WO2024234288A1 - Totally-enclosed testing device, system, and use - Google Patents

Abstract

A totally-enclosed testing device, comprising a sample receiving part used for receiving a sample under test; and a reaction/test part sealedly connected to the sample receiving part by means of a coupling part. A coupling channel is formed between the sample receiving part and the reaction/test part, and the reaction/test part is used for carrying out a biological, chemical and/or physical reaction and result checking on the sample under test; the coupling channel is closed when not in use so that the sample receiving part is not communicated with the reaction/test part, and in a test state, the coupling channel can be passively opened so that the sample receiving part is communicated with the reaction/test part, and a substance in the sample receiving part can be actively introduced into the reaction/test part by means of the coupling channel.

Description

A fully enclosed detection device, system and application Technical Field

The present invention relates to a detection device, and in particular to a fully enclosed detection device, system and application for detecting target components in biological samples.

Background Art

Respiratory infectious diseases represented by SARS, MERS, SARS-COV-2, and sexually transmitted diseases represented by AIDS, syphilis, etc. are all caused by infection with pathogenic microorganisms. The samples of such patients are very dangerous. If they are not handled properly during sample collection, storage, transportation and testing, they can easily cause infection in people who come into contact with them. At the same time, these patients are highly hidden and mainly rely on test results to identify them.

At present, in the testing operation process of clinical testing laboratories, the sample pretreatment and reaction process are basically exposed to the air, and the risk of cross-contamination between samples and infection of operators always exists. For POCT (point-of-care testing) on-site rapid testing equipment, the above problems are particularly prominent.

Although fully integrated reaction chips based on microfluidics can effectively reduce this risk, microfluidic chips are generally expensive and require relatively complex supporting equipment, making them difficult to promote and popularize on a large scale.

Technical issues

The present invention aims to solve the technical problems existing in the prior art. To this end, the present invention provides a fully enclosed detection device, which aims to achieve fully enclosed, multi-step reaction steps, simple and easy-to-use fully enclosed detection.

Technical Solutions

In the first aspect, the present invention provides a fully enclosed detection device, comprising: a sample receiving part, used to receive a sample to be detected; a reaction/detection part, which is sealed and connected to the sample receiving part through a coupling member, and a coupling channel is formed between the sample receiving part and the reaction/detection part, and the reaction/detection part is used to perform biological, chemical and/or physical reactions on the sample to be detected and detect the results; the coupling channel is closed when not in use so that the sample receiving part and the reaction/detection part are not connected, and can be passively opened in a detection state so that the sample receiving part and the reaction/detection part are connected, and the substance in the sample receiving part can be actively introduced into the reaction/detection part through the coupling channel.

In the fully enclosed detection device, preferably, the sample receiving part includes a sample cavity, and the sample cavity includes: the sample receiving cavity, which is a hollow structure with one end open and the other end closed, for receiving the sample to be detected; a first closing part, sealed and connected to the open end of the sample receiving cavity; a first puncture part, connected to the closed end of the sample receiving cavity, and the inner hole of the first puncture part is connected to the inner cavity of the sample receiving cavity, and the inner hole of the first puncture part forms a coupling channel; a first protecting part, covering the outside of the first puncture part and being sealed and connected to the closed end of the sample receiving cavity; thereby, a closed chamber is formed between the sample receiving cavity, the first closing part, the first puncture part and the first protecting part.

In the fully enclosed detection device, preferably, the reaction/detection part comprises a detection cavity, the detection cavity is sealedly connected to the sample cavity via a coupling member, and a coupling channel is formed between the detection cavity and the sample cavity.

In the fully enclosed detection device, preferably, the reaction/detection part includes a reaction chamber and a detection chamber, the reaction chamber is sealed and connected to the sample chamber through a coupling member, and the reaction chamber is sealed and connected to the sample chamber through a coupling member. A coupling channel is formed between the sample chambers, and the reaction chamber is used to perform biological, chemical and/or physical reactions on the sample to be detected and form intermediate reaction products; the detection chamber is sealed and connected to the reaction chamber through a coupling member, and a coupling channel is formed between the detection chamber and the reaction chamber, and the detection chamber is used to perform result detection on the intermediate reaction product.

In the fully enclosed detection device, preferably, there are multiple reaction chambers, the sample chamber and the primary reaction chamber are sealed and connected by a coupling piece, and a coupling channel is formed between the sample chamber and the primary reaction chamber; each of the reaction chambers is sealed and connected in sequence by a coupling piece, and a coupling channel is formed between two adjacent reaction chambers; the detection chamber and the final reaction chamber are sealed and connected by a coupling piece, and a coupling channel is formed between the detection chamber and the final reaction chamber.

In the fully enclosed detection device, preferably, the reaction chamber comprises: a sample reaction chamber, which is a hollow structure with one end open and the other end closed; a second closing portion, which is sealed and connected to the open end of the sample reaction chamber; a second puncture portion, which is connected to the closed end of the sample reaction chamber, and the inner hole of the second puncture portion is connected to the inner cavity of the sample reaction chamber, and the inner hole of the second puncture portion forms a coupling channel; a second protection portion, which is coated on the outside of the second puncture portion and is sealed and connected to the closed end of the sample reaction chamber; thereby, a closed chamber is formed between the sample reaction chamber, the second closing portion, the second puncture portion and the second protection portion.

In the fully enclosed detection device, preferably, the detection cavity comprises: a sample detection cavity, which is a hollow structure with one end open and the other end closed; and a third sealing part, which is sealed and connected to the open end of the sample detection cavity.

The fully enclosed detection device, preferably, the coupling member is mainly composed of two parts, the first part is a coupling hole formed on the second enclosed part and the third enclosed part, the second part is a first protection part and a second protection part, the coupling hole is connected to the first protection part and the second protection part The shape of the first protection part or the second protection part is adapted to the coupling hole, and a sealed connection can be formed by inserting the first protection part or the second protection part into the coupling hole.

In the fully enclosed detection device, preferably, the first enclosing part, the second enclosing part and/or the third enclosing part and the first protecting part and/or the second protecting part are all made of elastic material.

In the fully enclosed detection device, preferably, the reaction chamber and the detection chamber are in a negative pressure state, so that when the coupling channel is opened, the substance in the previous stage cavity can be quantitatively sucked into the next stage cavity under the action of negative pressure.

In the fully enclosed detection device, preferably, the pressures in the reaction chamber and the detection chamber are the same or different, and the inner volumes of the reaction chamber and the detection chamber are the same or different, thereby changing the pressures and inner volumes of the reaction chamber and the detection chamber, thereby changing the volume of material transfer in adjacent chambers when they are connected.

The fully enclosed detection device preferably further comprises at least one reagent chamber. When the reagent chamber is single, the reagent in the reagent chamber is introduced into the sample chamber, the reaction chamber and/or the detection chamber in a passive or active manner;

When there are multiple reagent chambers, the reagents in each reagent chamber are introduced into the sample chamber, the reaction chamber and/or the detection chamber individually or in groups in a passive or active manner.

In the fully enclosed detection device, preferably, the sample chamber, reaction chamber and/or detection chamber has multiple enclosed parts, or the first enclosed part, the second enclosed part and/or the third enclosed part are provided with multiple injection holes to adapt to the multiple reagent chambers.

In the fully enclosed detection device, preferably, the sample chamber and/or the reaction chamber is provided with a plurality of puncture parts, the inner cavity of each puncture part is connected to the corresponding sample chamber and/or reaction chamber, and each Each of the puncture parts is provided with a protective part outside to adapt to the multiple reaction chambers and/or detection chambers.

In the fully enclosed detection device, preferably, the sample chamber is a separate chamber, or a sample chamber combination is formed by a plurality of chambers with independent air pressures; the reaction chamber is a separate chamber, or a reaction chamber combination is formed by a plurality of chambers with independent air pressures; the detection chamber is a separate chamber, or a detection chamber combination is formed by a plurality of chambers with independent air pressures; the chamber units of the sample chamber combination, the reaction chamber combination and the detection chamber combination are arranged correspondingly along the center direction of the chamber.

In the fully enclosed detection device, preferably, the sample chamber contains a first preset reagent, the first preset reagent is used to achieve pretreatment of the sample to be detected, and the first preset reagent is liquid, solid or gaseous; the reaction chamber contains a second preset reagent, the second preset reagent is used to achieve an amplification reaction, an immune reaction, a hybridization reaction, a biochemical reaction, a cell culture, a non-specific binding reaction or a specific binding reaction of the sample to be detected, and the second preset reagent is liquid, solid or gaseous; the detection chamber contains a third preset reagent, the third preset reagent is used to achieve result detection of the intermediate reaction product, and the third preset reagent is liquid, solid or gaseous.

In a second aspect, the present invention provides a fully enclosed detection system, comprising the fully enclosed detection device of the first aspect of the present invention, and motion transmission and control components, temperature control components and/or signal detection components used in conjunction therewith.

In a third aspect, the present invention provides an application of a fully enclosed detection device. The fully enclosed detection device of the first aspect of the present invention can be applied to cell analysis, biochemical analysis, physical and chemical analysis, immune detection and gene detection.

Beneficial Effects

The present invention adopts the above technical solution, which has the following advantages:

1. The present invention has a compact structure, is easy to process and manufacture, has a low cost, is simple to operate, and has portable supporting equipment. It can complete the qualitative detection of target components in biological samples in one stop, is particularly suitable for on-site detection, and can also be used for high-throughput detection applications.

2. The present invention adopts a mature negative pressure method to quantitatively transfer substances between cavities. The liquid transfer amount can be adjusted and the number of reaction chambers can be increased or decreased according to the detection purpose and detection process of the detection device. When a major epidemic occurs, the present invention can be used to quickly develop devices suitable for on-site rapid detection and high-throughput detection.

3. The present invention can complete the collection, reaction and detection of samples to be tested in one stop, and the whole process is completely closed, avoiding the risk of cross-contamination between samples and the risk of operators being infected by pathogenic microorganisms contained in the samples. It can be widely used in applications such as cell analysis, biochemical analysis, physicochemical analysis, immunoassay and genetic testing.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are used to provide a further understanding of the present invention and constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute improper limitations of the present invention, as shown in the figure:

FIG1 is a schematic diagram of the overall structure of a fully enclosed detection device provided by an embodiment of the present invention;

FIG2 is a schematic diagram of the structure of the sample chamber provided by this embodiment of the present invention;

FIG3 is a schematic diagram of the structure of the reaction chamber provided in this embodiment of the present invention;

FIG4 is a schematic diagram of the structure of the detection chamber provided in this embodiment of the present invention;

FIG5 is a schematic structural diagram of a fully enclosed detection device provided by another embodiment of the present invention;

FIG6 is a schematic diagram of the structure of a reaction chamber provided by another embodiment of the present invention;

FIG. 7 is a schematic structural diagram of a sample chamber assembly provided by another embodiment of the present invention.

Best Mode for Carrying Out the Invention

In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

In the description of the present invention, it should be noted that the terms "upper", "lower", "axial", "circumferential", "horizontal", "vertical" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the system or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. In addition, the terms "first", "second" and the like are used to define components only for the convenience of distinguishing the above components, and unless otherwise stated, the above terms have no special meanings and cannot be understood as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "assembly", "setting", and "connection" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

The fully enclosed detection device provided by the present invention comprises: a sample receiving part for receiving the sample to be detected; a reaction/detection part, which is sealed and connected to the sample receiving part through a coupling member, and a coupling channel is formed between the sample receiving part and the reaction/detection part, and the reaction/detection part is used to react with the sample to be detected. Biological, chemical and/or physical reactions and result detection; the coupling channel is closed when not in use so that the sample receiving part is not connected to the reaction/detection part, and can be passively opened in the detection state so that the sample receiving part is connected to the reaction/detection part, and the substance in the sample receiving part can be actively introduced into the reaction/detection part through the coupling channel. The present invention has a compact structure, is easy to process and manufacture, has a low cost, is simple to operate, and has portable supporting equipment. It can complete qualitative detection of target components in biological samples in one stop, is particularly suitable for on-site detection, and can also be used for high-throughput detection applications.

The fully enclosed detection device and system provided by the embodiments of the present invention are described in detail below with reference to the accompanying drawings.

As shown in FIG1 , the fully enclosed detection device provided in this embodiment may include a sample chamber 1 and at least one reaction chamber 2 and a detection chamber 3. The sample chamber 1 is sealed and connected to the primary reaction chamber 2 through a coupling, and a coupling channel is formed between the sample chamber 1 and the primary reaction chamber 2. The sample chamber 1 is used to receive the sample to be detected. If there are multiple reaction chambers 2, each reaction chamber 2 is sealed and connected in sequence through a coupling, and a coupling channel is formed between two adjacent reaction chambers 2. The reaction chamber 2 is used to perform biochemical, immune, amplification, hybridization, culture or other biological, physical and chemical reactions on the sample to be detected, and form an intermediate reaction product. The detection chamber 3 is also sealed and connected to the final reaction chamber 2 (when there is only one reaction chamber 2, the final reaction chamber is the primary reaction chamber) through a coupling, and a coupling channel is also formed between the detection chamber 3 and the final reaction chamber 2. The detection chamber 3 is used to perform result detection on the intermediate reaction product. The coupling channels are closed when not in use so that adjacent cavities are not connected, and can be passively opened in the detection state to connect adjacent cavities, and the substance in the previous stage cavity (such as the sample to be detected or the intermediate reaction product) can be actively introduced into the next stage cavity through the coupling channel.

In the above embodiment, preferably, as shown in FIG. 2 , the sample chamber 1 includes a sample receiving chamber 101, Cavity cap 102, puncture needle 103 and protective cover 104. The sample receiving cavity 101 is a hollow structure with one end open and the other end closed, which is used to receive the sample to be tested. The cavity cap 102 covers the open end of the sample receiving cavity 101 and is used to seal the sample receiving cavity 101. The puncture needle 103 is connected to the closed end of the sample receiving cavity 101, and the inner hole of the puncture needle 103 is connected to the inner cavity of the sample receiving cavity 101, and the inner hole of the puncture needle 103 forms a coupling channel. The protective cover 104 is coated on the outside of the puncture needle 103 and connected to the sample receiving cavity 101. The length of the protective cover 104 is longer than that of the puncture needle 103, and the inner diameter is larger than the outer diameter of the puncture needle 103. Thus, a closed chamber is formed between the sample receiving cavity 101, the cavity cap 102, the puncture needle 103 and the protective cover 104. Those skilled in the art should understand that the sample chamber 1 can be configured as a structure suitable for actively collecting the sample to be tested (in this case, the closed chamber is at negative pressure) and collecting the sample to be tested by blood sampling or the like; the sample chamber 1 can also be configured as a structure suitable for passively receiving the sample to be tested (in this case, the closed chamber is at normal pressure) and receiving the sample to be tested by opening the chamber cap 102 to add the sample or by piercing the chamber cap 102 with a sample needle to add the sample.

In the above embodiment, preferably, the sample chamber 1 may contain a first preset reagent (such as an anticoagulant or a cell lysis solution, etc.), which can realize the pretreatment of the sample to be detected, and the first preset reagent may be liquid, solid or gaseous.

In the above embodiment, preferably, as shown in Figure 3, the reaction chamber 2 includes a sample reaction chamber 201, a cavity cap 202, a puncture needle 203 and a protective cover 204. The sample reaction chamber 201 is a hollow structure with one end open and the other end closed. The cavity cap 202 covers the open end of the sample reaction chamber 201 to seal the sample reaction chamber 201. The puncture needle 203 is connected to the closed end of the sample reaction chamber 201, and the inner hole of the puncture needle 203 is connected to the inner cavity of the sample reaction chamber 201, and the inner hole of the puncture needle 203 forms a coupling channel. The protective cover 204 is coated on the outside of the puncture needle 203 and is connected to the sample reaction chamber 201. The length of the protective cover 204 is longer than the puncture needle 203, the inner diameter is larger than the outer diameter of the puncture needle 203, and the diameter is smaller than the outer diameter of the puncture needle 203. The bottom tip portion of the sample reaction chamber 201. Thus, a closed chamber is formed between the sample reaction chamber 201, the chamber cap 202, the puncture needle 203 and the protective cover 204.

In the above embodiment, preferably, the reaction chamber 2 may contain a second preset reagent, which can be used to realize an amplification reaction, an immune reaction, a hybridization reaction, a biochemical reaction, a cell culture, a non-specific binding reaction or a specific binding reaction of the sample to be detected, and the second preset reagent may be in liquid, solid or gaseous state.

In the above embodiment, preferably, as shown in FIG4 , the detection chamber 3 includes a sample detection chamber 301 and a chamber cap 302. The sample detection chamber 301 is a hollow structure with one end open and the other end closed. The chamber cap 302 covers the open end of the sample detection chamber 301 to seal the chamber 301.

In the above embodiment, preferably, the detection chamber 3 may contain a third preset reagent, and the third preset reagent can realize the result detection of the intermediate reaction product, and the third preset reagent may be in liquid, solid or gaseous state.

In the above embodiments, preferably, the detection method corresponding to the detection cavity 3 can be a single indicator or multiple indicators, or can be fluorescence method, chemiluminescence method, quantum dot method, colorimetric method, photometric method or other physical and chemical methods.

In the above embodiments, preferably, the couplings between the cavities can be threads, buckles and/or push-pull structures. This embodiment shows a push-pull structure coupling, the first part of which is a blind hole opened on the cavity cap 202 and the cavity cap 302, and the second part of which is a protective sleeve 103 and a protective sleeve 203, the blind hole is adapted to the shape of the protective sleeve 103 and the protective sleeve 203, and the protective sleeve 103 and the protective sleeve 203 can be inserted into the blind hole of the cavity cap 202 and the cavity cap 302 respectively to form a sealed connection.

In the above embodiments, preferably, the cavity cap 102, the cavity cap 202 and/or the cavity cap 302 and the protective The sleeve 103 and/or the protective sleeve 203 are both made of elastic material, preferably medical grade thermoplastic polyurethane elastomer (TPU), which not only has good flexibility to facilitate the puncture needle to pierce the protective sleeve and the cavity cap, but also can form a good sealing interface between the two when the protective sleeve is inserted into the blind hole of the cavity cap.

In the above embodiment, preferably, the reaction chamber 2 and the detection chamber 3 are in a negative pressure state, so that when the coupling channel is opened, the substance in the previous stage chamber can be quantitatively sucked into the next stage chamber under the action of negative pressure. Further, the pressure in the reaction chamber 2 and the detection chamber 3 can be different, and the inner cavity volume of the reaction chamber 2 and the detection chamber 3 can also be different, so that by changing the pressure and volume in the reaction chamber 2 and the detection chamber 3, the substance transfer volume of the adjacent chambers when they are connected can be changed.

In the above-mentioned embodiment, preferably, the fully enclosed detection device may also include at least one reagent chamber. In the embodiment of a single reagent chamber, the reagent in the reagent chamber may be introduced into the sample chamber 1, the reaction chamber 2 and/or the detection chamber 3 in a passive or active manner; in the embodiment of multiple reagent chambers, the reagent in each reagent chamber may be introduced into the sample chamber 1, the reaction chamber 2 and/or the detection chamber 3 individually or in groups.

In the above embodiments, preferably, as shown in FIG. 6 , the sample chamber 1, the reaction chamber 2 and/or the detection chamber 3 may have multiple chamber caps, or the chamber cap 102, the chamber cap 202 and/or the chamber cap 302 may be provided with multiple injection holes, so as to adapt to the situation of multiple sample chambers 1, reaction chambers 2 and/or detection chambers 3.

In the above embodiment, preferably, the sample chamber 1 and/or the reaction chamber 2 may have a plurality of puncture needles connected to the chamber body, the inner cavity of each puncture needle is connected to the corresponding sample chamber 1 and/or the reaction chamber 2, and each puncture needle is provided with a protective cover on the outside, so that the sample or the intermediate reaction product can be conveniently divided into a plurality of different reaction chambers 2 or detection chambers 3. It should be noted that the figure only shows another structural form of the reaction chamber 2, and the sample chamber 1 and the detection chamber 3 are similar in structure, so the corresponding figure is not repeated.

In the above embodiment, preferably, as shown in FIG7 , the sample chamber 1 can be a single chamber, or a plurality of chambers with independent air pressures can form a sample chamber combination; the reaction chamber 2 can be a single chamber, or a plurality of chambers with independent air pressures can form a reaction chamber combination; the detection chamber 3 can be a single chamber, or a plurality of chambers with independent air pressures can form a detection chamber combination; the chamber units of the sample chamber combination, the reaction chamber combination, and the detection chamber combination are arranged correspondingly along the center direction of the chamber. It should be noted that FIG7 only shows a schematic diagram of a sample chamber combination, and the reaction chamber combination and the detection chamber combination are similar in structure, so the corresponding diagrams are not provided repeatedly.

In the above embodiments, preferably, the shapes of the sample chamber 1 , the reaction chamber 2 and/or the detection chamber 3 include but are not limited to columnar, conical, spherical, block-shaped or irregular shapes.

In the above embodiments, preferably, the second preset reagent can be a biochemical reaction reagent, an immune reaction reagent, a cell culture reagent, a nucleic acid hybridization reagent, a nucleic acid extraction reagent, a nucleic acid purification reagent, a nucleic acid amplification reagent, a protein purification reagent or a cell capture reagent, etc.

Those skilled in the art should understand that the detection chamber 3 and the final reaction chamber 2 can be one chamber, that is, there can be only one sample chamber 1 and one detection chamber 3. In this case, the detection chamber 3 serves as both an intermediate reaction chamber and a detection chamber (as shown in FIG. 5 ).

When the fully enclosed detection device provided by the present invention is in use, when the sample chamber 1 is pushed to move in the direction close to the primary reaction chamber 2, the puncture needle 103 of the sample chamber 1 sequentially pierces the protective cover 104 and the chamber cap 202 of the primary reaction chamber 2, so that the coupling channel between the sample chamber 1 and the primary reaction chamber 2 is opened. At this time, under the action of the specific negative pressure in the primary reaction chamber 2, the sample to be detected in the sample chamber 2 can be quantitatively sucked into the primary reaction chamber 2; if the fully enclosed detection device includes multiple reaction chambers 2, the substances in the previous reaction chamber 2 are introduced into the next reaction chamber 2 and even into the detection chamber 3 in a similar manner between the adjacent reaction chambers 2, thereby realizing a fully enclosed, multi-step reaction step. Simple, easy-to-use detection.

Based on the fully enclosed detection device provided in the above embodiment, the present invention also provides a fully enclosed detection system, which includes the above-mentioned fully enclosed detection device, and motion transmission and control components, temperature control components and/or signal detection components used therewith.

It should be noted that the implementation method in the above-mentioned fully enclosed detection device embodiment is also applicable to the embodiment of the fully enclosed detection system and can achieve the same technical effect, which will not be repeated here.

The above embodiments are only used to illustrate the present invention, in which the components and devices of the embodiments can be changed, and each implementation method can be combined or deleted as needed. Not all components in the drawings are necessary. The general principles defined in this document can be implemented in other embodiments without departing from the spirit or scope of this application. Therefore, this application will not be limited to the embodiments described herein, and all equivalent changes and improvements based on the technical solution of the present invention should not be excluded from the protection scope of the present invention.

Claims (17)

A fully enclosed detection device, characterized in that it comprises: A sample receiving unit, used for receiving a sample to be tested; A reaction/detection part, which is sealed and connected to the sample receiving part through a coupling member, and a coupling channel is formed between the sample receiving part and the reaction/detection part, and the reaction/detection part is used to perform biological, chemical and/or physical reactions on the sample to be detected and detect the results; The coupling channel is closed when not in use so that the sample receiving part is not connected to the reaction/detection part, and can be passively opened in the detection state so that the sample receiving part is connected to the reaction/detection part, and the substance in the sample receiving part can be actively introduced into the reaction/detection part through the coupling channel. The fully enclosed detection device according to claim 1, characterized in that the sample receiving portion includes a sample cavity, and the sample cavity includes: The sample receiving cavity is a hollow structure with one end open and the other end closed, and is used to receive the sample to be tested; the first closing part is sealed and connected to the open end of the sample receiving cavity; A first puncture portion is connected to the closed end of the sample receiving cavity, and the inner hole of the first puncture portion is connected to the inner cavity of the sample receiving cavity, and the inner hole of the first puncture portion forms a coupling channel; A first protection portion, covering the outside of the first puncture portion and sealedly connected to the closed end of the sample receiving cavity; Thus, a closed chamber is formed among the sample receiving cavity, the first sealing portion, the first puncturing portion and the first protecting portion. The fully enclosed detection device according to claim 2, characterized in that the reaction/detection part includes a detection cavity, the detection cavity is sealed and connected to the sample cavity through a coupling member, and the A coupling channel is formed between the detection cavity and the sample cavity. The fully enclosed detection device according to claim 2 is characterized in that the reaction/detection part includes a reaction chamber and a detection chamber, the reaction chamber is sealed and connected to the sample chamber via a coupling member, a coupling channel is formed between the reaction chamber and the sample chamber, and the reaction chamber is used to perform biological, chemical and/or physical reactions on the sample to be detected and form intermediate reaction products; the detection chamber is sealed and connected to the reaction chamber via a coupling member, a coupling channel is formed between the detection chamber and the reaction chamber, and the detection chamber is used to perform result detection on the intermediate reaction product. The fully enclosed detection device according to claim 4 is characterized in that there are multiple reaction chambers, the sample chamber and the primary reaction chamber are sealed and connected by a coupling piece, and a coupling channel is formed between the sample chamber and the primary reaction chamber; each of the reaction chambers is sealed and connected in sequence by a coupling piece, and a coupling channel is formed between two adjacent reaction chambers; the detection chamber and the final reaction chamber are sealed and connected by a coupling piece, and a coupling channel is formed between the detection chamber and the final reaction chamber. The fully enclosed detection device according to claim 4 or 5, characterized in that the reaction chamber comprises: The sample reaction chamber is a hollow structure with one end open and the other end closed; A second sealing portion, sealed and connected to the open end of the sample reaction chamber; A second puncture portion is connected to the closed end of the sample reaction chamber, and the inner hole of the second puncture portion is connected to the inner cavity of the sample reaction chamber, and the inner hole of the second puncture portion forms a coupling channel; A second protection portion, covering the outside of the second puncture portion and sealedly connected to the closed end of the sample reaction chamber; Thus, a space is formed between the sample reaction chamber, the second sealing portion, the second puncture portion and the second protection portion. Close the chamber. The fully enclosed detection device according to any one of claims 3 to 5, characterized in that the detection chamber comprises: The sample detection cavity is a hollow structure with one end open and the other end closed; A third sealing portion is sealed and connected to the open end of the sample detection cavity. The fully enclosed detection device according to claim 7 is characterized in that the coupling part is mainly composed of two parts, the first part is a coupling hole formed on the second enclosed part and the third enclosed part, and the second part is a first protecting part and a second protecting part. The coupling hole is adapted to the shape of the first protecting part and the second protecting part, and a sealed connection can be formed by inserting the first protecting part or the second protecting part into the coupling hole. The fully enclosed detection device according to claim 8 is characterized in that the first enclosing part, the second enclosing part and/or the third enclosing part and the first protecting part and/or the second protecting part are all made of elastic material. The fully enclosed detection device according to claim 4 is characterized in that the reaction chamber and the detection chamber are in a negative pressure state, so that when the coupling channel is opened, the substance in the previous stage chamber can be quantitatively sucked into the next stage chamber under the action of negative pressure; Preferably, the pressures in the reaction chamber and the detection chamber are the same or different, and the inner volumes of the reaction chamber and the detection chamber are the same or different, thereby changing the pressures and inner volumes of the reaction chamber and the detection chamber, thereby changing the volume of material transfer in adjacent chambers when they are connected. The fully enclosed detection device according to claim 4 is characterized in that it further comprises at least one reagent chamber, and when the reagent chamber is single, the reagent in the reagent chamber is introduced into the sample chamber, the reaction chamber and/or the detection chamber in a passive or active manner; When there are multiple reagent chambers, the reagents in each reagent chamber are introduced into the sample chamber, the reaction chamber and/or the detection chamber individually or in groups in a passive or active manner. The fully enclosed detection device according to claim 11 is characterized in that the sample chamber, reaction chamber and/or detection chamber has multiple enclosed parts, or the first enclosed part, the second enclosed part and/or the third enclosed part are provided with multiple injection holes to adapt to the multiple reagent chambers. The fully enclosed detection device according to claim 12 is characterized in that a plurality of puncture portions are provided on the sample chamber and/or the reaction chamber, the inner cavity of each puncture portion is connected to the corresponding sample chamber and/or the reaction chamber, and a protective portion is provided on the outside of each puncture portion to adapt to the plurality of reaction chambers and/or detection chambers. The fully enclosed detection device according to claim 4 is characterized in that the sample chamber is a separate chamber, or a sample chamber combination formed by a plurality of chambers with independent air pressures; The reaction chamber is a single chamber, or a combination of multiple chambers with independent gas pressures. The detection cavity is a single cavity, or a combination of multiple cavities with independent air pressures. The cavity units of the sample cavity assembly, the reaction cavity assembly and the detection cavity assembly are arranged correspondingly along the center direction of the cavity. The fully enclosed detection device according to claim 4 is characterized in that the sample chamber contains a first pre-set reagent, the first pre-set reagent is used to achieve pre-treatment of the sample to be detected, and the first pre-set reagent is liquid, solid or gaseous; The reaction chamber contains a second pre-set reagent, which is used to implement an amplification reaction, immune reaction, hybridization reaction, biochemical reaction, cell culture, non-specific binding of the sample to be detected. reaction or specific binding reaction, and the second preset reagent is liquid, solid or gaseous; the detection chamber contains a third preset reagent, and the third preset reagent is used to realize the result detection of the intermediate reaction product, and the third preset reagent is liquid, solid or gaseous. A fully enclosed detection system, characterized in that it comprises the fully enclosed detection device as described in any one of claims 1 to 15, and a motion transmission and control component, a temperature control component and/or a signal detection component used in conjunction with it. An application of the fully enclosed detection device as described in any one of claims 1 to 15, characterized in that it is applied to cell analysis, biochemical analysis, physicochemical analysis, immune detection and gene detection.