A collection chamber

Abstract

The present invention provides a collection chamber comprising at least two cavities for collecting samples, and the samples can be transferred between the cavities. The collection chamber can separate the collected samples, so that the samples that need to undergo secondary confirmation testing are separated from the samples of the initial testing, and can be independently sealed and sent to a testing agency for confirmation testing. The present invention can divide the collected samples into different chambers, and the different chambers can be partially connected or isolated according to the needs of collection, separation or testing. The samples required for the secondary test are obtained through one collection and can be stored separately. There will be no contamination between the samples for confirmation testing and the samples for the initial testing and the test elements, ensuring that the effect of the secondary confirmation will not be affected.

Description

Technical Field

[0001] The present invention relates to a device for collecting liquid samples, in particular to a device for collecting and detecting analytes in liquid samples in the field of rapid diagnosis, such as a urine collection and detection device. Background Art

[0002] Currently, testing devices for detecting the presence of an analyte in a sample are widely used in hospitals and homes. These rapid diagnostic devices, such as those used for pregnancy tests and drug abuse tests, contain one or more test strips. These rapid diagnostic devices are very convenient, providing test results on the test strip within one minute, or at most ten minutes.

[0003] Drug testing is widely used, often in institutions such as drug control departments, public security bureaus, drug rehabilitation centers, medical examination centers, and national military recruitment medical examination offices. Given the diverse and frequent nature of drug testing, there is a significant market demand for drug testing urine cups that can automatically separate the remaining sample from the sample being tested. Currently, drug testing urine cups on the market, for example, contaminate the sample after testing with the test reagent, making them unusable for a second, confirmatory test, as described in U.S. Patent 7,300,633.

[0004] Although, in traditional technology, the sample to be tested can be isolated from the sample to be collected, it is expensive and not easy to operate. For example, the piston urine cup described in U.S. Patent No. 7300633 allows the liquid sample in the collection chamber, such as urine, to be transferred from the collection chamber to the detection chamber when the piston is pushed forward. The detection chamber contains a test element for the substance to be analyzed in the detection sample, and the liquid sample in the collection chamber is separated by the piston, so that the samples in the two places will not be confused, and can be used for subsequent confirmation testing. Although this can isolate the sample to be tested and the sample to be collected, this piston urine cup is expensive and not easy to operate. After all, it takes a lot of force to push the piston. This is because the piston needs to achieve the transfer of the sample and must have a liquid sealing effect with the wall of the piston. To achieve the sealing effect, the piston and the piston chamber must be tightly combined.

[0005] For another example, U.S. Patent 8,992,855 describes a device for collecting liquid samples, which includes a piston structure that is integrated with a lid and moves with the lid. Although the detection sample can be separated from the collected sample, when the detection sample enters the detection chamber, it needs to overcome a large pressure to enter, and the dimensions of the lid and the cup mouth need to be precisely designed so that the piston integrated with the lid can be accurately inserted into the separation chamber.

[0006] In addition, after the preliminary tests of these traditional collection and detection devices are completed, if subsequent confirmation tests are required, the entire collection and detection device needs to be transported to a confirmation and detection agency for further confirmation tests. This brings many problems, at least the following problems: First, most of the current liquid collection and detection devices are only equipped with a preliminary detection chamber. If subsequent confirmation tests are required, the entire device containing urine and detection reagent strips can only be sent to a confirmation and detection agency for testing. The sample in the urine cup may be contaminated by the detection reagent. Second, when the entire device is sent to the confirmation and detection agency, due to the large cup mouth, there is a risk of liquid leakage during transportation, which requires more costs to make the device have a better sealing effect to minimize the risk of leakage; third, after the entire device is transported to the confirmation and detection agency, the confirmation and detection agency needs a huge low-temperature warehouse to store the entire detection device to prevent the liquid sample from deteriorating and to prepare for possible further confirmation tests. This causes the cost of the confirmation and detection agency (which can be called a secondary detection agency) to increase significantly.

[0007] In view of the above-mentioned technical problems, it is necessary to improve them and provide other ways to solve the shortcomings of existing traditional technologies. Summary of the Invention

[0008] In view of the above situation, in order to overcome the defects of the prior art, the technical problem to be solved by the present invention is to provide a collection chamber. The collection chamber can separate the collected samples, so that the samples that need to be tested for secondary confirmation are separated from the samples of the initial test, and can be independently sealed and sent to the testing agency for confirmation testing. The sample collection device of the present invention can divide the collected samples into different chambers, and the different chambers can be partially connected or isolated according to the needs of collection, separation or testing. The samples required for secondary testing are obtained through one collection and can be stored separately. There will be no contamination between the samples for confirmation testing and the samples for initial testing and the test elements, ensuring that the effect of the secondary confirmation will not be affected.

[0009] In order to solve the above technical problems, the present invention provides the following technical solutions:

[0010] A collection chamber comprises at least two cavities for collecting samples, and the samples can be transferred between the cavities.

[0011] Furthermore, the cavity includes a first cavity and a third cavity, and the first cavity and the third cavity can be in a state of liquid connection or isolation.

[0012] Furthermore, the sample collected in the third cavity can flow into the first cavity naturally, or the sample collected in the third cavity can flow into the first cavity under the action of a certain external force.

[0013] Furthermore, the cavity body includes a first channel for fluidly connecting the first cavity and the third cavity.

[0014] Furthermore, the first channel is located at the bottom of the third cavity.

[0015] Furthermore, the first channel can be closed or opened.

[0016] Furthermore, a collecting groove is provided on the side wall of the first channel, and the collecting groove is flush with or slightly higher than the bottom of the third cavity.

[0017] Furthermore, the collecting tank can be closed separately or simultaneously with the first channel.

[0018] Furthermore, the cavity includes a third cavity for collecting samples and a fourth cavity for collecting samples to be tested, and the fourth cavity can be in a state of liquid communication or isolation with the third cavity.

[0019] Furthermore, the sample collected in the third cavity can flow into the fourth cavity naturally, or the sample collected in the third cavity can flow into the fourth cavity under the action of a certain external force.

[0020] Furthermore, the chamber body includes a second channel for fluidly connecting the fourth chamber and the third chamber.

[0021] Furthermore, the second channel can be closed or opened.

[0022] Further, a pipetting channel is included.

[0023] Furthermore, samples can be transferred between chambers.

[0024] Furthermore, the sample collected in the cavity can flow into the pipetting channel naturally, or the sample collected in the cavity can flow into the pipetting channel under the action of a certain external force.

[0025] Furthermore, the pipetting channel is located at the bottom of the cavity.

[0026] Further, a pipetting element is included.

[0027] Furthermore, the pipetting element divides a portion of the pipetting channel into a first chamber.

[0028] Furthermore, the pipetting element is movable in the pipetting channel to change the volume of the first chamber.

[0029] Furthermore, the pipetting element can exert force on the sample in the first cavity so as to transfer the sample in the first cavity to other cavities or the outside.

[0030] Furthermore, the pipetting element divides a portion of the pipetting channel into a fourth chamber.

[0031] Furthermore, the pipetting element is movable in the pipetting channel to change the volume of the first chamber.

[0032] Furthermore, the pipetting element can exert force on the sample in the fourth cavity so as to transfer the sample in the fourth cavity to other cavities or the outside.

[0033] Furthermore, the pipetting element closes the second channel while transferring the sample in the fourth chamber.

[0034] Further, a detection area is included.

[0035] Furthermore, a detection inlet is included for connecting the pipetting channel and the detection area to each other.

[0036] Furthermore, a sealing connection cover is included, which can directly or indirectly seal the collection chamber.

[0037] Furthermore, the sealing connection cover includes a first cover for covering the sample collection inlet and a second cover for covering the test element inlet.

[0038] The following technical solutions also belong to the content of the present invention:

[0039] In a first aspect, the present invention provides a sample detection device, comprising a first chamber for collecting a liquid sample and a second chamber for collecting a confirmed test sample, wherein the first chamber and the second chamber can be in a liquid-connected or isolated state, and when the first chamber and the second chamber are in a liquid-connected state, the liquid in the first chamber can be transferred to the second chamber under the action of an external force.

[0040] In some preferred embodiments, the external force may be gravity. In some preferred embodiments, the external force is a force other than gravity. In some preferred embodiments, the force other than gravity includes contact and / or non-contact pressure, thrust, squeezing force, and the like. In some preferred embodiments, the external force may be a force that overcomes gravity. In some preferred embodiments, the external force may be a force other than gravity, such as breaking through an obstruction or passing through an opening. In some preferred embodiments, the external force may be a force generated within the structure. In some preferred embodiments, the external force may be a force generated within the structure through its structure or coordination, such as a driving force generated by a pressure differential or an attractive force generated by negative pressure or vacuum. In some preferred embodiments, the second chamber may be set to a vacuum. If the first and second chambers are in fluid communication, liquid may flow from the first chamber to the second chamber due to the pressure differential. In some preferred embodiments, the second chamber does not necessarily need to be completely evacuated; as long as the internal pressure of the second chamber is lower than that of the first chamber, the aforementioned pressure differential effect can be achieved. In some preferred embodiments, the first chamber may be pressurized to achieve the aforementioned pressure differential effect.

[0041] In some preferred embodiments, the first cavity can directly collect the sample, or the first cavity can be connected to another cavity to directly or indirectly receive the sample. Regardless of direct or indirect reception, this reception method does not require external force assistance. For example, the first cavity directly has an opening that can receive the sample, or the first cavity has an opening that is connected to the liquid of other cavities that directly receive the sample. The sample can slide into the first cavity through other chambers under the action of gravity. This process can be naturally achieved by the collection process and does not require external force assistance.

[0042] In some preferred embodiments, in the absence of an external force, the first and second chambers are in a liquid-isolated state, that is, in this case, there is no liquid communication between the first and second chambers; and when an external force is applied, the second chamber can be liquid-connected to the first chamber. When the first and second chambers are liquid-connected, the sample in the first chamber can be transferred to the second chamber under a certain pressure. In other words, a certain external force must be applied to transfer the sample in the first chamber to the second chamber, and this process cannot be achieved by natural force (such as gravity). After the second chamber has collected an appropriate amount of sample, the external force is removed and the first and second chambers can return to a liquid-isolated state. In some preferred embodiments, the external force that causes the first and second chambers to be liquid-connected and the external force that causes the sample in the first chamber to be transferred to the second chamber can be the same external force. In some preferred embodiments, the external force that causes the first and second chambers to be liquid-connected and the external force that causes the sample in the first chamber to be transferred to the second chamber can be different external forces.

[0043] As a possible implementation method, for example, the first chamber has an opening leading to the second chamber. This opening has the characteristics of being normally closed when not under pressure and being openable when under pressure. In this way, the liquid collected in the first chamber can enter the second chamber through this opening when under pressure. When the pressure is removed, the opening is closed again, completing the transfer of the sample in the first chamber to the second chamber.

[0044] As a possible implementation method, a communicating vessel can be set between the second cavity and the first cavity. This communicating vessel can connect the interiors of the first cavity and the second cavity under certain conditions (for example, under pressure), so that the first cavity and the second cavity are liquid-connected. In this case, the sample in the first cavity can be transferred to the second cavity. After the transfer is completed, the communicating vessel can be removed to seal the second cavity.

[0045] As a possible implementation method, this communicating vessel can have a puncture hole, and the second cavity has a sealing hole, which can be punctured by the puncture hole. When the communicating vessel is removed, the sealing hole can restore the liquid seal. For example, a rubber material seal is used. The puncture hole can pierce the sealing hole under the action of external force, so that the first cavity and the second cavity are connected. The liquid in the first cavity can enter the second cavity through the puncture hole under pressure.

[0046] In a second aspect of the present invention, a third chamber is provided for initially collecting samples. The third chamber can be in liquid communication with the first chamber or in a state of being isolated from the first chamber.

[0047] In some preferred embodiments, the third chamber can be in a state of natural liquid communication with the first chamber, that is, the liquid in the third chamber can naturally flow into the first chamber without the action of external force. In some preferred embodiments, the liquid in the first chamber can also naturally flow into the third chamber without the action of external force.

[0048] In some preferred embodiments, the third chamber and the first chamber are in a state of liquid communication under the action of an external force, that is, the fluid in the third chamber will not actively flow into the first chamber, and a certain external force must be applied to achieve the flow of fluid from the third chamber to the first chamber. In some preferred embodiments, the fluid in the first chamber will not actively flow into the third chamber, and a certain external force must be applied to achieve the flow of fluid from the first chamber to the third chamber.

[0049] In some preferred embodiments, the third chamber and the first chamber are in a liquid-isolated state, that is, liquid in the first chamber cannot flow into the third chamber, and liquid in the third chamber cannot flow into the first chamber. This isolation can be broken by external force. In other words, in some possible situations, liquid communication between the first and third chambers can be achieved by external force. For example, in some preferred embodiments, during initial sample collection, the sample is collected in the third chamber first, and the sample will not enter the first chamber in the absence of an applied force.

[0050] In some preferred embodiments, the third cavity can be used as a cavity for initially collecting samples. As described in the first aspect above, either the first cavity or the third cavity can be used as a cavity for initially collecting samples, and liquid communication can also be achieved between the first cavity and the third cavity, so that the liquid sample collected in the third cavity can flow into the first cavity, thereby achieving sample collection in the first cavity.

[0051] In some preferred embodiments, a first channel is provided between the first and third chambers for fluid communication, through which fluid can flow from the first chamber into the third chamber or vice versa. In some preferred embodiments, the first channel is located at the bottom of the third chamber, so that a sample entering the third chamber can flow naturally into the first chamber under the action of gravity.

[0052] In some preferred embodiments, the first channel between the first cavity and the third cavity can be closed. When the first channel is closed, the first cavity and the third cavity are in a liquid isolation state. For example, in some preferred embodiments, the sample first enters the third cavity and can flow into the first cavity along the aforementioned first channel. The liquid in the first cavity can enter the second cavity under the action of external force. In some preferred embodiments, when the first cavity and the second cavity are in a liquid connected state, the first channel can be closed.

[0053] In some preferred embodiments, the first chamber is located at the bottom of the third chamber. When the first chamber and the third chamber are fluidically connected, the liquid in the third chamber can flow directly into the first chamber under the action of its own weight.

[0054] In some preferred embodiments, the fluid in the third chamber cannot naturally flow into the first chamber under the action of gravity. For example, the first chamber and the third chamber are separated in a natural state, and the connecting port between the first chamber and the third chamber can be opened only under a certain pressure. In this case, the sample will be loaded into the third chamber first, and then under a certain pressure, such as the extrusion force generated by the closing of the cover, the sample in the third chamber will be squeezed downward and forced into the first chamber.

[0055] In some preferred embodiments, the third cavity is loaded with the sample first. In some preferred embodiments, the sample in the third cavity can enter the first cavity under the action of a certain external force.

[0056] In some preferred embodiments, the first cavity may be provided with a third channel passing through the third cavity. During the initial collection, the sample will not be loaded into the third channel. In some preferred embodiments, the second cavity and the assembly structure of the second cavity may be assembled to the third channel. In some preferred embodiments, the second cavity may be directly assembled to the third channel. In some preferred embodiments, the third channel and the third cavity have a common opening, but when loading the sample, care should be taken to prevent the sample from entering the third channel. In some preferred embodiments, during the initial collection of the sample, the third channel may be closed, for example, by plugging it with a stopper or sealing it with a film.

[0057] In some preferred embodiments, some openings that can communicate with the first chamber are provided at the bottom of the third chamber. In some preferred embodiments, the first chamber and the third chamber are connected via a pressure hole. When the third chamber is under pressure, the pressure hole opens, and the fluid can directly enter the first chamber from the third chamber. When the pressure is removed, the pressure hole can close again. In some preferred embodiments, the pressure hole can withstand the liquid pressure of the third chamber in a full state when it is closed. That is to say, just by loading samples into the third chamber, the weight of these samples is not enough to open the pressure hole. In some preferred embodiments, the pressure hole can be opened when the sample reaches a certain collection amount. In some preferred embodiments, the pressure that the pressure hole can withstand can be configured according to actual needs.

[0058] In a third aspect of the present invention, the present invention provides a fourth chamber for collecting samples to be detected, and the fourth chamber can be in a state of liquid communication or isolation with the third chamber.

[0059] In some preferred embodiments, the third chamber can be in a state of natural liquid communication with the fourth chamber, that is, the liquid in the third chamber can naturally flow into the fourth chamber without the action of external force. In some preferred embodiments, the liquid in the fourth chamber can also naturally flow into the third chamber without the action of external force.

[0060] In some preferred embodiments, the third and fourth chambers are in a state of fluid communication under the action of an external force, that is, the fluid in the third chamber will not actively flow into the fourth chamber, and a certain external force must be applied to enable the fluid to flow from the third chamber to the fourth chamber. In some preferred embodiments, the fluid in the fourth chamber will not actively flow into the third chamber, and a certain external force must be applied to enable the fluid to flow from the fourth chamber to the third chamber.

[0061] In some preferred embodiments, the third chamber and the fourth chamber are in a liquid isolation state, that is, the liquid in the first chamber cannot flow into the third chamber, and the liquid in the third chamber cannot flow into the fourth chamber. This isolation state can be broken by external force, that is, in some possible cases, the liquid connection state between the fourth chamber and the third chamber can be achieved by external force.

[0062] In some preferred embodiments, as described in the second aspect above, the third cavity can be used as a cavity for initially collecting samples, and liquid communication can also be achieved between the fourth cavity and the third cavity, so that the liquid sample collected in the third cavity can flow into the fourth cavity, thereby realizing sample collection in the fourth cavity.

[0063] In some preferred embodiments, a second channel is provided between the fourth chamber and the third chamber for fluid communication, through which fluid can flow from the third chamber into the fourth chamber or vice versa. In some preferred embodiments, the second channel is located at the bottom of the third chamber, so that a sample entering the third chamber can flow naturally into the fourth chamber under the action of gravity.

[0064] In some preferred embodiments, the second channel between the fourth cavity and the third cavity can be closed. When the second channel is closed, the fourth cavity and the third cavity are in a liquid isolation state. For example, in some preferred embodiments, the sample first enters the third cavity and can flow into the fourth cavity along the aforementioned second channel. The liquid in the fourth cavity can enter the detection area under the action of external force. In some preferred embodiments, when the fourth cavity and the detection area are in a liquid connected state, the second channel can be closed.

[0065] In a fifth aspect, the present invention provides a cover for covering a sample collection port. In some preferred embodiments, the cover can serve as a sealing element for the entire device. In some preferred embodiments, the cover can cover the sample collection port of the sample collection device.

[0066] As previously mentioned, the second cavity can be in fluid communication with the first cavity, so that there is a positional and mating relationship between the second cavity and the first cavity. In some preferred embodiments, the second cavity and the first cavity can be combined or separated. In some preferred embodiments, the second cavity and the third cavity can be combined or separated.

[0067] In some preferred embodiments, the second cavity is assembled on the cover. In some preferred embodiments, the second cavity is detachably connected to the cover. In some preferred embodiments, the cover is provided with an assembly passage for the second cavity. In some preferred embodiments, the second cavity is detachably connected to the assembly passage. In some preferred embodiments, the assembly passage can be sealed.

[0068] In some preferred embodiments, the cover can be assembled onto the third cavity. In some preferred embodiments, when the cover is assembled with the third cavity, the second cavity is thereby fluidically connected to the first cavity. In some preferred embodiments, when the cover is assembled with the third cavity, the communicating vessel pierces the second cavity, thereby fluidically connecting the first and second cavities. In some preferred embodiments, when the cover is assembled with the third cavity, the assembly channel combines with the first channel and seals the first channel, thereby isolating the third cavity from the first cavity.

[0069] In some preferred embodiments, the cover can be assembled onto the first cavity. In some preferred embodiments, when the cover is closed over the first cavity, the second cavity is thereby fluidically connected to the first cavity. In some preferred embodiments, when the cover is closed over the first cavity, the communicating device pierces the second cavity, thereby fluidically connecting the first and second cavities.

[0070] In a fifth aspect, the present invention provides an assembly structure for a second chamber. The assembly structure can cooperate with a channel within the cover body to insert or remove the second chamber into or from the cover body. In some preferred embodiments, the assembly structure is detachably coupled or connected to the cover body. In some preferred embodiments, the detachable coupling is a threaded connection. In some preferred embodiments, the detachable coupling is a plug-in fit.

[0071] In some preferred embodiments, the assembly structure is capable of fixing the second cavity therein. In some preferred embodiments, the assembly structure has a handle element that facilitates the combination or separation of the assembly structure and the cover body. In some preferred embodiments, the assembly structure has a knob element that facilitates the combination or separation of the assembly structure and the cover body. Whether it is a handle element or a knob element, its function is to facilitate the combination or separation of the assembly structure and the cover body. In some preferred embodiments, after the assembly structure and the cover body are separated, the cover body can be plugged with a plug. In some preferred embodiments, before the assembly structure and the cover body are assembled, the cover body can be plugged with a plug to prevent dust from falling into the space in the cover body for accommodating the assembly structure or being contaminated.

[0072] In some preferred embodiments, the assembly structure is provided with some hollow structures, and a certain external force, such as squeezing, can be applied to the second cavity through these hollow parts to make the sample therein flow out.

[0073] In a sixth aspect of the present invention, the present invention provides a communicating vessel, which is used to connect the first cavity or the second cavity or to achieve liquid communication between the first cavity and the second cavity. In some preferred embodiments, the communicating vessel itself also has a chamber (which may be referred to as a communicating cavity). In some preferred embodiments, when the communicating vessel is connected to the first cavity, the chamber inside the communicating vessel is in liquid communication with the first cavity. In some preferred embodiments, when the communicating vessel is in liquid communication with the second cavity, the communicating cavity inside the communicating vessel is in liquid communication with the second cavity. In some preferred embodiments, the communicating cavity inside the communicating vessel is in liquid communication with both the first cavity and the second cavity.

[0074] In some preferred embodiments, the communicating vessel and the second cavity are capable of being connected or separated. In some preferred embodiments, the communicating vessel is in fluid communication with the second cavity by puncturing the second cavity. In some preferred embodiments, after the communicating vessel and the second cavity are separated, the second cavity naturally closes. In some preferred embodiments, the communicating vessel and the second cavity are detachably connected.

[0075] In some preferred embodiments, the communicating vessel can be directly mounted on the first channel. In some preferred embodiments, the communicating vessel can be mounted on the first channel along with the cover. In some preferred embodiments, the communicating vessel is detachably connected or combined with the assembly channel on the cover. In some preferred embodiments, the communicating vessel can be mounted on the assembly channel, in which case the communicating vessel and the cover can move synchronously, and as the cover is closed, the communicating vessel can be covered on the first channel. In some preferred embodiments, the sample to be collected by the second cavity can enter the communicating vessel from the first channel and then enter the second cavity from the communicating vessel.

[0076] In some preferred embodiments, the communicating vessel is connected to the first cavity via the first channel. In some preferred embodiments, when the communicating vessel is connected to the first cavity, the first channel and the third cavity are in a liquid-isolated state.

[0077] In the seventh aspect of the present invention, the present invention provides a second cavity for collecting samples for secondary confirmation testing, and the second cavity is used to collect and store samples for secondary confirmation testing. In some preferred embodiments, the second cavity obtains samples from the first cavity. In some preferred embodiments, the second cavity can be naturally sealed. In some preferred embodiments, the second cavity can be sealed after collecting a sufficient amount of sample. In some preferred embodiments, the volume of the second cavity is variable. In some preferred embodiments, the second cavity can be a flexible cavity. In some preferred embodiments, the second cavity can be in a vacuum state before being loaded with the sample. In some preferred embodiments, the second cavity can be sealed by a rubber stopper. In some preferred embodiments, the communicating vessel can pierce the rubber stopper, and when the communicating vessel is removed, the rubber stopper can remain sealed under certain pressure conditions, so that the second cavity has the function of sealing and storing liquid samples.

[0078] In some preferred embodiments, the second cavity is directly and detachably coupled to or connected to the first cavity. In some preferred embodiments, the second cavity is detachably coupled to or connected to the first cavity via a cover. In some preferred embodiments, the second cavity is detachably coupled to or connected to the cover via an assembly structure.

[0079] In some preferred embodiments, the second cavity is detachably connected to the assembly structure. In some preferred embodiments, the second cavity can be placed in the assembly structure. In some preferred embodiments, the assembly structure is provided with some hollow structures, through which a certain external force can be applied to the second cavity, such as squeezing, to make the sample therein flow out. In some preferred embodiments, the second cavity has an opening, which can remain closed in the absence of pressure or within a certain pressure range, so that a certain amount of samples can be stored in the second cavity, and the hydraulic pressure of these samples is not sufficient to open the opening. At the same time, the opening can be opened when subjected to sufficiently large pressure to enable the second cavity to be liquid-connected with the outside or other cavities, sufficiently large pressure, such as squeezing or other forms of compression.

[0080] In some preferred embodiments, the second cavity may be a rigid cavity. In some preferred embodiments, the second cavity may be a flexible cavity. In some preferred embodiments, the shape and volume of the second cavity may change after the sample is placed in it. In some preferred embodiments, the second cavity may be configured to have a lower internal pressure, for example, its internal pressure is lower than that of the first cavity or the third cavity, so that the driving force generated by the pressure difference or the attraction generated by the negative pressure or the vacuum may transfer the sample in the first cavity or the third cavity to the second cavity. In some preferred embodiments, the second cavity may be set to be a vacuum, and when the first cavity and the second cavity are in liquid communication, the liquid may flow from the first cavity to the second cavity due to the pressure difference. In some preferred embodiments, the second cavity does not have to be completely vacuum, as long as the internal pressure of the second cavity is lower than that of the first cavity, the above-mentioned pressure difference effect may be achieved. In some preferred embodiments, the first cavity may be pressurized, which may also achieve the above-mentioned pressure difference effect.

[0081] In an eighth aspect, the present invention provides a pipetting element capable of transferring liquid in a first cavity to a second cavity. In some preferred embodiments, the pipetting element is capable of transferring liquid in a fourth cavity to a detection area.

[0082] In some preferred embodiments, the pipetting element includes a first pipetting element for transferring a sample from the first chamber to the second chamber, and a second pipetting element for transferring a sample from the fourth chamber to the detection area. In some preferred embodiments, the first pipetting element can be moved under the action of an external force to squeeze the sample from the first chamber, exerting pressure thereon and causing it to be transferred in a desired direction or chamber. In some preferred embodiments, the second pipetting element can be moved under the action of an external force to squeeze the sample from the fourth chamber, exerting pressure thereon and causing it to be transferred in a desired direction or chamber.

[0083] In some preferred embodiments, the first pipetting element and the first cavity are in the same pipetting channel, and pushing the first pipetting element can achieve the above-mentioned extrusion. In some preferred embodiments, the second pipetting element and the fourth cavity are in the same pipetting channel, and pushing the second pipetting element can achieve the above-mentioned extrusion. In some preferred embodiments, the first pipetting element, the second pipetting element, the first cavity and the fourth cavity are in the same pipetting channel, and pushing one of the first pipetting element or the second pipetting element can achieve the above-mentioned extrusion at the same time. In this case, the first pipetting element and the second pipetting element can achieve a step-by-step linkage state. For example, when the first pipetting element is pushed, the first pipetting element is first moved by force to squeeze the sample in the first cavity. The resistance to the movement of the second pipetting element may be greater than the resistance to the movement of the liquid in the first cavity. At this time, the sample in the first cavity is transferred first. When the sample in the first cavity is discharged to the first pipetting element, the effect of the first pipetting element on the second pipetting element When the force is greater than the resistance to movement of the second pipetting element, the second pipetting element begins to squeeze the sample in the fourth chamber, so that the sample in the fourth chamber is also transferred. Alternatively, in some other possible cases, the second pipetting element is pushed, and the second pipetting element is first moved by the force and squeezes the sample in the fourth chamber. At this time, the resistance to movement of the first pipetting element may be greater than the resistance to movement of the liquid in the fourth chamber, and the sample in the fourth chamber is transferred first. When the sample in the fourth chamber is discharged to the first pipetting element, and the force exerted by the second pipetting element on the first pipetting element is greater than the resistance to movement of the first pipetting element, the first pipetting element begins to squeeze the sample in the first chamber, so that the sample in the first chamber is also transferred. In some cases, it is desired that when the first and second pipetting elements are in the linkage state as described above, the liquid in the first chamber is transferred first.

[0084] In some preferred embodiments, the pipetting channel can be in liquid communication with or separated from the second cavity. In some preferred embodiments, the pipetting channel can be in liquid communication with or separated from the detection area. In some preferred embodiments, the first pipetting element and the second pipetting element separate the pipetting channel into a first cavity and a fourth cavity. In some preferred embodiments, the second pipetting element separates the fourth cavity from the second cavity.

[0085] In some preferred embodiments, when the sample in the first cavity is transferred to the second cavity, the volume of the first cavity is reduced. In some preferred embodiments, when the volume of the first cavity is reduced, the first pipetting element and the second pipetting element are moved closer. In some preferred embodiments, when the sample in the fourth cavity is transferred to the testing area, the volume of the fourth cavity is reduced. In some preferred embodiments, after the liquid in the first cavity is transferred, the liquid communication state between the first cavity and the second cavity is cut off. In some preferred embodiments, when the liquid in the fourth cavity is transferred, the liquid communication state between the fourth cavity and the third cavity is cut off. In some preferred embodiments, the connection state between the fourth cavity and the third cavity is cut off by the second pipetting element closing the second channel during the movement.

[0086] In some preferred embodiments, the initial volume of the fourth cavity is fixed, that is, before the fourth cavity is subjected to force and is compressed, the amount of sample that can be loaded into the fourth cavity is determinable. In some preferred embodiments, the initial position of the second pipetting element in the pipetting channel is fixed. In some preferred embodiments, the initial volume of the first cavity is fixed, that is, before the first cavity is subjected to force and is compressed, the amount of sample that can be loaded into the first cavity is determinable. In some preferred embodiments, the initial position of the first pipetting element in the pipetting channel is fixed. In some preferred embodiments, the relative initial positions of the first pipetting element and the second pipetting element in the pipetting channel are fixed.

[0087] In some preferred embodiments, the pipetting channel has a pipetting opening, through which external force can be applied to the pipetting channel to achieve above-mentioned extrusion. In some preferred embodiments, the pipetting opening can be sealed by the first pipetting element or the second pipetting element. In some preferred embodiments, the pipetting element also includes a pipetting plug that can push the first pipetting element and / or the second pipetting element. In some preferred embodiments, the pipetting plug can extend into the pipetting channel through the pipetting opening. In some preferred embodiments, the opening of the pipetting channel is provided with a socket that matches the pipetting plug on the first pipetting element and / or the second pipetting element.

[0088] In some preferred embodiments, a sealing element is provided between the pipetting element and the pipetting channel to ensure that the sample does not leak from between the pipetting element and the inner wall of the pipetting channel when the pipetting element moves in the pipetting channel.

[0089] In a ninth aspect of the present invention, a method for collecting liquid samples is provided, wherein the method adopts the sample collection device as described above, wherein the sample collection device includes a first cavity for collecting liquid samples and a second cavity for collecting confirmation detection samples, wherein the first cavity and the second cavity can be in a liquid connected or isolated state, and when the first cavity and the second cavity are in a liquid connected state, the liquid in the first cavity can be transferred to the second cavity.

[0090] In some preferred embodiments, a third chamber for collecting samples is further included. The third chamber and the first chamber can be in liquid communication or isolation with the first chamber. Initial samples can be collected through the third chamber, and the samples collected in the first chamber may be transferred to the second chamber for secondary detection.

[0091] In some preferred embodiments, when the first chamber and the third chamber are in a liquid-connected state, the liquid collected in the third chamber can enter the first chamber at the same time. That is, when the sample is initially collected in the third chamber, the first chamber can also be loaded with the initially collected sample at the same time.

[0092] In some preferred embodiments, when the liquid in the first chamber is transferred into the second chamber, the first chamber and the third chamber are in a liquid isolation state. Since the sample in the second chamber is used for secondary confirmation testing, in order to ensure that the sample in the second chamber is not contaminated, the first chamber is isolated from the other chambers before the transfer.

[0093] In some preferred embodiments, the device further comprises a fourth chamber for collecting samples to be detected, and the fourth chamber can be in a state of liquid connection or isolation with the third chamber.

[0094] In some preferred embodiments, when the fourth chamber is in a liquid-connected state with the third chamber, the liquid collected in the third chamber can enter the fourth chamber at the same time. The fourth chamber can also be in a connected state with the third chamber when initially collecting samples. In this way, the fourth chamber can also complete the required samples basically synchronously with the third chamber. The samples collected in the fourth chamber are mainly used for initial testing. The initial testing can be performed directly in the fourth chamber or transferred to other areas through the fourth chamber, such as the testing area.

[0095] In some preferred embodiments, a detection area is also included, and the fourth cavity can be in a liquid-connected or isolated state with the detection area. When the fourth cavity is initially collecting, the fourth cavity and the detection area can be isolated, that is, collection and detection can be independent links.

[0096] In some preferred embodiments, when the fourth chamber is in a liquid-connected state with the detection area, the fourth chamber and the third chamber are in a liquid-isolated state. On the one hand, this ensures that the detection area is not affected by possible contamination from other chambers, and on the other hand, quantitative detection can be achieved. As long as the volume of the fourth chamber is set, the quantification of the sample entering the detection area can be achieved.

[0097] In some preferred embodiments, the second cavity and the third cavity can be combined or separated. In some preferred embodiments, the second cavity and the first cavity can be combined or separated. Since the second cavity needs to obtain the collected sample from the first cavity or the third cavity, the second cavity must establish a liquid connection with the first cavity or the third cavity or one of them. After obtaining the required sample, the second cavity must be able to independently seal and preserve the cavity therein, and even be independently transported and sent to a secondary detection agency. Therefore, the second cavity must be separated from the first cavity or the third cavity or one of them. In some preferred embodiments, the second cavity can be detachably combined or connected with the first cavity or the third cavity or one of them.

[0098] In some preferred embodiments, a communication device is further included between the first cavity and the second cavity, and the communication device provides a more convenient channel and path for the sample in the first cavity to enter the second cavity.

[0099] In some preferred embodiments, the connecting device is not installed in place when the sample is initially collected, and the connecting device is installed when a secondary confirmation collection is required.

[0100] In some preferred embodiments, the communication device can place the first cavity and the second cavity in a state of liquid communication, or can isolate the communication between the first cavity and the second cavity.

[0101] In some preferred embodiments, the connecting device can isolate the connection between the first cavity and the third cavity. After the initial sample collection is completed, in order to ensure that the secondary confirmation sample is contamination-free, the first cavity and the third cavity can be isolated first.

[0102] In the present invention, since the initially collected sample cannot enter the second cavity naturally, it must be acted upon by a certain external force. In this case, a certain force must be applied to the initially collected sample.

[0103] Therefore, in some preferred embodiments, the method of the present invention further provides a pipetting element. After the initial collection is completed, there is already a sufficient amount of sample in the first cavity. At this time, the pipetting element is pushed to squeeze the sample in the first cavity so that it enters the second cavity directly or through a connecting device. At the same time, the volume of the first cavity itself is compressed. In some preferred embodiments, the pipetting element can also transfer the sample in the fourth cavity. In some preferred embodiments, the transfer of the sample in the fourth cavity can be after the transfer of the sample in the first cavity. In some preferred embodiments, the first cavity and the fourth cavity can be squeezed using different pipetting elements respectively. In some preferred embodiments, the pipetting elements of the first cavity and the fourth cavity can be linked.

[0104] In some preferred embodiments, the method of the present invention also provides a pipetting channel, in which the above-mentioned pipetting element can move, thereby squeezing the liquid in the first cavity or the fourth cavity. In some preferred embodiments, the first cavity or the fourth cavity can be a section in the pipetting channel, which is separated by different pipetting elements to form a cavity. In some preferred embodiments, the first cavity can be in liquid communication with the second cavity. In some preferred embodiments, the fourth cavity can be in liquid communication with the detection area. In other words, the pipetting channel itself can be in liquid communication with the second cavity or the detection area or both.

[0105] In some preferred embodiments, the method of the present invention also provides a pipette plug, which is mainly used to provide moving power to the pipette element, so that it moves in the pipette channel to generate a squeezing force on the samples in the first chamber and / or the fourth chamber, so that these samples are transferred.

[0106] In some preferred embodiments, the method of the present invention further provides a sealing structure between the pipetting element and the pipetting channel, ensuring that when the pipetting element is moved under force, no gap is generated between it and the inner wall of the pipetting channel, and no sample leakage occurs.

[0107] In its tenth aspect, the present invention provides a method for detecting the presence of an analyte in a liquid sample, the detection method comprising a sample collection device of any of the aforementioned methods, wherein the sample to be detected is collected by the sample collection device, and after the sample is collected in the fourth chamber, the sample therein is tested. In some preferred methods, after the sample is collected in the third chamber, the sample therein is tested. In some preferred methods, the sample in the fourth chamber is transferred to a detection area for testing. In some preferred methods, the sample in the third chamber is transferred to a detection area for testing. After the test results are obtained, the second chamber is separated from the sample collection device in any of the aforementioned methods.

[0108] The present invention has the following beneficial effects: the structure of the present invention is simple and rational, uses low-cost materials, and has excellent performance; it also facilitates secondary testing. In particular, when subsequent confirmation testing is required, the entire testing device does not need to be sent to a testing facility for testing; instead, only the second chamber is removed from the device and sent to the testing facility. This is not only safe, but also saves space, saves costs, and is more environmentally friendly. BRIEF DESCRIPTION OF THE DRAWINGS

[0109] Figure 1 It is an overall structural diagram of a sample detection device in a specific embodiment.

[0110] Figure 2 It is a partial exploded view of a sample detection device in a specific embodiment, in which the cover is in an open state and the pipette plug is not inserted.

[0111] Figure 3 FIG. 1 is a schematic diagram of a cover body in a specific embodiment, where the second chamber and the communicating vessel have been assembled to the cover body.

[0112] Figure 4 yes Figure 3 A schematic diagram of the cover body shown from another angle.

[0113] Figure 5 yes Figure 3 The structural diagram of the upper part of the cover body is shown, showing the assembled handle or knob structure.

[0114] Figure 6 FIG. 1 is a schematic diagram of a cover body in a specific embodiment, where the second chamber has not yet been assembled to the cover body.

[0115] Figure 7 The figure is an assembly relationship diagram of the second cavity, the assembly structure and the communicating vessel in a specific embodiment.

[0116] Figure 8 The figure is an assembly relationship diagram of the second chamber and the communicating vessel in a specific embodiment.

[0117] Figure 9 FIG. 1 is a schematic diagram of a communicating vessel in a specific embodiment.

[0118] Figure 10 FIG. 1 is a bottom view of a communicating vessel in a specific embodiment.

[0119] Figure 11 FIG. 1 is a top view of a communicating vessel in a specific embodiment.

[0120] Figure 12 is a schematic diagram of the second chamber in a specific embodiment.

[0121] Figure 13 yes Figure 12 The second cavity is shown in a schematic diagram from another angle, Figure 13 From the perspective of , it can be seen that the bottom of the second cavity has an opening, which enables the second cavity to be in liquid communication with the outside or other cavities.

[0122] Figure 14 yes Figure 13 Schematic diagram showing that the opening at the bottom of the second chamber is sealed.

[0123] Figure 15 yes Figure 12 The second cavity is shown in another perspective. Figure 15 It can be seen from the figure that when the second cavity is not loaded with a sample, the second cavity can be contracted into a flat state.

[0124] Figure 16 FIG. 1 is a schematic diagram of the assembly structure of the second cavity in a specific embodiment.

[0125] Figure 17 FIG. 1 is a schematic diagram of the combination of the second cavity and the assembly structure in a specific embodiment.

[0126] Figure 18 yes Figure 17 Schematic diagram of the second chamber after the sample is loaded.

[0127] Figure 19 The figure is a schematic diagram of a specific embodiment in which the second chamber is separated from the communicating vessel after completing sample collection.

[0128] Figure 20 It is a schematic diagram of the third cavity in a specific embodiment. The third cavity can be a box body. In this specific embodiment, the detection area can be set on one side of the third cavity.

[0129] Figure 21 yes Figure 20 A schematic diagram of the third cavity in FIG. 1 from another angle, from which the positions of the first channel and the second channel can be shown.

[0130] Figure 22 yes Figure 20 A schematic diagram of the third chamber from another angle, from which part of the structure of the pipetting channel can be seen.

[0131] Figure 23 Schematic diagram of the third cavity in another embodiment. In this embodiment, a sealing connection cover is assembled on the third cavity.

[0132] Figure 24 yes Figure 23 Schematic diagram of the sealing connection cover on the third cavity shown in .

[0133] Figure 25 yes Figure 24 Schematic diagram of the sealing connection cover from another angle.

[0134] Figure 26 It is a cross-sectional view of the third chamber in a specific embodiment. In the state shown in this figure, the first pipetting element and the second pipetting element have not yet been installed in the pipetting channel.

[0135] Figure 27 This is a cross-sectional view of a pipetting channel in a specific embodiment. In the state shown in this figure, the positions of the first pipetting element and the second pipetting element are the positions when the device is not in use. At this time, the first cavity and the fourth cavity are both compressed, the first channel is in liquid communication with the first cavity, and the second channel is in liquid communication with the fourth cavity.

[0136] Figure 28 It is a cross-sectional view of a pipetting channel in a specific embodiment. In the state shown in this figure, the second pipetting element moves in the direction of squeezing the fourth cavity and starts to seal the second channel at the same time.

[0137] Figure 29 This is a cross-sectional view of the third chamber in a specific embodiment. In the state shown in this figure, the first pipetting element and the second pipetting element are pushed to the inward limit position by the pipetting plug. At this time, the fourth chamber and the first chamber are both compressed, and the sample in the fourth chamber is pushed into the detection area, and the sample in the first chamber is pushed into the second chamber. The first chamber and the first channel are in a liquid isolation state, and the fourth chamber and the second channel are in a liquid isolation state.

[0138] Figure 30 is a schematic diagram of a pipette plug according to a specific embodiment.

[0139] Figure 31 is a schematic diagram of a first pipetting element in a specific embodiment.

[0140] Figure 32 FIG. 1 is a schematic diagram of the first pipetting element in a specific embodiment from another angle.

[0141] Figure 33 is a schematic diagram of a second pipetting element in accordance with one embodiment.

[0142] Figure 34 FIG. 1 is a schematic diagram of the second pipetting element from another angle in a specific embodiment.

[0143] Figure 35 FIG. 1 is a schematic diagram of a sealing structure on a first pipetting element and a second pipetting element in a specific embodiment.

[0144] Figure 36 It is a schematic diagram of the assembly relationship between the communicating vessel and the first channel.

[0145] Figure 37 It is a schematic diagram of the first chamber, the third chamber and the communicating vessel in a specific embodiment.

[0146] : Numbers in the figure: first cavity 41, second cavity 42, third cavity 43, fourth cavity 44, detection area 45, detection entrance 46, first channel 47, second channel 48, collecting port 49, collecting tank 50, pipetting channel 51, first pipetting element 52, second pipetting element 53, detection entrance partition 54, opening end 55, opening 56, sealing member 57, communicating vessel 58, puncturing element 59, communicating cavity 60, step surface 61, assembly structure 62 of second cavity, cover body 63, tapered surface 64, sealing connecting cover 66, first cover 67, second cover 68, connection part 69 cooperating with cover body, assembly channel 70, outer wall 71 of assembly structure, inner cavity 72 of assembly structure, hollow structure 73, fixing ring 74, assembly connecting member 75, sealing member 76, pipetting opening 77, pipetting plug 78, first movable cavity 79, supporting foot 80, sealing groove 81, third channel 82, pressure hole 83. DETAILED DESCRIPTION

[0147] The present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the embodiments are only specific descriptions of the present invention and should not be regarded as limitations of the present invention.

[0148] First, the structures involved in the present invention or the technical terms used are further explained. If not otherwise specified, they are understood and interpreted according to the general technical terms commonly used in the art.

[0149] Detection

[0150] "Assay" means to test or examine a substance or material for the presence or absence of a substance or material, such as, but not limited to, a chemical substance, an organic compound, an inorganic compound, a metabolite, a drug or drug metabolite, an organic tissue or its metabolite, a nucleic acid, a protein, or a polymer. Additionally, "assay" means to test for the amount of a substance or material. Furthermore, "assay" also includes immunoassays, chemical assays, and enzyme assays.

[0151] Confirmatory testing

[0152] Confirmatory testing can also be called secondary testing or secondary confirmation testing. When the first test result shows a possible positive or weak positive or cannot be accurately judged, in order to ensure the accuracy of the test result or obtain a more accurate test result, it is necessary to send the same batch of samples (preferably collected in the same batch) to an off-site or remote location with confirmation testing qualifications for a second test to verify the test result. The purpose of confirmatory testing is to confirm the results of on-site or initial testing. The testing instruments may be more accurate and the testing methods may be more rigorous, but the basic principles are the same or similar to those of the initial test. It is just a retest based on the initial test.

[0153] sample

[0154] The samples that can be detected by the detection device of the present invention include biological fluids (such as case fluids or clinical samples). Liquid samples or liquid samples can be derived from solid or semi-solid samples, including excreta, biological tissues and food samples. Solid or semi-solid samples can be converted into liquid samples by any appropriate method, such as mixing, crushing, macerating, incubating, dissolving or utilizing enzymatic digestion of solid samples in a suitable solution (such as water, phosphate solution or other buffer solution). "Biological samples" include samples derived from animals, plants and food samples, such as urine, saliva, blood and its components, spinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, cultures of tissues and organs, cell cultures and media derived from humans or animals. Preferably, the biological sample is urine. Food samples include food processed substances, final products, meat, cheese, wine, milk and drinking water. Plant samples include any plant, plant tissue, plant cell culture and media derived from. An "environmental sample" is derived from the environment (eg, a liquid sample from a lake or other body of water, a sewage sample, a soil sample, groundwater, seawater, and a wastewater sample). An environmental sample may also include sewage or other wastewater.

[0155] Using the present invention and suitable detection elements, any analyte can be detected. The present invention is preferably used to detect small drug molecules in saliva and urine. Of course, the collection device of the present invention can collect any of the above forms of samples, whether solid or liquid at the beginning. As long as these liquids or liquid samples flow into a certain chamber, these liquid samples can flow into other chambers at the same time or later. Since other chambers can be combined or separated with the chamber that first flows into, when initially collecting samples, the chamber that first flows into the other chambers is combined with the other chambers. The user can complete the collection of liquid samples from multiple chambers required through a single collection action. When subsequent confirmation testing is required, one of the chambers is separated from the whole. Thus, the liquid sample in one or more chambers can be tested for the first time, and the liquid sample in the separated chamber can be tested for the second time. Optionally, the functional status of these chambers can also be interchanged, that is, which chambers can be used for the first test and which chambers can be used for the second test.

[0156] Test components

[0157] The test element can be a lateral flow test strip, which can detect a variety of analytes. Of course, other suitable test elements can also be used in the present invention. Any element that can detect whether a sample or specimen contains an analyte of interest can be called a test element, regardless of the technical principle of the test, such as immunology, chemistry, electricity, optics, physics, etc.

[0158] Various test elements can be combined and applied to the present invention. One form is a test strip. The test strip used to analyze the analyte in the sample (such as drugs or metabolites indicating physical conditions) can be in various forms, such as immunoassays or chemical analyses. The test strip can adopt a non-competitive or competitive analysis mode. The test strip comprises a water-absorbing material with a sample addition area, a reagent area and a test area. The sample is added to the sample addition area and flows to the reagent area by capillary action. In the reagent area, if the analyte is present, the sample binds to the reagent. The sample then continues to flow to the detection area. Other reagents, such as molecules that specifically bind to the analyte, are fixed in the detection area. These reagents react with the analyte in the sample (if present) and bind the analyte to the area, or bind to a reagent in the reagent area. The marker used to display the detection signal is present in the reagent area or a separate labeling area.

[0159] In a typical non-competitive assay, a signal is generated if the sample contains the analyte, and no signal is generated if the analyte is absent. In a competitive assay, a signal is generated if the analyte is absent, and no signal is generated if the analyte is present.

[0160] The test element is a test strip, which can be made of absorbent or non-absorbent materials. The test strip can include multiple materials for liquid sample delivery. One test strip material can be covered on another material, such as filter paper covered on a nitrocellulose membrane. One area of ​​the test strip can be made of one or more materials, while another area can be made of one or more different materials. The test strip can be adhered to a support or hard surface to increase the strength of the test strip.

[0161] The analyte is detected by a signal generating system, such as by using one or more enzymes that react specifically with the analyte, and by using the method for fixing the specific binding substance on the test paper as described above, to fix the combination of one or more signal generating systems to the analyte detection area of ​​the test paper. The substance that generates the signal can be in the sample addition area, the reagent area, or the detection area, or on the entire test paper. The substance can be filled with one or more materials of the test paper. A solution containing the signal substance is added to the surface of the test paper or one or more materials of the test paper are immersed in the solution containing the signal substance. The test paper to which the signal substance solution is added is dried.

[0162] The various zones of the test strip can be arranged as follows: a sample addition zone, a reagent zone, a test zone, a control zone, a zone for determining whether the sample is adulterated, and a liquid sample absorption zone. The control zone is located after the test zone. All zones can be arranged on a single strip of test strip made of only one material. Alternatively, different zones can be made of different materials. Each zone can be in direct contact with the liquid sample, or different zones can be arranged according to the direction of liquid sample flow, with the ends of each zone connected to the front ends of other zones and overlapping. The materials used can be highly absorbent materials such as filter paper, glass fiber, or nitrocellulose membrane. The test strip can also be in other forms.

[0163] The commonly used reagent strips are nitrocellulose membrane reagent strips, that is, the detection area includes a nitrocellulose membrane, and specific binding molecules are fixed on the nitrocellulose membrane to display the detection results; it can also be a cellulose acetate membrane or a nylon membrane, etc. For example, the following patents describe reagent strips or devices containing reagent strips: US 4857453; US 5073484; US 5119831; US ​​5185127; US 5275785; US 5416000; US 5504013; US 5602040; US 5622871; US ​​5654162; US 5656503; US 5686315; US 5766961; US ​​5770460; US 5916815; US 5976895; US 6248598; US 6140136; US 6187269; US 6187598; US 6228660; US 6235241; US The test strips and similar devices with test strips disclosed in the above patent documents can be applied to the test element or detection device of the present invention to detect the analyte, such as the analyte in the sample.

[0164] The detection reagent strips applied to the present invention can be so-called lateral flow test strips (Lateralflow test strips), and the specific structure and detection principle of these detection reagent strips are technologies well known to those skilled in the art in the prior art. Common detection reagent strips include a sample collection area, a labeling area, a detection area and a water absorption area, wherein the sample collection area includes a sample receiving pad, the labeling area includes a labeling pad, and the water absorption area can include a water absorption pad, wherein the detection area includes necessary chemical substances that can detect whether the analyte is contained, such as immunoreagents or enzyme chemical reagents. The detection reagent strips commonly used are nitrocellulose membrane reagent strips, that is, the detection area includes nitrocellulose membrane, and specific binding molecules are fixed on the nitrocellulose membrane to display the result of detection; it can also be cellulose acetate membrane or nylon membrane, etc., and of course, a test result control area can also be included downstream of the detection area. Usually, the control area and the detection area appear in the form of horizontal lines, which are detection lines or control lines. Such detection reagent strips are traditional reagent strips, and of course, other types of reagent strips that utilize capillary action to detect can also be used. In addition, a typical test strip contains dry chemical reagent components, such as fixed antibodies or other reagents. When the liquid encounters a liquid, the liquid flows along the strip due to capillary action. As the liquid flows, the dry reagent components dissolve in the liquid, and then proceed to the next area for processing, where the dry reagent reacts, thereby performing the necessary test. The flow of liquid is mainly carried out by capillary action. These test elements are described and recorded in the following documents: "Regeneration and Treatment of Nitrocellulose Membranes and Their Protein Adsorption Capacity" by Li Fugang; "Analysis of Chromatographic Membrane Material Performance in Colloidal Gold Diagnostic Kits" by Ma Hongyan, Li Qiang, etc.; "A New Colloidal Gold Immunochromatographic Test Strip" by Wang Yong, Wang Luhai, etc. They can all be used in the detection device of the present invention, either being placed in the detection chamber to contact the liquid sample, or being used to detect the presence or amount of the analyte in the liquid sample entering the detection chamber.

[0165] In addition to the aforementioned test element being in the form of a reagent strip, which is itself used to contact the liquid in a larger chamber, such as the third chamber 43 in the present application, to test whether the liquid sample contains the substance to be analyzed, in some preferred embodiments, the test element can also be set on a centralized test card, which has many grooves, and the test element is located in the grooves. The entire test card is set in the detection area 45. Since there is a detection inlet 46 connecting the third chamber 43 and the detection area 45, the liquid sample entering the third chamber 43 can enter the detection area 45 through the detection inlet 46 and be detected by the test element on the test card. Of course, in addition to the carrier disclosed above, other carriers can also be used in the present invention as a carrier for carrying the test strip. For example, in some embodiments, the third chamber 43 or other chambers can first collect the liquid sample, and then a separate test strip or a card or carrier with a test strip can be inserted into the third chamber 43 for testing. Those skilled in the art will appreciate that, according to the present invention, these test strips may not be disposed on a carrier but may exist independently, the detection area 45 of the present invention may be absent in some cases, and the test strips may also be absent in some cases.

[0166] Liquid flow

[0167] Liquid flow, also known as sample flow or liquid sample flow, is sometimes used to transfer samples. Liquid circulation typically refers to the movement of liquids from one location to another. In general, most natural liquid flows rely on gravity to flow from high to low. This flow also relies on external forces, meaning flow under external gravity, which can be considered natural gravity flow. In addition to gravity, liquid flow can also overcome gravity and move from low to high. For example, this can occur through the extraction of liquid, the compression of liquid, or the flow of liquid from low to high due to pressure, or through the overcoming of the liquid's own gravity due to pressure.

[0168] For example, Figures 27-29 In the device, the third chamber is located above the first and fourth chambers, and the fourth chamber is located below the third chamber. When liquid enters the third chamber, the liquid can naturally flow from the third chamber to the first and fourth chambers by relying on its own gravity, or it can naturally flow from the upstream to the downstream position. When the device as a whole shakes, the liquid may also change its flow direction due to the change in the direction of gravity.

[0169] Analyte

[0170] Examples of analytes that can be used in the present invention include small molecules, including drugs (e.g., drugs of abuse). "Drugs of abuse" (DOA) refer to the use of drugs for non-medical purposes (usually to act as a narcotic). Abuse of these drugs can lead to physical and mental damage, dependence, addiction, and / or death. Examples of drugs of abuse include cocaine; amphetamines AMP (e.g., Black Beauty, White Amphetamine Pills, Dextroamphetamine, Dextroamphetamine Pills, Beans); methamphetamines MET (crank, methamphetamine, crystal, speed); barbiturates BAR (e.g., Valium, Roche Pharmaceuticals, Nutley, New Jersey); sedatives (i.e., sleep aids); lysergic acid diethylamide (LSD); depressants (downers, goofballs, barbs, blue devils, yellow jackets, methaqualone); tricyclic antidepressants (TCA, i.e. imipramine, amitriptyline and doxepin); dimethyldioxymethamphetamine (MDMA); phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); opiates (i.e. morphine MOP or opium, cocaine COC; heroin, hydroxydihydrocodeine); antianxiety drugs and sedative hypnotics. Antianxiety drugs are a class of drugs mainly used to relieve anxiety, tension, fear, stabilize mood, and Drugs with hypnotic and sedative effects include benzodiazepines (BZO), atypical BZs, fused diazepam NB23Cs, benzodiazepines, BZ receptor ligands, open-ring BZs, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazolinones, thiazine and thiazole derivatives, other heterocyclics, imidazole-type sedatives / analgesics (such as oxycodone OXY and methadone MTD), propylene glycol derivatives - carbamates, aliphatic compounds, anthracene derivatives, etc. The detection device of the present invention can also be used to detect drugs that are for medical purposes but are prone to overdose, such as tricyclic antidepressants (imipramine or analogs) and acetaminophen. After being absorbed by the human body, these drugs are metabolized into small molecules. These small molecules are present in body fluids such as blood, urine, saliva, sweat, or some body fluids.

[0171] For example, analytes detected by the present invention include, but are not limited to, creatinine, bilirubin, nitrite, protein (non-specific), hormones (e.g., human chorionic gonadotropin, progesterone, follicle-stimulating hormone, etc.), blood, white blood cells, sugars, heavy metals or toxins, bacterial substances (e.g., proteins or sugars specific to specific bacteria, such as Escherichia coli O157:H7, Staphylococcus, Salmonella, Clostridium, Campylobacter, L. monocytogenes, Vibrio, or Bacillus), and substances related to physiological characteristics in urine samples, such as pH and specific gravity. Any other clinical urine chemistry analysis can be performed using the lateral flow assay format in conjunction with the device of the present invention.

[0172] Connect and / or disconnect

[0173] In the present invention, connectivity refers to a state of fluid connectivity, that is, in this structure, the fluid can flow from one area to another, or from one part of the structure to another, or from the first cavity of the structure to another cavity. The "to" here is achieved through the fluidity of the fluid itself. Connectivity specifically refers to fluid connectivity, that is, gas connectivity or liquid connectivity. Gas connectivity or liquid connectivity means that liquid or gas can flow from one place to another, and the flow process may pass through some physical structures to play a guiding role. The so-called passing through physical structures generally refers to the liquid passing through the surface of these physical structures, or the internal space of these structures and passively or actively flowing to another place. Passive flow is generally caused by external force, such as flow under capillary action. The flow here can also be the liquid or gas due to its own action (gravity or pressure), or it can be passive flow. The connectivity here does not necessarily mean that liquid or gas must exist. It only indicates the connection relationship or state between two objects in some cases. If liquid exists, it can flow from one object to another. Here it refers to the state where two objects are connected. On the contrary, if there is no liquid connection or gas connection between the two objects, if there is liquid in or on one object, the liquid cannot flow into or onto the other object. Such a state is called non-connected, a state of non-liquid or gas connection. In the present invention, this state of gas connection or liquid connection is sometimes directly referred to as fluid connection or simply connection. This connection does not require the actual existence of fluid (such as liquid or gas) in the structure, but is only an indication that the structure can be in such a state. Correspondingly, the partition in the present invention refers to a state opposite to connection (fluid connection), that is, non-connected. That is to say, in the partition state, the fluid cannot achieve the above-mentioned movement from one area to another under the action of fluidity, or from one part of the structure to another part, or from the first cavity of the structure to another cavity. Similarly, partition does not require the actual existence of liquid in the structure, and can only be a state of the structure.

[0174] Detection device or collection device

[0175] A detection device refers to a device used to detect whether a sample contains an analyte. A collection device refers to a device for collecting and storing liquid samples. The detection device may include a collection device, or the collection device may be separated from the detection device. During detection, the collection device and the detection device are combined to complete the detection. Alternatively, the collection device and the detection device are an integrated structure. Once the liquid sample is collected, the test can be performed immediately to obtain the test results, and the test sample and the collected sample can be separated at the same time, so that a secondary test can be performed (if necessary). The meanings of the detection device or the detection cavity here are interchangeable, and the collection device and the collection cavity are also interchangeable. They are just interchangeable because they play different roles. For example, when the present invention refers to a collection device, it may not include a detection cavity, but the collection device may include a test element or a carrier containing a test element. The collection device containing a test element may also be referred to as a detection device. Of course, the collection device may include a space for arranging the test element, but it does not necessarily have to contain the test element. The test element can be combined with the collection device at any appropriate time to become a detection device. For example, the collecting device may include a space for accommodating a test element, such as containing a detection area 45, or a suitable position for arranging a test element or a carrier containing a test element in a liquid collecting cavity of the collecting device.

[0176] First chamber for collecting liquid samples

[0177] In some specific embodiments of the present invention, Figures 27-29 In the specific embodiment shown, the present invention provides a collection device for collecting liquid samples, or a detection device for detecting liquid samples. Of course, the detection device also has a collection function or also includes a collection device. This collection device or detection device includes a first cavity 41. The first cavity 41 can be used as a direct collection chamber, or the sample can be collected through other chambers such as the third cavity 43.

[0178] When the first cavity 41 is used as a direct collection cavity, it may have an opening directly connected to the outside, and the sample can be injected or loaded into the first cavity 41 through the opening, for example Figure 26 The structure shown in FIG. 4 shows, in this case, the first cavity 41 can directly collect samples from the outside. When the first cavity 41 collects samples through other cavities, such as Figures 27-29As shown, it is directly connected to the third chamber 43 through a first channel 47, and the first chamber 41 is located below the third chamber 43. The third chamber 43 has an upward collecting port 49. Through the collecting port 49, the liquid sample can enter the third chamber 43 and naturally fall or flow downward under the action of gravity. The part of the liquid sample that naturally falls and enters the first channel can directly fall into the first chamber 41. During the natural falling process, there must be a part of the liquid sample that cannot fall directly into the first channel 47. Then this part of the liquid sample can gather at the bottom of the third chamber 43. When the liquid level exceeds the height from the first channel 47 above the bottom of the third chamber 43, this part of the liquid will flow into the first chamber 41 through the first channel 47.

[0179] In some preferred embodiments, as can be seen in the figure, a collection trough 50 can be provided on the sidewall of the first channel 47. This collection trough 50 can be flush with or slightly higher than the bottom of the third chamber 43. During the natural falling process, the portion of the liquid sample that does not enter the first channel 47 will eventually collect at the bottom of the third chamber 43. Because the collection trough is relatively close to the bottom of the third chamber 43, the liquid sample at the bottom of the third chamber 43 is likely to enter the first channel 47 through the collection trough 50 and then flow into the first chamber 41 along the first channel 47. It should be noted that, since it is not necessary for all of the sample in the third chamber 43 to flow into the first chamber 41, only a portion is required. Therefore, as long as the amount of collected liquid is sufficient, some of the sample will inevitably enter the first channel 47. Furthermore, since the entire chamber may be in a non-stationary state during actual use, such as when being held by hand, the collected sample is more likely to enter the collection trough 50 due to shaking.

[0180] In some preferred embodiments, the liquid sample in the first cavity 41 can be directly used for testing. In some preferred embodiments, the liquid sample in the third cavity 43 can be directly used for testing. In some preferred embodiments, the liquid sample in the first cavity 41 can be transferred to another cavity, such as the second cavity 42.

[0181] In some preferred embodiments, the volume of the first cavity 41 is variable, for example Figures 27-29In the process shown, the first cavity 41 is actually a space in the pipetting channel 51, which is separated and formed by the first pipetting element 52 and the second pipetting element 53. When the first pipetting element 52 or the second pipetting element 53 or both pipetting elements move in the pipetting channel 51, the volume of the first cavity 41 will change. In some preferred embodiments, the volume of the first cavity 41 can be compressed, at which time the liquid sample stored therein will be squeezed out and transferred to other chambers or used for other purposes. In some preferred embodiments, the volume of the first cavity 41 can also be expanded. In this case, an inward attraction will be generated in the first cavity 41, allowing it to collect more liquid samples faster, or, in some preferred embodiments, the volume of the first cavity 41 will expand as the collected samples increase.

[0182] Self-sealing

[0183] The self-sealing means that, except for the pressure that the cavity itself or the objects contained in the cavity (including liquids, gases and other substances) may generate on the inner or outer wall of the cavity, when there is no other force acting on the cavity, the cavity can be in a sealed state, the interior of the cavity is in a state of fluid isolation from the outside world or other cavities, and fluid exchange (including liquids, gases, etc.) cannot be allowed. In some cases, the self-sealing means that, except for the pressure that the cavity itself or the objects contained in the cavity (including liquids, gases and other substances) may generate on the inner or outer wall of the cavity, even if a certain external force is applied to the inner or outer wall of the cavity, as long as the external force is not large enough or does not reach a certain value, the cavity will still be in the above-mentioned sealed state. In some cases, there may be an opening or a punctured hole on the cavity, but due to the material used for the cavity or a certain wall thickness, this opening or punctured hole may also meet the above-mentioned condition that it will not open under the action of internal force or external force that is not large enough. Moreover, when external force is applied or the external force is large enough, the cavity can achieve liquid communication with the outside world or other cavities without the intervention of other components (which may be through the said opening or punctured hole). After the external force is removed, it can return to the original fluid isolation state. We call this cavity a self-sealing cavity.

[0184] Third chamber for collecting liquid samples

[0185] In some specific embodiments of the present invention, Figure 20-23The present invention provides a collection device for collecting liquid samples, or a detection device for detecting liquid samples. Of course, the detection device also has a collection function or also includes a collection device. This collection device or detection device includes a third cavity 43. The third cavity 43 can be used as a direct collection chamber or as a detection cavity, or the third cavity 43 can also be used as a temporary storage cavity, so that the liquid sample entering it enters other cavities through the third cavity 43. The other cavities can be collection cavities or detection cavities.

[0186] For example, in Figures 27-29 In the specific embodiment shown, the third cavity 43 serves as a transition cavity for the first cavity 41 to collect liquid samples. Through some of the aforementioned methods, the first cavity 41 can simultaneously collect liquid samples entering the third cavity 43. Of course, the third cavity 43 can also collect samples through other cavities.

[0187] When the third cavity 43 serves as a transition cavity, Figure 21 As shown, the bottom may have a first channel 47 connected to the liquid of the first chamber 41, and a second channel 48 connected to the liquid of the fourth chamber 44. In this case, as long as the first channel 47 and the second channel 48 are not closed, the first chamber 41 and the fourth chamber 44 can complete the sample collection basically synchronously with the third chamber 43.

[0188] In some preferred embodiments, the third chamber 43 can also be liquid-connected to the detection area 45 via a detection inlet 46. The detection inlet 46 can be adjusted or configured to be connected or blocked, so that the liquid in the third chamber 43 can be introduced into the detection area 45 as needed. The detection area 45 may or may not be provided with a test element. When a test element is provided in the detection area, the detection area can be made of a transparent material for easy observation.

[0189] In some preferred embodiments, a collection trough 50 may be provided on the sidewall of the first channel 47. This collection trough 50 may be flush with or slightly higher than the bottom of the third chamber 43. The portion of the liquid sample that does not enter the first channel 47 during its natural fall will eventually collect at the bottom of the third chamber 43. Since the collection trough is relatively close to the bottom of the third chamber 43, the liquid sample at the bottom of the third chamber 43 is likely to enter the first channel 47 through the collection trough 50 and then flow into the first chamber 41 along the first channel 47. It should be noted that, since it is not necessary for all of the sample in the third chamber 43 to flow into the first chamber 41, only a portion is required. Therefore, as long as the amount of collected liquid is sufficient, some of the sample will inevitably enter the first channel 47. Furthermore, since the entire chamber may be in a non-stationary state during actual use, such as when being held by hand, the collected sample is more likely to enter the collection trough 50 due to shaking.

[0190] In some preferred embodiments, the first chamber 41 and the third chamber 43 can be in a liquid-isolated state during initial collection. That is, the liquid sample collected by the third chamber 43 will not automatically enter or cannot directly enter the first chamber 41 under the force of the sample's own weight. For example, the connection between the first chamber 41 and the third chamber 43 is blocked by a component. When a certain force is applied to the liquid sample in the third chamber 43, the component can be broken through, allowing the sample to enter the first chamber 41 from the third chamber 43. In other words, in this case, the first chamber 41 does not necessarily need to serve as a chamber for initial sample collection. It can serve as a channel, which provides a path for the sample to enter the second chamber 42 from the third chamber 43. Due to the existence of this path, the sample can directly enter the interior of the second chamber 42 without contaminating the outer wall of the second chamber 42.

[0191] In some preferred embodiments, the third cavity 43 can be sealed by a cover. In some preferred embodiments, the cover can be directly connected to the third cavity 43 to seal the third cavity. In some preferred embodiments, the cover can directly seal the third cavity including the detection area. In some preferred embodiments, the cover can only be used to seal the collection port of the third cavity. In some preferred embodiments, the cover can be connected to the cover by a sealing connector. For example Figures 24-25As shown, a sealing connection cover 66 can be used to seal the collection port 49 and the test element entrance. The sealing connection cover 66 includes a first cover 67 for covering the sample collection entrance and a second cover 68 for covering the test element entrance. Through the first cover 67 and the second cover 68, the sealing connection cover 66 can simultaneously cover the collection port 49 and the test element entrance. The sealing connection cover 66 can be connected to the cover body, or the sealing connection part itself is in a sealed state. As shown in the figure, the first cover 67 and the second cover 68 snap fit in the opening of the third cavity and the detection area. In addition to the method shown in the figure, a film can also be used for heat sealing. As long as the film is sealed and airtight or liquid-tight during the test, it is sufficient. After the test is completed, the second cavity is separated from the device body, and the device body (including the detection area) can be discarded without having to store and transport the entire detection device.

[0192] In some preferred embodiments, the sample is first loaded into the third cavity 43, and no sample is loaded into the first cavity 41. In some preferred embodiments, the sample in the third cavity 43 can enter the first cavity 41 under the action of a certain external force. For example, Figure 37 As shown, in some preferred embodiments, the first chamber 41 may be provided with a third channel 82 that passes through the third chamber 43. During initial collection, no sample is loaded into this third channel 82. In some preferred embodiments, the second chamber 42 and its mounting structure may be mounted onto the third channel, and similarly, a connecting piece 58 may be used to connect the first and second chambers 42. In some preferred embodiments, the sample in the third chamber 43 may be directly pressed from the first chamber 41 into the third channel 82 under pressure. In some preferred embodiments, the second chamber 42 may be directly mounted onto the third channel 82. In some preferred embodiments, the third channel 82 and the third chamber 43 share a common opening. However, when loading the sample, care should be taken to prevent the sample from entering the third channel 43. In some preferred embodiments, during initial sample collection, as a precaution, the third channel 43 may be sealed, for example, with a stopper or a film.

[0193] In some preferred embodiments, the bottom of the third chamber is provided with openings that connect to the first chamber. These openings can be opened under certain conditions. These openings connect only the first and third chambers and do not communicate with other chambers or the outside. In some preferred embodiments, these openings are located at the bottom of the third chamber. In some preferred embodiments, these openings are located on a wall shared by the first and third chambers. In some preferred embodiments, these openings are pressure ports 83. When sufficient pressure is applied to the third chamber 43, the pressure ports 83 open, allowing fluid communication between the first and third chambers, allowing the sample to flow directly from the third chamber into the first chamber. When the pressure is removed, the pressure ports 83 reclose. In some preferred embodiments, the pressure ports can be self-sealing openings as described above, such as those similar to the opening of a "scream bottle." In some preferred embodiments, when closed, the pressure ports can withstand the pressure of the liquid in the third chamber when it is full. In other words, simply adding a sample to the third chamber is not enough to open the pressure ports due to the weight of the sample. In some preferred embodiments, the pressure hole can be opened when the sample reaches a certain collection amount. In some preferred embodiments, the pressure that the pressure hole can withstand can be configured according to actual needs. In a specific embodiment, the cross-section of the first cavity 41 is wider than the cross-section of the third channel 82, so that there is a distance between the third channel 82 and the first cavity 41, and the pressure hole 83 is set at this distance. In some preferred embodiments, the pressure in the third cavity 43 can come from the cover body, for example, the cover body is provided with a piston to push down or squeeze the upper liquid surface, or the cover body can generate pressure when it is covered and act on the upper liquid surface.

[0194] Detection entrance

[0195] The detection inlet 46 is a connecting port between the collection chamber and the detection area. However, it is not necessary for the detection area and the collection chamber to be connected at all times. The collection chamber can be separated from the detection area and connected as needed. In this case, a detection inlet partition 54 can be set at the detection inlet 46. The detection inlet partition 54 can be used to adjust or set the detection inlet 46 to be connected or isolated, so that the liquid in the third chamber 43 can be introduced into the detection area 45 as needed.

[0196] For example, Figure 27In the manner shown, the detection entrance partition 54 has a certain hardness and thickness, and is provided with a cut, and the cross-sections of the cut are interference fit. Then, when there is no pressure or insufficient pressure, the entire cut is in a closed state, which can isolate the flow of liquid. However, when one side of the cut is under pressure, the cut will open in the direction of the pressure and naturally release the pressure. That is to say, when there is a certain amount of sample on one side of the cut, or a certain pressure is applied to the sample, the cut can be opened to connect the collection chamber and the detection area 45 liquid. When the pressure is removed, the cut can be restored to a closed state.

[0197] Detection area

[0198] The detection area 45 in the present invention is used to analyze the liquid sample to determine whether the substance to be analyzed is present. Generally, the detection area 45 may include a test element, which contacts the liquid sample to perform an assay or test on the liquid sample. In traditional products, when manufacturing a device with a detection cavity, the test element is generally first made or set on a carrier, and then the test element is inserted into the detection area, and then the detection area is sealed. In this case, the detection area generally has an opening to allow the test element to enter and exit the detection area. For example, Figure 1-2 As shown in Figures 20-21, a test element entrance is provided at the upper end of the detection area 45. As mentioned above, the test element can be inserted into the detection area 45 through this test element entrance. Normally, after being inserted into the detection cavity, the opening 65 of the detection area needs to be sealed. The sealing effect and quality requirements are very high. As explained above, the entire detection device or collection device needs to be transported and packaged together. In order to prevent the liquid in the detection area or the liquid in the third cavity from leaking, any place where leakage may occur needs to be strictly sealed, and each product needs to be tested for sealing, which increases the production cost. However, after adopting the second cavity with secondary confirmation of the present invention, these places that were previously considered to require good sealing effects do not need to be deliberately considered. This kind of sealing only requires temporary sealing and does not require permanent sealing. For example Figures 24-25As shown, a sealing connection cover 66 can be used to seal the collection port 49 and the test element entrance. The sealing connection cover 66 includes a first cover 67 for covering the sample collection entrance and a second cover 68 for covering the test element entrance. Through the first cover 67 and the second cover 68, the sealing connection cover 66 can cover the collection port 49 and the test element entrance at the same time. The sealing of the sealing connection cover 66 can be achieved by conventional sealing. For example, the first cover 67 and the second cover 68 are snap-fitted to the opening of the third cavity and the detection area. In addition to the method shown in the figure, a film can also be used for heat sealing. It is sufficient to ensure that the film is airtight or leak-proof during the detection. After the detection is completed, the second cavity is separated from the device body, and the device body (including the detection area) can be discarded without having to store and transport the entire detection device. In some preferred embodiments, the sealing connection cover 66 can also be provided with the following Figures 24-25 The connection portion 69 shown as cooperating with the cover body can, in some preferred embodiments, be a threaded connection, such as the one shown in the figure. Of course, the connection portion 69 can also be any other connection form, as long as it can achieve a sealed connection between the connection cover 66 and the cover body 63. Of course, the sealing connection cover 66 itself can also serve as the cover body of the device. In this case, the connection portion 69 is not required, and the sealing connection cover 66 can be directly formed into a shape that can seal the entire device.

[0199] Second chamber for collecting confirmatory test samples

[0200] In some specific embodiments of the present invention, a second chamber 42 is provided for collecting confirmatory test samples. In some preferred embodiments, the second chamber 42 can collect samples from the same batch as the initial test samples. That is, samples from the same batch can be loaded into the second chamber 42 simultaneously with the initial test samples. In some preferred embodiments, the samples in the second chamber 42 are collected from the first chamber 41. In some preferred embodiments, the samples in the second chamber 42 are collected from the third chamber 43. In some preferred embodiments, the second chamber 42 can directly collect samples.

[0201] As a specific implementation of the second cavity, Figure 12-15 As shown, the second cavity 42 is a cavity with a variable volume, and the cavity has an open end 55. In some preferred embodiments, the open end 55 cannot be compressed, such as Figure 13 As shown, an opening 56 is provided in the open end 55, and the opening 56 can connect the second cavity 42 with other cavities to collect samples through other cavities, or the opening can allow the second cavity 42 to collect samples by itself. In some preferred embodiments, the opening 56 can be sealed by a sealing member 57, such as Figure 14As shown, when sealed by the sealing member, the sealing member 57 can be fixedly connected, tightly fitted or detachably connected or combined with the opening 56. In some preferred embodiments, the communication between the communicating vessel 58 and the second cavity 42 can be achieved by piercing 57 with a piercing element.

[0202] In some preferred embodiments, the opening end 55 can also be compressed. In this case, a separate seal may not be provided, and the opening end and the second cavity 42 may be directly formed as one piece, or a seal that can be compressed along with the opening end 55 may be provided. In this case, the seal needs to have a certain degree of elasticity or scalability.

[0203] In some preferred embodiments, the second chamber 42 may have a self-sealing opening. As mentioned above, this opening can be in a sealed state under a certain range of pressure to ensure that the liquid in the second chamber 42 does not flow out. However, when the pressure exceeds a certain value, it may open. When the pressure exceeding this value is removed, it will return to a sealed state.

[0204] In some preferred embodiments, the seal 57 can be a rubber plug, a plastic plug, or a silicone plug, the material of which has a certain elasticity. When punctured, it can communicate with the outside world or other cavities through the puncture element. When the puncture element is removed, the seal can be restored. The restored seal can ensure that the liquid therein will not leak within a certain pressure range.

[0205] In some preferred embodiments, the second cavity 42 can be evacuated. In this way, since the second cavity 42 has no internal pressure, once it is connected to other cavities or the outside world, it will be beneficial for the sample to flow into the second cavity 42.

[0206] In some preferred embodiments, the shape and volume of the second cavity 42 may change after being filled with the liquid sample, such as Figure 18-19 As shown, when a certain amount of liquid sample is placed in the second cavity 42, its shape expands from a flat shape to a cylindrical shape. Since the second cavity 42 is elastic and its open end is punctured by the puncturing element when the sample is placed, the sample placed in the second cavity 42 can be squeezed out of the open end punctured by the puncturing element when it is needed.

[0207] In some preferred embodiments, the second cavity can also be a hard cavity, for example, made of glass or plastic material, and the sealing member 57 can be provided with a self-sealing opening, for example, an opening similar to a "screaming bottle". In some preferred embodiments, the self-sealing opening can be directly provided on the second cavity.

[0208] communicating vessel

[0209] like Figure 9-11As shown, in some specific implementations of the present invention, the present invention further provides a communicating vessel 58 for connecting the second cavity 42 and the first cavity 41. In some preferred embodiments, the communicating vessel 58 is detachably connected or combined with the second cavity 42. In some preferred embodiments, when the cavity and the communicating vessel are connected or combined, the communicating vessel can connect the interior of the cavity with other cavities or external liquid. In some preferred embodiments, when the cavity and the communicating vessel are disassembled, the cavity is in a self-sealing state. In some preferred embodiments, the communicating vessel 58 is used to connect the second cavity 42 with other cavities, such as the first cavity 41, or the third cavity 43. In some preferred embodiments, the communicating vessel 58 is used to connect the second cavity 42 with the external space.

[0210] like Figure 9 As shown, the communicating vessel 58 may have a puncturing element 59, which can puncture the second cavity 42 under a certain external force and establish a channel for the second cavity 42 to communicate with other cavities or the outside world. In some preferred embodiments, the puncturing element 59 is a needle as shown in the figure.

[0211] In some preferred embodiments, the communicating vessel 58 has a communicating cavity 60, and the puncturing element 59 is connected to the communicating cavity 60. The communicating cavity 60 itself can be connected to other cavities. For example, the communicating cavity 60 can be connected to the first cavity 41. When the first cavity 41 is squeezed, the sample therein can pass through the communicating cavity 60 along the puncturing element 59 into the second cavity 42. In some preferred embodiments, the communicating cavity 60 can also serve as an entrance for directly collecting samples.

[0212] In some preferred embodiments, the communicating cavity 60 can accommodate a portion of the first channel 47, which in particular includes the aforementioned collecting tank 50. Figure 36 As shown, this is an assembly method of the communicating vessel and the first channel. In this assembly method, the communicating vessel separates the first channel and the third chamber 43, so that the first channel can only connect the second chamber 42 and the first chamber 41. At this time, the second chamber 42 can only accept samples from the first chamber 41. This method is particularly suitable for situations where samples in other chambers are used for testing, ensuring that the samples entering the second chamber 42 for secondary testing will not be contaminated during the initial testing. At the same time, after the first channel is separated from the third chamber, the outer periphery of the second chamber will not be contaminated by the sample from the third chamber. After the second chamber completes the collection and takes out, its outer surface will not be contaminated by the sample.

[0213] In some preferred embodiments, a limiting structure can be provided for the manifold 58 and the cover 63. This limiting structure can prevent the manifold 58 from being removed from the cover, as the outer wall of the manifold 58 may come into contact with the sample. In this case, when the second cavity 42 is removed, it is best not to remove the manifold 58 and the second cavity 42 at the same time, otherwise the sample will be present. In other words, when the second cavity 42 is removed, the second cavity 42 and the manifold 58 must be separated. This separation can be achieved by limiting the movement of the manifold by the limiting structure. In some preferred embodiments, the limiting structure can be provided on the cover 63. In some preferred embodiments, the limiting structure can be provided on the manifold 58.

[0214] In some preferred embodiments, the end surface of the manifold 58 includes a stepped surface 61. This stepped surface 61 serves as a reference surface for the manifold 58 to cover the first channel 47. Furthermore, after the second chamber completes sample collection, the manifold 58 is connected to the second chamber 42 due to the action of the puncture element 59. At this point, the second chamber and manifold 58 need to be separated, which requires applying a certain amount of external force. However, since the manifold itself is contaminated with the sample and cannot be manually operated, the protrusion of the stepped surface 61 allows the second chamber assembly structure 62 on the cover 63 to act on this stepped surface 61, ensuring that the manifold 58 remains within the device when the second chamber 42 is separated and does not become dislodged. Furthermore, the manifold 58 also includes a tapered surface 64, the primary function of which is to facilitate installation of the manifold 58.

[0215] like Figure 3-4 As shown, in a specific embodiment of the present invention, the communicating vessel 58 can be installed at the lower end of the second chamber assembly structure 62 on the cover 63 during initial use, and when the cover 63 is closed, it is sleeved on the first channel 47. During initial use or initial assembly, the communicating vessel 58 does not connect to the second chamber. Only when it is necessary to collect samples for secondary confirmation testing, the communicating vessel 58 will connect to the second chamber under certain conditions.

[0216] For example Figure 7-8 The state shown in FIG36 is a state where the communicating vessel 58 has not yet been connected to the second cavity 42. At this time, no liquid sample has been collected in the second cavity 42. In this state, the communicating vessel 58 is pushed toward the second cavity 42 by the matching relationship or external force, and the piercing element 59 on the communicating vessel 58 can pierce the outer wall of the second cavity or pierce the sealing member 57 on the second cavity to connect the liquid of the second cavity. Figure 19The illustrated state can be understood as the state in which the communicating vessel 58 is removed from the second cavity. At this point, a sufficient amount of liquid sample has been collected in the second cavity. With the communicating vessel 58 removed, the punctured outer wall of the second cavity or the seal 57 of the second cavity can naturally close. This naturally closed state can withstand the pressure of the collected liquid sample. When needed, the second cavity is squeezed, and the liquid sample can flow out from the punctured area.

[0217] Cover

[0218] like Figure 3-6 As shown, in some specific embodiments of the present invention, the present invention provides a cover 63, in some preferred embodiments, such as Figure 2 As shown, the cover 63 can be connected to the sealing connection cover 66. The cover 63 and the sealing connection cover 66 can be detachably connected or coupled via a connection portion 69. In other words, the cover 63 can be placed on the sealing connection cover 66 or removed therefrom. In some preferred embodiments, the sealing connection cover 66 may not be provided, and the cover 63 can directly cover the opening of the third cavity 43. The cover 63 can also be detachably coupled or coupled to the opening of the third cavity 43. When the cover 63 is closed, the sample collection device of the present invention can be completely sealed. As previously mentioned, this seal can be a standard seal or a more demanding seal structure, depending on actual needs.

[0219] In some preferred embodiments of the present invention, the cover 63 can be sealed while simultaneously enclosing the second cavity 42, placing the second cavity 42 in a position or state where it can readily collect samples. Of course, the present invention does not exclude that in some preferred embodiments, the second cavity 42 can also be placed in a position or state where it can readily collect samples by other means. In some preferred embodiments, the cover 63 is provided with a second cavity assembly structure 62, and the second cavity 42 can be detachably connected or coupled to the assembly structure 62. Before the device of the present invention is used (e.g., during transportation, storage, or sales), the second cavity 42 can be separated from the assembly structure 62. If this separation reduces the space occupied by the overall structure of the present invention, the second cavity 42 can then be reinstalled into the assembly structure 62 during use, and the second cavity can be installed in the appropriate position along with the assembly structure. In some preferred embodiments, the cover 63 is provided with an assembly channel 70, and the second cavity assembly structure 62 can be detachably coupled or coupled to the assembly channel 70. In other words, the second cavity can first be installed into the assembly structure and then installed into the cover 63 through the assembly structure.

[0220] In some preferred embodiments, the communicating vessel 58 will also be installed in the assembly structure 62, but the installation of the communicating vessel 58 in the assembly structure 62 does not mean that it is directly connected to the second chamber 42. As mentioned above, the communicating vessel 58 can be connected to or separated from the liquid of the second chamber 42 under other cooperation or external force according to actual needs of use.

[0221] Assembly structure of the second cavity

[0222] In some preferred embodiments of the present invention, the present invention provides an assembly structure 62 for a second cavity, and the main function of the assembly structure 62 is to install the second cavity therein. In some preferred embodiments of the present invention, the second cavity 42 is a flexible body, and its outer wall can be squeezed, and the second cavity needs to be detachably combined or connected with the cover body or other cavity bodies. In the process of such detachable combination or connection, a certain external force will inevitably be applied to the second cavity. If there is no external protective structure for the flexible body such as the second cavity, it is very likely that improper force will be applied to squeeze out the liquid sample therein, which is a situation that absolutely needs to be avoided. Therefore, the assembly structure not only supports the second cavity, but also plays a role of supporting and temporarily protecting the second cavity.

[0223] In some preferred embodiments, the second cavity can also be a hard cavity, such as made of glass or plastic material. In this case, the assembly structure can also play a certain protective role for the second cavity, and more importantly, it serves as a convenient way to grasp and hold the second cavity.

[0224] In some preferred embodiments, Figure 7 、 16 -17, the assembly structure has an outer wall 71 and an inner cavity 72, and the second cavity can be installed in its inner cavity. The second cavity and the inner cavity can be assembled together in the form of fixed combination, fixed connection, or detachable combination and detachable connection. The purpose of assembly is to enable the second cavity and the assembly structure to be connected or combined with the cover body or other cavities and components as a whole. As mentioned above, the assembly structure 62 needs to support and protect the second cavity. Therefore, the outer wall of the assembly structure 62 must have a certain shape and hardness. This shape must exceed the outer shape range of the second cavity, and the hardness must be able to withstand a certain pressure without squeezing the second cavity, such as squeezing by fingers. Since the working environment of the second cavity is usually mobile or manually operated, the second cavity or the assembly structure will not be deliberately squeezed during use. Therefore, the hardness requirement will not be too high. The hardness of ordinary plastic materials can basically meet this requirement.

[0225] In some preferred embodiments, since the second cavity may release the sample by squeezing its outer wall, a plurality of hollow structures 73 are provided on the outer wall of the assembly structure, through which the second cavity can be squeezed. In some preferred embodiments, due to the presence of hollow structures 73, the assembly structure itself can withstand a certain range of squeezing deformation. When the sample needs to be released, the assembly structure can be squeezed to apply pressure to the second cavity through the assembly structure, thereby achieving the purpose of expelling the sample.

[0226] In some preferred embodiments, a fixing ring 74 is provided on the assembly structure 62 and matches the open end 55 of the second cavity. The outer wall of the open end 55 is fixedly connected, coupled, or removably connected or coupled to the inner wall of the fixing ring 74, thereby securing the second cavity to the assembly structure. In some preferred embodiments, the fixing ring 74 and the open end 55 are both located at the lower end of the second cavity and the assembly structure.

[0227] In some preferred embodiments, the assembly structure 62 is detachably coupled or connected to the cover 63. In some preferred embodiments, an assembly connector 75 is provided on the assembly structure 62, and the assembly connector 75 can be detachably coupled or connected to the cover. In some preferred embodiments, the assembly connector 75 is detachably coupled or connected to the cover 63 via threads. In other preferred embodiments, the assembly connector 75 can also be connected to the cover via other detachable connection methods.

[0228] In some preferred embodiments, in order to facilitate the separation and loading of the second chamber, as Figure 16-17 As shown, a knob 76 is provided on the assembly structure 62. Figure 1-3 As shown, after the assembly structure is installed on the cover body 63, the knob 76 is exposed on the outer surface of the cover body. The assembly structure and the second cavity can be removed therefrom by rotating the knob 76 in the opposite direction. It should be noted that the knob 76 is only one possible implementation method. In fact, specific implementation forms such as handles, paddles, and hanging rings can all achieve this function. As long as there is an element that can be exposed on the outer surface of the cover body to facilitate the installation and separation of the second cavity, the present invention does not limit the specific form of this element.

[0229] In some preferred embodiments, the seal 57 of the second cavity can be fixed on the assembly structure 62, for example, set at the fixing ring 74, or set outside the fixing ring 74, or at other positions that can pass through the seal 57 to connect to the interior of the second cavity 42.

[0230] First Channel

[0231] In some preferred embodiments, the first chamber of the present invention does not directly have an external collection port, but receives the liquid sample through another chamber, such as the third chamber 43. In this case, the first chamber and the third chamber are in liquid communication. In some preferred embodiments, the first chamber and the third chamber are directly connected. In some preferred embodiments, the first chamber and the third chamber are connected through a first channel 47, such as Figures 27-29 As shown, the function of the first channel 47 is to establish liquid communication between the first and third chambers, allowing fluid to enter the first chamber from the third chamber through the first channel. For example, in the embodiment shown in the figure, the first channel 47 is located at the bottom of the third chamber 43. In this way, the sample entering the third chamber can naturally flow into the first chamber under the action of its own gravity. The first channel 47 is directly connected to the third chamber 43, and the first chamber 41 is located below the third chamber 43. The third chamber 43 has an upward-facing collection port 49. Through this collection port 49, the liquid sample can enter the third chamber 43 and naturally fall or flow downward under the action of gravity. The portion of the liquid sample that naturally falls and enters the first channel can directly fall into the first chamber 41. During this natural fall, some of the liquid sample will inevitably be unable to directly fall into the first channel 47. In this way, this portion of the liquid sample can accumulate at the bottom of the third chamber 43. When the liquid level exceeds the height of the first channel 47 above the bottom of the third chamber 43, this portion of the liquid will flow through the first channel 47 into the first chamber 41. In some preferred embodiments, the sample can also enter the third chamber from the first chamber.

[0232] In some preferred embodiments, as can be seen in the figure, a collection trough 50 can be provided on the sidewall of the first channel 47. This collection trough 50 can be flush with or slightly higher than the bottom of the third chamber 43. During the natural falling process, the portion of the liquid sample that does not enter the first channel 47 will eventually collect at the bottom of the third chamber 43. Because the collection trough is relatively close to the bottom of the third chamber 43, the liquid sample at the bottom of the third chamber 43 is likely to enter the first channel 47 through the collection trough 50 and then flow into the first chamber 41 along the first channel 47. It should be noted that, since it is not necessary for all of the sample in the third chamber 43 to flow into the first chamber 41, only a portion is required. Therefore, as long as the amount of collected liquid is sufficient, some of the sample will inevitably enter the first channel 47. Furthermore, since the entire chamber may be in a non-stationary state during actual use, such as when being held by hand, the collected sample is more likely to enter the collection trough 50 due to shaking.

[0233] In some preferred embodiments, the first channel 47 can be closed. For example, when the sample in the first chamber is transferred to the second chamber, or when the second chamber is taken out and put in, since the second chamber is used to collect liquid samples for secondary confirmation detection, when the first channel is closed, the first chamber and the third chamber are in a liquid isolation state. For example, in some preferred embodiments, the sample first enters the third chamber and can flow into the first chamber along the aforementioned first channel. The liquid in the first chamber can enter the second chamber under the action of external force. In some preferred embodiments, when the first chamber and the second chamber are in a liquid communication state, the first channel can be closed. In some preferred embodiments, such as Figure 36 As shown, the first channel can be closed by a communicating vessel. In this assembly method, the communicating vessel separates the first channel and the third cavity 43, so that the first channel can only connect the second cavity 42 and the first cavity 41. At this time, the second cavity 42 can only accept samples from the first cavity 41. This method is particularly suitable for situations where samples in other cavities are used for testing, ensuring that the samples entering the second cavity 42 for secondary testing will not be contaminated during the initial testing. At the same time, after the first channel is separated from the third cavity, the outer periphery of the second cavity will not be contaminated by the sample from the third cavity. After the second cavity completes the collection and takes out, its outer surface will not be contaminated with the sample.

[0234] Fourth cavity

[0235] In some preferred embodiments, the present invention provides a fourth chamber for temporarily storing test samples, such as Figures 27-28 As shown, the sample in the fourth chamber is primarily used for initial testing. In some preferred embodiments, the sample is tested directly from the fourth chamber. In some preferred embodiments, the sample in the fourth chamber is pushed into the testing area for testing. In some preferred embodiments, the fourth chamber can directly collect the sample. In some preferred embodiments, the fourth chamber can collect the sample through other chambers.

[0236] When the fourth chamber collects samples through other chambers, in some preferred embodiments, the fourth chamber can be in a state of liquid connection or isolation with the third chamber. In some preferred embodiments, when the fourth chamber is in a state of liquid connection with the third chamber, the liquid collected in the third chamber can enter the fourth chamber at the same time. The fourth chamber can also be in a state of connection with the third chamber when the sample is initially collected, for example, Figures 27-28 As shown, the fourth chamber is located at the bottom of the third chamber, and an opening is provided at the bottom of the third chamber that communicates with the fourth chamber. In this way, the liquid sample entering the third chamber can flow directly into the fourth chamber under the action of gravity, and the fourth chamber can also complete the required sample substantially synchronously with the third chamber. In some preferred embodiments, the fourth chamber can be directly connected to the third chamber. In some preferred embodiments, the fourth chamber can be in liquid communication with the third chamber via a second channel.

[0237] In some preferred embodiments, the fourth cavity can be in a state of liquid connection or isolation with the detection area. When the fourth cavity is initially collecting, the fourth cavity and the detection area can be isolated, that is, collection and detection can be independent links. In some preferred embodiments, the isolation and connection of the fourth cavity and the detection area can be achieved through the detection inlet. As mentioned above, the detection inlet 46 is the connecting port between the collection cavity and the detection area. However, it is not necessary to connect the detection area and the collection cavity at all times. The collection cavity can be separated from the detection area and connected as needed. In this case, a detection inlet partition 54 can be set at the detection inlet 46. The detection inlet partition 54 can be used to adjust or set the detection inlet 46 to be connected or isolated, so that the liquid in the third cavity 43 can be introduced into the detection area 45 as needed.

[0238] For example, Figure 27 In the manner shown, the detection entrance partition 54 has a certain hardness and thickness, and is provided with a cut, and the cross-sections of the cut are interference fit. Then, when there is no pressure or insufficient pressure, the entire cut is in a closed state, which can isolate the flow of liquid. However, when one side of the cut is under pressure, the cut will open in the direction of the pressure and naturally release the pressure. That is to say, when there is a certain amount of sample on one side of the cut, or a certain pressure is applied to the sample, the cut can be opened to connect the collection chamber and the detection area 45 liquid. When the pressure is removed, the cut can be restored to a closed state.

[0239] In some preferred embodiments, when the fourth chamber 44 is in a liquid-connected state with the detection area 45, the fourth chamber 44 and the third chamber 43 are in a liquid-isolated state. On the one hand, this ensures that the detection area is not affected by possible contamination from other chambers, and on the other hand, quantitative detection can be achieved. As long as the volume of the fourth chamber is set, the quantification of the sample entering the detection area can be achieved.

[0240] Second channel

[0241] As mentioned above, the function of the second channel 48 is to connect the fourth chamber 44 with the third chamber 43 in liquid, so that the fourth chamber 44 can collect samples synchronously with the third chamber 43. In some preferred embodiments, considering that this part of the sample itself should avoid contamination, this part of the sample should avoid contact with samples in other chambers during detection, and this part of the sample should not flow back after contacting the test element in the detection area, when the sample in the fourth chamber is transferred to the detection area, the second channel is also closed at the same time. For example, Figure 28In the state shown, the second pipetting element 53 is initially positioned to one side below the second channel 48. While the fourth chamber 44 is collecting the sample, the second channel remains in a fixed position. When the sample needs to be pushed into the detection area, the second pipetting element 53 moves toward the detection area 45, gradually closing the second channel 48. In some preferred embodiments, the distance between the second channel 48 and the detection area is less than the length of the second pipetting element 53 itself. Thus, after the transfer is complete, the second channel 48 remains sealed by the second pipetting element 53.

[0242] First pipetting element, second pipetting element, pipetting channel and pipetting stopper

[0243] The present invention provides a pipetting element, which is used to transfer liquid in the first chamber 41 to the second chamber 42. In some preferred embodiments, the pipetting element can also transfer liquid in the fourth chamber 44 to the detection area 45. The above two transfers can be synchronous or independent processes.

[0244] In some preferred embodiments, Figures 27-29 As shown in Figures 31-34, the pipetting element includes a first pipetting element 52 for transferring the sample in the first cavity 41 to the second cavity 42, and a second pipetting element 53 for transferring the sample in the fourth cavity 44 to the detection area 45. The first pipetting element 52 and the second pipetting element 53 can move independently or in conjunction with each other. The first pipetting element 52 and the second pipetting element 53 are usually pushed to move and then generate thrust on the liquid in their respective cavities, so that these samples are transferred to other cavities or areas. For example, the first pipetting element 52 can move under the action of an external force to squeeze the sample in the first cavity 51, generate pressure on it, and transfer it to the desired direction or chamber, such as entering the second cavity through the connecting vessel 58. In some preferred embodiments, the second pipetting element 53 can move under the action of an external force to squeeze the sample in the fourth cavity 44, generate pressure on it, and transfer it to the desired direction or chamber, such as entering the detection area 45.

[0245] In some preferred embodiments, the first pipetting element 52 and the first cavity 41 are in the same pipetting channel 51, and pushing the first pipetting element can achieve the above-mentioned extrusion. In some preferred embodiments, the second pipetting element and the fourth cavity are in the same pipetting channel, and pushing the second pipetting element can achieve the above-mentioned extrusion. In some preferred embodiments, the first pipetting element, the second pipetting element, the first cavity and the fourth cavity are in the same pipetting channel 51, and pushing one of the first pipetting element or the second pipetting element can achieve the above-mentioned extrusion at the same time. In this case, the first pipetting element and the second pipetting element can achieve a step-by-step linkage state. For example, when the first pipetting element is pushed, the first pipetting element is first forced to move, squeezing the sample in the first cavity. The resistance to the movement of the second pipetting element may be greater than the resistance to the movement of the liquid in the first cavity. At this time, the sample in the first cavity is transferred first. When the sample in the first cavity is discharged to the first pipetting element, the action of the first pipetting element on the second pipetting element is performed. When the force applied is greater than the resistance to movement of the second pipetting element, the second pipetting element begins to squeeze the sample in the fourth chamber, thereby also transferring the sample in the fourth chamber. Alternatively, in other possible scenarios, the second pipetting element is pushed, and the second pipetting element is first moved by the force and squeezes the sample in the fourth chamber. In this case, the resistance to movement of the first pipetting element may be greater than the resistance to movement of the liquid in the fourth chamber, and the sample in the fourth chamber is preferentially transferred. When the sample in the fourth chamber is discharged to the first pipetting element, and the force exerted by the second pipetting element on the first pipetting element is greater than the resistance to movement of the first pipetting element, the first pipetting element begins to squeeze the sample in the first chamber, thereby also transferring the sample in the first chamber. In some cases, it is desirable that when the first and second pipetting elements are in the aforementioned linked state, the liquid in the first chamber is preferentially transferred, and then the liquid in the fourth chamber breaks through the entrance of the detection area. This is to ensure that the liquid sample transferred from the first chamber to the second chamber will not be contaminated during detection. Of course, the transfer of the first and fourth chambers can also be performed simultaneously. Since there is a sequential structure that follows the direction of liquid flow, the possibility of backflow or contamination is reduced.

[0246] In some preferred embodiments, the pipetting channel can be liquid-connected or liquid-isolated with the second cavity. In some preferred embodiments, the pipetting channel can be liquid-connected or liquid-isolated with the detection area. In some preferred embodiments, the first and second pipetting elements separate the pipetting channel into a first cavity and a fourth cavity. In some preferred embodiments, the second pipetting element separates the fourth cavity from the second cavity. In fact, as can be seen from the figure, in some preferred embodiments, the first and fourth cavities are two sections of the pipetting channel.

[0247] In some preferred embodiments, when the sample in the first cavity is transferred to the second cavity, the volume of the first cavity is reduced. In some preferred embodiments, when the volume of the first cavity is reduced, the first pipetting element and the second pipetting element are moved closer. In some preferred embodiments, when the sample in the fourth cavity is transferred to the testing area, the volume of the fourth cavity is reduced. In some preferred embodiments, after the liquid in the first cavity is transferred, the liquid communication state between the first cavity and the second cavity is cut off. In some preferred embodiments, when the liquid in the fourth cavity is transferred, the liquid communication state between the fourth cavity and the third cavity is cut off. In some preferred embodiments, the connection state between the fourth cavity and the third cavity is cut off by the second pipetting element closing the second channel during the movement.

[0248] Another feature of the present invention is that quantitative detection can be achieved. For example, in some preferred embodiments, the initial volume of the fourth cavity is fixed, that is, before the fourth cavity is subjected to force and compressed, the amount of sample that can be loaded into the fourth cavity can be determined. In some preferred embodiments, the initial position of the second pipetting element in the pipetting channel is fixed. In some preferred embodiments, the initial volume of the first cavity is fixed, that is, before the first cavity is subjected to force and compressed, the amount of sample that can be loaded into the first cavity can be determined. In some preferred embodiments, the initial position of the first pipetting element in the pipetting channel is fixed. In some preferred embodiments, the relative initial positions of the first pipetting element and the second pipetting element in the pipetting channel are fixed.

[0249] In some preferred embodiments, the pipetting channel has a pipetting opening 77, through which external force can be applied to the pipetting channel to achieve above-mentioned extrusion. In some preferred embodiments, the pipetting opening can be sealed by the first pipetting element or the second pipetting element. In some preferred embodiments, the pipetting element also includes a pipetting plug that can push the first pipetting element and / or the second pipetting element. In some preferred embodiments, the pipetting plug can extend into the pipetting channel through the pipetting opening. In some preferred embodiments, the opening of the pipetting channel is provided with a socket that matches the pipetting plug on the first pipetting element and / or the second pipetting element.

[0250] In some preferred embodiments, a sealing element 76 is provided between the pipetting element and the pipetting channel 51. The sealing element 76 may be Figure 35 The sealing ring shown can be made of a material with a certain degree of elasticity to ensure that the sample does not leak between the pipetting element and the inner wall of the pipetting channel when the pipetting element moves within the pipetting channel. The sealing element 76 also serves to increase the friction between the pipetting element and the inner wall of the pipetting channel. With sufficient friction, the liquid injected into the first and fourth chambers is insufficient to cause the pipetting element to move, thereby achieving quantitative collection and quantitative detection.

[0251] like Figures 31-32 As shown, in a specific embodiment, the first pipetting element 52 includes a first movable cavity 79, and a power component such as a pipetting plug 78 can partially extend into this movable cavity 79 to push the first pipetting element 52. Correspondingly, the pipetting plug 78 can also be provided with a cone. This cavity can provide a force application point for the power component and can also limit the direction of the push to a certain extent. In some preferred embodiments, the first movable cavity 79 may not be provided. In some preferred embodiments, the first pipetting element 52 is provided with a supporting foot 80, which can separate the first pipetting element 52 and the second pipetting element 53 to ensure that a certain space is always left between the two pipetting elements. In some preferred embodiments, the first pipetting element may also not be provided with a supporting foot. In some preferred embodiments, the first pipetting element is provided with a sealing groove 81, and the sealing element 76 is installed in the sealing groove 81. The sealing groove 81 can be one or more.

[0252] like Figures 33-34 As shown, in a specific embodiment, the second pipetting element 53 includes a second moving cavity 82, and the power component can partially extend into the moving cavity 82 to push the second pipetting element 53, thereby pushing the sample in the fourth cavity into the detection area, as shown in FIG. Figure 29 The sample in the fourth cavity is completely pushed into the detection area. In some preferred embodiments, the second moving cavity 82 may not be provided.

[0253] Methods for collecting fluid samples

[0254] The present invention provides a method for collecting liquid samples, which adopts the sample collection device as described above. The sample collection device includes a first chamber for collecting liquid samples and a second chamber for collecting confirmation test samples. The first chamber and the second chamber can be in a liquid connected or isolated state. When the first chamber and the second chamber are in a liquid connected state, the liquid in the first chamber can be transferred to the second chamber.

[0255] In some preferred embodiments, a third chamber for collecting samples is further included. The third chamber and the first chamber can be in liquid communication or isolation with the first chamber. Initial samples can be collected through the third chamber, and the samples collected in the first chamber may be transferred to the second chamber for secondary detection.

[0256] In some preferred embodiments, when the first chamber and the third chamber are in a liquid-connected state, the liquid collected in the third chamber can enter the first chamber at the same time. That is, when the sample is initially collected in the third chamber, the first chamber can also be loaded with the initially collected sample at the same time.

[0257] In some preferred embodiments, when the liquid in the first chamber is transferred into the second chamber, the first chamber and the third chamber are in a liquid isolation state. Since the sample in the second chamber is used for secondary confirmation testing, in order to ensure that the sample in the second chamber is not contaminated, the first chamber is isolated from the other chambers before the transfer.

[0258] In some preferred embodiments, the device further comprises a fourth chamber for collecting samples to be detected, and the fourth chamber can be in a state of liquid connection or isolation with the third chamber.

[0259] In some preferred embodiments, when the fourth chamber is in a liquid-connected state with the third chamber, the liquid collected in the third chamber can enter the fourth chamber at the same time. The fourth chamber can also be in a connected state with the third chamber when initially collecting samples. In this way, the fourth chamber can also complete the required samples basically synchronously with the third chamber. The samples collected in the fourth chamber are mainly used for initial testing. The initial testing can be performed directly in the fourth chamber or transferred to other areas through the fourth chamber, such as the testing area.

[0260] In some preferred embodiments, a detection area is also included, and the fourth cavity can be in a liquid-connected or isolated state with the detection area. When the fourth cavity is initially collecting, the fourth cavity and the detection area can be isolated, that is, collection and detection can be independent links.

[0261] In some preferred embodiments, when the fourth chamber is in a liquid-connected state with the detection area, the fourth chamber and the third chamber are in a liquid-isolated state. On the one hand, this ensures that the detection area is not affected by possible contamination from other chambers, and on the other hand, quantitative detection can be achieved. As long as the volume of the fourth chamber is set, the quantification of the sample entering the detection area can be achieved.

[0262] In some preferred embodiments, the second cavity and the third cavity can be combined or separated. In some preferred embodiments, the second cavity and the first cavity can be combined or separated. Since the second cavity needs to obtain the collected sample from the first cavity or the third cavity, the second cavity must establish a liquid connection with the first cavity or the third cavity or one of them. After obtaining the required sample, the second cavity must be able to independently seal and preserve the cavity therein, and even be independently transported and sent to a secondary detection agency. Therefore, the second cavity must be separated from the first cavity or the third cavity or one of them. In some preferred embodiments, the second cavity can be detachably combined or connected with the first cavity or the third cavity or one of them.

[0263] In some preferred embodiments, a communication device is further included between the first cavity and the second cavity, and the communication device provides a more convenient channel and path for the sample in the first cavity to enter the second cavity.

[0264] In some preferred embodiments, the connecting device is not installed in place when the sample is initially collected, and the connecting device is installed when a secondary confirmation collection is required.

[0265] In some preferred embodiments, the communication device can place the first cavity and the second cavity in a state of liquid communication, or can isolate the communication between the first cavity and the second cavity.

[0266] In some preferred embodiments, the connecting device can isolate the connection between the first cavity and the third cavity. After the initial sample collection is completed, in order to ensure that the secondary confirmation sample is contamination-free, the first cavity and the third cavity can be isolated first.

[0267] In the present invention, since the initially collected sample cannot enter the second cavity naturally, it must be acted upon by a certain external force. In this case, a certain force must be applied to the initially collected sample.

[0268] Therefore, in some preferred embodiments, the method of the present invention further provides a pipetting element. After the initial collection is completed, there is already a sufficient amount of sample in the first cavity. At this time, the pipetting element is pushed to squeeze the sample in the first cavity so that it enters the second cavity directly or through a connecting device. At the same time, the volume of the first cavity itself is compressed. In some preferred embodiments, the pipetting element can also transfer the sample in the fourth cavity. In some preferred embodiments, the transfer of the sample in the fourth cavity can be after the transfer of the sample in the first cavity. In some preferred embodiments, the first cavity and the fourth cavity can be squeezed using different pipetting elements respectively. In some preferred embodiments, the pipetting elements of the first cavity and the fourth cavity can be linked.

[0269] In some preferred embodiments, the method of the present invention also provides a pipetting channel, in which the above-mentioned pipetting element can move, thereby squeezing the liquid in the first cavity or the fourth cavity. In some preferred embodiments, the first cavity or the fourth cavity can be a section in the pipetting channel, which is separated by different pipetting elements to form a cavity. In some preferred embodiments, the first cavity can be in liquid communication with the second cavity. In some preferred embodiments, the fourth cavity can be in liquid communication with the detection area. In other words, the pipetting channel itself can be in liquid communication with the second cavity or the detection area or both.

[0270] In some preferred embodiments, the method of the present invention also provides a pipette plug, which is mainly used to provide moving power to the pipette element, so that it moves in the pipette channel to generate a squeezing force on the samples in the first chamber and / or the fourth chamber, so that these samples are transferred.

[0271] In some preferred embodiments, the method of the present invention further provides a sealing structure between the pipetting element and the pipetting channel, ensuring that when the pipetting element is moved under force, no gap is generated between it and the inner wall of the pipetting channel, and no sample leakage occurs.

[0272] Sample testing method

[0273] The present invention provides a method for detecting the presence of an analyte in a liquid sample. The detection method includes any of the aforementioned sample collection devices. The sample to be tested is collected by the sample collection device. After the sample is collected in the fourth chamber, the sample therein is tested. In some preferred embodiments, after the sample is collected in the third chamber, the sample therein is tested. In some preferred embodiments, the sample in the fourth chamber is transferred to a detection area for testing. In some preferred embodiments, the sample in the third chamber is transferred to a detection area for testing. After the test results are obtained, the second chamber is separated from the sample collection device according to any of the aforementioned methods.

[0274] A specific embodiment

[0275] like Figure 2 As shown, the sample collection device of the present invention may include a cover body 63 and a third cavity 43, and the cover body and the third cavity are detachably connected via a connection portion 69. The sample collection device may also include some components, which may be in a separate unassembled state before use, such as the second cavity 42, the assembly structure 62, the communicating vessel 58, the pipette plug 78, etc. These components can be loaded into the third cavity 43 during transportation packaging. A plug can be pre-configured on the assembly channel of the cover body 63 to plug the assembly channel to prevent dust accumulation or contamination inside the assembly channel. In some cases, the communicating vessel 58 can also be used as a component and assembled to the cover body when in use. When in use, the plug is removed, and then the second cavity 42 is assembled into the assembly channel of the cover body 63. The second cavity itself can be installed on an assembly structure. This assembly structure and the second cavity form an assembly, which is loaded into the assembly channel of the cover body 63. Then, the communicating vessel 58 is also loaded into the lower end of the assembly channel 70. The communicating vessel 58 can close the lower end of the assembly channel. Before use, as shown in FIG. Figure 36 As shown, the communicating vessel 58 does not puncture the second cavity. In some cases, the communicating vessel 58 can be pre-assembled at the bottom of the assembly channel of the cover body 62, but is not assembled to the extreme position of the fit.

[0276] When collecting samples, open the cover body, assemble the second cavity and other components into the cover body according to the above relationship, and then collect samples into the third cavity. While collecting samples in the third cavity, the samples will automatically flow into the first cavity and the fourth cavity until the required amount is reached, and then close the cover body 63. During the sealing process of the cover body, the communicating vessel 58 will first close the first channel, and then the cover body will continue to close downward, and the assembly channel will be pressed down, causing the communicating vessel to further enter the assembly channel until the seal 57 on the second cavity is punctured. At this time, the first channel is closed by the communicating vessel, and the first cavity and the third cavity are in an isolated state, while the first cavity and the second cavity are in a liquid communication state through the communicating vessel. However, since the communicating vessel is connected by a needle, the liquid in the first cavity is located below the second cavity. Therefore, the liquid in the first cavity will not actively flow into the second cavity, and the sample in the fourth cavity will not actively flow into the detection area.

[0277] When testing a sample, the first pipetting element 52 is pushed inward by the pipetting plug 78. This inward movement of the first pipetting element 52 reduces the volume of the first chamber 41, squeezing the liquid sample in the first chamber and causing it to move toward the second chamber. This also creates an inward thrust on the second pipetting element 53. However, until this inward thrust overcomes the frictional resistance between the second pipetting element 53 and the inner wall of the pipetting channel 51, the second pipetting element 53 remains stationary. This occurs until the first and second pipetting elements 52, 53 come into contact, at which point the second chamber has essentially completed sample collection. Further inward pushing of the pipetting plug causes the second pipetting element 53 to begin squeezing the liquid sample in the fourth chamber, pushing it into the detection area for testing by the test element. The state shown in FIG29 shows the sample in the fourth chamber completely pushed into the detection area. Since the position of the second pipetting element 51 is determinable in the initial state, the volume of the fourth chamber 44 can also be determined, thereby enabling quantitative testing.

[0278] In the method of this embodiment, a test element can be placed in the detection area, and the sample can be initially tested by the test element. The detection area is made of transparent material, and the test result can be directly observed through the outer surface of the detection area. When the test result may be positive or weakly positive or cannot be determined, a secondary confirmation test is required. By turning the knob 76, the second cavity and the assembly structure are taken out. At this time, the communicating vessel remains in the detection device, and the second cavity can be independently transported to the secondary confirmation detection mechanism for testing.

Claims

1. A collection chamber, characterized in that: The device comprises a first chamber for collecting a liquid sample and a second chamber for collecting a confirmation test sample. The first chamber and the second chamber can be in a liquid-connected or liquid-isolated state. When the first chamber and the second chamber are in the liquid-connected state, the liquid in the first chamber can be transferred to the second chamber under the action of an external force. The device includes a third chamber for initially collecting samples, the third chamber being capable of being in or out of liquid communication with the first chamber, a first channel being in liquid communication between the first and third chambers, the first channel being located at the bottom of the third chamber, and the sample entering the third chamber naturally flowing into the first chamber under the action of its own gravity; The apparatus comprises a fourth chamber for collecting a sample to be tested, the fourth chamber being capable of being in liquid communication or isolation with the third chamber, a second channel being provided between the fourth chamber and the third chamber, the second channel being located at the bottom of the third chamber, and the sample entering the third chamber naturally flowing into the fourth chamber under the action of its own gravity; The collecting chamber of the present invention is sealed when the cover is closed. An assembly structure comprising a second cavity, wherein the assembly structure is provided with an assembly connector, and the assembly connector is detachably combined or connected with the cover body; The communicating device comprises a communicating vessel for communicating with the second cavity and the first cavity, the communicating vessel being detachably connected or combined with the second cavity, the communicating vessel having a puncture element capable of puncturing the second cavity under the action of an external force, the communicating vessel having a connecting cavity, the puncture element communicating with the connecting cavity, and the connecting cavity communicating with the first cavity, so that when the first cavity is squeezed, the sample therein can pass through the connecting cavity and follow the puncture element into the second cavity; It also includes a pipetting element, which squeezes the sample in the first cavity so that it enters the second cavity through the communicating vessel, and the volume of the first cavity itself is compressed; it also includes a pipetting channel, and the pipetting element can move in the pipetting channel.

2. A collection chamber according to claim 1, characterized in that: The sample collected in the cavity can flow into the pipetting channel naturally, or the sample collected in the cavity can flow into the pipetting channel under the action of a certain external force.

3. A collection chamber according to claim 2, characterized in that: The pipetting element is movable within the pipetting channel to change the volume of the first chamber.

4. A collection chamber according to claim 3, characterized in that: The pipetting element can exert force on the sample in the first cavity so as to transfer the sample in the first cavity to other cavities or the outside.

5. A collection chamber according to claim 4, characterized in that: The pipetting element is movable in the pipetting channel to change the volume of the fourth chamber.

6. A collection chamber according to claim 5, characterized in that: The pipetting element can exert force on the sample in the fourth cavity so as to transfer the sample in the fourth cavity to other cavities or the outside.

7. A collection chamber according to claim 6, characterized in that: The pipetting element closes the second channel while transferring the sample in the fourth chamber.

8. The collection chamber according to claim 1, characterized in that: Including detection area.

9. A collection chamber according to claim 8, characterized in that: A detection inlet is included for connecting the pipetting channel and the detection area to each other.

10. A collection chamber according to claim 9, characterized in that: A sealing connection cover is included, which can directly or indirectly seal the collection chamber.

11. A collection chamber according to claim 10, characterized in that: The sealing connection cover comprises a first cover for covering the sample collection inlet and a second cover for covering the test element inlet.

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