CN117129670A

CN117129670A - Detection card, detection system, detection method and application

Info

Publication number: CN117129670A
Application number: CN202311269220.XA
Authority: CN
Inventors: 李富友; 徐�明; 刘嘉
Original assignee: Shanghai Taihui Biotechnology Co ltd
Current assignee: Shanghai Taihui Biotechnology Co ltd
Priority date: 2023-09-27
Filing date: 2023-09-27
Publication date: 2023-11-28

Abstract

The application belongs to the technical field of detection, and discloses a detection card, a detection system, a detection method and application thereof. The detection card comprises a liquid inlet, a liquid incubation groove and a liquid outlet. When the detection card is in the first position, the detection card is configured to be suitable for incubating the liquid phase sample to be detected, and when the detection card is turned from the first position to the second position, the liquid phase sample to be detected flows out from the liquid outlet and finally reaches the test area. The detection card can also comprise an incubation unit, and the liquid incubation groove and the incubation unit are arranged on the detection card, so that the temperature is not required to be controlled by transferring to other incubation equipment, the sample size is not reduced due to multiple transfers, and the detection can be performed when the sample size to be detected is smaller. In addition, the temperature control incubation process can be synchronously realized on the detection card, so that the detection can be realized only by simple sample adding operation and setting operation, and the operation safety and protection of operators are well ensured.

Description

Detection card, detection system, detection method and application

Technical Field

The application belongs to the technical field of detection, and particularly relates to a detection card, a detection system, a detection method and application thereof for detecting a liquid sample.

Background

Rapid detection of binding or reaction based on biological and chemical actions is a very important technology, and has been widely used in important fields such as in vitro diagnosis, chemical sensing and probes, biomedical analysis, food safety, environmental monitoring, etc. The liquid sample occupies most of the proportion in the rapid detection field, such as water solution, fluid, beverage, biological or chemical agent, blood, body fluid, saliva, urine and other objects to be detected are all common liquid samples.

In the rapid detection, the detection card and the detection equipment are generally matched for use, and the detection card is independent of the equipment and can be used as a consumable material to facilitate cleaning or replacement. At present, the detection equipment and the detection card of the liquid sample are various in forms, different test items are difficult to carry out on the same detection platform, the detection equipment and the detection card have no universality, and the conditions of the different detection platforms on the compatibility of systems or data are complex.

For the testing of these liquid samples, temperature is an important influencing factor due to the related effects of biological molecular recognition, immunological binding or chemical reactions, and a defined incubation process with controlled temperature is often required. However, the incubation of the liquid at the controlled temperature often cannot be performed synchronously on the detection card, such as the most common immunochromatographic test strip detection card, because chromatographic diffusion is started soon after the liquid sample is added into the liquid inlet of the test strip, and the pre-incubation process and operation at the controlled temperature need to be performed in another device. Thus, repeated liquid transfer is required during the operation, which is liable to cause contamination of the sample itself and the site of detection, and even increases the risk of operator exposure and infection.

In addition, the factors are also easy to cause the problems of complex testing operation, inaccurate testing data and the like. Therefore, there is an urgent need to develop a liquid phase detection card and a detection system with high system compatibility.

Disclosure of Invention

The application aims to provide a liquid phase detection card and a detection system for detecting a sample to be detected. The temperature control incubation process of the liquid in the liquid phase detection card can be synchronously carried out on the detection card without repeated transfer of the sample to be detected, so that the possibility of sample and site pollution is reduced; in addition, the detection system provided by the application has good compatibility, and can cover detection of most samples to be detected, including common immunochromatography detection, biochemical reagent detection, chemical probes, sensing detection and the like. Meanwhile, the detection system can be compatible with two or more different project types at the same time, and can be used for carrying out free collocation type composite project design according to actual requirements, so that quick and convenient detection of multiple project combination packages is realized.

In a first aspect of the application, there is provided a test card comprising a liquid inlet for adding a liquid phase sample to be tested, a liquid incubation tank for incubating the liquid phase sample to be tested, and a liquid outlet configured to allow the liquid phase sample to be tested to flow out of the liquid incubation tank. The liquid inlet, the liquid incubation groove and the liquid outlet are sequentially communicated, when the detection card is positioned at a first position, the detection card is configured to be suitable for incubating the liquid phase sample to be detected, and when the detection card is turned from the first position to a second position, the liquid phase sample to be detected flows out from the liquid outlet.

In one embodiment, the sample to be tested is pre-stored in the liquid incubation groove after being added from the liquid inlet, and is pre-incubated for a period of time by the incubation unit at a specific temperature, then the liquid in the liquid incubation groove flows out from the liquid outlet after the liquid phase detection card is turned over, and finally reaches the test area.

In a specific embodiment, the detection card further comprises an incubation unit configured for controlling the temperature of the liquid incubation well. In the technical scheme, the liquid incubation groove and the incubation unit are arranged on the detection card, and the temperature can be controlled according to the requirements of immune reaction or chemical reaction in the incubation process of the sample to be detected, so that the sample can be prevented from being reduced due to multiple times of transfer and can be detected when the sample to be detected is smaller. In addition, because the temperature control incubation process can be synchronously realized on the detection card, the detection can be realized only after simple sample adding operation and setting operation are carried out, detection personnel do not need to be reversely exposed in the infection risk among equipment, and especially under the condition that a sample to be detected has infectivity, the operation safety and the protection of the operation personnel are better ensured to a certain extent.

In some preferred embodiments, in general, the detection card further includes a limit stop, the limit stop is connected with the liquid incubation groove and the liquid outlet, the portion of the limit stop connected with the incubation groove also forms a groove wall of the incubation groove, the portion of the groove wall and the portion of the groove wall of the liquid incubation groove connected with the liquid inlet are compared, preferably, the portion of the groove wall of the limit stop connected with the incubation groove is of an arc design, more preferably, the connection parts of the incubation groove, the limit stop and the liquid outlet are of an arc design, and the highest point of the limit stop is higher than the bottom of the incubation groove and the liquid outlet, and the arc design is more convenient for all the liquid to be detected to flow out. The part of the inclined plane of the groove wall connected with the liquid inlet and the groove bottom is provided with a corner or is arranged into an arc design. For convenience of subsequent description, the part of the groove wall connected with the liquid inlet is also called a first groove wall, the part of the groove wall connected with the liquid outlet is called a second groove wall, and of course, in order to prevent liquid in the horizontal placement groove from flowing out, the height of the limit stop is higher than the bottom of the incubation groove, preferably, the height of the limit stop is consistent with the height of the part connected with the liquid inlet in design, namely, the height between the first groove wall and the second groove wall and the groove bottom is equal. When in actual use, the arc-shaped design of the liquid phase detection card after being overturned can ensure that the sample to be detected in the liquid incubation groove completely flows into the liquid outlet. Compared with the design of the inclined plane of the side, close to the liquid inlet, of the incubation groove, namely the design of the first groove wall, the ingenious design of the limit stop enables the second groove wall to have no dead angle, so that the accumulation of a sample to be tested during overturning is avoided, in addition, through smooth treatment, the surface roughness of the groove wall of the incubation groove is strictly controlled, the surface of the incubation groove is smooth, and liquid or liquid beads are not easy to adhere to the incubation groove wall. Therefore, the reasonable design of the circular arc limit stop enables the sample to be tested to have no dead angle in the incubation groove along with the overturning of the detection card, the wall of the sample to be tested cannot be caused, the rapid detection of the sample to be tested cannot be affected, and the detection efficiency is improved. In addition, preferably, the limit stop has a protrusion with respect to the inclined surface of the liquid outlet, so that the limit stop can separate the liquid in the incubation groove from the liquid in the liquid outlet, so as to avoid cross contamination caused by contact between the liquid in the incubation groove and the liquid in the liquid outlet in the incubation process after the sample to be detected is dripped.

In the detection of liquid phase samples, the incubation process is an important pretreatment step, and the process has strict requirements on light shielding and incubation temperature. As used herein, the term "incubation well" is used primarily for a container in which an antibody is specifically bound, e.g., the antibody may be diluted and incubated at a temperature and for a time in order to allow the antibody to bind sufficiently to the target protein antigen.

In some preferred embodiments, the liquid incubation slot is configured to be positioned within a chamber formed by the mating snap-fit of the upper and lower cartridge shells, proximate to one end of the liquid inlet.

In some preferred embodiments, the test card further comprises a test area configured to be positioned within a cavity formed by the mating snap-fit of the upper and lower card shells, proximate to one end of the liquid outlet. The sample to be detected enters the detection area after coming out of the liquid outlet, the sample moves downstream under the action of chromatographic force, certain substances in the sample move downwards along with the labeled substances, react with the substances fixed on the detection area, and the detection result is displayed on the detection area.

In some preferred embodiments, the portion of the upper cartridge housing located in the detection zone is transparent for signal acquisition. More preferably, the parts of the upper clamping shell and the lower clamping shell, which are positioned in the detection area, are transparent structures, so that signal acquisition is convenient and observation is convenient.

It should be noted that the term "transparent structure" includes two-layer meaning, i.e. light transmission and perspective, and the transparent structure does not absorb light or electromagnetic waves, nor scatter or multiple reflections of light or electromagnetic waves. Because the collected photon signals or the photographed image can directly influence the detection result after data processing, the transparent structure is arranged to try to restore the own optical signals, improve the detection accuracy and reduce the error of environmental factors or instrument factors on the detection result.

In some preferred embodiments, the upper and lower cartridge shells are made of glass, so that corrosion of the chemical reaction solvent or the sample to be tested can be prevented. For example, the upper and lower shells may be made of metal glass, so that on one hand, crystal defects such as crystal boundaries and phase boundaries which are easy to corrode in the crystalline material do not exist in the metal glass, and meanwhile, the components are uniform, so that a large amount of elements which are easy to form a stable passivation film can be contained, and on the other hand, the metal glass is high in hardness, strong in bonding force of the passivation film and not easy to peel off and separate. For example, the upper and lower shells may be made of ordinary glass, and because the main component is silica, and some Al, na, ca, K salts are also present, the valence states of the compounds formed by these elements are all saturated and do not react with most of the compounds, si and O in the glass form silicon oxygen tetrahedra, and these si—o tetrahedra structures have the characteristics of short-range order and long-range disorder, and can be regarded as forming an amorphous network structure. The stable si—o tetrahedral structure contributes to the stability of the glass and thus can prevent corrosion of the chemical reaction solvent. Of course, the description is given here only schematically, and other composite glasses and the like that meet the requirements are also possible.

In addition to the liquid phase detection card, in a second aspect of the present application, there is also provided a detection system including not only the detection card described in the first aspect of the present application, but also a detection module, a signal processing module, a control module, a light source, and a light-shielding housing. The detection module and the light source are both arranged in the light-shielding shell, the signal processing module is electrically connected with the detection module, the detection module is used for acquiring photon signals of the detection card testing area or photographing and imaging the detection card testing area, the light source is used for exposing the color-developing substance or exciting the luminescent substance, the control module is used for controlling the detection module and the light source to be opened and closed, and the signal processing module is used for processing photoelectric signals transmitted by the detection module to obtain information of a target object to be detected.

In a third aspect of the application, the application also provides a detection method using the detection system according to the second aspect, and the method comprising the steps of: s1, preparing a sample to be detected and a reaction solvent or a chemical reagent related to the sample to be detected; s2, dripping the prepared sample or solvent to be tested from a liquid inlet according to the detection requirement, and incubating in a liquid incubation tank at the temperature control of an incubation unit according to the temperature required by detection; s3, inserting a detection card carrying the incubated sample to be detected into a detection system, and after the detection card turns over in the detection system, carrying out a detection area of the detection card on the sample to be detected; s4, starting a light source and a detection module through a control module of the detection system, and detecting or photographing signals of a detection area; s5, comparing and analyzing the result processed by the signal processing module to obtain information of the sample to be detected.

In a fourth aspect of the application, the application provides a test card according to the first aspect and an application in a test system according to the second aspect, the application comprising at least one of the following: immunochromatography detection, biochemical reagent detection, chemical probe and sensing detection, and multi-item combination detection.

In the above technical scheme, after the sample to be detected in the liquid phase detection card is incubated in the liquid incubation groove at a controlled temperature, when the liquid phase detection card is overturned along with the inserted detection system, the liquid in the liquid incubation groove flows out through the liquid outlet and finally reaches the detection area, the control module starts the light source, then the chromogenic substance in the detection area is exposed or the luminescent substance is excited, the photon signal in the detection area of the detection card is captured by the detection module or the luminescent scene in the detection area is photographed and recorded by the detection module, and then the content of the sample to be detected is obtained through the conversion treatment of the signal processing module.

The term "luminescent material" as used herein refers to a material that has a distinct color under irradiation of a light source, such as colloidal gold nanoparticles, colored nanoparticles, or the like, and the term "luminescent material" refers to a material that is excited under irradiation of a light source to generate a luminescent signal, such as a fluorescent probe or a long afterglow probe. The term "photon signal" refers herein to an optical signal emitted by the test area, and thus the intensity of light may be captured by the detection module. The term "signal processing module is electrically connected to the detection module" as used herein is understood to mean that the two modules are electrically connected, so that the photon signal of the test area of the detection card or the imaging signal or the image of the test area of the detection card obtained by the detection module can be transmitted to the signal processing module, so that the signal processing module converts or processes the signal, for example, converts the optical signal into an electrical signal to obtain the content of the object to be detected.

In order to ensure that the detection system can meet the requirements of different samples to be detected, preferably, the angle range of the detection card overturned along with the detection system is 30-120 degrees, the overturned direction is anticlockwise overturned along the horizontal extending direction from the liquid inlet to the liquid outlet, and preferably 90 degrees is vertically overturned, so that the samples to be detected can be ensured to flow out of the incubation groove to a detection area for detection. In general, the volume of the sample to be tested in the incubation groove occupies at most 2/3 of the volume of the incubation groove, so that the observation can be facilitated, the range of the turnover angle is set to be 30-120 DEG, so that the sample to be tested can flow out of the liquid incubation groove and reach the detection area through the liquid outlet for detection, when the sample to be tested in the liquid incubation groove is vertically turned at 90 DEG, almost all the sample to be tested can flow out of the detection area, which is beneficial to preventing the wall of the sample to be tested from being hung but not all the sample to be tested when the sample to be tested is less, and meanwhile, for an instrument, the smaller the sample to be tested is usually prone to be tested, the error of the measurement result is larger, so that the vertical turning at 90 DEG is preferable, so that the detection system can be detected when the sample to be tested is very small, and the detection accuracy is within a controllable range.

The term "flip" referred to in the present application is a rotation about an axis, and includes a front-to-back flip along the X-axis direction and a left-to-right flip along the Y-axis direction, and the rotation locus is three-dimensional.

In some preferred embodiments, the detection system further includes a detection card base, where the detection card base is mainly used for fixing and positioning the detection card, so as to avoid that the detection card is offset during the overturning or detection process, so that the detection module cannot detect the photon signal or take a photo, and therefore, the content of the sample to be detected cannot be obtained, and repeated measurement is required.

In some preferred embodiments, the test card base is provided with a through hole corresponding to the test area of the test card, and the through hole is used for transmitting light. As described above, the detection system requires a light source to irradiate the region to be detected, so that the color-developing substance of the region to be detected is exposed or the light-emitting substance is excited.

In some preferred embodiments, the bottom of the test card base is also configured with a temperature adjustment assembly. It can be appreciated that the temperature adjusting component is connected with the control module, so that a target temperature value can be input into the control module in advance, and when the difference between the real-time temperature value of the incubation groove and the preset target temperature value is larger than a preset temperature threshold value, the temperature adjusting module can be controlled to increase the temperature or decrease the temperature to meet the requirement of constant temperature of the incubation groove. It will also be appreciated that the temperature adjustment assembly may be manually set by a detector, for example, when a constant temperature is desired to be controlled, the temperature may be set directly at the target temperature, or the constant temperature time of different temperatures may be controlled by a stepped setting. The temperature regulation module is important because the antibody may deteriorate or deactivate when the temperature is too high or too low in the detection of a sample to be detected, such as a biological sample, and the success rate of the detection is reduced.

In some preferred embodiments, a focusing module and/or a filter is provided in the optical path between the detection module of the detection system and the detection area of the detection card. In the whole detection, the detection system needs to collect the real optical signal of the detection area, or restore the optical signal of the detection area, when a focusing module exists on the optical path between the detection module of the detection system and the detection area of the detection card, for example, when the focusing module is a convex lens, the focusing module can be matched and adjusted to adapt to the focal length, so that the focusing is clearer, and the pixels of the image obtained by photographing are higher. In addition, when the filter exists on the light path between the detection module of the detection system and the detection area of the detection card, the filter selectively allows a certain spectral wavelength to pass through or prevents a certain spectral wavelength from passing through in the spectral range, or reduces the transmittance of a specified spectral wavelength range, so that the luminous flux is reduced, and the filter can be used for filtering redundant clutter in actual use, so that the interference of background signals or clutter on detection results is reduced. Therefore, the focusing module and/or the filter is/are arranged on the optical path between the detection module of the detection system and the detection area of the detection card, so that the detection is more beneficial.

In some preferred embodiments, the signal processing module of the detection system is configured with an embedded processor or an external smart terminal disposed inside a light-resistant housing. More preferably, the embedded processor may be an embedded chip, such as a single-chip microcomputer, a DSP (digital signal processing, digital signal processor), an FPGA (filtered-programmable gate array, programmable gate array), etc., and the smart terminal may be a smart phone, a notebook, a PDA (Personal Digital Assistant) smart terminal, a tablet computer, a VR/AR (Virtual Reality/Augmented Reality) device, a smart wearable device, etc. The connection between the intelligent terminal and the detection module of the detection system can be a wired or wireless connection or both.

In a third aspect of the application, application of a liquid phase detection card and a corresponding detection system is provided, including immunochromatography detection, biochemical reagent detection, chemical probe and sensing detection, and multi-item combination detection.

Firstly, immunochromatography detection refers to an in-vitro detection project based on an immunochromatography principle, wherein the detection card is an immunochromatography test strip which is matched with a detection system and uses the immunochromatography detection function. In one example, the immunochromatographic test strip detection card consists of an upper card shell, a liquid incubation groove, a card core and a lower card shell; the clamping core consists of a bottom plate, a sample loading pad, an NC film and a water absorbing pad; the sample loading pad, the NC film and the water absorbing pad are sequentially overlapped on the bottom plate; the liquid inlet is positioned on the card shell on the test strip; the liquid incubation groove is arranged in a cavity formed by the matching and buckling of the upper clamping shell and the lower clamping shell and is positioned at one end close to the liquid inlet; adding a liquid sample containing a target object to be detected from the position of a liquid inlet, and adding a biomarker I coupled with the probe nano microsphere; the liquid added from the liquid inlet flows into the liquid incubation groove for storage; a detection line (T line) and a quality control line (C line) are marked on the NC film, a biomarker II capable of being specifically combined with a target object to be detected is marked on the detection line, and an active detection object is marked on the quality control line; the biomarker I can be specifically combined with a target object to be detected; the activity detector is used for indicating the effectiveness of the biomarker coupled with the probe nano-microsphere; the biomarker I and the biomarker II are respectively combined with the target object to be detected through the action of immune reaction; the positions of the T line and the C line are in the test area; the upper clamping shell is provided with openings at the liquid inlet and the testing area, and is respectively used for liquid sample loading and signal acquisition.

The probe substance used in immunochromatography is a color-developing substance or a luminescent substance. The color-developing substance is a substance which has obvious color under the irradiation of a light source, such as colloidal gold nano particles, colored nano microspheres and the like; the luminescent substance is a substance which is excited under the irradiation of a light source to generate a luminescent signal, such as a fluorescent probe or a long afterglow probe.

Secondly, biochemical reagent detection refers to an in-vitro detection project based on a biochemical principle, wherein the detection card is a biochemical reagent strip and is matched with a detection system to use the biochemical reagent detection function. In one example, the biochemical reagent strip detection card consists of an upper card shell, a liquid incubation groove, a detection window and a lower card shell; the liquid inlet is positioned on the card shell on the test strip; the liquid incubation groove is arranged in a cavity formed by the matching and buckling of the upper clamping shell and the lower clamping shell and is positioned at one end close to the liquid inlet; the detection window is arranged in a cavity formed by the upper clamping shell and the lower clamping shell in a matched and buckled manner and is positioned at one end far away from the liquid inlet; adding a liquid sample containing a target object to be detected from the position of the liquid inlet, and adding a chromogenic substrate solution; the liquid added from the liquid inlet flows into the liquid incubation groove for storage; the chromogenic substrate solution can generate color or luminous signal change in the solution under the action of the target object to be detected; detecting that the position of the window is in the test area; the upper clamping shell is provided with an opening at the liquid inlet for adding a liquid sample; the upper clamping shell is transparent in the test area and is used for signal acquisition.

The chromogenic substrate applied to the biochemical reagent detection is a substance which does not develop color or does not emit light. The non-chromogenic substance is a substance which does not have obvious color under the irradiation of a light source; the non-luminescent material is a material which is not excited under the irradiation of a light source to generate a luminescent signal. Under the action of the object to be detected, the chromogenic substrate solution generates chromogenic substances due to biochemical reaction, so that the color or luminous signals are changed.

And the chemical probes and the sensing detection are detection items based on a chemical action principle, wherein the detection card is a chemical detection reagent strip and is matched with a detection system to use the chemical probes and the sensing detection functions. In one example, the chemical detection reagent strip detection card consists of an upper card shell, a liquid incubation groove, a detection window and a lower card shell; the liquid inlet is positioned on the card shell on the test strip; the liquid incubation groove is arranged in a cavity formed by the matching and buckling of the upper clamping shell and the lower clamping shell and is positioned at one end close to the liquid inlet; the detection window is arranged in a cavity formed by the upper clamping shell and the lower clamping shell in a matched and buckled manner and is positioned at one end far away from the liquid inlet; adding a liquid sample containing an object to be detected from the position of the liquid inlet, and adding a probe solution; the liquid added from the liquid inlet flows into the liquid incubation groove for storage; the probe solution can generate color or luminous signal change in the solution under the action of the target object to be detected; detecting that the position of the window is in the test area; the upper clamping shell is provided with an opening at the liquid inlet for adding a liquid sample; the upper clamping shell is transparent in the test area and is used for signal acquisition.

The probe applied to chemical probe and sensing detection generates color or luminous signal change due to chemical action under the action of the object to be detected. The chemical action includes chemical reaction, chemical ionization, chemical sensing, etc.

For a chemical probe and a sensing detection card, one or more probes can be compatible on the chemical probe and the sensing detection card, so that the diversification of detection is realized. The plurality of probes are independently distributed on the test card, with each probe being relatively isolated in spatial location.

Finally, according to the above design, the detection system is compatible for multiple project types. According to actual requirements, free collocation type project compounding can be carried out, and rapid and convenient detection of multiple project combination packages is realized. In the package, a combination of 1 to 10 test cards may be compounded, for example, in the following exemplary combination manner. In the package combination, the detection cards can be parallel combination of 1 to 10 single-channel detection cards, and 1 to 10 channels can be arranged in a single detection card.

Combination mode i: the detection card is set to be 3 cards, and all the 3 cards are immunochromatography detection items.

Combination ii: the detection card is set to be 2 cards, and all the 2 cards are biochemical reagent detection items.

Combination iii: the detection card is set to be 4 cards, and all the 4 cards are chemical probes and sensing detection items.

Combination mode iv: the detection card is set to be 3 cards, and the 3 cards are respectively an immunochromatography detection item, a biochemical reagent detection item, a chemical probe and a sensing detection item, wherein each item is 1 item.

Combination mode v: the detection card is set to be 4 cards, and the 4 cards are respectively an immunochromatography detection item, a biochemical reagent detection item, a chemical probe and a sensing detection item, wherein the immunochromatography detection item 1, the biochemical reagent detection item 2, the chemical probe and the sensing detection item 1.

Combination mode vi: the detection card is set to be 3 cards, and the 3 cards are respectively an immunochromatography detection item and a biochemical reagent detection item, wherein the immunochromatography detection item is 2 items, and the biochemical reagent detection item is 1 item.

Combination mode vii: the detection card is set to be 4 cards, and the 4 cards are respectively a biochemical reagent detection item, a chemical probe and a sensing detection item, wherein the biochemical reagent detection item is 2 items, and the chemical probe and the sensing detection item are 2 items.

Combination mode viii: the detection card is set to be 4 cards, and the 4 cards are respectively an immunochromatography detection item, a chemical probe and a sensing detection item, wherein the immunochromatography detection item 2, the chemical probe and the sensing detection item 2.

Combination mode ix: the detection card is set to be 6 cards, and the 6 cards are respectively an immunochromatography detection item, a biochemical reagent detection item, a chemical probe and a sensing detection item, wherein the immunochromatography detection item 2, the biochemical reagent detection item 2, the chemical probe and the sensing detection item 2.

Combination mode x: the detection card is set to be 8 cards, and the 8 cards are respectively an immunochromatography detection item, a biochemical reagent detection item, a chemical probe and a sensing detection item, wherein the immunochromatography detection item 1, the biochemical reagent detection item 2, the chemical probe and the sensing detection item 5.

The analysis of the above compatible items is integrated, and the analysis can be divided into a color development mode and a light-emitting mode from the generation and detection modes of signals. Both modes can realize rapid and convenient detection in the detection system. The exposed chromogenic probe can develop color, the excited fluorescent probe can emit fluorescence, and the excited long afterglow probe can emit residual glow; collecting color development signals during exposure, collecting fluorescence under the irradiation of a light source, and collecting residual glow in a certain period after the light source is turned off. The collection mode can be direct detector collection or a mode of photographing and imaging to obtain pictures, preferably photographing and imaging, and then analyzing and processing the pictures to obtain the content of the substances to be detected.

In the color development mode, a light source positioned at the bottom of the test strip is controlled to be turned on by a control module, excitation light emitted by the light source exposes color development substances on the test strip, the exposed color development substances emit color development signals, and a detector receives the signals or photographs the detection area of the test strip; the detector transmits the signal or the picture to the signal processing module, and the signal processing module processes the related signal and the picture according to an internal pre-stored program to obtain the content of the substance to be detected.

In a light-emitting mode, a light source positioned at the bottom of the test strip is firstly controlled to be turned on by a control module, excitation light emitted by the light source excites fluorescent substances or long-afterglow substances on the test strip, the excited fluorescent substances emit fluorescence, and a detector receives the emitted fluorescence signals or photographs a detection area of the test strip; the detector transmits the signal or the picture to the signal processing module, and the signal processing module processes the related signal and the picture according to an internal pre-stored program to obtain the content of the substance to be detected.

For most rapid detection projects of liquid samples, the detection card and the detection system have excellent compatibility. Items that were originally detected using multiple devices because of the impossibility of detection together, a platform universal detection is achieved in the detection system. The detection system based on the invention can be widely applied to important fields such as in-vitro diagnosis, chemical sensing, probes, biomedical analysis, food safety, environmental monitoring and the like. The sample to be tested may be the following very common liquids: aqueous solutions, fluids, beverages, biological or chemical agents, blood, body fluids, saliva, urine, and the like. The detection card is matched with the detection system for use, and the detection system has strong universality and does not need to be changed; the detection card is independent of the equipment and can be used as a consumable material to facilitate cleaning or replacement. The liquid phase detection card is provided with a liquid incubation groove, liquid is stored in the liquid incubation groove in advance after being added from the liquid inlet position, incubation is carried out for a period of time at a specific temperature in advance, and then when the liquid phase detection card is overturned along with the inserted detection system, the liquid in the liquid incubation groove flows out from the outlet position, and finally reaches the test area. In the testing of these liquid samples, a defined incubation process with controlled temperature can be performed, and the incubation with controlled temperature of the liquid can be performed simultaneously on the test card, thereby controlling the influence of temperature on the biological molecule recognition, immunological binding or chemical reaction. In addition, repeated liquid transfer is not needed in the operation process, so that the pollution to the sample and the detection site is effectively avoided, and the exposure and infection risk of operators are greatly reduced. Therefore, the invention develops a detection system with strong system compatibility and a multifunctional and pre-incubation matched detection card, realizes the rapid and convenient detection of various project types on the liquid phase sample, can solve the problems of complex operation, inaccurate test data and the like in the existing rapid detection field, has obvious technical progress and is expected to generate great economic benefit.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the description, serve to explain the principles of the disclosure. The embodiments set forth in the drawings are illustrative and exemplary in nature and are not intended to limit the disclosure. The following detailed description of exemplary embodiments will be clearly understood when read in conjunction with the following drawings, wherein like structure is indicated with like reference numerals, and wherein:

FIG. 1 schematically shows the structure of a liquid phase detection card according to an embodiment of the present application;

FIG. 2 schematically illustrates a state of the liquid phase detection card according to an embodiment of the present application;

FIG. 3 schematically illustrates a top view of a liquid phase detection card according to an embodiment of the present application;

FIG. 4 schematically illustrates an arrangement of standard color patches in an embodiment of the application;

FIG. 5 schematically illustrates another arrangement of standard color patches in an embodiment of the application;

FIG. 6 schematically shows the structure of another liquid phase detection card according to an embodiment of the present application;

FIG. 7 schematically illustrates a state of another liquid phase detection card according to an embodiment of the present application;

FIG. 8 schematically illustrates a top view of another liquid phase detection card in accordance with an embodiment of the present application;

FIG. 9 schematically illustrates a top view of a test card with standard color patches according to an embodiment of the application;

FIG. 10 schematically illustrates a test state diagram of a test card with standard color patches according to an embodiment of the present application;

FIG. 11 schematically illustrates a three-dimensional block diagram of a test card according to an embodiment of the present application;

FIG. 12 schematically illustrates an architectural block diagram of a detection system according to an embodiment of the present application;

fig. 13 schematically illustrates a detection card structure for point-by-point scanning spectrum acquisition and area imaging spectrum acquisition of luminescence chromatography in an embodiment of the present application.

Reference numerals illustrate: 1-a detection card; 11-a liquid inlet; 12-a liquid incubation tank; 120-a first groove wall; 121-a second groove wall; 13-a liquid outlet; 14-limit stops; 2-detection area; 21-an identification code; 22-transparent face mask; 3-an incubation unit; a 4-detector; 5-a detection system; 50-a control module; 51-a light source; 52-a detection module; 53-signal processing module.

Detailed Description

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following description will explain the specific embodiments of the present application with reference to the accompanying drawings. It is evident that the drawings in the following description are only examples of the application, from which other drawings and other embodiments can be obtained by a person skilled in the art without inventive effort.

The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way intended to limit the disclosure, its application, or uses. That is, the structures and methods herein are shown by way of example to illustrate different embodiments of the structures and methods in this disclosure. However, those skilled in the art will appreciate that they are merely illustrative of the exemplary ways in which the disclosure may be practiced, and not exhaustive. Moreover, the figures are not necessarily to scale, some features may be exaggerated to show details of particular components.

In addition, techniques, methods, and apparatus known to one of ordinary skill in the relevant art may not be discussed in detail, but are intended to be considered part of the specification where appropriate.

In all examples shown and discussed herein, any specific values should be construed as merely illustrative, and not a limitation. Thus, other examples of the exemplary embodiments may have different values.

In one aspect, the application provides a liquid phase detection card provided with a liquid incubation slot, wherein liquid is pre-stored in the liquid incubation slot after being added from a liquid inlet position, pre-incubated for a period of time at a specific temperature, and then the liquid in the liquid incubation slot flows out from an outlet position and finally reaches a test area after the liquid phase detection card is overturned along with an inserted detection system. Firstly, the detection card provided by the application is matched with the detection system, so that the corresponding detection system has strong universality and wide application range, and large changes are not required in structure or process production. Secondly, although the detection card and the detection system are matched, the detection card is independent of the detection system or the detection equipment, so that the detection card can be conveniently cleaned or replaced as a consumable, and the maintenance cost is lower. Finally, the detection card of the application can perform a definite temperature control incubation process, and the temperature control incubation of the liquid can be performed synchronously on the detection card, thereby reducing the negative influence of temperature on biological molecule identification, immune binding or chemical reaction. A test card and a test system according to various embodiments of the present application will be described in detail below with reference to the accompanying drawings. It should be understood that the actual test card and test system may also include other components, but in order to avoid obscuring the gist of the present disclosure, these other components are not discussed herein and are not shown in the drawings. It is also to be understood that the various embodiments may be combined with each other, but that the figures show only some combinations of these embodiments for the sake of simplicity of illustration.

Fig. 1 shows a test card 1 according to some embodiments of the application. As shown in fig. 1, the detection card 1 includes a liquid inlet 11, a liquid incubation groove 12, a liquid outlet 13, a liquid limit stopper 14, an incubation unit 3, and a detection area 2. It should be understood that while FIG. 1 shows the components as a single piece, this is by way of example only and not limitation, and that the inlet 11, the liquid incubation well 12, the outlet 13, and the liquid limit stop 14 may include two, three, or more side-by-side liquid channels as desired.

The liquid inlet 11 is configured to receive a sample fluid or other solvent, in particular, communication between the liquid inlet 11 and the liquid incubation tank 12, and the liquid inlet 11 is positioned higher than the liquid incubation tank 12 so that liquid can enter the liquid incubation tank 12 for incubation under gravity. In the drawings herein, unless otherwise specified, in the state before the test card 1 is turned over, the liquid inlet 11 is provided in a direction perpendicular to the cross section of the liquid incubation groove 12. Here, the cross section herein refers to a plane in which the width and the depth are located, and is perpendicular to the direction of the length thereof. In some embodiments, the cross section of the liquid inlet 11 is circular, the liquid channel formed between the liquid inlet 11 and the liquid incubation groove 12 is formed by three parts, one part is cylindrical with the same diameter as the liquid inlet 11, and can be understood as a straight line perpendicular to the height direction of the cylinder, namely, the right side b part of the liquid inlet 11, one part is formed by a horizontal line parallel to the horizontal plane, which is also understood as the bottom of the liquid incubation groove 12, and an inclined line is connected with the horizontal line and the cylindrical height direction, so that the liquid can reach the liquid incubation groove 12 faster after passing through the liquid inlet 11, because of the existence of the coanda effect, and the fluid or the liquid tends to flow along the wall surface always.

The liquid incubation groove 12 is disposed between the liquid inlet 11 and the liquid outlet 13, and is communicated with the liquid inlet 11 as described above, and receives a sample or other liquid from the liquid inlet 11, and the liquid incubation groove 12 may be understood as a place or a container for temporarily storing the liquid, or may be understood as a reactor in which mixing or reaction or combination of different liquids occurs. The incubation process is typically a process of reacting the sample and reagent in the liquid incubation well 12 in a stable temperature environment, and typically the reacted liquid incubation well 12 contains an immunological binding or immunoreactive conjugate and also contains a sample or reagent that has not reacted or bound. As described above, since the incubation process generally requires temperature control, it is generally required to place the incubation in an oven or a box, and this inevitably results in transfer of the sample, and there is a possibility of contamination or loss of the sample once there is transfer. In addition, in terms of structure, the side wall of the liquid incubation groove 12 near the liquid inlet 11 may be understood as a first groove wall 120, the first groove wall 120 forms an obtuse angle with the direction in which the bottom horizontal plane of the liquid incubation groove 12 extends toward the liquid outlet 13, the first groove wall 120 may be understood as an inclined plane, the side wall of the liquid incubation groove 12 near the liquid outlet 13 may be understood as a second groove wall 121, the direction in which the bottom horizontal plane of the second groove wall 121 extends toward the liquid outlet 13 may also form an obtuse angle, but the second groove wall 121 is different from the first groove wall 120 in that the second groove wall 121 is an arc surface. In addition, there is a limit stop 14 between the second groove wall 121 and the liquid outlet 13, in this embodiment, the limit stop 14 is a protruding portion, so, compared with the design of the inclined plane of the liquid incubation groove 12 with an edge angle near the liquid inlet 11, that is, the design of the first groove wall 120, the smart design of the limit stop 14 makes the second groove wall 121 have no dead angle, so as to avoid the accumulation of the sample to be tested during the overturning. Therefore, the reasonable design of the circular arc limit stop 14 ensures that the sample to be detected has no dead angle in the incubation groove 12 along with the overturning of the incubation groove 12, so that the wall of the sample to be detected is not caused, the rapid detection of the sample to be detected is not influenced, and the detection efficiency is improved. In addition, the limit stop 14 has a protrusion with respect to the inclined surface of the liquid outlet 13, so that the limit stop 14 can separate the liquid in the incubation groove 12 from the liquid in the liquid outlet 13, so as to prevent the liquid in the incubation groove 12 from contacting and cross-contaminating the liquid in the liquid outlet 13 during overturning.

In the present application, an incubation unit 3 is disposed at the bottom of the incubation liquid incubation groove 12, and the incubation unit 3 can control the temperature of the liquid in the liquid incubation groove 12, wherein the temperature control includes maintaining the liquid incubation groove 12 at a constant temperature, and can also control the temperature of the liquid stepwise according to a set temperature raising or lowering program. In actual use, the incubation unit 3 may be cooled as well as heated. The temperature of this area may rise due to heat generated by the light source after irradiating the test card 1 for a long period of time. The temperature is low at the beginning, the temperature needs to be increased, and the light source needs to be cooled after long-time irradiation, so that the temperature of the detection area 2 is kept constant. In some embodiments, the incubation unit 3 may be a semiconductor heating and cooling plate, which may be understood as a heat transfer tool, which can be used to perform both cooling and heating, and the working operation mainly uses a direct current, and the polarity of the direct current is changed to determine whether cooling or heating is performed on the same semiconductor heating and cooling plate. More specifically, the semiconductor heating and refrigerating sheet is a thermocouple pair formed by connecting an N-type semiconductor material and a P-type semiconductor material, when current passes through the thermocouple pair, heat transfer is generated between two ends, so that heat can be transferred from one end to the other end, a temperature difference is generated to form a cold end and a hot end, when the cold end and the hot end reach a certain temperature difference, a balance point is reached when the two heat transfer amounts are equal, heat transfer in the forward phase and the reverse phase are mutually offset, and the temperature of the cold end and the hot end can not continuously change at the moment. It will of course be appreciated that the incubation unit 3 may also be other temperature controllable elements, which are schematically illustrated here by means of a semiconductor heating and cooling fin, since the semiconductor heating and cooling fin has two functions, namely cooling and heating, the cooling efficiency is generally not high, but the heating efficiency is very high, always greater than 1, and therefore a single fin can be used instead of separate heating and cooling systems. In addition, the semiconductor refrigerating sheet is a current transduction sheet piece, high-precision temperature control can be realized through the control of input current, and in addition, the remote control, program control and computer control are easy to realize by a temperature detection and control means, so that an automatic control system is convenient to form. It should be noted that the incubation unit 3 may further include other elements, such as a temperature sensor, etc., and the number of incubation units 3 is not limited, and a plurality may be configured in series or in parallel as needed. For example, a temperature sensor can be used to detect the temperature change of the liquid in the liquid incubation tank 12, and when the temperature is too high or too low, the temperature in the liquid incubation tank 12 is adjusted in real time through the semiconductor heating and refrigerating sheet, so as to meet the dual monitoring requirements of different external temperature control internal detection adjustment.

The detection area 2 of the detection card 1 according to the present application is located behind the liquid outlet 13, i.e. after the liquid has been treated, and thus the detection area 2 is configured to receive the liquid from the liquid outlet 13, where the liquid from the liquid outlet 13 may enter the detection area 2 in its entirety or may enter the detection area 2 in part. The assay may be a conventional biochemical assay, such as blood assay, urine assay, stool assay, other body fluid sample assay, or a tumor marker assay, such as carcinoembryonic antigen, alpha fetoprotein, carbohydrate antigen CA125, carbohydrate antigen CA153, carbohydrate antigen CA19-9, carbohydrate antigen CA724, neuronal enolase, cytokeratin fragment 19, epididymal protein 4, gastrin releasing peptide precursor, total prostate specific antigen, free prostate specific antigen, prostate specific antigen isoforms, abnormal prothrombin, squamous cell carcinoma-associated antigen, lung cancer autoantibody assay, or infectious disease assay, examples of the detection include detection of viral serological markers such as hepatitis B virus-related antigen antibodies, hepatitis C antibodies, syphilis-specific antibodies, hepatitis A antibodies, hepatitis E antibodies, human immunodeficiency virus antibodies, TORCH antibodies, EB virus antibody series, mycoplasma pneumoniae antibodies, chlamydia pneumoniae antibodies, legionella pneumophila antibodies, respiratory syncytial virus antibodies, adenovirus antibodies, coxsackie virus antibodies, and novel coronavirus antibodies, detection of inflammatory markers such as procalcitonin, interleukin-6, C-reactive protein, and amyloid A, and detection of endocrine and metabolic disease items, cardiovascular disease-related detection, immune function detection, autoimmune disease-related antibody detection, and pathogen nucleic acid detection. Referring to fig. 2, fig. 2 exemplarily shows a detection state after the detection card 1 in this embodiment is inserted into the detection system 5 with the detection system 5 turned over.

Fig. 3 shows a cross-sectional view of a test card, which is illustrated in terms of immunochromatographic testing. As shown in fig. 3, a liquid or a sample enters the liquid incubation groove 12 through the liquid inlet 11, after incubation is completed, the detection card 1 is inserted into the detection system 5, and as the detection system 5 is turned over by a certain angle, for example, 30-120 °, preferably 90 °, the liquid enters the detection area 2 from the liquid limit stop 14 through exiting through the liquid outlet 13 for detection, the detection area 2 shown in fig. 3 is an immunochromatographic Test strip, a detection Line (Test Line, T Line) and a quality Control Line (Control Line, C Line) are marked on an NC film (Nitrocellulose Membrane, nitrocellulose film) of the detection area 2, and when antigen-antibody specific binding exists in the sample, both the C Line and the T Line are displayed.

In addition, the detection area 2 shown in fig. 3 further includes an identification code 21, where the identification code 21 may be a two-dimensional code, and the two-dimensional code area may include related information of the detection card 1, such as a usage instruction, a shelf life, a manufacturer, etc., and may further include a number of the detection card 1, so as to be convenient for inputting a statistical result, and may be further useful for a user to link. After successful scanning and identification, the user automatically jumps to a detection applet to directly log in the personal account, or after binding the personal account with the WeChat account, the user can see the operation description page and the detection function page. And then the smart phone is used for scanning the front of the code detection card, a micro-letter applet can be opened, or the mobile phone APP or the mobile phone browser website page can be jumped to, and the next detection operation can be carried out. Click scan detection, detection reports (graphic description for detection results) can be analyzed and obtained in real time. The detection report can be shared by WeChat, or can be stored in a screen capturing mode for picture sharing so as to be sent to doctors or professionals for evaluation.

It should be noted that, in fig. 3, the detection area 2 may also have a standard color block, which is not shown, and may be embedded in the link of the identification code 21, where the user scans the identification code 21 with an intelligent terminal, or may be set separately, where the setting of the color block may be referred to fig. 4, and the color of the standard color block is kept unchanged during the detection process due to the reaction between the detection sample and the pre-stored reagent in the detection area 2, and the standard color of the standard color block is used to calibrate the color difference generated in the open light environment, so that the color of the detection area 2 is determined more accurately by comparing the standard color block, thereby obtaining an accurate detection result. Referring to fig. 5, each standard color patch corresponds to one standard color, and the greater the number of standard color patches in the detection area 2, the more contributes to improving the accuracy of the detection result. The same color system, such as black, violet, red, blue, green, etc., is shown in fig. 4 in a two-row five-column arrangement, i.e., one color system has ten color blocks. In fig. 5, color patches of different color systems are shown, for example, in an arrangement of three rows and five columns, so that there are fifteen color patches of five color columns, for example, red, green, blue, violet, and black in sequence from left to right, and color patches with saturation decreasing in sequence from top to bottom.

In another embodiment of the test card, see fig. 6, the test card 1 comprises a liquid inlet 11, an incubation groove 12, a limit stop 14, a test area 2, an incubation unit 3, an identification code 21. In the detection card 1 provided in this embodiment, a liquid sample containing a target object to be detected is added from a liquid inlet 11 to an incubation groove 12 for storage, and then a chromogenic substrate solution is added, so that the liquid sample containing the target object to be detected and the chromogenic substrate solution are mixed in the incubation groove 12, and are fully contacted under a certain temperature condition to generate a chromogenic reaction, and the chromogenic reaction is detected through a liquid outlet 13 to a detection area 2, wherein the liquid outlet 13 of the detection card 1 in this embodiment is fused in the detection area 2, and the solution enters the detection area 2 under the action of gravity after the detection card 1 is inserted into a detection system 5 and turned over. The detection card of this embodiment may further include adding a liquid sample containing the target object to be detected from the position of the liquid inlet 11, and then adding a probe solution, where the liquid sample containing the target object to be detected added first flows into the liquid incubation tank 12 for storage, and the probe solution may generate a color or a luminescence signal change in the solution under the action of the target object to be detected, so that the probe solution is detected. Fig. 7 schematically illustrates a state of the detection card 1 in this embodiment when the detection card 1 is detected, similar to the detection card 1 in the foregoing embodiment, in which the detection card 1 is turned from a horizontal position to a vertical position, and fig. 8 illustrates a top view of the detection card 1 in this embodiment, and description of other components may refer to the detection card 1 in the foregoing embodiment and will not be repeated herein.

With reference to fig. 9 and 10, it can be further seen that the arrangement condition and the detection state of the color blocks in the detection area 2 of the detection card 1 in the embodiment of the present application, the plurality of detection blocks and the plurality of standard color blocks in the detection area 2 are arranged in 2 rows or more, and the plurality of detection blocks and the plurality of standard color blocks are interlaced. The detection block is used for accommodating a detection sample and reacting with a preset reagent in the detection block, so that color change occurs. In some embodiments, standard color blocks with smaller areas than the detection blocks are used as a preferred solution, so as to accommodate a larger number of standard color blocks, so as to improve the accuracy of the detection result. In addition, in some embodiments, the closer the standard color patch is to the detection block, the more helpful it is to improve the accuracy of the detection result, such as a row of detection blocks being interspersed with a row of standard color patches. In other embodiments, the color lump can further include a color lump correction area and a color lump reference area, and the color lump of the color lump correction area is used as a reference object to analyze the test paper, and the color is not directly compared with the standard color comparison card in the analysis process, so that a spot color printing color comparison card is not needed.

To more clearly illustrate other structures of the test card in the embodiments of the present application, referring to fig. 11, in some embodiments, the test card 1 further includes an upper card housing and a lower card housing, the liquid incubation groove 12 is configured to be located in a cavity formed by the mating snap of the upper card housing and the lower card housing, near one end of the liquid inlet 11, and the test area 2 is configured to be located in a cavity formed by the mating snap of the upper card housing and the lower card housing, near one end of the liquid outlet 13.

Thus, the detection area 2, the liquid incubation groove 12, and other components of the detection card 1 are disposed in a space formed by the upper card case and the lower card case, and the internal components are protected. Further, to facilitate signal acquisition, the portion of the upper cartridge housing located in the detection zone 2 is transparent, such as a transparent mask 22. Even further, the parts of the upper and lower shells located in the detection area 2 are transparent structures, such as a transparent mask 22, so that signal acquisition and observation are facilitated. It is understood that the transparent structures herein do not absorb light or electromagnetic waves, nor scatter or multiple reflections of light or electromagnetic waves. Because the collected photon signals or the photographed image can directly influence the detection result after data processing, the transparent structure is arranged to try to restore the own optical signals, improve the detection accuracy and reduce the error of environmental factors or instrument factors on the detection result. In some preferred embodiments, the upper and lower cartridge shells are made of glass, so that corrosion of the chemical reaction solvent or the sample to be tested can be prevented. For example, the upper and lower shells may be made of metal glass, so that on one hand, crystal defects such as crystal boundaries and phase boundaries which are easy to corrode in the crystalline material do not exist in the metal glass, and meanwhile, the components are uniform, so that a large amount of elements which are easy to form a stable passivation film can be contained, and on the other hand, the metal glass is high in hardness, strong in bonding force of the passivation film and not easy to peel off and separate. For example, the upper and lower shells may be made of ordinary glass, and because the main component is silica, and some Al, na, ca, K salts are also present, the valence states of the compounds formed by these elements are all saturated and do not react with most of the compounds, si and O in the glass form silicon oxygen tetrahedra, and these si—o tetrahedra structures have the characteristics of short-range order and long-range disorder, and can be regarded as forming an amorphous network structure. The stable si—o tetrahedral structure contributes to the stability of the glass and thus can prevent corrosion of the chemical reaction solvent. Of course, the description is given here only schematically, and other composite glasses and the like that meet the requirements are also possible.

The application provides a detection system in a second aspect, which comprises the detection card, a detection module, a signal processing module, a control module, a light source and a light-shielding shell. The detection module and the light source are both arranged in the light-shielding shell, the signal processing module is electrically connected with the detection module, the detection module is used for acquiring photon signals of the detection card testing area or photographing and imaging the detection card testing area, the light source is used for exposing the color-developing substance or exciting the luminescent substance, the control module is used for controlling the detection module and the light source to be opened and closed, and the signal processing module is used for processing photoelectric signals transmitted by the detection module to obtain information of a target object to be detected. Therefore, the automatic acquisition of the detection result and the automatic storage and processing of the data can be realized. It should be understood that the detection system may also include other modules according to actual needs, or add other modules that are more convenient for detection according to different detection projects and intelligent trends.

Specifically, referring to fig. 12, the control module 50 is connected to the light source 51 in a wired or wireless manner, in some embodiments, the control module 50 may instruct the light source 51 to start the light source 51 according to feedback information of other modules of the detection system 5, such as the detection module 52, to start the light source 51, so that information of the sample to be tested may be captured, and after the test is completed, the control module 50 issues an instruction to instruct the light source 51 to turn off the control signal. Of course, it will be appreciated that in other embodiments, when the detection card 1 is turned over with the detection system 5, the control module 50 issues a control command to activate the light source 51, and when the detection is completed, the light source 51 is turned off. It is also possible that the operator activates the light source 51, for example after inserting the test card 1 into the test system 5, by entering information or parameters at the control module 50 or manually stopping the light source 51 by the control module 50 after the test is completed. It will also be appreciated that the light source 51 may be not only connected to the control module 50 for control thereof by the control module 50, but may also be provided with a switch for an operator to manually turn off or activate the light source 51. In addition to controlling the turning on and off of the light source 51, the control module 50 is configured to adjust the excitation wavelength or emission wavelength of the light source 51 so that an operator selects an appropriate light source 51 according to actual needs, and may also be configured to adjust other parameters of the light source 51, such as current, power, luminous flux, light attenuation, light color, color rendering, and the like. It will be appreciated that the detection system 5 may be configured with different types and numbers of light sources 51, without limitation.

In addition, the control module 50 is further connected to a detection module 52, which detection module 52 may also be understood as a detector in some scenarios, the detection module 52 being configured to acquire photon signals of the detection area 2 of the detection card 1 or to take a photo of the detection area 2 of the detection card 1. In some embodiments, the control module 50 may issue a power-on command and a detection command to the detection module 52, and the detection area of the detection module 52 may cover the detection area 2, and it may be understood that the detection module 52 may include a photographing unit, and in some embodiments, the detection module 52 may switch to a different mode, for example, the detection mode or the photographing mode may be adjusted according to the condition of ambient light. The detection module 52 may also be movable, for example, according to the photographing requirement of the detection area 2, so as to facilitate focusing photographing or obtaining optical information or photon signals, so it is understood that the detection module 52 may also be provided with a distance sensor.

Further, a focusing module and/or a filter is arranged on the optical path between the detection module 52 of the detection system 5 and the detection area 2 of the detection card 1, in the whole detection, the detection system 5 needs to collect the real optical signal of the detection area 2, or restore the optical signal of the detection area 2, when the focusing module exists on the optical path between the detection module 52 of the detection system 5 and the detection area 2 of the detection card 1, for example, the focusing module is a convex lens, the focusing module can be adjusted to adapt to the focal length, so that the focusing is clearer, and the image pixels obtained by photographing are higher. In addition, when a filter exists on the optical path between the detection module 52 of the detection system 5 and the detection area 2 of the detection card 1, the filter selectively allows or prevents a certain spectral wavelength from transmitting in the spectral range, or reduces the transmittance of the specified spectral wavelength range, so as to reduce the luminous flux, so that in practical use, the filter can be used for filtering out redundant clutter, and reduce the interference of background signals or clutter on the detection result. It is therefore advantageous to provide a focusing module and/or a filter in the optical path between the detection module 52 of the detection system 5 and the detection area 2 of the detection card 1. In some embodiments, the focusing module includes focusing adjustable optics, which may be designed in any known fashion, such as a single lens or objective lens. The focus adjuster acts on an actuator that changes the focus position. The required manipulation is performed by means of a focus controller which is responsible for bringing the optics to the desired focus position by means of a focus adjuster, i.e. setting the depth of field around a certain distance value.

Still further, the control module 50 is further connected to the signal processing module 53, so that the detection module 52 sends the detected or detected signal result or picture to the signal processing module 53, and meanwhile feeds back the detected information to the control module 50, and the control module 52 processes the received data or picture from the detection module 52 through the signal processing module 53 according to a preset instruction or parameter, so as to convert the optical signal into an electrical signal. Of course, it will be understood by those skilled in the art that the signal processing module 53 may further include a decoding module for decoding the optical signal from the detecting module 52 and converting the decoded optical signal into an electrical signal. The signal processing module 53 of the detection system 5 is configured with an embedded processor or an external intelligent terminal arranged inside the light-proof housing. More preferably, the embedded processor may be an embedded chip, such as a single-chip microcomputer, a DSP (digital signal processing, digital signal processor), an FPGA (filtered-programmable gate array, programmable gate array), etc., and the smart terminal may be a smart phone, a notebook, a PDA (Personal Digital Assistant) smart terminal, a tablet computer, a VR/AR (Virtual Reality/Augmented Reality) device, a smart wearable device, etc. The connection between the intelligent terminal and the detection module 52 of the detection system 5 may be a wired or wireless connection.

Furthermore, from the modules of the detection system 5, only the main structure thereof is described above, and it will be understood by those skilled in the art that the detection system 5 further comprises, for example, a power module for supplying power to the detection system 5 in order to realize the detection function thereof. In some embodiments, the system may further include a display module for displaying the detected information processed by the signal processing module 53, or for referring to the retrieved detection result, etc., where the display module and the control module 50 may interact, for example, the instruction information from the control module 50 may be displayed by the display module.

In addition to the above modules, in order to make the detection result of the detection system 5 more accurate or the detection result more reliable, it may be understood that the detection system 5 and the detection card 1 are more convenient to be used together, and the detection system 5 in the present application further includes a base (not shown) of the detection card 1, for example, a groove for carrying the detection card 1, or other structures designed to match with the detection card 1, where the base of the detection card 1 is mainly used for fixing and positioning the detection card 1, so as to avoid the deviation of the detection card 1 during the overturning or detection process, and the detection module 52 cannot detect a photon signal or take a photo, so that the content of the sample to be measured cannot be obtained, and repeated measurement is required. In some embodiments, the base of the test card 1 is provided with a chute for guiding the test strip, which chute can be in clearance fit with the test strip.

Further, the detection area 2 corresponding to the base of the detection card 1 in some embodiments is further configured with a through hole, and the through hole can be used for transmitting light. As described above, the detection system 5 requires the light source 51 to irradiate the region 2 to be detected, so that the color-developing substance of the region 2 to be detected is exposed or the light-emitting substance is excited. Of course, it is understood that the number and shape of the through holes are not limited, and may be, for example, circular or square, etc.

In a third aspect, the present application provides a detection method, which uses the detection card 1 and the detection system 5 to detect a sample to be detected, and the main detection process is as follows:

firstly, preparing a sample to be detected and a reaction solvent or a chemical reagent related to the sample to be detected;

secondly, dripping the prepared sample or solvent to be detected from a liquid inlet according to detection requirements, and incubating in a liquid incubation tank for a certain time at the temperature control of an incubation unit according to the temperature required by detection;

thirdly, inserting a detection card carrying the incubated sample to be detected into a detection system, and after the detection card turns over in the detection system, carrying out a detection area of the detection card on the sample to be detected;

fourthly, starting a light source and a detection module through a control module of the detection system, and detecting or photographing signals of a detection area;

Fifthly, comparing and analyzing the result processed by the signal processing module to obtain the information of the sample to be detected.

In a fourth aspect, the present application provides an application based on the detection card, detection system and detection method described above, including but not limited to applications such as immunochromatographic detection, biochemical reagent detection, chemical probe detection and sensing detection, and multi-item combination detection.

In some embodiments, the detection card, the detection system and the detection method are applied to immunochromatography detection, wherein immunochromatography refers to an in-vitro detection item based on an immunochromatography principle, and the detection card is an immunochromatography test strip in the item and is matched with the detection system to use the immunochromatography detection function. The detection clamp in the embodiment is provided with the liquid incubation groove, so that on one hand, the detection can be more accurate and controllable through the liquid incubation step; on the other hand, the probe and the target analyte react in the liquid incubation groove in advance, so that the detection performance, such as the detection sensitivity, is improved.

In one example, the immunochromatographic test strip detection card consists of an upper card shell, a liquid incubation groove, a card core and a lower card shell; the clamping core consists of a bottom plate, a sample loading pad, an NC film and a water absorbing pad; the sample loading pad, the NC film and the water absorbing pad are sequentially overlapped on the bottom plate; the liquid inlet is positioned on the card shell on the test strip; the liquid incubation groove is arranged in a cavity formed by the matching and buckling of the upper clamping shell and the lower clamping shell and is positioned at one end close to the liquid inlet; the clamping core is arranged in a cavity formed by the matching and clamping of the upper clamping shell and the lower clamping shell and is positioned at one end far away from the liquid inlet; adding a liquid sample containing a target object to be detected from the position of a liquid inlet, and adding a biomarker I coupled with the probe nano microsphere; the liquid added from the liquid inlet flows into the liquid incubation groove for storage; a detection line (T line) and a quality control line (C line) are marked on the NC film, a biomarker II capable of being specifically combined with a target object to be detected is marked on the detection line, and an active detection object is marked on the quality control line; the biomarker I can be specifically combined with a target object to be detected; the activity detector is used for indicating the effectiveness of the biomarker coupled with the probe nano-microsphere; the biomarker I and the biomarker II are respectively combined with the target object to be detected through the action of immune reaction; the positions of the T line and the C line are in the test area; the upper clamping shell is provided with openings at the liquid inlet and the testing area, and is respectively used for liquid sample loading and signal acquisition. For example, a T line and a C line are marked on the NC film, a chromogenic probe, a fluorescent probe or an antigen or an antibody modified by a long afterglow probe is coated on the binding pad, and an antibody or an antigen capable of specifically binding with a substance on the binding pad is coated on the T line; and the C line is coated with a secondary antibody.

The probe substance used in immunochromatography is a color-developing substance or a luminescent substance. The chromogenic material is a material which has obvious color under the irradiation of a light source, such as colloidal gold nano particles, colored nano microspheres and the like; the luminescent material is a material which is excited under the irradiation of a light source to generate a luminescent signal, such as a fluorescent probe or a long afterglow probe.

In addition, the upper card shell of the detection card is provided with an opening at the detection area for the detector to receive the signal. The lower card shell is provided with an opening, and the opening is used for emitting a light source at the bottom of the test strip to a detection area of the test strip and is used for exposing or exciting a color development probe, a fluorescent probe or a long afterglow probe in the detection area. The bottom plate is made of a light-transmitting material and at least transmits excitation light emitted by the excitation light source. The bottom plate is a PVC plate which can transmit light and has certain hardness to support the clamping core without loosening and deforming.

The embodiment provides a design scheme of the detection card, and further develops a detection system based on the detection card and is applied to the field of immunochromatography detection. The device comprises a light-shielding shell, a detection card seat, a detection card, a detection module, a light source, a signal processing module and a control module; the detection card seat, the detection module and the light source are all arranged in the light-shielding shell; the detection card seat is provided with a temperature adjusting module; the detection module is used for acquiring photon signals of the detection card testing area or photographing and imaging the detection card testing area; the light source is used for exposing the color-developing substance in the test strip test area or exciting the luminescent substance; the signal processing module is electrically connected with the detection module and is used for processing the photoelectric signals transmitted by the detection module to obtain the content of the target object to be detected; the control module is used for controlling the opening and closing of the detection module and the light source; the liquid phase detection card is provided with a liquid incubation groove, liquid is pre-stored in the liquid incubation groove after being added from a liquid inlet position, pre-incubated for a period of time at a specific temperature, and then the liquid in the liquid incubation groove flows out from an outlet position after the liquid phase detection card is overturned along with the inserted detection system, and finally reaches a test area; the flip angle ranges from 30 degrees to 120 degrees, preferably 90 degrees flip vertically.

The detection card and the detection system of the application have a plurality of advantages when applied to immunochromatography detection, for example, when an immunochromatography test strip is used for detecting specific antigens, the liquid phase reaction can ensure that the luminous probe coated by the antibody and the antigens in a sample are fully immunoreacted.

In another applicable embodiment of the application, the detection system comprises a light-proof shell, a test strip seat, a detection module, a light source, a signal processing module and a control module; the test paper strip seat, the detection module and the light source are arranged in the light-shielding shell; the detection module is arranged at the top of the test paper strip seat; the light source is arranged at the bottom of the test strip detection area through the test strip bottom plate; the test strip seat is used for positioning the test strip; the light source is used for exciting a chromogenic substance or a luminescent substance in the detection area of the test strip; the detection module is used for detecting the photon number of the detection area of the test strip or photographing the detection area of the test strip; the signal processing module is electrically connected with the detection module and is used for processing the photoelectric signal transmitted by the detection module to obtain the content of the test paper strip to be detected; the control module is used for controlling the opening and closing of the detection module and the light source; there is no separation between the detection module and the test strip detection area, and between the test strip detection area and the light source.

In one embodiment, the light-shielding shell comprises an upper shell cover and a lower shell seat which can be closed and buckled; the test strip seat is arranged on the lower shell seat, and the corresponding lower shell seat is provided with an inserting port for inserting the test strip into the test strip seat.

In one embodiment, the base plate is frosted at the detection zone.

In one embodiment, a light shielding plate for shielding the light radiation of the light source from the detection module is arranged at the bottom or the circumference of the test strip seat.

In actual use, the detection system comprises a light-proof shell, a test strip seat, a detection module and a light source. The detection module is a camera, the test strip is inserted into the test strip seat, and the test strip seat is provided with an opening for the light source to penetrate; the opening can enable the light source to be directly driven onto the bottom plate of the test strip, and after uniform treatment of the bottom plate, the chromogenic probes on the T line and the C line of the detection area of the test strip are exposed or the fluorescent probes or the long afterglow probes are excited. The detection device is provided with a signal processing module, and a pre-stored program in the signal processing module can compare RGB signals in the photo with a standard curve of a memory to obtain concentration information. In the color development mode, the developed color information can be processed into gray values or reflectances, so that quantitative operation can be performed, and gray or reflectance-concentration standard curves are compared to obtain the concentration of the color development probe; in the luminescence mode, the luminescence intensity is fitted to a luminescence material concentration standard curve to obtain the concentration of the luminescence probe. Since the concentration of the probe detected is positively correlated with the concentration of the substance to be detected in immunochromatographic analysis, the concentration of the target substance to be detected can be determined.

In yet another embodiment of the present application, the present application may be applied to multi-item combination detection, and it is understood that the detection card and the detection system of the present application may implement multi-channel combination detection, and various arrangements and combinations as mentioned in the foregoing description are included.

In addition, for the combined detection card, the application adopts the surface imaging spectrum acquisition, and referring to fig. 13, a plurality of samples can be detected conveniently and rapidly. The light source is a point light source or a surface light source, preferably a surface light source; the detector 4 is a photomultiplier array, a silicon photocell array, a camera, a mobile phone, a CCD, an EMCCD, preferably a camera, a mobile phone, a CCD, an EMCCD. By means of a photographing type wide-field imaging detection mode, signal images containing a plurality of test containers can be obtained through one-time imaging, and therefore detection flux is improved efficiently.

According to the detection card provided by the application, the liquid flows out of the incubation groove to the detection area through the turnover working principle, and the detection is carried out through the detection system to obtain the information of the object to be detected, so that the detection card is not required to be transferred for multiple times, has strong universality, can be suitable for various detections, and can be provided with multiple channels to carry out high-flux detection, so that the detection card has great application potential in research, development and market.

The words "left", "right", "front", "back", "top", "bottom", "upper", "lower", "high", "low", and the like in the description and in the claims, if present, are used for descriptive purposes and not necessarily for describing permanent relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments of the disclosure described herein are, for example, capable of operation in other orientations than those illustrated or otherwise described herein. For example, when the device in the figures is inverted, features that were originally described as "above" other features may be described as "below" the other features. The device may also be otherwise oriented (rotated 90 degrees or at other orientations) and the relative spatial relationship will be explained accordingly.

In the description and claims, an element is referred to as being "on," "attached to," connected to, "coupled to," contacting, "etc., another element, which may be directly on, attached to, connected to, coupled to or contacting the other element, or intervening elements may be present. In contrast, when an element is referred to as being "directly on," "directly attached to," directly connected to, "directly coupled" to or "directly contacting" another element, there are no intervening elements present. In the description and claims, a feature being disposed "adjacent" to another feature may refer to a feature having a portion that overlaps with, or is located above or below, the adjacent feature.

As used herein, the word "exemplary" means "serving as an example, instance, or illustration," and not as a "model" to be replicated accurately. Any implementation described herein by way of example is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, this disclosure is not limited by any expressed or implied theory presented in the technical field, background, brief summary or the detailed description.

As used herein, the term "substantially" is intended to encompass any minor variation due to design or manufacturing imperfections, tolerances of the device or element, environmental effects and/or other factors. The word "substantially" also allows for differences from perfect or ideal situations due to parasitics, noise, and other practical considerations that may be present in a practical implementation.

In addition, for reference purposes only, the terms "first," "second," and the like may also be used herein, and are thus not intended to be limiting. For example, the terms "first," "second," and other such numerical terms referring to structures or elements do not imply a sequence or order unless clearly indicated by the context.

It will be further understood that the terms "comprises" and/or "comprising," when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, and/or components, and/or groups thereof.

In this disclosure, the term "providing" is used in a broad sense to cover all ways of obtaining an object, and thus "providing an object" includes, but is not limited to, "purchasing," "preparing/manufacturing," "arranging/setting," "installing/assembling," and/or "ordering" an object, etc.

As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

Those skilled in the art will recognize that the boundaries between the above described operations are merely illustrative. The operations may be combined into a single operation, the single operation may be distributed among additional operations, and the operations may be performed at least partially overlapping in time. Moreover, alternative embodiments may include multiple instances of a particular operation, and the order of operations may be altered in other various embodiments. However, other modifications, variations, and alternatives are also possible. Aspects and elements of all of the embodiments disclosed above may be combined in any manner and/or in combination with aspects or elements of other embodiments to provide a number of additional embodiments. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense.

Although some specific embodiments of the present disclosure have been described in detail by way of example, it should be understood by those skilled in the art that the above examples are for illustration only and are not intended to limit the scope of the present disclosure. The embodiments disclosed herein may be combined in any desired manner without departing from the spirit and scope of the present disclosure. Those skilled in the art will also appreciate that various modifications might be made to the embodiments without departing from the scope and spirit of the present disclosure. The scope of the present disclosure is defined by the appended claims.

Claims

1. A test card, the test card comprising:

the liquid inlet is used for adding a liquid phase sample to be detected;

the liquid incubation groove is used for incubating the liquid phase sample to be detected;

a liquid outlet configured to be adapted to flow the liquid phase sample to be detected out of the liquid incubation tank;

wherein when the detection card is in a first position, the detection card is configured to be suitable for incubating the liquid phase sample to be detected, and the detection card is configured to flow out of the liquid outlet when the detection card is flipped from the first position to a second position.

2. The test card of claim 1, further comprising an incubation unit configured to control the temperature of the liquid incubation well.

3. The test card of claim 1, further comprising a limit stop, wherein the limit stop connects the liquid incubation well and the liquid outlet, and wherein a portion of the limit stop that is connected to the liquid incubation well forms a second well wall of the liquid incubation well.

4. The test card of claim 1, further comprising an upper card housing and a lower card housing, wherein the liquid incubation slot is configured to be positioned within a cavity formed by the mating snap fit of the upper card housing and the lower card housing, proximate to one end of the liquid inlet.

5. The test card of claim 1 or 4, further comprising a test area configured to be positioned within a cavity formed by the mating snap-fit of the upper and lower card shells, proximate to the outlet end.

6. The test card of claim 5, wherein the portion of the upper card housing located in the test area is transparent, preferably the portions of the upper card housing and the lower card housing located in the test area are both transparent.

7. The test card of claim 6, wherein the upper and lower card shells are glass.

8. A test system comprising the test card of any one of claims 1-7, wherein the test card is used in combination with the test system.

9. The detection system of claim 8, further comprising a detection module, a signal processing module, a control module, a light source, and a light shielding housing,

wherein the detection module and the light source are configured inside the light-shielding shell, and the signal processing module is connected with the detection module;

the detection module is configured to acquire photon signals of the detection area of the detection card and/or take a photograph of the detection area;

the light source is configured for exposure of the color-developing substance and/or excitation of the luminescent substance;

the signal processing module is configured to process the photoelectric signal transmitted by the detection module to obtain information of the object to be detected;

the control module is configured to perform at least one of: the detection module is opened and/or closed; turning on and/or off the light source; temperature regulation of the incubation unit.

10. The test system of claim 8, further comprising a test card base configured to secure or position the test card.

11. The system according to claim 8 or 10, wherein the detection card base is provided with a through hole corresponding to the detection area of the detection card, and the through hole is used for transmitting light.

12. The detection system according to claim 8 or 9, characterized in that a focusing module and/or a filter is arranged on the light path between the detection module and the detection area of the detection card.

13. The detection system according to claim 8 or 9, wherein the signal processing module is configured with an embedded processor and/or an external smart terminal provided inside the light-tight housing.

14. The detection system according to claim 13, wherein the connection between the embedded processor and/or the external intelligent terminal and the detection module is any one of wired connection and wireless connection.

15. A detection method, characterized in that the method uses a detection system according to any one of claims 8-14, and the method comprises the steps of:

s1: preparing a sample to be measured and a reaction solvent or a chemical reagent related to the sample to be measured;

s2: dripping the prepared sample or solvent to be detected from a liquid inlet according to detection requirements, and incubating in a liquid incubation groove at the temperature control of an incubation unit according to the temperature required by detection;

S3: inserting a detection card carrying the sample to be detected after incubation into a detection system, and after the detection card turns over in the detection system, carrying out a detection area of the detection card on the sample to be detected;

s4: starting a light source and a detection module through a control module of the detection system, and detecting or photographing signals of a detection area;

s5: and comparing and analyzing the result processed by the signal processing module to obtain the information of the sample to be detected.

16. Use of a test card according to any one of claims 1-7 and a test system according to any one of claims 8-14, the use comprising at least one of the following: immunochromatography detection, biochemical reagent detection, chemical probe and sensing detection, and multi-item combination detection.