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CN111887895A - A saliva collection device with a disease-enriching adsorption structure - Google Patents

A saliva collection device with a disease-enriching adsorption structure Download PDF

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CN111887895A
CN111887895A CN202010588003.7A CN202010588003A CN111887895A CN 111887895 A CN111887895 A CN 111887895A CN 202010588003 A CN202010588003 A CN 202010588003A CN 111887895 A CN111887895 A CN 111887895A
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CN111887895B (en
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徐赤坤
谭智群
何俊德
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Hebei Medai Health Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B10/0051Devices for taking samples of body liquids for taking saliva or sputum samples
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    • G01N1/405Concentrating samples by adsorption or absorption
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B2010/009Various features of diagnostic instruments

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Abstract

本发明提出一种带有病富集吸附结构的唾液收集装置,包括取样器和储样瓶;取样器包括中空的包装、树脂吸附模块和负压控制装置;包装上设有采集口和负压口;树脂吸附模块置于包装内,并且设于包装内靠近采集口的一端;负压控制装置可拆卸连接于包装的负压口;储样瓶内预设有样品保藏液;取样器取样后,插设于储样瓶内,以提出一种针对病毒实现有效的吸附富集,实现病毒短期保存的唾液收集装置。

Figure 202010588003

The invention provides a saliva collecting device with a disease-enriching adsorption structure, comprising a sampler and a sample storage bottle; the sampler includes a hollow package, a resin adsorption module and a negative pressure control device; the package is provided with a collection port and a negative pressure The resin adsorption module is placed in the package, and is located at the end of the package close to the collection port; the negative pressure control device is detachably connected to the negative pressure port of the package; the sample storage bottle is preset with a sample preservation solution; after sampling by the sampler , inserted in the storage bottle, to propose a saliva collection device that realizes effective adsorption and enrichment for viruses and realizes short-term preservation of viruses.

Figure 202010588003

Description

一种带有病富集吸附结构的唾液收集装置A saliva collection device with a disease-enriching adsorption structure

技术领域technical field

本发明涉及生物保藏技术领域,尤其涉及一种带有病富集吸附结构的唾液收集装置。The invention relates to the technical field of biological preservation, in particular to a saliva collecting device with a disease-enriching adsorption structure.

背景技术Background technique

唾液是一种重要的生物体液,也是生物医学研究和临床上常用的检测标本之一。正常生理状态下,唾液中除了带有供体口腔内脱落的口腔上皮细胞之外,还含有多种来源于唾液腺体分泌的蛋白质/酶分子、细胞外囊泡/外泌体、微小核酸分子已经正常菌群的微生物细胞等。在疾病状态如病毒或细菌感染时,其中还可能含有病毒颗粒、细菌或者真菌病原体细胞。已有研究显示,就呼吸道病毒感染后的病毒核酸检测而言,唾液标本比其它方法如鼻咽拭子所采集的样品更加稳定可靠。现有各种用于唾液收集与取样的装置皆为简单直接,没有针对待检测生物成分的吸附富集,没有无毒害的内置取样成功的标志、也不具有针对相关生物组分的保护性能;取样操作也必须由接受过训练的专业人员完成。因此,现有的唾液取样装置无法由普通人群自己完成,也不能用于样品的短期保藏,故不能用作唾液样本的远程传递。Saliva is an important biological fluid and one of the commonly used test specimens in biomedical research and clinical practice. Under normal physiological conditions, in addition to the oral epithelial cells exfoliated from the donor's mouth, saliva also contains a variety of protein/enzyme molecules, extracellular vesicles/exosomes, and micronucleic acid molecules secreted from salivary glands. Microbial cells of normal flora, etc. In disease states such as viral or bacterial infections, it may also contain viral particles, bacterial or fungal pathogen cells. Studies have shown that saliva samples are more stable and reliable than samples collected by other methods such as nasopharyngeal swabs for viral nucleic acid detection after respiratory virus infection. Various existing devices for saliva collection and sampling are simple and direct, without adsorption and enrichment for the biological components to be detected, no non-toxic built-in signs of successful sampling, and no protection against related biological components; Sampling operations must also be performed by trained professionals. Therefore, the existing saliva sampling device cannot be completed by the general population itself, nor can it be used for short-term preservation of samples, so it cannot be used for remote delivery of saliva samples.

发明内容SUMMARY OF THE INVENTION

本发明的目的在于提出一种针对病毒实现有效的吸附富集,实现病毒短期保存的唾液收集装置。The purpose of the present invention is to propose a saliva collection device for realizing effective adsorption and enrichment of viruses and short-term preservation of viruses.

为达到上述目的,本发明提出一种带有病富集吸附结构的唾液收集装置,包括取样器和储样瓶;In order to achieve the above object, the present invention proposes a saliva collection device with a disease-enriching adsorption structure, including a sampler and a sample storage bottle;

所述取样器包括中空的包装、树脂吸附模块和负压控制装置;所述包装上设有采集口和负压口;所述树脂吸附模块置于所述包装内,并且设于所述包装内靠近所述采集口的一端;所述负压控制装置可拆卸连接于所述包装的所述负压口;The sampler includes a hollow package, a resin adsorption module and a negative pressure control device; the package is provided with a collection port and a negative pressure port; the resin adsorption module is placed in the package and is arranged in the package one end close to the collection port; the negative pressure control device is detachably connected to the negative pressure port of the package;

所述储样瓶内预设有样品保藏液;所述取样器取样后,插设于所述储样瓶内。The sample storage bottle is preset with a sample preservation solution; the sampler is inserted into the sample storage bottle after sampling.

优选的,所述包装为中空的玻璃包装,所述包装为柱状结构,所述包装的首端为所述采集口,所述包装的尾端为所述负压口。Preferably, the package is a hollow glass package, the package has a columnar structure, the first end of the package is the collection port, and the tail end of the package is the negative pressure port.

优选的,所述树脂吸附模块为对病毒和细菌具有强吸附力的离子交换树脂和壳聚糖或者葡聚糖颗粒的混合物。Preferably, the resin adsorption module is a mixture of ion exchange resin and chitosan or dextran particles with strong adsorption force for viruses and bacteria.

优选的,所述树脂吸附模块为多孔离子交换树脂、唾液酸化的离子交换树脂或/和壳聚糖的混合物;Preferably, the resin adsorption module is a mixture of porous ion exchange resin, sialylated ion exchange resin or/and chitosan;

优选的,所述树脂吸附模块为纤维素、葡聚糖或/和琼脂糖凝胶。Preferably, the resin adsorption module is cellulose, dextran or/and agarose gel.

优选的,所述树脂吸附模块为圆柱体、方柱体、片状或者串珠状结构排布于所述包装内。Preferably, the resin adsorption module is arranged in the package in the form of a cylinder, a square cylinder, a sheet or a beaded structure.

优选的,所述负压装置为一个橡胶吸球,所述橡胶吸球套接于所述储样瓶的负压口上。Preferably, the negative pressure device is a rubber suction ball, and the rubber suction ball is sleeved on the negative pressure port of the sample storage bottle.

优选的,所述储样瓶为玻璃瓶,所述玻璃瓶的瓶口处旋拧固定有瓶盖;Preferably, the sample storage bottle is a glass bottle, and a bottle cap is screwed and fixed at the bottle mouth of the glass bottle;

所述样品保藏液为生理缓冲液,所述生理缓冲液包括无血清细胞培养液、Hank’s缓冲液、PBS磷酸缓冲液、TRIS缓冲液或者生理盐水;所述生理缓冲液中还添加有酚红指示剂、复合广谱抗菌素,包括青霉素、链霉素以及两性霉素B。The sample preservation solution is a physiological buffer, and the physiological buffer includes serum-free cell culture solution, Hank's buffer, PBS phosphate buffer, TRIS buffer or physiological saline; the physiological buffer is also added with phenol red indicator Antibiotics, compound broad-spectrum antibiotics, including penicillin, streptomycin, and amphotericin B.

优选的,还包括滤纸条,所述滤纸条置于所述包装内,所述滤纸条与所述树脂吸附模块相连接,所述滤纸条上印制有湿印标志线,所述湿印标志线采用遇水显色油墨刻制。Preferably, it also includes a filter paper strip, the filter paper strip is placed in the package, the filter paper strip is connected with the resin adsorption module, and the wet printing mark line is printed on the filter paper strip, so The wet-printed marking lines are engraved with water-colored ink.

与现有技术相比,本发明的优势之处在于:本发明的唾液收集装置内取样器中通过设置树脂吸附模块,可以提高针对病原体及其他待检生物组分的采集效率,亦即提高提取在样品中的浓度。Compared with the prior art, the advantage of the present invention lies in that: the resin adsorption module is arranged in the sampler in the saliva collection device of the present invention, which can improve the collection efficiency of pathogens and other biological components to be detected, that is, improve the extraction efficiency. concentration in the sample.

采用过程中可以通过取样器中滤纸条上的湿印标识观测判断是否取样足够,保证采样的精准度,提高采样效率。In the process of adopting, it can be judged whether the sampling is sufficient by observing the wet printing mark on the filter paper strip in the sampler, so as to ensure the accuracy of sampling and improve the sampling efficiency.

操作简单,普通成人无需专业培训即可按照图解说明即时操作实现;The operation is simple, and ordinary adults can operate it immediately according to the graphic instructions without professional training;

取样器与储样瓶组合使用,可以方便样品在一般室温条件下短期保藏,适用于远程递送,便捷样品的输送以及保证采样的质量。The sampler is used in combination with the storage bottle, which can facilitate the short-term preservation of samples under normal room temperature conditions, and is suitable for remote delivery, convenient sample transportation and guaranteeing the quality of sampling.

附图说明Description of drawings

图1为本发明实施例中唾液收集装置的结构示意图;1 is a schematic structural diagram of a saliva collection device in an embodiment of the present invention;

图2为本发明实施例中取样器的结构示意图;Fig. 2 is the structural representation of the sampler in the embodiment of the present invention;

图3为本发明实施例中取样器与储样瓶的使用流程图。FIG. 3 is a flow chart of the use of the sampler and the sample storage bottle in the embodiment of the present invention.

具体实施方式Detailed ways

为使本发明的目的、技术方案和优点更加清楚,下面将对本发明的技术方案作进一步地说明。In order to make the objectives, technical solutions and advantages of the present invention clearer, the technical solutions of the present invention will be further described below.

如图1所示,本发明提出一种带有病富集吸附结构的唾液收集装置,包括取样器1和储样瓶2;As shown in FIG. 1 , the present invention proposes a saliva collection device with a disease-enriching adsorption structure, comprising a sampler 1 and a sample storage bottle 2;

如图2所示,取样器1包括中空的包装4、树脂吸附模块3和负压控制装置5;包装4上设有采集口和负压口;树脂吸附模块3置于包装4内,并且设于包装4内靠近采集口的一端;负压控制装置5可拆卸连接于包装4的负压口;还包括滤纸条6,滤纸条6置于包装4内,滤纸条6与树脂吸附模块3相连接,滤纸条6上印制有湿印标志线7,湿印标志线7采用遇水显色油墨刻制。As shown in FIG. 2, the sampler 1 includes a hollow package 4, a resin adsorption module 3 and a negative pressure control device 5; the package 4 is provided with a collection port and a negative pressure port; the resin adsorption module 3 is placed in the package 4, and is provided with The negative pressure control device 5 is detachably connected to the negative pressure port of the package 4; it also includes a filter paper strip 6, and the filter paper strip 6 is placed in the package 4, and the filter paper strip 6 is adsorbed on the resin. The modules 3 are connected, and the filter paper strip 6 is printed with a wet printing mark line 7, and the wet printing mark line 7 is engraved with water-colored ink.

在本实施例中,取样器1的使用方法为:使用者通过操作负压控制装置5来使得包装4内部产生负压,此时将病毒吸附至树脂吸附模块3上,当树脂吸附模块3对病毒的吸附接近饱和的情况下,水分会顺着树脂吸附模块3延伸至滤纸条6上,当滤纸条6上的湿印标志线7湿润后,遇水变色后表示取样器1已经收集到所设定的足够量的唾液样品;其中,遇水显色油墨对样品没有任何的损害效果。In this embodiment, the method of using the sampler 1 is as follows: the user generates a negative pressure inside the package 4 by operating the negative pressure control device 5 , and at this time, the virus is adsorbed on the resin adsorption module 3 . When the adsorption of the virus is close to saturation, the water will extend to the filter paper strip 6 along the resin adsorption module 3. When the wet printing mark line 7 on the filter paper strip 6 is wet, it will change color when it encounters water, indicating that the sampler 1 has collected. To the set sufficient amount of saliva sample; wherein, the water-colored ink does not have any damaging effect on the sample.

在本实施例中,树脂吸附模块3为对多种病毒和细菌具有强吸附力的离子交换树脂与壳聚糖或者固化有特殊病毒受体结构的葡聚糖颗粒混合物;由无毒害的多孔离子交换树脂、唾液酸化的离子交换树脂或/和壳聚糖混合物组成;树脂吸附模块3还可以是纤维素、葡聚糖或/和琼脂糖凝胶;可以根据实际应用的需求来进行选择。In this embodiment, the resin adsorption module 3 is a mixture of ion-exchange resin and chitosan or dextran particles solidified with a special virus receptor structure, which has strong adsorption force for various viruses and bacteria; Exchange resin, sialylated ion exchange resin or/and chitosan mixture; resin adsorption module 3 can also be cellulose, dextran or/and agarose gel; it can be selected according to practical application requirements.

鉴于离子交换树脂、唾液酸及壳聚糖分子的表面基团对多种病毒颗粒包括流感病毒和COVID-19新冠病毒的高亲和特性,在取样过程中,树脂吸附模块3可以捕获唾液中的病毒颗粒并将其束缚于模块内,提高所采集样本中病毒颗粒的浓度。吸附模块的亲和捕获活性同样对细菌和真菌微生物、脱落的内皮细胞以及细胞外颗粒有效。因此,树脂吸附模块3将提高对潜在病原体或者其他生物成分的采集效率。In view of the high affinity of the surface groups of ion exchange resin, sialic acid and chitosan molecules to a variety of virus particles, including influenza virus and COVID-19 new coronavirus, during the sampling process, resin adsorption module 3 can capture saliva. Viral particles are trapped within the module, increasing the concentration of viral particles in the collected sample. The affinity capture activity of the adsorption module is also effective against bacterial and fungal microorganisms, exfoliated endothelial cells, and extracellular particles. Therefore, the resin adsorption module 3 will improve the collection efficiency of potential pathogens or other biological components.

树脂吸附模块3为圆柱体、方柱体、片状或者串珠状结构排布于包装4内,在本实施例中,树脂吸附模块3采用多层的片状结构12,便于病毒的分层吸附。The resin adsorption module 3 is a cylinder, a square cylinder, a sheet or a beaded structure and is arranged in the package 4. In this embodiment, the resin adsorption module 3 adopts a multi-layer sheet structure 12, which is convenient for the layered adsorption of viruses. .

在本实施例中,包装4为中空的玻璃包装4,包装4为柱状结构,包装4的首端为采集口,包装4的尾端为负压口。便于对包装4内样品采集情况的观察。In this embodiment, the package 4 is a hollow glass package 4, the package 4 has a columnar structure, the first end of the package 4 is a collection port, and the tail end of the package 4 is a negative pressure port. It is convenient to observe the sample collection situation in the package 4 .

在本实施例中,储样瓶2为玻璃瓶8,玻璃瓶的瓶口处旋拧固定有瓶盖10,瓶盖10与瓶口处设有密封盖11;储样瓶2内预设有样品保藏液;取样器1取样后,插设于储样瓶2内。In this embodiment, the sample storage bottle 2 is a glass bottle 8, a bottle cap 10 is screwed and fixed at the bottle mouth of the glass bottle, and a sealing cap 11 is provided at the bottle cap 10 and the bottle mouth; the sample storage bottle 2 is preset with a Sample preservation solution; after sampling by the sampler 1, it is inserted into the sample storage bottle 2.

在实际应用过程中,取样器1取样后,可以直接置于储样瓶2内,取下负压控制装置5进行保藏。在本实施例中,负压控制装置5采用橡胶吸球,橡胶吸球套接于所述储样瓶2的负压口上,操作人员挤压橡胶吸球,即可实现取样器1内部的负压状态,从而实现病毒样品的吸附以及取出。当取样器1置于储样瓶2内,同时挤压橡胶吸球,将部分唾液样品排入存储瓶内,然后从取样器1的负压口取下橡胶吸球,拧上瓶盖10,即可实现唾液样品安全的保存,继而当样品被送到实验室检测前,可以实现样品短时间的保藏,保证样品的采集质量。在被送到实验室后,打开瓶盖10,即可直接从取样器1上端开口处吸取样品,操作简单、方便,并且安全而极大地降低了样品被污染或者泄漏的风险。针对一些需要载体的检测设备,保藏有样品的储样瓶2可直接与检测设备实现配合,完成检测。In the actual application process, after sampling by the sampler 1, it can be directly placed in the storage bottle 2, and the negative pressure control device 5 can be removed for preservation. In this embodiment, the negative pressure control device 5 adopts a rubber suction ball, and the rubber suction ball is sleeved on the negative pressure port of the sample storage bottle 2. The operator squeezes the rubber suction ball to realize the negative pressure inside the sampler 1. Pressed state, so as to achieve the adsorption and removal of virus samples. When the sampler 1 is placed in the storage bottle 2, the rubber suction ball is squeezed at the same time, and part of the saliva sample is discharged into the storage bottle, then the rubber suction ball is removed from the negative pressure port of the sampler 1, and the bottle cap 10 is screwed on. The safe preservation of saliva samples can be achieved, and then before the samples are sent to the laboratory for testing, the samples can be stored for a short period of time to ensure the quality of sample collection. After being sent to the laboratory, the bottle cap 10 can be opened, and the sample can be directly drawn from the upper end opening of the sampler 1. The operation is simple and convenient, and it is safe and greatly reduces the risk of sample contamination or leakage. For some detection equipment that needs a carrier, the sample storage bottle 2 in which the sample is stored can be directly cooperated with the detection equipment to complete the detection.

在本实施例中,样品保藏液为生理缓冲液9,生理缓冲液9包括无血清细胞培养液、Hank’s缓冲液、PBS磷酸缓冲液、TRIS缓冲液或者生理盐水;生理缓冲液9中还添加有酚红指示剂、复合广谱抗菌素,包括青霉素、链霉素以及两性霉素B。针对特定病毒样品如COVID-19新冠病毒样品的采集,所述缓冲液中还可以加入帮助稳定RNA的RNA酶抑制剂diethylpyrocarbonate(DEPC)。所述抗菌素有助于在短期保藏过程中抑制潜在的微生物生长,酚红指示剂帮助指示保藏过程中样品缓冲液中pH有无改变。In this embodiment, the sample preservation solution is a physiological buffer 9, and the physiological buffer 9 includes serum-free cell culture solution, Hank's buffer, PBS phosphate buffer, TRIS buffer or physiological saline; the physiological buffer 9 is also added with Phenol red indicator, compound broad-spectrum antibiotics, including penicillin, streptomycin, and amphotericin B. For the collection of specific virus samples such as COVID-19 novel coronavirus samples, diethylpyrocarbonate (DEPC), an RNase inhibitor that helps stabilize RNA, can also be added to the buffer. The antibiotic helps to inhibit potential microbial growth during short-term storage, and the phenol red indicator helps to indicate whether the pH of the sample buffer has changed during storage.

上述仅为本发明的优选实施例而已,并不对本发明起到任何限制作用。任何所属技术领域的技术人员,在不脱离本发明的技术方案的范围内,对本发明揭露的技术方案和技术内容做任何形式的等同替换或修改等变动,均属未脱离本发明的技术方案的内容,仍属于本发明的保护范围之内。The above are only preferred embodiments of the present invention, and do not have any limiting effect on the present invention. Any person skilled in the art, within the scope of not departing from the technical solution of the present invention, makes any form of equivalent replacement or modification to the technical solution and technical content disclosed in the present invention, all belong to the technical solution of the present invention. content still falls within the protection scope of the present invention.

Claims (9)

1. A saliva collecting device with a disease enrichment adsorption structure is characterized by comprising a sampler and a sample storage bottle;
the sampler comprises a hollow package, a resin adsorption module and a negative pressure control device; the package is provided with a collection port and a negative pressure port; the resin adsorption module is arranged in the package and is arranged at one end, close to the acquisition port, in the package; the negative pressure control device is detachably connected to the negative pressure port of the package;
a sample preservation solution is preset in the sample storage bottle; and the sampler is inserted into the sample storage bottle after sampling.
2. The saliva collection device with a disease enrichment adsorption structure of claim 1, wherein the package is a hollow glass package, the package is a cylindrical structure, the head end of the package is the collection port, and the tail end of the package is the negative pressure port.
3. The saliva collection device with a disease enrichment adsorption structure of claim 1, wherein the resin adsorption module is a mixture of ion exchange resin and chitosan or dextran particles having strong adsorption force to viruses and bacteria.
4. The saliva collection device with a disease enrichment adsorption structure of claim 3, wherein the resin adsorption module is a porous ion exchange resin, a sialylated ion exchange resin, or/and a mixture of chitosan.
5. The saliva collection device with a disease enrichment adsorption structure of claim 1, wherein the resin adsorption module is cellulose, dextran or/and sepharose.
6. The saliva collection device with a disease enrichment adsorption structure of claim 1, wherein the resin adsorption modules are arranged in the package in a cylinder, a square cylinder, a sheet or a bead-like structure.
7. The saliva collecting device with the disease enrichment adsorption structure as claimed in claim 1, wherein the negative pressure device is a rubber suction ball which is sleeved on the negative pressure port of the sample storage bottle.
8. The saliva collecting device with the disease enrichment adsorption structure as claimed in claim 1, wherein the sample storage bottle is a glass bottle, and a bottle cap is screwed and fixed at the bottle mouth of the glass bottle;
the sample preservation solution is a physiological buffer solution, and the physiological buffer solution comprises serum-free cell culture solution, Hank's buffer solution, PBS phosphate buffer solution, TRIS buffer solution or physiological saline; the physiological buffer solution is also added with phenol red indicator and composite broad spectrum antibiotics, including penicillin, streptomycin and amphotericin B.
9. The saliva collection device with a disease enrichment adsorption structure of claim 1, further comprising a paper filter strip, wherein the paper filter strip is placed in the package and connected with the resin adsorption module, and wet-printed mark lines are printed on the paper filter strip and engraved with water-color ink.
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