WO2017156869A1

WO2017156869A1 - Sample measurement device, and sample collection and measurement device and method

Info

Publication number: WO2017156869A1
Application number: PCT/CN2016/083281
Authority: WO
Inventors: 凌世生; 董文坤
Original assignee: 杭州安旭科技有限公司
Priority date: 2016-03-16
Filing date: 2016-05-25
Publication date: 2017-09-21
Also published as: CN105784443B; CN105784443A

Abstract

Provided are a sample measurement device and a sample collection and measurement device and method, said sample measurement device comprising a measurement chamber (100) and a sample reaction chamber (300), a channel being provided between the sample measurement chamber (100) and the sample reaction chamber (300); in its initial state, the channel is closed so that the liquids of the measurement chamber (100) and the sample reaction chamber (300) are not in communication; in its measurement state, the channel is open so that the liquids of the measurement chamber (100) and the sample reaction chamber (300) are not in communication. The device and method of the present invention are such that the collection of a liquid sample and the buffer reaction and measurement can be accomplished at one time; in particular, it is necessary to perform a measurement of preprocessing at a certain time for the sample, and measurement may be performed at a set time.

Description

Sample detecting device and sample collecting detecting device and method

Technical field

The present invention relates to a sample detecting device, particularly a collecting and detecting device for collecting and detecting a sample, and a method for collecting and detecting an analyte in a liquid sample.

Background technique

The following background art is provided to assist the reader in understanding the present invention and is not to be considered as prior art.

The technique of detecting the presence or absence of an analyte in a sample using the principle of immunological binding reaction is widely used in various fields. It can be used to detect analytes in various biological samples (saliva, blood, urine, serum, sweat, etc.) to monitor disease and human health (early pregnancy, cancer, infectious diseases, drugs, etc.). The underlying principle of this detection technique is to establish specific binding properties between immune molecules, such as antibodies and antigens, haptens/antibodies, biotin and avidin, and the like.

In the field of medical diagnosis, it is a relatively common method to use a detecting device or a detecting cup to collect a liquid sample without detecting the liquid sample and to determine whether the liquid sample contains the analyte. Such a detection device or test cup generally requires that the sample be collected in a sample container. The skilled artisan encloses a test reagent strip and immerses a portion of the reagent strip in the sample. After a few time, the reagent strip is removed and the test result is read.

U.S. Patent Nos. 2004/0184954 and US 2004/0237674 disclose devices for collecting saliva and for detecting the presence or absence of illegal pharmaceutical ingredients in saliva. In both of these patents, there are provided apparatus and methods for collecting and detecting saliva, wherein, after the sample is sampled onto the collector, the sample in the absorbent member on the collector is squeezed into the collection chamber by applying an external force. Inside, then check again. However, in the process of cooperating with the collection chamber, the sample collector may be exposed to contamination or infection by the operator; and, in the case where the sample needs to be mixed with the buffer before being tested, such The collection device is not very convenient.

In addition, in some tests, samples need to be processed before they can be detected. For example, adding a buffer solution to the sample allows the sample to be diluted to reduce the viscosity and ensure that the sample can be smoothly dialyzed on the test strip. How to make the buffer solution and the sample smoothly mix, the mixing is sufficient and the operation is a problem that needs to be solved.

Summary of the invention

The invention provides a novel sample detecting device and a sample collecting and detecting set as a whole device, by which the sample can realize the functions of collecting, pre-processing and realizing detection.

Specifically, in one aspect, the present invention provides a sample detecting device including a detecting chamber, wherein the sample detecting device further includes a sample reaction chamber, and a channel is disposed between the detecting chamber and the sample reaction chamber; In the initial state, the detection chamber is not in communication with the sample reaction chamber liquid; the channel is opened in the detection state to connect the detection chamber to the sample reaction chamber liquid.

In some preferred embodiments, the sample reaction chamber is connected to the detection chamber, and the bottom of the sample reaction chamber is connected to the sample receiving end of the detection chamber; the channel is a communication between the bottom of the sample reaction chamber and the detection chamber. Hole; in the initial state, the through hole is sealed; when the state is detected, the sealed through hole is opened.

In some preferred embodiments, the through hole is provided with a sealing plug that seals the through hole.

In some preferred embodiments, the sample detecting device further includes a cover for covering the sample reaction chamber; and a rib is connected to the end of the cover.

In some preferred embodiments, after the cover covers the sample reaction chamber, the rib is located directly above the through hole in the reaction chamber. That is, the position of the ridge on the cover corresponds to the position of the through hole at the bottom of the reaction chamber. In some preferred embodiments, the sample detecting device further includes an annular buckle, and the snap fit is fixed on the top wall of the cover. The buckle center is provided with a protrusion, and the side wall of the cover body has a concave hole for receiving the protrusion. After the buckle protrusion engages the concave hole of the side wall of the cover body, the cover body and the buckle are fixed to each other. In a more specific embodiment, the projection is located at the center of the inner side wall of the buckle.

In some preferred embodiments, the cavity of the sample reaction chamber is provided with a recess for receiving and fixing the buckle.

In some preferred embodiments, the cover has a first position and a second position on the sample reaction chamber; in the initial state, when the cover is in the first position, the buckle is engaged between the cover and the sample reaction chamber and fixed The cover body does not contact the reaction chamber cavity at the top of the cover body, and the convex strip on the cover body does not contact the through hole plug on the through hole at the bottom of the sample reaction chamber; when the cover state is in the second position, the buckle is removed. After the lid body is pressed down, it is directly covered on the sample reaction chamber, and the top of the lid body directly contacts the reaction chamber cavity mouth, and the convex strip on the cover body contacts and punctures the through hole plug at the bottom of the sample reaction chamber, so that the sample reaction chamber and the sample reaction chamber The detection chambers are connected.

In some preferred embodiments, the end of the cover body is further provided with a card slot; a chip carrier is engaged in the card slot.

In some preferred embodiments, the cover has air holes therein. The pores allow the sample reaction chamber to be in gas communication with the outside, such that the gas pressure of the sample reaction chamber is the same as the atmospheric pressure. In a specific embodiment, the pores have a smaller pore size, typically between 0.5 and 2 mm.

In some preferred embodiments, the test chamber includes one or more test elements; the sample receiving area of the test element is located below the through hole at the bottom of the sample reaction chamber.

In another aspect, the present invention provides a sample collection and detection device, comprising a detection chamber, further comprising a sample reaction chamber and a sample collection chamber; the bottom of the sample reaction chamber is connected to the sample receiving end of the detection chamber. The sample reaction chamber is connected and connected to the sample collection chamber; a passage is formed between the detection chamber and the sample reaction chamber, and the passage is a through hole which is in communication with the detection chamber at the bottom of the sample reaction chamber; in the initial state, the through hole is Sealed; the sealed through hole is opened when the state is detected.

In some preferred embodiments, the sample collection chamber is located at one end of the detection chamber; the bottom of the sample collection chamber is connected to the sample reaction chamber sidewall; and the collection chamber bottom has a through hole communicating with the sample chamber sidewall.

In some preferred embodiments, a cover that covers the sample reaction chamber is further included; the end of the cover is connected with a ridge.

In some preferred embodiments, the method further includes an annular buckle, the buckle is snap-fitted to the side wall of the cover body; the buckle center is provided with a protrusion, and the side wall of the cover body has a concave hole for receiving the protrusion, the card After the buckle protrusion engages the recess hole in the side wall of the cover body, the cover body and the buckle are fixed to each other.

In some preferred embodiments, the cover has a first position and a second position on the sample reaction chamber; in the initial state, when the cover is in the first position, the buckle is engaged between the cover and the sample reaction chamber and fixed The cover body, the ridge on the cover body does not contact the through hole plug of the sealed through hole at the bottom of the sample reaction chamber; when the cover state is in the second position, the buckle is removed, and the cover body is directly pressed after being pressed down. On the sample reaction chamber, the ridge on the cover contacts and punctures the through-hole plug at the bottom of the sample reaction chamber to connect the sample reaction chamber to the detection chamber. During the process from the initial state to the detection state, that is, during the process of the cover body from the first position to the second position, the ridges on the cover body move to the bottom in the reaction chamber, and the first non-contact through-hole plug To contact the through-hole plug, then push and puncture the through-hole plug.

In some preferred embodiments, a sample collection rod is further included, the sample collection rod including an associated absorbent member and a handle; and a sealing member between the absorbent member and the handle.

In some preferred embodiments, the sample collection chamber cavity is provided with two symmetric card holes; the end of the sample collection bar handle connected to the absorbing member is provided with two symmetrical card strips.

After the sample collection rod is inserted into the collection chamber for sample collection, after the absorption member on the sample collection rod is completely squeezed, the strip on the handle reaches the card hole at the collection chamber cavity, and the card strip is engaged with the card hole. Together, the collecting rod is locked in the collecting chamber, so that the absorbing member on the collecting rod is always in a compressed state, ensuring sufficient squeeze out of the sample, and the sample collecting rod is locked in the collecting chamber without being randomly placed. , causing environmental pollution.

In some embodiments, the sample collection detecting device of the present invention comprises a test component comprising a sample receiving zone, a reagent zone and a detection zone, characterized in that it further comprises a detection cavity, the detection cavity comprising a bottom plate and an upper plate, and a bottom plate Engaging with the upper plate to form a hollow detecting cavity, wherein the testing component is located in the detecting cavity; the upper plate is connected with a sample reaction cavity which is closed by one end and a bottom end, wherein the bottom of the sample reaction cavity a portion of the upper plate; a through hole at the bottom of the sample reaction chamber; the through hole being located above the sample receiving area of the test element.

In some preferred embodiments, the through hole is provided with a through hole plug for sealing the through hole; in the initial state, the through hole is sealed by the through hole plug; when the state is detected, the through hole plug is opened to open the through hole. In the initial state, the through hole is sealed by the through hole plug so that the detection chamber is not in communication with the sample reaction chamber liquid; when the state is detected, the through hole plug is opened to open the through hole to connect the detection chamber to the sample reaction chamber liquid.

In some preferred embodiments, the method further includes an open-ended sample collection chamber surrounded by a sidewall and a bottom, the sample collection chamber being located at an end of the detection chamber upper plate adjacent to the sample reaction chamber.

In some preferred embodiments, the reaction chamber, the collection chamber, and the detection chamber upper plate are of a unitary structure.

In some preferred embodiments, the sample collection chamber is connected to the sample reaction chamber and is in fluid communication.

In some preferred embodiments, the sample collection chamber sidewall is connected to the detection chamber upper plate.

In a preferred embodiment, the reaction chamber is vertically located on the upper plate; the sample collection chamber is laterally located on the upper plate. In some preferred embodiments, the bottom of the sample collection chamber is connected to the side wall of the reaction chamber; the bottom of the sample collection chamber has a through hole communicating with the reaction chamber.

In the present invention, the collection chamber and the reaction chamber are all integrated on the upper plate of the detection chamber, and the collection chamber and the reaction chamber are also integrated, so that the entire sample collection and detection device is light in shape and enables the sample to be collected. The processing and detection are integrated and the operation is convenient and quick. Specifically, for convenient operation and beautiful appearance, the collection chamber and the reaction chamber are perpendicular to each other, that is, the reaction chamber is vertically located on the upper surface of the detection chamber, and the collection chamber is laterally lying on the upper surface of the detection chamber, that is, the bottom of the collection chamber and the reaction chamber. The side walls are joined together and the bottom of the reaction chamber is above the sample receiving area of the test element.

In some preferred embodiments, a cover body is further included, the cover body is configured to cover the sample reaction chamber, and the protrusion is connected to the end of the cover body.

In some preferred embodiments, the method further includes an annular buckle, the buckle is fixedly fixed on the top side wall of the cover body; the buckle center is provided with a protrusion, and the side wall of the cover body has a concave hole for receiving the protrusion, After the buckle protrusion engages the recessed hole in the side wall of the cover body, the cover body and the buckle are fixed to each other.

In some preferred embodiments, the cavity of the sample reaction chamber is provided with a recess for receiving and fixing the buckle. The buckle is fixed on the sample reaction chamber, and the cover fixed to the buckle is also fixed at the position of the sample reaction chamber, even if the ridge at the end of the cover is fixed directly above the through plug.

Further, the present invention provides a method of collecting and detecting a liquid sample for analyzing an analyte in a liquid sample, comprising a sample collection detecting device that collects and detects an analyte in the liquid sample, the sample collection The detecting device comprises a detecting cavity, a sample reaction cavity and a sample collecting cavity; the sample reaction cavity is connected and connected with the sample collecting cavity; a channel is provided between the detecting cavity and the sample reaction cavity, and the channel is located in the sample receiving with the detecting cavity a bottom of the sample reaction chamber connected to the end, the passage being a through hole; in the initial state, the through hole is sealed; when the state is detected, the sealed through hole is opened; and the sample collection detecting device further includes a cover sample reaction chamber The cover body, the snap fastener fixed on the cover body, and the sample collection rod; the specific steps are as follows:

(1) The sample collection detecting device is in an initial state, that is, the buckle fixes the cover body at the first position of the sample reaction chamber, and the protruding strip connected at the end of the cover body does not contact the through hole plug of the through hole at the bottom of the reaction chamber;

(2) inserting a sample collection rod collecting the liquid sample into the sample collection chamber, and sealing the collection chamber by the collection rod;

(3) continuously pushing the sample collection rod toward the bottom of the collection chamber, so that the liquid on the sample collection rod flows into the collection chamber and flows into the sample reaction chamber through the through hole at the bottom of the sample collection chamber that communicates with the side wall of the sample reaction chamber;

(4) engaging the strip on the collecting rod into the card hole at the mouth of the sample collecting chamber to lock the collecting rod in the collecting chamber;

(5) standing for a certain period of time, causing the liquid sample in the sample reaction chamber to react with the substance in the reaction chamber;

(6) Remove the buckle that is engaged with the cover body, close the air hole at the center of the cover body, and press the cover body downward so that the cover body is covered to the cavity of the sample reaction chamber, that is, the cover body is located in the reaction chamber. Two positions, at this time, the sample collection detecting device is in the detecting state, the end of the ridge at the top of the cover body contacts and punctures the sealed through hole at the bottom of the sample reaction chamber;

(7) The liquid sample enters the detection chamber through the pierced through hole, contacts the test element, and detects the analyte in the liquid sample.

In some preferred embodiments, the substance in the reaction chamber is a reagent loaded on the carrier; and the end of the carrier is fixed in the reaction chamber through the card slot on the cover.

In the present invention, after the sample enters the reaction chamber, in order to allow the sample to have sufficient time to react with the substance or reagent in the reaction chamber, the sample can be sufficiently pretreated, and usually, the device is allowed to stand for a certain period of time. For example, 1-5 minutes, 1 minute, 2 minutes or 3 minutes. Of course, it is also possible to make the sample enter the reaction chamber for pre-treatment, and it is not urgent to perform the detection. Therefore, the device can be used for a certain period of time in the detection, which can be long, usually only for more than 1 minute, for example, 1 minute. It can be up to 1 day.

Beneficial effect

The apparatus and method of the present invention enables one-stop completion of collection, buffering, and detection of liquid samples, particularly for samples that require a certain amount of pre-treatment, and enables detection at set times.

DRAWINGS

1 is an exploded perspective view of a sample collection and detection device of the present invention;

2 is a schematic cross-sectional view showing a sample collection detecting device of the present invention;

3 to FIG. 6 are schematic diagrams showing the operation process of sample collection and detection of the sample collection and detection device of the present invention; wherein:

Figure 3 is a schematic view showing the state in which the sample collection and detection device of the present invention is separated from the collecting member;

Figure 4 is a schematic view showing the collection member of the present invention being compression-bonded in the sample collection detecting device (the cover is in the first position);

Figure 5 is a schematic view showing the separation of the buckle and the sample collection detecting device of the present invention;

Figure 6 is a schematic view of the sample collection and detection device of the cover of the present invention (the cover is in the second position);

7 to FIG. 10 are schematic cross-sectional views showing the operation process of sample collection and detection of the sample collection and detection device of the present invention: wherein:

Figure 7 is a schematic cross-sectional view showing the state in which the sample collection and detection device of the present invention is separated from the collecting member;

Figure 8 is a schematic cross-sectional view showing the collection member of the present invention compressed and coupled to the sample collection and detection device (the cover is in the first position);

Figure 9 is a schematic cross-sectional view showing the buckle of the present invention separated from the sample collection detecting device;

Figure 10 is a cross-sectional view showing the sample collection and detection device of the present invention after the cover is pressed down (the cover is in the second position).

Description of the reference signs:

Sample collection detecting device 800; detection chamber 100; bottom plate 102; upper plate 101; window 103; test element 200; sample receiving area 201; sample reaction chamber 300; chamber 303 of sample reaction chamber; sample reaction chamber bottom 304; Side wall 305; through hole 301 at the bottom of the reaction chamber; reaction chamber cavity groove 302; through hole plug 310; cover body 400; cover top 450; cover end 460; cover recess 401; carrier 410; 420; vent 430; sample collection chamber 500; collection chamber bottom 510 communicating with the reaction chamber; collection chamber 520, collection chamber sidewall 530; collection chamber bottom 540; card hole 501; snap 600; a protrusion 601; a sample collection rod 700; a collecting member 701; a handle 702; a sealing ring 703; a strip 704; a bump on the strip 705;

detailed description

The structure involved in the present invention or the technical terms used therein will be further described below.

Detection

Detecting means testing or testing for the presence of a substance or material, such as, but not limited to, chemicals, organic compounds, inorganic compounds, metabolites, drugs or drug metabolites, metabolites of organic or organic tissues, nucleic acids, Protein Or polymer. In addition, the test indicates the amount of test substance or material. Further, the test also indicates immunoassay, chemical detection, enzyme detection, and the like.

sample

The samples referred to in the present invention refer to those substances which can be used to detect, assay or diagnose the presence or absence of an analyte of interest. The sample may be, for example, a liquid sample, which may include blood, plasma, serum, urine, saliva, and various exudates, and may also include a liquid solution formed by pre-treating the solid sample and the semi-solid sample. The collected samples can be used for immunoassays, chemical tests, enzyme assays, etc. to detect the presence of analytes.

Analyzed substance

Any analyte can be analyzed using the apparatus and method of the present invention. The analyte can be detected in any liquid or liquefied sample, such as urine, saliva, saliva, blood, plasma, or serum.

The analyte can also be some hapten material, including drugs (such as drugs of abuse). "Drug of Drugs" (DOA) refers to the use of drugs in non-medical destinations (usually the role of paralysis). The device can also be used to detect tests that are medically useful but are easily overdose, such as tricyclic antidepressants (imipramine or the like) and acetaminophen. These drugs are decomposed into different small molecular substances after being absorbed by the human body. These small molecular substances are present in body fluids such as blood, urine, saliva, sweat, etc., or some of the small molecules are present in some body fluids.

Test component 200

The test element 200 can be selected as a laterally flowing test strip that can detect a plurality of analytes. Of course, other suitable test elements can also be utilized in the present invention. Various test elements can be combined into the present invention. One form is the detection of test strips. Test strips for analyzing analytes in a sample, such as drugs or metabolites indicative of physical condition, can be in various forms, such as immunoassays or chemical assays. Test strips can be analyzed using non-competitive or competitive methods. The test strip contains a water absorbing material having a sample receiving area, a reagent zone and a test zone. The sample is added to the sample receiving zone 201 and flows to the reagent zone by capillary action. In the reagent zone, if an analyte is present, the sample is combined with the reagent. The sample then continues to flow to the detection zone. Other reagents, such as molecules that specifically bind to the analyte, are immobilized in the detection zone. These reagents react with the analyte (if present) in the sample and bind the analyte to the region, or to a reagent in the reagent zone. A marker for displaying a detection signal is present in the reagent zone or in a separate marker zone.

A typical non-competitive method of analysis is that if the sample contains the analyte, the signal is generated, and if it is not included, no signal is produced. In the competition method, if the analyte is not present in the sample, the signal is generated, and if the analyte is present, no signal is generated.

The test element 200 is a test strip, and a material that absorbs water or does not absorb water may be used. The test strip can include a variety of materials for liquid sample transfer. One of the materials for detecting the test paper may be covered on another material such as a filter paper coated on the nitrocellulose membrane. One zone of the test strip may be selected from one or more materials, and the other zone may be selected from one or more different materials. Test strip can It is adhered to a kind of support or hard surface to improve the strength of the test strip. The analyte is detected by a signal generating system, such as one or more enzymes that specifically react with the analyte, using one or more methods of immobilizing the specific binding substance on the test strip as described above A composition of the signal generating system is immobilized on the analyte detection zone of the test strip. The signal generating material can be on the sample receiving zone 201, the reagent zone, or the detection zone, or the entire test strip, which can be filled with one or more materials that test the test strip. The solution containing the signal is added to the surface of the test paper or one or more materials of the test paper are immersed in the signal-containing solution. The test paper added to the signal containing solution was dried.

The various areas of the test strip can be arranged in the following manner: sample receiving area 201, reagent area, detection area, control area, determining whether the sample is adulterated, and the liquid sample absorption area. The control area is located after the detection area. All zones can be arranged on a strip of test paper using only one material. It is also possible to use different materials in different zones. Each zone may be in direct contact with the liquid sample, or different zones may be arranged in the direction in which the liquid sample flows, and the ends of the zones are connected to and overlapped with the front end of the other zone. The material used may be a material having good water absorption such as filter paper, glass fiber or nitrocellulose membrane. Test strips can also take other forms.

Sample collection rod 700

Typically, the sample collection bar includes an absorbent member 701 and a handle 702 that is located at one end of the handle 702. Absorbent components are typically made of medical grade sponge or foam materials commonly used in the art. However, many other materials can also be made into absorbent members such as cotton or paper, or any other material having water absorbing properties. The handle is typically rigid to facilitate handling of the absorbent member. The handle can be made of materials commonly used in the art, such as plastic, wood, metal or cardboard. In some embodiments, the end of the handle that is coupled to the absorbent member further has an O-ring 703 that surrounds the junction of the handle and the absorbent member. It is used to seal the collection chamber that receives the collection rod so that the liquid sample located therein does not flow back to the handle. In some more preferred manners, in order to make the liquid in the absorbing member more compact, and at the same time, to prevent the sample collecting rod from being randomly placed, symmetric strips 704 are provided on the sample collecting rod, and the strips have The elasticity is compressed after entering the collecting chamber. After reaching a certain position, the bump 705 on the strip contacts the hole in the side wall of the collecting chamber and is released, and the bump enters the card hole and is engaged and fixed.

Detection chamber 100

The detection chamber 100 is typically a cavity for receiving the test element 200 and enabling a liquid sample to enter the cavity to contact the test element for detection. The shape is varied and can be designed according to the shape and number of test components that need to be accommodated. In the present invention, the test component is a test strip. Therefore, in one embodiment, the detection cavity is a plate structure, and has a bottom plate 102 and an upper plate 101. The two are combined to form a cavity 100 by means of a snap fit. Specifically, after the test strip 200 is placed on the bottom plate 102, the upper plate 101 is covered, and the upper plate 101 is locked and fixed on the bottom plate 102 to form the detection chamber 100. More specifically, the base plate 102 has one or more raised strip-shaped card slots for placing and securing the test strip 200. In other limited embodiments, there is a window 103 on the upper panel, and the position of the window 103 corresponds to the detection area of the test strip, which facilitates the test result of the test strip.

Sample reaction chamber

300

In some tests, the sample needs to be pre-processed before being tested, for example, for dilution, or with a reagent in advance. The reaction is carried out to activate or label the analyte therein, so that the sample reaction chamber 300 allows the liquid sample to be mixed with the buffer solution in the cavity while the liquid sample is being stored, or to perform a reagent and a liquid sample. The pre-reaction allows the liquid sample to be pretreated in the sample reaction chamber. In a specific embodiment, the sample reaction chamber 200 is surrounded by a bottom and a side wall to form a hollow cylindrical structure.

In the following detailed description, reference to the accompanying drawings is a part of the description, which is illustrated by way of illustration of a particular embodiment of the invention. It is not to be understood that the invention may be practiced with other specific embodiments and modifications of the structure of the invention without departing from the scope of the invention.

First, the sample detecting device of the present invention mainly includes a sample reaction chamber 300 and a detecting chamber 100. Wherein, the detecting chamber 100 is used for arranging the testing component 100 while receiving the liquid sample, so that the liquid sample entering the detecting chamber 100 sequentially flows through the testing component 200 to realize detection. The sample reaction chamber 300 is configured to store a liquid sample, and the liquid sample is mixed with the buffer solution in the chamber 300, or a reagent is pre-reacted with the liquid sample, so that the liquid sample is in the sample reaction chamber 300. Pretreatment. In order to achieve the detection function, the detection chamber 100 and the sample reaction chamber 300 also require a liquid phase to circulate, i.e., the sample is reacted, and the liquid fluid in 300 reaches the detection chamber 100 and reaches the test strip 200. Therefore, a passage is also provided between the detection chamber 100 and the reaction chamber 300. Since the liquid sample needs to be processed in advance, and the unpretreated sample cannot be detected, the channel does not allow the reaction chamber 300 to be in communication with the detection chamber 300 at all times, that is, the channel is closed in the initial state. The detection chamber 100 is not in fluid communication with the sample reaction chamber 300; the passage is opened in the detection state to cause the detection chamber 100 to be in fluid communication with the sample reaction chamber 300. Therefore, how to realize the flow of the liquid between the detection chamber 100 and the reaction chamber 300 when it is necessary to detect is critical.

In the present invention, as shown in FIG. 1, the detecting chamber 100 is formed by the bottom plate 102 and the upper plate 101 being engaged with each other, and the test strip 200 is fixed between the bottom plate 102 and the upper plate 101 in the detecting chamber 100, in the test strip. A corresponding cavity 300 is connected to the upper portion of the sample receiving area 201. The cavity 300 is surrounded by a side wall 305 and a bottom portion 304. The cavity 300 has an open end 303, and the bottom of the cavity 300 is also on the detecting cavity. A portion of the plate 101; the cavity 300 has a cylindrical structure and is vertically positioned on the detection chamber upper plate 101 as shown in FIG. A through hole 301 is disposed at the bottom of the reaction chamber 300, and the through hole 301 communicates between the reaction chamber 300 and the detection chamber 100. More specifically, the through hole 301 is located above the sample receiving area 201 of the test element; At this time, the through hole 301 is sealed, and when the detection is required, the through hole 301 is opened to allow communication between the reaction chamber 300 and the detection chamber 100. The manner in which the through hole 301 is sealed is not limited, so that it can be opened when needed, and a material that does not chemically affect the detection of the liquid sample can be used. Therefore, a sealing film can be used, and various sealing plugs or the like can be used. In a specific embodiment, the through hole is sealed by the through hole plug 310, and the through hole plug is made of silica gel. Before the sample is detected, the through plug 310 is located in the through hole to seal the through hole, and the liquid sample in the reaction chamber 300 cannot reach the detecting chamber 100. When the strip sample is pretreated or when the sample needs to be detected, the through hole 301 is opened. That is, the via plug 310 is removed or the via plug 310 is opened. In some specific embodiments, the through-hole plug 310 opens the through-hole by being pierced for ease of operation.

In a more specific embodiment, the detecting device further includes a cover 400 that is attached to the sample reaction chamber 300, and a rib 420 fixedly attached to the cover, and is pierced or pierced by the rib 420. Hole plug 310. The rib 420 is coupled to the end 460 of the cover 400, when When the rib 420 is located in the reaction chamber 300, the rib 420 is located directly above the through plug 310. In order to enable the rib 420 to puncture the through plug 310 when needed, the length of the rib 420 is slightly larger than or equal to the reaction chamber. The height of 300. At the same time, in order for the rib 420 to pierce the through-hole plug 310 when needed, the rib 420 is not required to contact the through-hole plug 310 in the initial position. In one embodiment, a ring-shaped card is also wrapped around the cover 400. The buckle 600 is located at the top 450 of the cover 400. After the cover 400 is closed to the reaction chamber 300, the buckle 600 is located between the top 450 of the cover and the cavity 303 of the reaction chamber 300, so that the cover The body top 450 is not in contact with the reaction chamber port 303. As shown in FIGS. 3 and 4, the end of the rib 420 attached to the cover body is also not in contact with the through hole plug 310, as shown in FIG. In the initial position, that is, when the cover 400 is in the first position, the buckle 600 is engaged between the top of the cover 450 and the reaction cavity 303, and the ribs 420 located in the reaction chamber 300 do not contact the through-hole 310. When the detection is needed, the buckle 600 is removed, as shown in FIG. 5, the cover 400 is moved downward to the top of the cover 450 to contact the reaction cavity 303, as shown in FIG. 6, that is, the cover 400 reaches the second. Position, in this process, the end of the projection 420 that moves down with the cover 400 contacts and pierces the through plug 310, as shown in FIG. In some embodiments, in order to enable the rib 420 to be accurately positioned directly above the through-hole plug 310 so that the rib 420 can smoothly puncture the through-hole plug 310, it is necessary to fix the position of the cover 400 on the reaction chamber 300 so as to be convex. The position of the strip 420 is fixed, and the cover 600 is fixed by the buckle 600, so that the cover 400 cannot be freely changed in position on the reaction chamber 300. More specifically, the center of the annular buckle 600 has a protrusion 601. The side wall of the cover body 450 has a recessed hole 401 at a corresponding position. When the snap protrusion 601 is inserted into the recessed hole 401 of the cover body, the position between the buckle 600 and the cover 400 is fixed to each other. In a more specific embodiment, a recess 302 is provided in the cavity 303 of the reaction chamber for placing a portion of the annular snap 600, and more particularly, the latch is raised 601. The portion of the junction is located within the recess 302 of the reaction chamber cavity. The position of the buckle 600 is fixed, and even if the position of the cover 400 fixed to the buckle is fixed, the ridge 420 on the cover can be accurately positioned directly above the through hole 301 in the reaction chamber.

In order to allow the liquid sample in the reaction chamber 300 to be pretreated, a buffer or other reagent may be added to the reaction chamber 300. In one embodiment, the reagent is loaded on the carrier 410, and the carrier 410 is placed in the reaction chamber 300 in advance. For easy operation. More specifically, the cover 400 has a card slot, and one end of the carrier 410 is engaged and fixed in the card slot. After the cover 400 covers the reaction cavity, the carrier 410 is located in the reaction chamber 300.

In some embodiments, an air hole 430 is further disposed on the cover 400 to allow the reaction chamber 300 to communicate with the outside atmosphere.

Secondly, the sample collection detecting device 800 provided by the present invention includes a sample collection chamber 500 in addition to the detection chamber 100 of the detection device, and the sample collection chamber 500. In one embodiment, the detection chamber 100 is integral with the reaction chamber 300 and the sample collection chamber 500. That is, the detection chamber 100 is also engaged by the bottom plate 102 and the upper plate 101, and the test component 200 is fixed in the card slot of the bottom plate 102, wherein the test component 200 is plural, more specifically, the test component is a test. A strip of paper having a sample receiving area 201, a reagent zone and a detection zone. The sample reaction chamber 300 is vertically located on the upper plate 101 at a position directly above the sample receiving area 201 of the test strip 200, and the reaction chamber 300 is formed by one end (sample receiving end) of the upper plate 101 as a bottom 304, plus The hollow cylindrical structure enclosed by the side wall 305 has an open end which is a cavity 303. A through hole 301 is provided in the bottom (upper plate 101) of the reaction chamber 300, as shown in FIG. 2, which is located above the sample receiving area 201 of the test element 200 (test strip). When the liquid is from the opposite When the chamber 300 flows out of the detection chamber 100 through the through hole 301, the liquid first contacts the sample receiving area 201 of the test element. As shown in FIG. 1, the sample collection chamber 500 is also a cavity of an end opening 520 surrounded by a side wall 530 and a bottom portion 540. The cavity 500 is located at one end of the upper plate 101 of the detection chamber 100, and the upper plate. The collection chamber 500 is connected to the reaction chamber 300. Specifically, the opening direction of the collection chamber is perpendicular to the opening direction of the reaction chamber, that is, the collection chamber 500 is laterally located on the upper chamber 101 of the detection chamber. That is, the collecting chamber side wall 530 is connected to the detecting chamber upper plate 101, that is, the bottom of the collecting chamber 500 is connected to the side wall of the reaction chamber 300. More specifically, the bottom of the collecting chamber 500 is simultaneously the side of the reaction chamber 300. wall. At the bottom of the collection chamber 500, a through hole 510 is provided to allow the collection chamber 500 to communicate with the reaction chamber 300. In the present invention, the collection chamber 500 and the reaction chamber 300 are all integrated on the upper plate 101 of the detection chamber, and the collection chamber 500 and the reaction chamber 300 are also integrated, so that the entire sample collection and detection device 800 is light in shape, and The sample can be collected, pre-processed and tested in one piece, which is convenient and quick to operate. Specifically, for convenient operation and beautiful appearance, the collection/500 and the reaction chamber 300 are perpendicular to each other, that is, the reaction chamber 300 is vertically located on the detection chamber upper plate 101, and the collection chamber 500 is laterally lying on the detection chamber upper plate 101, that is, collecting The bottom 540 of the chamber is coupled to the sidewall 305 of the reaction chamber, while the bottom 304 of the reaction chamber is positioned above the sample receiving region 201 of the test element 200.

The sample collection detecting device 800 further includes a sample collection rod 700. The collection rod 700 mainly includes an absorbing member 701 and a handle 702. The two are connected, and the sample is sucked by the absorbing member 701, for example, into the oral cavity of the subject to absorb the saliva sample. The handle bar 702 is used to grip the collecting rod.

The collection chamber 500 is combined with the collection rod 700 to cause the liquid sample on the absorbing member 701 to be discharged, specifically, the absorbing member 701 is inserted into the collection chamber 500, and moved toward the bottom portion of the collection chamber 500, so that the absorbing member 701 contacts the collection chamber. The bottom of the 500 is compressed and the sample located in the absorbing member 701 is squeezed out therefrom to flow into the collection chamber 500. Preferably, in order to prevent liquid from flowing out of the collection chamber 500, an annular sealing ring 703 is provided at the junction of the absorbent member 701 and the handle 702, as shown in Figures 2 and 3, the sealing ring 703 is inserted into the collection chamber 500 at the collection rod 700. The side wall of the collection chamber 500 is sealed, so that the collection chamber 500 forms a sealed cavity to avoid the outflow of the liquid. At the same time, as the collection rod 700 moves, the volume of the sealing chamber gradually decreases, and the pressure in the sealed chamber increases. Larger, it is more advantageous to squeeze the absorbing member 701 to allow the liquid to flow out. In some embodiments, the collection rod 700 is locked within the collection chamber 500 when the collection member 701 of the collection rod is fully compressed within the collection chamber. In a particular embodiment, the end of the handle 702 that is coupled to the absorbent member 701 is designed with two A symmetrical strip 704 that is resilient and can be compressed into the collection chamber 500. The collecting chamber 500 has two symmetrical holes 501 on the side wall adjacent to the cavity. When the absorbing member 701 is fully compressed, the bump 705 on the strip is fixed in the hole 501, so that the collecting rod 700 is Locked within the collection chamber 500.

After being extruded from the absorbing member 701, the sample first flows into the sample collection chamber 500, and then flows into the sample reaction chamber 300 through the through hole 510. In the sample collection and detection device 800 of the present invention, the sample reaction chamber 300 is covered with a cover 400 having a gas hole 430 which makes the atmosphere inside and outside the reaction chamber 300 the same, that is, the gas pressure in the reaction chamber 300 is maintained. Atmospheric pressure, such that when the liquid in the collection chamber 500 is sealed and compressed by the collecting rod 700, the liquid is more smoothly flowed through the through hole 510 because the air pressure is greater than the air pressure in the reaction chamber. There is a carrier 410 in the card slot of the cover 400, the carrier 410 is located in the reaction chamber 300, and the carrier 410 is uploaded. The reagent having the pretreatment sample, after the liquid sample flows into the sample reaction chamber 300, contacts the carrier 410 to carry out a reaction to effect pretreatment. There is a buckle 600 at the top of the cover 400. When the cover 400 with the buckle is capped to the reaction chamber 300, the rib 420 at the end of the cover is located directly above the through hole 301 at the bottom of the reaction chamber, but does not touch. The through hole plug 310 on the through hole, when the buckle 600 is removed, the cover 400 is pressed down, so that the top of the cover 400 contacts the cavity of the sample reaction chamber 300. In the process, the rib 420 contacts and punctures. The via plug 310 causes the liquid sample that has been pretreated in the reaction chamber 300 to flow into the detection chamber 100 through the puncture through plug 310, and is in contact with the sample receiving area 201 of the test strip to complete the detection.

Next, a method of collecting the sample and detecting the analyte in the sample by the sample collection detecting device 800 of the present invention will be described.

1. In the initial position, as shown in FIG. 3 and FIG. 7, on the sample collection and detection device 800 of the unitary structure, the annular buckle 600 is connected to the cover sidewall recess 401 through the protrusion 601 and the protrusion connection, respectively. The reaction chamber recess 302 is fixed, and the cover 400 is located at the first position. At this time, the rib 420 at the end of the cover is located in the reaction chamber 300, and is directly above the through plug 310, and is not in contact with the through plug 310. The collection rod 700 is separated from the collection chamber 500;

2. Inserting one end of the absorbing member 701 of the collecting rod 700 collecting the liquid sample into the lateral collecting chamber 500. After the absorbing member 701 all enters the collecting chamber 500, the sealing ring 703 connected to the end of the absorbing member 701 seals the collecting chamber 500. a sidewall at the cavity, such that the collection chamber 500 forms a sealed cavity;

3. Continue to advance the collecting rod 700 so that the absorbing member 701 is squeezed and compressed by the bottom of the collecting chamber 500, and the liquid on the absorbing member 701 flows out into the collecting chamber 500; at the same time, the reaction through the collecting chamber 500 and the through hole 501 of the reaction chamber 300 Inside the cavity 300;

4. When the absorbing member 701 is fully squeezed, the bump 705 of the clip 704 on the handle is engaged into the bayonet 501 of the side wall of the collecting chamber, and the collecting rod 700 is locked in the collecting chamber 500, as shown in FIG. And Figure 8;

5. The sample collection detecting device 800 is allowed to stand for 1 minute. At this time, the liquid sample located in the reaction chamber 300 contacts and reacts with the reagent on the carrier 410 to complete the pretreatment of the sample;

6. Remove the annular buckle 600 that is engaged with the cover 400, as shown in Figures 5 and 9;

7. Pressing the cover 400 downwardly, during the pressing process, closing the air hole 430 of the cover; during this process, the rib 420 moves toward the bottom of the reaction chamber 300 along with the cover 400, gradually contacting and piercing the through hole. Plug 310;

8. When the top of the cover 400 contacts the cavity of the reaction chamber 300, the pressing is stopped. At this time, the cover 400 is in the second position, at which time the through plug 310 is punctured, and the liquid in the reaction chamber 300 The sample enters the sample receiving area 201 of the test strip 200 in the detection chamber 100 through the through hole 301 for detection.

Claims

A sample detecting device includes a detecting chamber, wherein the sample detecting device further comprises a sample reaction chamber, and a channel is provided between the detecting chamber and the sample reaction chamber; and the channel is closed in an initial state to make the detecting chamber and The sample reaction chamber liquid is not in communication; the channel is opened in the detection state to connect the detection chamber to the sample reaction chamber liquid.
The sample detecting device according to claim 1, wherein the sample reaction chamber is connected to the detection chamber, and the bottom of the sample reaction chamber is connected to the sample receiving end of the detection chamber; the channel is located in the sample reaction chamber. The through hole is connected to the detection chamber at the bottom; in the initial state, the through hole is sealed; when the state is detected, the sealed through hole is opened.
The sample detecting device according to claim 2, wherein the through hole is provided with a sealing plug that seals the through hole.
The sample detecting device according to claim 1, wherein the sample detecting device further comprises a cover body for covering the sample reaction chamber; and a rib is connected to the end of the cover body.
The sample detecting device according to claim 4, wherein after the cover body covers the sample reaction chamber, the ridge is located directly above the through hole in the reaction chamber.
The sample detecting device according to claim 5, wherein the sample detecting device further comprises an annular buckle, the buckle is snap-fitted to the top wall of the cover body; the buckle center is provided with a protrusion, and the side wall of the cover body The upper surface has a concave hole for receiving the protrusion, and after the buckle protrusion engages the concave hole of the side wall of the cover body, the cover body and the buckle are fixed to each other.
The sample detecting device according to claim 6, wherein the cover body has a first position and a second position on the sample reaction chamber; and in the initial state, when the cover body is in the first position, the buckle is engaged with the cover body The cover body is fixed between the sample reaction chamber and the top of the cover body does not contact the reaction chamber cavity mouth, and the convex strip on the cover body does not contact the through hole plug on the through hole at the bottom of the sample reaction chamber; when detecting the state, the cover body is located in the second When the position is removed, the buckle is removed, the cover body is directly pressed and closed on the sample reaction chamber, and the top of the cover body directly contacts the reaction cavity cavity, and the convex strip on the cover body contacts and punctures the bottom of the sample reaction chamber. The plug allows the sample reaction chamber to communicate with the detection chamber.
The sample detecting device according to claim 4, wherein the end of the cover body is further provided with a card slot; and the chip carrier is engaged in the card slot.
The sample detecting device according to claim 2, wherein the detecting chamber includes one or more test elements; and the sample receiving portion of the test element is located below the through hole at the bottom of the sample reaction chamber.
A sample collection and detection device includes a detection chamber, which further includes a sample reaction chamber and a sample collection chamber; a bottom of the sample reaction chamber is connected to a sample receiving end of the detection chamber, and the sample reaction chamber and the sample are collected The collecting chamber is connected and connected; a passage is formed between the detecting chamber and the sample reaction chamber, and the passage is a through hole which is in communication with the detecting chamber at the bottom of the sample reaction chamber; in the initial state, the through hole is sealed; when detecting the state, The sealed through hole is opened.
The sample collection and detection device according to claim 10, wherein the sample collection chamber is located at one end of the detection chamber; the bottom of the sample collection chamber is connected to the side wall of the sample reaction chamber; and the bottom of the collection chamber has a side with the sample chamber Through holes that communicate with the walls.
The sample collection and detection device according to claim 11, further comprising a cover covering the sample reaction chamber; and a rib is connected to the end of the cover.
The sample collection and detection device according to claim 12, further comprising an annular buckle, the buckle is snap-fitted to the side wall of the cover body; the buckle center is provided with a protrusion, and the side wall of the cover body is accommodated The convex recessed hole, the cover body and the buckle are fixed to each other after the latching protrusion is engaged with the recessed hole of the side wall of the cover body.
The sample collection and detection device according to claim 13, wherein the cover body has a first position and a second position on the sample reaction chamber; and when the cover body is in the first position, the buckle is engaged in the cover body and the sample reacts The cover body is fixed between the cavities, and the convex strip on the cover body does not contact the through-hole plug of the sealed through-hole at the bottom of the sample reaction chamber; when the cover body is in the second position, the buckle is removed, and the cover body is pressed down and directly covered Cooperating on the sample reaction chamber, the ribs on the cover contact and puncture the through-hole plug at the bottom of the sample reaction chamber to connect the sample reaction chamber to the detection chamber.
The sample collection and detection device according to claim 11, further comprising a sample collection rod, the sample collection rod comprising an associated absorbent member and a handle; and a sealing member between the absorbent member and the handle.
The sample collection and detection device according to claim 15, wherein the sample collection chamber cavity is provided with two symmetric card holes; the end of the sample collection bar handle connected to the absorbing member is provided with two symmetrical card strips. .
A method for collecting and detecting a liquid sample for analyzing an analyte in a liquid sample, comprising: a sample collection detecting device for collecting and detecting an analyte in the liquid sample, the sample collection detecting device comprising a detection chamber, a sample reaction chamber, a sample collection chamber; the sample reaction chamber is connected and connected to the sample collection chamber; a channel is provided between the detection chamber and the sample reaction chamber, and the channel is located in a sample reaction connected to the sample receiving end of the detection chamber At the bottom of the cavity, the channel is a through hole; in the initial state, the through hole is sealed; when the state is detected, the sealed through hole is opened; the sample collection detecting device further includes a cover covering the sample reaction chamber and is connected a ridge at the end of the cover, a snap that is fixed to the cover, and a sample collection rod; the specific steps are as follows:

(1) When the sample collection detecting device is in an initial state, the buckle fixes the cover body at the first position of the sample reaction chamber, and the protruding strip connected at the end of the cover body does not contact the through hole plug of the through hole at the bottom of the reaction chamber;

(2) inserting a sample collection rod collecting the liquid sample into the sample collection chamber, and sealing the collection chamber by the collection rod;

(3) continuously pushing the sample collection rod toward the bottom of the collection chamber, so that the liquid on the sample collection rod flows into the collection chamber and flows into the sample reaction chamber through the through hole at the bottom of the sample collection chamber that communicates with the side wall of the sample reaction chamber;

(4) engaging the strip on the collecting rod into the card hole at the mouth of the sample collecting chamber to lock the collecting rod in the collecting chamber;

(5) standing for a certain period of time, causing the liquid sample in the sample reaction chamber to react with the substance in the reaction chamber;

(6) Remove the buckle that is engaged with the cover body, press the cover body downward, so that the cover body is covered to the cavity of the sample reaction chamber, that is, the cover body is located at the second position of the reaction chamber. At this time, the sample Collecting and detecting the detecting device, the end of the ridge at the top of the cover body contacts and pierces the sealed through hole at the bottom of the sample reaction chamber;

(7) The liquid sample enters the detection chamber through the pierced through hole, contacts the test element, and detects the analyte in the liquid sample.
The method according to claim 17, wherein the substance in the reaction chamber is a reagent loaded on the carrier; and the one end of the carrier is fixed in the reaction chamber through a card slot on the cover.