In Vitro Diagnostic Test Device

Abstract

The present invention provides an in vitro diagnostic test device, which relates to the technical field of medical devices. The in vitro diagnostic test device provided by the present invention has: a sample pool, a detection flow channel, a waste liquid pool and a pump chamber; one end of the detection flow channel is communicated with the bottom of the sample pool, and the other end of the detection flow channel is in fluid communication with the top of the waste liquid pool; the pump chamber is in fluid communication with the top of the waste liquid pool. The in vitro diagnostic test device provided by the present invention can be used in cooperation with an instrument for reaction testing. After one test is completed, the gas flows through the top of the waste liquid pool, the detection flow channel and the sample pool in sequence and is finally discharged, which can prevent the liquid in the waste liquid pool from remaining in the detection flow channel, and further prevent the liquid that has undergone the reaction test from affecting subsequent reaction tests.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an in vitro diagnostic test device. Background Art

[0002] Currently, there are mainly two types of microfluidic in vitro diagnostic test cards in application. One type is passive microfluidics, whose main principle is to control microfluidics through capillary action. The disadvantage is that the control is not precise enough, resulting in large errors in measurement results. The other type is active microfluidics, whose main principle is that a specific test card structure cooperates with a motion control module in the instrument to achieve precise control of the fluid displacement and velocity in the test card, so as to make the test results more accurate. However, for some test items that require high - proportion dilution of samples in the previous active microfluidic in vitro diagnostic test cards, it is necessary to manually dilute them externally and then quantitatively add them to the sample pool of the test card. The test operation is relatively complex. When using multiple reagents for testing, the liquid that has already participated in the test is likely to remain in the detection flow channel, thereby affecting the reaction test in the subsequent stage. Summary of the Invention

[0003] The purpose of the present invention is to provide an in vitro diagnostic test device that can avoid the liquid that has already participated in the test from affecting the reaction test in the subsequent stage.

[0004] In a first aspect, the in vitro diagnostic test device provided by the present invention has: a sample pool, a detection flow channel, a waste liquid pool, and a pump chamber;

[0005] One end of the detection flow channel is in communication with the bottom of the sample pool, and the other end of the detection flow channel is in fluid communication with the top of the waste liquid pool;

[0006] The pump chamber is in fluid communication with the top of the waste liquid pool.

[0007] In combination with the first aspect, the present invention provides a first possible implementation manner of the first aspect, wherein the in vitro diagnostic test device includes: a substrate and an elastic pressing cover;

[0008] The sample pool, the detection flow channel, the waste liquid pool, and the pump chamber are respectively arranged on the substrate;

[0009] The elastic pressing cover covers the pump chamber.

[0010] In combination with the first possible implementation manner of the first aspect, the present invention provides a second possible implementation manner of the first aspect, wherein the substrate is provided with a wedge - shaped groove, and the elastic pressing cover is provided with an elastic plug;

[0011] When pressing the elastic pressing cover and inserting the elastic plug into the wedge - shaped groove, the volume of the pump chamber is compressed, and the elastic plug has a tendency to move outward from the wedge - shaped groove.

[0012] Combined with the second possible implementation manner of the first aspect, the present invention provides a third possible implementation manner of the first aspect, wherein the substrate is provided with ventilation holes, and the ventilation holes are in fluid communication with the wedge-shaped grooves.

[0013] Combined with the first possible implementation manner of the first aspect, the present invention provides a fourth possible implementation manner of the first aspect, wherein a sample dilution pool, a solid reagent encapsulation pool, and a liquid reagent encapsulation pool are provided on the substrate, and the sample pool, the sample dilution pool, the solid reagent encapsulation pool, and the liquid reagent encapsulation pool are arranged at intervals.

[0014] Combined with the fourth possible implementation manner of the first aspect, the present invention provides a fifth possible implementation manner of the first aspect, wherein a sealing film is attached to the substrate, and the sample pool, the sample dilution pool, the solid reagent encapsulation pool, and the liquid reagent encapsulation pool are all sealed by the sealing film.

[0015] Combined with the fifth possible implementation manner of the first aspect, the present invention provides a sixth possible implementation manner of the first aspect, wherein a first notch and a second notch are provided on the substrate, and the first notch and the second notch are respectively in communication with the top of the waste liquid pool;

[0016] The sealing film covers the first notch and the second notch;

[0017] The first notch is in fluid communication with the detection flow channel, and the second notch is in fluid communication with the pump chamber.

[0018] Combined with the first possible implementation manner of the first aspect, the present invention provides a seventh possible implementation manner of the first aspect, wherein the substrate is connected to a detection circuit, and the detection flow channel is in fluid communication with the test part of the detection circuit.

[0019] Combined with the seventh possible implementation manner of the first aspect, the present invention provides an eighth possible implementation manner of the first aspect, wherein a sealing gasket is provided between the substrate and the detection circuit;

[0020] The sealing gasket is provided with a test port, the test port faces the test part, and the test port is in communication with the detection flow channel.

[0021] Combined with the eighth possible implementation manner of the first aspect, the present invention provides a ninth possible implementation manner of the first aspect, wherein a liquid groove is provided in the middle of the detection flow channel, and the test port is located between the liquid groove and the test part.

[0022] The embodiments of the present invention bring the following beneficial effects: One end of the detection flow channel is in communication with the bottom of the sample pool, the other end of the detection flow channel is in fluid communication with the top of the waste liquid pool, and the pump chamber is in fluid communication with the top of the waste liquid pool. During testing, the pump chamber can form a negative pressure state, so that the sample flows from the sample pool into the detection flow channel, and reaction testing is carried out in the detection flow channel. The liquid after the reaction testing finally flows into the waste liquid pool; after one test is completed, the gas flows through the top of the waste liquid pool, the detection flow channel and the sample pool in sequence from the pump chamber and is finally discharged, which can avoid the liquid in the waste liquid pool from staying in the detection flow channel, and thus avoid the liquid after the reaction testing from affecting subsequent reaction testing.

[0023] To make the above objects, features and advantages of the present invention more obvious and understandable, the following specifically describes preferred embodiments in conjunction with the accompanying drawings as follows. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the related art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the related art. Obviously, the following drawings are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained according to these drawings.

[0025] Figure 1 Schematic diagram of the fluid flow direction of the in vitro diagnostic test device provided by the embodiment of the present invention when pressing the elastic pressing cover;

[0026] Figure 2 Schematic diagram of the fluid flow direction of the in vitro diagnostic test device provided by the embodiment of the present invention when the elastic pressing cover rebounds;

[0027] Figure 3 Exploded view of the in vitro diagnostic test device provided by the embodiment of the present invention;

[0028] Figure 4 Top view of the base body of the in vitro diagnostic test device provided by the embodiment of the present invention;

[0029] Figure 5 Bottom view of the base body of the in vitro diagnostic test device provided by the embodiment of the present invention.

[0030] Icons: 001 - Sample pool; 002 - Detection flow channel; 021 - Liquid tank; 003 - Waste liquid pool; 004 - Pump chamber; 005 - Sample dilution pool; 051 - First dilution pool; 052 - Second dilution pool; 006 - Solid reagent encapsulation pool; 061 - First solid reagent pool; 062 - Second solid reagent pool; 007 - Liquid reagent encapsulation pool; 071 - First liquid reagent pool; 072 - Second liquid reagent pool; 073 - Third liquid reagent pool; 074 - Fourth liquid reagent pool; 075 - Fifth liquid reagent pool; 076 - Sixth liquid reagent pool; 077 - Seventh liquid reagent pool; 078 - Eighth liquid reagent pool; 079 - Ninth liquid reagent pool; 100 - Substrate; 101 - Wedge-shaped groove; 102 - First notch; 103 - Second notch; 104 - Vent hole; 200 - Elastic gland; 201 - Elastic plug; 300 - Sealing film; 400 - Detection circuit; 410 - Test section; 500 - Gasket; 501 - Test port. Detailed implementation mode

[0031] The technical solutions of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of them. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative work shall fall within the protection scope of the present invention.

[0032] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present invention. In addition, the terms "first", "second", "third" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. Physical quantities in the formula, unless otherwise separately marked, should be understood as the basic quantities of the basic units of the International System of Units, or derived quantities derived from the basic quantities through mathematical operations such as multiplication, division, differentiation, or integration.

[0033] In the description of the present invention, it should be noted that unless otherwise clearly specified and limited, the terms "installation", "connection", "connection" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

[0034] Example 1

[0035] As Figure 1 and Figure 2 shown, the in-vitro diagnostic test device provided by the embodiment of the present invention has: a sample pool 001, a detection flow channel 002, a waste liquid pool 003, and a pump chamber 004; one end of the detection flow channel 002 is communicated with the bottom of the sample pool 001, and the other end of the detection flow channel 002 is fluidly communicated with the top of the waste liquid pool 003; the pump chamber 004 is fluidly communicated with the top of the waste liquid pool 003.

[0036] Specifically, the in-vitro diagnostic test device can cooperate with a detection instrument for diagnostic testing. At the beginning of the test, the pump chamber 004 is pressurized, and gas flows out from the pump chamber 004 through the top of the waste liquid pool 003, the detection flow channel 002, and the sample pool 001 in sequence; subsequently, the test instrument injects a sample to be tested into the sample pool 001, and the pump chamber 004 is switched to a negative pressure state. The sample to be tested flows from the sample pool 001 through the detection flow channel 002 and completes a reaction test in the detection flow channel 002, and the tested liquid flows into the waste liquid pool 003; after the sequential test is completed, the pump chamber 004 is pressurized to make the gas flow through the top of the waste liquid pool 003, the detection flow channel 002, and the sample pool 001 and finally discharged. The waste liquid can only flow into the waste liquid pool 003 and cannot flow out from the waste liquid pool 003, thereby avoiding the retention of the waste liquid after the reaction in the detection flow channel 002, and preventing the liquid that has undergone the reaction test from affecting the subsequent reaction in the detection flow channel 002, thus improving the accuracy of the diagnostic test.

[0037] In the embodiment of the present invention, the in-vitro diagnostic test device includes: a base body 100 and an elastic pressing cover 200;

[0038] The sample pool 001, the detection flow channel 002, the waste liquid pool 003, and the pump chamber 004 are respectively arranged on the base body 100;

[0039] The elastic pressing cover 200 covers the pump chamber 004.

[0040] Specifically, the elastic pressing cover 200 is made of rubber or silica gel. Pressing the elastic pressing cover 200 can cause the elastic pressing cover 200 to undergo elastic deformation, thereby compressing the volume of the pump chamber 004, and increasing the air pressure in the pump chamber 004; after releasing the elastic pressing cover 200, the elastic pressing cover 200 rebounds, and the volume of the pump chamber 004 increases, thereby reducing the air pressure in the pump chamber 004 to form a negative pressure state. By pressing and releasing the elastic pressing cover 200, the fluid can be driven to flow reciprocally along the sample pool 001, the detection flow channel 002, the waste liquid pool 003, and the pump chamber 004, without adding a liquid pump, thereby avoiding the pollution risk caused by the liquid pump.

[0041] Furthermore, the base body 100 is provided with a wedge-shaped groove 101, and the elastic pressing cover 200 is provided with an elastic plug 201;

[0042] When pressing the elastic gland 200 and inserting the elastic plug 201 into the wedge-shaped groove 101, the volume of the pump chamber 004 is compressed, and the elastic plug 201 has a tendency to move outward from the wedge-shaped groove 101.

[0043] Specifically, the cross-sections of the wedge-shaped groove 101 and the elastic plug 201 are both annular. The width of the wedge-shaped groove 101 decreases from top to bottom. When the elastic plug 201 is inserted into the wedge-shaped groove 101, the inner wall of the wedge-shaped groove 101 presses the elastic plug 201, so that the elastic plug 201 has an upward movement tendency. Under the condition of releasing the elastic gland 200, the elastic gland 200 will automatically move upward, thereby increasing the volume of the pump chamber 004, driving the liquid to flow from the sample pool 001 through the detection flow channel 002 into the waste liquid pool 003. The gas at the top of the waste liquid pool 003 then flows into the pump chamber 004 to maintain the air pressure balance inside and outside the pump chamber 004. When pressing the elastic gland 200, the gas in the pump chamber 004 flows through the top of the waste liquid pool 003, the detection flow channel 002 and the sample pool 001 in sequence and finally discharges from the puncture port at the top of the sample pool 001.

[0044] As Figure 1 、 Figure 2 、 Figure 3 and Figure 4 shown, the base body 100 is provided with a ventilation hole 104, and the ventilation hole 104 is in fluid communication with the wedge-shaped groove 101.

[0045] When pressing the elastic gland 200 to assemble the elastic gland 200 on the base body 100, the gas in the wedge-shaped groove 101 can be discharged outward through the ventilation hole 104. Thus, the air pressure balance inside and outside the wedge-shaped groove 101 can be ensured.

[0046] Furthermore, a sample dilution pool 005, a solid reagent encapsulation pool 006 and a liquid reagent encapsulation pool 007 are provided on the base body 100, and the sample pool 001, the sample dilution pool 005, the solid reagent encapsulation pool 006 and the liquid reagent encapsulation pool 007 are arranged at intervals.

[0047] Specifically, the sample dilution cell 005 includes: a first dilution cell 051 and a second dilution cell 052. The first dilution cell 051 and the second dilution cell 052 are arranged at intervals. When used in conjunction with the instrument, the sample to be tested can be diluted in the first dilution cell 051 or the second dilution cell 052, thus eliminating the need for complex manual operations outside. The solid reagent encapsulation cell 006 includes: a first solid reagent cell 061 and a second solid reagent cell 062, and the first solid reagent cell 061 and the second solid reagent cell 062 can contain solid reagents respectively. The liquid reagent encapsulation cell 007 includes: a first liquid reagent cell 071, a second liquid reagent cell 072, a third liquid reagent cell 073, a fourth liquid reagent cell 074, a fifth liquid reagent cell 075, a sixth liquid reagent cell 076, a seventh liquid reagent cell 077, an eighth liquid reagent cell 078 and a ninth liquid reagent cell 079. Multiple reagent cells can store different types of reagents respectively, so that various reagent reaction tests can be carried out, which helps to improve the detection efficiency.

[0048] Further, a sealing film 300 is attached to the substrate 100, and the sample cell 001, the sample dilution cell 005, the solid reagent encapsulation cell 006 and the liquid reagent encapsulation cell 007 are all enclosed by the sealing film 300.

[0049] Specifically, the sealing film 300 is an aluminum-plastic film (PE / AL composite film). The sealing film 300 is attached to the substrate 100 by heat melting connection. The top openings of the sample cell 001, the sample dilution cell 005, the solid reagent encapsulation cell 006 and the liquid reagent encapsulation cell 007 are all enclosed by the sealing film 300. When the sample cell 001, the sample dilution cell 005, the solid reagent encapsulation cell 006 and the liquid reagent encapsulation cell 007 are needed, the corresponding positions of the sealing film 300 can be punctured by the instrument.

[0050] Further, a first notch 102 and a second notch 103 are provided on the substrate 100, and the first notch 102 and the second notch 103 are respectively communicated with the top of the waste liquid cell 003;

[0051] The sealing film 300 is attached to the first notch 102 and the second notch 103;

[0052] The first notch 102 is in fluid communication with the detection flow channel 002, and the second notch 103 is in fluid communication with the pump chamber 004.

[0053] Specifically, both the first notch 102 and the second notch 103 are located at the top of the waste liquid cell 003. The liquid can flow back to the waste liquid cell 003 through the first notch 102, and the gas flows through the second notch 103 and the first notch 102, thus preventing waste liquid from mixing into the gas.

[0054] Such as Figure 3As shown, the substrate 100 is connected to the detection circuit 400, and the detection flow channel 002 is in fluid communication with the test section 410 of the detection circuit 400.

[0055] Specifically, the detection circuit 400 adopts a printed circuit board. The printed circuit board is provided with assembly positioning holes opposite to the substrate 100. The test section 410 has a detection chip. The sample to be tested in the detection flow channel 002 can contact the detection chip, thereby realizing the detection of the sample to be tested.

[0056] Furthermore, a gasket 500 is provided between the substrate 100 and the detection circuit 400; the gasket 500 is provided with a test port 501. The test port 501 is opposite to the test section 410 and is in communication with the detection flow channel 002. The gasket 500 can be made of elastic rubber or silica gel. The gasket 500 is clamped between the substrate 100 and the detection circuit 400, so as to ensure good sealing of the detection flow channel 002.

[0057] As Figure 3 and Figure 5 shown, a liquid tank 021 is provided in the middle of the detection flow channel 002, and the test port 501 is located between the liquid tank 021 and the test section 410. The samples to be tested in the detection flow channel 002 are collected in the liquid tank 021, so as to ensure that a sufficient amount of samples to be tested contact the test section 410 through the test port 501, and then enable a sufficient amount of samples to be tested to participate in the reaction test.

[0058] As Figure 1 、 Figure 2 and Figure 3 shown, the in vitro diagnostic test device can be used in cooperation with a diagnostic instrument. The suction volume, flow rate, reciprocating oscillation time and number of times of the reagent can be precisely controlled by operating the elastic pressing cover 200 through the pressing mechanism inside the diagnostic instrument.

[0059] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An in vitro diagnostic test device, characterized in that, The in vitro diagnostic test device has: a sample pool (001), a detection flow channel (002), a waste liquid pool (003), and a pump chamber (004); One end of the detection flow channel (002) communicates with the bottom of the sample pool (001), and the other end of the detection flow channel (002) is in fluid communication with the top of the waste liquid pool (003); The pump chamber (004) is in fluid communication with the top of the waste liquid pool (003); The in vitro diagnostic test device includes: a substrate (100) and an elastic gland (200); The sample pool (001), the detection flow channel (002), the waste liquid pool (003), and the pump chamber (004) are respectively arranged on the substrate (100); The elastic gland (200) covers the pump chamber (004); The substrate (100) is provided with a first notch (102) and a second notch (103), and the first notch (102) and the second notch (103) respectively communicate with the top of the waste liquid pool (003); A sealing film (300) is attached to the substrate (100), and the sealing film (300) covers the first notch (102) and the second notch (103); The first notch (102) is in fluid communication with the detection flow channel (002), and the second notch (103) is in fluid communication with the pump chamber (004).

2. The in vitro diagnostic test device according to claim 1, wherein The substrate (100) is provided with a wedge-shaped groove (101), and the elastic gland (200) is provided with an elastic plug (201); When pressing the elastic gland (200) and inserting the elastic plug (201) into the wedge-shaped groove (101), the volume of the pump chamber (004) is compressed, and the elastic plug (201) has a tendency to move outside the wedge-shaped groove (101).

3. The in vitro diagnostic test device according to claim 2, characterized in that, The substrate (100) is provided with a vent hole (104), and the vent hole (104) is in fluid communication with the wedge-shaped groove (101).

4. The in vitro diagnostic test device according to claim 1, characterized in that, The substrate (100) is provided with a sample dilution pool (005), a solid reagent encapsulation pool (006), and a liquid reagent encapsulation pool (007), and the sample pool (001), the sample dilution pool (005), the solid reagent encapsulation pool (006), and the liquid reagent encapsulation pool (007) are arranged at intervals.

5. The in vitro diagnostic test device according to claim 4, characterized in that, The sample pool (001), the sample dilution pool (005), the solid reagent encapsulation pool (006), and the liquid reagent encapsulation pool (007) are all sealed by the sealing film (300).

6. The in vitro diagnostic test device according to claim 1, characterized in that, The substrate (100) is connected to a detection circuit (400), and the detection flow channel (002) is in fluid communication with a test part (410) of the detection circuit (400).

7. The in vitro diagnostic test device according to claim 6, characterized in that, A sealing gasket (500) is provided between the substrate (100) and the detection circuit (400); The sealing gasket (500) is provided with a test port (501), the test port (501) faces the test part (410), and the test port (501) is in communication with the detection flow channel (002).

8. The in vitro diagnostic test device according to claim 7, characterized in that, A liquid tank (021) is provided in the middle of the detection flow channel (002), and the test port (501) is located between the liquid tank (021) and the test section (410).

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