CN212586388U - Test strip for testing specimen sample - Google Patents

Abstract

The present disclosure relates to a test strip for testing a specimen sample. The detection system for detecting the test strip 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 simulates to obtain a calibration curve at the actual ambient temperature, so that the accuracy of the concentration measurement of the luminescent probe is obviously improved.

Description

Test strip for testing specimen sample

Technical Field

The disclosure relates to the technical field of in-vitro diagnosis of medical instruments, in particular to a test strip for testing a specimen sample.

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. Immunochromatography is one of the most important means for real-time detection. The immunochromatography technology quantitatively detects the markers on the test strip by detecting fluorescence or afterglow generated by excitation on the test strip.

Specifically, the 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 a luminescent conjugate of the antigen substance and the luminescent probe migrate on the nitrocellulose membrane made of the strip-shaped fibers by virtue of capillary action. The luminescent 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 or afterglow with certain intensity under the excitation of the exciting light, thereby realizing qualitative or quantitative specific immunodiagnosis.

At present, the detection instruments used for immunochromatography mainly include 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 luminescent probe on the test strip, and the fluorescence generated by the excitation of the luminescent probe is collected and 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 content of the measured sample 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 higher 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 volume, 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.

It is also well known that ambient temperature is one of the most important parameters of the immune response, and that the immune calibration curves at each ambient temperature are not identical. Currently, the industrial detector only stores a calibration curve at 37 ℃, which requires incubation of the test environment to 37 ℃, otherwise the concentration of the luminescent probe obtained by the test is inaccurate. In the case of incubation of test strips with measured ambient temperatures other than 37 deg.C, the incubation unit is required to incubate for approximately half an hour. The incubation unit additionally adds to the size and weight of the meter, the handling steps, and the time for each sample measurement.

SUMMERY OF THE UTILITY MODEL

One of the objectives of the present disclosure is to provide an instant detection system for immunochromatographic test strips, which can overcome 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 an immunochromatographic test strip, wherein:

the immunochromatographic test strip instant detection system comprises an information acquisition device and a computing device which are separated from each other, the test strip comprises a light-emitting region, and the test strip and/or the information acquisition device comprises a temperature sensing pattern;

the information acquisition device comprises an acquisition component and a first communication component, wherein the acquisition component sends exciting light to the test strip and acquires light-emitting information and temperature-sensing pattern information of a light-emitting region of the test strip, the first communication component sends the acquired light-emitting information and temperature-sensing pattern information of the light-emitting region of the test strip to the computing device, and the light-emitting information comprises the light-emitting intensity of the light-emitting region of the test strip;

the computing device comprises a control module, a storage module, a second communication module and an output module, wherein the storage module stores the corresponding relation between the temperature sensing pattern information and the ambient temperature and a plurality of calibration curves of the luminous intensity of the luminous probe and the concentration of the luminous probe under a plurality of preset temperatures, the second communication module and the first communication assembly are communicated with each other in a wireless mode or a wired mode,

the control module obtains the light-emitting information and the temperature-sensing pattern information of the light-emitting area of the test strip through the communication between the first communication assembly and the second communication module, the control module calls the corresponding relation between the temperature-sensing pattern information and the ambient temperature from the storage module to obtain the ambient temperature T0 around the test strip, and the control module judges whether the ambient temperature T0 is equal to one of the preset temperatures:

in the case that the ambient temperature T0 is equal to one of the preset temperatures, the control module retrieves a calibration curve L0 of the luminescence probe luminescence intensity-luminescence probe concentration at the ambient temperature T0 from the storage module;

under the condition that the ambient temperature T0 is not equal to any one of the preset temperatures, the control module selects a preset temperature T1 and a preset temperature T2 which are vertically adjacent to the ambient temperature T0, calls a luminous probe luminous intensity-luminous probe concentration calibration curve L1 under the preset temperature T1 and a luminous probe luminous intensity-luminous probe concentration calibration curve L2 under the preset temperature T2 from the storage module, and simulates a luminous probe luminous intensity-luminous probe concentration calibration curve L0 under the ambient temperature T0 through a luminous probe luminous intensity-luminous probe concentration calibration curve L1 under the preset temperature T1 and a luminous probe luminous intensity-luminous probe concentration calibration curve L2 under the preset temperature T2;

the control module obtains a concentration value of the luminescent probe in the luminescent region of the test strip by fitting according to a luminescent probe luminescent intensity-luminescent probe concentration calibration curve L0 under the ambient temperature T0 and the obtained luminescent information of the luminescent region of the test strip, and outputs the concentration value of the luminescent probe in the luminescent region of the test strip through the output module.

2. The immunochromatographic test strip real-time detection system of item 1, wherein: the control module obtains n light-emitting probe light-emitting intensity values corresponding to the n light-emitting probe concentration values at a preset temperature T1 by using a light-emitting probe light-emitting intensity-light-emitting probe concentration calibration curve L1 at a preset temperature T1, obtains n light-emitting probe light-emitting intensity values corresponding to the n light-emitting probe concentration values at a preset temperature T2 by using a light-emitting probe light-emitting intensity-light-emitting probe concentration calibration curve L2 at a preset temperature T2, and obtains n light-emitting probe light-emitting intensity values corresponding to the n light-emitting probe concentration values at a preset temperature T1, and the n light-emitting probe concentration values and the n light-emitting probe light-emitting intensity values at a preset temperature T2, and obtaining the concentration values of the n luminescent probes and the corresponding luminescent intensity values of the luminescent probes under the ambient temperature T0 by a linear interpolation method, wherein n is an integer greater than 1.

3. The immunochromatographic strip immediate detection system of item 2, wherein: the control module simulates a calibration curve L0 of the luminous intensity of the luminous probe to the luminous probe concentration at the ambient temperature T0 by using a logarithmic logit-log4p model or a Spline curve Spline function from the n luminous probe concentration values and the corresponding luminous intensity values of the luminous probe at the ambient temperature T0.

4. The immunochromatographic test strip real-time detection system of item 1, wherein: the temperature sensing pattern is made of temperature sensing color-changing ink.

5. The immunochromatographic strip immediate detection system of item 4, wherein: the thermochromic ink includes a cholesteric liquid crystal thermochromic ink.

6. The immunochromatographic strip immediate detection system of item 4, wherein: the temperature sensing pattern comprises a plurality of small blocks which are adjacent, and each small block changes color at different critical temperatures due to different material proportions of the temperature sensing color-changing ink.

7. The immunochromatographic test strip real-time detection system of item 1, wherein: the luminescence information includes the luminescence intensity of fluorescence emitted by the fluorescent probe on the test strip.

8. The immunochromatographic test strip real-time detection system of item 1, wherein: the luminous information comprises the luminous intensity of afterglow emitted by the long afterglow luminous probe on the test strip.

9. The immunochromatographic test strip point-of-care system of any one of clauses 1-8, 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.

10. The immunochromatographic strip immediate detection system of clause 9, 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.

11. The immunochromatographic strip immediate detection system of clause 9, wherein: the identification code is a two-dimensional code or a bar code.

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

13. The immunochromatographic test strip point-of-care system of any one of clauses 1-8, 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 on the test strip through the filter.

14. The instant detection system of the fluoroimmunoassay test strip of clause 13, 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.

15. The immunochromatographic strip immediate detection system of item 13, wherein: the light source is an LED lamp with a diaphragm.

16. The immunochromatographic strip immediate detection system of item 13, wherein: the camera is a wide-angle digital camera.

17. The immunochromatographic test strip point-of-care system of any one of clauses 1-8, 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-proof cavity inside.

18. The immunochromatographic strip immediate detection system of clause 17, wherein: a support frame is arranged in the light-shading cavity and is fixed on the lower shell.

19. The immunochromatographic strip point-of-care test system of clause 18, wherein: the support frame includes a plurality of compartments configured to support a plurality of components of the information-gathering device.

20. The instant detection system of the fluoroimmunoassay test strip of clause 17, 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.

21. The fluorescence immunochromatographic test strip real-time detection system according to any one of clauses 1 to 8, wherein: the information acquisition device comprises a power supply assembly, and the power supply assembly supplies power to the information acquisition device.

22. The immunochromatographic test strip point-of-care system of any one of clauses 1-8, 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 10 cm.

23. The immunochromatographic test strip point-of-care system of any one of clauses 1-8, 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.

24. The immunochromatographic test strip point-of-care system of any one of clauses 1-8, wherein: the test strip comprises a card shell and a nitrocellulose membrane arranged in the card shell, wherein the card shell is provided with a sample loading port and a display port which are spaced along the axial direction, and the display port is the light-emitting area.

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

inserting the test strip into the information acquisition device and initiating a test command in the computing device;

the information acquisition device sends exciting light to the test strip and acquires light-emitting information and temperature-sensing pattern information of a light-emitting area of the test strip, wherein the light-emitting information comprises the light-emitting intensity of the light-emitting 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 acquire the luminous information and the temperature sensing pattern information of the luminous area of the test strip;

the calculation means obtains an ambient temperature T0 around the strip based on a correspondence between preset temperature-sensitive pattern information and the ambient temperature, and the calculation means judges whether the ambient temperature T0 is equal to one of the plurality of preset temperatures:

in the case where the ambient temperature T0 is equal to one of the plurality of preset temperatures, the calculation means retrieves a luminescent probe luminous intensity-luminescent probe concentration calibration curve L0 at the ambient temperature T0;

under the condition that the ambient temperature T0 is not equal to any of the preset temperatures, the computing device selects a preset temperature T1 and a preset temperature T2 which are adjacent to the ambient temperature T0 up and down, and calls a calibration curve L1 of the luminous probe luminous intensity-luminous probe concentration at the preset temperature T1 and a calibration curve L2 of the luminous probe luminous intensity-luminous probe concentration at the preset temperature T2, and the computing device simulates a calibration curve L0 of the luminous probe luminous intensity-luminous probe concentration at the ambient temperature T0 through the calibration curve L1 of the luminous probe luminous intensity-luminous probe concentration at the preset temperature T1 and the calibration curve L2 of the luminous probe luminous intensity-luminous probe concentration at the preset temperature T2;

and fitting the light-emitting probe concentration value of the light-emitting region of the test strip by the computing device according to the light-emitting probe light-emitting intensity-light-emitting probe concentration calibration curve L0 under the ambient temperature T0 and the obtained light-emitting information of the light-emitting region of the test strip, and outputting the light-emitting probe concentration value of the light-emitting region of the test strip.

26. The detection method of clause 25, wherein: 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.

27. The detection method according to clause 25 or 26, wherein: the immunochromatographic strip real-time detection system according to any one of clauses 1 to 24.

28. An instant detection method of an immunochromatographic test strip, wherein the method comprises the following steps:

receiving light-emitting information and temperature-sensing pattern information of a light-emitting area of the test strip;

obtaining an ambient temperature T0 around the test strip based on a corresponding relationship between preset temperature-sensitive pattern information and the ambient temperature, and judging whether the ambient temperature T0 is equal to one of a plurality of preset temperatures:

in the case that the ambient temperature T0 is equal to one of the plurality of preset temperatures, retrieving a calibration curve L0 of luminescence probe luminescence intensity-luminescence probe concentration at a preset ambient temperature T0;

under the condition that the ambient temperature T0 is not equal to any one of the preset temperatures, selecting a preset temperature T1 and a preset temperature T2 which are adjacent to the ambient temperature T0 at the upper and lower sides, calling a luminous probe luminous intensity-luminous probe concentration calibration curve L1 at the preset temperature T1 and a luminous probe luminous intensity-luminous probe concentration calibration curve L2 at the preset temperature T2, and simulating a luminous probe luminous intensity-luminous probe concentration calibration curve L0 at the ambient temperature T0 through a luminous probe luminous intensity-luminous probe concentration calibration curve L1 at the preset temperature T1 and a luminous probe luminous intensity-luminous probe concentration calibration curve L2 at the preset temperature T2;

and fitting to obtain a concentration value of the luminescent probe in the luminescent region of the test strip according to a luminescent probe luminescent intensity-luminescent probe concentration calibration curve L0 under the ambient temperature T0 and the obtained luminescent information of the luminescent region of the test strip, and outputting the concentration value of the luminescent probe in the luminescent region of the test strip.

29. The detection method of clause 28, wherein: obtaining n light-emitting probe light-emitting intensity values corresponding to n light-emitting probe concentration values at a preset temperature T1 by using a light-emitting probe light-emitting intensity-light-emitting probe concentration calibration curve L1 at a preset temperature T1, obtaining n light-emitting probe light-emitting intensity values corresponding to n light-emitting probe concentration values at a preset temperature T2 by using a light-emitting probe light-emitting intensity-light-emitting probe concentration calibration curve L2 at a preset temperature T2, and obtaining the n light-emitting probe concentration values and the corresponding light-emitting probe light-emitting intensity values at an ambient temperature T0 by a linear interpolation method from the n light-emitting probe concentration values and the corresponding light-emitting probe light-emitting intensity values at a preset temperature T1, and the n light-emitting probe concentration values and the corresponding light-emitting probe light-emitting intensity values at a preset temperature T2, wherein n is an integer greater than 1.

30. The detection method of clause 28, wherein: from the n values of the concentration of the luminescent probe at the ambient temperature T0 and the corresponding n values of the luminescence intensity of the luminescent probe, a calibration curve L0 of the luminescence intensity of the luminescent probe at the ambient temperature T0 versus the concentration of the luminescent probe was simulated by using a logarithmic logit-log4p model or a Spline curve Spline function.

31. The detection method according to any one of clauses 28-30, wherein: and receiving the identification code information of the test strip, identifying the traceability data of the test strip from the identification code information, and outputting the traceability data of the test strip.

32. 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 of clauses 28-31.

33. 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 28-31.

34. An information acquisition device for instant detection of an immunochromatographic test strip, wherein the information acquisition device comprises:

the light shielding device comprises an upper shell and a lower shell which are matched together to form a light shielding cavity inside;

a test strip receiving slot located within the light-shielded cavity and configured to open on the upper or lower housing to receive an inserted test strip, the test strip including a light-emitting region having a long-afterglow luminescent probe; and

a collection component which is positioned in the light-proof cavity and comprises a light source for sending exciting light to the inserted test strip, a filter and a camera for shooting the test strip, wherein the filter comprises a double-filter switcher consisting of an infrared cut-off filter and full-spectrum optical glass, and the double-filter switcher can be switched between the infrared cut-off filter and the full-spectrum optical glass,

the double-filter switcher is configured to switch the filter to the infrared cut-off filter in the excitation period of the long-afterglow luminescent probe so as to filter the high-intensity excitation light, and the camera can shoot color pictures for the test paper strip through the infrared cut-off filter; and the filter plate is switched to the full-spectrum optical glass in the afterglow period of the long-afterglow luminescent probe, so that the camera can shoot color pictures on the test paper strip through the full-spectrum optical glass.

35. The information collecting device according to clause 34, wherein the test strip receiving slot is disposed opposite to the camera and the filter, and the light source is disposed off a path between the camera and the filter, and the test strip receiving slot opposite to each other.

36. The information collecting apparatus according to clause 34, wherein the light source is an LED lamp with a diaphragm.

37. The information acquisition apparatus of clause 34, wherein the camera is a wide-angle digital camera.

38. The information acquisition apparatus according to clause 34, wherein the combination of the filter and the camera is an IR-Cut camera.

39. The information acquisition device of any one of clauses 34-38, wherein the information acquisition device further comprises a communication assembly located within the light-tight cavity, the communication assembly configured to transmit the captured color photograph to a computing device separate from the information acquisition device.

40. The information collecting apparatus according to clause 39, wherein the communication component is a wireless communication component or a wired communication component.

41. The information gathering device as recited in any one of clauses 34-38, wherein the information gathering device further comprises a power supply assembly to power the information gathering device.

42. The information-gathering device as recited in any one of clauses 34-38, wherein the information-gathering device further comprises a support frame positioned within the light-protected cavity and secured to the lower housing.

43. The information acquisition device of clause 42, wherein the support frame comprises a plurality of compartments configured to support the acquisition assembly.

44. The information collecting apparatus according to any one of clauses 34 to 38, wherein the information collecting apparatus further comprises a temperature sensitive pattern provided on the lower case or on a support of the lower case and capable of taking a color photograph by the camera.

45. The information collecting apparatus according to clause 44, wherein: the temperature sensing pattern is made of temperature sensing color-changing ink.

46. The information collecting apparatus according to clause 45, wherein: the thermochromic ink includes a cholesteric liquid crystal thermochromic ink.

47. The information collecting apparatus according to clause 44, wherein: the temperature sensing pattern is arranged into a plurality of adjacent small blocks, and each small block changes color at different critical temperatures due to different material proportions of the temperature sensing color-changing ink.

48. The information acquisition device of any one of clauses 34-38, wherein the information acquisition device has a length of no greater than 10cm, a width of no greater than 8cm, and a height of no greater than 10 cm.

49. The test strip for testing the sample comprises a card shell, wherein the card shell is provided with a temperature sensing pattern capable of collecting the ambient temperature around the test strip.

50. The test strip of clause 49, wherein the temperature sensitive pattern is made of a thermochromic ink.

51. The test strip of clause 50, wherein: the thermochromic ink includes a cholesteric liquid crystal thermochromic ink.

52. The test strip of clause 50, wherein: the temperature sensing pattern comprises a plurality of small blocks, and each small block changes color at different critical temperatures due to different material proportions of the temperature sensing color-changing ink.

53. The test strip of clause 52, wherein: the small blocks are arranged according to the high-low order of the critical temperature.

54. The test strip of clause 53, wherein: the temperature sensing pattern is rectangular, and the small blocks are arranged in a plurality of rows and a plurality of columns.

55. The test strip of clause 53, wherein: the temperature sensing pattern is in a straight line shape, and the small blocks are arranged in a line.

56. The test strip of clause 53, wherein: the temperature sensing pattern is annular, and the plurality of small pieces are arranged in an annular shape.

57. The test strip of clause 49, wherein: the temperature sensing pattern is arranged on the card shell by printing or pasting.

58. The test strip of any one of clauses 49-57, wherein: the card shell is further provided with an identification code adjacent to the temperature sensing pattern, and the identification code contains traceability data bound with the specimen sample.

59. The test strip of clause 58, wherein: the identification code is a two-dimensional code or a bar code.

60. The test strip of clause 58, wherein: the identification code is arranged on the card shell by printing or pasting.

61. The test strip of any one of clauses 49-57, wherein: the test strip further includes a nitrocellulose membrane disposed within the cartridge housing, and the test strip has a sample loading port and a display port spaced apart in the axial direction.

62. The test strip of clause 61, wherein: the temperature sensing pattern is arranged on the card shell and is positioned on one side of the display port far away from the sample loading port.

63. The test strip of clause 61, wherein: the display port includes a nitrocellulose membrane exposed in the area of the display port and T and C lines for testing.

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 is a schematic diagram of an immunochromatographic 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 immunochromatographic strip point-of-care test system of FIG. 1;

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

FIG. 5 is a graph showing the luminescence characteristics of a long persistence luminescent probe;

FIG. 6 shows a perspective view of an IR-Cut camera from different angles; and

FIG. 7 is a flow chart of the detection method of the instant detection system of the 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 embodied in many different forms and should not be construed as limited to the embodiments set forth herein; 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 be limiting of 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 is disposed "adjacent" another feature, and may mean that one feature has a portion overlapping with or above or below an adjacent feature.

In the specification, spatial relations such as "upper", "lower", "left", "right", "front", "rear", "high", "low", and the like may explain the relation 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 may be described as "above" other features when the device in the figures is inverted. 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, reference 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) is a reference 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 "storage 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 an 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 (for example, light-emitting information, temperature-sensitive pattern information, identification code information, and the like) 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 processing results (e.g. luminescence 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 sample loading port 43 is used for receiving a sample (e.g., urine, serum, etc.), and the substance to be detected and its luminescent 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 luminescent conjugate of the substance to be detected is produced by binding the antigen to an antibody conjugated to the surface of the luminescent probe.

The display opening 44 includes a nitrocellulose membrane 42 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 luminescent conjugate thereof are coupled and fixed by immunoreaction when reaching the T-line and the C-line 45. The display port 44 serves as a light emitting region for the information collection device 2 to collect light emission information. Display port 44 contains a luminescent probe, such as a fluorescent probe or a long persistence luminescent probe. The fluorescent probe generates fluorescence during excitation by the excitation light; the long-afterglow luminescent probe generates afterglow after being excited by excitation light, and the afterglow luminescence can last for more than 100ms after the excitation light is turned off. The luminescence information may be information on fluorescence emitted from the fluorescent probe (for example, luminescence intensity) or information on afterglow emitted from the long afterglow luminescence probe (for example, luminescence intensity).

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.

The temperature sensitive pattern 47 is provided on the card case 41 (for example, by printing or pasting), and serves as an area where the information acquisition device 2 acquires information of the temperature sensitive pattern. In some embodiments, the temperature sensing pattern 47 may be located on the card housing 41 on a side of the display port 44 away from the loading port 43 and adjacent to the identification code 46. In some embodiments, the temperature sensitive pattern 47 is made of a thermochromic ink, such as a cholesteric liquid crystal temperature sensitive ink. The thermochromic ink has a high sensitivity over the test temperature range of the test strip 4 and exhibits different colours at different test temperatures, for example a temperature change of 1 ℃ is sufficient to produce a recognisable colour difference. In some embodiments, the temperature sensitive pattern 47 is provided as a plurality of small pieces. Each small block changes color at different critical temperatures due to different material proportions of the thermochromic ink, so that the small blocks can be arranged according to the high sequence of the critical temperatures. For example, the temperature sensitive pattern 47 may be rectangular, and a plurality of small blocks are arranged in a plurality of rows and columns; the temperature sensing pattern 47 may be a straight line type, and a plurality of small blocks are arranged in a line; the temperature sensitive pattern 47 may be in the shape of a ring, and a plurality of small blocks are arranged in the shape of a ring. In some embodiments, the temperature-sensitive pattern 47 may be provided on the information acquisition device 2 (e.g., on a support stand or lower housing of the information acquisition device 2 as described in detail below) instead of on the test strip 4.

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 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 collection member 24 sends excitation light to the strip 4, and collects various information (e.g., luminescence information, temperature-sensitive pattern information, identification code information, etc.) of the strip 4 during and/or after the excitation. The luminescence information includes fluorescence intensity information of the fluorescent probe or long afterglow luminescence intensity information of the long afterglow luminescence probe, respectively. In one embodiment, the luminescence information includes fluorescence intensity information of the fluorescence probe, the light source is in an on state during the fluorescence intensity test, and the acquisition device acquires the fluorescence intensity information + the temperature sensing pattern information + the identification code information, preferably acquires three kinds of information respectively by multiple acquisition, and more preferably acquires three kinds of information simultaneously at one time. In another embodiment, the luminescence information comprises long-afterglow luminescence intensity information of the long-afterglow luminescence probe, preferably the temperature sensing pattern information + the identification code information is collected while the excitation light is excited, and the long-afterglow luminescence intensity information is collected after the light source is turned off. 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 scattered light. The camera 243 captures light emission information of the light emitting region, temperature sensitive pattern information and identification code information on the test strip 4, and the like 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. In some embodiments, camera 243 may be a wide-angle digital camera, such as a CCD camera or a CMOS camera, among others.

In some embodiments, when display port 44 comprises a long persistence luminescent probe, filter 242 may comprise a dual filter switch comprised of an infrared cut filter and a full spectrum optical glass, and the dual filter switch may switch back and forth between the infrared cut filter and the full spectrum optical glass. As shown in FIG. 5, the excitation of the long-afterglow luminescent probe is divided into two stages, the first stage is an excitation period in which the light source 241 is turned on to transmit the excitation light to the long-afterglow luminescent probe, and the second stage is an afterglow period in which the long-afterglow luminescent probe emits afterglow after the light source 241 is turned off. In the excitation period, the dual filter switcher switches the filter 242 to the infrared cut filter to attenuate or filter out the excitation light of high intensity, thereby protecting the detector of the camera 243 and collecting the identification code information and the temperature-sensitive pattern information. In the afterglow period, the long afterglow luminescent probe emits afterglow, and the dual-filter switcher switches the filter 242 to full spectrum optical glass to acquire afterglow information emitted by the long afterglow luminescent probe. In some embodiments, the combination of filter 242 with dual filter switcher and camera 243 may be the IR-Cut camera shown in FIG. 6. The IR-Cut camera is a finished lens sold in the market, the selling price is only ten yuan, and compared with a high-precision camera used for collecting short afterglow in the existing instrument, the cost is reduced by hundreds to thousands of times.

Returning to fig. 3 and 4, the communication component 25 transmits the information collected by the collection component 24 to the computing device 3. Communications component 25 may be a wireless communications device (e.g., WIFI, bluetooth, etc.) or a wired communications device (e.g., through a USB port) for use with communications components on computing device 3.

The power supply component 27 is used to power the acquisition component 24, the communication component 25, and the like. 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 10 cm.

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 storage module 32 stores the corresponding relationship between the temperature sensing pattern information and the ambient temperature T0, and stores a plurality of calibration curves L of the light emitting probe light emitting intensity-light emitting probe concentration at a preset temperature. 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 the temperature-sensitive pattern information and the light-emitting information through the communication between the communication module 34 and the communication assembly 25. The control module 31 retrieves the correspondence between the temperature-sensitive pattern information and the ambient temperature from the storage module 32 to obtain the ambient temperature T0 around the test strip 4. The control module 31 retrieves one or more calibration curves L of luminescence probe luminescence intensity versus luminescence probe concentration at a preset temperature from the storage module 32 according to the ambient temperature T0. The control module 31 obtains the concentration of the luminescent probe of the test strip 4 according to the luminescent intensity in the luminescent information based on the calibration curve L. The control module 32 outputs the concentration of the luminescent probe 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.

Fig. 7 shows a flow chart of the detection method of the immunochromatographic test strip instant detection system 1. As shown in the figure, in step S1, the test strip 4 is inserted into the test strip receiving slot 28 of the information collection device 2, and a test command is turned on in the test program of the computing device 3.

In step S2, 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. In the case where the display port 44 contains a fluorescent probe, the camera 243 takes a color photograph of the strip 4 during excitation. In the case where display port 44 includes a long afterglow luminescence probe, filter 242 includes a dual filter switch composed of an infrared cut filter and a full spectrum optical glass. Therefore, in the excitation period, the dual-filter switcher switches the filter 242 to the infrared cut-off filter to protect the detector of the camera 243 and take a first color picture of the test strip 4; in the afterglow period, the long afterglow luminescent probe emits afterglow, and the dual filter switcher switches the filter 242 to full spectrum optical glass to take a second color picture of the test strip 4. The first color photograph captures the temperature sensing pattern information and the identification code information on the test strip 4, and the second color photograph captures the light emitting information of the display port 44 of the test strip 4. The color picture is converted into an electric signal by the photoelectric signal, and the temperature sensing pattern information, the identification code information and the light emitting information are 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 S3, the control module 31 identifies the traceability data of the test strip 4 from the collected identification code information, and outputs the traceability data to the storage module 32.

In step S4, the control module 31 retrieves the correspondence between the temperature sensitive pattern information and the ambient temperature from the storage module 32, and identifies the ambient temperature T0 around the test strip 4 from the retrieved temperature sensitive pattern information. The control module 31 includes a temperature calibration function. The control module 31 determines whether the ambient temperature T0 is equal to a preset temperature corresponding to the calibration curve L. If the ambient temperature T0 is equal to one of the preset temperatures, the control module 31 retrieves the calibration curve L0 of the light emitting probe light intensity-light emitting probe concentration at the ambient temperature T0 from the storage module 32. If the ambient temperature T0 is different from all the preset temperatures, the control module 31 selects two preset temperatures T1 and T2 that are vertically adjacent to the ambient temperature T0, and retrieves a calibration curve L1 of the light emitting probe light intensity-light emitting probe concentration at the preset temperature T1 and a calibration curve L2 of the light emitting probe light intensity-light emitting probe concentration at the preset temperature T2 from the storage module 32. The control module 31 obtains the light-emitting probe light-emitting intensity values corresponding to n (n is an integer greater than 1, for example, at least 5) light-emitting probe concentration values at the preset temperature T1 by using the calibration curve L1, and obtains the light-emitting probe light-emitting intensity values corresponding to n light-emitting probe concentration values at the preset temperature T2 by using the calibration curve L2. The control module 31 obtains n light-emitting probe concentration values and corresponding light-emitting probe light-emitting intensity values at the ambient temperature T0 from the n light-emitting probe concentration values and the corresponding light-emitting probe light-emitting intensity values at the preset temperatures T1 and T2 by using a certain algorithm (e.g., a linear interpolation method), so as to simulate a calibration curve L0 of light-emitting probe light-emitting intensity-light-emitting probe concentration at the ambient temperature T0, for example, by using a linear simulation software, such as a logarithmic logit-log4p model or a Spline function.

The control module 31 fits the calibration curve L0 of the luminescence intensity of the luminescence probe-the luminescence probe concentration at the ambient temperature T0 and the measured luminescence intensity of the luminescence probe to obtain the luminescence probe concentration.

In step S5, the output module 33 outputs the luminescence probe concentration and/or the tracing data, for example, to be displayed on the display screen of the computing device 3.

For example, the predetermined temperature may include, for example, 10 ℃, 20 ℃, 25 ℃, 30 ℃, 35 ℃, 37 ℃, 39 ℃, 42 ℃ and the like. The luminescence intensity of the luminescent probe at a concentration of at least 5 luminescent probes is measured at the above-mentioned preset temperature, and the measured points are simulated by the linear simulation software to obtain a calibration curve L of the luminescence intensity of the luminescent probe at the above-mentioned preset temperature (including, for example, 10 ℃, 20 ℃, 25 ℃, 30 ℃, 35 ℃, 37 ℃, 39 ℃ and 42 ℃), and stored in the storage module 32. Thereafter, as shown in fig. 6, the control module 31 retrieves the ambient temperature corresponding to the temperature sensitive pattern information from the storage module 32, and obtains that the ambient temperature is 27 ℃. The ambient temperature of 27 ℃ is not equal to any of the preset temperatures, so that the control module 31 selects the preset temperatures of 25 ℃ and 30 ℃ which are adjacent to the ambient temperature of 27 ℃ and retrieves a calibration curve L1 of the luminous intensity of the luminescent probe at the preset temperature of 25 ℃ and a calibration curve L2 of the luminous intensity of the luminescent probe at the preset temperature of 30 ℃ and the concentration of the luminescent probe from the storage module 32. The control module 31 obtains the light emission intensities of the 6 light-emitting probes corresponding to the concentrations of the 6 light-emitting probes at the preset temperature of 25 ℃ by using the calibration curve L1, and obtains the light emission intensities of the 6 light-emitting probes corresponding to the concentrations of the 6 light-emitting probes at the preset temperature of 30 ℃ by using the calibration curve L2. The control module 31 calculates the light emission intensity of 6 light-emitting probes corresponding to the concentration of 6 light-emitting probes at 27 ℃ from the data by using a linear interpolation method, and simulates a calibration curve L0 of the light emission intensity of the light-emitting probes at 27 ℃ and the concentration of the light-emitting probes by using a logarithmic threshold-log 4p model or a Spline curve Spline function. The control module 31 fits the calibration curve L0 and the measured luminescence intensity of the luminescence probe to obtain the concentration of the luminescence probe. The output module 33 displays the luminescent probe concentration and/or the traceability data on a display screen of the computing device 3.

The instant detection system of the 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 immunochromatographic test strip, which is disclosed by the embodiment of the disclosure, a processor and a scanning device which occupy a larger space are omitted, the device can be only palm-sized, and the convenience is greatly improved.

The instant detection system of the immunochromatographic test strip according to the embodiment of the present disclosure transfers the processing work to a processor in a mobile phone to complete. 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.

According to the immunochromatographic test strip instant detection system disclosed by the embodiment of the disclosure, the environmental temperature is measured by adopting thermochromic ink. The thermochromic ink is sensitive to temperature (the temperature resolution is less than 1 ℃), and can be used for truly, effectively and repeatedly identifying the temperature. The temperature sensing color-changing printing ink can be conveniently printed on the test strip, and the process of collecting the temperature sensing pattern information and the process of collecting the luminous information can be carried out simultaneously.

According to the instant detection system of the immunochromatographic test strip disclosed by the embodiment of the disclosure, calibration curves of the luminous intensity of the luminous probe and the concentration of the luminous probe of the test strip to be detected at a plurality of preset temperatures are prestored, and a linear interpolation method and linear simulation software are adopted to obtain the calibration curve at the ambient temperature. According to actual comparative experiments, the accuracy of the concentration measurement of the luminescent probe is remarkably improved.

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 (14)

1. The utility model provides a test paper strip for testing sample, its characterized in that, the test paper strip includes the card shell and sets up the nitrocellulose membrane in the card shell, be equipped with the temperature sensing pattern that can gather the ambient temperature around the test paper strip on the card shell, the test paper strip has along axially spaced sample loading mouth and display mouth, the display mouth contains luminescent probe, luminescent probe is fluorescence probe or long afterglow luminescent probe.

2. The test strip of claim 1, wherein the temperature sensitive pattern is made of a thermochromic ink.

3. The test strip of claim 2, wherein: the thermochromic ink includes a cholesteric liquid crystal thermochromic ink.

4. The test strip of claim 2, wherein: the temperature sensing pattern comprises a plurality of small blocks, and each small block changes color at different critical temperatures.

5. The test strip of claim 4, wherein: the small blocks are arranged according to the high-low order of the critical temperature.

6. The test strip of claim 5, wherein: the temperature sensing pattern is rectangular, and the small blocks are arranged in a plurality of rows and a plurality of columns.

7. The test strip of claim 5, wherein: the temperature sensing pattern is in a straight line shape, and the small blocks are arranged in a line.

8. The test strip of claim 5, wherein: the temperature sensing pattern is annular, and the plurality of small pieces are arranged in an annular shape.

9. The test strip of claim 1, wherein: the temperature sensing pattern is arranged on the card shell by printing or pasting.

10. The test strip of any one of claims 1-9, wherein: the card shell is further provided with an identification code adjacent to the temperature sensing pattern, and the identification code contains traceability data bound with the specimen sample.

11. The test strip of claim 10, wherein: the identification code is a two-dimensional code or a bar code.

12. The test strip of claim 10, wherein: the identification code is arranged on the card shell by printing or pasting.

13. The test strip of claim 1, wherein: the temperature sensing pattern is arranged on the card shell and is positioned on one side of the display port far away from the sample loading port.

14. The test strip of claim 1, wherein: the display port includes a nitrocellulose membrane exposed in the area of the display port and T and C lines for testing.

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