CN114574337A - Sampling swab with sample quality control function - Google Patents

Sampling swab with sample quality control function Download PDF

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CN114574337A
CN114574337A CN202210305994.2A CN202210305994A CN114574337A CN 114574337 A CN114574337 A CN 114574337A CN 202210305994 A CN202210305994 A CN 202210305994A CN 114574337 A CN114574337 A CN 114574337A
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detection
sampling
quality control
swab
sample
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李东
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Chengdu Maya Lightyear Technology Co ltd
Wuxi Boao Maya Medical Technology Co ltd
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Wuxi Boao Maya Medical Technology Co ltd
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    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12MAPPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M33/00Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus
    • C12M33/02Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus by impregnation, e.g. using swabs or loops
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • A61B10/0051Devices for taking samples of body liquids for taking saliva or sputum samples
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12MAPPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M41/00Means for regulation, monitoring, measurement or control, e.g. flow regulation
    • C12M41/30Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration
    • C12M41/36Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration of biomass, e.g. colony counters or by turbidity measurements
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements

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Abstract

The embodiment of the invention discloses a sampling swab with a sample quality control function, relates to the field of medical inspection, and can be used for collecting respiratory tract samples and simultaneously controlling the quality of the samples. The invention comprises the following steps: the sampling device comprises a main body rod (1), a sampling head (2) and a detection area (3), wherein the sampling head (2) is fixedly arranged at one end of the main body rod (1), and the detection area (3) is arranged on the rod body of the main body rod (1) and is arranged at a position close to the sampling head (2); the detection zone (3) comprises at least: the liquid suction device (3-1), the detection channel (3-2) and the air guide hole (3-3), wherein the outer surface of the detection channel (3-2) is provided with an observation window (3-4); one end of the detection channel (3-2) is provided with a liquid suction device (3-1), the other end of the detection channel (3-2) is provided with an air vent (3-3), and a detection test strip (3-5) is placed in the detection channel (3-2). Substances for reacting with protein components in cells and developing color are added in the detection test paper strips (3-5).

Description

Sampling swab with sample quality control function
Technical Field
The invention relates to the field of medical inspection, in particular to a sampling swab with a sample quality control function.
Background
With the frequent sampling of large-scale nucleic acid, the current pharyngeal swab for sampling also exposes a plurality of defects, wherein one of the more fatal defects is the problem of easy false negative. Especially for the sampling work of the centralized isolation points, once the problem of false negative occurs, asymptomatic infectors are easily missed to cause epidemic prevention loopholes.
The main causes of the above problems are: lie in the present pharynx swab that is used for the nucleic acid sampling, need put into sample preservation liquid with the sample can be unified after the sampling and dilute, wait to transport sample liquid to possess certain operating device and operational environment's check point after, carry out subsequent detection again. However, if the throat swab is not stained with the sample or is not stained with enough sample due to misoperation or other reasons during sampling, the diluted sample solution cannot obtain an accurate detection result, and thus a false positive problem is caused.
Therefore, the nucleic acid sampling process has some defects, especially the on-site quality control link after sampling is lacked, and the quality of the collected sample cannot be determined on the sampling site. Therefore, how to solve the quality control problem of field sampling becomes a direction that needs to be further improved.
Disclosure of Invention
The embodiment of the invention provides a sampling swab with a sample quality control function, which can be used for collecting respiratory tract samples and simultaneously controlling the quality of the samples.
In order to achieve the above purpose, the embodiment of the invention adopts the following technical scheme:
a sampling swab with a sample quality control function comprises the following components: the sampling device comprises a main body rod (1), a sampling head (2) and a detection area (3), wherein the sampling head (2) is fixedly arranged at one end of the main body rod (1), and the detection area (3) is arranged on the rod body of the main body rod (1) and is arranged at a position close to the sampling head (2); the detection zone (3) comprises at least: the liquid suction device (3-1), the detection channel (3-2) and the air guide hole (3-3), wherein the outer surface of the detection channel (3-2) is provided with an observation window (3-4); one end of the detection channel (3-2) is provided with a liquid suction device (3-1), the other end of the detection channel (3-2) is provided with an air vent (3-3), and a detection test strip (3-5) is placed in the detection channel (3-2). Substances for reacting with protein components in cells and developing color are added in the detection test paper strips (3-5).
And, a detection method applied to the sampling swab having the sample quality control function, comprising: after sample collection, putting the used sampling swab into a sample preservation solution for mixing, wherein the liquid level of the sample preservation solution cannot exceed a preset horizontal line during mixing, and the preset horizontal line is lower than a liquid absorption device (3-1); after the uniform mixing, immersing a liquid absorbing device (3-1) into the preset horizontal line so that the liquid absorbing device (3-1) can absorb the uniformly mixed sample preservation liquid, wherein the time for immersing the liquid absorbing device (3-1) into the preset horizontal line is not less than 2 seconds; and displaying the color development condition of the test strip (3-5) through the observation window (3-4).
The embodiment provides a pharyngeal swab with a quality control function, which can detect the main components of a sample immediately after sampling and can qualitatively or quantitatively control the sample collection effect. Meanwhile, the embodiment also considers the universality of the product, namely the throat swab which is directly detected after sampling can be assembled by being assembled with the existing commercial test strip. Besides the quality control function on the throat swab, the test strip for detection can be further added in the independent detection unit, namely, the quality control after sample collection can be completed on one throat swab, the detection can be further and directly completed, and the detection is more convenient and faster. In general, the present embodiment can collect the respiratory tract sample and perform quality control on the sample, and then perform sample inspection.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without creative efforts.
Fig. 1, 2, 5, 6 and 9 are schematic views of possible general structures provided by the embodiment of the invention;
fig. 3 and 4 are schematic diagrams of possible specific structures provided by an embodiment of the present invention;
FIG. 7 is a schematic diagram of an embodiment of a joint according to the present invention;
FIG. 8 is a schematic view of the fluid level in an operational mode provided by an embodiment of the present invention;
fig. 10 is a partially enlarged structural diagram according to an embodiment of the present invention.
Detailed Description
In order to make the technical solutions of the present invention better understood, the present invention is further described in detail with reference to the accompanying drawings and the detailed description below. Reference will now be made in detail to the embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are illustrative only for the purpose of explaining the present invention, and are not to be construed as limiting the present invention. As used herein, the singular forms "a", "an", "the" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. It will be understood that when an element is referred to as being "connected" or "coupled" to another element, it can be directly connected or coupled to the other element or intervening elements may also be present. Further, "connected" or "coupled" as used herein may include wirelessly connected or coupled. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items. It will be understood by those skilled in the art that, unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the prior art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
An embodiment of the present invention provides a sampling swab with a sample quality control function, as shown in fig. 1, the sampling swab at least includes: the device comprises a main body rod (1), a sampling head (2) and a detection area (3), wherein the sampling head (2) is fixedly arranged at one end of the main body rod (1), and the detection area (3) is arranged on the rod body of the main body rod (1) and is close to the sampling head (2) in the installation position. Wherein, as shown in fig. 1, the detection area (3) and the sampling swab itself may be of one-piece construction.
As shown in fig. 2-4, the detection zone (3) comprises at least the following components: the liquid suction device (3-1), the detection channel (3-2) and the air guide hole (3-3), and the outer surface of the detection channel (3-2) is provided with an observation window (3-4). One end of the detection channel (3-2) is provided with a liquid suction device (3-1), the other end of the detection channel (3-2) is provided with an air vent (3-3), and a detection test strip (3-5) is placed in the detection channel (3-2).
Substances for reacting with protein components in cells and developing color are added in the detection test paper strips (3-5). For example: substances which can be detected, including biomacromolecule or inorganic salt solution, such as metal ions, protein, fat, nucleic acid and the like, are added to the detection test strip (3-5) in the detection area (3), the substances for detecting protein can be ninhydrin, silver nitrate, Coomassie brilliant blue, bromophenol blue, iodine, potassium permanganate, copper sulfate and the like which directly react with protein in color, and a colloidal gold technology can also be adopted to specifically detect a certain antigen or antibody for color development.
Alternatively, an embedded structure as shown in fig. 5 may be adopted in this embodiment, where the detection region (3) is an independent detection unit, an embedded groove (1-1) is processed on the main body rod (1), and the independent detection unit is embedded and installed in the embedded groove (1-1) and fixed.
As a further alternative, a split configuration may be used, as shown in FIG. 6, in which the detection zone (3) may be used in conjunction with a conventional pharyngeal swab product. The detection area (3) is an independent detection unit. The main body rod (1) and the sampling head (2) are integrated into a conventional throat swab, and the independent detection unit is adhered to the body of the main body rod (1) and is close to the position of the sampling head (2) through medical waterproof glue.
In general, the present embodiment can be expressed in at least 3 product forms in practical application: the part for quality control detection positioned on the pharyngeal swab can be integrated with the pharyngeal swab body, as shown in figures 1-4; or the middle lower part of the pharynx swab is provided with a groove, and the groove and the detection unit form an embedded structure, as shown in figure 5; the quality control detection unit can also be an independent structure, and can be directly connected with a commercial pharyngeal swab for use at present, as shown in fig. 9. In practical application, if the throat swab is designed in such a way that the part for quality control detection on the throat swab is integrated with the throat swab body, the main rod (1) can be a hollow tube; alternatively, the main body rod (1) is designed to be hollow only at the detection area (3) so as to form a detection channel (3-2), and the rest of the hand-held part can be a solid rod; if the design that the quality control detection part and the pharynx swab are separable is adopted, for example, the detection unit forms an embedded structure, or the quality control detection unit is an independent structure, the main body rod (1) can be a solid rod.
The embodiment provides a throat swab with quality control detection function, which can detect whether a sample is collected or not after the sample is collected, or detect the concentration of the sample, and can be assembled with an existing test strip to form the throat swab which can collect the sample firstly and then directly detect the sample.
In a preferred embodiment of the present embodiment, the size of the area of the observation window (3-4) is 1mm2~1000mm2(ii) a And the observation window (3-4) is covered by waterproof transparent material.
The liquid suction device (3-1) is a liquid suction hole formed on the detection channel (3-2); or the liquid absorption device (3-1) is made of liquid absorption paper, wherein one end of the liquid absorption paper is fixed in the detection channel (3-2), and the other end of the liquid absorption paper is exposed out of the detection channel (3-2).
The area of the air guide hole (3-3) is 0.01mm2~10mm2(ii) a And/or if the liquid suction device (3-1) is a liquid suction hole formed in the detection channel (3-2), the area size of the liquid suction hole is 0.01mm2~10mm2. Specifically, the liquid suction holes and the air guide holes can be round, square and the like, and the area size is 0.01mm2~10mm2The liquid absorbing hole can be a hole or a section of liquid absorbing paper which is exposed, the appearance of the observation window can be round, square and the like, and the area size is 1mm2~1000mm2
Further, as shown in fig. 4, the detection channel (3-2) is an internal cavity structure, the internal cavity structure is a cuboid or a cylinder, and the length of the internal cavity structure is 3mm to 50 mm. Wherein a water absorbent material is disposed in the internal cavity structure. The inner cavity can guide liquid from the liquid suction hole to the detection area, and the liquid can be guided to the detection area by the siphon suction force through the hollow channel; or water absorbent material such as absorbent paper, absorbent resin, absorbent sponge, etc. can be placed in the cavity
Further, the main body rod (1) is connected with the sampling head (2) through a connecting part (4); the connecting part (4) is made of materials, and when the main body rod (1) is held and pressure is applied to the sampling head (2), the connecting part (4) is compressed and deformed.
Alternatively, as shown in fig. 7, the elastic net-shaped compressible structure connecting part (4) adopts an elastic net-shaped structure; when the main body rod (1) is held and pressure is applied to the sampling head (2), the connecting part (4) is compressed and deformed; the length of the compressible structure of the net structure is 3-30 mm. For example: after the samples are mixed, the net-shaped structure can be deformed by pressing with a certain downward pressure, the detection unit moves downwards, and liquid to be detected is absorbed into the detection unit through the liquid absorption hole at the lower end, wherein the length of the net-shaped compressible structure is 3-30 mm.
The present embodiment further provides a method for detecting a sampling swab with a sample quality control function, including:
after sample collection, putting the used sampling swab into a sample preservation solution for mixing, wherein the liquid level of the sample preservation solution cannot exceed a preset horizontal line during mixing, and the preset horizontal line is lower than a liquid absorption device (3-1); after the uniform mixing, immersing a liquid absorbing device (3-1) into the preset horizontal line so that the liquid absorbing device (3-1) can absorb the uniformly mixed sample preservation liquid, wherein the time for immersing the liquid absorbing device (3-1) into the preset horizontal line is not less than 2 seconds; and displaying the color development condition of the test strip (3-5) through the observation window (3-4). For example: as shown in fig. 8, in actual practice, after a sample is collected from a site such as the oral cavity by using a pharyngeal swab, the pharyngeal swab is put into a sample storage tube and mixed, and when mixing, the liquid level of the sample storage liquid in the above-mentioned figure is ensured not to exceed a preset horizontal line a (as shown in fig. 7) so as not to enter a liquid suction hole without being uniformly mixed with the sample;
after the mixture is uniformly mixed, the liquid suction device (3-1) is kept for about 2 seconds under the liquid level, after the liquid suction hole sucks in the sample mixed liquid, the liquid rises to the detection area along with the siphon principle or the stretching of a fiber membrane, the detection area is pre-added with a substance capable of reacting with protein components in cells to develop color, and the detection area is a transparent observation window so that the detection result can be seen. If the color can be developed, the cells are effectively collected in the sampling process, and if the color is not developed, the collection is invalid and needs to be collected again.
Further optionally, in this embodiment, as shown in fig. 10, various different test strips can be placed in a channel inside the detection unit, the width of a commercially available test strip that can be accommodated is 1-5 mm, and the length of the commercially available test strip is 10-50 mm, so that various different detection items, such as influenza a virus, novel coronavirus, and the like, can be detected. Also, the test unit loaded with the commercial test strip may be of one-piece, embedded or split construction.
At present, nucleic acid detection or immunological detection is carried out, whether the detection effect is good when the throat swab is used is unknown in the sampling process, the detection can only be known after the detection is finished, and even some detection kits have no evaluation capability on the sampling effect; on the other hand, after the sample is diluted with the sample preservation solution, a pipetting gun or a dropper is required to be used for pipetting and then carrying out subsequent tests, certain operating equipment and operating environment are required, the operation is troublesome, and if the pharynx swab can be directly tested after sampling, the pharynx swab greatly facilitates operators. Therefore, there is a need to develop a sampling means or method that can be used for quality control or inspection of samples during the detection process.
In order to solve the above technical problems, the present embodiment proposes a pharyngeal swab with a quality control function, which can detect the main components of a sample immediately after sampling, and can qualitatively or quantitatively control the effect of sample collection. Meanwhile, the embodiment also considers the universality of the product, namely the throat swab which is directly detected after sampling can be assembled by being assembled with the existing commercial test strip.
Except that the quality control function is realized on the throat swab, a test strip for detection can be further added in the independent detection unit, namely, the quality control after sample collection can be finished on one throat swab, the detection can be further and directly finished, and the detection is more convenient and faster. In general, the present embodiment can collect the respiratory tract sample and perform quality control on the sample, and then perform sample inspection.
The embodiments in the present specification are described in a progressive manner, and the same and similar parts among the embodiments are referred to each other, and each embodiment focuses on the differences from the other embodiments. In particular, for the apparatus embodiment, since it is substantially similar to the method embodiment, it is relatively simple to describe, and reference may be made to some descriptions of the method embodiment for relevant points. The above description is only for the specific embodiments of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are also within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims (11)

1. A sampling swab with a sample quality control function is characterized in that the sampling swab at least comprises the following components: the sampling device comprises a main body rod (1), a sampling head (2) and a detection area (3), wherein the sampling head (2) is fixedly arranged at one end of the main body rod (1), and the detection area (3) is arranged on the rod body of the main body rod (1) and is arranged at a position close to the sampling head (2);
the detection zone (3) comprises at least: the liquid suction device (3-1), the detection channel (3-2) and the air guide hole (3-3), wherein the outer surface of the detection channel (3-2) is provided with an observation window (3-4);
one end of the detection channel (3-2) is provided with a liquid suction device (3-1), the other end of the detection channel (3-2) is provided with an air vent (3-3), and a detection test strip (3-5) is placed in the detection channel (3-2);
substances for reacting with protein components in cells and developing color are added in the detection test paper strips (3-5).
2. The sampling swab with the sample quality control function according to claim 1, wherein the detection region (3) is an independent detection unit, an embedded groove (1-1) is formed in the main body rod (1), and the independent detection unit is embedded in and fixed to the embedded groove (1-1).
3. The sampling swab with sample quality control function according to claim 1, wherein the detection area (3) is an independent detection unit;
the main body rod (1) and the sampling head (2) are integrated into a conventional throat swab, and the independent detection unit is adhered to the body of the main body rod (1) and is close to the position of the sampling head (2) through medical waterproof glue.
4. The sampling swab with sample quality control function of claim 1, wherein the size of the area of the observation window (3-4) is 1mm2~1000mm2
And the observation window (3-4) is covered by waterproof transparent material.
5. The sampling swab with the sample quality control function according to claim 1, wherein the pipetting device (3-1) is a pipetting hole formed in the detection channel (3-2);
or the liquid absorption device (3-1) is made of liquid absorption paper, wherein one end of the liquid absorption paper is fixed in the detection channel (3-2), and the other end of the liquid absorption paper is exposed out of the detection channel (3-2).
6. The device of claim 1The sampling swab with the essence control function is characterized in that the area of the air guide hole (3-3) is 0.01mm2~10mm2
And/or if the liquid suction device (3-1) is a liquid suction hole formed in the detection channel (3-2), the area size of the liquid suction hole is 0.01mm2~10mm2
7. The sampling swab with the sample quality control function of claim 1, wherein the detection channel (3-2) is an internal cavity structure, the internal cavity structure is a cuboid or a cylinder, and the length of the internal cavity structure is 3mm to 50 mm.
8. The sample swab with sample quality control of claim 1, wherein a water-absorbing material is disposed within the interior cavity structure.
9. The sampling swab with sample quality control function according to claim 1, wherein the main body rod (1) is connected with the sampling head (2) through a connecting part (4);
the connecting part (4) is made of materials, and when the main body rod (1) is held and pressure is applied to the sampling head (2), the connecting part (4) is compressed and deformed.
10. The sampling swab with the sample quality control function according to claim 1, wherein the connecting part (4) adopts an elastic net structure;
when the main body rod (1) is held and pressure is applied to the sampling head (2), the connecting part (4) is compressed and deformed;
the length of the compressible structure of the net structure is 3-30 mm.
11. A method for detecting a sampling swab having a sample quality control function according to any one of claims 1 to 10, comprising:
after sample collection, putting the used sampling swab into a sample preservation solution for mixing, wherein the liquid level of the sample preservation solution cannot exceed a preset horizontal line during mixing, and the preset horizontal line is lower than a liquid absorption device (3-1);
after the uniform mixing, immersing a liquid absorbing device (3-1) into the preset horizontal line so that the liquid absorbing device (3-1) can absorb the uniformly mixed sample preservation liquid, wherein the time for immersing the liquid absorbing device (3-1) into the preset horizontal line is not less than 2 seconds;
and displaying the color development condition of the test strip (3-5) through the observation window (3-4).
CN202210305994.2A 2022-03-25 2022-03-25 Sampling swab with sample quality control function Pending CN114574337A (en)

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