CN206594173U - Device for detecting the analyte in fluid sample - Google Patents
Device for detecting the analyte in fluid sample Download PDFInfo
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- CN206594173U CN206594173U CN201621295498.XU CN201621295498U CN206594173U CN 206594173 U CN206594173 U CN 206594173U CN 201621295498 U CN201621295498 U CN 201621295498U CN 206594173 U CN206594173 U CN 206594173U
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Abstract
本实用新型提供一种用于检测流体样品中被分析物质的装置,该装置包括:流体样品收集元件;测试元件载体;和保持元件,其中,测试元件载体位于保持元件中,在优选的方式中,所述的流体样品收集元件包括吸收元件和拿捏部,其中,拿捏部包括有与保持元件配合的结构。
The utility model provides a device for detecting an analyte in a fluid sample. The device includes: a fluid sample collection element; a test element carrier; and a holding element, wherein the test element carrier is located in the holding element. In a preferred manner , the fluid sample collection element includes an absorbing element and a handle part, wherein the handle part includes a structure that cooperates with the holding element.
Description
技术领域technical field
本实用新型涉及一种用于检测流体样品中的分析物的装置。The utility model relates to a device for detecting analytes in fluid samples.
背景技术Background technique
下面的背景技术用于帮助读者理解本实用新型,而不能被认为是现有技术。The following background art is used to help readers understand the utility model, and should not be regarded as prior art.
在我们的社会,违法药物滥用已经成为了一个公认且日趋恶化的社会问题。 2003年,美国卫生和人类服务部调查发现约有1950万美国人或8.2%年龄在12 岁以上的人群正在吸食违法药品。“最近使用违法药品”是指在美国卫生和人类服务部进行调查前一个月内使用过一种违法药物。大麻被发现是最常用的违法药物,占6.2%(1460万)。估计230万人(1.0%)现在正在使用可卡因,604,000 人使用了快克,有100万人使用致幻剂,并估计119,000人正在使用海洛因。Illegal drug abuse is a well-recognized and worsening social problem in our society. In 2003, the U.S. Department of Health and Human Services found that about 19.5 million Americans, or 8.2% of the population over the age of 12, were taking illicit drugs. "Recent illicit drug use" refers to use of an illicit drug within the month preceding the investigation by the U.S. Department of Health and Human Services. Cannabis was found to be the most commonly used illicit drug, accounting for 6.2% (14.6 million). An estimated 2.3 million people (1.0%) are currently using cocaine, 604,000 have used crack, 1 million are using hallucinogens, and an estimated 119,000 are using heroin.
为了打击药物滥用和监测这一社会问题,药物测试在各行业中譬如雇佣、教育、体育、执法等已经成为了标准检测程序。为了推动这一努力,药物测试产业已经形成。这一产业提供各种各样药物测试产品。可对样品进行分析的尿样收集杯是一款经典的测试产品。这些装置对使用者来说可能是复杂、困难或肮脏的,或为隐瞒最近使用违法药品的情况,可能会造成样品掺假的问题。另外,尿样无法在某些场合被收集,譬如在路边或公共场合。To combat drug abuse and monitor this social problem, drug testing has become a standard procedure in various industries such as employment, education, sports, law enforcement and more. To fuel this effort, a drug testing industry has formed. This industry offers a wide variety of drug testing products. The urine collection cup for sample analysis is a classic test product. These devices may be complicated, difficult, or dirty for the user, or may create problems with sample adulteration in order to conceal recent use of illicit drugs. In addition, urine samples cannot be collected in certain settings, such as on the side of the road or in public places.
一些文献中已经可以得到并且描述过各种用于临床或家用的样品收集和测试装置。例如,美国专利US 5,376,337公开了一种唾液采样装置,其中一张滤纸被用于从受检者的口中收集唾液并且将唾液传送到指示试剂上。美国专利US 5,576,009和US 5,352,410各自公开了一种注射器型的流体采样装置。在这些装置中,在获得初始结果之后,不能存储被收集的流体样品以便在随后用于确认测试。Various sample collection and testing devices for clinical or home use are available and described in several literatures. For example, US Pat. No. 5,376,337 discloses a saliva sampling device in which a filter paper is used to collect saliva from a subject's mouth and transfer the saliva to an indicator reagent. US Patents US 5,576,009 and US 5,352,410 each disclose a syringe-type fluid sampling device. In these devices, after initial results are obtained, the collected fluid samples cannot be stored for later use in confirmatory testing.
许多其他的样品收集和测试装置在从收集装置提取样品方面是效率低下的。许多这样的装置在其设计和制造方面非常复杂并且需要使用相当昂贵的材料。因此需要更好的方法和装置对样品进行收集和检测。Many other sample collection and testing devices are inefficient at extracting samples from the collection device. Many of these devices are very complex in their design and manufacture and require the use of relatively expensive materials. Therefore, better methods and devices are needed to collect and detect samples.
实用新型内容Utility model content
为了解决现有技术中存在的问题,一种收集和检测流体样品中被分析物质的装置,其特征在于,该装置包括:In order to solve the problems existing in the prior art, a device for collecting and detecting analytes in fluid samples is characterized in that the device includes:
流体样品收集元件,其中,流体样品收集元件包括吸收液体样品的吸收元件和拿捏部,以及连接吸收元件和拿捏部的连接杆;A fluid sample collecting element, wherein the fluid sample collecting element includes an absorbing element and a handle for absorbing a liquid sample, and a connecting rod connecting the absorbing element and the handle;
测试元件载体,其中,测试元件载体包括用于承载测试元件的本体和用于收容吸收元件的收容腔,其中,本体和收容腔为一体注塑成型的结构;The test element carrier, wherein the test element carrier includes a body for carrying the test element and a housing cavity for accommodating the absorbing element, wherein the body and the housing cavity are integrally formed by injection molding;
含腔的保持元件,其中,保持元件的腔由开口和开口的沿,以及侧壁围成;A cavity-containing retaining element, wherein the cavity of the retaining element is bounded by the opening, the rim of the opening, and the side walls;
其中,保持元件包括让其站立的结构。Therein, the retaining element includes a structure allowing it to stand.
在一个具体的方式中,站立的结构包括竖直站立结构或/和倾斜站立结构。In a specific manner, the standing structure includes a vertical standing structure or/and an inclined standing structure.
在一个具体的方式中,所述的竖直站立结构或/和倾斜站立结构包括与支撑面接触的接触面;其中,竖直站立结构包括让保持元件竖直站立的第二接触面,倾斜站立结构包括让保持元件倾斜站立的第一接触面,第一接触面和第二接触面不在同一个平面上。In a specific manner, the vertical standing structure or/and the inclined standing structure include a contact surface that is in contact with the support surface; wherein, the vertical standing structure includes a second contact surface that allows the holding element to stand vertically, and the inclined standing structure The structure includes a first contact surface allowing the holding element to stand obliquely, and the first contact surface and the second contact surface are not on the same plane.
在一个具体的方式中,所述的第一接触面或/和第二接触面构位于保持元件的侧壁的边沿上。In a specific manner, the first contact surface and/or the second contact surface are located on the edge of the side wall of the holding element.
在一个具体的方式中,所述的第一接触面和第二接触面由保持元件的侧壁的边沿所构成。In a specific manner, the first contact surface and the second contact surface are formed by edges of side walls of the holding element.
在一个具体的方式中,其中,第一接触面包括侧壁的两个边沿形成的面以及两个边沿所形成的面的一端交汇而形成的支点构成,其中,所述的两个边沿的面和支点形成所述的第一接触面。In a specific manner, the first contact surface includes a surface formed by two edges of the side wall and a fulcrum formed by the intersection of one end of the surfaces formed by the two edges, wherein the surfaces of the two edges and the fulcrum form the first contact surface.
在一个具体的方式中,所述侧壁的两个边沿形成的面的宽度由侧壁的厚度所限定。In a specific manner, the width of the surface formed by the two edges of the side wall is limited by the thickness of the side wall.
在一个具体的方式中,其中,所述的第一接触面的形状为三角形,第二接触面的形状为三角形。In a specific manner, the first contact surface is triangular in shape, and the second contact surface is triangular in shape.
在一个具体的方式中,测试元件载体位于保持元件的腔中;其中,拿捏部、保持元件的开口具有相同横切面的形状,横截面为正方形、椭圆形、长方形、菱形、五边形、三角形、六边形、七边形中的一种形状。In a specific manner, the test element carrier is located in the cavity of the holding element; wherein, the opening of the handle and the holding element have the same cross-sectional shape, and the cross-section is square, oval, rectangular, rhombus, pentagon, triangle , a hexagon, or a heptagon.
另一方面,本实用新型提供一种收集和检测流体样品中被分析物质的装置,该装置包括:流体样品收集元件;测试元件载体;和保持元件,其中,测试元件载体位于保持元件中。On the other hand, the utility model provides a device for collecting and detecting analyte in a fluid sample, the device comprising: a fluid sample collecting element; a test element carrier; and a holding element, wherein the test element carrier is located in the holding element.
在一些优选的方式中,流体样品收集元件包括吸收元件和拿捏部。优选的方式中,拿捏部具有与保持元件开口配合的结构,从而当流体样品收集元件插入到保持元件中,拿捏部与保持元件的开口配合,从而流体样品收集元件被“保持”在保持元件中。在一些优选的方式中,拿捏部与保持元件的开口都具有三角形的结构。优选的方式中,拿捏部具有与保持元配合的结构,从而让而让流体样品收集元件被保持在保持元件中一种相对固定的位置。在一些优选的方式中,拿捏部具有突起的拿捏沿,该沿与保持元件的开口沿配合,从而让流体样品收集元件处于保持元件中相对固定的位置。优选的,拿捏部与保持元件具有配合的锁扣、暗扣、插接、卡口方式,从而当流体样品收集元件插入到保持元件中,让流体样品收集元件被保持在保持元件中,或者让流体样品收集元件处于保持远近中相对固定的位置。所谓的“保持”是指收集元件在收集样品后,插入到保持元件中,在其中一个状态下,位于保持元件中的一个相对固定的位置,不能继续插入到保持元件中,也不能抽出来,脱离保持元件。In some preferred embodiments, the fluid sample collection element includes an absorbent element and a handle. In a preferred manner, the handle portion has a structure that cooperates with the opening of the holding element, so that when the fluid sample collection element is inserted into the holding element, the handle portion cooperates with the opening of the holding element, so that the fluid sample collection element is "held" in the holding element . In some preferred manners, both the handle portion and the opening of the holding element have a triangular structure. In a preferred manner, the handle portion has a structure that cooperates with the holding element, so that the fluid sample collection element is held in a relatively fixed position in the holding element. In some preferred manners, the handle portion has a protruding handle edge, which is matched with the opening edge of the holding element, so that the fluid sample collection element is in a relatively fixed position in the holding element. Preferably, the holding part and the holding element have matching locks, snaps, inserts, and bayonets, so that when the fluid sample collection element is inserted into the holding element, the fluid sample collection element is held in the holding element, or the fluid sample collection element is held in the holding element. The fluid sample collection element is in a relatively fixed position between the distance and the center. The so-called "holding" means that the collection element is inserted into the holding element after collecting the sample, and in one of the states, it is located in a relatively fixed position in the holding element, and cannot be further inserted into the holding element, nor can it be pulled out. Disengage the retaining element.
在一些优选的方式中,吸收元件和拿捏部通过一杆连接。优选的,收集元件、拿捏部、连接杆为一体结构。在一些优选的方式中,流体样品收集元件包括密封元件,当流体样品收集元件插入到保持元件中,吸收元件被该密封元件密封与一个腔中,从而让吸收元件中的流体被密封在一个腔中,而不泄露到外部环境中。In some preferred forms, the absorbent element and the handle are connected by a rod. Preferably, the collecting element, the handle and the connecting rod are integrally structured. In some preferred forms, the fluid sample collection element includes a sealing element, when the fluid sample collection element is inserted into the holding element, the absorbent element is sealed with a cavity by the sealing element, so that the fluid in the absorbent element is sealed in a cavity in, without leaking to the external environment.
在一些优选的方式中,测试元件载体包括容纳测试元件的本体和用于收容吸收元件的腔体。优选的,测试本体上包括一个多个容纳、放置、设置测试元件的槽。收容吸收元件的腔体包括收容腔,该收容腔由开口、侧壁和底部围成。其中国,该收容腔的开口让吸收元件插入,侧壁与流体样品收集元件包括密封元件配合让吸收元件被密封在收容腔中,和底部与吸收元件接触,从而挤压出吸收元件中的流体样品。在一个优选的方式中,收容强的底部包括一通孔,被挤压出的流体样品通过该通孔从收容腔中流出。In some preferred modes, the test element carrier includes a body for accommodating the test element and a cavity for accommodating the absorbing element. Preferably, the test body includes a plurality of grooves for accommodating, placing and setting test elements. The cavity for accommodating the absorbing element includes a receiving cavity, which is surrounded by an opening, a side wall and a bottom. Among them, the opening of the receiving cavity allows the absorbing element to be inserted, and the side wall cooperates with the fluid sample collecting element including the sealing element so that the absorbing element is sealed in the containing cavity, and the bottom is in contact with the absorbing element, thereby extruding the fluid in the absorbing element sample. In a preferred manner, the bottom of the containment cell includes a through hole through which the squeezed fluid sample flows out of the containment chamber.
在一些优选的方式中,容纳测试元件的本体和用于收容吸收元件的腔体为一体结构。形成一体结构可以为一体注塑形成,也可以让容纳测试元件的本体和收容吸收元件的腔体通过激光、粘合试剂粘合形成。In some preferred manners, the body for accommodating the test element and the cavity for accommodating the absorbing element are integrally structured. The integral structure can be formed by integral injection molding, or can be formed by bonding the body for accommodating the test element and the cavity for accommodating the absorbing element by laser and adhesive reagents.
在一些优选的方式中,构成收容吸收元件的腔体的底部向外部延伸,从而形成一个底部板的结构,该底部板的一部分为腔体的底部,另外的部分与保持元件配合,从而让测试元件载体处于保持元件中的一个相对固定的位置。优选的,收容腔的底板与保持元件的腔体为大体相同的横切面,优选的,流体样品收集元件的拿捏部、收容强的底板、保持元件的腔体为大体相同的切面,例如为正方形、椭圆形、长方形、菱形、五边形、三角形、六边形、七边形等。In some preferred forms, the bottom of the cavity forming the absorbing element extends outwards, thereby forming a bottom plate structure, a part of the bottom plate is the bottom of the cavity, and the other part is matched with the holding element, so that the test The component carrier is in a relatively fixed position in the holding component. Preferably, the bottom plate of the receiving chamber and the cavity of the holding element have substantially the same cross-section, preferably, the holding part of the fluid sample collection element, the bottom plate with strong accommodation, and the cavity of the holding element have substantially the same cross-section, such as a square , Oval, Rectangle, Rhombus, Pentagon, Triangle, Hexagon, Heptagon etc.
在一些优选的方式中,保持元件为一个大体横切面为三角形的结构,保持元件包括第一腔体和第二腔体,该第一腔体用来容纳或保持测试元件载体,第二腔体用来收集或汇集吸收元件上的流体样品。在一些优选的方式中,测试元件载体的底板把保持元件的腔体分割为上下两个腔体,上腔体为第一腔体,靠近保持元件的开口并保持有测试元件载体。保持元件由包括开口、侧壁和底部围成,保持元件的开口用来插入流体样品收集元件并与流体样品收集元件的拿捏部配合,从而让流体样品收集元件处于相对固定的位置。侧壁包括多个面或者一个面,其中面对纳测试元件的本体的面为透明的,这样,通过该透明的面可以直接读取本提上测试元件上的测试结果。保持元件的其它面可以为透明,也可以不为透明的。In some preferred modes, the holding element is a substantially triangular structure in cross section, and the holding element includes a first cavity and a second cavity, the first cavity is used to accommodate or hold the test element carrier, and the second cavity Used to collect or pool fluid samples on absorbent elements. In some preferred manners, the bottom plate of the test element carrier divides the cavity of the holding element into upper and lower cavities, and the upper cavity is the first cavity, which is close to the opening of the holding element and holds the test element carrier. The holding element is surrounded by an opening, a side wall and a bottom. The opening of the holding element is used to insert the fluid sample collection element and cooperate with the handle of the fluid sample collection element, so that the fluid sample collection element is in a relatively fixed position. The side wall includes multiple faces or one face, wherein the face facing the body of the nano-test element is transparent, so that the test results on the test element can be directly read through the transparent face. The other sides of the retaining element may or may not be transparent.
在保持元件的第一腔体的底部的侧壁上具有一些结构设计,该结构为测试元件载体上的收容腔的底板提供支点,从而让测试元件载体处于保持元件中的一个固定的位置,同时,底板就把保持元件的腔体分割为上下两个腔体。提供支点的结构可以为侧壁上的突起平台,这些平台可以为多个或者至少两个,也可以是位于保持元件的腔体中的其它结构附带的支点结构。例如,保持元件的下腔体包括汇集流体样品的结构,该结构处于收容吸收元件的腔体的下面,也位于收容腔的底板的下面,在汇集结构上设置一些支点结构来为收容腔的底板提供支点。在一些优选的方式中,支点结构的支点处于同一个平面,从而让载体上的收容腔的底板处于同一个水平面。There are some structural designs on the side wall of the bottom of the first cavity of the holding element, which provides a fulcrum for the bottom plate of the receiving cavity on the test element carrier, so that the test element carrier is in a fixed position in the holding element, and at the same time , the bottom plate divides the cavity of the holding element into two cavities, the upper and the lower. The structure providing the fulcrum may be a protruding platform on the side wall, and there may be multiple or at least two platforms, or a fulcrum structure attached to other structures located in the cavity of the holding element. For example, the lower cavity of the holding element includes a structure for collecting fluid samples, which is located below the cavity for accommodating the absorbing element and also below the bottom plate of the storage cavity. Provide pivot. In some preferred manners, the fulcrums of the fulcrum structure are on the same plane, so that the bottom plates of the receiving chambers on the carrier are on the same horizontal plane.
在另外一些具体实施方式中,所述的该装置进一步包括让装置竖直站立和倾斜站立的站立结构,其中,所述的站立结构位于保持元件上。优选的,所述的竖直站立结构和倾斜站立结构再保持元件的侧壁的底部边沿形成,而且竖直站立结构和倾斜站立结构为可以互换站立状态。优选的,所述的竖直站立结构和倾斜站立结构为三角形的接触面,该接触面用来与支撑面接触;其中,竖直站立结构包括第二接触面,倾斜站立结构包括第一接触面,第一接触面和第二接触面不在同一个平面上。In some other specific embodiments, the device further comprises a standing structure allowing the device to stand vertically and stand obliquely, wherein the standing structure is located on the holding element. Preferably, the vertical standing structure and the inclined standing structure are formed on the bottom edge of the side wall of the holding element, and the vertical standing structure and the inclined standing structure are in interchangeable standing states. Preferably, the vertical standing structure and the inclined standing structure are triangular contact surfaces, and the contact surface is used to contact the supporting surface; wherein, the vertical standing structure includes a second contact surface, and the inclined standing structure includes a first contact surface , the first contact surface and the second contact surface are not on the same plane.
另一方面,本实用新型提供一种收集和检测流体样品中被分析物质的装置,该装置包括:On the other hand, the utility model provides a device for collecting and detecting an analyte in a fluid sample, the device comprising:
流体样品收集元件,其中,流体样品收集元件包括吸收液体样品的吸收元件和拿捏部,以及连接吸收元件和拿捏部的连接杆;A fluid sample collecting element, wherein the fluid sample collecting element includes an absorbing element and a handle for absorbing a liquid sample, and a connecting rod connecting the absorbing element and the handle;
测试元件载体,其中,测试元件载体包括用于承载测试元件的本体和用于收容吸收元件的收容腔,其中,本体和收容腔为一体注塑成型结构;The test element carrier, wherein the test element carrier includes a body for carrying the test element and a housing cavity for accommodating the absorbing element, wherein the body and the housing cavity are integrally formed by injection molding;
含腔的保持元件,其中,保持元件的腔由开口和开口的沿,以及侧壁围成;A cavity-containing retaining element, wherein the cavity of the retaining element is bounded by the opening, the rim of the opening, and the side walls;
其中,保持元件包括让其竖直站立和倾斜站立的结构。Wherein, the holding element includes a structure to allow it to stand upright and to stand obliquely.
在一些具体的实施方式中,所述的竖直站立结构和倾斜站立结构为三角形的接触面,该接触面用来与支撑面接触;其中,竖直站立结构包括第二接触面,倾斜站立结构包括第一接触面,第一接触面和第二接触面不在同一个平面上,其中,第二接触面让保持元件竖直站立,第一接触面让保持元件倾斜站立。In some specific embodiments, the vertical standing structure and the inclined standing structure are triangular contact surfaces, and the contact surface is used to contact the support surface; wherein, the vertical standing structure includes a second contact surface, and the inclined standing structure It includes a first contact surface, the first contact surface and the second contact surface are not on the same plane, wherein the second contact surface allows the holding element to stand vertically, and the first contact surface allows the holding element to stand obliquely.
在一些具体的实施方式中,所述的竖直站立结构和倾斜站立结构位于保持元件的侧壁的边沿上。In some specific embodiments, the vertical standing structure and the inclined standing structure are located on the edge of the side wall of the holding element.
在一些具体的实施方式中,第一接触面为侧壁的两个边沿形成的面以及两个边沿所形成的面的一端交汇而形成的支点构成,其中,所述的两个边沿的面和支点形成三角形的第一接触面。In some specific embodiments, the first contact surface is formed by a surface formed by two edges of the side wall and a fulcrum formed by the intersection of one end of the surfaces formed by the two edges, wherein the surfaces of the two edges and The fulcrum forms a triangular first contact surface.
在一些具体的实施方式中,其中,测试元件载体位于保持元件的腔中;其中,拿捏部、保持元件的开口具有相同横切面形状,横截面为正方形、椭圆形、长方形、菱形、五边形、三角形、六边形、七边形中的一种形状。In some specific embodiments, wherein the test element carrier is located in the cavity of the holding element; wherein, the handle portion and the opening of the holding element have the same cross-sectional shape, and the cross-section is square, oval, rectangular, rhombus, pentagonal , triangle, hexagon, heptagon in a shape.
有益效果Beneficial effect
使用本发明的装置,不仅可以低成本的制造,而且可以让检测和读取结果更为方面和快捷,而且制造成本低。Using the device of the present invention not only can be manufactured at low cost, but also can make detection and reading results more convenient and fast, and the manufacturing cost is low.
附图说明Description of drawings
图1为本实用新型的一个具体实施方式中的样品收集元件的结构示意图。Fig. 1 is a schematic structural diagram of a sample collection element in a specific embodiment of the present invention.
图2是本实用新型一个实施例的检测和收集装置的结构分解示意图。Fig. 2 is an exploded schematic view of the detection and collection device of an embodiment of the present invention.
图3是图2中的测试元件载体。FIG. 3 is the test element carrier in FIG. 2 .
图4是除去测试载体元件和样品收集元件后的保持元件的立体结构示意图。Fig. 4 is a schematic perspective view of the holding element after the test carrier element and the sample collection element are removed.
图5是本实用新型一个实施例的检测和收集装置配合使用过程中的纵剖面图。Fig. 5 is a longitudinal sectional view of the detection and collection device of an embodiment of the present invention during cooperating use.
图6是图5所示的装的中局部放大结构示意图。Fig. 6 is a schematic diagram of a partial enlarged structure of the device shown in Fig. 5 .
图7是进行测试后进行读取测试元件上测试结果的示意图。Fig. 7 is a schematic diagram of reading the test results on the test element after the test is performed.
图8为本实用新型一个实施例中的保持元件的“站立”结构示意图。Fig. 8 is a schematic diagram of the "standing" structure of the holding element in one embodiment of the present invention.
图9为本实用新型一个实施例中的保持元件的“站立”结构示意图。Fig. 9 is a schematic diagram of the "standing" structure of the holding element in one embodiment of the present invention.
图10为本实用新型一个实施例中的保持元件的“站立”后进行结果读取的实际使用效果图。Fig. 10 is an actual use effect diagram of reading results after the holding element "stands up" in one embodiment of the present invention.
具体实施方式detailed description
下面对本实用新型涉及的结构或这些所使用的技术术语做进一步的说明。这些说明仅仅是采用举例的方式进行说明本实用新型的方式是如何实现的,并不能对本实用新型构成任何的限制。The structures involved in the present invention or the technical terms used are further described below. These descriptions are only used as examples to illustrate how the method of the present utility model is realized, and cannot constitute any limitation to the present utility model.
检测detection
检测表示化验或测试一种物质或材料是否存在,比如,但并不限于此,化学物质、有机化合物、无机化合物、新陈代谢产物、药物或者药物代谢物、有机组织或有机组织的代谢物、核酸、蛋白质或聚合物。另外,检测表示测试物质或材料的数量。进一步说,化验还表示免疫检测,化学检测、酶检测等。To detect means to assay or test for the presence of a substance or material such as, but not limited to, a chemical substance, an organic compound, an inorganic compound, a metabolic product, a drug or a drug metabolite, an organic tissue or a metabolite of an organic tissue, a nucleic acid, protein or polymer. Additionally, detection means the amount of a substance or material tested. Further, assay also means immunoassay, chemical assay, enzyme assay, etc.
测试元件test element
多种测试元件可以组合应用到本实用新型中。测试元件包括测试条,分析测试条可以有多种形式,例如采用免疫或者化学测试形式,用于检测样品中的被分析物,例如毒品或指示身体状况的相关代谢物。在有些形式中,测试条是具有加样区,试剂区和检测结果区的吸水性材料。样品被加到加样区,利用毛细管作用流入试剂区。在试剂区,样品溶解试剂并与其混合可用于检测被分析物(如果样品中存在被分析物)。此时带有试剂的样品继续流动到检测结果区。另外的试剂被固定在检测结果区。这些被固定在检测区的试剂与被分析物(如果存在)或者与试剂区的第一种试剂进行反应并结合。在非竞争性检测形式中,如果样品中存在被分析物就会产生信号,如果被分析物不存在,则不产生信号。在竞争检测形式中,如果样品中不存在被分析物则产生信号,如果存在被分析物则不产生信号。本实用新型适用于各种分析形式。Various test elements can be combined and applied in the utility model. The test elements include test strips, which can take various forms, such as immunological or chemical tests, for detecting analytes, such as drugs or related metabolites indicative of physical conditions, in a sample. In some forms, the test strip is an absorbent material having a sample application area, a reagent area and a test result area. The sample is added to the sample application area and flows into the reagent area by capillary action. In the reagent zone, the sample dissolves and mixes with reagents that can be used to detect the analyte (if the analyte is present in the sample). At this time, the sample with the reagent continues to flow to the detection result area. Additional reagents are immobilized in the test result area. These immobilized reagents in the detection zone react with and bind to the analyte, if present, or to the first reagent in the reagent zone. In a noncompetitive assay format, a signal is generated if the analyte is present in the sample, and no signal is generated if the analyte is absent. In a competition assay format, a signal is generated if the analyte is absent from the sample and no signal is generated if the analyte is present. The utility model is applicable to various analysis forms.
当测试元件是测试条时,它可以用吸水或者非吸水性材料制成,一个测试条可以使用多种材料,用于液体的传递。测试条的一种材料可以叠加在另一种测试条材料上,例如,滤纸叠加在硝化纤维上。或者,测试条中至少含有一种材料的一个区域位于另一种至少含有一种不同材料的区域之后。在这种情况下,各区域之间液体是流通的,它们之间可以相互叠加或者不叠加。测试条上的材料可以固定在例如塑料衬片的支持物上或者硬质表面,以加强测试条可持力。When the test element is a test strip, it can be made of absorbent or non-absorbent material, and a single test strip can use multiple materials for liquid transfer. One material of the test strip can be superimposed on another test strip material, for example, filter paper superimposed on nitrocellulose. Alternatively, a region of the test strip comprising at least one material is located behind another region of the test strip comprising at least one different material. In this case, the liquids are in communication between the regions, and they may or may not be superimposed on each other. The material on the test strip can be secured to a support such as a plastic liner or a hard surface to enhance test strip retention.
在一些被检测物通过信号产生系统被检测到的实施例中(如至少一种酶与被检测物发生特异性反应),至少一种产生信号的物质可以被吸附在测试条的被分析物检测区,就如上所述特异性地吸附在测试条的材料上一样。另外,存在于测试条的加样区、试剂区、被分析物检测区,或者是遍及整个测试条的产生信号的物质可提前预处理在测试条的一个或多个材料上。可以通过将产生信号的物质溶液加到应用区的表面或者将测试条的一或多个材料浸泡在信号溶液中实现。测试条加入了信号溶液或者浸泡在溶液中之后,将测试条烘干。另外,以上方法存在于测试条的加样区、试剂区、被分析物检测区,或者是遍及整个测试条的产生信号的物质可提前预处理在测试条的一个或多个材料上。另外,存在于测试条加样区,试剂区,或检测区的信号物质作为标记试剂可以被加到测试条材料的一个或多个表面。In some embodiments where the analyte is detected by a signal generating system (eg, at least one enzyme reacts specifically with the analyte), at least one signal-generating substance can be detected by the analyte adsorbed on the test strip zone, as described above specifically adsorbs on the material of the test strip. Additionally, signal-generating substances present in the sample application region, reagent region, analyte detection region, or throughout the test strip may be pre-treated on one or more materials of the test strip in advance. This can be done by adding a solution of a signal producing substance to the surface of the application area or by soaking one or more materials of the test strip in the signal solution. After the test strips have been added to the signal solution or soaked in the solution, dry the test strips. In addition, the above methods exist in the sample loading area, reagent area, and analyte detection area of the test strip, or the signal-generating substances throughout the entire test strip can be pre-treated on one or more materials of the test strip in advance. Alternatively, a signal substance present in the application area, reagent area, or detection area of the test strip may be added to one or more surfaces of the test strip material as a labeled reagent.
测试条各区域可按如下排列:加样区,至少一个试剂区,至少一个检测结果区,至少一个控制区,至少一个掺假检测区和液体吸收区。如果检测区包括一个控制区,优选控制区位于检测结果区的被分析物检测区之后。所有这些区或其组合可以在含有一种材料的单一试纸条上。另外,这些区由不同的材料制成,并按液体传递的方向连接在一起。例如,不同区域可以直接或者间接进行液体传递。在本例子中,不同的区可以沿液体传递的方向末端和末端相连,或沿液体传递方向相互叠加,或者通过其他材料相连接,例如连接介质材料(优选吸水性材料例如滤纸,玻璃纤维或硝酸纤维素)。在用连接材料时,连接材料能使包含各区域的末端与末端相接的材料、包含各区域的末端与末端相接但液体不流通的材料、或包含各区域相互重叠(例如但不限于从头到尾重叠)但液体不流通的材料,形成液体流通。The regions of the test strip can be arranged as follows: a sample application region, at least one reagent region, at least one test result region, at least one control region, at least one adulteration detection region and a liquid absorption region. If the detection zone includes a control zone, preferably the control zone is located after the analyte detection zone of the test result zone. All or a combination of these zones can be on a single strip containing one material. Additionally, these zones are made of different materials and are joined together in the direction of fluid transfer. For example, the different regions may be directly or indirectly in fluid transfer. In this example, the different zones can be connected end to end in the direction of fluid transfer, or superimposed on each other in the direction of fluid transfer, or connected by other materials, such as connecting media materials (preferably absorbent materials such as filter paper, glass fibers or nitric acid). cellulose). When a connecting material is used, the connecting material can be a material comprising regions end-to-end, a material comprising regions end-to-end but not fluidly connected, or a material comprising regions overlapping each other (such as but not limited to de novo Overlapping to the end) but the liquid does not flow through the material, forming a liquid flow.
如果测试条含有掺假检测控制区,该区可以放置在结果检测区之前或之后。当结果判定区含有控制区,掺假控制区优选放置在控制区之前,也可以不是这样的情况。本实用新型的一个实施例,测试条是用于掺假分析判断和/或控制的控制测试条,掺假控制区可以位于控制区之前或之后,优选位于控制区之前。If the test strip contains an adulteration detection control zone, this zone can be placed before or after the result detection zone. When the result determination zone contains the control zone, the adulteration control zone is preferably placed before the control zone, which may not be the case. In one embodiment of the present invention, the test strip is a control test strip for adulteration analysis, judgment and/or control, and the adulteration control area can be located before or after the control area, preferably before the control area.
在本实用新型的具体实施方式中,测试元件或者测试条可以位于测试元件载体的中。优选的,位于测试元件载体的本体的槽中。In a specific embodiment of the invention, a test element or a test strip may be located in a test element carrier. Preferably, in a groove of the body of the test element carrier.
样品sample
用本实用新型的检测装置可以检测的样品包括生物液体(例如病例液体或者临床样品)。液体样品或者流体样品可以来源于固态或者半固态的样品,包括排泄物,生物组织和食品样品。利用任何适当的方法可以将固态或半固态的样品转化成液体样品,例如混合、捣碎、浸软、孵育、溶解或在合适的溶液中(例如水,磷酸盐溶液或其他缓冲溶液)利用酶解作用消化固体样品。“生物样品”包括来源于动物,植物和食品样品,例如包括来源于人或动物的尿,唾液,血及其成分,脊髓液、阴道分泌物,精子,粪便,汗液,分泌物,组织,器官,瘤,组织和器官的培养物,细胞培养物和介质。优选生物样品是尿。食品样品包括食品加工的物质,最终产品,肉,干酪,酒,牛奶和引用水。植物样品包括源于任何植物,植物组织,植物细胞培养物和介质。“环境样品”来源于环境(例如,来自于湖或者其他水体的液体样品,污水样品,土质样品,地下水,海水和废液样品)。环境样品还可包括污水或者其他废水。The samples that can be detected by the detection device of the present invention include biological fluids (such as case fluids or clinical samples). Liquid or fluid samples can be derived from solid or semi-solid samples, including excreta, biological tissue and food samples. Solid or semi-solid samples can be converted to liquid samples by any suitable method, such as mixing, mashing, macerating, incubating, dissolving or using enzymes in a suitable solution (such as water, phosphate solution or other buffer solution) Hydrolysis digests solid samples. "Biological samples" include samples of animal, plant and food origin, including for example urine, saliva, blood and its components, spinal fluid, vaginal fluid, sperm, feces, sweat, secretions, tissues, organs of human or animal origin , tumors, tissue and organ cultures, cell cultures and media. Preferably the biological sample is urine. Food samples include food processing substances, end products, meat, cheese, wine, milk and drinking water. Plant samples include any plant origin, plant tissues, plant cell cultures and media. "Environmental samples" are derived from the environment (eg, liquid samples from lakes or other bodies of water, sewage samples, soil samples, groundwater, seawater, and waste liquid samples). Environmental samples may also include sewage or other wastewater.
利用本实用新型和合适的检测元件,可以检测任何被分析物。优选利用本实用新型检测唾液中的毒品。Any analyte can be detected using the present invention and a suitable detection element. Preferably, the utility model is used to detect drugs in saliva.
例如,用本实用新型检测的被分析物包括但不限于,肌氨酸酐、胆红素、亚硝酸盐、蛋白(非特异性),激素(例如,人绒毛促进性激素、黄体酮激素、卵泡刺激素等),血液,白血球,糖,重金属或毒素,细菌物质(如针对特异性细菌的蛋白或糖类物质,如比如大肠杆菌0157:H7、葡萄球菌、沙门氏菌、梭菌属、弯曲菌属、L.monocytogenes、弧菌属、或仙人掌杆菌)和尿样中与生理特征相关的物质,如pH和比重。其他任何临床尿化学分析都可利用侧向横流检测形式配合本实用新型装置进行检测。For example, the analyte detected by the utility model includes, but is not limited to, creatinine, bilirubin, nitrite, protein (non-specific), hormone (for example, human chorion, progesterone hormone, follicle stimulating hormone etc.), blood, white blood cells, sugars, heavy metals or toxins, bacterial substances (such as protein or carbohydrate substances targeting specific bacteria, such as E. coli 0157:H7, Staphylococcus, Salmonella, Clostridium, Campylobacter, L .monocytogenes, Vibrios, or Opuntia sp.) and substances in urine samples associated with physiological characteristics, such as pH and specific gravity. Any other clinical urine chemical analysis can use the lateral cross-flow detection form to cooperate with the device of the utility model for detection.
被分析物质Analyte
能够用本实用新型中涉及的被分析物的例子包括一些半抗原物质,这些半抗原包括毒品(如滥用药物)。“滥用药物”(DOA)是指非医学目的地使用药品(通常起麻痹神经的作用)。滥用这些药物会导致身体和精神受到损害,产生依赖性、上瘾并且/或者死亡。药物滥用的例子包括可卡因;安非他明AMP(例如,黑美人、白色安非他命药片、右旋安非他命、右旋苯异丙胺药片、Beans);甲基苯丙胺MET(crank、甲安菲他明、crystal,speed);巴比妥酸盐BAR(如Valium ,Roche Pharmaceuticals,Nutley,New Jersey);镇静剂(即睡觉辅助药品);麦角酸酰二乙胺(LSD);抑制剂(downers,goofballs,barbs,blue devils,yellowjackets,安眠酮);三环类抗抗抑郁剂(TCA,即丙咪嗪、阿密曲替林和多虑平);二甲二氧基甲基苯胺MDMA;苯环己哌啶(PCP);四氢大麻醇(THC、pot,dope,hash,weed,等);鸦片制剂(即吗啡MOP或者、鸦片、可卡因COC;海洛因,羟二氢可待因酮);抗焦虑药与镇静催眠药,抗焦虑药是一类主要用于减轻焦虑、紧张、恐惧,稳定情绪,兼有催眠镇静作用的药物,包括苯二氮卓类BZO(benzodiazepines)、非典型BZ类、融合二氮NB23C类、苯氮卓类、BZ受体的配体类、开环BZ类、二苯甲烷衍生物、哌嗪羧酸盐类、哌啶羧酸盐类、奎唑啉酮类、噻嗪及噻唑衍生物、其他杂环类、咪唑型镇静/止痛药(如羟二氢可待因酮OXY,美沙酮MTD)、丙二醇衍生物—氨甲酸酯类、脂肪族化合物、蒽类衍生物等。使用本实用新型的检测装置也可以用于检测属于医学用途但又容易服药过量的检测,如三环类抗抑郁药(丙米嗪或类似物)和乙酰氨基酚等。这些药品被人体吸收后会分解成不同的小分子物质,这些小分子物质存在于血液、尿液、唾液、汗水等体液中或部分体液存在上述小分子物质。Examples of analytes that can be contemplated in the present invention include haptenic substances including drugs (eg, drugs of abuse). "Drugs of Abuse" (DOA) refers to the use of drugs (usually to paralyze the nerves) for non-medical purposes. Abuse of these drugs can lead to physical and mental impairment, dependence, addiction and/or death. Examples of drugs of abuse include cocaine; amphetamine AMP (e.g., Black Beauty, White Amphetamine Tablets, Dextroamphetamine, Dextroamphetamine Tablets, Beans); methamphetamine MET (crank, methamphetamine, crystal , speed); barbiturates BAR (such as Valium, Roche Pharmaceuticals, Nutley, New Jersey); sedatives (ie sleep aids); lysergic acid amide (LSD); inhibitors (downers, goofballs, barbs, blue devils, yellowjackets, methaphene); tricyclic antidepressants (TCAs, ie, imipramine, amitriptyline, and doxepin); dimethyldioxymethylaniline (MDMA); phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); opiates (ie, morphine MOP or, opium, cocaine COC; heroin, oxydihydrocodone); Sedative hypnotics, anti-anxiety drugs are a class of drugs mainly used to reduce anxiety, tension, fear, stabilize emotions, and have hypnotic and sedative effects, including benzodiazepines BZO (benzodiazepines), atypical BZ, fusion diazepam NB23Cs, benzodiazepines, BZ receptor ligands, ring-opening BZs, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazolones, thiazides and Thiazole derivatives, other heterocycles, imidazole-type sedative/analgesic drugs (such as oxydihydrocodone OXY, methadone MTD), propylene glycol derivatives-carbamates, aliphatic compounds, anthracene derivatives, etc. The detection device of the utility model can also be used for detection of medical purposes but easy to overdose, such as tricyclic antidepressants (imipramine or similar) and acetaminophen. These medicines will be decomposed into different small molecular substances after being absorbed by the human body. These small molecular substances exist in blood, urine, saliva, sweat and other body fluids or some of the above-mentioned small molecular substances exist in body fluids.
样品收集元件100sample collection element 100
本实用新型还提供流体样品收集元件100。在一个实施例中,流体或者液体样品收集元件有一吸收元件103和拿捏部101。吸收元件103通常由本领域常用的医用级别的海绵或泡沫塑料材料制成。但是许多其他材料也可制成吸收元件,例如棉花或者纸,或者其他任何具有吸水性能的材料。拿捏部通常是刚性的,有利于对吸收元件的操作。拿捏部101可以由本领域常用的材料制成,例如塑料、木材、金属或纸板。一个实施例中,拿捏部通过一个杆状结构102与吸收元件 103连接,杆状结构一端与拿捏部101连接,另一端包括具有轮边110(见附图 1),吸收元件103粘贴在其上。在一些具体的实施方式中,轮边110上包括一个密封元件108,例如硅胶弹性密封圈,用于密封吸收元件103到载体300的收容腔3041中。在一些实施例子中,拿捏部101上包括横切面为三角形的结构(见附图1)。在三角形的拿捏部101上包括围绕三角形的结构的面111,在面111 上设置或者包括有突起的边沿105,突起的边沿105可以为连续的或者不连续的围绕面111而形成。该突起的边沿105把面111分为上下两个面,第一面104,第二面106,该突起的边沿103与200保持元件的开口沿配合,让拿捏部101处于保持元件上的固定的位置,不能继续进入到保持元件200的腔中。拿捏部可以为中空的结构,这样并不显得笨重,方便操作。同时,拿捏部的设置的突起的边沿105不仅可以起到限制位置的作用,另外,也可以让手或者手指更加容易的抓紧,由于突起边沿让面111具有更大的摩擦力。在一些具体实施方式中,在三角形的拿捏部101的每个边长为2.5,3,4,5厘米。The utility model also provides a fluid sample collection element 100 . In one embodiment, the fluid or liquid sample collection element has an absorbent element 103 and a handle 101 . The absorbent member 103 is generally made of medical grade sponge or foam plastic material commonly used in the art. But many other materials could also be used to form the absorbent element, such as cotton or paper, or any other material that has water-absorbing properties. The handle is generally rigid to facilitate handling of the absorbent element. The grip part 101 can be made of commonly used materials in the field, such as plastic, wood, metal or cardboard. In one embodiment, the handle part is connected to the absorbing element 103 through a rod-shaped structure 102, one end of the rod-shaped structure is connected to the handle part 101, and the other end includes a wheel edge 110 (see Figure 1), on which the absorbing element 103 is pasted. . In some specific embodiments, the wheel rim 110 includes a sealing element 108 , such as a silicone elastic sealing ring, for sealing the absorbing element 103 into the receiving cavity 3041 of the carrier 300 . In some implementation examples, the holding portion 101 includes a triangular structure in cross-section (see FIG. 1 ). The triangular handle 101 includes a surface 111 surrounding the triangular structure, and the surface 111 is provided with or includes a protruding edge 105 , and the protruding edge 105 may be formed continuously or discontinuously around the surface 111 . The edge 105 of the protrusion divides the surface 111 into two surfaces, the first surface 104 and the second surface 106. The edge 103 of the protrusion cooperates with the opening edge of the holding element 200, so that the handle 101 is fixed on the holding element. position, no further access to the cavity of the retaining element 200 is possible. The handle part can be a hollow structure, which does not appear bulky and is convenient to operate. At the same time, the protruding edge 105 provided on the grip part can not only play a role in restricting the position, but also allow the hand or fingers to grasp it more easily, because the protruding edge allows the surface 111 to have greater friction. In some specific embodiments, each side length of the triangular handle 101 is 2.5, 3, 4, 5 cm.
在一些优选的方式中,拿捏部101的表面106的对应包括突起结构107,130。优选的,当拿捏部三角形的时候,在三个面上都设置有突起结构,该突起结构和保持元件上的凹槽配合,让拿捏部保持在保持元件200上,从而提供固定的位置。In some preferred manners, corresponding portions of the surface 106 of the handling portion 101 include protrusion structures 107 , 130 . Preferably, when the holding part is triangular, there are protruding structures on three sides, and the protruding structures cooperate with the grooves on the holding element to keep the holding part on the holding element 200, thereby providing a fixed position.
测试元件载体300Test element carrier 300
本实用新型的测试元件的载体主要用于承载测试元件的载体300,其包括容纳测试元件的本体308。本体308包括前后两个面310,311,在本体的前面310 上包括多个槽结构301,在槽301中可以设置或者放置测试元件。为了让测试元件可以固定的不容易脱落的放置在卡槽结构301中,在卡槽结构301中设置2 对突起312,313,可以保持测试元件不从槽结构301中脱落下来。在一些实施方式中,测试元件的样品吸收区域外露出本体,从卡槽301的一段开口3130延伸出来,直接与流体样品接触,检测区域位于突起对312和313之间。在一些方式中,当测试元件设置在槽301中,在面310上覆盖一层透明的薄片,例如塑料、铝箔、不干胶等,让测试条保持在一个干燥的环境或者不受外界环境的影响,例如装配过程可以避免意外损坏测试条。当然,测试条的样品吸收区域可以不露出卡槽的开口。The test element carrier of the present invention is mainly used for carrying the test element carrier 300 , which includes a body 308 for accommodating the test element. The body 308 includes two front and rear faces 310, 311, and a plurality of groove structures 301 are included on the front face 310 of the body, and test components can be arranged or placed in the grooves 301. In order to allow the test element to be placed in the slot structure 301 in a fixed manner and not easy to fall off, two pairs of protrusions 312 and 313 are provided in the slot structure 301 to keep the test element from falling out of the slot structure 301 . In some embodiments, the sample absorption area of the test element is exposed from the body, extends from an opening 3130 of the slot 301 , and directly contacts the fluid sample, and the detection area is located between the pair of protrusions 312 and 313 . In some ways, when the test element is placed in the groove 301, a layer of transparent sheet, such as plastic, aluminum foil, stickers, etc., is covered on the surface 310, so that the test strip is kept in a dry environment or protected from external environment. Influences such as the assembly process avoid accidental damage to the test strip. Of course, the sample absorbing area of the test strip may not expose the opening of the card slot.
在一些具体的实施方式中,本实用新型的测试元件的载体还包括收容吸收元件103的腔体307,该腔体包括腔体开口304和侧壁317以及底部318,开口304 和侧壁317以及底部318围成收容腔3041。在底部318上包括一个通孔306。该通孔306的直径可以小于吸收元件103的直径,当吸收元件接触到底部的时候,可以受到作用力而被挤压,从而让吸收在吸收元件103上的液体样品被挤出,从而通过通孔306流出。优选的,该通孔306的直径与吸收元件103的直径大体相当,在通孔处设置“十字架”的镂空结构,这样,当吸收元件接触到底部通孔处的“镂空”接结构,可以受到作用力而被挤压,从而让吸收在吸收元件103上的液体样品被挤出,从而通过通孔306流出或者通过镂空结构的缝隙流出道收容腔 3041之外。In some specific embodiments, the carrier of the test element of the present utility model also includes a cavity 307 for accommodating the absorbing element 103, the cavity includes a cavity opening 304 and a side wall 317 and a bottom 318, the opening 304 and the side wall 317 and The bottom 318 defines a receiving chamber 3041 . A through hole 306 is included in the bottom 318 . The diameter of the through hole 306 can be smaller than the diameter of the absorbing element 103. When the absorbing element touches the bottom, it can be squeezed by force, so that the liquid sample absorbed on the absorbing element 103 can be squeezed out, thereby passing through the Holes 306 flow out. Preferably, the diameter of the through hole 306 is roughly equivalent to the diameter of the absorbing element 103, and a "cross" hollow structure is provided at the through hole, so that when the absorbing element touches the "hollow" connection structure at the bottom through hole, it can be Forced to be squeezed, so that the liquid sample absorbed on the absorbing element 103 is squeezed out, so as to flow out through the through hole 306 or out of the receiving chamber 3041 through the slit of the hollow structure.
在一些优选的方式中,腔体307的形状或者收容腔3041的形状与吸收元件相当,但是稍微小于吸收元件的直径,但是与流体样品收集元件100的轮边110 相当,在轮边110上的突起的弹性密封圈与腔体307的收容腔3041的侧壁317 的内表面配合,可以让弹性密封圈与侧壁317的内表面接触,形成密封,从而当吸收元件被插入到收容腔307中的时候,随着吸收元件进入到收容腔3041之后,密封圈108与侧壁317的内表面形成密封,从而让吸收元件被密封在腔体307 中,不会让流体样品流出到腔体307外,从而只能让流体通过通孔318流出到腔体307外。这种密封的性质至少液密封,这样,从吸收元件被挤出的流体不会通过收容腔3041的开口304流到腔体307外面,从而只能让流体通过通孔318流出到腔体307外。In some preferred modes, the shape of the cavity 307 or the shape of the receiving cavity 3041 is equivalent to that of the absorbing element, but slightly smaller than the diameter of the absorbing element, but is equivalent to the wheel edge 110 of the fluid sample collection element 100, and the diameter on the wheel edge 110 The protruding elastic sealing ring cooperates with the inner surface of the side wall 317 of the receiving cavity 3041 of the cavity 307, so that the elastic sealing ring can contact the inner surface of the side wall 317 to form a seal, so that when the absorbing element is inserted into the receiving cavity 307 When the absorbing element enters the receiving cavity 3041, the sealing ring 108 forms a seal with the inner surface of the side wall 317, so that the absorbing element is sealed in the cavity 307, and the fluid sample will not flow out of the cavity 307 , so that the fluid can only flow out of the cavity 307 through the through hole 318 . The nature of this seal is at least liquid-tight, so that the fluid squeezed out from the absorbent element will not flow out of the cavity 307 through the opening 304 of the receiving cavity 3041, so that the fluid can only flow out of the cavity 307 through the through hole 318 .
在一些优选的方式中,腔体307与纳测试元件的本体308为一体结构,优选的,腔体307与本体308为一次性注塑成型。在一些优选的方式中,腔体的底部 318向四周延伸,形成底板305,底板的一部分为腔体的底部308,另外的剩余部分与保持元件200中的支撑结构配合,从而让测试元件载体300位于保持元件 200中某一个固定的位置。优选的,底板305包括接两个触面302,303,该两个面302,303分别位于长方形纳测试元件的本体308的两侧,大体靠近本体308 的测试槽开口的位置,大体位于本体长度方向三分之一的位置处(图2)。优选的,底板305为三角形结构,两个接触面302,303分别位于三角形的两个顶点处 (见图2,图3),而另外一个角为第三个接触面385。In some preferred manners, the cavity 307 is integrated with the body 308 of the nanotest element, preferably, the cavity 307 and the body 308 are injection molded at one time. In some preferred forms, the bottom 318 of the cavity extends around to form a bottom plate 305, a part of the bottom plate is the bottom 308 of the cavity, and the other remaining part cooperates with the support structure in the holding element 200, so that the test element carrier 300 It is located at a fixed position in the holding element 200 . Preferably, the bottom plate 305 includes two contact surfaces 302, 303, the two surfaces 302, 303 are respectively located on both sides of the body 308 of the rectangular nano-test element, generally close to the opening of the test slot of the body 308, and generally located in one-third of the length direction of the body One position (Figure 2). Preferably, the bottom plate 305 has a triangular structure, and the two contact surfaces 302, 303 are respectively located at the two vertices of the triangle (see FIG. 2, FIG. 3), and the other corner is the third contact surface 385.
由于在本体308上开有卡槽301,本体具有一定的厚度,在本体的两侧靠近两个接触面302,303的下面包括两个面326,325,这两个面与保持元件的沟槽两边的立柱1204,1291限制,从而让本体处于固定在保持元件的腔体中,优选的,让本体的前面310与保持元件200的面1220保持相对固定的位置。Since there is a card slot 301 on the body 308, the body has a certain thickness, and two surfaces 326, 325 are included below the two contact surfaces 302, 303 on both sides of the body. , 1291 is restricted, so that the body is fixed in the cavity of the holding element, preferably, the front face 310 of the body and the surface 1220 of the holding element 200 are relatively fixed.
保持元件holding element
在一个具体的实施方式中,本实用新型的保持元件200如图2,4,的形状,当然除了这样的结构,还可以具有其他合适的结构。保持元件200具有开口212 和侧壁220,和底部围成。开口212具有保持元件开口沿208,开口沿208由侧壁的厚度自然形成。该沿208与流体收集元件100上的拿捏部101的突起沿105 配合,从而让流体收集元件100插入到保持元件200中合适的位置,或者合适的某一个固定的位置(下面会有详细的介绍)。优选的,在保持元件200的开口212 的附近,侧壁220的内表面有稍微凹陷的结构209,210,该凹陷的结构与拿捏部 101的表面106的对应的突起结构107,130配合,当拿捏部101插入到保持元件的开口处,拿捏部101的表面106的对应的突起结构107,130“咔嚓”卡接进入侧壁220的内表面有稍微凹陷的结构209,210中,从而可以提示已经进入到预先设置的位置了。这样,让流体样品收集元件插入到保持元件200中,具有两个结构来限制流体样品收集元件插入到保持元件的位置,具有双重保险的作用。当然,如果拿捏部101为三角形结构(图1),而保持元件200的开口的沿208也为三角结构,可以在三角结构的三面分别设置突起和凹陷结构来进行配合,从而让拿捏部101固定在保持元件中。优选的,拿捏部101也可以起到密封保持元件200 的开口212的作用,避免保持元件内的试剂污染外部的环境。In a specific embodiment, the holding element 200 of the present invention has the shape shown in Fig. 2, 4, of course, besides this structure, it can also have other suitable structures. The holding element 200 has an opening 212 and a side wall 220, surrounded by a bottom. The opening 212 has a retaining element opening rim 208 formed naturally by the thickness of the side walls. The edge 208 cooperates with the protruding edge 105 of the handling part 101 on the fluid collection element 100, so that the fluid collection element 100 can be inserted into a suitable position in the holding element 200, or a suitable fixed position (there will be a detailed introduction below) ). Preferably, near the opening 212 of the holding element 200, the inner surface of the side wall 220 has slightly recessed structures 209, 210, and the recessed structures cooperate with the corresponding protrusion structures 107, 130 on the surface 106 of the handle 101, when the handle 101 is inserted When reaching the opening of the holding element, the corresponding protruding structures 107, 130 on the surface 106 of the handle 101 "snap" into the slightly concave structures 209, 210 on the inner surface of the side wall 220, so as to indicate that it has entered the preset position . In this way, when the fluid sample collection element is inserted into the holding element 200, there are two structures to limit the position where the fluid sample collection element is inserted into the holding element, which has the effect of double insurance. Of course, if the holding part 101 has a triangular structure (FIG. 1), and the edge 208 of the opening of the holding element 200 is also a triangular structure, protrusions and recesses can be respectively provided on the three sides of the triangular structure to cooperate, so that the holding part 101 is fixed. in the holding element. Preferably, the holding part 101 can also function to seal the opening 212 of the holding element 200, preventing the reagent in the holding element from polluting the external environment.
在一些具体的实施方式中,保持元件200的靠近底部包括流体汇集结构(图 5,图6),该汇集结构一般位于收容吸收元件103的收容腔3041的底305的下边。具体的,汇集结构一般为倾斜的板205构成,倾斜的板205一端280向上与保持原件200的侧壁2220和侧壁3220的内表面接触,在两个侧壁,侧壁2220 和侧壁3220的交汇处截止;另一端281向下与保持原件200的侧壁1220的内表面接触。在倾斜板205的另一端281与侧壁1220附近弯曲折叠为沟槽206,从板205流下的流体样品汇集到沟槽206中,从而让流体样品在沟槽206中与位于沟槽中的测试元件的吸收区域接触,从而流体沿着测试元件向上流动,完成流体样品中被分析物质的检测。本技术领域的人员,通过阅读本实用新型的描述,有理由相信随着保持元件的腔体的横切面的形状的不同,倾斜的板205也可以随着自由变化。例如,保持元件的腔体的横切面的形状的为三角形的时候,倾斜的板 205结构也可以为三角形,只是板205是倾斜的,起到引流来自收容腔3041的流体样品到沟槽中汇集的作用。In some specific embodiments, the retaining element 200 includes a fluid collection structure near the bottom (FIG. 5, FIG. 6), and the collection structure is generally located below the bottom 305 of the receiving chamber 3041 for receiving the absorbent element 103. Specifically, the collection structure is generally composed of an inclined plate 205, and one end 280 of the inclined plate 205 is in contact with the inner surface of the side wall 2220 and the side wall 3220 of the original element 200, and on the two side walls, the side wall 2220 and the side wall 3220 and the other end 281 is in contact with the inner surface of the side wall 1220 of the retaining element 200 downward. The other end 281 of the inclined plate 205 and the side wall 1220 are bent and folded into a groove 206, and the fluid sample flowing down from the plate 205 is collected in the groove 206, so that the fluid sample can be tested in the groove 206 and the groove. The absorbent regions of the elements are in contact, so that the fluid flows upward along the test element to complete the detection of the analyte in the fluid sample. Those skilled in the art, after reading the description of the utility model, have reason to believe that the inclined plate 205 can also change freely with the shape of the cross-section of the cavity of the holding element. For example, when the shape of the cross-section of the cavity of the holding element is triangular, the structure of the inclined plate 205 can also be triangular, but the plate 205 is inclined, so as to drain the fluid sample from the receiving cavity 3041 into the groove role.
在一些优选的方式中,保持元件200包括一个腔体,该腔体被收容腔体307 的底板305分隔为上腔体201和下腔体202(图5,6所示)。优选的,汇集结构位于下腔体202中,收容吸收元件的腔体307位于上腔体中,而容纳测试元件的本体308占据上腔体201和下腔体202,其中,带有测试元件的吸收区域的一头位于下腔体202中并靠近沟槽206附近,方便接触流体样品,而容纳测试元件的本体308的另一头位于上腔体201中,而且前面310直接面对侧壁1220,从而当有检测结果的时候,可以直接透过透明的侧壁1220(例如第一面1220)来读取测试元件上的测试结果,读取可以为肉眼的读取,也可以是采用读取设备进行直接读取,例如也可以用手机、照相机拍照、扫描机扫描的形似读取。In some preferred manners, the holding element 200 includes a cavity, which is divided into an upper cavity 201 and a lower cavity 202 by the bottom plate 305 of the receiving cavity 307 (shown in FIGS. 5 and 6 ). Preferably, the collecting structure is located in the lower cavity 202, the cavity 307 for accommodating the absorbing element is located in the upper cavity, and the body 308 for accommodating the test element occupies the upper cavity 201 and the lower cavity 202, wherein, the cavity with the test element One end of the absorption area is located in the lower cavity 202 and near the groove 206, which is convenient for contacting the fluid sample, while the other end of the body 308 containing the test element is located in the upper cavity 201, and the front 310 directly faces the side wall 1220, thereby When there is a test result, the test result on the test element can be read directly through the transparent side wall 1220 (such as the first surface 1220). The reading can be read by naked eyes, or by using a reading device. Direct reading, for example, can also be read with a mobile phone, a camera to take pictures, and a scanner to scan.
为了让测试元件载体在保持元件的腔中具有固定的位置,可以在保持元件中设置一个或者多个支撑结构来支撑测试元件载体。具体的讲,在保持元件的侧壁上有突出的面203,在沟槽206的底部2061的两端也具有两个面立柱1204,1291,立柱的一端从沟槽的底部连接,另一端向上延伸,另一顶形成支撑面204,291 (省略),该三个支撑面203,204,291分别与收容吸收元件的腔的底板205的接触面302,303,385对应接触,从而让承载测试元件300位于保持元件中固定的位置。这样配合立柱1204,1291之间的距离与测试元件载体的本体308的宽度相当,这样,当测试元件载体300插入到保持元件200的腔体中,具体精确的限制了测试元件载体300在保持元件的腔中的具体位置,立柱1204,1291之间的距离限制测试元件载体的本体309的左右位置,三个支撑面203,204,291限制了测试元件载体的上下位置。In order for the test element carrier to have a fixed position in the cavity of the holding element, one or more support structures can be arranged in the holding element to support the test element carrier. Specifically, there is a protruding surface 203 on the side wall of the holding element, and two surface columns 1204, 1291 are also provided at the two ends of the bottom 2061 of the groove 206. One end of the column is connected from the bottom of the groove, and the other end is upward. Extending, the other top forms supporting surfaces 204, 291 (omitted), and the three supporting surfaces 203, 204, 291 are respectively in contact with the contact surfaces 302, 303, 385 of the bottom plate 205 of the cavity containing the absorbing element, so that the bearing test element 300 is placed in the holding position. A fixed position in the component. In this way, the distance between the matching columns 1204, 1291 is equivalent to the width of the body 308 of the test element carrier. In this way, when the test element carrier 300 is inserted into the cavity of the holding element 200, the test element carrier 300 is precisely limited in the holding element. The specific position in the cavity, the distance between the columns 1204, 1291 limits the left and right position of the body 309 of the test element carrier, and the three support surfaces 203, 204, 291 limit the up and down position of the test element carrier.
更为具体的讲,在一些优选的方式中,当保持元件的侧壁为三个面围成横切面为三角形的时候,保持元件200具有三个面1220,2220,3220。其中,承载测试元件300的容纳测试元件的本体308的前面310面对保持元件200的第一面 1220,同时,在第一面的里面的下部设置沟槽206,在沟槽的两端分别设置两个立柱1204,1291,两个立柱之间具有一定的距离,该距离与容纳测试元件的本体308的宽度相当。两个立柱1204,1291从沟槽底部3061向上延伸,两个立柱的顶部具有两个面204,291(省略)。当承载测试元件300上的收容吸收元件的腔 307的底板的形状也为三角形的时候,底板305的三个接触面接302,303,385与保持元件200中的三个支撑面203,204,291对应。当承载测试元件300插入到保持元件200中,底板305的三个接触面接302,303,385与保持元件200中的三个支撑面203,204,291分别对接触,同时,容纳测试元件的本体308的下部插入到两个立柱之间的距离中,这样,不仅让当承载测试元件300固定在保持元件 200中,同时通过收容吸收元件103的收容腔307的底板把保持元件200分隔为上腔体201和下腔体202。装配的如图5和6所示(除去流体样品收集元件100)。More specifically, in some preferred manners, when the side wall of the holding element is surrounded by three faces and the cross section is triangular, the holding element 200 has three faces 1220 , 2220 , 3220 . Wherein, the front face 310 of the body 308 containing the test element carrying the test element 300 faces the first surface 1220 of the holding element 200, and at the same time, a groove 206 is provided at the bottom of the inside of the first surface, and a groove 206 is arranged at two ends of the groove respectively. The two uprights 1204, 1291 have a certain distance between the two uprights, which is equivalent to the width of the body 308 accommodating the test element. Two uprights 1204, 1291 extend upwardly from the trench bottom 3061, and the tops of the two uprights have two faces 204, 291 (omitted). When the shape of the bottom plate of the cavity 307 containing the absorbing element on the test element 300 is also triangular, the three contact surfaces 302, 303, 385 of the bottom plate 305 correspond to the three support surfaces 203, 204, 291 of the holding element 200. When the bearing test element 300 is inserted into the holding element 200, the three contact surfaces 302, 303, 385 of the bottom plate 305 are respectively in contact with the three supporting surfaces 203, 204, 291 of the holding element 200, and at the same time, the lower part of the body 308 accommodating the test element is inserted In this way, not only when the test element 300 is fixed in the holding element 200, but also the holding element 200 is divided into the upper cavity 201 and the lower cavity by the bottom plate of the receiving cavity 307 of the absorbing element 103. cavity 202 . Assembled is shown in Figures 5 and 6 (fluid sample collection element 100 removed).
为了简单的生产和装配,保持元件200以及带有的三个支撑面203,204,291 以及汇集结构,例如倾斜板205,沟槽206以及在沟槽的两端分别设置两个立柱 1204,1291等都可以一次性成型。而容纳测试元件的本体308、收容吸收元件103 的收容腔307以及构成收容腔体307的底板为连为一体结构,它们也是一次性注塑成型的。更为具体的讲,容纳测试元件的本体308的前面310上开有容纳测试元件的槽301,在后面311上设置收容吸收元件的腔体307,底板305的一边与后面311接触,或者,收容腔体307的部分侧壁由部分后面311构成,还或者,收容腔307的侧壁317单独围成而不与本体308的后面311接触。这样,在装配的时候,先把测试元件插入到本体308的前面310上的卡槽307中,然后直接把测试元件载体300通过保持元件的开口212插入到保持元件的中,从而非常容易的形成了检测装置,该检测装置包括保持元件200和位于其中的带有测试元件的测试元件载体300,形成如图5和6所示的结构(除去流体样品收集元件100)。For simple production and assembly, the holding element 200 with the three supporting surfaces 203, 204, 291 and the collection structure, such as the inclined plate 205, the groove 206 and two uprights 1204, 1291 respectively arranged at the two ends of the groove etc. can be molded at one time. The main body 308 for accommodating the test element, the accommodating cavity 307 for accommodating the absorbing component 103 and the bottom plate constituting the accommodating cavity 307 are integral structures, and they are also one-time injection molding. More specifically, a groove 301 for accommodating the test element is provided on the front 310 of the body 308 for accommodating the test element, and a cavity 307 for accommodating the absorbing element is arranged on the back 311, and one side of the bottom plate 305 is in contact with the back 311, or accommodates A part of the side wall of the cavity 307 is formed by a part of the rear surface 311 , or, the side wall 317 of the receiving cavity 307 is surrounded by itself without contacting the rear surface 311 of the body 308 . In this way, when assembling, the test element is first inserted into the draw-in groove 307 on the front 310 of the body 308, and then the test element carrier 300 is directly inserted into the holding element through the opening 212 of the holding element, thereby forming a very easy A detection device is provided, which includes a holding element 200 and a test element carrier 300 with a test element located therein, forming a structure as shown in FIGS. 5 and 6 (the fluid sample collection element 100 is removed).
本技术领域的人员,通过阅读本实用新型的描述,有理由相信随着保持元件的腔体的横切面的形状的不同,底板的结构也可以随着自由变化,例如,保持元件的腔体的横切面的形状的不同为三角形的时候,底板的结构也可以为三角形。本技术领域的人员,通过阅读本实用新型的描述,有理由相信随着保持元件的腔体的横切面的形状的不同,流体收集元件的拿捏部111结构也可以随着自由变化,例如,保持元件的腔体的横切面的形状的为三角形的时候,流体收集元件的拿捏部111结构的结构也可以为三角形。除了流体收集元件的拿捏部111,收容腔的底板305以及保持元件200的腔体201的横切面为相同的形状外,例如三角形外,还可以是其它的相互配合适合的形状,例如,在一些优选的方式中,收容腔的底板与保持元件的腔体为大体相同的横切面,优选的,流体样品收集元件的拿捏部、收容强的底板、保持元件的腔体,以及汇集结构的倾斜板都为大体相同的切面或者接欧冠,例如为正方形、椭圆形、长方形、菱形、五边形、三角形、六边形、七边形等。Those skilled in the art, by reading the description of the utility model, have reason to believe that along with the difference in the shape of the cross-section of the cavity of the holding element, the structure of the bottom plate can also be changed freely, for example, the cavity of the holding element When the difference in shape of the cross-section is triangular, the structure of the bottom plate may also be triangular. Those skilled in the art, by reading the description of the utility model, have reason to believe that as the shape of the cross section of the cavity of the holding element is different, the structure of the handle part 111 of the fluid collecting element can also be changed freely, for example, holding When the shape of the cross section of the cavity of the element is triangular, the structure of the handle portion 111 of the fluid collection element may also be triangular. In addition to the handle portion 111 of the fluid collection element, the bottom plate 305 of the receiving cavity and the cross-section of the cavity 201 of the holding element 200 are the same shape, such as a triangle, they can also be other suitable shapes for mutual cooperation, for example, in some In a preferred manner, the bottom plate of the receiving cavity and the cavity of the holding element are substantially the same cross-section, preferably, the handle portion of the fluid sample collection element, the bottom plate with strong accommodation, the cavity of the holding element, and the inclined plate of the collection structure They are all substantially the same cut planes or connected shapes, such as squares, ellipses, rectangles, rhombuses, pentagons, triangles, hexagons, heptagons, etc.
站立结构standing structure
在一些优选的方式中,该装置包括站立结构,能够让检测装置保持站立的姿势,这样方便地通过一个透明的面,例如1220来读取本体308上的测试元件上的检测结果。优选的,站立结构包括能够让保持元件倾斜站立的结构。该站立结构包括两个面401和402,该两个为非平行的面(图8),这两个面401和402 交叉处形成接触面为408(也成为交叉点),这样,两个面401和402和交叉接触面408形成一个类似三角形的接触面,三角形的接触面的各个面都处于同一个平面,该三角形形成的平面不与保持元件竖直站立的平面平行,而是具有一定的角度,例如30°;25°;45°等。当需要让保持元件200倾斜站立的时候,就让两个面401和402以及他们交叉接触面为408形成的接触面来与支撑面500(例如试验台、检测台、操作台的面)接触,他们就稳当的倾斜站立在这些这支撑面上,从而方便检验这进行读取测试元件检测区域上的测试结果,或者直接用读取设备 (手机、照相机)进行拍照读取,从而保存测试结果(图10)。In some preferred manners, the device includes a standing structure, which can keep the detection device in a standing posture, so that the detection results on the test elements on the body 308 can be read conveniently through a transparent surface, such as 1220 . Preferably, the standing structure comprises a structure enabling the holding element to stand inclined. This standing structure comprises two faces 401 and 402, and these two are non-parallel faces (Fig. 8), and the intersection of these two faces 401 and 402 forms contact face 408 (also becomes intersection point), like this, two faces 401 and 402 and the intersection contact surface 408 form a contact surface similar to a triangle, and each surface of the triangle contact surface is in the same plane, and the plane formed by the triangle is not parallel to the plane on which the holding element stands vertically, but has a certain Angle, such as 30°; 25°; 45°, etc. When it is necessary to allow the holding element 200 to stand obliquely, the contact surface formed by the two surfaces 401 and 402 and their intersecting contact surface 408 is contacted with the support surface 500 (such as the surface of a test bench, a detection bench, and an operating table), They stand on these support surfaces stably and tiltedly, so that it is convenient to check and read the test results on the detection area of the test element, or directly use the reading device (mobile phone, camera) to take pictures and read, so as to save the test results ( Figure 10).
为了更好的完成检测,站立结构还可以包括让保持元件竖直站立的结构。在优选的方式中,在两个面401和402的两端分别形成站立平面403,404,以及站立点407,平面403,404与站立点407构成一个类似三角形的结构,平面403,404 与站立点407处于同一平面,这样让保持元件200竖直的站立在台面上。竖直地让保持元件站立有利于测试元件的反应和测试。而让保持元件倾斜站立的结构可以方便测试结果的读取。In order to better complete the detection, the standing structure may also include a structure allowing the holding element to stand vertically. In a preferred manner, standing planes 403, 404 and a standing point 407 are respectively formed at the two ends of the two faces 401 and 402. The planes 403, 404 and the standing point 407 form a similar triangular structure, and the planes 403, 404 and the standing point 407 are on the same plane. This allows the holding element 200 to stand upright on the table. Standing the holding element vertically facilitates the reaction and testing of the test element. And the structure that allows the holding element to stand obliquely can facilitate the reading of the test results.
所谓的竖直站立和倾斜站立为相对的概念,一般相对于接触的支撑面500而言的,当保持远近垂直于支撑面500上的时候,一般为竖直站立,而保持元件与支撑面500具有一定的夹角的时候,称之为倾斜站立(例如图10所示意)。所以,第一接触面与第二接触面本身具有一定的夹角,例如锐角的夹角。The so-called vertical standing and inclined standing are relative concepts, generally relative to the supporting surface 500 in contact, when keeping far and near perpendicular to the supporting surface 500, it is generally standing vertically, and the holding element and the supporting surface 500 When there is a certain angle, it is called inclined standing (such as shown in Figure 10). Therefore, the first contact surface and the second contact surface themselves have a certain angle, such as an acute angle.
竖直站立和倾斜站立可以方便的互换,例如图9所示的结构,408,402和401 形成的三角形的第一接触面因为与保持元件的竖直站立的平面形成一个夹角,这样让第一三角形的接触接触支撑面500的时候,就让保持元件倾斜站立,而站立点404,406和407又构成另外一个类似三角形的第二接触面,而第二接触面与第一接触面不在同一个平面,而是第二接触面能够让保持元件竖直站立。优选的方式中,形成第一接触面的各个点或者面与形成第二接触面的各个面或者点都是在保持元件的侧壁的的底部形成,直接由围城保持元件侧壁的各个面 1220,2220,3220的底部切割而形成,不需要额外的结构,这样方便低成本的生产,例如一次性注塑成型。而侧壁220的厚度可以确定构成接触面的各个边沿的宽度的尺寸,比如侧壁越厚,侧壁所限定的边沿401,402,408,406,406,以及407 的款都越款,越有利于形成更大的实体接触面。其实,由于三角形的稳定性质可以知道,接触面只要有三个点与支撑面500接触,就可以让保持提稳定的站立,例如竖直的站立或者倾斜的站立。例如,构成接触面并不定是实体平面结构,只要形成接触面的几个边沿,例如401,402,408,406,406,以及407他们分布在侧壁的边沿上,因为位置的关系,他们可以任意构成各种形状的面,例如三角形,正方形,椭圆形,菱形等,这些边沿围成的面能够让保持元件站立,例如竖直站立或者倾斜站立。Vertical standing and inclined standing can be interchanged conveniently. For example, in the structure shown in FIG. When the triangular contact contacts the support surface 500, the holding element is allowed to stand obliquely, and the standing points 404, 406 and 407 form another second contact surface similar to a triangle, and the second contact surface is not on the same plane as the first contact surface. Instead, the second contact surface enables the holding element to stand upright. In a preferred manner, each point or surface forming the first contact surface and each surface or point forming the second contact surface are all formed at the bottom of the side wall of the holding element, and are directly surrounded by each surface 1220 of the side wall of the holding element. ,2220,3220 formed by cutting the bottom, no additional structure, which is convenient for low-cost production, such as one-time injection molding. The thickness of the side wall 220 can determine the size of the width of each edge constituting the contact surface. For example, the thicker the side wall is, the more the edges 401, 402, 408, 406, 406, and 407 defined by the side wall are, the more favorable it is to form a larger physical contact. noodle. In fact, due to the stable nature of the triangle, it can be known that as long as there are three points on the contact surface in contact with the support surface 500, it is possible to maintain a stable standing, such as standing vertically or standing obliquely. For example, the contact surface is not necessarily a solid planar structure, as long as several edges of the contact surface are formed, such as 401, 402, 408, 406, 406, and 407, they are distributed on the edges of the side walls. Because of the positional relationship, they can form surfaces of various shapes arbitrarily. Such as triangle, square, ellipse, rhombus, etc., the surface surrounded by these edges can make the holding element stand, for example stand vertically or stand obliquely.
检测进行的时候,为了让保持元件竖直站立,让第二接触面与支撑面500接触。当检测完成后,需要让保持元件倾斜的时候,只需要轻轻移动(给一个力让保持元件200倾斜的力量),就让保持元件200向后慢慢倾斜,从而让第一接触面与支撑面500接触,从而保持倾斜。从而可以容易的互换。When the detection is performed, in order to allow the holding element to stand upright, the second contact surface is brought into contact with the support surface 500 . After the detection is completed, when the holding element needs to be tilted, it only needs to be moved slightly (a force is given to make the holding element 200 tilt), and the holding element 200 is slowly tilted backward, so that the first contact surface and the support The surface 500 is in contact, thereby maintaining the inclination. Thus, they can be easily interchanged.
本领域的一般技术人员容易理解,除了本实用新型所列举的站立姿势的结构外,还有其他类似的结构能够让保持元件处于竖直站立和倾斜站立姿势的结构。或者,采用类似的设计,让让保持元件在不同的需求情况下可以同处于竖直站立的状态变换为倾斜站立姿势的状态,或者从倾斜站立姿势的状态转变为竖直站立的状态。因为竖直站立状态有利于测试元件的反应,而倾斜站立姿势的状态有利于读取测试元件上的测试结果,例如非常容易使用拍照的方式读取测试元件上的而是结果,而方便保存读取结果。Those of ordinary skill in the art can easily understand that, in addition to the structure of the standing posture listed in the utility model, there are other similar structures that can make the holding element be in the vertical standing and inclined standing postures. Or, a similar design is adopted, so that the holding element can be changed from the state of standing upright to the state of inclined standing posture under different requirements, or from the state of inclined standing posture to the state of standing vertically. Because the vertical standing state is conducive to the reaction of the test element, and the state of the inclined standing posture is conducive to reading the test result on the test element, for example, it is very easy to read the test result on the test element by taking a photo, and it is convenient to save and read Get the result.
检测方法Detection method
下面结合附图来说明如何进行流体样品中被分析物质的检测。How to detect the analyte in the fluid sample will be described below with reference to the accompanying drawings.
准备流体收集元件100,以及组装好的检测装置,该检测装置包括保持元件 200以及位于保持元件中的测试元件载体300(如图5,6所示)。用流体收集元件的吸收元件103放入到人的口中,进行唾液的收集。当整个吸收头吸满唾液样品的时候,吸收头变软。这个时候,把吸收有唾液样品的收集元件100通过保持元件200的开口212插入到保持元件的上腔体201中,随着收集元件100的进入或者插入,吸收头进入收容腔体307的收容腔3041中,由于收集元件100上带有密封元件108,从而密封元件108与收容腔3041的侧壁317的内表面接触,从而形成密封状态,从而把吸收元件103密封在收容腔304中,随着进一步的挤压,保持在吸收元件103中的唾液被挤压出来,通过通孔306流到下面位于下腔体的斜板205上,斜板汇集唾液样品到沟槽206中,与位于沟槽中的测试元件的吸收区域接触,从而唾液样品因为毛细作用沿着测试元件上升,流到检测区域,从而进行被分析物质的检测。The fluid collection element 100 and the assembled detection device are prepared. The detection device includes a holding element 200 and a test element carrier 300 located in the holding element (as shown in FIGS. 5 and 6 ). The absorbent member 103 of the fluid collection member is put into the mouth of a person to collect saliva. When the entire absorbent tip is filled with saliva sample, the absorbent tip becomes soft. At this time, the collection element 100 that has absorbed the saliva sample is inserted into the upper cavity 201 of the holding element through the opening 212 of the holding element 200, and as the collection element 100 enters or is inserted, the absorption head enters the accommodation cavity of the accommodation cavity 307 In 3041, since the collecting element 100 has the sealing element 108, the sealing element 108 is in contact with the inner surface of the side wall 317 of the receiving chamber 3041, thereby forming a sealed state, thereby sealing the absorbing element 103 in the receiving chamber 304, as Further extruding, the saliva kept in the absorbent element 103 is squeezed out, and flows through the through hole 306 to the sloping plate 205 located in the lower cavity below, and the sloping plate collects the saliva sample into the groove 206, and is located in the groove. The absorption area of the test element in the test element contacts, so that the saliva sample rises along the test element due to capillary action, and flows to the detection area, so that the analyte is detected.
当收集元件100插入到保持元件200中的时候,由于拿捏部101带有的突起边沿105与保持元件的开口208形成的边沿抵靠,让收集元件不能再向下运动,从而完成流体样品的挤压,同时,收集元件100的拿捏部101的面106上的突出结构107与保持元件的侧壁内表面的凹陷结构209配合,从而让让收集元件保持在保持元件中。另外,由于收集元件100上的密封元件与收容腔304的侧壁317 的内表面紧密接触,从而让收集元件100更加牢固的保持在保持元件的上腔体中 201中,从而不容易从保持元件中脱落出来。When the collection element 100 is inserted into the holding element 200, since the protruding edge 105 of the handling part 101 abuts against the edge formed by the opening 208 of the holding element, the collection element can no longer move downward, thereby completing the extrusion of the fluid sample. At the same time, the protruding structure 107 on the surface 106 of the handling part 101 of the collecting element 100 cooperates with the concave structure 209 on the inner surface of the side wall of the holding element, so that the collecting element is held in the holding element. In addition, since the sealing element on the collecting element 100 is in close contact with the inner surface of the side wall 317 of the receiving chamber 304, the collecting element 100 is more firmly held in the upper cavity 201 of the holding element, so that it is not easy to dislodge from the holding element. fall out.
这个时候,保持元件依靠底部的站立结构,例如第二接触面处于竖直站立的状态,例如站立点407,平面403,404与站立点407构成一个三角形的结构,这样让保持元件200竖直的站立在台面上。当需要拍摄本体308上前面310上的测试元件上的测试结果的时候,让保持元件处于倾斜的角度(图10),这样让两个面401和402交叉接触面408,形成一个类似三角形的第一接触面接触台面,倾斜的站立在台面上,方便进行拍照。At this time, the holding element relies on the standing structure of the bottom, for example, the second contact surface is in a vertical standing state, such as the standing point 407, and the planes 403, 404 and the standing point 407 form a triangular structure, so that the holding element 200 stands vertically. on the countertop. When it is necessary to take pictures of the test results on the test element on the front 310 of the body 308, the holding element is placed at an inclined angle (Fig. One contact surface touches the countertop, standing on the countertop obliquely is convenient for taking pictures.
当拍完照片后,可以直接丢弃整个测试装置,因为保持元件200,测试元件载体300和收集元件100连为一体结构。从而不会造成样品的泄露,也不会造成对环境的二次污染。After the pictures are taken, the whole test device can be discarded directly, because the holding element 200, the test element carrier 300 and the collecting element 100 are integrated into one structure. Thus, the leakage of the sample will not be caused, and the secondary pollution to the environment will not be caused.
实例1Example 1
通过将样品收集元件的吸收元件103放在受检者口中直到其充满唾液,使用本文所述的样品收集元件从150个受检者收集了150个唾液样品。在装载有样品之后,将样品收集器放在装置的保持元件200的上腔体201中的吸收元件收容腔304中压缩吸收元件、并且挤出样品,直接进行测试。50个阴性样品中掺有滥用药物的混合物,包括安非他明、可卡因、甲基苯丙胺、鸦片剂、THC和苯环己哌啶。采用同样的方法用吸元件103吸收液体,进行同样的操作。10分钟后,记录结果为阳性或者阴性。每个本体308上构制有三个测试条,每个测试条测试三种滥用药物。在三个测试条之间,测试了下面六种滥用药物:安非他命(AMP)、可卡因(COC)、甲基苯丙胺类(MET)、鸦片剂(OPI)、tetra-hydrocannabinol (THC)、和苯环己哌啶(PCP)。150 saliva samples were collected from 150 subjects using the sample collection element described herein by placing the absorbent element 103 of the sample collection element in the subject's mouth until it was full of saliva. After loading the sample, the sample collector is placed in the absorbent member receiving chamber 304 in the upper chamber 201 of the holding member 200 of the device to compress the absorbent member and extrude the sample for direct testing. The 50 negative samples were spiked with a cocktail of drugs of abuse, including amphetamines, cocaine, methamphetamine, opiates, THC and phencyclidine. Use the same method to absorb the liquid with the suction element 103, and perform the same operation. After 10 minutes, record the result as positive or negative. Three test strips are constructed on each body 308, each testing for three drugs of abuse. Between the three test strips, the following six drugs of abuse were tested: amphetamine (AMP), cocaine (COC), methamphetamine (MET), opiate (OPI), tetra-hydrocannabinol (THC), and phenylcyclo Capperidine (PCP).
没有掺杂滥用药物的100个样品全都测试为阴性。对于六种药物中的每一种,已经掺有药物混合物的50个样品全都提供了阳性结果,只是,20个样品中只有19个对于THC的测试为阳性。All 100 samples that were not adulterated with drugs of abuse tested negative. For each of the six drugs, all 50 samples that had been spiked with the drug mixture provided positive results, although only 19 of the 20 samples tested positive for THC.
然后在这些样品上进行使用广泛接受的程序的确认测试。在确认测试中,对于所有六种药物,所有50个样品测试为阳性。Confirmatory testing using widely accepted procedures is then performed on these samples. In confirmatory testing, all 50 samples tested positive for all six drugs.
实施例2——检测灵敏度实验Embodiment 2——detection sensitivity experiment
本实施例为了说明本实用新型装置和使用方法的检测灵敏度。每一个样品溶液用十个装置进行检测,共300次测试。这些装置用唾液样品检测,所使用的测试条上有被检测毒品的抗原。测试条使用竞争法,标记区有胶体金标记的抗体,测试线上有抗原。This embodiment is for the purpose of illustrating the detection sensitivity of the device and method of use of the present invention. Each sample solution was tested with ten devices for a total of 300 tests. These devices use a saliva sample on test strips that contain antigens from the drugs being tested. The test strip uses the competition method, with colloidal gold-labeled antibody in the label area and antigen on the test line.
该装置同时又用含有0倍,0.5倍,1.5倍和3倍于检测限的可卡因(COC),甲基安非他命(MAMP),苯环己哌啶(PCP),四氢大麻酚(THC),吗啡(MOP)或者安非他明(AMP)PBS溶液进行检测。例如唾液中THC的检测限是4ng/ml。因此对含有THC为0ng/ml,2ng/ml,6ng/ml和8ng/ml的PBS溶液进行检测。下表是被检测毒品的用量。The device simultaneously uses cocaine (COC), methamphetamine (MAMP), phencyclidine (PCP), tetrahydrocannabinol (THC) containing 0 times, 0.5 times, 1.5 times and 3 times the detection limit Morphine (MOP) or amphetamine (AMP) in PBS solution for detection. For example, the detection limit of THC in saliva is 4 ng/ml. Therefore, PBS solutions containing 0 ng/ml, 2 ng/ml, 6 ng/ml and 8 ng/ml of THC were tested. The table below shows the amount of drugs tested.
进行检测时,上述阴性唾液,PBS,或掺料的PBS被样品收集器的吸收海绵吸收,然后挤出进入吸收头收容腔进行测试,让液体进入沟槽206中与测试条接触,液体利用毛细管作用通过测试条。10分钟后记录测试结果并显示在下表中。When testing, the above-mentioned negative saliva, PBS, or PBS spiked is absorbed by the absorbent sponge of the sample collector, and then extruded into the absorptive head receiving cavity for testing, allowing the liquid to enter the groove 206 to contact the test strip, and the liquid uses the capillary Function through test strips. The test results were recorded after 10 minutes and displayed in the table below.
在缺少本文中所具体公开的任何元件、限制的情况下,可以实现本文所示和所述的实用新型。所采用的术语和表达法被用作说明的术语而非限制,并且不希望在这些术语和表达法的使用中排除所示和所述的特征或其部分的任何等同物,而且应该认识到各种改型在本实用新型的范围内都是可行的。因此应该理解,尽管通过各种实施例和可选的特征具体公开了本实用新型,但是本文所述的概念的修改和变型可以被本领域普通技术人员所采用,并且认为这些修改和变型落入所附权利要求书限定的本实用新型的范围之内。The invention shown and described herein can be practiced in the absence of any element, limitation, specifically disclosed herein. The terms and expressions employed are used as terms of description and not of limitation, and there is no intention in the use of these terms and expressions to exclude any equivalents of the features shown and described or parts thereof, and it should be recognized that each All modifications are feasible within the scope of the present utility model. It should therefore be understood that while the invention has been specifically disclosed by way of various embodiments and optional features, modifications and variations of the concepts described herein may be employed by those of ordinary skill in the art and are considered to fall within within the scope of the invention as defined by the appended claims.
本文中所述或记载的文章、专利、专利申请以及所有其他文献和以电子方式可得的信息的内容在某种程度上全文包括在此以作参考,就如同每个单独的出版物被具体和单独指出以作参考一样。申请人保留把来自任何这种文章、专利、专利申请或其他文献的任何及所有材料和信息结合入本申请中的权利。The contents of articles, patents, patent applications, and all other literature and electronically available information described or recorded herein are hereby incorporated by reference in their entirety to the same extent as if each individual publication were specifically identified Same as pointing out individually for reference. Applicants reserve the right to incorporate into this application any and all materials and information from any such articles, patents, patent applications, or other documents.
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CN110441091A (en) * | 2018-05-03 | 2019-11-12 | 浙江东方基因生物制品股份有限公司 | A kind of device collected and detect analyte in fluid sample |
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CN108120828B (en) * | 2016-11-30 | 2025-01-07 | 杭州博拓生物科技股份有限公司 | Device and method for detecting an analyte in a fluid sample |
CN110441091A (en) * | 2018-05-03 | 2019-11-12 | 浙江东方基因生物制品股份有限公司 | A kind of device collected and detect analyte in fluid sample |
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