CN114814189A

CN114814189A - Detection device

Info

Publication number: CN114814189A
Application number: CN202110084209.0A
Authority: CN
Inventors: 雷似愚; 沈莉荔; 方剑秋
Original assignee: Zhejiang Orient Gene Biotech Co Ltd
Current assignee: Zhejiang Orient Gene Biotech Co Ltd
Priority date: 2021-01-21
Filing date: 2021-01-21
Publication date: 2022-07-29

Abstract

The invention provides a detection device, which comprises a storage cavity, wherein an additive is arranged in the storage cavity, a sharp part is arranged in the detection device, the storage cavity can move relative to the sharp part, the storage cavity can be punctured by the sharp part in the moving process of the storage cavity, so that the additive in the storage cavity can be released, the detection device also comprises a collection cavity, the released additive can enter the collection cavity, the collection cavity is used for accommodating a sample, the collection cavity is arranged in a first shell, an opening is arranged at the upper side position of the first shell, a test element for detecting an analyzed substance is arranged in the collection cavity, the test element is arranged on a carrier, and the carrier and the collection cavity have a specific matching form. The buffer solution is arranged in an independent cavity in the detection device, and can be obtained at any time when detection is needed, so that the use is very convenient; the carrier has a specific form of fit with the collection chamber in the first housing to allow a defined, unique orientation of the carrier after insertion into the collection chamber.

Description

Detection device

Technical Field

The invention relates to the technical field of in-vitro rapid detection, in particular to a device for collecting and detecting analyzed substances in a liquid sample in the field of rapid diagnosis, such as a urine and saliva collecting and detecting device.

Background

The following background description is merely an introduction to the general knowledge and is not intended to limit the invention in any way.

Currently, a large number of test devices for detecting whether a sample contains an analyte are used in hospitals or homes, and these test devices for rapid diagnosis include one or more test reagent strips, such as an early pregnancy test, a drug abuse test, and the like. The rapid diagnosis test device is convenient, and can obtain the test result on the test reagent strip within one minute or at most ten minutes.

Drug detection is widely applied and is commonly used in drug-resistant departments, public security bureaus, drug rehabilitation centers, physical examination centers, national soldier physical examination places and other institutions. The drug detection is various in types and frequent in times. Some require the collection of a sample and then require a specialized testing facility or testing laboratory to perform the test. Some people need to complete detection on site in time, for example, people who drive after taking poison (called poison driving for short) need to perform detection on site, and then obtain the detection result in time. And (4) detecting drugs, wherein the samples can be urine, sweat, hair and saliva samples.

In some tests, in order to obtain a more accurate test result, a buffer solution is added to a sample in the test process, so that the pH value of the solution is relatively stable to a certain extent. And because buffer solution exposes can breed the bacterium under room temperature air for a long time, the metabolite of bacterium can change the pH valve of buffer solution, so in order to avoid contacting with the air, buffer solution generally can not directly be located detection device, and under most circumstances, buffer solution and detection device separately deposit, add in addition when detecting again, and this kind of mode is operated very loaded down with trivial details.

There is a need for an improved conventional test device that provides a simpler means of sample collection and testing.

Disclosure of Invention

The present invention is directed to a detection device to solve the above problems.

In order to achieve the above object, the present invention provides a detection device, which includes a storage chamber, an additive disposed in the storage chamber, and a sharp portion disposed in the detection device, wherein the storage chamber is capable of moving relative to the sharp portion, and the storage chamber is pierced by the sharp portion during the movement of the storage chamber, so that the additive in the storage chamber is released.

Further, a collecting chamber is included, into which the released additive can enter.

Further, the collection cavity is used for containing a sample, the collection cavity is arranged in the first shell, and an opening is formed in the upper side of the first shell. Furthermore, a test element for detecting the analyte is arranged in the collection cavity.

Further, the test element is arranged on a carrier, which carrier has a specific matching form with the collecting chamber, and which carrier can be inserted into the collecting chamber from an opening at a position on the upper side of the first housing, and which carrier has a defined, unique orientation position when inserted into the collecting chamber.

Furthermore, a clamping strip is arranged in the collection cavity, one carrier is fixed through two clamping strips, and one side of the carrier, on which the test element is arranged, is attached to the inner wall of one side of the collection cavity.

Furthermore, the thickness of the upper end of the clamping strip is smaller, and the thickness of the lower end of the clamping strip is larger; correspondingly, the thickness of the bottom position of the carrier is smaller, and the thickness of the top position of the carrier is larger.

Furthermore, a corner of the collecting cavity is provided with a round corner; correspondingly, the two sides of the surface of the carrier, on which the test element is arranged, are also provided with round corners.

Further, a sample collector for collecting a sample is included, the sample collector including a closed end that can be used to close the opening of the collection chamber.

Further, the sample collector further comprises a sampling end and a rod, wherein the sampling end is connected with the absorption element, the rod is used for connecting the cover end and the sampling end, and the rod is detachably connected with the cover end.

Further, the sample collector and/or the collection cavity are provided with holes which enable the collection cavity to be in gas communication with the outside.

Furthermore, a hollow pipe extending towards the direction of the collecting cavity is arranged at the hole position on the covering end.

Further, the diameter of the hole is less than 1 mm.

Further, the liquid in the storage cavity is a buffer liquid.

Furthermore, the cover end of the sample collector is provided with a connector back to one side of the rod body, the connector is hollow, and the storage cavity can enter the hollow position of the connector.

Furthermore, the sharp part is in a protruding shape and is arranged at the hollow position of the connector.

Furthermore, the storage cavity is arranged in the second shell, a layer of sealing film is arranged on the second shell and used for sealing liquid in the storage cavity, the storage cavity enters the hollow position of the connector, and the sharp part can puncture the sealing film on the second shell, so that the liquid in the storage cavity is released.

Furthermore, the sharp part is provided with a through hole which penetrates up and down.

Furthermore, a second sealing ring is arranged on the second shell, and the second sealing ring can fill a gap between the second shell and the connector.

Furthermore, the detection device also comprises a cover body, and the cover body is connected with the second shell body together, wherein the connection relationship is detachable or non-detachable.

Further, the cover body and the connector can be mutually covered.

Furthermore, the cover body and the connector are provided with matched threads.

Furthermore, the upper end of the second shell of the cover body and the second shell is provided with a rotating part, the rotating part is provided with a first bulge, the cover body is provided with a connecting hole, and the rotating part can be inserted into the connecting hole and buckled on the connecting hole through the first bulge to enable the second shell to rotate on the connecting hole.

Further, the detection device also comprises a protection element for limiting the cover body from being excessively covered.

Further, detection device still closes excessive protection component including being used for restricting the lid, and protection component is including supporting the section, and the support section cover is on the connector, and the lower extreme of supporting the section can close with the lid and hold the upper surface butt, supports the section upper end and can and lid butt.

Furthermore, the supporting section is in a hollow cylindrical shape and is sleeved on the connecting head.

Furthermore, a first notch is arranged on the supporting section of the protection element.

Further, the protective element has elasticity.

Furthermore, the protection element also comprises a holding part, stripes are arranged on the holding part, the position of the holding part is connected with the supporting section, and the connecting position of the holding part and the supporting section just faces the first notch.

Further, the protection component is located support section bottom position and is equipped with the second arch of inside convex, and the second arch is the annular, corresponds with it, and the connector is close to bottom position and also is equipped with annular structure, and the second arch can be gone into annular structure and the lid and close in the gap between the end upper surface.

Furthermore, a second notch is formed in the annular structure, a third protrusion which is opposite to the first notch is arranged on the inner side of the supporting section of the protection element, and the third protrusion can be embedded into the second notch.

Furthermore, the cover end is rectangular, and the second notch is positioned on one side close to the long edge of the cover end.

Furthermore, a retaining wall is arranged on the supporting section of the protection element, and the retaining wall is arc-shaped.

Further, the inner diameter of the protective element at the location of the retaining wall is larger than the inner diameter of the protective element at the location of the support section.

Furthermore, a buckle is arranged on the inner side of the blocking wall, a circle of flange is arranged at the bottom of the cover body, and the flange of the cover body can enter the blocking wall and is buckled below the buckle.

Furthermore, the upper end of the flange is horizontal, and the lower end surface of the buckle is also horizontal; the upper end of the buckle is in an inclined plane shape, and a chamfer is arranged at the lower side position of the flange of the cover body.

In conclusion, the beneficial effects of the invention are as follows: the buffer solution is arranged in an independent cavity in the detection device, and can be obtained at any time when detection is needed, so that the use is very convenient; the carrier and the collection cavity in the first shell have a specific matching form, so that the carrier has a determined and unique direction position after being inserted into the collection cavity; the sample collector is provided with a hole for communicating the collecting cavity with the outside air, so that the covering problem caused by air pressure in the use process of the detection device can be eliminated, and meanwhile, the hollow pipe extending towards the direction of the collecting cavity is arranged at the position of the hole on the covering end, so that the leakage of the sample can be avoided; the bottom of the collection cavity is provided with an extruding part which is upwards opened and is in a circular truncated cone shape, when an absorption element on the sampling end is contacted with the extruding part to extrude a sample, the circular truncated cone-shaped opening can extrude the side part of the absorption element besides the bottom of the extruding part, so that the extruding efficiency is improved, more liquid samples can be released, and the samples can be gathered to a certain extent; the detection device also comprises a protection element for limiting the excessive covering of the cover body, and the protection element can prevent the storage cavity from being punctured by a sharp part before detection; be equipped with a plurality of recesses on the carrier surface, can be used for installing different test element, realize the function of multiple detection of single.

Drawings

FIG. 1 is a schematic view of the overall structure of a detection apparatus;

FIG. 2 is a fully exploded view of the detection device;

FIG. 3 is a schematic view of the carrier as installed in the first housing;

fig. 4 is a front sectional view of the first housing;

FIG. 5 is a side sectional view of the first housing;

FIG. 6 is an exploded view of the detection device in use;

FIG. 7 is an enlarged partial schematic view of region "A" in FIG. 6;

FIG. 8 is a top view of the first housing;

FIG. 9 is a schematic view of the structure of the capped end;

FIG. 10 is a schematic view of the second housing installed in the cover;

fig. 11 is a schematic structural view of the protective member.

Detailed Description

The structures referred to in the present invention or these terms of art used therein are further described below, and if not otherwise indicated, they are understood and interpreted in accordance with the common general terminology used in the art.

Detection of

Detection refers to assaying or testing for the presence of a substance or material, such as, but not limited to, a chemical, organic compound, inorganic compound, metabolic product, drug or drug metabolite, organic tissue or a metabolite of organic tissue, nucleic acid, protein, or polymer. In addition, detection indicates the amount of the test substance or material. Further, the assay means immunodetection, chemical detection, enzyme detection, and the like.

Sample(s)

The test device or collected sample of the present invention comprises a biological fluid (e.g., a case fluid or a clinical sample). Liquid or liquid samples, or fluid samples, may be derived from solid or semi-solid samples, including fecal, biological tissue and food samples. The solid or semi-solid sample may be converted to a liquid sample by any suitable method, such as mixing, triturating, macerating, incubating, dissolving, or enzymatically digesting a solid sample in a suitable solution (e.g., water, phosphate solution, or other buffered solution). "biological samples" include samples derived from animals, plants and food, including, for example, urine, saliva, blood and components thereof, spinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, cultures, cell cultures and media of tissues and organs derived from humans or animals. Preferably, the biological sample is urine and preferably, the biological sample is saliva. Food samples include food processing materials, end products, meat, cheese, wine, milk and drinking water. Plant samples include those derived from any plant, plant tissue, plant cell culture and medium. An "environmental sample" is derived from the environment (e.g., a liquid sample from a lake or other body of water, a sewage sample, a soil sample, groundwater, seawater, and a waste liquid sample). Environmental samples may also include sewage or other wastewater.

Any analyte can be detected using a suitable detection element or test element of the present invention. The invention is preferably used for detecting drug small molecules in saliva and urine. Of course, any of the above forms of samples, whether initially solid or liquid, may be collected using the collection device of the present invention, provided that the liquid or liquid sample is absorbed by the absorbent member. Absorbent members herein are generally made of a water-absorbent material that is initially dry and capable of absorbing a liquid or fluid sample by capillary or other properties of the absorbent member material. The absorbent material may be any material capable of absorbing liquid, such as sponge, filter paper, polyester fiber, gel, nonwoven fabric, cotton, polyester film, yarn, and the like. Of course the absorbent member need not be made of absorbent material and may be made of non-absorbent material, but rather the absorbent member has holes, threads, cavities therein, and samples, typically solid or semi-solid samples, may be collected on such structures and filled between the threads, the holes, or the pores.

Downstream and upstream

Downstream or upstream is divided with respect to the direction of liquid flow, typically liquid flows from upstream to downstream regions. The downstream region receives liquid from the upstream region, and liquid may also flow along the upstream region to the downstream region. It is also generally divided in the direction of liquid flow, for example, on materials that use capillary forces to urge liquid flow, the liquid may flow by gravity in the opposite direction to gravity, and in this case, the upstream and downstream are also divided in the direction of liquid flow.

Gas or liquid communication

By gas or liquid communication is meant that liquid or gas can flow from one place to another, possibly guided by some physical structure during the flow. By physical structures is generally meant that the liquid flows passively or actively to another place through the surface of the physical structures or the space inside the physical structures, and passively is generally a flow caused by external force, such as a flow under capillary action. The flow here can also be a liquid or a gas, because of its own effect (gravity or pressure), or a passive flow. Communication herein does not necessarily mean that a liquid or gas is required to be present, but merely that in some cases a connection or condition between two objects, if any, may flow from one object to the other. This refers to a state in which two objects are connected, and conversely, if there is no liquid communication or gas communication between the two objects, if there is liquid in or on one object, the liquid cannot flow into or on the other object, and such a state is a state of non-communication, non-liquid or gas communication.

Test element

The term "test element" as used herein refers to an element that can detect whether a sample or specimen contains an analyte of interest, and the detection can be based on any technical principles, such as immunology, chemistry, electricity, optics, molecular, nucleic acid, physics, etc. The test element may be a lateral flow test strip which detects a plurality of analytes. Of course, other suitable test elements may be used with the present invention.

Various test elements may be combined for use in the present invention. One form is a test strip. Test strips for the analysis of analytes, such as drugs or metabolites indicative of a physical condition, in a sample may be in various forms, such as immunoassay or chemical assay forms. The test strip may be used in a non-competitive or competitive assay format. The test strip generally comprises a bibulous material having a sample application area, a reagent area, and a test area. The sample is added to the sample addition zone and flows to the reagent zone by capillary action. In the reagent zone, the sample binds to the reagent if the analyte is present. The sample then continues to flow to the detection zone. Other reagents, such as molecules that specifically bind to the analyte, are immobilized at the detection zone. These reagents react with the analyte (if present) in the sample and bind the analyte to the zone, or to one of the reagents of the reagent zone. The label for indicating the detection signal is present in the reagent zone or in a separate label zone.

A typical non-competitive assay format is one in which a signal is generated if the sample contains the analyte and no signal is generated if the analyte is not present. In a competition method, a signal is generated if the analyte is not present in the sample and no signal is generated if the analyte is present.

The test element can be a test paper, and can be made of water-absorbing or non-water-absorbing materials. The test strip may include a variety of materials for liquid sample delivery. One of the test strips may be coated with another material, such as a nitrocellulose membrane coated with filter paper. One region of the test strip may be selected from one or more materials and another region may be selected from a different one or more materials. The test strip may be adhered to some support or hard surface for improved strength when the test strip is held in place.

The analyte is detected by a signal producing system, such as one or more enzymes that specifically react with the analyte, and one or more compositions of the signal producing system are immobilized on the analyte detection zone of the test strip by a method such as that described above for the immobilization of a specific binding substance on the test strip. The signal-producing substance can be on the sample addition zone, reagent zone, or detection zone, or the entire test strip, and the substance can be impregnated on one or more materials of the test strip. A solution containing the signal is applied to the surface of the strip or one or more materials of the strip are immersed in the solution containing the signal. The strip to which the solution containing the signal substance was added was dried.

The various regions of the test strip may be arranged as follows: the device comprises a sample adding area, a reagent area, a detection area, a control area, a sample adulteration area and a liquid sample absorption area. The control zone is located behind the detection zone. All zones may be arranged on a strip of test paper using only one material. It is also possible to use different materials for the different zones. The zones may be in direct contact with the liquid sample, or different zones may be arranged according to the direction of flow of the liquid sample, with the ends of each zone being contiguous with and overlapping the ends of the other zone. The material used can be a material with good water absorption such as filter paper, glass fiber or nitrocellulose membrane. The test strip may take other forms.

A commonly used reagent strip is a nitrocellulose membrane reagent strip, i.e., a detection area comprises a nitrocellulose membrane, and a specific binding molecule is fixed on the nitrocellulose membrane to display the detection result; and may be a cellulose acetate film, a nylon film, or the like. Such as the reagent strips or devices containing the reagent strips described in some of the following patents: US 4857453; US 5073484; US 5119831; US 5185127; US 5275785; US 5416000; US 5504013; US 5602040; US 5622871; US 5654162; US 5656503; US 5686315; US 5766961; US 5770460; US 5916815; US 5976895; US 6248598; US 6140136; US 6187269; US 6187598; US 6228660; US 6235241; US 6306642; US 6352862; US 6372515; US 6379620; and US 6403383. The test strips disclosed in the above patent documents and similar devices with test strips can be applied to the test element or the test device of the present invention for detecting an analyte, such as an analyte in a sample.

The test strip used in the present invention may be a so-called Lateral flow test strip (Lateral flow test strip), and the specific structure and detection principle of these test strips are well known to those skilled in the art. A typical test strip comprises a sample collection area or application area, a labeling area comprising a label pad, a detection area comprising a bibulous pad, and a bibulous area comprising the necessary chemicals to detect the presence of the analyte, such as immunological or enzymatic reagents. A commonly used detection reagent strip is a nitrocellulose membrane reagent strip, that is, a detection area comprises a nitrocellulose membrane, and a specific binding molecule is fixed on the nitrocellulose membrane to display a detection result; it may be a cellulose acetate film, a nylon film, etc., and it may also include a detection result control region downstream of the detection region, and usually, the control region and the detection region are in the form of a transverse line, which is a detection line or a control line. Such test strips are conventional, but other types of test strips that utilize capillary action for testing are also contemplated. In addition, typically, the test strip has a dry chemical reagent component, such as an immobilized antibody or other reagent, which when exposed to a liquid, flows along the test strip by capillary action, and as it flows, the dry reagent component is dissolved in the liquid, and the next zone is processed to react the dry reagent in that zone, thereby performing the necessary test. The liquid flow is mainly by capillary action. The detection device can be used in the detection device of the present invention, or can be disposed in the detection chamber to contact the liquid sample, or can be used to detect the presence or quantity of an analyte in the liquid sample entering the detection chamber.

In addition to the test strips described above or the lateral flow test strip itself being used to contact a fluid sample to determine whether the fluid sample contains an analyte. In some preferred forms, the test elements may also be provided on some carriers, such as carrier 40 shown in fig. 3, which have a plurality of recesses 43 therein, the test elements being located in the recesses 43. In some embodiments, carrier 40 includes a recessed area for receiving test elements, where a plurality of recesses are provided, each of which may receive a test strip, each of which may detect an analyte. The carrier 40 is in a form matching with the collection cavity 22, for example, the collection cavity 22 is a square cavity, correspondingly, the plate-shaped carrier 40 can be placed in the collection cavity 22, a plurality of grooves 43 are arranged on the outer surface of the carrier 40, the grooves 43 are also uniformly arranged in an array manner, test elements are placed in the grooves 43, the test elements can be test strips, sharp corners 41 are arranged on two sides in the grooves 43, and the sharp corners 41 can clamp the test strips in the grooves 43, so that the test strips are mainly used for fixing the test strips. In some embodiments, after the test elements are disposed in recesses 43 of carrier 40, carrier 40 is covered with a transparent film, which seals the recess areas of carrier 40 and facilitates viewing of the test results on the final test areas. The transparent film may also be a transparent plastic sheet, transparent only in the test area.

Typically, the test strip includes a sample application area, a labeling area and a detection area, the sample application area being positioned near the bottom of the carrier and slightly exposing the recess, for example 2-3 mm, when the test strip is placed, with a portion of the sample application area reserved to absorb fluid sample flowing into the bottom of the collection chamber 22. Typically, the sample application zone is located upstream of the labeling zone, which is located upstream of the detection zone.

Carrier and collection chamber

The collection chamber is a place for containing a sample, the collection chamber 22 is provided in the first housing 20, the collection chamber 22 includes an opening at an upper side position of the first housing 20, and the carrier 40 is inserted into the collection chamber 22 from the opening at the upper side position of the first housing 20. In some forms, carrier 40 is of a form that has a specific fit with collection chamber 22. With this form of mating, the carrier is allowed to have a defined, unique orientation position after insertion into the collection chamber. Specifically, referring to fig. 5, a card strip 21 is disposed in the collection cavity 22, preferably two card strips 21 are fixed on one carrier 40, the two card strips 21 can limit the carrier 40 in the collection cavity 22 by limiting two sides of the carrier 40, and allow one side of the carrier 40 on which the test strip is mounted to be attached to the inner wall of one side of the collection cavity 22, and the first casing 20 is preferably made of a transparent material, so that the inspector can directly read the detection result from the carrier 40. Further, referring to fig. 5, the thickness of the upper end of the clip strip 21 is smaller, the thickness of the lower end is larger, and accordingly, the thickness of the bottom of the carrier 40 is smaller, and the thickness of the top of the carrier 40 is larger, so that the carrier 40 cannot be inserted into the collection chamber 22 in a reversed manner. In addition, the corner position of collecting chamber 22 is equipped with the fillet, it is corresponding, the both sides that are equipped with the test strip one side on the carrier 40 also are equipped with the fillet, this makes carrier 40 can slide down only when it is equipped with the test strip one side and collects the chamber 22 inner wall laminating, when the carrier 40 is gone up the one side of keeping away from the test strip and is slided down with the inner wall laminating of collecting chamber 22, because the both sides that are the one side of keeping away from the test strip on the carrier 40 are the non-fillet (both sides are the closed angle), at the gliding in-process, this non-fillet can block with the fillet of collecting chamber 22 corner position, lead to carrier 40 unable packing into in the collecting chamber 22, the specific matching form of carrier 40 with collection chamber 22 has been realized.

Analyte substance

Examples of analytes that can be used in the present invention include small molecule substances, including drugs of abuse (e.g., drugs of abuse). By "drug of abuse" (DOA) is meant the use of a drug (usually acting to paralyze nerves) at a non-medical destination. Abuse of these drugs can result in physical and mental damage, dependence, addiction and/or death. Examples of drug abuse include cocaine; amphetamine AMP (e.g., black americane, white amphetamine tablets, dextroamphetamine tablets, Beans); methamphetamine MET (crank, methamphetamine, crystal, speed); barbiturate BAR (e.g., Valium, Roche Pharmaceuticals, Nutley, New Jersey); sedatives (i.e., sleep-aid drugs); lysergic acid diethylamide (LSD); inhibitors (downs, goofballs, barbs, blue devils, yellow jacks, hypnones); tricyclic antidepressants (TCAs, i.e., imipramine, amitriptyline and doxepin); dimethyldioxymethylaniline MDMA; phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); opiates (i.e. morphine MOP or, opiates, cocaine COC, heroin, dihydrocodeinone); anxiolytic and sedative hypnotic, anxiolytic is a kind of mainly used for relieving anxiety, stress, fear, stabilize mood, have hypnotic sedative effects at the same time, including benzodiazepine BZO (benzodiazepines), atypical BZ, fuse dinitrogen NB23C, benzodiazepine, BZ receptor ligand, ring-opening BZ, diphenylmethane derivatives, piperazine carboxylate, piperidine carboxylate, quinazolone, thiazine and thiazole derivatives, other heterocycles, imidazole type sedative/analgesic (such as dihydrocodeinone OXY, methadone MTD), propylene glycol derivative-carbamate, aliphatic compound, anthracene derivatives, etc.. The detection device of the invention can also be used for detecting the detection which belongs to the medical application and is easy to take overdose, such as tricyclic antidepressant (imipramine or the like) and acetaminophen. After being absorbed by human body, the medicines are metabolized into small molecular substances, and the small molecular substances exist in body fluids such as blood, urine, saliva, sweat and the like or exist in partial body fluids.

For example, analytes to be detected using the present invention include, but are not limited to, creatinine, bilirubin, nitrite, protein (non-specific), hormones (e.g., human chorionic gonadotropin, progesterone hormone, follicle stimulating hormone, etc.), blood, leukocytes, sugars, heavy metals or toxins, bacterial material (e.g., proteins or carbohydrate materials directed against specific bacteria, such as Escherichia coli 0157: H7, staphylococci, Salmonella, Clostridium, Campylobacter, L.monocytogenes, Vibrio, or Cactus), and substances associated with physiological characteristics in urine samples, such as pH and specific gravity. Any other clinical urine chemistry assay can be tested using a lateral flow assay format in conjunction with the device of the present invention.

Flow of liquid

The flow of liquid usually refers to a flow from one place to another, and in general, the natural liquid flow mostly depends on gravity from high to low, and the flow here also depends on external force, i.e. the flow under the external gravity condition, and can be the natural gravity flow. In addition to gravity, the flow of liquid may also overcome gravity and move from low to high. For example, the liquid is pumped, or the liquid is compressed, or the liquid is pressurized and flows from the bottom to the top, or the pressure is concerned and flows by the gravity of the liquid itself. For example, in the present embodiment, if there is a liquid sample in the collection cavity 22, the liquid sample will collect to the bottom of the collection cavity 22 under the action of gravity, and when the liquid sample at the bottom of the collection cavity 22 contacts with the lower end of the test strip on the carrier 40, the liquid sample starts to flow from bottom to top by virtue of capillary force for detection.

Sample collector and collection chamber

The sample collector is used for collecting samples, and as shown in fig. 6 in particular, the sample collector 30 comprises a cover end 31, a rod 32 and a sampling end 33, the cover end 31 can be used for covering the opening of the collection cavity 22 to prevent the sample in the collection cavity 22 from leaking, the sampling end 33 is used for connecting an absorbent element, the absorbent element can be a nontoxic sponge with strong water absorption, the absorbent element and the sampling end 33 can be bonded through special glue, when the sample collector 30 is inserted into the collection cavity 22 along the opening of the collection cavity 22, an absorbent element (not shown) on the sampling end 33 is pressed with the bottom of the collection cavity 22, the sample is squeezed out of the absorbent element, and as the sample collector 30 moves downwards, the liquid sample in the absorbent element is squeezed out continuously until the cover end 31 completely covers the opening of the collection cavity 22, at this time, the sample collector 30 cannot move downwards continuously, the absorbent element is also in a compressed state.

Preferably, the upper end of the rod 32 is detachably connected with the cover end 31, for example, by screw-fitting connection, which is convenient for production.

In the process of covering the collecting cavity 22 by the covering end 31, because the collecting cavity 22 is closed, the air pressure inside the collecting cavity 22 is increased along with the covering of the covering end 31, which may cause the covering end 31 not to be completely covered (the covering is not firm), or the covering end 31 is easy to pop out after being covered. Preferably, to eliminate the effects of air pressure, the sample collector 30 and/or the collection chamber 22 are provided with an aperture that allows the collection chamber 22 to communicate with the atmosphere. For example, in fig. 7, the covering end 31 is provided with a hole 35, the diameter of the hole 35 is less than 1mm, and the covering end 31 provided with the hole 35 can be well covered with the collecting cavity 22. Although the hole 35 can solve the problem of air pressure, the hole 35 also allows the covering end 31 to have the possibility of leaking a liquid sample, in order to avoid the leakage of the liquid sample as much as possible, a hollow tube 36 extending towards the collecting cavity 22 is arranged at the position of the hole 35 on the covering end 31, the hollow tube 36 still allows the inside of the collecting cavity 22 to keep a communication relationship with the outside, meanwhile, when the detection device is inverted, the liquid sample is collected to the position of the covering end 31 under the action of gravity, the height of the hole at the position of the communication position is raised by the hollow tube 36, the hole cannot be contacted with the liquid sample, namely, the liquid sample cannot leak from the hole 35, meanwhile, the diameter of the hole 35 is small, and the possibility of the leakage of the liquid sample is further reduced due to the existence of water tension.

Preferably, in order to enable the absorption element on the sampling end 33 to be pressed against the bottom of the collection cavity 22, as much liquid sample can be extruded as possible, the pressing part 23 is arranged at the bottom of the collection cavity 22, the pressing part 23 is provided with the opening 24 which is opened upwards, the opening 24 is large in upper part and small in lower part and is in a circular truncated cone shape, when the absorption element on the sampling end 33 is contacted with the pressing part 23 to press the sample, in addition to the pressing of the absorption element against the bottom of the pressing part 23, the circular truncated cone-shaped opening 24 can also press the side part of the absorption element, so that the pressing efficiency is improved, more liquid samples can be released at the same time, and a certain collecting effect on the samples can be achieved.

Here, the absorption element is intended to absorb a liquid sample, such as saliva, urine, sweat or other samples. The material of the absorbent member may be any absorbent material, such as a sponge.

Preferably, the collection chamber 22 is provided with sample grooves 25 at positions on both sides of the squeezing portion 23, the sample grooves 25 are positioned under the carriers 40, the central position of the squeezing portion 23 is provided with a communicating groove 26 communicating the two sample grooves 25, the communicating groove 26 enables the liquid heights in the two sample grooves 25 to be consistent when the detection device is placed flat, and because the carriers 40 are positioned over the communicating groove 26, when samples in the sample grooves 25 are collected, the samples in the two sample grooves 25 can be simultaneously contacted with the lower ends of the detection test paper on the two carriers 40 for detection, so as to avoid the situation that one carrier 40 has already started to detect and the other carrier 40 has not started to detect. Further, the height of the communication groove 26 is lower than the height of the pressing portion 23, which enables the sample released by the pressing of the absorbent member to flow into the sample groove 25 as much as possible.

Preferably, two vents 27 are provided in the collection chamber 22 at locations on either side of the sample well 25, the vents 27 being capable of directing a sample that spills past the location of the expression portion 23 into the sample well 25.

Preferably, in order to make the lid end 31 can better cover the opening of the collection chamber 22, the lid end 31 is provided with a first sealing ring 34, the first sealing ring 34 has elasticity, and the sealing between the lid end 31 and the opening of the collection chamber 22 can be well realized, so that the liquid sample is prevented from flowing out. Meanwhile, the friction force of the first sealing ring 34 is increased, so that the covering end 31 is not easy to separate from the opening of the collecting cavity 22, and when the covering end 31 covers the opening of the collecting cavity 22, the absorbing element is always in a compressed state, and liquid samples can be continuously released into the collecting cavity 22.

Collecting and storing chamber

The storage chamber is used for storing an additive, which may be a solid, liquid, or gas, and a common additive is a liquid, such as a buffer, which is separately sealed in the storage chamber 90. after the sample collector collects the sample, it is necessary to open the storage chamber 90 and add the buffer in the storage chamber 90 to the collection chamber 22 to mix with the sample, and the resulting mixed liquid is contacted with the test strip on the carrier 40 for detection. The size of the absorption element is designed to control the sample sampling amount of the absorption element, or the size of the sample groove 25 is designed to control the sample amount required when the sample is contacted with the detection test paper, so that the sample in the sample groove 25 can not be contacted with the detection test paper after the liquid sample absorbed by the absorption element on the sample collector is completely released. The resulting mixed liquid can contact the test strip only after the buffer solution in the storage chamber 90 is added to the collection chamber 22, which allows the detection device to detect more accurately.

Preferably, in the present invention, the storage chamber 90 is a separate chamber which can be separated from the collection chamber 22, the storage chamber 90 is disposed in the second housing 91, a sealing film 92 is disposed on the second housing 91, and the sealing film 92 may be an aluminum foil to seal the buffer solution in the storage chamber 90.

Preferably, in order to improve the integrity of the detection device, the detection personnel can use the detection device more conveniently, a connecting head 37 is arranged on one side, back to the rod 32, of the covering end 31 of the sample collector 30, the connecting head 37 is hollow, the second shell 91 can enter the hollow position of the second shell, an upward protruding sharp part 38 is further arranged at the hollow position of the connecting head 37, a through hole 39 which penetrates through the sharp part 38 up and down is formed in the sharp part 38, when one side of a sealing membrane 92 on the second shell 91 is extruded with the sharp part 38, the sealing membrane 92 is punctured, liquid in the storage cavity 90 leaks out, and the liquid enters the collection cavity 22 through the through hole 39 and is mixed with the sample. Further, since the second housing 91 can enter the hollow position of the connection head 37, a gap exists between the second housing 91 and the connection head 37, and the buffer solution in the storage chamber 90 may leak from the gap at the moment of puncturing the sealing film 92, which causes leakage of the buffer solution.

After the second sealing ring 93 is introduced, the air pressure in the storage chamber 90 may rise in the process of moving the storage chamber 90 to the hollow position of the connecting head 37, which may hinder the movement of the storage chamber 90, and the hole 35 formed in the cover end 31 can well eliminate the influence of the air pressure in the storage chamber 90, thereby solving the potential technical problem.

Cover body

Since the second housing 91 is removable from or insertable into the connecting head 37, it is two parts, and when the two parts are used, a detection person may misunderstand that a certain part is useless without being familiar with the use method of the device, which may result in the loss of the part. To address this problem, it is desirable to enhance the integrity of the test device so that the test person can see the device and know how to use it, knowing that the two components are used in combination. Preferably, the detecting device further includes a cover 80, the cover 80 is connected to the second housing 91, the connection relationship can be detachable or non-detachable, the cover 80 and the connecting head 37 can be covered with each other, for example, the common cover 80 and the connecting head 37 are provided with matching screw threads, so that the cover 80 can be screwed onto the connecting head 37, and during the screwing process of the cover 80, the cover 80 drives the second housing 91 to move toward the sharp portion 38 until the sharp portion 38 pierces the sealing film 92.

After the detection device includes the cover 80, the second sealing ring 93 may not be provided, because the cover 80 can also have a certain night leakage prevention effect. As a preferable technical solution, the second sealing ring 93 is still retained in the detection device, because when the sharp portion 38 pierces the sealing film 92, the cover 80 is not completely covered tightly, and the cover 80 can achieve a certain night leakage prevention effect, but cannot completely avoid the situation that when the second sealing ring 93 is disposed on the second housing 91, since the second sealing ring 93 seals the gap between the second housing 91 and the connection head 37, if the cover 80 and the second housing 91 are non-detachably connected, that is, a common fixed connection, when the cover 80 is rotated, the second sealing ring 93 will tend to rub against the inner wall of the connection head 37, which will greatly affect the covering of the cover 80, so that the covering needs a large force. Therefore, it is preferable that the cover 80 is detachably connected to the second casing 91, or referred to as a movable connection, for example, in this embodiment, the upper end of the second casing 91 is provided with a rotating portion 94, the rotating portion 94 is provided with a first protrusion 95, the cover 80 is provided with a connection hole 81, the rotating portion 94 can be inserted into the connection hole 81 and buckled on the connection hole 81 through the first protrusion 95, so that the second casing 91 can rotate on the connection hole 81, in the process of covering the connection head 37 with the cover 80, due to the existence of the second sealing ring 93, the second casing 91 can move up and down corresponding to the connection head 37, and hardly rotates, and the second casing 91 can rotate corresponding to the cover 80, so that the covering of the cover 80 can be easily performed, and the second sealing ring 93 can achieve a better anti-leakage effect.

Protective element

The storage cavity 90 can be connected to the connecting head 37 through the cover 80, for example, the cover 80 is connected to the connecting head 37 by screwing the cover 80 slightly for several turns, so that the cover 80 can be fixed to the connecting head 37, but at this time, the cover 80 is easily detached from the connecting head 37 because the number of turns of the cover 80 is not large, and if the cover 80 is rotated for several turns, the sharp portion 38 is easily caused to pierce the sealing film 92 because the position of the storage cavity 90 is not clearly seen from the outside. Finding a location where the cap 80 will not fall off and the storage chamber 90 inside the cap will not be punctured is very difficult, and even if the location is found, the detection personnel can easily perform a wrong operation without knowing how to operate the detection device, for example, the cap 80 is screwed before the detection by carelessness, so that the sealing film 92 is punctured, the buffer solution is released to enter the collection chamber 22, bacteria can grow after the buffer solution enters the collection chamber 22 and is exposed for a long time, and metabolites of the bacteria can change the pH value of the buffer solution, so that the detection result is inaccurate.

In order to solve the technical problem, the detection device further includes a protection element 70, the protection element 70 is used for limiting the excessive rotation of the cover 80, that is, the sharp part 38 is prevented from puncturing the storage cavity 90, the protection element 70 includes a supporting section 71, the supporting section 71 is sleeved on the connecting head 37, the lower end of the supporting section 71 is abutted against the upper surface of the covering end 31, and the upper end of the supporting section 71 is abutted against the cover 80, so that the excessive rotation of the cover 80 can be avoided. The support section 71 may be hollow cylindrical, and may be sleeved on the connecting head 37. Further, when the support section 71 is hollow cylindrical, if the sharp portion 38 needs to pierce the storage cavity 90, the cap 80 is unscrewed, the protection element 70 is removed, and the cap 80 is screwed, which is cumbersome. In this embodiment, the supporting section 71 of the protection element 70 is provided with the first notch 72, and the protection element 70 has elasticity and can be elastically deformed, so that the protection element 70 can be directly taken down without screwing down the cover 80, and the storage cavity 90 can be conveniently punctured by directly rotating the cover 80.

Preferably, in order to facilitate the removal of the protective element 70, the protective element 70 further includes a grip portion 73, and the grip portion 73 is provided with stripes, so that the frictional force between the detecting person and the grip portion 73 can be increased. Further, the holding portion 73 is connected to the supporting section 71, and the connecting position of the holding portion 73 and the supporting section 71 is just opposite to the first notch 72.

Preferably, in order to make the protection element 70 more firmly mounted on the connection head 37, the protection element 70 is provided with a second protrusion 44 protruding inwards at the bottom of the supporting section 71, the second protrusion 44 may be in a ring shape, correspondingly, the connection head 37 is also provided with a ring-shaped structure 42 at a position close to the bottom, and the second protrusion 44 can be snapped into a gap between the ring-shaped structure 42 and the upper surface of the covering end 31, so that the protection element 70 is firmly mounted.

Preferably, in order to make the detecting device beautiful, the position of the holding portion 73 on the protecting element 70 is correct, rather than random, the annular structure 42 is provided with the second notch 45, and correspondingly, the inner side of the supporting section 71 of the protecting element 70 is provided with a third protrusion 74 facing the first notch 72, the third protrusion 74 can be inserted into the second notch 45, so as to limit the rotation of the protecting element 70 on the connecting head 37, when the second notch 45 is located near the long side of the covering end 31, the holding portion 73 of the protecting element 70 is also located near the long side of the covering end 31, as shown in fig. 1.

When the protection component 70 is mounted on the connector 37, the supporting section 71 of the protection component 70 can prevent the cover 80 from being excessively screwed in, but cannot prevent the cover 80 from being screwed out, and if the cover 80 can still be screwed out after the protection component 70 is mounted, a tester does not know to take in and take off the protection component 70 first or to screw out the cover 80 first on the premise of not knowing how to use the testing apparatus. Preferably, the supporting section 71 of the protection element 70 is provided with a blocking wall 75, the blocking wall 75 corresponds to the shape of the supporting section 71 and is also arc-shaped, since the cover 80 is pressed on the upper end of the supporting section 71 during the use of the detection device, the inner diameter of the blocking wall 75 is slightly larger than that of the supporting section 71, the inner side of the blocking wall 75 is provided with a buckle 76, and correspondingly, the bottom of the cover 80 is provided with a ring of flange 82, and the flange 82 of the cover 80 can enter the blocking wall 75 and be buckled below the buckle 76. Further, the upper end of the flange 82 is horizontal, and the lower end surface of the catch 76 is also horizontal, and after the cover 80 is mounted, the upper end of the flange 82 abuts or nearly abuts against the lower end surface of the catch 76. At this time, if the inspector wants to unscrew the cover 80, the flange 82 of the cover 80 abuts against the catch 76, the catch 76 drives the protection element 70 to move upward, and the second protrusion 44 of the protection element 70 is in a state of being caught between the ring structure 42 and the covering end 31, so that the protection element 70 cannot complete the upward movement, and therefore the cover 80 cannot be unscrewed. The structural design enables a tester to firstly pull out the protection element 70 when using the detection device, only the cover body 80 is left on the detection device after the protection element 70 is pulled out, and at the moment, the tester releases the buffer solution by rotating the cover body 80, so that the tester does not need to know the using method of the detection device in advance, and how to use the device for detection is obvious to the tester.

Preferably, the upper end of the buckle 76 is inclined, and a chamfer 83 is provided at a lower side position of the flange 82 of the cover 80, so that during production and assembly of the detection device, an assembly worker firstly sleeves the protection element 70 on the connection head 37, matches the third protrusion 74 with the second notch 45, then screws the cover 80 on the connection head 37, and during downward movement of the cover 80 (the second housing 91 is already installed inside the cover 80), the chamfer 83 of the flange 82 abuts against an upper end surface (inclined surface) of the buckle 76, and the downward movement of the cover 80 can provide a horizontal force which can slightly expand the protection element 70 until the buckle 76 is buckled above the flange 82 of the cover 80. At this time, when the cover 80 is rotated in the reverse direction, since the upper end of the flange 82 and the lower end surface of the catch 76 are horizontal surfaces, a horizontal force cannot be generated therebetween, and thus the protective element 70 cannot be spread, thereby achieving the purpose of locking the cover 80.

The above description is only an embodiment of the invention, but the scope of the invention is not limited thereto, and any changes or substitutions that are not thought of through the inventive work should be included in the scope of the invention, and therefore, the scope of the invention should be subject to the scope defined by the claims.

The invention shown and described herein may be practiced in the absence of any element or elements, limitation or limitations, which is specifically disclosed herein. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, and it is recognized that various modifications are possible within the scope of the invention. It should therefore be understood that although the present invention has been specifically disclosed by various embodiments and optional features, modification and variation of the concepts herein described may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims.

The contents of the articles, patents, patent applications, and all other documents and electronically available information described or cited herein are hereby incorporated by reference in their entirety to the same extent as if each individual publication was specifically and individually indicated to be incorporated by 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.

Claims

1. A detection device comprising a storage chamber, wherein an additive is present in the storage chamber, wherein a pointed portion is present in the detection device, wherein the storage chamber is movable relative to the pointed portion, and wherein during movement of the storage chamber is pierced by the pointed portion, thereby releasing the additive from the storage chamber.

2. The detecting device for detecting the rotation of a motor rotor according to claim 1, further comprising a collecting chamber into which the released additive can enter.

3. The testing device as claimed in claim 2, wherein the collection chamber is used for containing the sample, the collection chamber is disposed in the first housing, and the first housing is provided with an opening at an upper side thereof.

4. A test device according to claim 2, wherein the collection chamber is provided with a test element for detecting the analyte.

5. A testing device according to claim 3, wherein the test element is provided on a carrier, the carrier having a specific mating form with the collection chamber, the carrier being insertable into the collection chamber from an opening at an upper side position of the first housing, the carrier having a defined, unique orientation position when inserted into the collection chamber.

6. The detecting device for detecting the rotation of a motor rotor as claimed in claim 5, wherein the collecting cavity is provided with clamping strips, a carrier is fixed through the two clamping strips, and one side of the carrier, on which the test element is arranged, is attached to the inner wall of one side of the collecting cavity.

7. The detecting device for detecting the rotation of a motor rotor as claimed in claim 6, wherein the thickness of the upper end of the clamping strip is smaller, and the thickness of the lower end of the clamping strip is larger; correspondingly, the thickness of the bottom position of the carrier is smaller, and the thickness of the top position of the carrier is larger.

8. The detecting device for detecting the rotation of a motor rotor as claimed in claim 5, wherein the corner positions of the collecting cavities are provided with round corners; correspondingly, both sides of the surface of the carrier on which the test element is mounted are also provided with round corners.

9. The test device of claim 3, further comprising a sample collector for collecting the sample, the sample collector comprising a capped end, the capped end operable to cap the opening of the collection chamber.

10. The test device of claim 1, wherein the sample collector further comprises a sampling end and a body, the sampling end is connected to the absorbent member, the body is adapted to connect the cap end to the sampling end, and the body is removably connected to the cap end.

11. A test device according to claim 9, wherein the sample collector and/or the collection chamber is provided with an aperture which allows the collection chamber to be in gaseous communication with the environment.

12. A test device according to claim 11 wherein the blind end is provided with a hollow tube extending in the direction of the collection chamber at the location of the aperture.

13. A test device according to claim 11 wherein the diameter of the bore is less than 1 mm.

14. The testing device of claim 1, wherein the additive in the reservoir is a buffer.

15. The test device of claim 9, wherein the sample collector has a connector at a side of the cap opposite the body, the connector being hollow and the storage chamber being accessible at the hollow.

16. A testing device according to claim 15 wherein the sharpened portion is in the form of a projection which is received in a hollow portion of the connector.

17. A testing device according to claim 16 wherein the reservoir is provided in the second housing, the second housing being provided with a sealing membrane for sealing the additive within the reservoir, the reservoir being accessible from the hollow location of the connector, the sharp portion being capable of piercing the sealing membrane of the second housing to release the additive from the reservoir.

18. The detecting device for detecting the rotation of a motor rotor as claimed in claim 16, wherein the pointed portion is provided with a through hole which penetrates up and down.

19. A testing device according to claim 17 wherein the second housing is provided with a second sealing ring which fills a gap between the second housing and the connector.

20. The testing device of claim 17, further comprising a cover, wherein the cover is removably attached to the second housing.

21. The detecting device for detecting the rotation of a motor rotor as claimed in claim 20, wherein the cover body and the connecting head can be mutually covered.

22. The detecting device for detecting the rotation of a motor rotor as claimed in claim 21, wherein the cover body and the connecting head are provided with mating threads.

23. The detecting device for detecting the rotation of a motor rotor as claimed in claim 20, wherein the cover body and the second housing are provided with a rotating portion at the upper end of the second housing, the rotating portion is provided with a first protrusion, the cover body is provided with a connecting hole, and the rotating portion can be inserted into the connecting hole and buckled on the connecting hole through the first protrusion, so that the second housing can rotate on the connecting hole.

24. A testing device according to claim 20 wherein the testing device further comprises a protective element for limiting over-closure of the cover.

25. The detecting device for detecting the rotation of a motor rotor as claimed in claim 24, wherein the protecting element comprises a supporting section, the supporting section is sleeved on the connecting head, the lower end of the supporting section can be abutted against the upper surface of the covering end, and the upper end of the supporting section can be abutted against the cover body.

26. The detecting device for detecting the rotation of a motor rotor as claimed in claim 25, wherein the supporting section has a hollow cylindrical shape and is fitted over the connecting head.

27. A testing device according to claim 25 wherein the support section of the protective member is provided with a first notch.

28. A testing device according to claim 24 wherein the protective member is resilient.

29. The detecting device for detecting the rotation of a motor rotor as claimed in claim 27, wherein the protecting member further comprises a holding portion, the holding portion is provided with stripes, the holding portion is connected with the supporting section, and the connecting position of the holding portion and the supporting section is just opposite to the first notch.

30. A testing device according to claim 25, wherein the protection member is provided with a second protrusion protruding inwardly at a bottom portion of the support section, the second protrusion is ring-shaped, and correspondingly, the connector is provided with a ring-shaped structure at a position near the bottom portion, and the second protrusion can be snapped into a gap between the ring-shaped structure and the upper surface of the cap end.

31. A testing device according to claim 30, wherein the ring-shaped structure is provided with a second notch, and correspondingly, the inner side of the supporting section of the protection member is provided with a third protrusion facing the first notch, and the third protrusion can be inserted into the second notch.

32. The detecting device for detecting the rotation of a motor rotor as claimed in claim 31, wherein the covering end is rectangular and the second notch is located at a side close to the long side of the covering end.

33. The detecting device for detecting the rotation of a motor rotor as claimed in claim 26, wherein the supporting section of the protective member is provided with a blocking wall which is arc-shaped.

34. A testing device according to claim 33 wherein the inner diameter of the protective member at the location of the abutment wall is greater than the inner diameter of the protective member at the location of the support section.

35. The detecting device for detecting the rotation of a motor rotor as claimed in claim 33, wherein the inside of the blocking wall is provided with a buckle, the bottom of the cover body is provided with a circle of flanges, and the flanges of the cover body can enter the blocking wall and be buckled below the buckle.

36. A testing device according to claim 35 wherein the upper end of the flange is horizontal and the lower end surface of the latch is horizontal; the upper end of the buckle is in an inclined plane shape, and a chamfer is arranged at the lower side position of the flange of the cover body.