CN213148955U

CN213148955U - Fluorescence immunoassay system

Info

Publication number: CN213148955U
Application number: CN202021426572.3U
Authority: CN
Inventors: 张辉; 赵雪娇; 赵勇杰
Original assignee: Origin Quantum Computing Technology Co Ltd
Current assignee: Origin Quantum Computing Technology Co Ltd
Priority date: 2020-07-17
Filing date: 2020-07-17
Publication date: 2021-05-07
Anticipated expiration: 2030-07-17

Abstract

The utility model discloses a fluorescence immunoassay system belongs to medical science detection technology field. The device comprises a fluorescence immunoassay instrument and a detection card, wherein the detection card comprises a detection area and an identification area, and an identification code for recording a user ID is arranged on the identification area; the analyzer includes: a transfer unit for transferring the inserted test card to a first position and a second position; the identification reading unit and the photoelectric detection unit are sequentially arranged at positions corresponding to the first position and the second position and are respectively used for reading the identification code and detecting the concentration of an object to be detected on the detection card; the control analysis unit is in communication connection with the transmission unit, the identification reading unit and the photoelectric detection unit and is used for sending a control instruction, receiving a feedback signal and generating a detection result corresponding to the user ID; and the data transmission module is connected with the control analysis unit and used for transmitting the detection result to the user terminal corresponding to the user ID. The utility model discloses latency has been reduced, and the testing result has secret nature.

Description

Fluorescence immunoassay system

Technical Field

The utility model belongs to the technical field of medical science detects, more specifically says, relates to a fluorescence immunoassay system.

Background

At present, after the concentration of an object to be detected is determined, related fluorescence immunoassay detecting instruments mostly directly print or output a detecting result to a display interface of the fluorescence immunoassay detecting instrument for displaying, so that a detected user needs to wait in line for detection and wait in line for getting a detecting report, and the detection result is very inconvenient to obtain.

SUMMERY OF THE UTILITY MODEL

The fluorescence immunoassay of the utility model relates to a technology for carrying out rapid and accurate quantitative analysis on the content of various analytes (CRP, PCT, NT-proBNl, eTnI and the like) in human blood, urine and the like by adopting lateral chromatography and fluorescent tracing. The detection molecules marked by near-infrared fluorescent markers are fixed on an antibody pad of the chromatographic test strip, after a sample to be detected after buffer dilution is added into the chromatographic test strip, the sample to be detected is electrophoresed on the test strip, when a compound formed by the object to be detected and the detection molecules moves to a detection line, the compound is captured by the capture molecules fixed at the position of the detection line, the detection molecules which are not combined with the object to be detected continue to move upwards, and when the compound passes through a control line, the compound is captured by the antibodies on the control line. And then, irradiating the chromatographic test strip by using a light source, respectively exciting the control line and the detection line to generate fluorescence with different intensities, collecting and converting the fluorescence into an electric signal, strictly correlating the strength of the electric signal with the number of fluorescent marker molecules, and determining the concentration of the substance to be detected in the sample to be detected by analyzing and calculating through a specific algorithm.

Aiming at the problems in the prior art, the invention provides a fluorescence immunoassay system, which comprises a fluorescence immunoassay instrument and a detection card for inserting the fluorescence immunoassay instrument for detection, wherein the detection card comprises a detection area and an identification area, and the identification area is provided with an identification code for recording a user ID; the analyzer includes:

a transfer unit for transferring the inserted test card to a first position and a second position;

the identification reading unit and the photoelectric detection unit are sequentially arranged at positions corresponding to the first position and the second position and are respectively used for reading the identification code and detecting the concentration of an object to be detected on the detection card;

the control analysis unit is in communication connection with the transmission unit, the identification reading unit and the photoelectric detection unit and is used for sending a control instruction, receiving a feedback signal and generating a detection result corresponding to the user ID; and

and the data transmission module is connected with the control analysis unit and used for transmitting the detection result to the user terminal corresponding to the user ID.

Preferably, the system further comprises a database which is in communication connection with the control analysis unit and is used for storing the user ID and the detection result corresponding to the user ID.

Preferably, the identification code is a two-dimensional code or a bar code arranged on the upper surface of the detection card, and the identification reading unit is a code scanning reader.

Preferably, the identification code is an RFID electronic tag, and the identification reading unit is an RFID reader.

Preferably, the transfer unit includes:

the rail is arranged in the analyzer, one end of the rail extends to the entrance and the exit, and the rail is provided with the first position and the second position;

the transfer platform is arranged on the moving track and used for bearing the inserted detection card;

and the driving unit is in communication connection with the control analysis unit and is used for driving the mobile platform to move on the track.

Preferably, the driving unit comprises a stepping motor and a screw rod, an output shaft of the stepping motor is connected with one end of the screw rod, and the other end of the screw rod is connected with the transfer platform.

Preferably, the fixed test paper strip that is provided with in detection zone, be equipped with the detection mark line on the test paper strip, the detection zone still be equipped with be used for right the application of sample hole of test paper strip application of sample and be used for observing the observation window of detection mark line.

Preferably, the photoelectric detection unit comprises an excitation light source and a fluorescence detector, wherein the excitation light source and the fluorescence detector are located on two sides of the second position and are connected with the control analysis unit, the excitation light source is used for emitting pulse excitation light to the detection area located at the second position, and the fluorescence detector is used for receiving fluorescence emitted from the detection area.

Preferably, the photodetecting unit further includes a filter element, the filter element is disposed on one side of the second position, and the fluorescence is received by the fluorescence detector after being filtered by the filter element.

Preferably, the fluorescence detector comprises a photomultiplier tube for receiving the fluorescence and converting the fluorescence into an electrical signal, and a digital photoelectric intensity conversion calculation component connected with the photomultiplier tube for receiving the electrical signal and digitally processing the electrical signal.

Compared with the prior art, the utility model discloses a set up sign reading unit and photoelectric detection unit in the analysis appearance, set up detection zone and identification area on detecting the card, in the detection analysis process, convey the first position that corresponds with sign reading unit earlier through the transfer unit to detect the card, with discernment user ID, convey the second position that corresponds with photoelectric detection unit with detecting the card again, with the concentration of the thing to be measured on detecting the card, through control analysis unit to user ID and the thing concentration that awaits measuring that sign reading unit and photoelectric detection unit feedback handle and produce the testing result, control analysis unit sends the testing result to the user terminal that corresponds with user ID through the data transmission module again, consequently, the user that is examined need not to wait in line for detection, wait for to print the detection report, the system can be according to detect card automated inspection, and generate the testing result and directly send for the user, compared with the prior art, the method is convenient for the detected user to receive and store the detection result, and has the characteristics of high efficiency and convenience.

Drawings

Fig. 1 is a schematic structural diagram of a detection card provided by the present invention.

Fig. 2 is a schematic structural diagram of a fluorescence immunoassay analyzer provided by the present invention.

In the figure: 1. detecting the card; 2. a transfer unit; 3. an identification reading unit; 4. a photodetecting unit; 5. a first position; 6. a second position; 11. a detection zone; 12. an identification area; 111. a sample application hole; 112. an observation window; 41. an excitation light source; 42. a fluorescence detector; 43. a filter element; 44. a light source lens group.

Detailed Description

In order to facilitate understanding of the invention, the invention is further described below with reference to the accompanying drawings and specific embodiments. The preferred embodiments of the present invention are shown in the drawings. The invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that when an element is referred to as being "secured to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

The utility model relates to a fluorescence immunoassay technique utilizes the high sensitivity of fluorescence technique and the high specific binding of immunological technique, provides the detection technique that other methods can not replace, have unique style for immunology, clinical histochemistry and laboratory diagnosis. The fluorescence immunoassay technology is widely used for detecting serum antibodies (including autoantibodies), diagnosing and researching autoimmune diseases, identifying and positioning pathological antigens, antibodies and complements, diagnosing and researching tumor immunity and the like besides being used for identifying bacteria, viruses, protozoa, worms, fungi and the like and diagnosing related diseases.

The following exemplary explanations explain the principles of the fluorescence immunoassay technique: some substances can emit light with a wavelength slightly longer than that of incident light after absorbing the incident light with a certain wavelength by the irradiation of ultraviolet light, and the emitted ultraviolet light disappears once the irradiation of the ultraviolet light is stopped, and the emitted ultraviolet light is called fluorescence. Due to different molecular structures of substances, the wavelength of ultraviolet light which can be absorbed and the wavelength of fluorescence which can be emitted are also different, and the substance to be detected can be determined qualitatively by utilizing the characteristic. Under a certain condition, the higher the concentration of a substance to be detected is, the stronger the fluorescence emitted after the ultraviolet light irradiation is; conversely, the lower the concentration, the weaker the light emitted; accordingly, the substance to be measured can be quantitatively analyzed.

The utility model provides a fluorescence immunoassay system can be applied to the detection to whole blood, serum or plasma, urine or other body fluids, or go on through the above-mentioned sample of dilution, the biological substance in the sample indicates the macromolecular protein of accessible chromatography mode detection, small molecule hapten, nucleic acid or oligonucleotide.

Referring to the drawings, the fluorescence immunoassay system provided in this embodiment is described below, and as shown in fig. 1 and fig. 2, the fluorescence immunoassay system includes a fluorescence immunoassay instrument, and a detection card 1 for being inserted into the fluorescence immunoassay instrument for detection, where the detection card 1 includes a detection area 11 and an identification area 12, and the identification area 12 is provided with an identification code for recording a user ID; the analyzer comprises a transmission unit 2, an identification reading unit 3, a photoelectric detection unit 4, a control analysis unit and a data transmission unit, wherein:

the conveying unit 2 is used for conveying the inserted detection card 1 to a first position 5 and a second position 6;

the identification reading unit 3 and the photoelectric detection unit 4 are sequentially disposed at positions corresponding to the first position 5 and the second position 6, and are respectively used for reading the identification code and detecting the concentration of the object to be detected on the detection card 1, as shown in fig. 2, in this embodiment, the identification reading unit 4 is disposed at a position corresponding to the first position 5 and is used for reading the identification code; the photoelectric detection unit 4 is arranged at a position corresponding to the second position 6 and is used for detecting the concentration of the object to be detected on the detection card 1;

the control analysis unit is in communication connection with the transmission unit 2, the identification reading unit 3 and the photoelectric detection unit 4, and is used for sending a control instruction, receiving a feedback signal and generating a detection result corresponding to the user ID; in this embodiment, the control analysis unit sends a first control instruction to the transmission unit 2 to cause the control analysis unit to transmit the detection card 1 to the first location 5, the transmission unit 2 feeds back location information to the control analysis unit when transmitting the detection card 1 to the first location 5, triggers the control analysis unit to send a second control instruction to the identification reading unit 3 to cause the identification reading unit 3 to read the identification code and parse the identification code to obtain user ID information, the identification reading unit 3 sends the read and parsed user ID information to the control analysis unit, triggers the control analysis unit to send a third control instruction to the transmission unit 2 to cause the transmission unit 2 to transmit the detection card 1 to the second location 6, the transmission unit 2 feeds back location information to the control analysis unit when transmitting the detection card 1 to the second location 6, triggering the control and analysis unit to send a fourth control instruction to the photoelectric detection unit 4 so that the photoelectric detection unit 4 detects the concentration of the object to be detected on the detection card 1, feeding back the obtained concentration of the object to be detected to the control and analysis unit by the photoelectric detection unit 4, and generating a detection result corresponding to the user ID by the control and analysis unit; in this embodiment, the user ID includes information such as identity information of a user, a name of a detection item, and a detection result receiving address, where the detection result receiving address may be an address of a user terminal, such as an email address, a mobile phone number, and the like;

the data transmission unit is connected with the control analysis unit and used for sending the detection result to the user terminal corresponding to the user ID, in some embodiments, the data transmission unit comprises a 5G communication module, and the control analysis unit can transmit data through the 5G communication module by using an Internet network and send the detection result to the mobile terminal corresponding to the user ID.

The utility model solves the problem that the user needs to wait for obtaining the detection report in the fluorescence immunoassay detection process in the prior art, the embodiment is characterized in that the analyzer is provided with an identification reading unit 3 and a photoelectric detection unit 4, the detection card 1 is provided with a detection area 11 and an identification area 12, during the detection analysis process, the detection card 1 is firstly transmitted to a first position 5 corresponding to the identification reading unit 3 through a transmission unit 2 to identify the user ID, and then the detection card 1 is transmitted to a second position 6 corresponding to the photoelectric detection unit 4 to detect the concentration of the object to be detected on the detection card 1, the user ID and the concentration of the object to be detected fed back by the identification reading unit 3 and the photoelectric detection unit 4 are processed by a control analysis unit to generate a detection result, and the control analysis unit transmits the detection result to the user terminal corresponding to the user ID through a data transmission module, therefore, the detected user does not need to wait for detection in a queue and print a detection report, the system can automatically detect according to the detection card 1 and generate a detection result to be directly sent to the user, compared with the prior art, the method is convenient for the detected user to receive and store the detection result, and compared with the method in the prior art that the detection result is directly printed or output to a display screen for display, the embodiment is beneficial to protecting personal privacy, and the detection result is not easy to be obtained or read by other people.

In this embodiment, the immunofluorescent assay system further comprises a database (not shown in fig. 2) communicatively connected to the control and analysis unit for storing the user ID and the detection result corresponding to the user ID. In some embodiments, in order to facilitate the user to uniquely log in the database to check the detection result, the identification code is further recorded with a database login password.

In the present embodiment, the transfer unit 2 includes:

the rail is arranged in the analyzer, one end of the rail extends to a detection card entrance and exit of the analyzer, and the rail is provided with the first position 5 and the second position 6;

the transfer platform is arranged on the moving track and used for bearing the inserted detection card 1;

In some examples, the driving unit includes a stepping motor and a screw rod, wherein an output shaft of the stepping motor is connected to one end of the screw rod, the other end of the screw rod is connected to the transfer platform, the stepping motor is a digital control motor, which is more favorable for precise control than other types of motors, and has the advantages of low price, easy control, convenient computer interface, and the like.

In some embodiments, the identification code is a two-dimensional code or a bar code disposed on the upper surface of the detection card 1, and the identification reading unit 3 is a code scanner, which may be a red CCD bar code, a laser bar code, a two-dimensional image bar code, or the like. In order to overcome the defect that the two-dimensional code or the bar code can be read only by the code scanning reader only in a short distance without being blocked by an object, in other embodiments, the identification code is an RFID electronic tag, the identification reading unit 2 is an RFID reader, and compared with the two-dimensional code and the bar code, the RFID tag can repeatedly add, modify and delete data stored in an RFID volume label, so that the information is updated and managed conveniently, and the RFID tag can still perform penetrating communication under the condition that the RFID tag is covered. In some embodiments, the identification code may also be an NFC electronic tag instead of a two-dimensional code or a barcode, and in this case, the identification reading unit 2 is an NFC reader. In other embodiments, the identification code may also be in the form of a pattern, electromagnetic induction information, etc., as long as the identification code can uniquely record user ID information, and can be read by the identification reading unit 2 and can analyze information including user identity information, detection item name, detection result receiving address, etc.

In this embodiment, the detection area 11 is provided with a test strip, the test strip is provided with a detection mark line, such as a detection line and a control line, the exterior of the detection card is provided with a sample application hole 111 and an observation window 112, the position of the observation window 112 corresponds to the positions of the detection line and the control line, the detection line and the control line can be observed through the observation window 112, and the photoelectric detection unit 4 is used for detecting fluorescence emitted from the detection line and the control line. In some examples, the detection area 11 of the detection card 1 is provided with a test strip slot for inserting a test strip. In the embodiment, the width of the detection line and the control line is 1mm, the length of the detection line and the control line is 4mm, and the interval between the detection line and the control line is 2 mm. In some embodiments, the test strip and the test card 1 are detachably connected, so that the test card 1 can be reused.

In this embodiment, the photodetecting unit 4 is a key element for detecting the detection card 1, and includes an excitation light source 41 and a fluorescence detector 42 which are located at two sides of the second position 6 and connected to the control and analysis unit, wherein the excitation light source 41 is used for emitting pulsed excitation light to the detection region 11 located at the second position 6, and the fluorescence detector 42 is used for receiving fluorescence emitted from the detection region 11, converting a fluorescence intensity value into an electrical signal capable of being measured, such as voltage, current, etc., and then sending the electrical signal to the control and analysis unit for subsequent processing. The excitation light source 41 is generally an ultraviolet light source, in some embodiments, the excitation light source 41 may be any one of a xenon lamp, a laser and an LED, and since the LED has the advantages of low power consumption, long light emitting life, stable light intensity, and the like, the LED is preferably used as the excitation light source 41, and a constant current source may be used as an LED power supply, the constant current source is a power source capable of outputting a constant current, and when a load changes within a certain range, the output current may also keep constant or slightly change, which ensures that the current is constant, so as to improve the reliability of the LED operation and prolong the service life.

In some embodiments, the photodetection unit 4 further includes a filter element 43, the filter element 43 is disposed on one side of the second position 6, the fluorescence is received by the fluorescence detector 42 after being filtered by the filter element 43, the filter element 43 is used for filtering interference of radiation in other spectral bands in the system, for example, in the receiving light path, a band-pass filter element 43 needs to be selected, the peak value of the transmission peak is 610nm, so that the filter element 43 with the central wavelength of 610nm, the peak transmittance Ts > 90%, and the cut-off depth Tp < 0.1% is selected, and is used for filtering all light except 610 nm. In other embodiments, the photodetecting unit 4 further comprises a light source lens group 44 for focusing the excitation light, the light source lens group 44 is disposed at the other side of the second position 6, the excitation light is irradiated to the detection region 11 via the light source lens group 44, and the light source lens group 44 comprises two convex lenses and a light source filter, wherein the light source filter is disposed between the two convex lenses, as shown in fig. 2.

In other embodiments, the fluorescence detector 42 includes a photomultiplier tube (PMT) for receiving the fluorescence and converting the fluorescence into an electrical signal, and a digital photoelectric intensity conversion calculating component connected to the PMT for receiving the electrical signal and performing digital processing on the electrical signal, where the detection line and the quality control line on the test strip have different fluorescence signal values, and the photomultiplier tube transmits different electrical signals to the digital photoelectric intensity conversion calculating component, so that the digital photoelectric intensity conversion calculating component can calculate the concentration of the analyte according to the received electrical signals.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only represent some embodiments of the present invention, and the description thereof is specific and detailed, but not to be construed as limiting the scope of the present invention. It should be noted that, for those skilled in the art, without departing from the spirit of the present invention, several variations and modifications can be made, which are within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the appended claims.

Claims

1. A fluorescence immunoassay system comprises a fluorescence immunoassay instrument and a detection card inserted into the fluorescence immunoassay instrument for detection, and is characterized in that the detection card comprises a detection area and an identification area, and the identification area is provided with an identification code for recording a user ID; wherein the analyzer comprises:

2. The fluoroimmunoassay system of claim 1, further comprising a database communicatively coupled to said control and analysis unit for storing said user ID and the detection result corresponding to said user ID.

3. The fluoroimmunoassay system of claim 1, wherein the identification code is a two-dimensional code or a bar code provided on an upper surface of the detection card, and the identification reading unit is a bar code reader.

4. The fluoroimmunoassay system of claim 1, wherein the identification code is an RFID electronic tag and the identification reading unit is an RFID reader.

5. The fluoroimmunoassay system of claim 1, wherein the transfer unit comprises:

the rail is arranged in the analyzer, one end of the rail extends to a detection card entrance and exit of the analyzer, and the rail is provided with the first position and the second position;

the transfer platform is arranged on the track and used for bearing the inserted detection card;

and the driving unit is in communication connection with the control analysis unit and is used for driving the transfer platform to move on the track.

6. The fluoroimmunoassay system of claim 5, wherein the driving unit comprises a stepping motor and a lead screw, an output shaft of the stepping motor is connected to one end of the lead screw, and the other end of the lead screw is connected to the transfer platform.

7. The fluoroimmunoassay system of claim 1, wherein the detection zone is fixedly provided with a test strip, the test strip is provided with a detection mark line, and the detection zone is further provided with a sample application hole for applying a sample to the test strip and an observation window for observing the detection mark line.

8. The immunofluorescent assay system according to claim 1, wherein the photodetection unit comprises an excitation light source and a fluorescence detector both located on both sides of the second position and connected to the control and analysis unit, wherein the excitation light source is configured to emit pulsed excitation light to the detection zone located in the second position, and the fluorescence detector is configured to receive fluorescence emitted from the detection zone.

9. The fluoroimmunoassay system of claim 8, further comprising a filter element disposed on a side of the second position, the fluorescence being received by the fluorescence detector after being filtered by the filter element.

10. The fluoroimmunoassay system of claim 8, wherein the fluorescence detector comprises a photomultiplier tube for receiving the fluorescence and converting it into an electrical signal, and a digital intensity conversion calculation component connected to the photomultiplier tube for receiving the electrical signal and digitally processing the electrical signal.