AU2021100840A4

AU2021100840A4 - Gene Amplification Tube and Test Cassette

Info

Publication number: AU2021100840A4
Application number: AU2021100840A
Authority: AU
Inventors: Juan Chen; Wenjie FANG; Hongwei JV; Xiaoping Li; Wanqing LIAO; Weihua Pan; Lei Zhang; Qingjie Zhao
Original assignee: Shanghai Changzheng Hospital
Current assignee: Shanghai Changzheng Hospital
Priority date: 2020-07-07
Filing date: 2021-02-10
Publication date: 2021-04-22
Anticipated expiration: 2029-02-10
Also published as: CN111849731A

Abstract

The present disclosure provides a gene amplification tube and a test cassette. The gene amplification tube includes a tube body and a cap. The tube body is provided with an opening at the top and is sealed at the bottom, the cap seals the opening at the top of the tube body, the tube body includes a side tube wall and a bottom tube wall, the side tube wall includes a cylindrical side tube wall and a conical side tube wall located below the cylindrical side tube wall, the bottom tube wall is provided with a recessed area recessed toward the inside of the tube body, and a thickness of the bottom tube wall in the recessed area is less than a thickness of the side tube wall. By adopting the gene amplification tube in the present disclosure in which the bottom of the gene amplification tube is provided with a recess and the wall thickness at the bottom is set to be smaller, compared with the scotch protruding out of the tube body in the prior art, the gene amplification tube can be effectively prevented from accidental rupture during use. 1/4 Drawing 130 - 100 110 140 150 111 120 121 Fig. 1 130 - 100 160 '-' 110 150 120 Fig. 2

Description

1/4

Drawing

130 - 100

110

140

150 111

120 121

Fig. 1

130

- 100

160 '-' 110

150

120

Fig. 2

Description

Gene Amplification Tube and Test Cassette

TECHNICAL FIELD

The present disclosure relates to the field of testing, in particular to a gene

amplification tube and a test cassette.

BACKGROUND Nucleic acid diagnostics is one of the most dynamic segments in the IVD (in vitro

diagnostics) industry in the future. The increase in the prevention and treatment of

infectious diseases, the promotion of blood screening nucleic acid testing and the

development of individualized medicine in China are the main drivers for the

development of domestic nucleic acid diagnostics. Driven by these factors, the future

growth rate of domestic nucleic acid diagnostics will be 25-30%, significantly

exceeding the average growth rate of domestic IVD industry. On one hand, nucleic

acid diagnostics benefits large medical centers and achieves early, rapid, specific and

high-throughput testing of pathogens, genetic diseases and the like.

POCT (point-of-care testing) is an emerging segment of the in vitro diagnostics (IVD)

industry, and is a new method to analyze specimens immediately at the sampling site,

omitting the complex processing procedures for the specimens in the laboratory

testing and obtaining test results quickly. The main criteria of POCT are: it does not

require a fixed testing site, and the reagents and instruments are portable and can be

operated timely. POCT assumes the functions of a laboratory without the need of

traditional hospital laboratory equipment, and can serve patients 24 hours a day,

regardless of time and location restrictions.

However, these nucleic acid amplification methods are prone to cross-contamination

of amplification products, and false-positive signals generated by product

contamination may lead to incorrect interpretation of test results. Cross-contamination

between samples is often seen during target nucleic acid amplification operations. The

contamination may come from known or unknown positive substances introduced

during the processing of negative samples, which can cause false-positive reactions

through air contamination or aerosols.

A series of methods have been developed in the prior art to prevent

cross-contamination of amplification products. For example, Reference 1

(CN105199940A) discloses an anti-contamination portable gene testing method and

device. The device can realize testing by sealing the PCR tube containing the

amplification product into the device and then piercing the PCR tube. Therefore, the

nucleic acid amplification products are prevented from contamination and

false-positive is avoided.

SUMMARY Compared with the traditional gene amplification tube, in a totally enclosed test

cassette in the prior art, in order to facilitate piercing the bottom of a gene

amplification tube, the gene amplification tube is generally provided with an

additional scotch protruding out of the gene amplification tube at the bottom.

However, before the gene amplification tube is inserted into a test cassette, it may

break along the cut when moving or performing an amplification reaction, such that a

to-be-tested sample solution leaks, causing great harm.

The objective of the present disclosure is to solve the problem that the to-be-tested sample solution tube is easily damaged in the prior art. In order to solve the above problem, the present disclosure discloses a gene amplification tube and a test cassette in a brand-new structure, by which the possibility of leakage of the to-be-tested sample is greatly reduced and the safety of point-of-care testing is ensured.

The present disclosure discloses a gene amplification tube, including a tube body and

a cap. The tube body is provided with an opening at the top and is sealed at the bottom,

the cap seals the opening at the top of the tube body, the tube body includes a side

tube wall and a bottom tube wall, the side tube wall includes a cylindrical side tube

wall and a conical side tube wall located below the cylindrical side tube wall, the

bottom tube wall is provided with a recessed area recessed toward the inside of the

tube body, and a thickness of the bottom tube wall in the recessed area is less than a

thickness of the side tube wall.

By adopting the technical solution in the present disclosure in which the bottom of the

gene amplification tube is provided with a recess and the wall thickness at the bottom

is set to be smaller, compared with the scotch protruding out of the tube body in the

prior art, the gene amplification tube can be effectively prevented from accidental

rupture during use.

According to another specific embodiment of the present disclosure, a thickness of the

conical side tube wall is less than a thickness of the cylindrical side tube wall, and the

thickness of the bottom tube wall in the recessed area is less than the thickness of the

conical side tube wall.

conical side tube wall is less than 0.3 mm.

bottom tube wall in the recessed area is less than 0.3 mm.

bottom tube wall in the recessed area is 0.1-0.2 mm.

According to another specific embodiment of the present disclosure, the present

disclosure further discloses a test cassette, including a case and any aforementioned

gene amplification tube. A containing cavity is arranged in the case, an upper surface

of the case is provided with a tube insertion opening, a test cassette strip and a tube

piercing portion are sequentially arranged from bottom to top in the containing cavity

below the tube insertion opening, and after the gene amplification tube is inserted into

the tube insertion opening, the containing cavity is sealed, the tube piercing portion

pierces the gene amplification tube and a nucleic acid solution flows into the

containing cavity.

According to another specific embodiment of the present disclosure, a nucleic acid

removal portion is further arranged in the containing cavity, and the nucleic acid

removal portion is openable such that a destroying liquid flows into the containing

cavity.

BRIEF DESCRIPTION OF THE DRAWINGS The present disclosure will be described in further detail below in conjunction with

the accompanying drawings and specific embodiments:

Fig. 1 is a sectional view of a gene amplification tube provided by the present disclosure;

Fig. 2 is a schematic structural diagram of the gene amplification tube provided by the

present disclosure;

Fig. 3 is a sectional view of a gene amplification tube and a test cassette in a matched

state provided by the present disclosure;

Fig. 4 is a sectional view of the gene amplification tube and the test cassette in another

matched state provided by the present disclosure;

Fig. 5 is a schematic structural diagram of the gene amplification tube and the test

cassette in a matched state provided by the present disclosure;

Fig. 6 is an exploded schematic diagram of the gene amplification tube and the test

cassette provided by the present disclosure;

Fig. 7 is a schematic structural diagram of a tube piercing portion provided by the

present disclosure; and

Fig. 8 is a schematic structural diagram of the tube piercing portion provided by the

present disclosure.

Reference signs:

Gene amplification tube 100

Side tube wall 110

First convex portion 111

Bottom tube wall 120

Recessed area 121

Cap 130

Nucleic acid solution storage cavity 140

Seal ring 150

Temperature indicating portion 160

Case 200

Containing cavity 210

Nucleic acid removal portion 220

Liquid seal 230

Test cassette strip 240

Tube piercing portion 250

Positioning portion 251

Fourth limiting portion 2511

Third convex portion 2512

Piercing portion 252

Fluid channel 253

Tube insertion opening 260

First groove 261

Third limiting portion 262

Test result observation area 270

Elastic pressing structure 280

DETAILED DESCRIPTION The embodiments of the present disclosure are described below through specific

examples. Those skilled in the art can easily understand the other advantages and

effects of the present disclosure from the content disclosed in the description.

Although the description of the present disclosure will be introduced in conjunction

with preferred examples, this does not mean that the features of the present disclosure

are limited to the embodiments. Rather, the purpose of introducing the present

disclosure in conjunction with the embodiments is to cover other options or

modifications that may be extended based on the claims of the present disclosure. In

order to provide an in-depth understanding of the present disclosure, the following

description will contain many specific details. The present disclosure may also be implemented without using these details. In addition, in order to avoid confusing or obscuring the focus of the present disclosure, some specific details will be omitted from the description. It should be noted that in the case of no conflict, the examples in the present disclosure and the features in the examples may be combined with each other.

In the description of this example, it should be noted that the orientation or positional

relationship indicated by the term "upper", "lower", "inner", "bottom" or the like is

based on the orientation or positional relationship shown in the accompanying

drawings, or the orientation or positional relationship in which the products of the

present disclosure are usually placed in use. It is only for the convenience of

describing the present disclosure and simplifying the description, rather than

indicating or implying that the device or element referred to must have a specific

orientation or be constructed and operated in a specific orientation, and therefore

cannot be understood as a limitation of the present disclosure.

The terms "first", "second", "third" and the like are only used for distinguishing

description, and cannot be understood as indicating or implying relative importance.

In the description of this example, it should also be noted that, unless otherwise

clearly specified and defined, the term "arranged", "connected" or "connection"

should be understood in a broad sense. For example, it may be fixed connection,

detachable connection or integral connection; or may be mechanical connection or

electrical connection; or may be direct connection or indirect connection through an

intermediate medium, or may be internal communication between two elements. For

those of ordinary skill in the art, the specific meaning of the above terms in this

example can be understood in specific cases.

In order to make the objectives, technical solutions and advantages of the present

disclosure clearer, the embodiments of the present disclosure will be described in

further detail below in conjunction with the accompanying drawings.

As shown in Fig. 1 and Fig. 2, the present disclosure discloses a gene amplification

tube 100, including a tube body and a cap 130. The tube body is provided with an

opening at the top and is sealed at the bottom, the cap 130 seals the opening at the top

of the tube body, the tube body includes a side tube wall 110 and a bottom tube wall

120, the side tube wall 110 includes a cylindrical side tube wall and a conical side

tube wall located below the cylindrical side tube wall, the bottom tube wall 120 is

provided with a recessed area 121 recessed toward the inside of the tube body, and a

thickness of the bottom tube wall 120 in the recessed area 121 is less than a thickness

of the side tube wall 110.

gene amplification tube 100 is provided with a recess and the wall thickness at the

bottom is set to be smaller, compared with the scotch protruding out of the tube body

in the prior art, the gene amplification tube 100 can be effectively prevented from

accidental rupture during use.

Moreover, the lower part of the gene amplification tube 100 is set as a conical tube

body, which can effectively increase the heat transfer area of the reaction system in

the gene amplification tube 100 and ensure rapid and uniform proceeding of the

amplification reaction.

According to another specific embodiment of the present disclosure, in order to further reduce the waiting time for heating, a thickness of the conical side tube wall is preferably less than a thickness of the cylindrical side tube wall.

Further, due to the smaller thickness of the conical side tube wall, in order to prevent

the bottom of the gene amplification tube 100 from being deformed toward the inside

of the tube body when being inserted into the test cassette such that a tube piercing

portion 250 cannot smoothly pierce the gene amplification tube 100, the thickness of

the bottom tube wall in the recessed area 121 at the bottom of the gene amplification

tube 100 is less than the thickness of the conical side tube wall.

Further, in order to increase the heating efficiency of the gene amplification tube 100,

the thicknesses of the conical side tube wall and the bottom tube wall in the recessed

area are both less than 0.3 mm. More preferably, the thickness of the bottom tube wall

in the recessed area is 0.1-0.2 mm.

According to another specific embodiment of the present disclosure, the gene

amplification tube 100 in the present disclosure is a specially-made PCR tube, and the

side tube wall 110 of the gene amplification tube 100 may be made of a series of

materials, preferably materials with good thermal conductivity, high strength and

good fluidity, such as metals, alloys, thermally conductive plastics and organic

composite materials, with a height of 1-3 cm, preferably 2 cm, and a general shape

similar to that of an ordinary PCR tube, but with some differences.

According to another specific embodiment of the present disclosure, the gene

amplification tube 100 of the present disclosure is provided with a temperature

indicating portion 160, and the temperature indicating portion 160 may be a reversible

temperature test strip. A suitable reversible temperature test strip can be selected according to the temperature of the nucleic acid amplification reaction. For example, when the temperature of the nucleic acid amplification reaction is 38°C, a

THERMAX reversible temperature test strip of 0-50°C can be selected. If the nucleic

acid amplification reaction requires 63°C, a THERMAX reversible temperature test

strip can be selected of 50-100°C. In addition, a special test strip can be customized to

suppliers according to actual conditions.

According to another specific embodiment of the present disclosure, a surface of the

gene amplification tube 100 is coated with at least two reversible thermochromic

materials. The color change temperature of the thermochromic material may be set

according to actual needs, and the specific reversible thermochromic materials may be

commercially available products. For a particular amplification reaction, if the

reaction temperature needs to be between a first temperature TI and a second

temperature T2, the surface of the gene amplification tube 100 may be coated with

two thermochromic materials, the color change temperature of the first

thermochromic material is the first temperature TI, and the color change temperature

of the second thermochromic material is the second temperature T2. In this way,

during this amplification reaction, when the first thermochromic material changes

color and the second thermochromic material does not change color, it indicates that

the temperature is just suitable for performing the amplification reaction in the gene

amplification tube 100. In this case, the gene amplification tube 100 may be directly

placed into a thermos bottle, and the temperature of water in the thermos bottle may

be controlled by adjusting the amount of cold and hot water, so that the amplification

reaction can be maintained without thermostatic equipment, and samples can be tested

anytime and anywhere.

For example, if the optimal reaction temperature is about 38°C, two temperatures for the thermochromic coatings may be selected, greater than 380 C and less than 38C, preferably 37C and 39 0C. If the optimal reaction temperature is 63 0 C, then the temperatures for the thermochromic coatings may be 62 0 C and 640 C. The thermochromic coating may be coated in any shapes, but preferably an Arabic number corresponding to the temperature, for example, a thermochromic material that changes color at 38 0C would be shown as "38". This can provide a more direct reflection to the temperature of the gene amplification tube 100.

Further, if the gene amplification tube 100 is used in a variety of amplification

reaction systems with different temperatures, a variety of thermochromic materials

can be provided.

According to another specific embodiment of the present disclosure, the general gene

amplification tube 100 is of an openable cap structure, that is, the cap 130 is an

openable cap. After the sample to be amplified and reagents related to the

amplification reaction system are put into the gene amplification tube 100, the cap is

closed to achieve sealing. In addition, the upper part of the gene amplification tube

100 may also be a sealed structure directly, that is, the cap 130 and the side tube wall

110 are fixedly connected, or are even directly integrally formed and cannot be

opened. When in use, a syringe with a thin needle pierces the cap 130 of the gene

amplification tube 100 to inject the reaction system, and then the pierced opening is

sealed with a sealing film or wax drops with a higher melting point, so that the gene

amplification tube 100 can be sealed better.

According to another specific embodiment of the present disclosure, an outer surface

of the side tube wall 110 is provided with one or a plurality of first convex portions

111. If there are a plurality of first convex portions 111, the plurality of first convex portions 111 may be located on the same cross section of the side tube wall 110, at least part of the side tube wall 110 is a cylindrical side tube wall, an outer surface of the cylindrical side tube wall is provided with an external thread (not shown in the figures), and the external thread is located below the first convex portions 111.

Wherein, the structure of the first convex portion 111 is not particularly limited, as

long as the first convex portion 111 can be matched with a first groove 261 to limit the

position of the gene amplification tube 100 relative to a first channel in the axial

direction. The first convex portion 111 may be a convex point, a convex strip

extending along the circumferential direction, or a complete circular convex ring.

From the perspective of more effectively and stably limiting the position of the gene

amplification tube 100 in the axial direction, the first convex portion 111 is preferably

a complete circular convex ring, or a plurality of convex points or convex strips

uniformly distributed along the circumferential direction of the side tube wall 110.

According to another specific embodiment of the present disclosure, as shown in Fig.

1 and Fig. 2, the first convex portion 111 on the side tube wall 110 of the gene

amplification tube 100 is a circular convex ring, the side tube wall 110 of the gene

amplification tube 100 below the first convex portion 111 is a cylindrical side tube

wall, and the cylindrical side tube wall is provided with an external thread matched

with an internal thread of a positioning portion 251 of the tube piercing portion 250.

Further, as shown in Fig. 3 to Fig. 6, the present disclosure further discloses a test

cassette, including a case 200 and any aforementioned gene amplification tube 100. A

containing cavity 210 is arranged in the case 200, an upper surface of the case 200 is

provided with a tube insertion opening 260, a test cassette strip 240 and a tube

piercing portion 250 are sequentially arranged from bottom to top in the containing cavity 210 below the tube insertion opening 260, the tube insertion opening 260 is configured for the insertion of the gene amplification tube 100, and after the gene amplification tube 100 is inserted into the tube insertion opening 260, the containing cavity 210 is sealed, the tube piercing portion 250 pierces the bottom tube wall 120 of the gene amplification tube 100 and a nucleic acid solution flows into the containing cavity 210.

In some poor or backward areas, the gene amplification tube 100 provided by the

present disclosure may be used to complete the nucleic acid amplification reaction,

and then the gene amplification tube 100 may be inserted into the tube insertion

opening 260 to rapidly complete the nucleic acid test. Since the gene amplification

tube 100 and the tube insertion opening 260 are in sealed connection, the sample can

be effectively prevented from volatilizing into the air and polluting the environment.

removal portion 220 is further arranged in the containing cavity 210, and the nucleic

acid removal portion 220 is openable such that a destroying liquid flows into the

containing cavity 210. The nucleic acid destroying reagent is used to remove residual

nucleic acids in the test cassette, thereby further avoiding potential contamination in

subsequent processes.

According to another specific embodiment of the present disclosure, a containing

cavity 210 is arranged in the case 200, and a nucleic acid removal portion 220, a test

cassette strip 240 and a tube piercing portion 250 are sequentially arranged from

bottom to top in the containing cavity 210. An upper surface of the nucleic acid

removal portion 220 is provided with an opening, the opening is sealed by a liquid

seal 230, the liquid seal 230 is openable, and the nucleic acid removal portion 220 may store a nucleic acid destroying reagent therein, for example, a sodium hypochlorite solution, a commercial DNA detergent or the like.

An upper surface of the case 200 is provided with a tube insertion opening 260 and a

test result observation area 270. The tube insertion opening 260 includes a cylindrical

first channel. The first channel includes an insertion end and a non-insertion end. The

insertion end is configured for the insertion of the gene amplification tube 100, and

the shape of the insertion end is matched with that of the gene amplification tube 100

so as to seal the containing cavity 210. The insertion end of the first channel is

provided with an annular first groove 261. When the gene amplification tube 100 is

inserted into the first channel, the first convex portion 111 and the first groove 261 are

matched with each other to limit the movement of the gene amplification tube 100

relative to the first channel in the axial direction.

As shown in Fig. 7 and Fig. 8, the tube piercing portion 250 includes a cylindrical

positioning portion 251 and a piercing portion 252 located on the central axis of the

positioning portion 251. The tube piercing portion 250 is further provided with a fluid

channel 253. The non-insertion end of the first channel is provided with a third

limiting portion 262, and the positioning portion 251 is provided with a fourth

limiting portion 2511. The third limiting portion 262 and the fourth limiting portion

2511 are matched with each other to limit the rotation of the tube piercing portion 250

around the central axis of the positioning portion 251. An inner surface of the

positioning portion 251 is provided with an internal thread (not shown in the figures),

and an outer surface of the gene amplification tube 100 is provided with an external

thread matched with the internal thread.

When the gene amplification tube 100 is inserted into the first channel and the gene amplification tube 100 is rotated, as shown in Fig. 3, since the first convex portion

111 is matched with the annular first groove 261, the gene amplification tube 100 can

only rotate, and cannot be inserted inward relative to the first channel. As the gene

amplification tube 100 rotates, since the external thread on the side tube wall 110 of

the gene amplification tube 100 is matched with the internal thread on the positioning

portion 251, the positioning portion 251 will drive the piercing portion 252 to move

toward the gene amplification tube 100 to the position shown in Fig. 4 (in Fig. 4, the

liquid seal 230 has already been opened, but the liquid seal 230 cannot be opened

before the completion of the test, and here, Fig. 4 is only used to show the relative

positional relationship between the tube piercing portion 250 and the gene

amplification tube 100), and to pierce the gene amplification tube 100, and then the

nucleic acid solution flows into the containing cavity 210 from the fluid channel 253.

The sample can be tested by the test cassette strip 240 in the containing cavity 210,

and the tester can observe the test result through the test result observation area 270.

By using the above technical solution, during the testing, the containing cavity 210 is

always kept sealed, which prevents the amplification product from leaking out.

Furthermore, after the test result is recorded, as shown in Fig. 4, the liquid seal 230

may be opened, such that the test cassette strip 240 may react with the nucleic acid

destroying reagent, thereby completely removing the residual nucleic acids in the test

cassette. In this way, even if the gene amplification tube 100 accidentally falls off in

the subsequent processes, or the test cassette is damaged, causing internal exposure, it

will not cause any contamination.

In addition, in the method in which the gene amplification tube 100 is inserted

downward while the tube piercing portion 250 remains stationary in the prior art,

since gas in the case 200 is compressed, amplification products may leak from the gap between the gene amplification tube 100 and the case 200, causing contamination.

According to the enclosed test cassette in a brand-new structure provided by the

present disclosure, the device allows the gene amplification tube 100 to remain

stationary in the axial direction, and the tube piercing portion 250 is allowed to move

upward through rotation so as to pierce the gene amplification tube 100. During the

piercing, the air pressure in the case 200 does not change, and the aerosol of the

amplification product will not leak to the outside, thereby better avoiding

contamination. Moreover, the gene amplification tube 100 and the case 200 are

connected by threads, so that the connection structure is more stable and the gene

amplification tube may not fall off easily, thereby further preventing the amplification

product from being exposed and causing contamination. Besides, the nucleic acid

destroying reagent is finally used to remove the residual nucleic acids in the test

cassette, thereby further avoiding potential contamination in subsequent processes.

According to another specific embodiment of the present disclosure, the third limiting

portion 262 is a second groove extending along an axial direction, and the fourth

limiting portion 2511 is a second convex portion. The second convex portion may be a

convex point or a convex strip extending along the axial direction. The length of the

second groove should allow the tube piercing portion 250 to move upward to the

position where the gene amplification tube 100 is pierced. Before the gene

amplification tube 100 is inserted into the positioning portion 251 and starts to rotate,

the second convex portion is located at the lowest end of the second groove. As the

gene amplification tube 100 rotates, the entire tube piercing portion 250 moves

upward, and the second convex portion moves upward along the second groove until

the tube piercing portion 250 pierces the bottom tube wall 120 of the gene

amplification tube 100.

Further, from a more reliable perspective, a plurality of second convex portions and

second groove extending in the axial direction and matched with the second convex

portions may also be provided. Preferably, the plurality of second convex portions and

the second groove extending in the axial direction and matched with the second

convex portions are uniformly distributed along the circumferential direction of the

first channel.

It is easily conceivable that the third limiting portion 262 may also be set as the

second convex portion, and the fourth limiting portion 2511 may also be set as the

second groove extending along the axial direction.

3 to Fig. 6, the case 200 is provided with a through hole, and the liquid seal 230 runs

through the case 200 through the through hole. The liquid seal 230 includes an

operating portion located outside the case 200 and a sealing portion located inside the

case 200. The sealing portion seals the upper surface of the nucleic acid removal

portion 220, and the liquid seal 230 has a first position and a second position. When

the test cassette is not used, the liquid seal 230 is located in the first position shown in

Fig. 3. The liquid seal 230 may be moved to the second position shown in Fig. 4

through the operating portion to open the nucleic acid removal portion 220. In the

whole process, the liquid seal 230 and the case 200 are always in sealed connection,

the containing cavity 210 is always in a sealed state, and the amplification product

does not leak.

According to another specific embodiment of the present disclosure, a lower end of

the positioning portion 251 is provided with a third convex portion 2512, and the

liquid seal 230 is provided with a corresponding third groove. Before the tube piercing portion 250 moves upward, the third convex portion 2512 is arranged in the third groove. Due to the matching of the third convex portion 2512 and the third groove, the liquid seal 230 is always in the first position and cannot be moved to the second position. After the gene amplification tube 100 is inserted into the positioning portion 251 and rotates to raise the tube piercing portion 250, the third convex portion

2512 also moves upward and is detached from the third groove. At this time, the tester

may move the liquid seal 230 from the first position to the second position through

the operating portion to open the nucleic acid removal portion 220, such that the test

cassette strip 240 may be in contact with the destroying liquid in the nucleic acid

removal portion 220.

According to another specific embodiment of the present disclosure, an elastic

pressing structure 280 is arranged above the test cassette strip 240. After the liquid

seal 230 is opened, the elastic pressing structure 280 presses at least part of the test

cassette strip 240 into the nucleic acid removal portion 220. The elastic pressing

structure 280 is not particularly limited, and may be a spring or an elastic piece.

Further, for the specific structure for realizing the sealing of the containing cavity 210,

reference can be made to any existing method in the prior art, and details will not be

repeated in the present disclosure. For example, the shape of the tube insertion

opening 260 may be matched with that of the gene amplification tube 100, so that

after the gene amplification tube 100 is inserted into the tube insertion opening 260,

the surfaces of the two can be attached to each other, thereby realizing sealing of the

containing cavity 210. According to another specific embodiment of the present

disclosure, in order to more effectively prevent the amplification product from leaking

into the air, a seal ring 150 made of an elastomer may be arranged at the insertion end

of the first channel, or a seal ring 150 made of an elastomer may be arranged outside the side tube wall 110 of the gene amplification tube 100.

According to another specific embodiment of the present disclosure, the test result

observation area 270 is made of a transparent material.

Although the present disclosure has been illustrated and described by reference to

certain preferred embodiments of the present disclosure, it should be understood by

those of ordinary skill in the art that the above content is a further detailed description

of the present disclosure in conjunction with specific embodiments, and it cannot be

considered that the specific implementation of the present disclosure is limited to

these descriptions. Those skilled in the art can make various changes in form and

details, including some simple deductions or substitutions, without departing from the

spirit and scope of the present disclosure.

Claims

1. A gene amplification tube, comprising a tube body and a cap, wherein the tube

body is provided with an opening at the top and is sealed at the bottom, the cap seals

the opening at the top of the tube body, the tube body comprises a side tube wall and a

bottom tube wall, the side tube wall comprises a cylindrical side tube wall and a

conical side tube wall located below the cylindrical side tube wall, the bottom tube

wall is provided with a recessed area recessed toward the inside of the tube body, and

a thickness of the bottom tube wall in the recessed area is less than a thickness of the

side tube wall.

2. The gene amplification tube according to claim 1, wherein a thickness of the

conical side tube wall.

3. The gene amplification tube according to claim 1, wherein a thickness of the

conical side tube wall is less than 0.3 mm.

4. The gene amplification tube according to claim 1, wherein a thickness of the

bottom tube wall in the recessed area is less than 0.3 mm.

5. The gene amplification tube according to claim 1, wherein a thickness of the

bottom tube wall in the recessed area is 0.1-0.2 mm.

6. A test cassette, comprising a case and the gene amplification tube according to any

one of claims 1-5, wherein a containing cavity is arranged in the case, an upper surface of the case is provided with a tube insertion opening, a test cassette strip and a tube piercing portion are sequentially arranged from bottom to top in the containing cavity below the tube insertion opening, and after the gene amplification tube is inserted into the tube insertion opening, the containing cavity is sealed, the tube piercing portion pierces the gene amplification tube and a nucleic acid solution flows into the containing cavity.

7. The test cassette according to claim 6, wherein a nucleic acid removal portion is

arranged in the containing cavity, and the nucleic acid removal portion is openable

such that a destroying liquid flows into the containing cavity.