CN111122855B

CN111122855B - Instant detection system of fluorescence immunochromatographic test strip

Info

Publication number: CN111122855B
Application number: CN202010027571.XA
Authority: CN
Inventors: 吴勇
Original assignee: Shanghai Taihui Biotechnology Co ltd
Current assignee: Shanghai Taihui Biotechnology Co ltd
Priority date: 2020-01-10
Filing date: 2020-01-10
Publication date: 2023-04-11
Anticipated expiration: 2040-01-10
Also published as: CN111122855A

Abstract

The present disclosure relates to an instant detection system of a fluorescence immunochromatographic test strip, wherein the test strip has a fluorescence area containing a fluorescence probe and a non-fluorescence area containing no fluorescence probe. The detection system comprises an information acquisition device and a calculation device which are separated from each other; the information acquisition device comprises an acquisition assembly and a first communication assembly, and the computing device comprises a control module, a storage module, a second communication module and an output module. The detection system adopts an improved noise reduction algorithm, so that the detection sensitivity of the system is improved. The information acquisition device of the detection system only has the size of a palm, and the convenience of the detection system is greatly improved.

Description

Instant detection system of fluorescence immunochromatographic test strip

Technical Field

The disclosure relates to the technical field of in-vitro diagnosis of medical instruments, in particular to a fluorescence immunochromatographic test strip instant detection system and an instant detection method.

Background

The instant detection refers to that a non-professional detector utilizes a portable instrument to quickly diagnose and analyze a sample of a patient, and has the characteristics of convenience in carrying, simplicity in operation, field inspection and the like. Fluorescence immunochromatography is one of the most important means for instant detection. The fluorescence immunochromatography technology is used for quantitatively detecting the marker on the test strip by detecting fluorescence generated by excitation on the test strip.

Specifically, the fluorescence immunochromatography technique fixes specific antibodies to a certain zone (e.g., T line and C line) of a nitrocellulose membrane. When one end of the dry nitrocellulose membrane is immersed in or dripped into a sample (urine or serum), the antigen substance to be detected in the sample and the fluorescent conjugate of the antigen substance and the fluorescent probe migrate on the nitrocellulose membrane made of the strip-shaped fibers by virtue of capillary action. The fluorescent conjugate of the antigen substance to be detected is combined with the specific antibody on the zone to generate specific immunoreaction. Therefore, the zone displays a certain color or emits fluorescence with a certain intensity under the excitation of the exciting light, thereby realizing qualitative or quantitative specific immunodiagnosis.

At present, the detection instruments used for the fluorescence immunochromatography technology mainly comprise a scanning type detector and an imaging type detector. The scanning detector consists of an optical module and a mechanical scanning structure. The exciting diode of the optical module excites the fluorescent probe on the test strip, and the fluorescence generated by the excitation of the fluorescent probe is converged and then received by detectors such as a photodiode and the like. The detector can only detect local fluorescence of the test strip once, so that a transmission mechanism is needed to drive an optical module or a test strip tray to carry out scanning detection on the whole test strip, a fluorescence curve is obtained after ten seconds, and the content of a sample is calculated. The scanning type detector is simple to operate, but the measuring speed is slow, and the measured sample content has larger deviation from an actual value.

The imaging detector utilizes a fluorescence imaging camera to shoot and image the test strip once, and then processes the image. The imaging detector has high requirements on the performance of hardware such as an operating host, an imaging camera, a light-emitting diode light source and the like, and has the characteristics of large individual, complex specimen identification, complex operation, professional operation and the like. The instrument is mainly used in laboratory occasions and is rarely used in daily clinical examination occasions. In addition, the image "noise reduction" algorithm of the imaging detector generally adopts the gray signal of a black and white camera or the luminous intensity value of a certain single color signal of a color camera to subtract a uniform "baseline" value. Such processing tends to discard weak signal information, the detection of which determines the system sensitivity.

Disclosure of Invention

It is an object of the present disclosure to provide an instant detection system for a fluorescence immunochromatographic test strip that overcomes at least one of the drawbacks of the prior art.

The subject technology of the present disclosure is illustrated in accordance with aspects described below. For convenience, various examples of aspects of the subject technology are described as clauses (1, 2, 3, etc.) of the reference numerals. These terms are provided as examples and do not limit the subject technology of the present disclosure.

1. An instant detection system of a fluorescence immunochromatographic test strip, the test strip is provided with a fluorescence area containing a fluorescence probe and a non-fluorescence area containing no fluorescence probe, wherein:

the instant detection system of the fluorescence immunochromatographic test strip comprises an information acquisition device and a computing device which are separated from each other;

the information acquisition device comprises an acquisition component and a first communication component, wherein the acquisition component transmits exciting light to the test strip, acquires luminescence information of a fluorescence area and luminescence information of a non-fluorescence area of the test strip, and transmits the acquired luminescence information of the fluorescence area and the luminescence information of the non-fluorescence area of the test strip to the computing device;

the computing device comprises a control module, a storage module, a second communication module and an output module, wherein the storage module stores a fluorescent probe luminous intensity-fluorescent probe concentration calibration curve of the test strip, the second communication module and the first communication component are communicated with each other in a wireless mode or a wired mode,

the control module obtains the luminous information of the fluorescent area and the luminous information of the non-fluorescent area of the test strip through the communication between the first communication assembly and the second communication assembly, and performs noise reduction algorithm processing on the luminous information of the fluorescent area by using the luminous information of the non-fluorescent area to obtain the luminous intensity value of the fluorescent probe of the fluorescent area; the control module calls a preset fluorescent probe luminous intensity-fluorescent probe concentration calibration curve from the storage module, the fluorescent probe concentration value of the fluorescent region is obtained through fitting of the luminous intensity value of the fluorescent probe of the fluorescent region, and the fluorescent probe concentration value of the fluorescent region is output through the output module.

2. The instant detection system of the fluorescence immunochromatographic test strip according to item 1, wherein: the luminescence information of the fluorescent region includes a total luminescence intensity of the first single-color element signal of the fluorescent region and a total luminescence intensity of the second single-color element signal of the fluorescent region, and the luminescence information of the non-fluorescent region includes a total luminescence intensity of the first single-color element signal of the non-fluorescent region and a total luminescence intensity of the second single-color element signal of the non-fluorescent region, the fluorescence emitted by the fluorescent probe of the fluorescent region is the first single-color element signal, and the first single-color element signal and the second single-color element signal are different.

3. The instant detection system of the fluorescence immunochromatographic test strip according to item 2, wherein: the first single-color element signal and the second single-color element signal are any one of a red element signal, a blue element signal, and a green element signal.

4. The instant detection system of the fluorescence immunochromatographic test strip according to item 2, wherein: the formula of the noise reduction algorithm comprises

R＝Rt-Gy×(Rf/Gf)

Wherein, the first and the second end of the pipe are connected with each other,

r is the luminous intensity of the fluorescent probe in the fluorescent area,

rt is the total luminous intensity of the first single-color element signal of the fluorescent region,

gy is the total luminous intensity of the second single-color element signal of the fluorescence area,

rf is the total luminous intensity of the first single-color element signal of the non-fluorescent region, and

gf is the total luminous intensity of the second single-color element signal of the non-fluorescent area.

5. The fluorescence immunochromatographic test strip real-time detection system according to any one of clauses 1 to 4, wherein: the card shell of test paper strip is equipped with the identification code, the identification code contains the traceability data that bind with the sample.

6. The instant detection system of the fluorescence immunochromatographic test strip according to item 5, wherein: the collection component is configured to also collect identification code information of the test strip, and the control module identifies the traceability data of the test strip from the identification code information.

7. The instant detection system of the fluorescence immunochromatographic test strip according to item 5, wherein: the identification code is a two-dimensional code or a bar code.

8. The instant detection system of the fluorescent immunochromatographic test strip of any one of clauses 1-4, wherein: the first communication assembly and the second communication module are wireless communication devices or wired communication devices used in cooperation.

9. The fluorescence immunochromatographic test strip real-time detection system according to any one of clauses 1 to 4, wherein: the collection assembly comprises a light source, a filter and a camera, wherein the light source is configured to send exciting light to the test strip, and the camera is configured to shoot color pictures in a fluorescent area and a non-fluorescent area of the test strip through the filter.

10. The instant detection system of the fluorescence immunochromatographic test strip according to item 9, wherein: the test strip is placed opposite the camera and the filter, and the light source is disposed offset from the path between the camera and the filter, and the test strip, which are opposite to each other.

11. The instant detection system of the fluorescence immunochromatographic test strip according to item 9, wherein: the light source is an LED lamp with a diaphragm.

12. The instant detection system of the fluorescence immunochromatographic test strip according to item 9, wherein: the camera is a wide-angle digital camera.

13. The fluorescence immunochromatographic test strip real-time detection system according to any one of clauses 1 to 4, wherein: the information acquisition device further comprises an incubation component for maintaining the test strip at a predetermined temperature.

14. The instant detection system of the fluoroimmunoassay test strip of clause 13, wherein: the incubation assembly includes a heater, a refrigerator, a temperature controller, and a temperature sensor, the heater, the refrigerator, and the temperature sensor being disposed proximate to the test strip, and the temperature controller being configured to control the heater and/or the refrigerator to heat and/or cool the test strip based on the temperature of the test strip measured by the temperature sensor.

15. The fluorescence immunochromatographic test strip real-time detection system according to any one of clauses 1 to 4, wherein: the information acquisition device comprises an upper shell and a lower shell, wherein the upper shell and the lower shell are matched together to form a light-shading cavity inside.

16. The instant detection system of the fluoroimmunoassay test strip of clause 15, wherein: a support frame is arranged in the light-shading cavity and is fixed on the lower shell.

17. The instant detection system of the fluoroimmunoassay test strip of clause 16, wherein: the support frame includes a plurality of compartments configured to support a plurality of components of the information-gathering device.

18. The instant detection system of the fluoroimmunoassay test strip of clause 15, wherein: the information collecting device includes a test strip receiving slot fixed to the upper or lower housing and opened at the corresponding housing to receive the inserted test strip.

19. The fluorescence immunochromatographic test strip real-time detection system according to any one of clauses 1 to 4, wherein: the information acquisition device comprises a power supply assembly, and the power supply assembly supplies power to the information acquisition device.

20. The fluorescence immunochromatographic test strip real-time detection system according to any one of clauses 1 to 4, wherein: the length of the information acquisition device is not more than 10cm, the width is not more than 8cm, and the height is not more than 10cm.

21. The fluorescence immunochromatographic test strip real-time detection system according to any one of clauses 1 to 4, wherein: the computing device is a mobile terminal installed with the detection program, or one part of the computing device is arranged in the mobile terminal installed with the detection program, and the other part of the computing device is arranged in a server communicated with the mobile terminal.

22. The instant detection system of the fluorescent immunochromatographic test strip of any one of clauses 1-4, wherein: the test strip comprises a card shell and a nitrocellulose membrane arranged in the card shell, the test strip is provided with a sample loading port and a display port which are spaced along the axial direction, and the display port comprises a T line and a C line for test exposed in the area of the display port and a blank nitrocellulose membrane except the T line and the C line.

23. The instant detection system of the fluoroimmunoassay test strip of clause 22, wherein: the fluorescent areas include T and C lines in the display port, and the non-fluorescent areas include blank nitrocellulose membranes exposed in the display port.

24. The instant detection system of the fluoroimmunoassay test strip of clause 22, wherein: the non-fluorescent area is a blank nitrocellulose membrane exposed in the display port on the side of the T-line and C-line away from the loading port.

25. A method for carrying out instant detection on a test strip by using a fluorescent immunochromatographic test strip instant detection system is disclosed, wherein the method comprises the following steps:

inserting the test strip into an information collection device and initiating a test command in a computing device, wherein the information collection device and the computing device are separate from each other;

the information acquisition device sends exciting light to a fluorescent area containing the fluorescent probe and a non-fluorescent area not containing the fluorescent probe of the test strip, and acquires the luminous information of the fluorescent area and the luminous information of the non-fluorescent area of the test strip;

the computing device is communicated in a wireless mode or a wired mode between the information acquisition device and the computing device to obtain the luminous information of the fluorescent area and the luminous information of the non-fluorescent area of the test strip, and the luminous information of the non-fluorescent area is used for carrying out noise reduction algorithm processing on the luminous information of the fluorescent area to obtain the luminous intensity value of the fluorescent probe of the fluorescent area;

and the computing device obtains the concentration value of the fluorescent probe in the fluorescent region through the luminous intensity value of the fluorescent probe in the fluorescent region based on a preset fluorescent probe luminous intensity-fluorescent probe concentration calibration curve, and outputs the concentration value of the fluorescent probe in the fluorescent region.

26. The detection method of clause 25, wherein: after the detection command is started, the information acquisition device carries out constant temperature treatment on the test strip before the information acquisition device sends exciting light to the fluorescence area and the non-fluorescence area of the test strip so as to maintain the test strip at a constant preset temperature.

27. The detection method according to

clause

25 or 26, wherein: the information acquisition device acquires identification code information of the test strip during the transmission of the exciting light, and the calculation device identifies the source tracing data of the test strip from the identification code information and outputs the source tracing data of the test strip.

28. The detection method according to

clause

25 or 26, wherein: the instant detection system of a fluorescence immunochromatographic test strip is the instant detection system of a fluorescence immunochromatographic test strip according to any one of clauses 1 to 24.

29. A fluorescence immunochromatographic test strip instant detection method comprises the following steps:

receiving the light-emitting information of the fluorescent area and the light-emitting information of the non-fluorescent area of the test strip, and performing noise reduction algorithm processing on the light-emitting information of the fluorescent area by using the light-emitting information of the non-fluorescent area to obtain the light-emitting intensity value of the fluorescent probe of the fluorescent area;

and obtaining the fluorescent probe concentration value of the fluorescent area through the luminous intensity value of the fluorescent probe of the fluorescent area based on a preset fluorescent probe luminous intensity-fluorescent probe concentration calibration curve, and outputting the fluorescent probe concentration value of the fluorescent area.

30. The detection method of clause 29, wherein: the luminescence information of the fluorescent region includes a total luminescence intensity of the first single-color element signal of the fluorescent region and a total luminescence intensity of the second single-color element signal of the fluorescent region, and the luminescence information of the non-fluorescent region includes a total luminescence intensity of the first single-color element signal of the non-fluorescent region and a total luminescence intensity of the second single-color element signal of the non-fluorescent region, the fluorescence emitted by the fluorescent probe of the fluorescent region is the first single-color element signal, and the first single-color element signal and the second single-color element signal are different.

31. The detection method of clause 30, wherein: the first single-color element signal and the second single-color element signal are any one of a red element signal, a blue element signal, and a green element signal.

32. The detection method of clause 30, wherein: the formula of the noise reduction algorithm comprises

R＝Rt-Gy×(Rf/Gf)

Wherein the content of the first and second substances,

r is the luminous intensity emitted by the fluorescent probe in the fluorescent region,

33. The detection method according to any one of clauses 29-32, wherein: and receiving the identification code information of the test strip, and identifying the traceability data of the test strip from the identification code information.

34. A computing device, wherein the computing device comprises:

one or more processors; and

one or more storage modules configured to store a series of computer-executable instructions and computer-accessible data associated with the series of computer-executable instructions,

wherein the series of computer-executable instructions, when executed by the one or more processors, cause the one or more processors to perform the method of any one of clauses 29-33.

35. A non-transitory computer-readable storage medium having stored thereon a series of computer-executable instructions that, when executed by one or more computing devices, cause the one or more computing devices to perform the method of any of clauses 29-33.

Additional features and advantages of the disclosed subject technology will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the disclosed subject technology. The advantages of the subject technology of the present disclosure will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology of the present disclosure as claimed.

Drawings

Various aspects of the disclosure will be better understood upon reading the following detailed description in conjunction with the drawings in which:

fig. 1 shows a schematic diagram of a fluorescence immunochromatographic test strip real-time detection system according to an embodiment of the present disclosure;

FIG. 2 shows a front view of a strip to be tested by the instant test system of the fluorescence immunochromatographic strip of FIG. 1;

FIGS. 3 and 4 are exploded and assembled perspective views of the information collecting device of the instant detection system of the fluorescence immunochromatographic test strip of FIG. 1; and

fig. 5 shows a flow chart of a detection method of the instant detection system of the fluorescence immunochromatographic test strip of fig. 1.

Detailed Description

The present disclosure will now be described with reference to the accompanying drawings, which illustrate several embodiments of the disclosure. It should be understood, however, that the present disclosure may be presented in many different ways and is not limited to the embodiments described below; rather, the embodiments described below are intended to provide a more complete disclosure of the present disclosure, and to fully convey the scope of the disclosure to those skilled in the art. It is also to be understood that the embodiments disclosed herein can be combined in various ways to provide further additional embodiments.

It should be understood that like reference numerals refer to like elements throughout the several views. In the drawings, the size of some of the features may be varied for clarity.

It is to be understood that the terminology used in the description is for the purpose of describing particular embodiments only, and is not intended to limit the disclosure. All terms (including technical and scientific terms) used in the specification have the meaning commonly understood by one of ordinary skill in the art unless otherwise defined. Well-known functions or constructions may not be described in detail for brevity and/or clarity.

As used in this specification, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. The terms "comprising," "including," and "containing" when used in this specification specify the presence of stated features, but do not preclude the presence or addition of one or more other features. The term "and/or" as used in this specification includes any and all combinations of one or more of the associated listed items. The terms "between X and Y" and "between about X and Y" as used in the specification should be construed to include X and Y. The term "between about X and Y" as used herein means "between about X and about Y" and the term "from about X to Y" as used herein means "from about X to about Y".

In the description, when an element is referred to as being "on," "attached" to, "connected" to, "coupled" to, or "contacting" another element, etc., another element 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, one feature may be "adjacent" to another feature, and may mean that one feature has a portion overlapping with or is located above or below the adjacent feature.

In the description, spatial terms such as "upper", "lower", "left", "right", "front", "rear", "high", "low", and the like may describe a relationship of one feature to another feature in the drawings. It will be understood that the spatial relationship terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, features originally described as "below" other features when the device in the drawings is turned over may now be described as "above" the other features. The device may also be otherwise oriented (rotated 90 degrees or at other orientations) and the relative spatial relationships may be interpreted accordingly.

The systems described herein may also utilize one or more control modules to receive information and transform the received information to generate an output. The control module may include any type of computing device, computing circuitry, or any type of processor or processing circuitry capable of executing a series of instructions stored in a memory module. The control module may include multiple processors and/or multi-core Central Processing Units (CPUs) and may include any type of processor, such as a microprocessor, digital signal processor, micro-control module, and the like. The control module may also include a memory module to store data and/or algorithms to execute a series of instructions.

Any of the methods, programs, algorithms or code described in this specification can be converted or expressed in a programming language or computer program. "programming language" and "computer program" are any language used to designate instructions to a computer, and include (but are not limited to) these languages and their derivatives: assembly language, basic, batch files, BCPL, C + +, delphi, fortran, java, javaScript, machine code, operating system command language, pascal, perl, PL1, scripting language, visual Basic, its own meta-language specifying programs, and first, second, third, fourth, and fifth generation computer languages. Also included are databases and other data schemas, as well as any other meta-language. For purposes of this definition, no distinction is made between languages that are interpreted, compiled, or languages that use both compiled and interpreted methods. For the purposes of this definition, no distinction is made between compiled and source versions of a program. Thus, references to a program in a programming language that may exist in more than one state (such as a source state, a compiled state, an object state, or a linked state) are references to any and all such states. The definition also contains valid instructions and the intent of those instructions.

Any of the methods, programs, algorithms or code described in this specification can be embodied on one or more machine-readable media or storage modules. The term "memory module" may include a mechanism that provides (e.g., stores and/or transmits) information in a form readable by a machine, such as a processor, computer, or digital processing device. For example, the memory module may include a read-only memory module (ROM), a random access memory module (RAM), a magnetic disk storage medium, an optical storage medium, a flash memory device, or any other volatile or non-volatile storage device. The code or instructions contained thereon may be represented by carrier wave signals, infrared signals, digital signals, and other similar signals.

Fig. 1 shows a schematic diagram of a fluorescence immunochromatographic test strip instant detection system 1 according to an embodiment of the present disclosure. As shown, the detection system 1 comprises a separate information acquisition device 2 and a calculation device 3. The information collecting device 2 and the computing device 3 are separated and communicate with each other in a wireless manner or a wired manner. The information collection device 2 collects various information (e.g., luminescence information, identification code information, etc.) from the strip 4 and transmits the collected information to the computing device 3. The computing means 3 processes the received information and outputs the result of the processing (e.g. fluorescent probe concentration, sample traceability data, etc.).

The test strip 4 detected by the detection system 1 is a test strip after receiving a sample and performing a test. As shown in fig. 2, the test strip 4 may include a cartridge 41 and a nitrocellulose membrane 42 disposed in the cartridge 41. The test strip 4 has a loading port 43 and a display port 44 spaced apart in the axial direction. The loading port 43 is used for receiving a sample (e.g., urine, serum, etc.), and the substance to be detected and its fluorescent conjugate in the sample are transferred to the display port 44 by capillary action of the nitrocellulose membrane 42. In some embodiments, the substance to be detected that is immunoreactive on the strip 4 is an antigen, and the fluorescent conjugate of the substance to be detected is generated by binding the antigen to an antibody conjugated to the surface of the fluorescent probe.

The display opening 44 comprises a blank nitrocellulose membrane 421 exposed in the area of the display opening and a T line and a C line 45 for testing, and the transmitted substance to be detected and the fluorescent conjugate thereof are coupled and fixed by immunoreaction when reaching the T line and the C line 45. In the test strip after effective test, the T-line and the C-line 45 in the display port 44 contain fluorescent probes and serve as fluorescent regions for the information acquisition device 2 to acquire luminescence information, and the fluorescent regions of the present disclosure are the positions of the T-line and the C-line 45. The fluorescent probe generates fluorescence during excitation by the excitation light. The blank nitrocellulose membrane 421 exposed in the display port 44 contains no fluorescent probe or less fluorescent probe in some portions and serves as a non-fluorescent region where the information acquisition apparatus 2 acquires luminescence information. In some embodiments, the non-fluorescence region may be a blank nitrocellulose membrane 421 in the display port region on the side of the T-line and C-line 45 away from the loading port 43, and the blank nitrocellulose membrane 421 on the side contains no or less fluorescence probes transmitted by capillary action, which may ensure the accuracy of information acquisition such as background light signal.

The identification code 46 is provided on the card case 41 (for example, by printing or pasting), and serves as an area where the information collection device 2 collects identification code information. In some embodiments, the identification code 46 may be located on the card housing 41 on a side of the display port 44 remote from the loading port 43. In some embodiments, the identification code 46 may be a two-dimensional code or a bar code.

Fig. 3 and 4 show an exploded perspective view and an assembled perspective view of the information collection device 2 (with the upper case removed). As shown in the figure, the information collecting device 2 includes an upper case 21 and a lower case 22, and the upper case 21 and the lower case 22 are fitted together to form a light-shielding cavity inside. The support frame 23 is located in the light-shielding cavity and is fixed to the lower case 22. The support shelf 23 includes a plurality of compartments for supporting one or more components of the collection assembly 24, the communication assembly 25, the incubation assembly 26, the power assembly 27, and/or the test strip receiving slot 28. The test strip receiving slot 28 is for receiving the inserted test strip 4. The incubation assembly 26 is used to maintain the inserted test strip 4 at a constant preset temperature. The collection member 24 sends excitation light to the strip 4 and collects various information (e.g., luminescence information, identification code information, etc.) of the strip 4 during excitation. The communication component 25 transmits the collected information to the computing device 3. The power supply unit 27 is used to supply power to the information acquisition apparatus 2.

The collection assembly 24 includes a light source 241, a filter 242, and a camera 243. The light source 241 is used for emitting excitation light to the strip 4. The filter 242 is used to filter the background light and the light scattered by the excitation light illuminating the nitrocellulose membrane 42. The camera 243 captures information such as light emission information of a fluorescent area and a non-fluorescent area and an identification code on the test strip 4 by taking a color photograph. In some embodiments, the test strip receiving slot 28 may be disposed opposite to the camera 243 and the filter 242; the light source 241 may be disposed offset from the path between the camera 243 and the filter 242, and the test strip receiving slot 28, which are opposite to each other. In some embodiments, the light source 241, the filter 242, and the camera 243 are all placed on the support frame 23. In some embodiments, the light source 241 may be an LED lamp with a diaphragm; the camera 243 may be a wide-angle digital camera, such as a CCD camera or a CMOS camera, or the like.

The communication component 25 transmits the information collected by the collection component 24 to the computing device 3. Communication component 25 may be a wireless communication device (e.g., WIFI, bluetooth, etc.) or a wired communication device (e.g., through a USB port) for use with a communication module on computing device 3.

The incubation assembly 26 maintains the test strip 4 in the test strip receiving well 28 at a predetermined temperature (e.g., 37 ℃). The incubation assembly 26 includes a heater 261, a refrigerator 262, a temperature controller 263, and a temperature sensor 264. The heater 261, the refrigerator 262 and the temperature sensor 264 are disposed in close proximity to the test strip 4. The temperature controller 263 controls the heater 261 and/or the refrigerator 262 to heat and/or cool the test strip 4 according to the temperature of the test strip 4 measured by the temperature sensor 264 to maintain the test strip 4 at a constant preset temperature.

The power supply component 27 is used to power the acquisition component 24, the communication component 25, the incubation component 26, etc. The power supply assembly 27 may include an internal power source (including a charging pad, lithium battery, etc.), and/or an external power source (e.g., via a USB port).

The test strip receiving groove 28 is fixed to the upper housing 21 or the lower housing 22 and is opened on the corresponding housing for receiving the inserted test strip 4.

In some embodiments, the information collection device 2 may have a length of no greater than 10cm, a width of no greater than 8cm, and a height of no greater than 10cm.

Returning to fig. 1, computing device 3 includes a control module 31, a storage module 32, an output module 33, and a communication module 34. The communication module 34 is a wireless communication module or a wired communication module that cooperates with the communication assembly 25. The control module 31 acquires light emission information and the like through the communication of the communication module 34 and the communication member 25. The control module 31 performs noise reduction on the luminescence information, and calculates and obtains the luminescence intensity of the fluorescent probe in the fluorescence area of the test strip 4. The storage module 32 stores a calibration curve of the fluorescence probe light intensity-fluorescence probe concentration. The control module 31 retrieves the calibration curve from the storage module 32, and obtains the fluorescent probe concentration of the test strip 4 according to the obtained fluorescent probe luminous intensity. The control module 32 outputs the fluorescent probe concentration of the test strip 4 through the output module 33.

In some embodiments, the computing device 3 may be a mobile terminal (e.g., a mobile phone, a tablet computer, etc.) installed with the detection program, or a part of the computing device 3 is disposed in the mobile terminal installed with the detection program and another part is disposed in a server in communication with the mobile terminal.

In some embodiments, the control module 31 further obtains the identification code information through the communication between the communication module 34 and the communication component 25, identifies the traceability data of the test strip 4, and stores the traceability data in the storage module 32. The output module 33 can output the stored tracing data of the test strip 4.

The principle of the noise reduction processing of the color picture taken by the acquisition component 24 by the control module 31 of the computing device 3 is described below. When the light source 241 emits excitation light to the strip 4, the fluorescent probes in the fluorescence region are excited to generate fluorescence. However, the light of the fluorescence region captured by the camera 243 includes not only the fluorescence emitted from the fluorescence probe but also scattered light generated by the nitrocellulose membrane 42 being irradiated with the excitation light not filtered by the filter 242, background light, and the like. These scattered light and background light interfere with the sensitivity of detection of the fluorescence emission intensity, thereby affecting the measured value of the fluorescence probe concentration. Therefore, it is necessary to perform noise reduction processing on the light emission information of the captured fluorescence region.

Preferably, the fluorescent probe used in the immunoassay chromatography test strip generally has a specific fluorescence emission peak, and the fluorescence emission peak covers one or two adjacent of three elements of blue, green and red (e.g., a fluorescence signal of blue-green element, a fluorescence signal of green-red element). More preferably, the fluorescent light emitted from the fluorescent probe of the fluorescent area may be any one of a red element signal, a blue element signal and a green element signal according to the material design of the fluorescent probe and the selection of the excitation light. By way of illustration, the present disclosure sets the fluorescence emitted by the fluorescent probes of the fluorescence region as a red elemental signal, employs the red elemental signal as a primary signal, and employs a signal of another color than the red elemental signal (e.g., a green elemental signal) as a reference signal.

In the embodiment of the present disclosure, the camera 243 simultaneously collects the luminescence information of the fluorescence region and the luminescence information of the non-fluorescence region. The light emission information of the fluorescence area includes the light emission intensity of the red element signal and also includes the light emission intensity of the green element signal. The red element signal in the luminescence information of the fluorescence region includes both the red element signal emitted by fluorescence (set as above) and the red element signal emitted by scattered light and background light, which are noise signals to be eliminated from the red element signal emitted by fluorescence. The green element signal in the luminescence information of the fluorescence area includes only the green element signal emitted by the scattered light and the background light because the fluorescence emits only the red element signal and does not emit the green element signal. Similarly, the light emission information of the non-fluorescence region includes the light emission intensity of the red element signal and also includes the light emission intensity of the green element signal. The red element signals in the luminous information of the non-fluorescent region comprise red element signals emitted by scattered light and background light; and the green element signal in the luminescence information of the fluorescence region comprises the green element signal emitted by scattered light and background light.

The ratio of the luminous intensities of the red element signal and the green element signal in the scattered light and the background light is fixed in both the fluorescent region and the non-fluorescent region. Therefore, by measuring the light emission intensities of the red element signal and the green element signal in the scattered light and the background light of the non-fluorescent region and the light emission intensities of the red element signal and the green element signal in the scattered light and the background light of the fluorescent region, the light emission intensities of the scattered light and the red element signal in the background light of the fluorescent region, that is, the light emission intensity of the noise signal can be obtained. The total luminous intensity of the red element signal in the luminous information of the fluorescent region is subtracted by the luminous intensity of the red element signal in the scattered light and the background light of the fluorescent region to obtain the luminous intensity of the red element signal of the fluorescence emitted by the fluorescent probe. And obtaining the concentration of the fluorescent probe according to a preset fluorescent probe luminous intensity-fluorescent probe concentration calibration curve.

The noise reduction formula is as follows:

Rn/Gy＝Rf/Gf (1)

R＝Rt-Rn (2)

thereby:

R＝Rt-Gy×(Rf/Gf) (3)

wherein Rn is the emission intensity of the red noise signal in the fluorescence region; gy is the total luminous intensity of the green element signal of the fluorescence area; rf is the total luminous intensity of the red element signal of the non-fluorescence area; gf is the total luminous intensity of the green element signal in the non-fluorescent region; r is the luminous intensity of the red element signal emitted by the fluorescent probe in the fluorescent region, and Rt is the total luminous intensity of the red element signal in the fluorescent region.

Gy × (Rf/Gf) on the right side of equation (3) may increase the correction coefficient for different detection items. Empirically, the correction factor is close to 1.

Fig. 5 shows a flow chart of the detection method of the instant detection system 1 of the fluorescence immunochromatographic test strip. As shown in the figure, in step S1, the test strip 4 is inserted into the test strip receiving slot 28 of the information collecting device 2, and a test command is turned on in a test program of the computing device 3.

In step S2, control module 31 of computing device 3 sends a detection-on command to incubation assembly 26 of information acquisition device 2 through communication between communication module 34 and communication assembly 25. The temperature controller 263 of the incubation assembly 26 controls the heater 261 and/or the refrigerator 262 to heat and/or cool the strip 4 for 5-30 minutes according to the temperature near the strip 4 measured by the temperature sensor 264 to maintain the strip 4 at a constant preset temperature (e.g., 37 ℃).

Subsequently, in step S3, the control module 31 of the computing apparatus 3 transmits a detection start command to the acquisition component 24 of the information acquisition apparatus 2 through communication between the communication module 34 and the communication component 25. The light source 241 of the collection assembly 24 is turned on and provides excitation light to the test strip 4. During the excitation, the camera 243 takes a color photograph of the test strip 4 to collect the luminescence information of the fluorescence area and the luminescence information of the non-fluorescence area on the test strip 4, and the identification code information. The color picture is converted into an electric signal by the photoelectric signal, and the identification code information and the light emitting information are respectively output to the control module 31 of the computing device 3 through the communication between the communication module 34 and the communication component 25.

In step S4, the control module 31 identifies the tracing data of the test strip 4 from the identification code information, and outputs the tracing data to the storage module 32.

In step S5, the control module 31 processes the received light-emitting information of the fluorescence region and the received light-emitting information of the non-fluorescence region by the noise reduction algorithm, so as to obtain the light-emitting intensity of the fluorescence probe in the fluorescence region. The control module 31 retrieves a pre-stored calibration curve of fluorescence probe light emission intensity-fluorescence probe concentration from the storage module 32, and fits the calibration curve to obtain the corresponding fluorescence probe concentration.

In step S6, the output module 33 outputs the fluorescent probe concentration and/or the tracing data, for example, to be displayed on a display screen of the computing device.

The instant detection system for the fluorescence immunochromatographic test strip according to the embodiment of the present disclosure has a fast measurement speed and is relatively accurate in measurement.

According to the information acquisition device of the instant detection system of the fluorescence immunochromatographic test strip, a processor and a scanning device which occupy a large space are omitted, the device can be only palm-sized, and the convenience is greatly improved.

The instant detection system of the fluorescence immunochromatographic test strip according to the embodiment of the present disclosure hands over the processing work to a processor in a mobile phone for completion. The mobile phone is also a terminal of future communication, network and information processing core technologies such as 5G, big data, artificial intelligence and the like, and the adoption of the terminal is favorable for directly butting the immunodetection data with the technologies.

The real-time detection system of the fluorescence immunochromatographic test strip according to the embodiment of the present disclosure adopts an improved noise reduction algorithm, and improves the sensitivity of system detection.

Although exemplary embodiments of the present disclosure have been described, it will be understood by those skilled in the art that various changes and modifications can be made to the exemplary embodiments of the present disclosure without substantially departing from the spirit and scope of the present disclosure. Accordingly, all changes and modifications are intended to be included within the scope of the present disclosure as defined in the appended claims. The disclosure is defined by the following claims, with equivalents of the claims to be included therein.

Claims

1. A real-time detection system of a fluorescence immunochromatographic test strip, the test strip is provided with a fluorescence area containing a fluorescence probe and a non-fluorescence area containing no fluorescence probe, and the system is characterized in that:

the control module obtains the luminous information of the fluorescent area and the luminous information of the non-fluorescent area of the test strip through the communication between the first communication assembly and the second communication assembly, and performs noise reduction algorithm processing on the luminous information of the fluorescent area by using the luminous information of the non-fluorescent area to obtain the luminous intensity value of the fluorescent probe of the fluorescent area; the control module calls a preset fluorescent probe luminous intensity-fluorescent probe concentration calibration curve from the storage module, obtains a fluorescent probe concentration value of the fluorescent region through fitting of the luminous intensity value of the fluorescent probe of the fluorescent region, outputs the fluorescent probe concentration value of the fluorescent region through the output module,

the luminescence information of the fluorescence area includes a total luminescence intensity of the first single color element signal of the fluorescence area and a total luminescence intensity of the second single color element signal of the fluorescence area, and the luminescence information of the non-fluorescence area includes a total luminescence intensity of the first single color element signal of the non-fluorescence area and a total luminescence intensity of the second single color element signal of the non-fluorescence area, the fluorescence emitted by the fluorescent probe of the fluorescence area is the first single color element signal, and the first single color element signal and the second single color element signal are different,

wherein the formula of the noise reduction algorithm comprises

R＝Rt-Gy×(Rf/Gf)

Wherein the content of the first and second substances,

r is the luminous intensity of the fluorescent probe in the fluorescent region,

2. The instant detection system of the fluorescence immunochromatographic test strip of claim 1, which is characterized in that: the first single-color element signal and the second single-color element signal are any one of a red element signal, a blue element signal, and a green element signal.

3. The instant detection system of the fluorescence immunochromatographic test strip according to any one of claims 1 to 2, characterized in that: the card shell of test paper strip is equipped with the identification code, the identification code contains the traceability data that bind with the sample.

4. The instant detection system of the fluorescence immunochromatographic test strip of claim 3, which is characterized in that: the collection component is configured to also collect identification code information of the test strip, and the control module identifies the traceability data of the test strip from the identification code information.

5. The instant detection system of the fluorescence immunochromatographic test strip of claim 3, characterized in that: the identification code is a two-dimensional code or a bar code.

6. The instant detection system of the fluorescence immunochromatographic test strip according to any one of claims 1 to 2, characterized in that: the first communication assembly and the second communication module are wireless communication devices or wired communication devices used in cooperation.

7. The instant detection system of the fluorescence immunochromatographic test strip according to any one of claims 1 to 2, characterized in that: the collection assembly comprises a light source, a filter and a camera, wherein the light source is configured to send exciting light to the test strip, and the camera is configured to shoot color pictures in a fluorescent area and a non-fluorescent area of the test strip through the filter.

8. The instant detection system of the fluorescence immunochromatographic test strip of claim 7, which is characterized in that: the test strip is placed opposite the camera and the filter, and the light source is disposed offset from a path between the camera and the filter, and the test strip, which are opposite to each other.

9. The instant detection system of the fluorescence immunochromatographic test strip of claim 7, which is characterized in that: the light source is an LED lamp with a diaphragm.

10. The instant detection system of the fluorescence immunochromatographic test strip of claim 7, which is characterized in that: the camera is a wide-angle digital camera.

11. The instant detection system of the fluorescence immunochromatographic test strip according to any one of claims 1 to 2, characterized in that: the information acquisition device further comprises an incubation component for maintaining the test strip at a predetermined temperature.

12. The instant detection system of the fluorescence immunochromatographic test strip of claim 11, which is characterized in that: the incubation assembly includes a heater, a refrigerator, a temperature controller, and a temperature sensor, the heater, the refrigerator, and the temperature sensor being disposed proximate to the test strip, and the temperature controller being configured to control the heater and/or the refrigerator to heat and/or cool the test strip based on the temperature of the test strip measured by the temperature sensor.

13. The instant detection system of the fluorescence immunochromatographic test strip according to any one of claims 1 to 2, characterized in that: the information acquisition device comprises an upper shell and a lower shell, wherein the upper shell and the lower shell are matched together to form a light-shading cavity inside.

14. The instant detection system of the fluorescence immunochromatographic test strip of claim 13, which is characterized in that: a support frame is arranged in the light-shading cavity and is fixed on the lower shell.

15. The instant detection system of the fluorescence immunochromatographic test strip of claim 14, which is characterized in that: the support frame includes a plurality of compartments configured to support a plurality of components of the information-gathering device.

16. The instant detection system of the fluorescence immunochromatographic test strip according to claim 13, characterized in that: the information collecting device includes a test strip receiving slot fixed to the upper housing or the lower housing and opened at the corresponding housing to receive the inserted test strip.

17. The instant detection system of the fluorescence immunochromatographic test strip according to any one of claims 1 to 2, characterized in that: the information acquisition device comprises a power supply assembly, and the power supply assembly supplies power to the information acquisition device.

18. The instant detection system of the fluorescence immunochromatographic test strip according to any one of claims 1 to 2, characterized in that: the length of the information acquisition device is not more than 10cm, the width of the information acquisition device is not more than 8cm, and the height of the information acquisition device is not more than 10cm.

19. The instant detection system of the fluorescence immunochromatographic test strip according to any one of claims 1 to 2, characterized in that: the computing device is a mobile terminal installed with the detection program, or one part of the computing device is arranged in the mobile terminal installed with the detection program, and the other part of the computing device is arranged in a server communicated with the mobile terminal.

20. The instant detection system of the fluorescence immunochromatographic test strip according to any one of claims 1 to 2, characterized in that: the test strip comprises a card shell and a nitrocellulose membrane arranged in the card shell, the test strip is provided with a sample loading port and a display port which are spaced along the axial direction, and the display port comprises a T line and a C line which are exposed out of the display port area and used for testing and a blank nitrocellulose membrane except the T line and the C line.

21. The instant detection system of the fluorescence immunochromatographic test strip of claim 20, which is characterized in that: the fluorescent area includes a T line and a C line in the display port, and the non-fluorescent area includes a blank nitrocellulose membrane exposed in the display port.

22. The instant detection system of the fluorescence immunochromatographic test strip of claim 20, which is characterized in that: the non-fluorescent area is a blank nitrocellulose membrane exposed in the display port on the side of the T-line and C-line away from the loading port.

23. A method for performing an on-line test on a test strip by using the fluorescent immunochromatographic test strip on-line test system according to any one of claims 1 to 22, the method comprising the steps of:

24. The detection method according to claim 23, characterized in that: after the detection command is started, before the information acquisition device sends exciting light to the fluorescence area and the non-fluorescence area of the test strip, the information acquisition device carries out constant temperature treatment on the test strip so as to maintain the test strip at a constant preset temperature.

25. The detection method according to claim 23 or 24, characterized in that: the information acquisition device acquires identification code information of the test strip during the transmission of the excitation light, and the calculation device identifies the traceability data of the test strip from the identification code information and outputs the traceability data of the test strip.

26. A fluorescence immunochromatographic test strip instant detection method is characterized by comprising the following steps:

receiving the luminous information of the fluorescent area and the luminous information of the non-fluorescent area of the test strip, and performing noise reduction algorithm processing on the luminous information of the fluorescent area by using the luminous information of the non-fluorescent area to obtain the luminous intensity value of the fluorescent probe of the fluorescent area;

based on a preset fluorescent probe luminous intensity-fluorescent probe concentration calibration curve, obtaining a fluorescent probe concentration value of a fluorescent area through the luminous intensity value of the fluorescent probe of the fluorescent area, outputting the fluorescent probe concentration value of the fluorescent area,

the luminescence information of the fluorescent region includes a total luminescence intensity of the first single-color element signal of the fluorescent region and a total luminescence intensity of the second single-color element signal of the fluorescent region, and the luminescence information of the non-fluorescent region includes a total luminescence intensity of the first single-color element signal of the non-fluorescent region and a total luminescence intensity of the second single-color element signal of the non-fluorescent region, the fluorescence emitted by the fluorescent probe of the fluorescent region is the first single-color element signal, and the first single-color element signal and the second single-color element signal are different,

wherein the formula of the noise reduction algorithm comprises

R＝Rt-Gy×(Rf/Gf)

Wherein the content of the first and second substances,

27. The detection method according to claim 26, characterized in that: the first single-color element signal and the second single-color element signal are any one of a red element signal, a blue element signal, and a green element signal.

28. The detection method according to any one of claims 26 to 27, wherein: and receiving the identification code information of the test strip, and identifying the traceability data of the test strip from the identification code information.

29. A computing device, wherein the computing device comprises:

one or more processors; and

wherein the series of computer-executable instructions, when executed by the one or more processors, cause the one or more processors to perform the method of any one of claims 26-28.

30. A non-transitory computer-readable storage medium having stored thereon a series of computer-executable instructions that, when executed by one or more computing devices, cause the one or more computing devices to perform the method of any of claims 26-28.