Patent Description:
The novel coronavirus belongs to the β-genus of coronavirus, has envelopes, and particles that are round or oval, but are usually polymorphic, and have a diameter of <NUM>-<NUM>, and has features obviously different from SARSr-CoV and MERSr-CoV. Current research shows that the homology between the novel coronavirus and bat-SL-CoVZC45 reaches <NUM>% or above. On the basis of current epidemiological survey, the incubation period is <NUM> day-<NUM> days, which is mostly <NUM> days-<NUM> days. Clinical manifestations are mostly mild symptoms having fever, dry cough and fatigue as main manifestations. However, there are also severe patients who develop dyspnea and/or hypoxemia a week later, and critical severe patients can rapidly progress to acute respiratory distress syndrome, septic shock, metabolic acidosis that is difficult to correct, bleeding and coagulation disorders, and multiple organ failure. Therefore, early detection, early treatment and early isolation can effectively prevent the spread of diseases and reduce the proportion of the severe patients and the critical severe patients.

Nucleic acid extraction has become the most important and the most basic operation in molecular biology experimental technology. However, there are a large number of current extraction solutions of viral nucleic acids, of which complexity is different. Densely populated units at the grass-root level are often the starting point of outbreak of infectious diseases. It is extremely necessary to rapidly diagnose nucleic acids in situ, which is of great significance to prevention and control of the infectious diseases. <CIT> is prior art and discloses an anti-pollution test device comprising a test portion and a mixing reaction chamber.

However, according to test level and treatment conditions in situ or at the grass-root level, it is urgent to develop a coronavirus disease <NUM> nucleic acid rapid test product suitable for communities and personnel in-situ test, so as to alleviate test pressure of medical institutions in areas having severe epidemic situations, and reduce the risk of cross infection of examinees.

In order to solve the problem of the prior art, on one hand, the present disclosure provides an anti-pollution test device for rapid test of nucleic acid amplifications. The anti-pollution test device includes a test portion and a mixing reaction chamber, where
the mixing reaction chamber includes:.

Further, the test kit includes an upper housing and a lower housing, the upper housing being hermetically connected to the lower housing, a test cavity accommodating the test inner core being formed between the upper housing and the lower housing, and the test inner core being arranged in the test cavity; and
the flow guide device being arranged on an upper surface of the upper housing.

Further, the flow guide device further includes a fixed seat and a plug, the flow guide tube being mounted on the fixed seat and penetrating the fixed seat, a scratching flow guide hole being provided on the upper housing, the fixed seat being arranged in the scratching flow guide hole in a sleeving manner and being located outside the test kit, the plug being fixedly or detachably connected to the fixed seat from an inner side of the upper housing, to fixedly connect the flow guide tube to the upper housing, and one end of the flow guide component being mounted on the plug, and making contact with the flow guide tube.

Further, the flow guide component is a water-conducting fiber membrane, and the water-conducting fiber membrane extends from a lower end of the flow guide tube to the test inner core.

Further, the test inner core is a nucleic acid colloidal gold test strip.

Further, the flow guide device is further provided with a fully-closed or semi-closed annular mounting portion extending upwards from an outer surface of the upper housing, the annular mounting portion matches the mixing reaction chamber in overall dimensions, and the mixing reaction chamber is mounted in the annular mounting portion in a clamped manner.

Further, the scratching flow guide hole is provided on the upper housing, and is located on one side of the annular mounting portion close to the transparent observation window, a reaction portion fixing hole is provided on the upper housing and located on the other side of the annular mounting portion away from the transparent observation window, the mixing reaction portion extends outwards from a lower surface of the reaction chamber body, to form a reaction area protrusion in a protruding manner, and the reaction area protrusion matches the reaction portion fixing hole in size.

Further, the reaction area protrusion is a combination of a cylinder and a cone, and a cavity accommodating a liquid inside the reaction area protrusion is also a combination of a cylinder and a cone.

Further, the flow guide port is provided above the corresponding mixing reaction portion.

Further, the hybridization solution accommodating portion includes a detachable hybridization solution container, a partition is arranged inside the reaction chamber body, to partition the reaction chamber body into two chambers, one side is the mixing reaction portion accommodating the sample, and the other side is a hybridization solution container placement portion placing the hybridization solution container.

Further, the hybridization solution container is sealed in a pre-packaged manner, and an opening of the hybridization solution container is sealed with a removable sealing membrane.

The present disclosure further provides an anti-pollution test method for rapid test of nucleic acid amplifications. The anti-pollution test method uses the anti-pollution test device for rapid test of nucleic acid amplifications of any one of the above, and includes:.

Further, the anti-pollution test method further includes d) after test, discarding the whole anti-pollution test device for rapid test of nucleic acid amplifications in a safety place without disassembly.

The present disclosure further provides a use of the anti-pollution test device for rapid test of nucleic acid amplifications of any one of the above or an anti-pollution test method for rapid test of nucleic acid amplifications of any one of the above in food industry, agriculture, animal husbandry, customs quarantine, test of genetic mutations and identification of deoxyribonucleic acid (DNA) single nucleotide polymorphisms.

The present disclosure has the following beneficial effects:.

In order to describe the technical solutions in examples of the present disclosure more clearly, the accompanying drawings required for describing the examples are briefly introduced below. Obviously, the accompanying drawings in the following description are merely some examples of the present disclosure, and those of ordinary skill in the art would also be able to derive other accompanying drawings from these accompanying drawings without making creative efforts.

Examples in the figures are represented as: mixing reaction chamber <NUM>; reaction chamber body <NUM>; reaction chamber cover <NUM>; mixing reaction portion <NUM>; hybridization solution container <NUM>; reaction area protrusion <NUM>; hybridization solution container placement portion <NUM>; flow guide port <NUM>; sealing cap <NUM>; upper housing <NUM>; lower housing <NUM>; sealing ring <NUM>; test inner core <NUM>; fixing clip <NUM>; flow guide component <NUM>; transparent observation window <NUM>; observation window sealing card <NUM>; flow guide tube <NUM>; sample <NUM>; metal bath device <NUM>; hybridization solution <NUM>; and protruding edge <NUM>.

In order to make the objectives, technical solutions and advantages of the present disclosure more clear, the technical solutions in examples of the present disclosure will be clearly and completely described below in conjunction with the accompanying drawings in the examples of the present disclosure, and obviously, the described examples are some examples rather than all examples of the present disclosure. All other examples obtained by those of ordinary skill in the art on the basis of the examples of the present disclosure without making creative efforts shall fall within the scope of protection of the present disclosure.

As shown in <FIG>, an anti-pollution test device for rapid test of nucleic acid amplifications. The anti-pollution test device includes a test portion and a mixing reaction chamber <NUM>, where
the mixing reaction chamber includes:.

As shown in <FIG>, in practical application, in order to facilitate production and assembly, the test kit includes an upper housing <NUM> and a lower housing <NUM>, the upper housing <NUM> being hermetically connected to the lower housing <NUM>. In an example of <FIG>, a sealing ring <NUM> is arranged between the upper housing and the lower housing to achieve the effect of sealed connection. A test cavity accommodating the test inner core <NUM> is formed between the upper housing and the lower housing, and the test inner core <NUM> is arranged in the test cavity. In the example of <FIG>, a plurality of supporting pieces protruding upwards and having an equal height are arranged on an inner bottom surface of the lower housing <NUM>, the test inner core <NUM> is horizontally placed on the supporting pieces, and the test inner core <NUM> is fixed inside the lower housing <NUM> by means of a fixing clip <NUM>. In the example in <FIG>, the guide flow component <NUM> is L-shaped, a horizontal section of the guide flow component makes contact with a right end of the test inner core, a vertical section of the guide flow component makes contact with the flow guide tube <NUM>, and the flow guide tube <NUM> is vertically arranged, such that the mixed solution of the hybridization solution and the sample is guided to the flow guide component <NUM> by gravity, and then is infiltrated and transmitted to the test inner core <NUM>, and finally a test result is displayed on the test inner core <NUM> (which is usually displayed in a color band).

The flow guide device is arranged on an upper surface of the upper housing <NUM>.

As shown in <FIG> and <FIG>, the flow guide device further includes a fixed seat <NUM> and a plug <NUM>, the flow guide tube <NUM> being mounted on the fixed seat <NUM> and penetrating the fixed seat <NUM>, a scratching flow guide hole <NUM> being provided on the upper housing <NUM>, the fixed seat <NUM> being arranged in the scratching flow guide hole <NUM> in a sleeving manner and being located outside the test kit, the plug <NUM> being fixedly or detachably connected to the fixed seat <NUM> from an inner side of the upper housing <NUM>, to fixedly connect the flow guide tube <NUM> to the upper housing <NUM>, and one end of the flow guide component <NUM> being mounted on the plug, and making contact with the flow guide tube <NUM>.

In some examples, the flow guide component <NUM> is a water-conducting fiber membrane, and the water-conducting fiber membrane extends from a lower end of the flow guide tube to the test inner core. The flow guide component may also be made of other materials having excellent water conductivity to satisfy the requirement of guiding the mixed solution of the hybridization solution and the sample into the test inner core <NUM> to achieve the test purpose.

The test inner core <NUM> may be selected from a nucleic acid colloidal gold test strip.

In some examples, the flow guide device is further provided with a fully-closed or semi-closed annular mounting portion <NUM> extending upwards from an outer surface of the upper housing <NUM>, the annular mounting portion <NUM> matches the mixing reaction chamber <NUM> in overall dimensions, and the mixing reaction chamber <NUM> is mounted in the annular mounting portion <NUM> in a clamped manner. The annular mounting portion <NUM> is arranged, such that the mixing reaction chamber <NUM> may be stably connected to the low guide device during flow guide test, so as to avoid external pollution caused by falling. Moreover, when a product is not in use, the mixing reaction chamber is connected to the flow guide device, so as to facilitate packaging, transportation and management, and avoid the trouble and cost increase in packaging, transportation and management caused by separation of the mixing reaction chamber and the flow guide device.

In examples of <FIG>, <FIG> and <FIG>, the scratching flow guide hole <NUM> is provided on the upper housing <NUM>, and is located on one side of the annular mounting portion <NUM> close to the transparent observation window <NUM>, a reaction portion fixing hole <NUM> is provided on the upper housing <NUM> and located on the other side of the annular mounting portion <NUM> away from the transparent observation window <NUM>, the mixing reaction portion <NUM> extends outwards from a lower surface of the reaction chamber body <NUM>, to form a reaction area protrusion <NUM> in a protruding manner, and the reaction area protrusion <NUM> matches the reaction portion fixing hole <NUM> in size. Thus, during packaging and transportation in which the product is not in use, the mixing reaction chamber <NUM> is placed forwards to be clamped on the annular mounting portion <NUM>, and the reaction area protrusion is just inserted into the reaction portion fixing hole <NUM>. The purpose of providing the reaction portion fixing hole <NUM> is that after the sample is added, the sample may be immersed into a metal bath device separately for isothermal amplification, and the hybridization solution and the hybridization solution accommodating portion at which the hybridization solution is located may be maintained by an appropriate distance from the metal bath device, which not only satisfies test requirements, but also facilitates mixing reaction operation after completion of isothermal amplification.

In the examples of the figures, the reaction area protrusion <NUM> is a combination of a cylinder and a cone, and a cavity accommodating a liquid inside the reaction area protrusion is also a combination of a cylinder and a cone.

In a particular embodiment, the flow guide port <NUM> is provided above the corresponding mixing reaction portion <NUM>.

In a preferred solution, the hybridization solution accommodating portion includes a detachable hybridization solution container <NUM>, a partition is arranged inside the reaction chamber body, to partition the reaction chamber body into two chambers, one side is the mixing reaction portion <NUM> accommodating the sample, and the other side is a hybridization solution container placement portion <NUM> placing the hybridization solution container <NUM>.

Thus, the hybridization solution container <NUM> may be manufactured into a form of pre-packaging sealing, and an opening of the hybridization solution container is sealed with the removable sealing membrane <NUM>, which is as shown in <FIG>. Thus, it may be ensured that the container containing the hybridization solution maintains necessary cleanliness before test, thereby ensuring accuracy of test.

As shown in <FIG>, the present disclosure further provides an anti-pollution test method for rapid test of nucleic acid amplifications. The anti-pollution test method uses the anti-pollution test device for rapid test of nucleic acid amplifications of any one of the above, and includes:.

Common pathogens include bacteria, fungi, viruses, mycoplasmas, chlamydia, parasites, etc..

The closed test device for nucleic acid amplifications may not only identify the pathogens, but also identify subtypes, virulent strains, mutant strains and drug resistance of the pathogens.

Claim 1:
An anti-pollution test device for rapid test of nucleic acid amplifications, comprising a test portion and a mixing reaction chamber, wherein
the mixing reaction chamber comprises:
a reaction chamber body, a hybridization solution accommodating portion and a mixing reaction portion being arranged in the reaction chamber body, and the hybridization solution accommodating portion and the mixing reaction portion being provided with chambers for accommodating a hybridization solution and a sample to be tested respectively; and
a reaction chamber cover, the reaction chamber cover being hermetically connected to and detachable from the reaction chamber body, a channel in communication with the hybridization solution accommodating portion and the mixing reaction portion being arranged between the reaction chamber cover and the reaction chamber body, the hybridization solution and the sample are subjected to a mixing reaction by means of the channel when the mixing reaction chamber containing the hybridization solution and the sample in an isolated manner is inversely placed, a flow guide port penetrating the reaction chamber cover being further provided on the reaction chamber cover, and a puncturable sealing cap being arranged on the flow guide port; and
the test portion comprises a test inner core and a test kit accommodating the test inner core, a transparent observation window being arranged on a position corresponding to a reaction area of the test inner core on the test kit, a flow guide device matching the mixing reaction chamber being further arranged on the test kit, and the flow guide device comprising:
a flow guide tube for puncturing the sealing cap and guiding a mixed solution of the hybridization solution and the sample after the mixing reaction onto a flow guide component; and
the flow guide component, one end of the flow guide component being connected to the flow guide tube, one end of the flow guide component being connected to the test inner core, to guide the mixed solution of the hybridization solution and the sample to the test inner core, and the test inner core displaying a final test result in an area corresponding to the transparent observation window.