cm, floating up and down 0.01, 0.02, 0.03, 0.04 or 0.05 cm. The transverse dimensions of the tube body and/or tube bottom allow for one or more (for example 1-10, for example 3-5, for example 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 ) swab head and optionally part or the entire swab shaft. In one embodiment, the inner diameter of the tube body and/or the tube bottom is less than or equal to 3.0, 2.9, 2.8, 2.7, 2.6, 2.5, 2.4, 2.3, 2.2, 2.1, 2.0, 1.9, 1.8, 1.7, 1.6, 1.5, 1.4, 1.3, 1.2, 1.1, 1.0, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2 or 0.1 cm, and/or, greater than or equal to 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9 or 3.0 cm, floating 0.01 , 0.02, 0.03, 0.04 or 0.05 cm. In one embodiment, the cross-sectional area of the tube body and/or the tube bottom is less than or equal to 5.0, 4.9, 4.8, 4.7, 4.6, 4.5, 4.4, 4.3, 4.2, 4.1, 4.0, 3.9, 3.8, 3.7, 3.6, 3.5, 3.4, 3.3, 3.2, 3.1, 3.0, 2.9, 2.8, 2.7, 2.6, 2.5, 2.4, 2.3, 2.2, 2.1, 2.0, 1.9, 1.8, 1.7, 1.6, 1.5, 1.4, 1.3, 1.2, 1.1, 1.0, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, or 0.1 cm², and/or, greater than or equal to 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1 , 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6 . In one embodiment, the height of the tube body is 3-15 cm, such as 5-10 cm, such as 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 cm, up and down Float 0.1, 0.2, 0.3, 0.4 or 0.5 cm. In one embodiment, the tube is capable of holding one or more (eg 1-10, eg 3-5, eg 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10) wipes Swab head and optional part or entire swab shaft. In one embodiment, the volume of the tube body is 1-50 milliliters, such as 3-20 or 5-15 milliliters, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 , 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37 , 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 or 50 ml, plus or minus 0.1, 0.2, 0.3, 0.4 or 0.5 ml, where applicable. In one embodiment, the tube body contains 1-10 ml, such as 3-5 ml, such as 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 ml of sample preservation solution, floating up and down by 0.1, 0.2 , 0.3, 0.4 or 0.5 ml.

In one embodiment, when the tube body accommodates one or more (for example, 5) swab heads, the deformable part of the tube body can still undergo a set maximum allowable deformation under the action of an external force.

The tube bodies can be made of the same or different materials. The tube body may include one section or one piece (or multiple sections or pieces) of rigid (non-deformable) walls, which can be used for affixing labels (such as two-dimensional codes), so as to mark samples and avoid sample confusion. The tube body may include one or one (or multiple segments or pieces) soft (deformable, including but not limited to elastic deformation and flexible deformation) walls, which can be used to achieve volume changes of the tube body.

Optionally, the whole or part of the tube body is made of transparent or translucent material, so as to observe whether there is a sample preservation solution in the tube body and judge its volume. Optionally, a volume scale is provided on the tube body, so as to judge the volume of the sample preservation solution in the tube body.

deformable part

Deformation includes, but is not limited to, elastic deformation and flexible deformation. Usually, elastic deformation is able to return to its original shape after the external force is removed. The flexible deformation can also return to its original state by itself after the tube body is restored to its upright position, especially in the case of retaining a sufficient volume of sample preservation solution; or, the flexible deformation can be restored to its original state with the help of external force or a reset auxiliary device.

The tube body is deformable in whole or in part. In one embodiment, one or more sections of the tubular body are deformable, such as the lower section, the middle section or the upper section of the tubular body ("upper" is defined as the top of the tube, and "lower" is defined as the bottom of the tube). In one embodiment, one or more pieces (eg 2 pieces, especially symmetrical 2 pieces) of the tube body are deformable, such as deformable windows on the tube body. In this embodiment, the deformable portion may be of any shape, such as circular, oval, square, rectangular, etc. or combinations thereof. In one embodiment, the base of the tube and the optional connected portion of the tube body are deformable. In this embodiment, the deformable portion may be of any shape, such as a sphere or part thereof (e.g., spherical cap, spherical band), an ellipsoid or part thereof (eg, ellipsoidal cap, ellipsoidal band), cube, cuboid, etc., or its combination.

The deformable parts are carefully designed, calculated and tested. When closing the airtight connection between the tube body and the adapter, opening the airtight connection between the cover body and the adapter body, and turning the tube body upside down, the single maximum allowable deformation of the deformable part (based on calculation or practical operation) is enough to cause N drops of the sample preservation solution with a set volume value or range are dripped from the drip outlet of the aptamer but not enough to cause N+1 drops of the sample preservation solution to drip from the drip outlet of the aptamer. Optionally, N is 1 to 10 drops, eg 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 drops. In one embodiment, the set volume value is about 1-100, 10-90, 20-80, 30-70 or 40-60 microliters, such as about 1, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 microliters, plus or minus 1, 2, 3, 4 or 5 microliters. In one embodiment, the set volume range is 1-25 microliters independently above and below the set volume value, such as about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 microliters. In one embodiment, the upper limit of the set volume range is about 1-25 microliters independently of one of the above-mentioned set volume values, such as about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 microliters. In one embodiment, the lower limit of the set volume range is about 1-25 microliters independently of one of the above set volume values, such as about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 microliters. In one embodiment, the maximum allowable deformation of the deformable portion results in a volume difference of about 1-600, 5-500, 10-400, 15-300, 20-200 or 25-100 microliters, for example about 1 ,10,20,30,40,50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250 ,260,270,280,290,300,310,320,330,340,350,360,370,380,390,400,410,420,430,440,450,460,470,480,490,500 , 510, 520, 530, 540, 550, 560, 570, 580, 590 or 600 microliters, plus or minus 1, 2, 3, 4 or 5 microliters.

Optionally, the outer wall of the deformable part is provided with an anti-slip structure, which may be any structure that can play an anti-slip function, such as straight lines, curved lines, or particles.

Aptamer

In one embodiment, the aptamer is in the form of a multilayer (eg, two, three or more layers) tower. The lower layer of the aptamer is airtightly connected with the tube body, the upper layer of the aptamer is airtightly connected with the cover body, and one or more intermediate layers connect the upper layer of the aptamer and the lower layer of the aptamer. Each layer of the aptamer can independently be a cylinder or a truncated cone.

The cross-section of the outer wall and/or inner wall of each layer of the aptamer can independently be in any shape, such as circular, oval, square, rectangular, etc., and circular is optional. In one embodiment, the cross-sectional shapes at different positions of the outer wall and/or inner wall of each layer of the aptamer are the same. In one embodiment, the cross-sectional shapes of different positions of the outer wall and/or inner wall of each layer of the aptamer are different. In one embodiment, the cross-sectional shapes of different positions of the outer wall and/or inner wall of each layer of the aptamer are the same but different in size, for example, they are all circular, with a big top and a small bottom, a small top and a big bottom, a small middle and two big ends, and a middle Large and small at both ends, etc.

In one embodiment, there is an adapter between two adjacent layers of the aptamer. Optionally, the inner wall of the connecting portion connected to the lower layer has a sealing skirt, which clamps the pipe body together with the lower layer wall.

Optionally, the outer wall of the aptamer (such as the upper layer and/or the second upper layer and/or the second upper layer, and so on) is provided with a non-slip structure, which can be linear stripes, curved stripes, particles, etc. structure for easy tightening or unscrewing of the adapter. In the embodiment where the aptamer has a multi-layered tower shape, optionally, the outer wall of the lower layer of the aptamer (ie the layer that is airtightly connected with the tube body) is provided with a non-slip structure.

The inner wall of the aptamer forms a liquid outlet channel. In one embodiment, the cross-sectional area of the outlet channel gradually increases from top to bottom. In one embodiment, the cross-sectional dimensions of the outlet channels of each layer are the same or have no significant change, for example, the difference between the largest diameter and the smallest diameter is no more than 25%, 20%, 15%, 10%, 9%, or less than the smallest diameter. 8%, 7%, 6%, 5%, 4%, 3%, 2% or 1%. In one embodiment, the cross-sectional area of the liquid outlet channel corresponding to the interface between the various layers of the aptamer gradually decreases upwards, so that a funnel effect is generated when the aptamer is inverted, which is beneficial to the collection of the sample preservation solution.

In one embodiment, the liquid outlet channel (especially the middle layer, if present) has a waist structure (such as a "tip-to-tip" double funnel-shaped channel) on the inner wall, which is used to buffer or weaken the rapid reversal. The impact of the sample preservation solution when the sample access tube or the deformable part of the tube body is squeezed hard to prevent the large-volume sample preservation solution from directly rushing out of the drip outlet. In one embodiment, the longitudinal section of the waist setting is triangular, rectangular or arc-shaped. This buffering effect can also be achieved by gradually or stepwise shrinking the outlet channel.

drip part

The tip of the aptamer is the drop outlet. The drip outlet is usually round. The part of the liquid outlet channel connected to the drip outlet is the drip channel (usually the upper layer of the aptamer, the joint part connected to it optionally, even the next layer, until the liquid outlet channel of the lower layer of the aptamer, or its connection part of the drip outlet). The other end of the drip channel is a drip inlet. The dripping outlet, the dripping channel and the dripping inlet constitute the dripping part. In other words, the dripping channel is the whole or part of the liquid outlet channel (that is, the part connected to the dripping outlet).

The drip outlet and/or the drip channel and/or the drip inlet have suitable internal diameters, which are independently arranged to: close the tight connection between the tube body and the adapter, open the tight connection between the lid and the adapter When the connection and the tube body are upside down, when there is no external force acting on the deformable part of the tube body, the sample preservation solution in the tube body will not be discharged from the drip outlet or even enter the drip channel; When the deformed part is deformed under the action of external force, the sample preservation liquid in the tube enters the dripping channel and drips out from the dripping outlet (drops with a set volume value or range can be optionally dropped).

In one embodiment, the drip outlet and/or the drip channel and/or the drip inlet independently have an 3.8, 3.7, 3.6, 3.5, 3.4, 3.3, 3.2, 3.1, 3.0, 2.9, 2.8, 2.7, 2.6, 2.5, 2.4, 2.3, 2.2, 2.1, 2.0, 1.9, 1.8, 1.7, 1.6, 1.5, 1.4, 1.3, 1.2, 1.1 or 1.0 mm, and/or, greater than or equal to 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 or 5.0 mm inner diameter, up and down Float 0.02, 0.02, 0.03, 0.04 or 0.05 mm. In one embodiment, the inner diameter of the drip inlet is smaller than the diameter of the swab shaft, eg 2.5 mm.

In one embodiment, the cross-sectional dimensions of the dripping channel are the same or have no significant change, for example, the difference between the largest diameter and the smallest diameter is no more than 25%, 20%, 15%, 10%, 9%, 8%, or less than the smallest diameter. 7%, 6%, 5%, 4%, 3%, 2% or 1%. In one embodiment, the drip channel gradually narrows upwards, and the difference between the largest diameter and the smallest diameter is no more than 25%, 20%, 25%, 10%, 9%, 8%, 7%, 6%, 5% of the smallest diameter. %, 4%, 3%, 2% or 1%.

In one embodiment, the cross-sectional shapes of different positions of the dripping channel are the same but different in size, for example, they are all circular, with a big top and a small bottom, a small top and a big bottom, a small middle and two big ends, a big middle and two small ends, etc. ( Take the top of the cover as "up" and the bottom of the tube as "down").

In one embodiment, the length of the drip channel is less than or equal to 50, 49, 48, 47, 46, 45, 44, 43, 42, 41, 40, 39, 38, 37, 36, 35, 34, 33, 32, 31, 30, 29, 28, 27, 26, 25, 24, 23, 22, 21, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2 or 1 mm, and/or, greater than or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 or 50 mm, up and down 0.1, 0.2, 0.3, 0.4 or 0.5 mm.

In one embodiment, the drip outlet produces about 1-100, 10-90, 20-80, 30-70, or 40-60 microliters, such as about 1, 10, 20, 30, 40, 50, 60, 70 , 80, 90 or 100 droplets of a set volume range, floating 1, 2, 3, 4 or 5 microliters up and down.

In one embodiment, the tip of the aptamer is pointed, flat or rounded/arc.

Cover

One end of the cover body is closed and the other end is open. The closed end is a cover top, the open end is a cover opening, and the cover body is between the cover top and the cover opening. In other words, the cover body includes a cover wall and a cover cavity surrounded by the cover wall.

The lid opening can be in any shape, such as circle, ellipse, square, rectangle, etc., and circle is optional. Cover top can be any shape, for example flat top (can be any shape, for example circle, ellipse, square, rectangle etc.), arc top (for example ball top), pointed top (for example cone top) etc. The body cross section can be any shape, such as circle, ellipse, square, rectangle etc., optional circle. In one embodiment, the cross-sectional shape of the body is the same at different locations. In one embodiment, the cross-sectional shape is different at different locations on the body. In one embodiment, the cross-sectional shapes of different positions of the cover body are the same but different in size, for example, they are all circular, the top is large and the bottom is small, the top is small and the bottom is large, the middle is small and the two ends are large, the middle is large and the two ends are small, and so on. In one embodiment, the cover body is segmented, wherein each segment independently has the characteristics described above. In one embodiment, the change in cross-section is gradual. In one embodiment, the change in cross-section is abrupt. In mutational embodiments, there is a junction between the two segments involved in the mutation.

In one embodiment, the cover is cylindrical, frustoconical or conical (for the upper layer) in shape. In one embodiment, the lid is hermetically attached to the upper layer of the aptamer. In one embodiment, the cap covers (completely or partially) the upper layer of the aptamer. In one embodiment, the cover has a flap which completely or partially covers the junction with the upper layer of the adapter. In one embodiment, the cover is a multi-layer (eg, two-layer) tower-like configuration, wherein each layer is independently a cylindrical, frustoconical, or conical (for the upper layer) configuration. In this embodiment, the upper layer of the cap is hermetically fitted to the upper layer of the aptamer. In this embodiment, the upper layer of the cover completely covers the upper layer of the aptamer, and the layers of the cover other than the upper layer in turn (completely or partially) cover the layers of the aptamer except the upper layer. These can avoid or reduce the operator's hand contact with the sample and avoid or reduce contamination. In any case, the top of the cap seals the adapter's drip outlet.

Optionally, the outer wall of the cover (for example, the upper layer and/or the second upper layer and/or the second upper layer, etc.) is provided with an anti-slip structure, which is convenient for screwing or unscrewing the cover. In the embodiment where the cover body has a multi-layer tower shape, optionally, the outer wall of the upper layer of the cover body and/or the second upper layer is provided with a non-slip structure. Optionally, the inner wall of the roof has sealing protrusions. Optionally, the outer wall of the sealing protrusion can be in sealing fit with the inner wall of the section where the dripping channel is connected to the dripping outlet.

closed connection

The airtight connection between the various components of the sample access tube of the present application (i.e., the tube body, the adapter body and the cover body) needs to be realized, that is, the airtight connection between the tube body and the adapter body and the connection between the cover body and the adapter body. closed connection.

Connections can be reversible (ie, can be opened and closed repeatedly) or irreversible (ie, cannot be opened and closed repeatedly). In one embodiment, the connection between the tube body and the adapter is irreversible, ie it cannot be opened again after being closed. The advantage is to avoid sample contamination caused by related misoperations. This requires tubes and adapters to be provided separately when storing samples. In one embodiment, the connection between the lid and the aptamer is reversible, ie it can be opened and closed repeatedly. The advantage is that it is convenient to review samples.

Various connection methods in the related art may be used, such as slots, buckles, threads, and the like. Optionally, the connection method is threaded connection (screwed connection for short). In the case that both the connection between the pipe body and the fitting body and the connection between the cap body and the fitting body are threaded, the directions of the two sets of threads can be the same or opposite. On the other hand, the numbers of two sets of threads can be the same or different, for example, the number of threads between the pipe body and the adapter body is more or less. Optionally, the number of threads between the cover body and the fitting body is less than the number of threads between the tube body and the fitting body. On the other hand, the densities of the two sets of threads can be the same or different, for example, the thread density between the pipe body and the adapter body is greater or lesser. Optionally, the thread density between the cover body and the fitting body is smaller than the thread density between the pipe body and the fitting body. This can avoid or reduce the risk of related mishandling to open the tight connection between the tube body and the adapter body. Alternatively, the opening resistance of the connection between the cap body and the adapter body is lower than that between the tube body and the adapter body. For example, connection opening resistance can be set by carefully setting the gap between the contact surfaces and the thickness of the thread, as well as by using specific materials. Alternatively, the screw connection between the tube body and the adapter body may adopt child safety threads, such as pressing down the rotating thread, pressing the rotating thread or aligning the rotating thread. To ensure a tight seal, screw connections can be combined with gaskets or rings.

When the tube body is airtightly connected with the adapter body, the adapter body covers the upper opening of the tube body (that is, the nozzle). At this time, the inner cavity of the tube body communicates with the liquid outlet channel of the aptamer, and the sample preservation liquid in the inner cavity of the tube can and can only flow out through the liquid outlet channel of the aptamer.

When the cover body is airtightly connected with the adapter body, the cover body covers the upper end opening (that is, the drop outlet) of the adapter body. At this time, the drip outlet of the aptamer is sealed, and the sample preservation solution in the liquid outlet channel of the aptamer and/or the inner cavity of the tube body cannot flow out through the drip outlet of the aptamer.

Accessory elements/structures

In addition to the basic tube body, adapter body and cover body, the sample access tube of the present application may also have auxiliary elements/structures for realizing auxiliary functions.

In one embodiment, the sample access tube of the present application has a blocking protrusion or a blocking net, which is used to block the swab head and/or swab rod from entering and blocking the downstream liquid outlet channel and/or drip outlet when the tube body is inverted . The arresting protrusion or arresting net can be located at any position of the liquid outlet channel, including the inlet and outlet of the liquid outlet channel (ie, the drip outlet). In one embodiment, the liquid outlet channel (including the drip outlet) has one or more (for example, 4, 6 or 8) blocking protrusions arranged on the inner wall. The arresting protrusions can be evenly distributed along the circumference and arranged in a cross shape or a rice font. The size and arrangement of the arresting protrusions are such that the swab head and/or the swab shaft cannot pass through the gaps between the respective arresting protrusions.

In one embodiment, the sample access tube of the present application has a transverse skirt (ie, extends outward from the body in a horizontal or approximately horizontal direction). Typically, transverse skirts can be provided on various parts of the tubular body or adapter body. The horizontal skirt can be used to realize the suspension of the sample access tube on the tube rack.

In one embodiment, the sample access tube of the present application has a vertical skirt (ie, extends downward from the body in a vertical or near-vertical direction). Vertical skirts are usually provided on the pipe body, especially around the bottom of the pipe. The vertical skirt can be used to realize the standing of the sample access tube on the table.

In one embodiment, the sample access tube of the present application has a sealing gasket (for example, for the cover, for example, for strengthening the seal of the cover to the adapter), a sealing protrusion (for example, for the cover, for example, for strengthening cover to the fitting body), sealing ring (such as for the fitting body, such as for strengthening the sealing of the fitting body to the Ligand to the sealing of the tube body), used to realize or enhance the airtight connection between the cover body and the adapter and/or the airtight connection between the tube body and the adapter and/or the sealing during the above-mentioned airtight connection (for example Seal to drip outlet).

In one embodiment, there is a connecting band between the tube body and the adapter of the sample access tube of the present application, which is used to prevent the adapter (optionally together with cover) onto the table or floor, reducing the risk of contamination. Similarly, there may be a connecting band between the cover and the adapter of the sample access tube of the present application, which is used to prevent the cover from falling off the desktop or the ground when the airtight connection between the cover and the adapter is opened, thereby Reduce the risk of contamination. Similarly, there may be a connecting band between the cover and the tube of the sample access tube of the present application, which is used to prevent the cover from falling on the desktop or the ground when the airtight connection between the cover and the adapter is opened, thereby reducing the pollution risk.

In one embodiment, the sample access tube of the present application has a wiper protrusion. In one embodiment, the inner wall of the tube body has multiple (for example 4, 6, 8 or 12) centripetal protrusions evenly distributed along the circumference, or there are multiple (for example 4, 12) uniformly distributed at the bottom of the tube 6, 8 or 12) protrude upwards, and the swab head rubs against the protrusions when moving up and down at this position, which is beneficial for the body fluid attached to the swab head to mix with the sample preservation solution. In one embodiment, the swab head may not be stored.

In one embodiment, the sample access tube of the present application has a volume adjustment member, which is used to adjust the volume of the inner cavity of the sample access tube, which helps to realize the formation and detachment of droplets at the drip outlet. Optionally, the adjustment is stepwise, eg linear or non-linear. For example, isometric bellows-like structures can be used to achieve linear stepwise regulation. As another example, expanding concentric circular bellows-like structures can be used to realize nonlinear step-by-step regulation. The volume adjusting member can be arranged on the bottom of the tube or on the wall of the tube. In one embodiment, the volume adjustment means provides greater than or equal to 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 60% of the set volume value or range median value of the droplet , 70%, 80%, 90% or 100% and/or less than or equal to 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 25%, 20%, 15%, 10% or 5% volume adjustment capability.

In one embodiment, the sample access tube of the present application has a non-slip structure. The anti-slip structure can be provided on various parts of the sample access tube, namely the cover and/or the adapter and/or the tube, or parts thereof, such as the middle or upper section of the tube, the lower layer of the adapter, and the upper layer of the cover Or the next upper layer, such as the deformable part of the pipe body. The anti-skid structure can be any structure that can play a role in anti-skid, such as straight stripes, curved stripes, and particles.

Materials and Processes

Unless otherwise specified, the sample access tubes of the present application and their individual elements (ie, the tube body (except the deformable portion), the adapter body and the cap body, and various parts thereof) are made of rigid materials.

The tube body of the sample access tube of the present application has a deformable (including but not limited to elastic deformation and flexible deformation) part. Deformation may be achieved through deformable materials and/or structures.

The sample access tube of the present application and its various elements (i.e., the tube body, the adapter body and the cover body, and their various parts) can be made of any suitable material in the related art, especially medical plastics, such as polyethylene ( PE, including low-density polyethylene and high-density polyethylene), polypropylene (PP), polypropylene (PPE), polybutene, acrylonitrile butadiene styrene copolymer (ABS), styrene acrylonitrile, etc., and A modified material of the aforementioned material. The various components of the sample access tube (ie, the tube body, the adapter, and the cap, and parts thereof) can be made of the same material or different materials. Typically, the pipe body (or parts thereof, independently of each other) can be made of low density polyethylene (LDPE), linear low density polyethylene (LLDPE), high density polyethylene (HDPE), 2,2,2,2-tetraphenylene Made of ethylene (TPE), etc. or a combination thereof. In general, aptamers (or parts thereof, independently of each other) may be made of, or may be coated with, a hydrophobic material, such as a fluoropolymer such as polytetrafluoroethylene. Generally, the cover body (or parts thereof, independently of each other) can be made of high-density polyethylene (HDPE), polypropylene (PP), acrylonitrile-butadiene-styrene copolymer (ABS), polyethylene (PE), etc. or its composition. In one embodiment, the cover is made of polypropylene (PP). In one embodiment, the aptamer is made of polypropylene (PP). In one embodiment, the tube body is made of thermoplastic elastomer (TPE). In one embodiment, the deformable portion of the tube body is made of thermoplastic elastomer (TPE).

The sample access tube of the present application and its various components (i.e., the tube body, the adapter body and the cover body, and their various parts) can be formed by any molding method in the related art, including but not limited to injection molding, blow molding or its combination.

Optionally, the tube body, the adapter body and the cap body are sterilized and sterilized separately, or sterilized after being assembled.

How to use the sample access tube

In another aspect, the present application provides a method for using the sample access tube of the present application (such as a drip type) (such as accessing a swab sample), which includes one or more of the following steps:

(1) Preparation: close the airtight connection between the lid and the adapter, and distribute a predetermined volume (for example, 1-10 milliliters, such as 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 ml) of sample storage buffer, close the airtight connection between the tube body and the aptamer (together with the cap);

(2) Sample storage: Without opening the airtight connection between the cover and the adapter, open the airtight connection between the tube and the adapter (together with the cover), and rub the subject repeatedly with the swab head. The nasopharyngeal swab obtained from the nasopharynx of the tester is inserted into the tube body, the swab shaft is broken off, and the swab head and an optional part of the swab shaft fall into the tube body, and the whole or part is immersed in the sample preservation buffer; optionally , repeating the sample storage step, so that one sample access tube preserves multiple (for example 1-10, for example 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10) swab samples; After the sample is over, restore the airtight connection between the tubing and the adapter (together with the cap); and

(3) Sampling: without opening the airtight connection between the adapter body and the tube body, open the airtight connection between the cover body and the adapter body (together with the tube body), and collect samples in the sample collection container (such as corresponding to the sample) Eppendorf tube or ELISA plate well) above the inverted (vertical or inclined, such as relative to horizontal or vertical inclined about 30, 40, 45, 50 or 60 degrees) sample access tube, squeeze the deformable part of the tube body to make it happen. Deformation (at which point the sample preservation solution within the tube exits as a droplet and falls into the sample collection container or its compartments) (optionally, in the sample collection container, one compartment acquires one drop and one sample occupies one compartment; Or, get one drop from one compartment, and one sample replicate occupies multiple compartments; or get multiple drops from one compartment, and one sample occupies a single compartment; or, get multiple drops from one compartment, and one sample replicates alone, Occupy multiple compartments; or, take multiple drops from one compartment, and multiple samples share one compartment, one drop per sample; or, take multiple drops from one compartment, and multiple samples share one compartment, one sample Multiple drops; or, multiple drops from one compartment, multiple samples occupying multiple compartments, one drop per sample; or, multiple drops from one compartment, multiple samples occupying multiple compartments, one multiple drops of sample); after the sampling is finished, restore the airtight connection between the cap and the adapter (together with the tube). In one embodiment, one drop is about 15-20 microliters. In one embodiment, three drops are harvested per compartment. In one embodiment, three compartments are replicated per sample.

Example

As shown in Figures 1-9, the following describes embodiments of the present application in detail, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals represent the same or similar elements or have the same or similar functions element. The embodiments described below by referring to the figures are exemplary, and are only for explaining the present application, and should not be construed as limiting the present application.

Example 1

This embodiment depicts an example of a sample access tube. As shown in FIG. 2 , this embodiment provides a sample access tube, which includes a tube body 1 , an adapter body 2 and a cover body 3 .

The tube body 1 is a cylindrical tubular structure with one end closed and one end open. The pipe body 1 includes a pipe body lower section 11 , a pipe body middle section 13 and a pipe body upper section 12 . The lower section 11 of the pipe body is a bottom cover and a hollow cylinder. The middle section 13 of the pipe body is a hollow cylinder made of elastic material capable of elastic deformation. The upper section 12 of the pipe body is a hollow cylinder with threads on the outer wall, which is used for airtight screw connection with the lower section 21 of the adapter body. There is a horizontal skirt 14 at the bottom of the upper section 12 of the pipe body.

Aptamer 2 is a hollow three-layer tower structure. The aptamer 2 includes an aptamer lower section 21 , an aptamer middle section 23 and an aptamer upper section 22 . The lower section 21 of the adapter body is a hollow cylinder with threads on the inner wall, and is used for airtight screw connection with the upper section 12 of the pipe body. The outer wall of the lower section 21 of the aptamer has non-slip vertical lines. The upper section 22 of the adapter body is a hollow cylinder with threads on the outer wall for airtight screw connection with the main body 31 of the cover body. The aptamer middle section 23 connects the aptamer lower section 21 and the aptamer upper section 22 . There is a connecting portion 24 between the lower section 21 of the aptamer and the middle section 23 of the aptamer. There is a connecting portion 25 between the upper section 22 of the adapter body and the middle section 23 of the adapter body.

The cover body 3 is a two-layer tower structure with one end closed and one end open. The cover body 3 includes a cover body body 31 and a cover body lower section 33 . The cover main body 31 is a capped, hollow cylinder with threads on the inner wall for airtight screw connection with the upper section 22 of the adapter body. The cover body 31 has a cap 32 . The lower section 33 of the cover body is a hollow cylinder for contacting the middle section 23 of the adapter body. There are non-slip vertical lines on the outer wall of the lower section 33 of the cover body. There is an engaging portion 34 between the cover main body 31 and the cover lower section 33 .

All components are of rigid material unless otherwise specified.

When the adapter body 2 is tightly screwed with the pipe body 1 , the adapter body 2 (partially) covers the top opening of the pipe body 1 . Specifically, when the lower part 21 of the fitting body is tightly screwed with the upper part 12 of the tubular body, the connecting part 24 between the lower part 21 of the fitting body and the middle part 23 of the fitting body covers (partially) the top opening of the upper part 12 of the tubular body. At this time, the inner cavity of the tube body 1 communicates with the outlet channel of the aptamer 2, and the solution in the inner cavity of the tube can only flow out through the outlet channel of the aptamer.

When the cover body 3 and the adapter body 2 are airtightly screwed, the cover body 3 (completely) covers the top opening of the adapter body 2 . Specifically, when the cover body 31 is airtightly screwed to the upper part of the fitting body 22 , the capping 32 of the cover body 31 (completely) covers the top opening of the upper part of the fitting body 22 . At this time, the top opening of the aptamer liquid outlet channel is sealed, and the solution in the aptamer liquid outlet channel and/or the inner cavity of the tube cannot flow out through the top opening of the upper section 22 of the aptamer.

As mentioned above, the middle section 13 of the pipe body is made of elastic material and can be elastically deformed. When the aptamer 2 is airtightly screwed with the tube body 1 and turned upside down, the deformation of the middle section 13 of the tube body causes the solution in the tube body to be discharged through the top opening of the upper section 22 of the aptamer.

Example 2

This example describes the use of the sample access tube.

(1) Preparation before depositing samples

Prepare sample preservation buffer and sterilize.

Prepare sample access tubes and sterilize.

Close the airtight screw connection between the cover body 3 and the adapter body 2, dispense 3mL of sample storage buffer into the tube body 1, and close the airtight screw connection between the tube body 1 and the aptamer 2 (together with the cover body 3) .

(2) Saving samples

Nasopharyngeal swabs were obtained by repeatedly rubbing the subject's nasopharynx with the swab head of a sterilized flocked swab.

Without opening the airtight screw connection between the cover body 3 and the adapter body 2, open the airtight screw connection between the tube body 1 and the adapter body 2 (together with the cover body 3), and insert the nasopharyngeal swab into the tube. Body 1, break off the swab rod so that the swab head and the connected part of the swab rod fall into the tube body 1.

After the sample is stored, the airtight screw connection between the tube body 1 and the adapter body 2 (together with the cover body 3) is restored.

(3) Sampling

Without opening the airtight screw connection between the tube body 1 and the adapter body 2, open the airtight screw connection between the cover body 3 and the adapter body 2 (together with the tube body 1), on the ELISA plate corresponding to the sample Invert the sample access tube directly above the hole, and squeeze the middle section 13 of the tube body to deform it. At this time, three drops (about 50 microliters) of the sample access solution in the sample access tube drop from the top opening of the aptamer 2 and fall into the corresponding wells of the ELISA plate.

After the sampling is finished, the airtight screw connection between the cover body 3 and the adapter body 2 (together with the tube body 1 ) is restored.

Example 3

This embodiment depicts an example of a sample access tube. The aptamer is shown in Figure 7. The tube body is shown in Figure 8A.

With the tube upside down (50° or 90° relative to the horizontal), squeeze the deformable part of the tube so that three consecutive drops of the sample preservation solution fall into the container, measure the total mass of the three drops, and calculate the average volume. The results are shown in Table 1.

Table 1

Example 4

This embodiment depicts an example of a sample access tube. The tube, adapter and cap are shown in Figures 8A, 8B and 8C, respectively.

With the tube upside down (50 degrees relative to the horizontal), squeeze the deformable part of the tube so that three consecutive drops fall into the container, measure the total mass of the three drops, and calculate the average volume of each drop. The results are shown in Table 2.

Table 2

serial number	Total mass (g)	Average volume (μL)
1	0.1276	42.533
2	0.1305	43.500
3	0.1361	45.367
4	0.1141	38.033
5	0.1347	44.900
6	0.1458	48.600
7	0.1480	49.333
8	0.1426	47.533
9	0.1531	51.033
10	0.1470	49.000
11	0.1521	50.700
12	0.1431	47.700

With the tube upside down (50 degrees relative to the horizontal), squeeze the deformable part of the tube so that a drop of liquid falls into the container, repeat the squeeze three times, measure the total mass of the three drops, and calculate the average volume of each drop. The results are shown in Table 3.

table 3

serial number	Total mass (g)	Average volume (μL)
1	0.1729	57.633
2	0.1840	61.333
3	0.1785	59.500
4	0.1830	61.000
5	0.1865	62.167
6	0.1795	59.833
7	0.1815	60.500
8	0.1845	61.500
9	0.1832	61.067
10	0.1844	61.467

Example 5

This embodiment depicts two examples of sample access tubes. The tube, adapter and cap are substantially as shown in Figures 8A, 8B and 8C, respectively. Only the inner diameter of the drip inlet is 2.44mm or 2.36mm (the measurement method is shown in Figure 9).

With the tube upside down (50 degrees relative to the horizontal), squeeze the deformable part of the tube so that three consecutive drops fall into the container, measure the total mass of the three drops, and calculate the average volume of each drop. The results are shown in Table 4.

Table 4

Neither the 2.42mm nasal swab nor the 2.53mm pharyngeal swab affected the drip at 2.36mm or 2.44mm pore size.

Claims (10)

1. A sample access tube, comprising a tube body, an adapter body and a cover body, the tube body and the adapter body can be airtightly connected, the cover body and the adapter body can be airtightly connected, the tube body has a deformable part and the adapter body has a drip liquid part.
2. The sample access tube according to claim 1, wherein when the airtight connection between the tube body and the adapter is closed, the airtight connection between the cover body and the adapter is opened, and the tube body is inverted, when there is no When external force acts on the deformable part of the tube body, the sample preservation solution in the tube body will not be discharged from the drip outlet of the adapter; when the deformable part of the tube body is deformed under the action of external force, the sample preservation solution in the tube body will The liquid drips out from the drip outlet of the aptamer.
3. The sample access tube according to claim 1 or 2, wherein a single maximum allowable deformation of the deformable portion of the tube body is sufficient to cause N drops of the sample preservation solution to drip out from the drip outlet of the adapter but not enough to cause N +1 drop of sample preservation solution is dripped out from the drop outlet of the aptamer, preferably, N is an integer from 1 to 10, such as 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10.
4. The sample access tube according to any one of claims 1-3, wherein the sample storage liquid in the tube body drips from the drip outlet of the aptamer with a volume of about 1-100, 10-90, 20-80, 30-70 or 40-60 microliters, eg about 1, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 microliters, ±1, 2, 3, 4 or 5 microliter.
5. The sample access tube according to any one of claims 1-4, wherein the inner diameter of the drip outlet, the drip channel and/or the drip inlet of the drip portion is less than about 5.0, 4.9, 4.8, 4.7, 4.6, 4.5, 4.4, 4.3, 4.2, 4.1, 4.0, 3.9, 3.8, 3.7, 3.6, 3.5, 3.4, 3.3, 3.2, 3.1, 3.0, 2.9, 2.8, 2.7, 2.6, 2.5, 2.4, 2.3, 2.2, 2.1, 2.0, 1.9, 1.8, 1.7, 1.6, 1.5, 1.4, 1.3, 1.2, 1.1 or 1.0 mm, ±0.01, 0.02, 0.03, 0.04 or 0.05 mm.
6. The sample access tube according to any one of claims 1-5, wherein the length of the drip channel of the drip part is greater than about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 or 50 mm, ±0.1, 0.2, 0.3, 0.4 or 0.5 mm.
7. The sample access tube of any one of claims 1-6, wherein a single maximum allowable deformation of the deformable portion results in about 1-600, 5-500, 10-400, 15-300, 20-200 or 25-100 microliters, such as about 1, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 410, 420, 430, 440, 450, 460, 470, 480, 490, 500, 510, 520, 530, 540, 550, 560, 570, 580, 590, or 600 µl, ±1, 2, 3, 4, or 5 µl tube volume difference.
8. The sample access tube according to any one of claims 1-7, wherein the airtight connection between the tube body and the adapter and the airtight connection between the cover and the adapter are threaded connections, optionally ,

   (1) two sets of threads are in the same direction, or, two sets of threads are in the same direction and opposite; and/or

   (2) The number of threads between the body and the adapter is greater than the number of threads between the cap and the adapter; and/or

   (3) The thread density between the pipe body and the adapter body is greater than the thread density between the cover body and the adapter body; and/or

   (4) The thread twist resistance between the tube body and the adapter body is greater than the thread twist resistance between the cover body and the adapter body; and/or

   (5) The thread between the pipe body and the adapter body is a safety thread.
9. The sample access tube according to any one of claims 1-8, further comprising

   (1) hanging skirts; and/or

   (2) standing skirts; and/or

   (3) Gaskets; and/or

   (4) seal thrusts; and/or

   (5) sealing ring; and/or

   (6) sealing skirt; and/or

   (7) arresting protrusions; and/or

   (8) wipe protrusions; and/or

   (9) connecting straps; and/or

   (10) Anti-slip structure.
10. The sample access tube according to any one of claims 1-9, wherein it has the following characteristics:

    (1) Capable of holding 1-10 swab heads and optionally partial or entire swab shafts; and/or

    (2) having a tube inside diameter of about 0.5-3.0 centimeters; and/or

    (3) have a tube body height of about 3-15 cm; and/or

    (4) have a tube volume of about 1-50 milliliters; and/or

    (5) The airtight connection between the tube body and the adapter cannot be opened after being closed; and/or

    (6) The airtight connection between the lid and the adapter can be opened and closed repeatedly; and/or

    (7) Part or whole of the tube body is transparent or translucent.

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