WO2014176753A1 - 量子点免疫层析试条检测系统及其应用 - Google Patents

量子点免疫层析试条检测系统及其应用 Download PDF

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Publication number
WO2014176753A1
WO2014176753A1 PCT/CN2013/075028 CN2013075028W WO2014176753A1 WO 2014176753 A1 WO2014176753 A1 WO 2014176753A1 CN 2013075028 W CN2013075028 W CN 2013075028W WO 2014176753 A1 WO2014176753 A1 WO 2014176753A1
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WIPO (PCT)
Prior art keywords
test strip
test
cds
detection
strip
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PCT/CN2013/075028
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English (en)
French (fr)
Inventor
马义才
顾敏
马灵
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成都领御生物技术有限公司
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Application filed by 成都领御生物技术有限公司 filed Critical 成都领御生物技术有限公司
Priority to PCT/CN2013/075028 priority Critical patent/WO2014176753A1/zh
Priority to CN201380076286.5A priority patent/CN105393108A/zh
Publication of WO2014176753A1 publication Critical patent/WO2014176753A1/zh

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor

Definitions

  • the invention relates to the field of biomedical devices, and in particular relates to a quantum dot immunochromatographic strip detection system and an application thereof.
  • Multi-component analysis of samples plays a very important role in disease diagnosis, environmental monitoring, food safety, drug analysis, and microbiological testing.
  • clinical tumor diagnosis it is often necessary to jointly detect several tumor markers to achieve accurate diagnosis of a certain tumor.
  • environmental monitoring it is often necessary to simultaneously monitor the concentration indicators of various insecticides and herbicides in natural waters to comprehensively evaluate environmental pollution levels.
  • the content of various components in the mixed system is determined.
  • Parallel one-component analysis is used, that is, only one component is determined in each analysis process, and the process is performed in parallel several times to obtain all the required components. content.
  • the analysis takes a long time, consumes a lot of reagents, has low analytical throughput, and is labor intensive.
  • Nano quantum dots (quantum dots, developed in recent years) QDs) has high fluorescence luminescence efficiency, wide excitation line range, “one-element excitation, multiple emission”, narrow and symmetrical emission line, slow photobleaching, long fluorescence lifetime, similar particle size to biomolecules, and surface modification.
  • the multi-functional, quantum dot mixture of different particle sizes and types produces a characteristic wavelength fluorescence spectrum that does not overlap, making it ideal for multi-component analysis of samples.
  • Immunochromatography is simple and fast, and results are available in minutes.
  • the existing immunochromatography technology mostly uses colloidal gold as a marker for sample detection.
  • Colloidal gold strip test samples can only be qualitative, can not be quantified, and can not achieve multi-component test of samples.
  • the invention discloses a quantum dot immunochromatographic strip detection system and an application thereof according to the unique advantages of QDs in multi-component analysis of samples and the simple and rapid advantages of immunochromatography technology, and combines advanced manufacturing techniques to solve the prior art.
  • the problem of “multi-component on-site rapid quantitative detection, remote quantitative detection, and the need for additional equipment and reagents, and ordinary personnel can perform operation detection”, which can not be solved, enables biomedical detection technology to enter the community and go to the streets. Enter the family and benefit the society for the benefit of the people.
  • a first object of the present invention is to disclose a quantum dot immunochromatographic strip detection system.
  • Another object of the present invention is to disclose the use of the quantum dot immunochromatographic strip detection system in the field of biomedical detection.
  • the quantum dot immunochromatographic strip detection system comprises a strip card 1 and a detecting device 2.
  • the test strip card 1 includes a cartridge 16 and a quantum dot immunochromatographic test strip 15 that can be inserted into the cartridge 16 in a timely manner.
  • the detecting device 2 includes an optical system 3, a photodetector 4, an analog/digital converter 5, a data processing device 6, an electronic tag reading and writing module 10, an output display device 8, a voice module 18, a power source 7, and a detecting device 2
  • the button 9 on the surface and a plurality of communication interfaces 31 are provided for the temporary connection of the detection device 2.
  • the imaging signal end of the optical system 3 is connected to the photodetector 4.
  • the signal output of the photodetector 4 is amplified by a signal and connected to the signal input terminal of the analog/digital converter 5.
  • the signal output of the A/D converter 5 is connected to the signal input of the data processing device 6.
  • the data processing device 6 is also connected to the output display device 8, the voice module 18, the electronic tag reading and writing module 10, the power source 7, the button 9 on the surface of the detecting device 2, and the communication interfaces 31 that are reserved for the detecting device 2.
  • the power source 7 supplies power to the optical system 3, the photodetector 4, the analog/digital converter 5, the output display device 8, the voice module 18, and the electronic tag reading and writing module 10 through the data processing device 6.
  • the detecting device 2 has a test strip card jack 33.
  • the test strip card 1 is a detached structure of the detecting device 2.
  • the test strip 15 is a detached structure of the test strip card 1.
  • the test strip card 1 is provided with a test strip locking insertion mark 19 at the test strip card insertion hole 33 corresponding to the detecting device 2. After the test strip 15 is inserted into the test strip card 1, the test strip card 1 is inserted into the test strip card insertion hole 33 of the detecting device 2 to detect the sample on the test strip.
  • test strip card case 16 and the upper case opening of the card case end form a test strip slot opening 17 for facilitating insertion of the test strip 15.
  • the test strip 15 in the cartridge 16 includes a sample pad 21, a marker pad 22, an analysis film 23, and an absorbent pad 24 which are sequentially attached to the backing 26.
  • the analysis membrane 23 has a detection belt 27 and a quality control belt 28.
  • the detection tape 27 is one or more.
  • the upper casing of the cartridge 16 is provided with a detection window 29 at a position corresponding to the test strip analysis film 23.
  • the detection window 29 of the cartridge 16 corresponds to the light irradiation surface of the optical system 3 of the detecting device 2.
  • An electronic tag 20 storing information for detecting the test strip 15 is attached to any portion of the cartridge 16.
  • the marking pad 22 of the test strip 15 in the cartridge 16 is coated with one or more related molecules for detecting the target analyte by quantum dots, including ZnS, CdS, HgS, ZnSe, CdSe, HgSe, CdTe, ZnTe, ZnO, PbSe, HgTe, CaAs, InP, InAs, InCaAs, CdS/ZnS, CdS/Ag 2 S, CdS/PbS, CdS/Cd(0H) 2 , CdS/HgS, CdS/HgS/ CdS, ZnS/CdS, ZnS/CdS/ZnS, ZnS/HgS/ZnS/CdS, CdSe/CdS, CdSe/ZnS, CdSe/CuSe, CdSe/HgTe, CdSe/HgSe,
  • the test strip 27 of the test strip 15 in the cartridge 16 is coated with one or more other molecules associated with the detection of the target analyte.
  • the quality control tape 28 of the test strip 15 in the cartridge 16 is coated with a quality control comprising a secondary antibody.
  • the electronic tag 20 on the cartridge 16 includes, but is not limited to, an RFID tag, a contactlessly recognized IC card chip.
  • the mounting manner of the electronic tag 20 in the cartridge 16 includes a film-adhesive type, a package-embedded type, a card type, a nail type, or a button type.
  • the test strip detection information stored in the electronic tag 20 includes the same working curve or coefficient parameter for quantifying the sample concentration of the sample by the same batch of quantum dot immunochromatographic test strips, and the reference density control band optical density reference monitoring value (OD quality) Control belt ' ), test strip name, test strip batch number, test strip validity period, electronic label password, clinical index reference value, test strip manufacturer information, etc., and can be read into the measured object identity information, tester information, sample name , sample number, date of detection, test results and other information.
  • the standard working curve of the object stored in the electronic tag 20 has various forms to choose from, including but not limited to one of the following curves:
  • the OD detection zone is defined as the detection band optical density value measured by the concentration of the sample standard series
  • the OD quality control zone is defined as the quality control zone optical density value measured by the concentration of the sample standard series.
  • the structural composition of the optical system 3 is available in a variety of options including, but not limited to:
  • the illumination system includes an excitation source 311. On the output light path of the light source 311, the fiber bundle 312, the collimation illumination lens 313, the dichroic mirror 314, and the front lens group 315 are sequentially arranged up to the test strip card 1.
  • the excitation light source 311 includes a light emitting diode LED or a laser diode.
  • the imaging system includes a front lens group 315 of a common optical axis, a dichroic mirror 314, a filter 316, and a rear lens group 317. The angle between the reflecting surface of the dichroic mirror 314 and the optical axis is 45o. Both the front mirror group 315 and the rear mirror group 317 employ a separate structure.
  • the illumination system optical path is perpendicular to the optical axis of the imaging system in front of the dichroic mirror 314, and the portion after the dichroic mirror 314 is coaxial with the imaging system.
  • the photodetector 4 is located on the image side of the rear mirror group 317.
  • the fiber bundle 312 divides the light emitted by the light source 311 into laser beams having a certain pitch and the same intensity, and the laser beam is collimated by the collimating illumination lens 313 into a parallel beam incident on the surface of the dichroic mirror 314, and is reflected by the dichroic mirror 314.
  • the quantum dot reaction signal which is oscillated to the detection zone 27 and the quality control zone 28 by the front lens group 315 and the detection tape 27 and the quality control tape 28 which are irradiated to the test strip 15 of the front mirror group 315 object interview strip card 1 are excited.
  • the characteristic frequency reflected fluorescence is emitted, and the detection band 27 and the control strip 28 reflect the fluorescence through the same front lens group 315, through the dichroic mirror 314, and the filter 316 to filter out the stray light, and then the mirror group 317 enters the photodetector 4
  • the detection is converted into an electrical signal.
  • the excitation light source 321 includes an excitation light source 321 on the output light path of the excitation light source 321 as an incident optical coupler 322, an incident optical fiber 323, a fiber optic probe 324, an exiting optical fiber 325, and an outgoing optical coupler 326 until the photodetector 4 .
  • the excitation light source 321 includes a light emitting diode LED or a laser diode. The light emitted by the light source 321 is split into the incident optical fiber 323 via the incident optical coupler 322, and the incident optical fiber 323 is irradiated to the test strip of the test strip 15 of the test strip card 1 by the strip detection fiber probe and the test strip control fiber probe respectively.
  • the fiber optic probe 324 employs a combined beam structure with an incident fiber 323 at the center and an exit fiber 325 at the periphery.
  • Photodetector 4 has a variety of alternatives including CCD, CMOS, photomultiplier tubes, photodiodes, phototransistors.
  • the data processing device 6 is a microprocessor, a single chip microcomputer, or a PC with corresponding data processing and control software.
  • the electronic tag reading and writing module 10 automatically reads/writes the electronic tag 20 information in a non-contact manner.
  • the plurality of communication interfaces 31 reserved by the detecting device 2 are USB interfaces or RS-232 interfaces, and are used for the detector to temporarily insert an external printer, an external storage medium, a host computer, a keyboard or other instrument equipment according to the detection needs.
  • the output display device 8 is an alphanumeric LCD screen, an LED, a touch display screen, a sound device, or a host computer.
  • the power source 7 is an external power source or a removable battery.
  • the battery includes a lithium battery.
  • the test strip 15 inserted into the test strip cartridge 16 has one end of the sample pad 21 overhanging the open end of the test strip card case 16 to be immersed to suck the sample.
  • the light emitted by the optical system 3 excites the quantum dot reaction signal of the strip detection strip 27 and the control strip 28 to emit characteristic frequency reflection fluorescence, which is received by the photodetector 4 and converted into an electrical signal, and the converted electrical signal After being amplified by the signal, it is transmitted to the analog/digital converter 5 to be converted into a digital signal and transmitted to the data processing device 6.
  • the data processing device 6 automatically recognizes the transmitted characteristic frequency fluorescent signal and transmits it in conjunction with the electronic tag reading and writing module 10.
  • the standard working curve or coefficient parameter of the test object sent to the test strip electronic tag 20 is subjected to the object concentration calculation and technical analysis, and the result is transmitted to the output display device 8, and the voice module 18 voice prompts the detection result information.
  • the quantum dot immunochromatographic strip detection system of the present invention may further comprise a wireless communication module 12 connected to the data processing device 6 of the system and a communication with the signal transmitting end of the wireless communication module 12, including a remote The wireless network system 13, 14 of the server 14 or/and other mobile terminal devices 14.
  • the communication manner between the wireless communication module 12 and the wireless network systems 13, 14 includes, but is not limited to, Wifi, Bluetooth, SMS, WeChat, mobile phone, and the like.
  • the power source 7 also supplies power to the wireless communication module 12.
  • the data processing device 6 automatically recognizes the characteristic frequency fluorescent signal transmitted from the detecting tape 27 and the quality control tape 28, and combines the standard working curve of the detected object transmitted on the test strip electronic tag 20 transmitted by the electronic tag reading and writing module 10.
  • the coefficient parameter performs the sample concentration calculation and the technical analysis, and the result is transmitted to the output display device 8.
  • the voice module 18 promptly displays the detection result information, and the detection result and related information are sent to the wireless network system 13 through the wireless communication module 12.
  • the remote server 14 or/and the mobile terminal device 14 performs data management and information consultation feedback.
  • the data processing device 6 of the quantum dot immunochromatographic strip detection system of the present invention may also be integrated with the electronic tag reading and writing module 10 to form the data processing device 6, the data processing device 6
  • the characteristic frequency fluorescent signal transmitted from the detection tape 27 and the quality control tape 28 is automatically recognized, and the sample concentration calculation and technical analysis are performed in conjunction with the standard working curve or coefficient parameter of the sample transmitted from the test strip electronic tag 20.
  • the electronic tag 20 of the quantum dot immunochromatographic strip detection system of the present invention can also be mounted anywhere in the test strip 15 in the cartridge 16.
  • a sample pad 11 for sample separation processing may be overlapped between the sample pad 21 of the test strip 15 of the cartridge 16 and the marker pad 22.
  • the filter pad 11 includes a blood filter membrane.
  • the end of the absorbent pad 24 of the test strip 15 of the cartridge 16 may be overlapped with a strip reaction end point indicating label 25.
  • the strip reaction endpoint indication label 25 includes, but is not limited to, a precision pH test strip having a discoloration range of 5.0-9.0.
  • the strip card cassette 16 has a strip reaction end observation window 30 at a position corresponding to the strip reaction end point indicating label 25.
  • the detecting device 2 of the quantum dot immunochromatographic strip detecting system of the present invention is a portable instrument, a medium/large instrument, or a combination with a wireless communication product having a function of transmitting and receiving information as a whole, including a mobile phone, A combination of choices in a tablet, personal digital assistant, mobile terminal device, or collection of computers.
  • the test strip 15 in the test strip card 1 of the quantum dot immunochromatographic strip detection system of the present invention is a disposable test strip; the cassette 16 and the cassette 16 of the test strip card 1 for inserting the test strip 15
  • the electronic tag 20 mounted on the upper or the test strip 15 is a used product matched with the test strip of the same batch; the detecting device 2 is a continuous universal product.
  • the preparation method of the test strip of the invention comprises the following steps:
  • Filter pad 11 Select the sample filter membrane according to the pore size of the filter membrane, cut into a certain size membrane block, and dry for use.
  • marker pad 22 a glass fiber membrane is selected as a marker pad material, which is cut into a membrane block having a certain specification, and a conjugate solution of a quantum dot and a target analyte detection molecule is added to the membrane block, and the membrane block is dried. spare.
  • the cellulose film is selected as the analysis membrane material, and is cut into a membrane block having a certain specification, and the other specific molecule related to the detection of the target object is sprayed from the bottom edge of the membrane block at a certain distance from the bottom of the membrane block as a detection zone.
  • 27 and the spray point include the quality control of the secondary antibody as the quality control belt 28, and the dry membrane block is reserved.
  • 5Absorbing pad 24 Select a cellulose film with strong water absorption and cut into a film block with a certain specification, and dry it thoroughly.
  • test strip reaction end point indication label 25 A precision pH test paper with a color change range of 5.0-9.0 is used, and it is cut into a film block having a certain specification and sufficiently dried for use.
  • the prepared test strip assembly is sequentially attached to the plastic underlay 26 by the suction pad 21, the marking pad 22, the analysis film 23, and the absorbent pad 24, and is cut into strips of a certain specification. , dry and spare.
  • the prepared test strip assembly is sequentially attached to the plastic underlay 26 by the suction sample pad 21, the filter sample pad 11, the marker pad 22, the analysis film 23, and the absorbent pad 24, and is cut. Cut into strips of a certain size and dry for use.
  • the prepared test strip assembly is sequentially attached to the plastic underlay 26 by the suction sample pad 21, the marking pad 22, the analysis film 23, the absorbent pad 24, and the test strip reaction end point label 25. And cut into a certain specification of the test strip, dry and spare.
  • the prepared test strip assembly is sequentially attached to the sample by the suction sample pad 21, the filter sample pad 11, the marker pad 22, the analysis film 23, the water absorption pad 24, and the test strip reaction end point label 25.
  • the plastic underlay 26 is cut into a strip of a certain specification and dried for use.
  • the strip reaction is a dynamic process. Different test object test strips and different batch test strips, the preparation process, material selection, detection environment and other differences, the detection sensitivity, stability, specificity, etc. may be different, which will affect the concentration of the test substance Accurate determination (for example, the source of the cellulose membrane used to make the test strip, the size of the membrane pores, the thickness of the test strips, etc. may cause the strip reaction to proceed at the exact same siphon rate, the reactants It may even be stuck in the test strips before the strip test strip 27 and the quality control strip 28; the field field test and indoor test, temperature, humidity and other differences may also affect the test strip reactant on the test strip. The rate of oozing advances makes them not exactly the same, etc.).
  • the invention can solve the above problems well, and improves the accuracy and flexibility of sample detection: the invention uses the electronic tag 20 to store the corresponding standard working curve or coefficient parameter of the same batch test strip to quantify the same batch test strip.
  • concentration of the sample, the standard working curve or coefficient parameter on the electronic tag 20 can be calibrated according to the difference between the test strips and the batch before the test strip card 1 product leaves the factory, which conforms to the national batch test "batch batch inspection"specification; the invention
  • the electronic tag 20 further stores a test strip optical density reference monitoring value (OD quality control band ' ).
  • the sample When the sample is actually detected, it may prompt whether the test strip reaction process is established, and determine whether the test result is true or not (if the test strip fails to react)
  • the OD quality control tape obtained in the detection will have a great statistical error with the corresponding test strip optical density reference monitoring value (OD quality control band ' ) read from the electronic tag 20; the tail of the test strip 15 of the present invention
  • the end of the strip may be provided with a strip reaction end point indicating label 25, which may indicate whether the siphon bleed chromatography of the strip reaction reagent on the strip is sufficient, and whether the reaction reaches the end point;
  • the strip 15 of the present invention is provided with quality control With a belt 28, the control strip 28 serves to detect the control.
  • the method for manufacturing the standard working curve of the object stored in the electronic tag 20 of the present invention comprises the following steps: (1) preparing a series of standards of the test object standard. (2) Detecting the corresponding OD detection zone and OD quality control zone of the standard concentration of the test object, and calculating the OD detection zone /OD control zone ratio or OD detection zone /(OD detection zone + OD quality control zone ) ratio. (3) The X-axis is taken as the standard product concentration.
  • the test result is the OD test band /OD control band ratio for the Y-axis, and the standard working curve is drawn; or the standard product series concentration is used as the X-axis, and the test result is the OD test tape / (OD detection zone + OD quality control zone ) ratio is used as the Y axis to draw the standard working curve; or the standard product series concentration is used as the X axis, and the test result is taken as the Y axis by the OD detection band value, and the standard working curve is drawn.
  • the optical density value of the test strip obtained from the test of the standard product is taken as the reference value of the optical density reference of the test strip (ie OD quality control belt ); the standard working curve software and the OD quality control belt are taken And stored on the electronic tag 20.
  • the spectral signal of the quantum dot reaction signal of the detection sample of the present invention based on the quantum dot immunochromatographic strip detection strip 27 is positively correlated with the concentration of the sample to be tested.
  • the greater the concentration of the analyte in the sample the stronger the characteristic frequency reflected fluorescence signal emitted by the quantum dot reaction signal that migrates to the strip detection zone 27.
  • the smaller the concentration of the analyte in the sample the weaker the characteristic frequency reflected fluorescent signal emitted by the quantum dot reaction signal on the strip detection zone 27.
  • the present invention impregnates the sample at the interference overhanging end (i.e., the end of the aspirating pad 21) of the test strip inserted in the test strip card 1, and the liquid sample containing the target test object is located at the other end of the test strip.
  • the capillary siphon of the test strip microporous filter is used to slowly migrate to the rear end of the test strip.
  • target analyte molecule such as an antigen or an antibody
  • the corresponding quantum dot-labeled immune molecules coated on the glass fiber membrane marker pad 22 in the middle section of the test strip are combined and migrated together to the test strip of the strip analysis membrane 23, and coated with Another specific target analyte-related reaction molecule of the detection zone 27 (such as another specific antibody or antigen of the corresponding target analyte molecule) combines to form a detection band quantum dot reaction signal and is trapped and enriched on the detection zone 27.
  • the remaining part of the quantum dot immunolabeling molecule continues to migrate to the strip control strip 28, and combines with the control substance (such as the secondary antibody) coated in the control strip 28 to form a QC quantum dot reaction signal, and The interception is concentrated on the quality control belt 28.
  • the light emitted by the excitation light sources 311, 321 of the optical system 3 excites the quantum dot reaction signals of the strip detection strip 27 and the control strip 28 to emit a characteristic frequency fluorescent signal, which is received by the photodetector 4 and converted into corresponding intensity.
  • the electrical signal, the converted electrical signal is amplified by the signal and transmitted to the analog/digital converter 5 for conversion to a digital signal and transmitted to the data processing device 6 for storage and data processing.
  • the data processing device 6 automatically recognizes the characteristic frequency fluorescence signals transmitted from the detection tape 27 and the quality control tape 28, and obtains the optical density value (OD detection zone ) of the test object detection zone 27 and the optical density value of the quality control zone 28 (OD quality). Control band ) and calculate the ratio of OD detection belt / OD quality control belt ratio or OD detection belt / (OD detection belt + OD quality control belt ), and automatically read the test strip card 1 electronic label 20 through the electronic tag reading and writing module 10
  • the stored standard working curve or coefficient parameter of the detected object is combined with the standard working curve or coefficient parameter of the detected object to obtain the concentration of the detected object, the output display device 8 displays the detection result and the information, and the voice module 18 prompts the detection result information, and the detection result
  • the related information is transmitted to the remote server 14 of the wireless network system 13, 14 or/and other mobile terminal devices 14 via the wireless communication module 12 for data management and information consultation feedback.
  • the sample of the present invention includes clinical or non-clinical blood, body fluid, urine, saliva, genital secretions or other liquid samples or viscous samples, wherein the clinical samples include infectious diseases, hormones, cardiovascular diseases, tumors.
  • Samples such as cancer, diabetes, and autoimmune diseases, including non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary testing, and drug testing.
  • the present invention simultaneously performs quantitative detection of a single component or a plurality of components of a target analyte in the above sample.
  • the method for detecting the use of the quantum dot immunochromatographic strip detection system of the present invention is achieved by the following steps:
  • test strip is immersed in the sample end
  • the quantum dot immunochromatographic strip detection system starts sample detection. After the detection is completed, the output display device 8 displays the test strip detection result information, and the voice module 18 promptly displays the test result information;
  • the beneficial effects of the present invention mainly include:
  • the quantum dot has high fluorescence luminescence efficiency, wide excitation line range, narrow emission line range, long fluorescence lifetime, large Stokes displacement, similar particle size to biomolecules, and multi-functionality after surface modification.
  • Quantum dots of different particle sizes, types and structures can produce continuous fluorescence peak spectra with different characteristic wavelengths, and the characteristic wavelength fluorescence peak spectra produced by the quantum dot mixture do not overlap.
  • Different quantum dots are used to mark the corresponding reaction molecules of the test object, and the mixture is coated on the immunoassay test strip to react with the sample to be tested. By measuring the specific fluorescent signal of the test strip, the sample can be quickly and accurately measured within a few minutes. Component concentration.
  • the test strip of the system of the invention can not only synthesize multiple components of the sample by synchronous detection and quantitative detection, but when the test strip is provided with a plurality of detection strips, the system can realize synchronous quantitative quantitative joint inspection of sample components with greater flux.
  • the amount of sample is small, and a few microliters to several tens of microliters can meet the detection needs.
  • a filter pad 11 capable of automatically separating and processing a sample may be disposed between the aspiration pad 21 of the quantum dot immunochromatographic strip of the system and the marker pad 22.
  • the sample to be inspected is a blood sample, and the filter pad 11 can filter the blood cells and only allow the serum to permeate the filter pad 11 and can be detected by whole blood.
  • the serum should be separated by using equipment such as a centrifuge. After the lack of detection.
  • the finished product form of the test strip detecting system of the present invention may be a large and medium-sized detecting instrument for use by various professional institutions in the society (in this case, the finished product data processing device 6 may adopt a PC);
  • the portable detector is used for immediate detection in the home, supermarket, street, bedside and people's daily life (in this case, the finished product data processing device 6 can employ a microprocessor).
  • the test result information is provided in three ways: 1 output display device 8 displays the test result information; 2 voice module 18 voice prompts the test result information (to facilitate the operator with poor vision, such as the elderly can listen to the test result) 3; detection results information can be remotely managed and information feedback through the mobile Internet (including the operator's ability to check the validity and significance of the test results, etc.).
  • the test strip 15 in the test strip card 1 is a one-time use test strip; the test strip for inserting the disposable test strip 15 and the electronic label mounted on the cassette 16 or the test strip 15 20 is a use product matched with the same batch test strip; the detecting device 2 is a continuous universal product. When testing different samples, only need to replace the corresponding test strips and the corresponding test strip card box 16 to achieve rapid quantitative detection of samples.
  • a tester user who has prepared the detecting device 2 (for continuous use) of the present invention only needs to purchase the required test strip 15 (for disposable articles) and a test strip card cartridge 16 matched with the test strip (its The electronic tag 20 matched with the same batch of test strips is installed on the electronic tag 20, and the electronic tag 20 stores the standard working curve or coefficient parameter for the concentration of the sample of the same batch of test strips, which is the accessory product of the same batch test strip) , you can achieve the detection needs.
  • the test strip 15 and the test strip card cassette 16 are inexpensive, and can be tolerated by ordinary testers.
  • the test result information can be remotely managed and consulted and feedback through the mobile internet.
  • the strip detection system of the present invention can have a built-in wireless communication module 12, which is connected to the data processing device 6, and its signal transmitting end communicates with the wireless network systems 13, 14.
  • the data processing device 6 analyzes the obtained detection result and related information through the wireless communication module 12 to the remote server 14 of the wireless network system 13, 14 or/and other mobile terminal devices 14 and the like for corresponding data management and information consultation feedback.
  • the electronic tag 20 of the present invention stores the test strip optical density reference monitoring value (OD quality control tape ' ).
  • the strip optical density reference monitoring value (OD quality control band ' ) may generate a great statistical error; the tail end of the test strip 15 of the present invention may be provided with a strip reaction end point indicating label 25, which can monitor the strip reaction reactant at Whether the siphon bleed chromatography on the strip is sufficient and whether the reaction reaches the end point.
  • the test strip 15 is provided with a quality control belt 28, and its optical density intensity is used for detecting and controlling.
  • the electronic tag 20 stores the standard working curve or coefficient parameter of the corresponding object for accurately quantifying the concentration of the corresponding object.
  • 3Electronic tag 20 stores the same batch test strip quality control band optical density reference monitoring value (OD quality control band ' ), used to monitor whether the test strip reaction in the sample test is established, and whether the test result is valid.
  • the strip 15 is provided with a test strip end point indicating label 25 for indicating whether the siphon bleed chromatography of the strip reaction reagent on the strip is sufficient and whether the reaction reaches the end point.
  • the detecting device 2 of the strip detecting system is provided with a plurality of USB interfaces or RS-232 interfaces for temporarily plugging an external printer, an external storage medium, a host computer, a keyboard or other instruments, so as to facilitate the user of the detector.
  • the detection result information can be accessed, printed or transferred at the right time.
  • the test strip detection system is applicable to a wide range of samples.
  • the test strip is a one-time use test strip; the test strip card cassette 16 and the cassette 16 for inserting the test strip 15 or the electronic label 20 mounted on the test strip 15 are matched with the same batch test strip.
  • the product is used; the detecting device 2 is a continuous product.
  • the detector can select the quantum dot test strip of the corresponding category according to different detection needs, and can quickly realize the multi-component quantitative analysis of the required sample.
  • the sample to be tested may be from clinical or non-clinical blood (including whole blood, serum, plasma), body fluids, urine, saliva, genital tract secretions or other liquid samples or viscous samples.
  • Clinical samples include infectious diseases, hormones, cardiovascular diseases, tumors, cancer, diabetes, autoimmune diseases and other samples; non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary medicine Samples such as testing and drug testing.
  • Figure 1 is a block diagram showing the appearance of a test strip detection system in which the detection device of the present invention adopts a mobile phone style and the detection result does not require remote data management and information feedback.
  • Fig. 2 is a block diagram showing the internal structure of the test strip detection system in which the detection device of the present invention adopts the mobile phone style and the detection result does not require remote data management and information feedback.
  • the strip detection strip is one.
  • Fig. 3 is a block diagram showing the internal structure of the test strip detection system in which the detection device of the present invention adopts the mobile phone style and the detection result does not require remote data management and information feedback. Among them, there are two test strips.
  • FIG. 4 is a block diagram showing the internal structure of the test strip detection system in which the detection device of the present invention adopts a mobile phone style and the detection result does not require remote data management and information feedback. It is shown that the strip detection strip is one; the data processing device 6 has integrated the electronic tag module 10.
  • FIG. 5 is a block diagram showing the appearance of a test strip detection system capable of remote data management and information consultation feedback using the mobile phone style and the detection result.
  • Fig. 6 is a block diagram showing the internal structure of a detecting device of the strip detecting system capable of remote data management and information feedback using the mobile phone pattern and the detection result.
  • the strip detection strip is one.
  • Fig. 7 is a block diagram showing the internal structure of a detecting device of the strip detecting system capable of remote data management and information feedback using the mobile phone pattern and the detection result. Among them, there are two test strips.
  • Fig. 8 is a block diagram showing the internal structure of a detecting device of the strip detecting system capable of remote data management and information feedback using the mobile phone pattern and the detection result. It is shown that the strip detection strip is one; the data processing device 6 has integrated the electronic tag module 10.
  • FIG. 9 is a structural block diagram of a preferred embodiment 1 of an optical system of the strip detecting system of the present invention, wherein the strip detecting strip is one piece.
  • FIG. 10 is a structural block diagram of a second preferred embodiment of the optical system of the test strip detecting system of the present invention, wherein the strip detecting strip is one piece.
  • Figure 11 Side view of the test strip. It is shown that the test strip assembly comprises a sample pad 21, a marker pad 22, an analysis film 23, and an absorbent pad 24; the detection tape 27 is one piece.
  • Figure 12 Side view of the test strip. It is shown that the test strip assembly comprises a sample pad 21, a marker pad 22, an analysis film 23, and an absorbent pad 24; and the detection tape 27 is a plurality of strips.
  • Figure 13 Top view of the test strip card. Among them, the strip detection strip is one.
  • Figure 14 Top view of the test strip card. Among them, the test strips are shown as multiple strips.
  • Figure 15 Side view of the test strip. It is shown that the test strip assembly comprises a sample pad 21, a filter pad 11, a marker pad 22, an analysis film 23, and an absorbent pad 24; and the detection tape 27 is a strip.
  • Figure 16 Side view of the test strip. It is shown that the test strip assembly includes a sample aspiration pad 21, a marker pad 22, an analysis membrane 23, an absorbent pad 24, a test strip reaction end point indicating label 25, and a detection strip 27 as one.
  • Figure 17 Top view of the test strip card.
  • the test strip card cartridge 16 has a test strip reaction end observation window 30 at a position corresponding to the strip reaction end point indicating label 25.
  • Figure 18 Side view of the test strip. It is shown that the test strip assembly includes a sample aspiration pad 21, a filter sample pad 11, a marker pad 22, an analysis film 23, an absorbent pad 24, a test strip reaction end point indicating label 25, and a detecting strip 27 as one.
  • Figure 19 Standard operating curves for tumor markers AFP, CEA, PSA.
  • Figure 20 Quantum dot-labeled AFP, CEA, PSA fluorescence spectral curves.
  • Figure 21 Standard operating curve for detection of hepatitis B virus surface antigen (HBsAg).
  • Figure 22 Quantum dot-labeled HBsAg spectral curve.
  • Figure 23 Block diagram of a top view of another application of the test strip card.
  • the serial number is as follows: 1 test strip card, 2 detecting device, 3 optical system, 4 photodetector, 5 Analog/digital converter, 6 data processing device, 7 power supply, 8 output display device, 9 buttons, 10 electronic tag reader module, 11 filter pad, 12 wireless communication module, 13 wireless network system, 14 wireless network system remote Server or mobile terminal device, 15 test strips, 16 test strip card box, 17 test strip slot, 18 voice module, 19 test strip card insertion mark, 20 electronic label, 21 sample pad, 22 mark pad, 23 analysis membrane, 24 absorbent pad, 25 test strip reaction end point indication label, 26 backing, 27 detection belt, 28 quality control belt, 29 detection window, 30 test strip reaction end observation window, 31 multiple communication interfaces, 32 sample hole, 33 test strip card socket, 311 excitation light source, 312 fiber bundle, 313 collimation illumination lens, 314 dichroic mirror, 315 front mirror group, 316 filter, 317 rear mirror group, 321 excitation light source, 322 incident optical coupler, 323 incident optical fiber, 324 optical fiber probe, 325 outgoing
  • This embodiment is a preferred technical solution for the quantum dot test strip detection system of the present invention, wherein the detecting device 2 adopts a mobile phone pattern and the detection result does not require remote data management and information feedback.
  • the technical solution described in this embodiment will be described below with reference to FIGS. 1-4 and 9-18.
  • FIG. 1 is a block diagram of the appearance of the system.
  • Figure 2-4 is a block diagram of the internal structure of the system.
  • the test strip card 1 includes a cartridge 16 and a quantum dot immunochromatographic test strip 15 that can be inserted into the cartridge 16 in a timely manner.
  • the detecting device 2 includes an optical system 3, a photodetector 4, an analog/digital converter 5, a data processing device 6, an electronic tag reading and writing module 10, an output display device 8, a voice module 18, a power source 7, and a surface of the detecting device 2.
  • the button 9 and a plurality of communication interfaces 31 that are reserved for the external connection of the detecting device 2 are temporarily plugged.
  • the imaging signal end of the optical system 3 is connected to the photodetector 4.
  • the signal output of the photodetector 4 is amplified by a signal and connected to the signal input terminal of the analog/digital converter 5.
  • the signal output of the A/D converter 5 is connected to the signal input of the data processing device 6.
  • the data processing device 6 is also connected to the output display device 8, the voice module 18, the electronic tag reading and writing module 10, the power source 7, the button 9 on the surface of the detecting device 2, and the communication interfaces 31 that are reserved for the detecting device 2.
  • the power source 7 supplies power to the optical system 3, the photodetector 4, the analog/digital converter 5, the output display device 8, the voice module 18, and the electronic tag reading and writing module 10 through the data processing device 6.
  • the front end of the detecting device 2 has a test strip card jack 33.
  • the test strip card 1 is a detached structure of the detecting device 2.
  • the test strip 15 is a detached structure of the test strip card 1.
  • the test strip card 1 is provided with a test strip locking insertion mark 19 at the test strip card insertion hole 33 corresponding to the detecting device 2. After the test strip 15 is inserted into the test strip card 1, the test strip card 1 is inserted into the test strip card insertion hole 33 of the detecting device 2 to detect the sample on the test strip.
  • test strip card case 16 and the upper case opening of the card case end form a test strip slot opening 17 for facilitating insertion of the test strip 15.
  • the test strip 15 shown in FIGS. 11-12 includes a sample pad 21, a marker pad 22, an analysis film 23, and an absorbent pad 24 which are sequentially attached to the substrate 26.
  • the test strip 15 shown in Fig. 15 includes a sample pad 21, a filter pad 11, a marker pad 22, an analysis film 23, and an absorbent pad 24 which are sequentially attached to the backing 26.
  • the 16 includes a sample pad 21, a marker pad 22, an analysis film 23, an absorbent pad 24, and a strip reaction end point indicating label 25 which are sequentially attached to the backing 26.
  • the test strip 15 shown in Fig. 18 includes a sample pad 21, a filter pad 11, a marker pad 22, an analysis film 23, an absorbent pad 24, and a strip reaction end point indicating label 25 which are sequentially attached to the substrate 26.
  • the analysis film 23 of the test strip 15 has a detection tape 27 and a quality control tape 28, and the detection tape 27 is one or more (test strips 15 as shown in Figs. 2, 4, 9-11, 13, and 15-18.
  • the detection tape 27 is one piece; the test strips 15 shown in Figs. 3, 12, and 14 have a plurality of detection strips 27 for the analysis film 23.
  • the upper casing of the test strip cartridge 16 is provided with a detection window 29 at a position corresponding to the test strip analysis film 23.
  • the cartridge 16 has a test strip reaction end observation window 30 (shown in Fig. 17) at a position corresponding to the strip reaction end point indicating label 25.
  • An electronic tag 20 storing information for detecting the test strip 15 is attached to any portion of the cartridge 16.
  • the detection window 29 of the cartridge 16 corresponds to the light irradiation surface of the optical system 3 of the detecting device 2.
  • the marking pad 22 of the test strip 15 in the cartridge 16 is coated with one or more related molecules for detecting the target analyte by quantum dots, including ZnS, CdS, HgS, ZnSe, CdSe, HgSe, CdTe, ZnTe, ZnO, PbSe, HgTe, CaAs, InP, InAs, InCaAs, CdS/ZnS, CdS/Ag 2 S, CdS/PbS, CdS/Cd(0H) 2 , CdS/HgS, CdS/HgS/ CdS, ZnS/CdS, ZnS/CdS/ZnS, ZnS/HgS/ZnS/CdS, CdSe/CdS, CdSe/ZnS, CdSe/CuSe, CdSe/HgTe, CdSe/HgSe,
  • the test strip 27 of the test strip 15 in the cartridge 16 is coated with one or more other molecules associated with the detection of the target analyte.
  • the quality control tape 28 of the test strip 15 in the cartridge 16 is coated with a quality control comprising a secondary antibody.
  • the electronic tag 20 on the cartridge 16 includes, but is not limited to, an RFID tag, a contactlessly recognized IC card chip.
  • the mounting manner of the electronic tag 20 in the cartridge 16 includes a film-adhesive type, a package-embedded type, a card type, a nail type, or a button type.
  • the test strip detection information stored in the electronic tag 20 includes the same working curve or coefficient parameter for quantifying the sample concentration of the sample by the same batch of quantum dot immunochromatographic test strips, and the reference density control band optical density reference monitoring value (OD quality) Control belt ' ), test strip name, test strip batch number, test strip validity period, electronic label password, clinical index reference value, test strip manufacturer information, etc., and can be read into the measured object identity information, tester information, sample name , sample number, date of detection, test results and other information.
  • the standard working curve of the object stored in the electronic tag 20 has various forms to choose from, including but not limited to one of the following curves:
  • the OD detection zone is defined as the detection band optical density value measured by the concentration of the sample standard series
  • the OD quality control zone is defined as the quality control zone optical density value measured by the concentration of the sample standard series.
  • the structural composition of the optical system 3 is available in a variety of options including, but not limited to, the solution described in Figure 9 or the solution illustrated in Figure 10.
  • the optical system 3 comprises an illumination system and an imaging system.
  • the illumination system includes an excitation light source 311.
  • On the output light path of the light source 311, the fiber bundle 312, the collimation illumination lens 313, the dichroic mirror 314, and the front lens group 315 are sequentially arranged up to the test strip card 1.
  • the excitation light source 311 includes a light emitting diode LED or a laser diode.
  • the imaging system includes a front lens group 315 of a common optical axis, a dichroic mirror 314, a filter 316, and a rear lens group 317. The angle between the reflecting surface of the dichroic mirror 314 and the optical axis is 45o. Both the front mirror group 315 and the rear mirror group 317 employ a separate structure.
  • the illumination system optical path is perpendicular to the optical axis of the imaging system in front of the dichroic mirror 314, and the portion after the dichroic mirror 314 is coaxial with the imaging system.
  • the photodetector 4 is located on the image side of the rear mirror group 317.
  • the fiber bundle 312 divides the light emitted by the light source 311 into laser beams having a certain pitch and the same intensity, and the laser beam is collimated by the collimating illumination lens 313 into a parallel beam incident on the surface of the dichroic mirror 314, and is reflected by the dichroic mirror 314.
  • the quantum dot reaction signal which is oscillated to the detection zone 27 and the quality control zone 28 by the front lens group 315 and the detection tape 27 and the quality control tape 28 which are irradiated to the test strip 15 of the front mirror group 315 object interview strip card 1 are excited.
  • the characteristic frequency reflected fluorescence is emitted, and the detection band 27 and the control strip 28 reflect the fluorescence through the same front lens group 315, through the dichroic mirror 314, and the filter 316 to filter out the stray light, and then the mirror group 317 enters the photodetector 4
  • the detection is converted into an electrical signal.
  • the optical system 3 includes an excitation light source 321, and an incident optical coupler 322, an incident optical fiber 323, a fiber optic probe 324, an exiting optical fiber 325, and an outgoing optical coupler 326 are sequentially disposed on the output optical path of the excitation light source 321.
  • the excitation light source 321 includes a light emitting diode LED or a laser diode. The light emitted by the light source 321 is split into the incident optical fiber 323 via the incident optical coupler 322, and the incident optical fiber 323 is irradiated to the test strip of the test strip 15 of the test strip card 1 by the strip detection fiber probe and the test strip control fiber probe respectively.
  • the fiber optic probe 324 employs a combined beam structure with an incident fiber 323 at the center and an exit fiber 325 at the periphery.
  • the photodetector 4 has a plurality of alternative objects including a CCD, a CMOS, a photomultiplier tube, a photodiode, and a phototransistor.
  • the data processing device 6 is a microprocessor, a microcontroller, or a PC with corresponding data processing and control software.
  • the electronic tag reading and writing module 10 automatically reads/writes the electronic tag 20 information in a non-contact manner.
  • the plurality of communication interfaces 31 reserved by the detecting device 2 are a USB interface or an RS-232 interface, and are used for the detector to temporarily insert an external printer, an external storage medium, a host computer, a keyboard or other instrument equipment according to the detection needs.
  • the output display device 8 is an alphanumeric LCD liquid crystal panel, an LED, a touch display screen, a sound device or a host computer, and the like.
  • the power source 7 is an external power source or a replaceable battery.
  • the battery includes a lithium battery.
  • the detecting device 2 of the strip detecting system as a whole is a portable instrument, a medium/large instrument, or a combination with a wireless communication product having a function of transmitting and receiving information, including a mobile phone, a tablet computer, a personal digital assistant, A combination of choices in a mobile terminal device or collection of computers.
  • the test strip 15 in the test strip card 1 is a one-time use test strip; the cassette 16 of the test strip card 1 for inserting the test strip 15 and the electronic label 20 mounted on the cassette 16 are the same batch test strip A matching product; the detecting device 2 is a continuous product.
  • test strip 15 When the sample is detected, the test strip 15 is inserted into the test strip card 1, and the test strip card 1 into which the test strip is inserted is inserted into the test strip card insertion hole 33 of the detecting device 2, and the test strip 15 is over the protruding end ( That is, the end of the sample pad 21 is immersed in the liquid sample.
  • the liquid sample of the test object is slowly moved toward the rear end of the test strip 15 by capillary siphoning of the microporous filter under the pulling of the absorbent pad 24 at the other end of the test strip.
  • target analyte molecules such as antigens or antibodies
  • they are combined with the corresponding quantum dot-labeled immune molecules coated on the label pad 22 in the middle of the strip before the strip, and are then attached to the strip.
  • the end of the test strip 27 which is oozing to the strip analysis membrane 23 is combined with another specific target analyte-related reaction molecule (such as another specific antibody or antigen of the corresponding target analyte molecule) coated in the detection zone 27.
  • the quantum dot reaction signal is detected and intercepted and enriched on the detection zone 27.
  • the remaining part of the quantum dot immunolabeling molecule continues to migrate to the strip control strip 28, and combines with the control substance (such as the secondary antibody) coated in the control strip 28 to form a QC quantum dot reaction signal, and The interception is concentrated on the quality control belt 28.
  • the quantum dot reaction signal of the strip detection strip 27 is excited by the light emitted by the optical system 3 to emit a characteristic frequency reflection fluorescence, and the quantum dot fluorescence signal reflected by the strip detection strip 27 is positively correlated with the concentration of the sample to be tested. The greater the concentration of the analyte in the sample, the stronger the characteristic frequency fluorescence signal emitted by the strip detection zone 27.
  • the light emitted by the optical system 3 excites the strip detection strip 27 and the quantum dot reaction signal of the control strip 28 to emit reflected fluorescence, which is received by the photodetector 4 and converted into an electrical signal, and the converted electrical signal is amplified by the signal.
  • the post-transfer to analog/digital converter 5 converts the digital signal into a digital signal and transmits it to the data processing device 6.
  • the data processing device 6 automatically recognizes the transmitted characteristic frequency fluorescent signal and transmits it in conjunction with the transmission transmitted by the electronic tag reading and writing module 10.
  • the test object concentration calculation and technical analysis are performed on the test object standard working curve or coefficient parameter of the test strip electronic tag 20, and the result is transmitted to the output display device 8, and the voice module 18 voice prompts the detection result information.
  • the method for preparing the standard working curve of the test object comprises the following steps: (1) preparing a series of concentrations of the standard product of the test object. (2) Detecting the corresponding OD detection zone and OD quality control zone of the standard concentration of the test object, and calculating the OD detection zone /OD control zone ratio or OD detection zone /(OD detection zone + OD quality control zone ) ratio. (3) The X-axis is taken as the standard product concentration.
  • the test result is the OD test band /OD control band ratio for the Y-axis, and the standard working curve is drawn; or the standard product series concentration is used as the X-axis, and the test result is the OD test tape / (OD detection zone + OD quality control zone ) ratio is used as the Y axis to draw the standard working curve; or the standard product series concentration is used as the X axis, and the test result is taken as the Y axis by the OD detection band value, and the standard working curve is drawn.
  • the optical density value of the test strip obtained from the test of the standard product is taken as the reference value of the optical density reference of the test strip (ie OD quality control belt ); the standard working curve software and the OD quality control belt are taken And stored on the electronic tag 20.
  • the detection and use method of the test strip detection system is implemented by the following steps:
  • test strip is immersed in the sample end
  • the quantum dot strip detection system starts sample detection. After the detection is completed, the output display device 8 displays the test strip detection result information, and the voice module 18 promptly presents the detection result information.
  • This embodiment is a preferred technical solution for the quantum dot test strip detection system of the present invention, wherein the detecting device 2 adopts the mobile phone pattern and the detection result can perform remote data management and information feedback.
  • the technical solution described in this embodiment will be described below with reference to FIGS. 5-18.
  • FIG. 5 is a block diagram showing the appearance of the system.
  • 6-8 are block diagrams showing the internal structure of the detecting device 2 of the system.
  • the quantum dot immunochromatographic strip detection system includes a strip card 1, a detection device 2, and a wireless network system including a remote server 14 or/and other mobile terminal devices 14. 13,14.
  • the test strip card 1 includes a cartridge 16 and a quantum dot immunochromatographic test strip 15 that can be inserted into the cartridge 16 in a timely manner.
  • the detecting device 2 includes an optical system 3, a photodetector 4, an analog/digital converter 5, a data processing device 6, an electronic tag reading and writing module 10, an output display device 8, a voice module 18, a wireless communication module 12, and a power supply 7.
  • the button 9 on the surface of the detecting device 2 and the plurality of communication interfaces 31 that are reserved for the external connection of the detecting device 2 are temporarily plugged.
  • the imaging signal end of the optical system 3 is connected to the photodetector 4.
  • the signal output of the photodetector 4 is amplified by a signal and connected to the signal input terminal of the analog/digital converter 5.
  • the signal output of the A/D converter 5 is connected to the signal input of the data processing device 6.
  • the data processing device 6 is also respectively connected to the wireless communication module 12, the output display device 8, the voice module 18, the electronic tag reading and writing module 10, the power source 7, the button 9 on the surface of the detecting device 2, and the communication interfaces 31 reserved for the detecting device 2. Connected.
  • the signal transmitting end of the wireless communication module 12 communicates with the wireless network systems 13, 14 including the remote server 14 or/and other mobile terminal devices 14, including but not limited to Wifi, Bluetooth, SMS, WeChat, mobile phones. Wait.
  • the power source 7 supplies power to the optical system 3, the photodetector 4, the analog/digital converter 5, the output display device 8, the voice module 18, and the electronic tag reading and writing module 10 through the data processing device 6.
  • the power source 7 also supplies power to the wireless communication module 12.
  • the front end of the detecting device 2 has a test strip card jack 33.
  • the test strip card 1 is a detached structure of the detecting device 2.
  • the test strip 15 is a detached structure of the test strip card 1.
  • the test strip card 1 is provided with a test strip locking insertion mark 19 at the test strip card insertion hole 33 corresponding to the detecting device 2. After the test strip 15 is inserted into the test strip card 1, the test strip card 1 is inserted into the test strip card insertion hole 33 of the detecting device 2 to detect the sample on the test strip.
  • test strip card case 16 and the upper case opening of the card case end form a test strip slot opening 17 for facilitating insertion of the test strip 15.
  • the test strip 15 in the cartridge 16 shown in FIGS. 11-12 includes a sample pad 21, a marker pad 22, an analysis film 23, and an absorbent pad 24 which are sequentially attached to the substrate 26.
  • the test strip 15 shown in Fig. 15 includes a sample pad 21, a filter pad 11, a marker pad 22, an analysis film 23, and an absorbent pad 24 which are sequentially attached to the backing 26.
  • the 16 includes a sample pad 21, a marker pad 22, an analysis film 23, an absorbent pad 24, and a strip reaction end point indicating label 25 which are sequentially attached to the backing 26.
  • the test strip 15 shown in Fig. 18 includes a sample pad 21, a filter pad 11, a marker pad 22, an analysis film 23, an absorbent pad 24, and a strip reaction end point indicating label 25 which are sequentially attached to the substrate 26.
  • the analysis film 23 of the test strip 15 has a detection tape 27 and a quality control tape 28, and the detection tape 27 is one or more (detection of the analysis film 23 of the test strip 15 shown in Figs. 6, 8-11, 13, and 15-18).
  • the belt 27 is one piece; the test strips 15 shown in Figs.
  • the upper casing of the test strip cartridge 16 is provided with a detection window 29 at a position corresponding to the test strip analysis film 23.
  • the cartridge 16 has a test strip reaction end observation window 30 (shown in Fig. 17) at a position corresponding to the strip reaction end point indicating label 25.
  • An electronic tag 20 storing information for detecting the test strip 15 is attached to any portion of the cartridge 16.
  • the marking pad 22 of the test strip 15 in the cartridge 16 is coated with one or more related molecules for detecting the target analyte by quantum dots, including ZnS, CdS, HgS, ZnSe, CdSe, HgSe, CdTe, ZnTe, ZnO, PbSe, HgTe, CaAs, InP, InAs, InCaAs, CdS/ZnS, CdS/Ag 2 S, CdS/PbS, CdS/Cd(0H) 2 , CdS/HgS, CdS/HgS/ CdS, ZnS/CdS, ZnS/CdS/ZnS, ZnS/HgS/ZnS/CdS, CdSe/CdS, CdSe/ZnS, CdSe/CuSe, CdSe/HgTe, CdSe/HgSe,
  • the test strip 27 of the test strip 15 in the cartridge 16 is coated with one or more other molecules associated with the detection of the target analyte.
  • the quality control tape 28 of the test strip 15 in the cartridge 16 is coated with a quality control comprising a secondary antibody.
  • the electronic tag 20 on the cartridge 16 includes, but is not limited to, an RFID tag, a contactlessly recognized IC card chip.
  • the mounting manner of the electronic tag 20 in the cartridge 16 includes a film-adhesive type, a package-embedded type, a card type, a nail type, or a button type.
  • the test strip detection information stored in the electronic tag 20 includes the same working curve or coefficient parameter for quantifying the sample concentration of the sample by the same batch of quantum dot immunochromatographic test strips, and the reference density control band optical density reference monitoring value (OD quality) Control belt ' ), test strip name, test strip batch number, test strip validity period, electronic label password, clinical index reference value, test strip manufacturer information, etc., and can be read into the measured object identity information, tester information, sample name , sample number, date of detection, test results and other information.
  • the standard working curve of the object stored in the electronic tag 20 has various forms to choose from, including but not limited to one of the following curves:
  • the OD detection zone is defined as the detection band optical density value measured by the concentration of the sample standard series
  • the OD quality control zone is defined as the quality control zone optical density value measured by the concentration of the sample standard series.
  • the structural composition of the optical system 3 is available in a variety of options including, but not limited to, the solution described in Figure 9 or the solution illustrated in Figure 10.
  • the optical system 3 comprises an illumination system and an imaging system.
  • the illumination system includes an excitation light source 311.
  • On the output light path of the light source 311, the fiber bundle 312, the collimation illumination lens 313, the dichroic mirror 314, and the front lens group 315 are sequentially arranged up to the test strip card 1.
  • the excitation light source 311 includes a light emitting diode LED or a laser diode.
  • the imaging system includes a front lens group 315 of a common optical axis, a dichroic mirror 314, a filter 316, and a rear lens group 317. The angle between the reflecting surface of the dichroic mirror 314 and the optical axis is 45o. Both the front mirror group 315 and the rear mirror group 317 employ a separate structure.
  • the illumination system optical path is perpendicular to the optical axis of the imaging system in front of the dichroic mirror 314, and the portion after the dichroic mirror 314 is coaxial with the imaging system.
  • the photodetector 4 is located on the image side of the rear mirror group 317.
  • the fiber bundle 312 divides the light emitted by the light source 311 into laser beams having a certain pitch and the same intensity, and the laser beam is collimated by the collimating illumination lens 313 into a parallel beam incident on the surface of the dichroic mirror 314, and is reflected by the dichroic mirror 314.
  • the quantum dot reaction signal which is oscillated to the detection zone 27 and the quality control zone 28 by the front lens group 315 and the detection tape 27 and the quality control tape 28 which are irradiated to the test strip 15 of the front mirror group 315 object interview strip card 1 are excited.
  • the characteristic frequency reflected fluorescence is emitted, and the detection band 27 and the control strip 28 reflect the fluorescence through the same front lens group 315, through the dichroic mirror 314, and the filter 316 to filter out the stray light, and then the mirror group 317 enters the photodetector 4
  • the detection is converted into an electrical signal.
  • the optical system 3 includes an excitation light source 321, and an incident optical coupler 322, an incident optical fiber 323, a fiber optic probe 324, an exiting optical fiber 325, and an outgoing optical coupler 326 are sequentially disposed on the output optical path of the excitation light source 321.
  • the excitation light source 321 includes a light emitting diode LED or a laser diode. The light emitted by the light source 321 is split into the incident optical fiber 323 via the incident optical coupler 322, and the incident optical fiber 323 is irradiated to the test strip of the test strip 15 of the test strip card 1 by the strip detection fiber probe and the test strip control fiber probe respectively.
  • the fiber optic probe 324 employs a combined beam structure with an incident fiber 323 at the center and an exit fiber 325 at the periphery.
  • the photodetector 4 has a plurality of alternative objects including a CCD, a CMOS, a photomultiplier tube, a photodiode, and a phototransistor.
  • the data processing device 6 is a microprocessor, a microcontroller, or a PC with corresponding data processing and control software.
  • the electronic tag reading and writing module 10 automatically reads/writes the electronic tag 20 information in a non-contact manner.
  • the plurality of communication interfaces 31 reserved by the detecting device 2 are a USB interface or an RS-232 interface, and are used for the detector to temporarily insert an external printer, an external storage medium, a host computer, a keyboard or other instrument equipment according to the detection needs.
  • the output display device 8 is an alphanumeric LCD liquid crystal panel, an LED, a touch display screen, a sound device or a host computer, and the like.
  • the power source 7 is an external power source or a replaceable battery.
  • the battery includes a lithium battery.
  • the detecting device 2 of the strip detecting system as a whole is a portable instrument, a medium/large instrument, or a combination with a wireless communication product having a function of transmitting and receiving information, including a mobile phone, a tablet computer, a personal digital assistant, A combination of choices in a mobile terminal device or collection of computers.
  • the test strip 15 in the test strip card 1 is a one-time use test strip; the cassette 16 of the test strip card 1 for inserting the test strip 15 and the electronic label 20 mounted on the cassette 16 are the same batch test strip A matching product; the detecting device 2 is a continuous product.
  • the test strip 15 inserted into the test strip cartridge 16 has one end of the sample pad 21 overhanging the open end of the test strip card case 16 to be immersed to suck the sample.
  • the light emitted by the optical system 3 excites the strip detection strip 27 and the quantum dot reaction signal of the control strip 28 to emit reflected fluorescence, which is received by the photodetector 4 and converted into an electrical signal, and the converted electrical signal is amplified by the signal.
  • the post-transfer to analog/digital converter 5 converts the digital signal into a digital signal and transmits it to the data processing device 6.
  • the data processing device 6 automatically recognizes the transmitted characteristic frequency fluorescent signal and transmits it in conjunction with the transmission transmitted by the electronic tag reading and writing module 10.
  • the voice module 18 voice prompting detection result information, the detection result and related
  • the information is transmitted by the wireless communication module 12 to the remote server 14 of the wireless network system 13, 14 or/and the mobile terminal device 14 for data management and information consultation feedback.
  • the method for preparing the standard working curve of the test object comprises the following steps: (1) preparing a series of concentrations of the standard product of the test object. (2) Detecting the corresponding OD detection zone and OD quality control zone of the standard concentration of the test object, and calculating the OD detection zone /OD control zone ratio or OD detection zone /(OD detection zone + OD quality control zone ) ratio. (3) The X-axis is taken as the standard product concentration.
  • the test result is the OD test band /OD control band ratio for the Y-axis, and the standard working curve is drawn; or the standard product series concentration is used as the X-axis, and the test result is the OD test tape / (OD detection zone + OD quality control zone ) ratio is used as the Y axis to draw the standard working curve; or the standard product series concentration is used as the X axis, and the test result is taken as the Y axis by the OD detection band value, and the standard working curve is drawn.
  • the optical density value of the test strip obtained from the test of the standard product is taken as the reference value of the optical density reference of the test strip (ie OD quality control belt ); the standard working curve software and the OD quality control belt are taken And stored on the electronic tag 20.
  • the detection and use method of the test strip detection system is implemented by the following steps:
  • test strip is immersed in the sample end
  • the quantum dot strip detection system starts sample detection. After the detection is completed, the output display device 8 displays the test strip detection result information, and the voice module 18 promptly displays the test result information;
  • the quantum dot immunochromatographic strip detection system of the present embodiment is the same as Embodiment 1 or 2, except that the data processing device 6 is integrated with the electronic tag reading and writing module 10. At the time of sample detection, the data processing device 6 integrated with the electronic tag reading and writing module 10 automatically recognizes the characteristic frequency fluorescent signal transmitted from the detecting tape 27 and the quality control tape 28, and combines it with the electronic tag 20 transmitted from the test strip card.
  • the standard working curve or coefficient parameter of the test object is used to calculate the concentration of the test object and technical analysis. As shown in Figure 4 and Figure 8.
  • the quantum dot immunochromatographic strip detection system of the present embodiment is the same as the embodiment 1, 2 or 3, except that the sample pad 21 and the mark of the quantum dot test strip 15 in the test strip card cartridge 16 are different.
  • a filter pad 11 for sample separation processing is also overlapped between the pads 22, as shown in Figs. 15 and 18.
  • the filter pad 11 includes a blood filter membrane.
  • the filter pad 11 can block blood cells and only allow serum in the blood sample to permeate the filter pad 11, so that blood sample detection can be performed with whole blood.
  • the prior art has overcome the shortcomings of detecting blood samples by using serum equipment such as centrifuges to separate the serum.
  • the quantum dot immunochromatographic strip detection system of the present embodiment is the same as the embodiment 1, 2, 3 or 4, except that the water absorption pad 24 of the test strip 15 in the strip card cassette 16 is overlapped.
  • the test strip card cartridge 16 has a test strip reaction end observation window 30 at a position corresponding to the test strip reaction end point indicating label 25, as shown in Figs. 16-18.
  • the strip reaction endpoint indication label 25 includes, but is not limited to, a precision pH test strip having a discoloration range of 5.0-9.0.
  • the test strip reaction end point indicator 25 is used to indicate whether the siphon bleed chromatography of the test strip reactant on the test strip is sufficient and whether the reaction reaches the end point.
  • the quantum dot immunochromatographic strip detection system of the present embodiment is the same as the embodiment 1, 2, 3, 4 or 5, except that the electronic tag 20 storing the information for detecting the test strip 15 is mounted on the card. Any portion of the test strip 15 in the cartridge 16 (not shown in the drawings).
  • the present embodiment is described with reference to FIGS. 19-20 for the quantum dot immunochromatographic strip detection system of the present invention for simultaneous rapid quantitative detection of serum tumor markers alpha fetoprotein (AFP), carcinoembryonic antigen (CEA) and prostate specific antigen ( PSA) (one check).
  • AFP alpha fetoprotein
  • CEA carcinoembryonic antigen
  • PSA prostate specific antigen
  • the quantum dot immunochromatographic strip 15 is provided with a sample pad 21 attached to each other, a glass fiber membrane marker pad 22, an analysis film 23 having a detection tape 27 and a quality control tape 28, and an absorbent pad 24.
  • the glass fiber membrane marker pad 22 is coated with a mixture of quantum dot-labeled AFP mAb, quantum dot-labeled CEA mAb, and quantum dot-labeled PSA mAb; the detection zone 27 is coated with AFP antibody, CEA antibody, and PSA antibody.
  • the control strip 28 is coated with a secondary antibody such as a goat anti-mouse IgM antibody, or a goat anti-mouse IgG antibody, or a rabbit anti-mouse IgM antibody, or a rabbit anti-mouse IgG antibody.
  • a secondary antibody such as a goat anti-mouse IgM antibody, or a goat anti-mouse IgG antibody, or a rabbit anti-mouse IgM antibody, or a rabbit anti-mouse IgG antibody.
  • 2 marker pad 22 glass fiber membrane is selected, cut into 297 ⁇ 10mm membrane block, placed in elongated tank, and prepared with quantum dot label solution prepared in advance (ie AFP monoclonal antibody with quantum dot labeling, quantum dot-labeled CEA) A solution of the mixture of the monoclonal antibody and the quantum dot-labeled PSA monoclonal antibody was applied thereto, and the membrane block was taken out and dried at 37 ° C for use.
  • quantum dot label solution prepared in advance
  • Analytical membrane 23 Select nitrocellulose membrane, cut into 297 ⁇ 25mm membrane block, and place it in the elongated tank. From the bottom of the membrane block, spray AFP antibody (0.5-5mg/ml) from the bottom of the membrane at a certain distance. A mixture of CEA antibody (0.5-5 mg/ml) and PSA antibody (0.5-5 mg/ml) was used as test strip 27, sprayed with 0.5-5 mg/ml goat anti-mouse IgM antibody, or goat anti-mouse IgG antibody, or rabbit anti-mouse An IgM antibody, or a rabbit anti-mouse IgG antibody, was used as the control strip 28, and the resulting pellet was then dried at 37 ° C until use.
  • AFP antibody 0.5-5mg/ml
  • 4Absorbing pad 24 Select a cellulose film with strong water absorption, cut into 297 ⁇ 30mm film pieces, and dry thoroughly for use.
  • the prepared test strip assembly is sequentially adhered to the plastic underlay 26 by the suction pad 21, the marking pad 22, the analysis film 23, and the absorbent pad 24, and is cut into a quantum dot of a certain specification.
  • the test strips are dried and kept for later use.
  • Figure 19 is a standard operating curve for AFP, CEA, and PSA detection. Its production method is as follows:
  • the series concentration is 20 parts each.
  • the concentration of each tumor marker standard series was detected by 10 quantum dot-labeled tumor markers, and the multiple test strips were tested 10 times under the same system setting conditions, and the optical density values of the detection bands (OD detection bands ) were respectively read. With the quality control band optical density value (OD quality control band ), the average value and the OD detection band /OD control band ratio are obtained.
  • the X-axis was used for each series of AFP, CEA, and PSA standards, and the OD test band /OD control band ratio corresponding to the concentration of each series of AFP, CEA, and PSA standards was used to draw a standard working curve for the Y-axis. The results are shown in Figure 19.
  • the RFID tag 20 storing the AFP, CEA, PSA standard work curve and test strip detection information is attached to the cartridge 16 of the test strip card.
  • test strips are sampled at the end of the sample
  • the serum sample is tested by the strip detection system to have an AFP concentration of 1753.4526 pg/m1, a CEA concentration of 87.83892 pg/m1, and a PSA concentration of 983.4257 pg/m1.
  • Figure 20 is a fluorescence dot curve of quantum dot-labeled AFP, CEA, and PSA.
  • I is the AFP spectral peak in the detection zone
  • II is the CEA spectral peak in the detection zone
  • III is the PSA spectral peak in the detection zone
  • IV is the spectral peak of the quality control in the QC zone.
  • This embodiment describes the quantum dot immunochromatographic strip detection system for rapid quantitative detection of hepatitis B surface antigen HBsAg (single item detection) in conjunction with FIGS. 21-22.
  • the quantum dot immunochromatographic strip 15 is provided with a sample pad 21, a filter pad 11, a fiberglass membrane marker pad 22, an analysis membrane 23 having a detection tape 27 and a quality control tape 28, The absorbent pad 24 and the test strip reaction end point indicator label 25.
  • the glass fiber membrane marker pad 22 is coated with a quantum dot-labeled HBsAg monoclonal antibody, and the detection zone 27 is coated with an HBsAg antibody.
  • the control tape 28 is coated with a secondary antibody such as a goat anti-mouse IgM antibody, or a goat anti-mouse IgG antibody, or a rabbit anti-mouse IgM antibody, or a rabbit anti-mouse IgG antibody.
  • Filter sample pad 11 Select the filter membrane according to the pore size of the filter membrane, cut into a certain size membrane block, and dry and store for use.
  • 3 marker pad 22 glass fiber membrane is selected, cut into 297 ⁇ 10mm membrane block, placed in elongated tank, and pre-prepared quantum dot-HBsAg monoclonal antibody conjugate solution is added thereon, and the membrane block is taken out and dried at 37 ° C. spare.
  • Analytical membrane 23 Select nitrocellulose membrane, cut into 297 ⁇ 25mm membrane block, set in the long trough, from the bottom edge of the membrane block from the bottom from the top a certain distance from the spray point 0.5-5mg / ml HBsAg monoclonal antibody is used as a detection zone 27, spraying 0.5-5mg/ml goat anti-mouse IgM antibody, or goat anti-mouse IgG antibody, or rabbit anti-mouse IgM antibody, or rabbit anti-mouse IgG antibody as quality control tape 28, after which The resulting pellet was dried at 37 ° C until use.
  • 5Absorbing pad 24 Select a cellulose film with strong water absorption, cut into 297 ⁇ 30mm film pieces, and dry thoroughly for use.
  • test strip reaction end point indication label 25 A precision pH test paper having a color change range of 5.0 to 9.0 was used, and cut into a film piece having a size of 297 ⁇ 5 mm, and sufficiently dried for use.
  • Each of the prepared test strip assemblies is sequentially adhered to the plastic underlay 26 by the suction sample pad 21, the filter sample pad 11, the marker pad 22, the analysis film 23, the absorbent pad 24, and the test strip reaction end point indicating label 25. And cut into a certain size of quantum dot immunochromatographic strips, dry and stored for later use.
  • Figure 21 is a standard operating curve for HBsAg detection. Its production method is as follows:
  • the PB buffer is diluted as a diluent, and the HBsAg standard is formulated into a series concentration of 20 parts: 0 pg/ml, 100 pg/ml, 200 pg/m1, 300 pg/ml, 400 pg/ml, 500 pg/ml, 600 pg/ml, 700 pg/ Ml, 800 pg/ml, 900 pg/ml, 1000 pg/ml, 1100 pg/ml, 1200 pg/ml, 1300 pg/ml, 1400 pg/ml, 1500 pg/ml, 1600 pg/ml, 1700 pg/ml, 1800 pg/ml, 1900 pg/ml.
  • the concentration of each HBsAg standard series was tested 10 times with 10 quantum dot-labeled HBsAg strips under the same system setting conditions, and the optical density values (OD detection bands ) and quality control band optical density values of the detection bands were respectively read. (OD quality control zone ), calculate the average value and its OD detection zone / (OD detection zone + OD quality control zone ) ratio.
  • the X-axis is taken as the concentration of the HBsAg standard series, and the OD detection band /(OD detection zone + OD quality control zone ) ratio corresponding to the concentration of each HBsAg standard series is plotted as a standard working curve for the Y-axis. The results are shown in Fig. 21.
  • the HBsAg detection standard working curve software Prepares the HBsAg detection standard working curve software, and compare the standard working curve software data together with the OD quality control value obtained when testing the standard used. (When the sample is actually tested, the OD quality control band value is used as the test strip quality control band optical density. Refer to the monitoring value OD quality control belt ' ) and the test strip test information (including the test strip batch number, the test strip name, the test strip validity period, the IC card chip password, the clinical standard reference value, the test strip manufacturer, etc.) and other data together. It is stored on the IC card chip 20.
  • the IC card chip 20 storing the HBsAg detection standard operation curve and the test strip detection information is attached to the cartridge (16) of the test strip card.
  • Sample source The serum sample of hepatitis B patients is provided by a maternal and child health care center.
  • the PB buffer was diluted 10-fold.
  • test strips are sampled at the end of the sample
  • a serum sample is detected by the strip detection system to have a HBsAg concentration of 205.9563 pg/m1. From this:
  • Figure 22 is a quantum dot-labeled HBsAg fluorescence spectrum curve. Among them, I is the peak spectrum of HBsAg in the detection zone, and II is the spectral peak of the quality control in the QC zone.
  • the quantum dot immunochromatographic strip detection system of the present invention may have other improvements.
  • the left end of the strip 1 may also be sealed by mounting the strip in the strip card for testing.
  • the test strip card 1 is generally provided with a sample loading hole 32 on the upper surface of the cartridge 16 corresponding to the test strip sample pad 21 (as shown in FIG. 23); the test strip 15 inserted into the cartridge can also be replaced.
  • biochips including antigen-antibody chips, protein chips, DNA chips, microfluidic chips
  • any other technical solutions formed by any equivalent replacement or equivalent transformation of the test strip detection system of the present invention fall within the scope of protection of the present invention.

Abstract

一种量子点免疫层析检测系统及其应用，其中检测系统包括试条卡（1）和检测装置（2），试条卡（1）包括卡盒（16）和量子点免疫层析试条（15），卡盒（16）有一张存储有被检物标准工作曲线等参数的电子标签（20）；检测装置（2）包括光学系统（3）、光电检测器（4）、模/数转换器（5）、数据处理装置（6）、电子标签读写模块（10）、语音模块（18）、电源（7）和输出显示装置（8）；检测系统还有一个无线通信模块（12）和一个与无线通信模块（12）相联系的无线网络系统（13）。数据处理装置（6）对试条（15）的检测带（27）和质控带（28）传输来的特征频率光信号结合电子标签（20）发送的参数计算获得样品检测结果，检测结果由输出装置（8）显示，语音模块（18）提示检测结果信息，检测结果信息通过无线通信模块（12）发送给无线网络系统（13）的远程服务器或/和移动终端设备（14）进行数据管理和信息咨询反馈。上述系统检测样品具有简便快捷、灵敏度高、结果客观和使用灵活等特点。

Description

量子点免疫层析试条检测系统及其应用
技术领域
本发明涉及生物医疗器械领域，具体涉及一种量子点免疫层析试条检测系统及其应用。
背景技术
样品多组分分析对疾病诊断、环境监测、食品安全、药物分析、微生物检验等具有非常重要的作用。临床肿瘤诊断中，常需通过联合检测相关几项肿瘤标志物以实现对某种肿瘤准确诊断。环境监控中，常需要同时监测自然水体中多种杀虫剂与除草剂的浓度指标以综合评价环境污染水平。传统上测定混合体系中样品多种组分含量，多采用平行单组分分析法，即每个分析流程只测定其中一种组分含量，多次平行执行该流程，最后得到所有所需组分含量。分析所需时间长，消耗试剂多，分析通量低，且劳动量大。实现样品多种组分同步快速定量分析，特别是不需要借助额外仪器设备和试剂、和不依赖专业技术人员即能进行的样品多组分现场同步快速定量分析，一直是人们长期渴望解决而未能解决的问题。
近年发展的纳米量子点（quantum dots, QDs）荧光发光效率高，激发谱线范围宽，能“一元激发，多元发射”，发射谱线范围窄且对称，光漂白速度慢，荧光寿命长，粒径与生物分子相近，表面修饰后能多功能化，不同粒径和种类的量子点混合物产生的特征波长荧光光谱不交叠，非常适用于样品多组分分析。
免疫层析技术简单、快速，几分钟就能获得检测结果。但现有的免疫层析技术多采用胶体金作标记进行样品检测。胶体金试条检测样品只能定性，不能定量，更不能实现样品多组分检测。
本发明根据QDs在样品多组分分析方面的独特优势和免疫层析技术简单、快速优势，结合先进制造技术，公开一种量子点免疫层析试条检测系统及其应用，以解决现有技术尚不能解决的“样品多组分现场快速定量检测、远程定量检测、和不需要借助额外仪器设备和试剂，普通人员就能进行操作检测”的问题，使生物医学检测技术走进社区、走向街道、走进家庭，造福社会，造福人民。
本发明内容
本发明的第一个目的是公开一种量子点免疫层析试条检测系统。
本发明的另一目的是公开所述量子点免疫层析试条检测系统在生物医学检测领域中的应用。
本发明所述量子点免疫层析试条检测系统是通过下述技术方案实现的：
所述量子点免疫层析试条检测系统，包括试条卡1和检测装置2。试条卡1包括卡盒16和可适时插放到卡盒16内的量子点免疫层析试条15。所述检测装置2包括光学系统3、光电检测器4、模/数转换器5、数据处理装置6、电子标签读写模块10、输出显示装置8、语音模块18、电源7、位于检测装置2表面的按键9和备留于检测装置2的多个可供临时插接外连的通讯接口31。光学系统3的成像信号端与光电检测器4相连。光电检测器4的信号输出端经信号放大后与模/数转换器5的信号输入端相连。模/数转换器5的信号输出端与数据处理装置6的信号输入端相连。数据处理装置6还分别与输出显示装置8、语音模块18、电子标签读写模块10、电源7、检测装置2表面的按键9和备留于检测装置2的各通讯接口31相连。电源7通过数据处理装置6向光学系统3、光电检测器4、模/数转换器5、输出显示装置8、语音模块18和电子标签读写模块10供电。检测装置2有一试条卡插孔33。试条卡1为检测装置2的离式即插结构。试条15为试条卡1的离式即插结构。试条卡1在对应于检测装置2的试条卡插孔33处设有试条卡止插位标志19。试条15插入试条卡1后连同试条卡1一并插入检测装置2的试条卡插孔33中对试条上的样品进行检测。
试条卡卡盒16的一端连同该卡盒端的上盒面开口形成试条插槽口17以方便插放试条15。卡盒16内的试条15包括顺次搭接固定在底衬26上的吸样垫21、标记垫22、分析膜23、吸水垫24。分析膜23具有检测带27和质控带28。检测带27为一条或多条。卡盒16的上盒面在对应于试条分析膜23位置处开有检测窗29。试条15插入到试条卡卡盒16时，卡盒16的检测窗29对应位于检测装置2的光学系统3的光照射面。卡盒16的任意处安装有一张存储有试条15检测用信息的电子标签20。
卡盒16内试条15的标记垫22包被有一种或多种由量子点标记的用于目标被检物检测用的相关分子，所述量子点包括ZnS、CdS、HgS、ZnSe、CdSe、HgSe、CdTe、ZnTe、ZnO、PbSe、HgTe、CaAs、InP、InAs、InCaAs、CdS/ZnS、CdS/Ag2S、CdS/PbS、CdS/Cd(0H)2、CdS/HgS、CdS/HgS/CdS、ZnS/CdS、ZnS/CdS/ZnS、ZnS/HgS/ZnS/CdS、CdSe/CdS、CdSe/ZnS、CdSe/ZnSe、CdSe/CuSe、CdSe/HgTe、CdSe/HgSe、CdSe/HgSe/CdSe、CdTe/HgS、CdTe/HgTe、InAs/InP、InAs/CdSe、InAs/ZnSe、MgS、MgSe、MgTe、CaS、CaSe、CaTe、SrS、SrSe、SeTe、BaS、BaSe、BaTe、CdS:Mn、ZnS:Mn、CdS:Cu、ZnS:Cu、CdS:Tb、ZnS:Tb中的任意一种或任意几种纳米粒子的组合，以及由上述任意一种量子点为核、二氧化硅为壳的核-壳型纳米复合粒子。
卡盒16内试条15的检测带27包被有一种或多种与目标被检物检测相关的另一分子。
卡盒16内试条15的质控带28包被有包括二抗的质控物。
卡盒16上的电子标签20包括但不限于RFID标签、非接触式识别的IC卡芯片。电子标签20在卡盒16的安装方式包括薄膜粘贴式、封装植入式、卡式、钉式、或纽扣式等。电子标签20存储的试条检测用信息包括同批次量子点免疫层析试条15定量样品被检物浓度用的标准工作曲线或系数参数、试条质控带光密度参考监控值（OD质控带’）、试条名称、试条批号、试条效期、电子标签密码、临床指标参考值、试条生产厂商信息等，且可读入被测对象身份信息、检测者信息、样品名称、样品编号、检测日期、检测结果等信息。电子标签20所存储的被检物标准工作曲线有多种形式可供选择，其包括但不限于下述曲线之一：
（1）被检物标准品系列浓度与OD检测带/OD质控带之间的对应关系曲线；或，
（2）被检物标准品系列浓度与OD检测带/（OD检测带+OD质控带）之间的对应关系曲线；或，
（3）被检物标准品系列浓度与OD检测带之间的对应关系曲线。
所述OD检测带定义为被检物标准品系列浓度测得的检测带光密度值，OD质控带定义为被检物标准品系列浓度测得的质控带光密度值。
光学系统3的结构组成有多种方案可供选择，其包括但不限于：
（1）其包括一照明系统和成像系统。照明系统包括一激发光源311。在该光源311的输出光路上依次为光纤束312、准直照明透镜313、分色镜314、前镜组315，直至试条卡1。激发光源311包括发光二极管LED或激光二极管。成像系统包括共光轴的前镜组315、分色镜314、滤光片316、后镜组317。分色镜314反射面与光轴夹角成45o角。前镜组315和后镜组317均采用分离结构。照明系统光路在分色镜314之前部分与成像系统的光轴相垂直，在分色镜314之后的部分与成像系统共光轴。光电检测器4位于后镜组317像面上。光纤束312将光源311发出的光分为具有一定间距且强度相同的激光束，该激光束由准直照明透镜313准直为平行光束入射到分色镜314表面，经分色镜314反射后通过前镜组315同步照射到位于前镜组315物面试条卡1的试条15的检测带27和质控带28上激发渗移到检测带27和质控带28的量子点反应信号物发出特征频率反射荧光，检测带27和质控带28反射荧光经同一前镜组315、透过分色镜314、滤光片316滤去杂光后出后镜组317进入光电检测器4中被检测转换为电信号。或：
（2）其包括一激发光源321，在该激发光源321的输出光路上依次为入射光耦合器322、入射光纤323、光纤探头324、出射光纤325、出射光耦合器326，直至光电检测器4。激发光源321包括发光二极管LED或激光二极管。光源321发出的光经入射光耦合器322分束进入入射光纤323，入射光纤323经试条检测带光纤探头和试条质控带光纤探头分别照射到试条卡1的试条15的检测带27和质控带28上以激发试条检测带27和质控带28的量子点反应信号物发出特征频率反射荧光，反射荧光分别经检测带光纤探头和质控带光纤探头、相应出射光纤325、出射光耦合器326后进入光电检测器4中被检测转换为电信号。光纤探头324采用合束共用结构，其中心为入射光纤323，周缘为出射光纤325。
光电检测器4具有多种可供选择对象，其包括CCD、CMOS、光电倍增管、光电二极管、光电三极管。
数据处理装置6为具有相应数据处理和控制软件的微处理器、单片机、或PC机。
电子标签读写模块10以非接触方式自动读/写电子标签20信息。
检测装置2备留的多个通讯接口31为USB接口或RS-232接口，其用于检测者根据检测需要临时插接外连打印机、外存介质、上位机、键盘或其他仪器设备。
输出显示装置8为字母数字LCD液晶屏、LED、触摸显示屏、声音装置或上位机等。
电源7为外接电源或可拆换的电池。所述电池包括锂电池。
样品检测时，插放到试条卡卡盒16内的试条15其吸样垫21一端过盈伸出试条卡卡盒16的开口端以浸渍吸取样品。光学系统3发出的光激发试条检测带27和质控带28的量子点反应信号物发出特征频率反射荧光，该反射荧光信号被光电检测器4接收并转换成电信号，转换后的电信号经信号放大后传输给模/数转换器5转换为数字信号并传输给数据处理装置6，数据处理装置6对传输来的特征频率荧光信号进行自动识别、并结合电子标签读写模块10传输来的发送于试条卡电子标签20的被检物标准工作曲线或系数参数进行被检物浓度计算和技术分析，将结果传输给输出显示装置8，语音模块18语音提示检测结果信息。
本发明所述量子点免疫层析试条检测系统还可包括一个与所述系统的数据处理装置6相连的无线通信模块12和一个与所述无线通信模块12信号发射端相通讯的、包括远程服务器14或/和其它移动终端设备14在内的无线网络系统13，14。所述无线通信模块12与所述无线网络系统13，14之间的通讯方式包括但不限于Wifi、蓝牙、短信、微信、移动电话等。电源7还向无线通信模块12供电。数据处理装置6对检测带27和质控带28传输来的特征频率荧光信号进行自动识别、并结合电子标签读写模块10传输来的发送于试条卡电子标签20的被检物标准工作曲线或系数参数进行被检物浓度计算和技术分析，将结果传输给输出显示装置8，语音模块18语音提示检测结果信息，检测结果及其相关信息通过无线通信模块12发送给无线网络系统13，14的远程服务器14或/和移动终端设备14进行数据管理与信息咨询反馈。
本发明所述量子点免疫层析试条检测系统的所述数据处理装置6还可以与电子标签读写模块10集成在一起构成所述的数据处理装置6，该所述的数据处理装置6对检测带27和质控带28传输来的特征频率荧光信号进行自动识别、并结合从试条卡电子标签20发送来的被检物标准工作曲线或系数参数进行被检物浓度计算和技术分析。
本发明所述量子点免疫层析试条检测系统的电子标签20还可以安装在卡盒16内试条15的任意处。
本发明所述量子点免疫层析试条检测系统的卡盒16内试条15的吸样垫21与标记垫22之间还可搭接有一块用于样品分离处理的滤样垫11。所述滤样垫11包括滤血膜。
本发明所述量子点免疫层析试条检测系统的卡盒16内试条15的吸水垫24的尾端还可以搭接有一试条反应终点指示标签25。所述试条反应终点指示标签25包括但不限于变色范围为5.0-9.0的精密pH试纸。所述试条卡卡盒16在对应于试条反应终点指示标签25的位置处开有试条反应终点观察窗30。
本发明所述量子点免疫层析试条检测系统的检测装置2在整体上为便携式仪器、中/大型仪器、或为与具有相应发射和接收信息功能的无线通讯品的结合包括与移动电话、平板电脑、个人数字助理、移动终端设备或计算机集合中的挑选品的结合。
本发明所述量子点免疫层析试条检测系统的试条卡1内的试条15为一次性使用试条；用来插放试条15的试条卡1的卡盒16及卡盒16上、或试条15上安装的电子标签20为同批次试条相配套的使用品；所述检测装置2为持续通用品。
本发明所述试条的制备方法包括以下步骤：
（1）试条组件制备
①吸样垫21: 选用纤维素膜作吸样垫材料，将其切成具有一定规格的膜块，将该膜块放入吸样垫处理液（pH＝7.2，0.03mol/L磷酸盐缓冲液+5%BSA+0.1%Tween 20）中浸泡，取出，烘干，使其充分干燥备用。
②滤样垫11：按滤膜孔径选择样品过滤膜，切成一定规格膜块，干燥备用。
③标记垫22：选用玻璃纤维膜作标记垫材料，将其切成具有一定规格的膜块，在该膜块上加上量子点与目标被检物检测相关分子的结合物溶液，干燥膜块备用。
④分析膜23： 选用纤维素膜作分析膜材料，将其切成具有一定规格的膜块，自膜块底边起由下自上相隔一定距离分别喷点目标被检物检测相关的另种特异分子作为检测带27和喷点包括二抗的质控物作为质控带28，干燥膜块备用。
⑤吸水垫24： 选用具有强吸水作用的纤维素膜并切成具有一定规格的膜块，充分干燥备用。
⑥试条反应终点指示标签25： 选用变色范围为5.0-9.0的精密pH试纸，将其切成具有一定规格的膜块，充分干燥备用。
（2）试条装配
优选地，将上述制备好的试条组件按吸样垫21、标记垫22、分析膜23、吸水垫24顺次相互搭接粘贴于塑料底衬26上，并剪切成一定规格的试条，干燥备用。
另一优选地，将上述制备好的试条组件按吸样垫21、滤样垫11、标记垫22、分析膜23、吸水垫24顺次相互搭接粘贴于塑料底衬26上，并剪切成一定规格的试条，干燥备用。
再优选地，将上述制备好的试条组件按吸样垫21、标记垫22、分析膜23、吸水垫24、试条反应终点指示标签25顺次相互搭接粘贴于塑料底衬26上，并剪切成一定规格的试条，干燥备用。
再一优选地，将上述制备好的试条组件按吸样垫21、滤样垫11、标记垫22、分析膜23、吸水垫24、试条反应终点指示标签25顺次相互搭接粘贴于塑料底衬26上，并剪切成一定规格的试条，干燥备用。
试条层析反应是一动态过程。不同被检物检测用试条和不同批次试条，其制备工艺、材质选用、检测环境等差异，其检测敏感性、稳定性、特异性等可能存在差异，从而会影响到被检物浓度的精确测定（例如，制作试条所用的纤维素膜来源不同、膜滤孔大小不同、试条厚度不同等有可能使试条反应物不会以完全相同的虹吸渗移速率前行，反应物甚至有可能被滞留在试条检测带27、质控带28之前的试条渗移途中；野外现场检测和室内检测，温度、湿度等差异，也有可能影响到试条反应物在试条上的渗移前行速率，使其不完全相同，等等）。本发明能很好解决上述问题，提高了样品检测的精确性和灵活性：本发明采用电子标签20存储同批次试条被检物相应标准工作曲线或系数参数以定量同批次试条被检物浓度，电子标签20上的标准工作曲线或系数参数可在试条卡1产品出厂前根据试条批间和批内差异进行校准，此符合国家试条“批批检”规范；本发明所述电子标签20还存储有试条光密度参考监控值（OD质控带’），样品实际检测时，其可提示试条反应过程是否成立，判断检测结果是否真实有效（如果试条反应失败，检测中得到的OD质控带会与从电子标签20读取的相应试条光密度参考监控值（OD质控带’）产生极大统计学误差）；本发明所述试条15的尾端可设置有试条反应终点指示标签25，可提示试条反应物在试条上的虹吸渗移层析是否充分，反应是否到达终点；本发明所述试条15均设置有质控带28，该质控带28起检测对照作用。
本发明所述电子标签20存储的被检物标准工作曲线的制作方法包括如下步骤：（1）配制被检物标准品系列浓度。（2）检测获得被检物标准品系列浓度的相应OD检测带和OD质控带，并计算获得OD检测带/OD质控带比值或OD检测带/（OD检测带+OD质控带）比值。（3）以标准品系列浓度作X轴，测试结果以OD检测带/OD质控带比值作Y轴，绘制标准工作曲线；或以标准品系列浓度作X轴，测试结果以OD检测带/（OD检测带+OD质控带）比值作Y轴，绘制标准工作曲线；或以标准品系列浓度作X轴，测试结果以OD检测带值作Y轴，绘制标准工作曲线。（4）编写标准工作曲线软件。（5）将标准品测试时得到的试条质控带光密度值作为试条质控带光密度参考监控值（即OD质控带’）；将标准工作曲线软件和OD质控带’一并存储于电子标签20上。
本发明检测样品基于量子点免疫层析试条检测带27的量子点反应信号物的光谱信号与待测样品浓度呈正相关。样品中被检物浓度越大，渗移至试条检测带27的量子点反应信号物发出的特征频率反射荧光信号就越强。反之，样品中被检物浓度越小，试条检测带27上的量子点反应信号物发出的特征频率反射荧光信号就越弱。根据这一关系，本发明将插放在试条卡1中的试条的过盈伸出端（即吸样垫21端）浸渍样品，含目标被检物的液体样品在位于试条另一端的吸水垫24的拉动下，利用试条微孔滤膜的毛细管虹吸作用慢慢向试条后端渗移，当液体样品中有目标被检物分子（如抗原或抗体）时，它们便与包被在试条前中段的玻璃纤维膜标记垫22上的相应被量子点标记好的免疫分子结合并一起向试条后端渗移至试条分析膜23的检测带27，与包被在检测带27的另一特异目标被检物相关反应分子（如相应目标被检物分子的另一特异抗体或抗原）结合形成检测带量子点反应信号物并截流富集在检测带27上。剩余的一部分量子点免疫标记分子继续前行渗移至试条质控带28，与包被在质控带28的质控物（如二抗）结合形成质控带量子点反应信号物，并截流富集在质控带28上。光学系统3的激发光源311，321发出的光激发试条检测带27和质控带28的量子点反应信号物后发出特征频率荧光信号，荧光信号被光电检测器4接收并被转换成相应强度电信号，转换后的电信号经信号放大后传输给模/数转换器5转换为数字信号并传输给数据处理装置6进行存储和数据处理。数据处理装置6对检测带27和质控带28传输来的特征频率荧光信号进行自动识别，获得被检物检测带27光密度值（OD检测带）和质控带28光密度值（OD质控带）并计算得到OD检测带/OD质控带比值或OD检测带/（OD检测带+OD质控带）比值，同时通过电子标签读写模块10自动读取试条卡1电子标签20存储的被检物标准工作曲线或系数参数，结合被检物标准工作曲线或系数参数计算获得被检物浓度，输出显示装置8显示检测结果及信息，语音模块18语音提示检测结果信息，检测结果及其相关信息通过无线通信模块12发送给无线网络系统13，14的远程服务器14或/和其它移动终端设备14进行数据管理与信息咨询反馈。
本发明所述样品包括来自临床或非临床的血液、体液、尿液、唾液、生殖道分泌物或其他液态样品或粘稠状样品，其中，临床样品包括传染病、激素、心血管病、肿瘤、癌症、糖尿病、自身免疫病在内的样品，非临床样品包括食品检测、环境污染检测、农药残留量检测、生物沾染检测、生物制剂检测、兽医学检测、毒品检测在内的样品。本发明对上述样品中的目标被检物单一组分或多组分同时进行定量检测。
本发明所述量子点免疫层析试条检测系统的检测使用方法通过下述步骤实现：
（1）开机接通电源；
（2）将试条15插入试条卡1中；插放有试条的试条卡1再插放入所述试条检测系统的检测装置2的试条卡插孔33中；
（3）试条吸样端浸渍样品；
（4）按下检测键，所述量子点免疫层析试条检测系统开始样品检测。检测结束后，输出显示装置8显示试条检测结果信息，语音模块18语音提示检测结果信息；
（5）按下发送键，检测结果及信息发送给无线网络系统13，14的远程服务器14或/和移动终端设备14进行数据管理与信息咨询反馈。
本发明有益效果：
与现有技术相比，本发明有益效果主要有：
（1）一次吸样能同时定量联检样品多组分。量子点荧光发光效率高，激发谱线范围宽，发射谱线范围窄，荧光寿命长，Stokes位移大，粒径与生物分子相近，表面修饰后能多功能化。不同粒径、种类和结构的量子点能产生不同特征波长持续荧光峰谱，量子点混合物产生的特征波长荧光峰谱不交叠。采用不同量子点分别标记被检物相应反应分子，将其混合物包被在免疫层分析试条上与待测样品进行反应，通过测定试条特定荧光信号，几分钟内能快速准确测出样品多组分浓度。本发明所述系统的试条不仅单一检测带能同步定量联检样品多组分，当试条设置多条检测带时，所述系统则能更大通量实现样品组分同步定量联检。
（2）联检样品快速，几分钟内就能获得检测结果。
（3）样品用量少，几微升至几十微升就能满足检测需要。
（4）样品不需要预处理。所述系统的量子点免疫层析试条的吸样垫21与标记垫22之间可设置有能自动分离处理样品的滤样垫11。例如，待检样品为血液样品，滤样垫11可过滤血细胞而仅让血清渗过滤样垫11，用全血就能检测，克服了现有技术检测血液样品须用离心机等仪器设备分离血清后才能进行检测的不足。
（5）本发明所述试条检测系统的成品形式可以为大中型检测仪器，供社会各专业机构检测使用（此种情形下的成品其数据处理装置6可采用PC机）；也可以为小型便携式检测器，供家庭、超市、街道、病床旁和人们日常生活现场即刻检测使用（此种情形下的成品其数据处理装置6可采用微处理器）。
（6）操作简单、质控方便、不需要另外借助仪器设备和试剂，普通人员就能实现样品多组分快速定量检测，克服了现有技术必须由专业技术人员、和需要实验室等条件才能进行操作之不足。本发明检测样品时，检测者只需将试条15插入试条卡1，将插放有试条的试条卡1再插放到检测装置2的试条卡插孔33中，将试条的过盈伸出端浸渍检品，几分钟就能准确获得检测结果。
（7）检测结果信息备以3种方式给出：①输出显示装置8显示检测结果信息；②语音模块18语音提示检测结果信息（以方便视力较差的操作者如老年人能耳听检测结果）；③检测结果信息能通过移动互联网实行远程管理和信息反馈（包括操作者对检测结果的有效性及其意义等能适时进行咨询等）。
（8）试条卡1内的试条15为一次性使用试条；用来插放一次性试条15的试条卡卡盒16及卡盒16上、或试条15上安装的电子标签20为同批次试条相配套的使用品；所述检测装置2为持续通用品。不同样品检测时，仅需更换相应试条和相应配套的试条卡卡盒16即可实现样品快速定量检测。已备有本发明所述检测装置2（为持续通用品）的检测者用户，仅需购买所需试条15（为一次性用品）和与试条相配套的试条卡卡盒16（其上安装有与同批次试条相配套的电子标签20，电子标签20存储有同批次试条定量样品被检物浓度用的标准工作曲线或系数参数，为同批次试条配套用品），就能实现检测需要。试条15和试条卡卡盒16价格低廉，普通检测者用户均能承受。
（9）检测结果信息能通过移动互联网进行远程管理和咨询反馈。本发明所述试条检测系统可以内置无线通信模块12，该无线通信模块12与数据处理装置6相连，其信号发射端与无线网络系统13，14相通讯。数据处理装置6分析获得的检测结果及其相关信息可通过无线通信模块12发射给无线网络系统13，14的远程服务器14或/和其它移动终端设备14等进行相应数据管理和信息咨询反馈。
（10）能对试条层析反应过程进行动态监测。本发明所述电子标签20存储有试条光密度参考监控值（OD质控带’），试条反应失败时，检测中得到的OD质控带与电子标签20存储并读取来的相应试条光密度参考监控值（OD质控带’）会产生极大统计学误差；本发明所述试条15的尾端可设置有试条反应终点指示标签25，可监示试条反应物在试条上的虹吸渗移层析是否充分，反应是否到达终点。
（11）检测质量采用多种质控措施同步精准控制：①试条15上设置质控带28，其光密度强度起检测对照作用。②电子标签20存储相应被检物标准工作曲线或系数参数，用于精确定量相应被检物浓度。③电子标签20存储同批次试条质控带光密度参考监控值（OD质控带’），用于监控样品检测中试条反应是否成立，检测结果是否有效。④试条15上设置试条反应终点指示标签25，用以提示试条反应物在试条上的虹吸渗移层析是否充分，反应是否到达终点。
（12）样品检测体现个性化。所述试条检测系统的检测装置2备留有多个可供临时插接外连打印机、外存介质、上位机、键盘或其他仪器设备的USB接口或RS-232接口，以方便检测者用户对检测结果信息能适时存取、打印或移携等。
（13）所述试条检测系统适用样品广泛。所述试条为一次性使用试条；用来插放试条15的试条卡卡盒16及卡盒16上、或试条15上安装的电子标签20为同批次试条相配套的使用品；检测装置2为持续通用品。检测者可根据不同检测需要，选择更换相应类别的量子点试条就能快速实现所需样品多组分定量分析。待检样品可以是来自临床或非临床的血液（包括全血、血清、血浆）、体液、尿液、唾液、生殖道分泌物或其他液态样品或粘稠状样品。临床样品包括传染病、激素、心血管病、肿瘤、癌症、糖尿病、自身免疫病等样品；非临床样品包括食品检测、环境污染检测、农药残留物检测、生物沾染检测、生物制剂检测、兽医学检测、毒品检测等样品。
附图说明
图l：本发明检测装置采用移动电话样式、检测结果不需进行远程数据管理和信息反馈的试条检测系统的外观结构框图。
图2：本发明检测装置采用移动电话样式、检测结果不需进行远程数据管理和信息反馈的试条检测系统的内部结构框图。其中，示试条检测带为一条。
图3：本发明检测装置采用移动电话样式、检测结果不需进行远程数据管理和信息反馈的试条检测系统的内部结构框图。其中，示试条检测带为两条。
图4：本发明检测装置采用移动电话样式、检测结果不需进行远程数据管理和信息反馈的试条检测系统的内部结构框图。其中示：试条检测带为一条；数据处理装置6已集成电子标签模块10。
图5：本发明检测装置采用移动电话样式、检测结果能进行远程数据管理和信息咨询反馈的试条检测系统的外观结构框图。
图6：本发明检测装置采用移动电话样式、检测结果能进行远程数据管理和信息反馈的试条检测系统的检测装置的内部结构框图。其中，示试条检测带为一条。
图7：本发明检测装置采用移动电话样式、检测结果能进行远程数据管理和信息反馈的试条检测系统的检测装置的内部结构框图。其中，示试条检测带为两条。
图8：本发明检测装置采用移动电话样式、检测结果能进行远程数据管理和信息反馈的试条检测系统的检测装置的内部结构框图。其中示：试条检测带为一条；数据处理装置6已集成电子标签模块10。
图9：本发明所述试条检测系统的光学系统较佳方案一的结构框图，其中，示试条检测带为一条。
图10：本发明所述试条检测系统的光学系统较佳方案二的结构框图，其中，示试条检测带为一条。
图11：试条侧视结构图。其中示：试条组件包括吸样垫21、标记垫22、分析膜23、吸水垫24；检测带27为一条。
图12：试条侧视结构图。其中示：试条组件包括吸样垫21、标记垫22、分析膜23、吸水垫24；检测带27为多条。
图13：试条卡俯视结构图。其中，示试条检测带为一条。
图14：试条卡俯视结构图。其中，示试条检测带为多条。
图15：试条侧视结构图。其中示：试条组件包括吸样垫21、滤样垫11、标记垫22、分析膜23、吸水垫24；检测带27为一条。
图16：试条侧视结构图。其中示：试条组件包括吸样垫21、标记垫22、分析膜23、吸水垫24、试条反应终点指示标签25；检测带27为一条。
图17：试条卡俯视结构图。其中，示试条卡卡盒16在对应于试条反应终点指示标签25的位置处开有试条反应终点观察窗30。
图18：试条侧视结构图。其中示：试条组件包括吸样垫21、滤样垫11、标记垫22、分析膜23、吸水垫24、试条反应终点指示标签25；检测带27为一条。
图19：肿瘤标志物AFP、CEA、PSA检测标准工作曲线。
图20：量子点标记的AFP、CEA、PSA荧光光谱曲线。
图21：乙肝病毒表面抗原（HBsAg）检测标准工作曲线。
图22：量子点标记的HBsAg光谱曲线。
图23：试条卡另一应用方案的俯视结构框图。
序号表示如下：1试条卡、2检测装置、3光学系统、4光电检测器、5 模/数转换器、6数据处理装置、7电源、8输出显示装置、9按键、10电子标签读写模块、11滤样垫、12无线通讯模块、13无线网络系统、14无线网络系统的远程服务器或移动终端设备、15试条、16试条卡卡盒、17试条插槽口、18语音模块、19试条卡止插位标志、20电子标签、21吸样垫、22标记垫、23分析膜、24吸水垫、25试条反应终点指示标签、26底衬、27检测带、28质控带、29检测窗、30试条反应终点观察窗、31备留的多个通讯接口、32加样孔、33试条卡插孔、311激发光源、312光纤束、313准直照明透镜、314分色镜、315前镜组、316滤光片、317后镜组、321激发光源、322入射光耦合器、323入射光纤、324光纤探头、325出射光纤、326出射光耦合器
具体实施方式
实施例1
本实施例为本发明所述量子点试条检测系统其检测装置2采用移动电话样式、检测结果不需要进行远程数据管理和信息反馈的一种较佳技术方案。下面结合附图1-4、9-18说明本实施例所述技术方案。
图1-4是本实施例所述量子点试条检测系统技术方案的结构框图。其中，图1为所述系统外观结构框图。图2-4为所述系统内部结构框图。
图1结合图2-4中，所述量子点免疫层析试条检测系统，包括试条卡1和检测装置2。试条卡1包括卡盒16和可适时插放到卡盒16内的量子点免疫层析试条15。检测装置2包括光学系统3、光电检测器4、模/数转换器5、数据处理装置6、电子标签读写模块10、输出显示装置8、语音模块18、电源7、位于检测装置2表面的按键9和备留于检测装置2的多个可供临时插接外连的通讯接口31。光学系统3的成像信号端与光电检测器4相连。光电检测器4的信号输出端经信号放大后与模/数转换器5的信号输入端相连。模/数转换器5的信号输出端与数据处理装置6的信号输入端相连。数据处理装置6还分别与输出显示装置8、语音模块18、电子标签读写模块10、电源7、检测装置2表面的按键9和备留于检测装置2的各通讯接口31相连。电源7通过数据处理装置6向光学系统3、光电检测器4、模/数转换器5、输出显示装置8、语音模块18和电子标签读写模块10供电。检测装置2的前端有一试条卡插孔33。试条卡1为检测装置2的离式即插结构。试条15为试条卡1的离式即插结构。试条卡1在对应于检测装置2的试条卡插孔33处设有试条卡止插位标志19。试条15插入试条卡1后连同试条卡1一并插入检测装置2的试条卡插孔33中对试条上的样品进行检测。
试条卡卡盒16的一端连同该卡盒端的上盒面开口形成试条插槽口17以方便插放试条15。图11、12、15、16、18所示卡盒16试条15的侧视结构。其中，图11-12所示试条15包括顺次搭接固定在底衬26上的吸样垫21、标记垫22、分析膜23、吸水垫24。图15所示试条15包括顺次搭接固定在底衬26上的吸样垫21、滤样垫11、标记垫22、分析膜23、吸水垫24。图16所示试条15包括顺次搭接固定在底衬26上的吸样垫21、标记垫22、分析膜23、吸水垫24、试条反应终点指示标签25。图18所示试条15包括顺次搭接固定在底衬26上的吸样垫21、滤样垫11、标记垫22、分析膜23、吸水垫24、试条反应终点指示标签25。所述试条15的分析膜23具有检测带27和质控带28，检测带27为一条或多条（图2、4、9-11、13、15-18所示试条15分析膜23的检测带27为一条；图3、12、14所示试条15分析膜23的检测带27为多条）。图13、14、17所示试条卡1的俯视结构。试条卡卡盒16的上盒面在对应于试条分析膜23位置处开有检测窗29。卡盒16在对应于试条反应终点指示标签25的位置处开有试条反应终点观察窗30（图17所示）。卡盒16的任意处安装有一张存储有试条15检测用信息的电子标签20。试条15插入到试条卡卡盒16时，卡盒16的检测窗29对应位于检测装置2的光学系统3的光照射面。
卡盒16内试条15的标记垫22包被有一种或多种由量子点标记的用于目标被检物检测用的相关分子，所述量子点包括ZnS、CdS、HgS、ZnSe、CdSe、HgSe、CdTe、ZnTe、ZnO、PbSe、HgTe、CaAs、InP、InAs、InCaAs、CdS/ZnS、CdS/Ag2S、CdS/PbS、CdS/Cd(0H)2、CdS/HgS、CdS/HgS/CdS、ZnS/CdS、ZnS/CdS/ZnS、ZnS/HgS/ZnS/CdS、CdSe/CdS、CdSe/ZnS、CdSe/ZnSe、CdSe/CuSe、CdSe/HgTe、CdSe/HgSe、CdSe/HgSe/CdSe、CdTe/HgS、CdTe/HgTe、InAs/InP、InAs/CdSe、InAs/ZnSe、MgS、MgSe、MgTe、CaS、CaSe、CaTe、SrS、SrSe、SeTe、BaS、BaSe、BaTe、CdS:Mn、ZnS:Mn、CdS:Cu、ZnS:Cu、CdS:Tb、ZnS:Tb中的任意一种或任意几种纳米粒子的组合，以及由上述任意一种量子点为核、二氧化硅为壳的核-壳型纳米复合粒子。
卡盒16内试条15的检测带27包被有一种或多种与目标被检物检测相关的另一分子。
卡盒16内试条15的质控带28包被有包括二抗的质控物。
卡盒16上的电子标签20包括但不限于RFID标签、非接触式识别的IC卡芯片。电子标签20在卡盒16的安装方式包括薄膜粘贴式、封装植入式、卡式、钉式、或纽扣式等。电子标签20存储的试条检测用信息包括同批次量子点免疫层析试条15定量样品被检物浓度用的标准工作曲线或系数参数、试条质控带光密度参考监控值（OD质控带’）、试条名称、试条批号、试条效期、电子标签密码、临床指标参考值、试条生产厂商信息等，且可读入被测对象身份信息、检测者信息、样品名称、样品编号、检测日期、检测结果等信息。电子标签20所存储的被检物标准工作曲线有多种形式可供选择，其包括但不限于下述曲线之一：
（1）被检物标准品系列浓度与OD检测带/OD质控带之间的对应关系曲线；或，
（2）被检物标准品系列浓度与OD检测带/（OD检测带+OD质控带）之间的对应关系曲线；或，
（3）被检物标准品系列浓度与OD检测带之间的对应关系曲线。
所述OD检测带定义为被检物标准品系列浓度测得的检测带光密度值，OD质控带定义为被检物标准品系列浓度测得的质控带光密度值。
光学系统3的结构组成有多种方案可供选择，其包括但不限于图9所述方案或图10所述方案。
图9方案中，所述光学系统3包括照明系统和成像系统。其中照明系统包括一激发光源311。在该光源311的输出光路上依次为光纤束312、准直照明透镜313、分色镜314、前镜组315，直至试条卡1。激发光源311包括发光二极管LED或激光二极管。其中成像系统包括共光轴的前镜组315、分色镜314、滤光片316、后镜组317。分色镜314反射面与光轴夹角成45o角。前镜组315和后镜组317均采用分离结构。照明系统光路在分色镜314之前部分与成像系统的光轴相垂直，在分色镜314之后的部分与成像系统共光轴。光电检测器4位于后镜组317像面上。光纤束312将光源311发出的光分为具有一定间距且强度相同的激光束，该激光束由准直照明透镜313准直为平行光束入射到分色镜314表面，经分色镜314反射后通过前镜组315同步照射到位于前镜组315物面试条卡1的试条15的检测带27和质控带28上激发渗移到检测带27和质控带28的量子点反应信号物发出特征频率反射荧光，检测带27和质控带28反射荧光经同一前镜组315、透过分色镜314、滤光片316滤去杂光后出后镜组317进入光电检测器4中被检测转换为电信号。
图10方案中，所述光学系统3包括一激发光源321，在该激发光源321的输出光路上依次为入射光耦合器322、入射光纤323、光纤探头324、出射光纤325、出射光耦合器326，直至光电检测器4。激发光源321包括发光二极管LED或激光二极管。光源321发出的光经入射光耦合器322分束进入入射光纤323，入射光纤323经试条检测带光纤探头和试条质控带光纤探头分别照射到试条卡1的试条15的检测带27和质控带28上以激发试条检测带27和质控带28的量子点反应信号物发出特征频率反射荧光，反射荧光分别经检测带光纤探头和质控带光纤探头、相应出射光纤325、出射光耦合器326后进入光电检测器4中被检测转换为电信号。光纤探头324采用合束共用结构，其中心为入射光纤323，周缘为出射光纤325。
所述光电检测器4具有多种可供选择对象，其包括CCD、CMOS、光电倍增管、光电二极管、光电三极管。
所述数据处理装置6为具有相应数据处理和控制软件的微处理器、单片机、或PC机。
所述电子标签读写模块10以非接触方式自动读/写电子标签20信息。
所述检测装置2备留的多个通讯接口31为USB接口或RS-232接口，其用于检测者根据检测需要临时插接外连打印机、外存介质、上位机、键盘或其他仪器设备。
所述输出显示装置8为字母数字LCD液晶屏、LED、触摸显示屏、声音装置或上位机等。
所述电源7为外接电源或可拆换的电池。所述电池包括锂电池。
所述试条检测系统的检测装置2在整体上为便携式仪器、中/大型仪器、或为与具有相应发射和接收信息功能的无线通讯品的结合包括与移动电话、平板电脑、个人数字助理、移动终端设备或计算机集合中的挑选品的结合。
所述试条卡1内的试条15为一次性使用试条；用来插放试条15的试条卡1的卡盒16及卡盒16上安装的电子标签20为同批次试条相配套的使用品；所述检测装置2为持续通用品。
样品检测时，将试条15插入试条卡1中，插放有试条的试条卡1再插放入检测装置2的试条卡插孔33中，试条15过盈伸出端（即吸样垫21端）浸渍于液体样品。被检物液体样品在位于试条另一端的吸水垫24的拉动下，利用微孔滤膜的毛细管虹吸作用慢慢向试条15后端渗移。当液体样品中有目标被检物分子（如抗原或抗体）时，它们便与包被在试条前中段的标记垫22上的相应被量子点标记好的免疫分子结合并一起向试条后端渗移至试条分析膜23的检测带27，与包被在检测带27的另一特异目标被检物相关反应分子（如相应目标被检物分子的另一特异抗体或抗原）结合形成检测带量子点反应信号物并截流富集在检测带27上。剩余的一部分量子点免疫标记分子继续前行渗移至试条质控带28，与包被在质控带28的质控物（如二抗）结合形成质控带量子点反应信号物，并截流富集在质控带28上。试条检测带27的量子点反应信号物被光学系统3发出的光激发后发出特征频率反射荧光，试条检测带27反射的量子点荧光信号与待测样品浓度呈正相关。样品中被检物浓度越大，试条检测带27发出的特征频率荧光信号就越强。反之，样品中被检物浓度越小，试条检测带27发出的特征频率荧光信号就越弱，由此可定量样品中被检物浓度。光学系统3发出的光激发试条检测带27和质控带28的量子点反应信号物发出反射荧光，该反射荧光信号被光电检测器4接收转换成电信号，转换后的电信号经信号放大后传输给模/数转换器5转换为数字信号并传输给数据处理装置6，数据处理装置6对传输来的特征频率荧光信号进行自动识别、并结合电子标签读写模块10所传输来的发送于试条卡电子标签20的被检物标准工作曲线或系数参数进行被检物浓度计算和技术分析，将结果传输给输出显示装置8，语音模块18语音提示检测结果信息。
被检物标准工作曲线制作方法包括如下步骤：（1）配制被检物标准品系列浓度。（2）检测获得被检物标准品系列浓度的相应OD检测带和OD质控带，并计算获得OD检测带/OD质控带比值或OD检测带/（OD检测带+OD质控带）比值。（3）以标准品系列浓度作X轴，测试结果以OD检测带/OD质控带比值作Y轴，绘制标准工作曲线；或以标准品系列浓度作X轴，测试结果以OD检测带/（OD检测带+OD质控带）比值作Y轴，绘制标准工作曲线；或以标准品系列浓度作X轴，测试结果以OD检测带值作Y轴，绘制标准工作曲线。（4）编写标准工作曲线软件。（5）将标准品测试时得到的试条质控带光密度值作为试条质控带光密度参考监控值（即OD质控带’）；将标准工作曲线软件和OD质控带’一并存储于电子标签20上。
所述试条检测系统的检测使用方法通过下述步骤实现：
（1）开机接通电源；
（2）将试条15插入试条卡1中；插放有试条的试条卡1再插放入所述试条检测系统的检测装置2的试条卡插孔33中；
（3）试条吸样端浸渍样品；
（4）按下检测键，所述量子点试条检测系统开始样品检测。检测结束后，输出显示装置8显示试条检测结果信息，语音模块18语音提示检测结果信息。
实施例2
本实施例为本发明所述量子点试条检测系统其检测装置2采用移动电话样式、检测结果能进行远程数据管理和信息反馈的一种较佳技术方案。下面结合附图5-18说明本实施例所述技术方案。
图5-8是本实施例所述量子点试条检测系统技术方案的结构框图。其中，图5为所述系统外观结构框图。图6-8为所述系统的检测装置2的内部结构框图。
图5结合图6-8中，所述量子点免疫层析试条检测系统，包括试条卡1、检测装置2和一个包括远程服务器14或/和其他移动终端设备14在内的无线网络系统13，14。其中，所述试条卡1包括卡盒16和可适时插放到卡盒16内的量子点免疫层析试条15。所述检测装置2包括光学系统3、光电检测器4、模/数转换器5、数据处理装置6、电子标签读写模块10、输出显示装置8、语音模块18、无线通信模块12、电源7、位于检测装置2表面的按键9和备留于检测装置2的多个可供临时插接外连的通讯接口31。光学系统3的成像信号端与光电检测器4相连。光电检测器4的信号输出端经信号放大后与模/数转换器5的信号输入端相连。模/数转换器5的信号输出端与数据处理装置6的信号输入端相连。数据处理装置6还分别与无线通信模块12、输出显示装置8、语音模块18、电子标签读写模块10、电源7、检测装置2表面的按键9和备留于检测装置2的各通讯接口31相连。无线通信模块12的信号发射端与包括远程服务器14或/和其它移动终端设备14在内的无线网络系统13，14相通讯，其通讯方式包括但不限于Wifi、蓝牙、短信、微信、移动电话等。电源7通过数据处理装置6向光学系统3、光电检测器4、模/数转换器5、输出显示装置8、语音模块18和电子标签读写模块10供电。电源7还向无线通信模块12供电。检测装置2的前端有一试条卡插孔33。试条卡1为检测装置2的离式即插结构。试条15为试条卡1的离式即插结构。试条卡1在对应于检测装置2的试条卡插孔33处设有试条卡止插位标志19。试条15插入试条卡1后连同试条卡1一并插入检测装置2的试条卡插孔33中对试条上的样品进行检测。
试条卡卡盒16的一端连同该卡盒端的上盒面开口形成试条插槽口17以方便插放试条15。图11、12、15、16、18所示卡盒16试条15的侧视结构。其中，图11-12所示卡盒16内的试条15包括顺次搭接固定在底衬26上的吸样垫21、标记垫22、分析膜23、吸水垫24。图15所示试条15包括顺次搭接固定在底衬26上的吸样垫21、滤样垫11、标记垫22、分析膜23、吸水垫24。图16所示试条15包括顺次搭接固定在底衬26上的吸样垫21、标记垫22、分析膜23、吸水垫24、试条反应终点指示标签25。图18所示试条15包括顺次搭接固定在底衬26上的吸样垫21、滤样垫11、标记垫22、分析膜23、吸水垫24、试条反应终点指示标签25。所述试条15的分析膜23具有检测带27和质控带28，检测带27为一条或多条（图6、8-11、13、15-18所示试条15分析膜23的检测带27为一条；图7、12、14所示试条15分析膜23的检测带27为多条）。图13、14、17所示试条卡1的俯视结构。试条卡卡盒16的上盒面在对应于试条分析膜23位置处开有检测窗29。卡盒16在对应于试条反应终点指示标签25的位置处开有试条反应终点观察窗30（图17所示）。卡盒16的任意处安装有一张存储有试条15检测用信息的电子标签20。试条15插入到试条卡卡盒16时，卡盒16的检测窗29对应位于检测装置2的光学系统3的光照射面。
卡盒16内试条15的标记垫22包被有一种或多种由量子点标记的用于目标被检物检测用的相关分子，所述量子点包括ZnS、CdS、HgS、ZnSe、CdSe、HgSe、CdTe、ZnTe、ZnO、PbSe、HgTe、CaAs、InP、InAs、InCaAs、CdS/ZnS、CdS/Ag2S、CdS/PbS、CdS/Cd(0H)2、CdS/HgS、CdS/HgS/CdS、ZnS/CdS、ZnS/CdS/ZnS、ZnS/HgS/ZnS/CdS、CdSe/CdS、CdSe/ZnS、CdSe/ZnSe、CdSe/CuSe、CdSe/HgTe、CdSe/HgSe、CdSe/HgSe/CdSe、CdTe/HgS、CdTe/HgTe、InAs/InP、InAs/CdSe、InAs/ZnSe、MgS、MgSe、MgTe、CaS、CaSe、CaTe、SrS、SrSe、SeTe、BaS、BaSe、BaTe、CdS:Mn、ZnS:Mn、CdS:Cu、ZnS:Cu、CdS:Tb、ZnS:Tb中的任意一种或任意几种纳米粒子的组合，以及由上述任意一种量子点为核、二氧化硅为壳的核-壳型纳米复合粒子。
卡盒16内试条15的检测带27包被有一种或多种与目标被检物检测相关的另一分子。
卡盒16内试条15的质控带28包被有包括二抗的质控物。
卡盒16上的电子标签20包括但不限于RFID标签、非接触式识别的IC卡芯片。电子标签20在卡盒16的安装方式包括薄膜粘贴式、封装植入式、卡式、钉式、或纽扣式等。电子标签20存储的试条检测用信息包括同批次量子点免疫层析试条15定量样品被检物浓度用的标准工作曲线或系数参数、试条质控带光密度参考监控值（OD质控带’）、试条名称、试条批号、试条效期、电子标签密码、临床指标参考值、试条生产厂商信息等，且可读入被测对象身份信息、检测者信息、样品名称、样品编号、检测日期、检测结果等信息。电子标签20所存储的被检物标准工作曲线有多种形式可供选择，其包括但不限于下述曲线之一：
（1）被检物标准品系列浓度与OD检测带/OD质控带之间的对应关系曲线；或，
（2）被检物标准品系列浓度与OD检测带/（OD检测带+OD质控带）之间的对应关系曲线；或，
（3）被检物标准品系列浓度与OD检测带之间的对应关系曲线。
所述OD检测带定义为被检物标准品系列浓度测得的检测带光密度值，OD质控带定义为被检物标准品系列浓度测得的质控带光密度值。
光学系统3的结构组成有多种方案可供选择，其包括但不限于图9所述方案或图10所述方案。
图9方案中，所述光学系统3包括照明系统和成像系统。其中照明系统包括一激发光源311。在该光源311的输出光路上依次为光纤束312、准直照明透镜313、分色镜314、前镜组315，直至试条卡1。激发光源311包括发光二极管LED或激光二极管。其中成像系统包括共光轴的前镜组315、分色镜314、滤光片316、后镜组317。分色镜314反射面与光轴夹角成45o角。前镜组315和后镜组317均采用分离结构。照明系统光路在分色镜314之前部分与成像系统的光轴相垂直，在分色镜314之后的部分与成像系统共光轴。光电检测器4位于后镜组317像面上。光纤束312将光源311发出的光分为具有一定间距且强度相同的激光束，该激光束由准直照明透镜313准直为平行光束入射到分色镜314表面，经分色镜314反射后通过前镜组315同步照射到位于前镜组315物面试条卡1的试条15的检测带27和质控带28上激发渗移到检测带27和质控带28的量子点反应信号物发出特征频率反射荧光，检测带27和质控带28反射荧光经同一前镜组315、透过分色镜314、滤光片316滤去杂光后出后镜组317进入光电检测器4中被检测转换为电信号。
图10方案中，所述光学系统3包括一激发光源321，在该激发光源321的输出光路上依次为入射光耦合器322、入射光纤323、光纤探头324、出射光纤325、出射光耦合器326，直至光电检测器4。激发光源321包括发光二极管LED或激光二极管。光源321发出的光经入射光耦合器322分束进入入射光纤323，入射光纤323经试条检测带光纤探头和试条质控带光纤探头分别照射到试条卡1的试条15的检测带27和质控带28上以激发试条检测带27和质控带28的量子点反应信号物发出特征频率反射荧光，反射荧光分别经检测带光纤探头和质控带光纤探头、相应出射光纤325、出射光耦合器326后进入光电检测器4中被检测转换为电信号。光纤探头324采用合束共用结构，其中心为入射光纤323，周缘为出射光纤325。
所述光电检测器4具有多种可供选择对象，其包括CCD、CMOS、光电倍增管、光电二极管、光电三极管。
所述数据处理装置6为具有相应数据处理和控制软件的微处理器、单片机、或PC机。
所述电子标签读写模块10以非接触方式自动读/写电子标签20信息。
所述检测装置2备留的多个通讯接口31为USB接口或RS-232接口，其用于检测者根据检测需要临时插接外连打印机、外存介质、上位机、键盘或其他仪器设备。
所述输出显示装置8为字母数字LCD液晶屏、LED、触摸显示屏、声音装置或上位机等。
所述电源7为外接电源或可拆换的电池。所述电池包括锂电池。
所述试条检测系统的检测装置2在整体上为便携式仪器、中/大型仪器、或为与具有相应发射和接收信息功能的无线通讯品的结合包括与移动电话、平板电脑、个人数字助理、移动终端设备或计算机集合中的挑选品的结合。
所述试条卡1内的试条15为一次性使用试条；用来插放试条15的试条卡1的卡盒16及卡盒16上安装的电子标签20为同批次试条相配套的使用品；所述检测装置2为持续通用品。
样品检测时，插放到试条卡卡盒16内的试条15其吸样垫21一端过盈伸出试条卡卡盒16的开口端以浸渍吸取样品。光学系统3发出的光激发试条检测带27和质控带28的量子点反应信号物发出反射荧光，该反射荧光信号被光电检测器4接收转换成电信号，转换后的电信号经信号放大后传输给模/数转换器5转换为数字信号并传输给数据处理装置6，数据处理装置6对传输来的特征频率荧光信号进行自动识别、并结合电子标签读写模块10所传输来的发送于试条卡电子标签20的被检物标准工作曲线或系数参数进行被检物浓度计算和技术分析，将结果传输给输出显示装置8，语音模块18语音提示检测结果信息，检测结果及其相关信息通过无线通信模块12发送给无线网络系统13，14的远程服务器14或/和移动终端设备14进行数据管理与信息咨询反馈。
被检物标准工作曲线制作方法包括如下步骤：（1）配制被检物标准品系列浓度。（2）检测获得被检物标准品系列浓度的相应OD检测带和OD质控带，并计算获得OD检测带/OD质控带比值或OD检测带/（OD检测带+OD质控带）比值。（3）以标准品系列浓度作X轴，测试结果以OD检测带/OD质控带比值作Y轴，绘制标准工作曲线；或以标准品系列浓度作X轴，测试结果以OD检测带/（OD检测带+OD质控带）比值作Y轴，绘制标准工作曲线；或以标准品系列浓度作X轴，测试结果以OD检测带值作Y轴，绘制标准工作曲线。（4）编写标准工作曲线软件。（5）将标准品测试时得到的试条质控带光密度值作为试条质控带光密度参考监控值（即OD质控带’）；将标准工作曲线软件和OD质控带’一并存储于电子标签20上。
所述试条检测系统的检测使用方法通过下述步骤实现：
（1）开机接通电源；
（2）将试条15插入试条卡1中；插放有试条的试条卡1再插放入所述试条检测系统的检测装置2的试条卡插孔33中；
（3）试条吸样端浸渍样品；
（4）按下检测键，所述量子点试条检测系统开始样品检测。检测结束后，输出显示装置8显示试条检测结果信息，语音模块18语音提示检测结果信息；
（5）按下发送键，检测结果及信息发送给无线网络系统13，14的远程服务器14或/和移动终端设备14进行数据管理与信息咨询反馈。
实施例3
本实施例所述量子点免疫层析试条检测系统如实施例1或2，区别仅在于，其中所述数据处理装置6与所述的电子标签读写模块10集成于一起。样品检测时，该集成了电子标签读写模块10的数据处理装置6对检测带27和质控带28传输来的特征频率荧光信号进行自动识别、并结合从试条卡电子标签20发送来的被检物标准工作曲线或系数参数进行被检物浓度计算和技术分析。如图4和图8所示。
实施例4
本实施例所述量子点免疫层析试条检测系统如实施例1、2或3，区别仅在于，其中所述试条卡卡盒16内的量子点试条15的吸样垫21与标记垫22之间还搭接有用于样品分离处理的滤样垫11，如图15和图18所示。所述滤样垫11包括滤血膜。例如，当所述试条检测系统用于检测血液样品时，所述滤样垫11可阻止血细胞而仅让血液样品中的血清渗过滤样垫11，因而用全血就能进行血液样品检测，克服了现有技术检测血液样品须用离心机等仪器设备分离血清后才能进行检测之不足。
实施例5
本实施例所述量子点免疫层析试条检测系统如实施例1、2、3或4，区别仅在于：其中所述试条卡卡盒16内试条15的吸水垫24之后还搭接有一试条反应终点指示标签25。试条卡卡盒16在对应于该试条反应终点指示标签25的位置处开有试条反应终点观察窗30，如图16-18所示。所述试条反应终点指示标签25包括但不限于变色范围为5.0-9.0的精密pH试纸。样品检测时，所述试条反应终点指示标签25用以提示试条反应物在试条上的虹吸渗移层析是否充分，反应是否到达终点。
实施例6
本实施例所述量子点免疫层析试条检测系统如实施例1、2、3、4或5，区别仅在于，其中，存储有试条15检测用信息的所述电子标签20安装在卡盒16内试条15的任意处（说明书附图未显示）。
实施例7
本实施例结合图19-20说明本发明所述量子点免疫层析试条检测系统用于同步快速定量检测血清肿瘤标志物甲胎蛋白（AFP）、癌胚抗原（CEA）和前列腺特异抗原（PSA）（一检多项）。
1、用于AFP、CEA和PSA同步检测的量子点一检多项试条制作
所述量子点免疫层析试条15顺次设有相互搭接粘贴的吸样垫21、玻璃纤维膜标记垫22、具有检测带27和质控带28的分析膜23、吸水垫24。玻璃纤维膜标记垫22包被有量子点标记的AFP单抗、量子点标记的CEA单抗、和量子点标记的PSA单抗的混合物；检测带27包被有AFP抗体、CEA抗体和PSA抗体的混合物；质控带28包被有二抗质控物如羊抗鼠IgM抗体、或羊抗鼠IgG抗体、或兔抗鼠IgM抗体、或兔抗鼠IgG抗体。
（1）试条组件制备
①吸样垫21: 选用纤维素膜，切成297×15mm膜块，置长形槽中，加吸样垫处理液（pH＝7.2，0.03mol/L磷酸盐缓冲液＋5%BSA＋0.1%Tween 20）常温浸泡30min。取出膜块，37℃干燥备用。
②标记垫22：选用玻璃纤维膜，切成297×10mm膜块，置长形槽中，加预先准备好的量子点标记物溶液（即含有量子点标记的AFP单抗、量子点标记的CEA单抗、量子点标记的PSA单抗的混合物溶液）于其上，取出膜块，37℃干燥备用。
③分析膜23：选用硝酸纤维素膜，切成297×25mm膜块，置长形槽中，自膜块底边起由下自上相隔一定距离喷点AFP抗体（0.5-5mg/ml）、CEA抗体（0.5-5mg/ml）和PSA抗体（0.5-5mg/ml）的混合物作检测带27，喷点0.5-5mg/ml羊抗鼠IgM抗体、或羊抗鼠IgG抗体、或兔抗鼠IgM抗体、或兔抗鼠IgG抗体作质控带28，之后将所制膜块于37℃干燥备用。
④吸水垫24：选用具有强吸水作用的纤维素膜，切成297×30mm膜块，充分干燥备用。
（2）试条装配
将制备好的各试条组件按吸样垫21、标记垫22、分析膜23、吸水垫24顺次相互搭接粘贴于塑料底衬26上，并剪切成一定规格的量子点一检多项试条，干燥保存备用。
2、标准工作曲线绘制与存储
图19是AFP、CEA、PSA检测标准工作曲线。其制作方法如下：
（1）标准品系列浓度配制
用1:10稀释的正常人血清(以pH＝7.2，0.03mol/L PB缓冲液稀释)作稀释液，将AFP、CEA和PSA标准品分别按0pg/ml、100pg/ml、200pg/m1、300pg/ml、400pg/ml、500pg/ml、600pg/ml、700pg/ml、800pg/ml、900pg/ml、1000pg/ml、1100pg/ml、1200pg/ml、1300pg/ml、1400pg/ml、1500pg/ml、1600pg/ml、1700pg/ml、1800pg/ml、1900pg/m1配成系列浓度各20份。
（2）绘制肿瘤标志物检测标准工作曲线
每份肿瘤标志物标准品系列浓度分别用10条量子点标记的肿瘤标志物一检多项试条在相同系统设置条件下检测10次，分别读得其检测带光密度值（OD检测带）与质控带光密度值（OD质控带），得到平均值及其OD检测带/OD质控带比值。分别以AFP、CEA、PSA标准品每一系列浓度作X轴，以AFP、CEA、PSA标准品各系列浓度对应求得的OD检测带/OD质控带比值作Y轴绘制标准工作曲线。结果见图19。
（3）编写肿瘤标志物检测标准工作曲线软件，将标准工作曲线软件数据连同所用标准品测试时获得的OD质控带值（样品实际检测时，该OD质控带值作为试条质控带光密度参考监控值OD质控带’）以及试条检测用信息（包括试条批号、试条名称、试条效期、RFID标签密码、临床标准参考值、试条生产厂商等）等数据一并存储于RFID标签20上。
（4）将存储有AFP、CEA、PSA标准工作曲线和试条检测用信息的RFID标签20贴附安装于试条卡的卡盒16上。
3、肿瘤患者血清样品肿瘤标志物检测
（1）样品来源：血清样品由某肿瘤医院化验室提供。检测前血清样品用 pH＝7.2，0.03mol/L PB缓冲液作10倍稀释。
（2）样品检测：
①开机接通电源；
②将所制备的量子点标记的AFP、CEA、PSA一检多项试条15插入试条卡1中；插放有试条的试条卡1再一并插放入所述试条检测系统的检测装置2的试条卡插孔33中；
③试条吸样端浸渍样品；
④按下检测键，所述试条检测系统开始样品检测。检测结束后，输出显示装置8显示试条检测结果信息，语音模块18语音提示检测结果信息；
⑤按下发送键，检测结果及信息发送给无线网络系统13，14的远程服务器14或/和移动终端设备14进行数据管理与信息咨询反馈。
（3）肿瘤患者血清样品AFP、CEA、PSA最终浓度计算：
公式为：血清样品肿瘤标志物最终浓度(pg/m1)＝所述试条检测系统测得浓度×血清稀释倍数
例如：血清样品经所述试条检测系统检测其AFP浓度为1753.4526pg/m1、CEA浓度为878.3892pg/m1、PSA浓度为983.4257pg/m1，则：
血清样品AFP最终浓度(pg/m1)＝1753.4526pg/m1×10=17534.526pg/m1
血清样品CEA最终浓度(pg/m1)＝878.3892pg/m1×10=8783.892pg/m1
血清样品PSA最终浓度(pg/m1)＝983.4257pg/m1×10=9834.257pg/m1
图20为量子点标记的AFP、CEA、PSA荧光光谱曲线。其中，Ⅰ为检测带中的AFP光谱峰，Ⅱ为检测带中的CEA光谱峰，Ⅲ为检测带中的PSA光谱峰，Ⅳ为质控带中的质控物光谱峰。
实施例8
本实施例结合图21-22说明所述量子点免疫层析试条检测系统用于快速定量检测乙肝表面抗原HBsAg（单项检测）。
1、用于HBsAg检测的量子点免疫层析试条制作
所述量子点免疫层析试条15顺次设有相互搭接粘贴的吸样垫21、滤样垫11、玻璃纤维膜标记垫22、具有检测带27和质控带28的分析膜23、吸水垫24、试条反应终点指示标签25。玻璃纤维膜标记垫22包被有量子点标记的HBsAg单克隆抗体，检测带27包被有HBsAg抗体。质控带28包被有二抗质控物如羊抗鼠IgM抗体、或羊抗鼠IgG抗体、或兔抗鼠IgM抗体、或兔抗鼠IgG抗体。
（1）试条组件制备
①吸样垫21: 选用纤维素膜，切成297×15mm膜块，置长形槽中，加封闭液（pH＝7.2，0.03mol/L磷酸盐缓冲液+5%BSA，+0.1%Tween 20）常温浸泡30min。取出膜块，37℃干燥备用。
②滤样垫11：按滤膜孔径选择滤血膜，切成一定规格膜块，干燥保存备用。
③标记垫22：选用玻璃纤维膜，切成297×10mm膜块，置长形槽中，加预先准备好的量子点-HBsAg单克隆抗体结合物溶液于其上，取出膜块，37℃干燥备用。
④分析膜23：选用硝酸纤维素膜，切成297×25mm膜块，置长形槽中，自膜块底边起由下自上相隔一定距离喷点0.5-5mg/ml HBsAg单克隆抗体作检测带27，喷点0.5-5mg/ml羊抗鼠IgM抗体、或羊抗鼠IgG抗体、或兔抗鼠IgM抗体、或兔抗鼠IgG抗体作质控带28，之后将所制膜块于37℃干燥备用。
⑤吸水垫24：选用具有强吸水作用的纤维素膜，切成297×30mm膜块，充分干燥备用。
⑥试条反应终点指示标签25： 选用变色范围为5.0-9.0的精密pH试纸，切成具有297×5mm的膜块，充分干燥备用。
（2）试条装配
将制备好的各试条组件按吸样垫21、滤样垫11、标记垫22、分析膜23、吸水垫24、试条反应终点指示标签25顺次相互搭接粘贴于塑料底衬26上，并剪切成一定规格的量子点免疫层析试条，干燥保存备用。
2、标准工作曲线绘制与存储
图21是HBsAg检测标准工作曲线。其制作方法如下：
（1）HBsAg标准品系列浓度配制
用1:10稀释的正常人血清(以pH＝7.2，0.03mol/L PB缓冲液稀释)作稀释液，将HBsAg标准品配成系列浓度20份：0pg/ml、100pg/ml、200pg/m1、300pg/ml、400pg/ml、500pg/ml、600pg/ml、700pg/ml、800pg/ml、900pg/ml、1000pg/ml、1100pg/ml、1200pg/ml、1300pg/ml、1400pg/ml、1500pg/ml、1600pg/ml、1700pg/ml、1800pg/ml、1900pg/m1。
（2）绘制HBsAg检测标准工作曲线
上述每一HBsAg标准品系列浓度分别用10条量子点标记的HBsAg试条于相同系统设置条件下检测10次，分别读得其检测带光密度值（OD检测带）与质控带光密度值（OD质控带），计算平均值及其OD检测带/（OD检测带+OD质控带）比值。以HBsAg标准品系列浓度作X轴，以每一HBsAg标准品系列浓度对应求得的OD检测带/（OD检测带+OD质控带）比值作Y轴绘制标准工作曲线，结果见图21。
（3）编写HBsAg检测标准工作曲线软件，将标准工作曲线软件数据连同所用标准品测试时获得的OD质控带值（样品实际检测时，该OD质控带值作为试条质控带光密度参考监控值OD质控带’）以及试条检测用信息（包括试条批号、试条名称、试条效期、IC卡芯片密码、临床标准参考值、试条生产厂商等）等数据一并存储于IC卡芯片20上。
（4）将存储有HBsAg检测标准工作曲线和试条检测用信息的IC卡芯片20贴附安装于试条卡的卡盒（16）上。
3、乙肝患者血清样品HBsAg检测
（1）样品来源：乙肝患者血清样品由某妇幼保健院提供，检测前血清样品用 pH＝7.2，0.03mol/L PB缓冲液作10倍稀释。
（2）样品检测：
①开机接通电源；
②将所制备的用于HBsAg检测的量子点免疫层析试条15插入试条卡1中；插放有试条的试条卡1再一并插放入所述试条检测系统的检测装置2的试条卡插孔33中；
③试条吸样端浸渍样品；
④按下检测键，所述试条检测系统开始样品检测。检测结束后，输出显示装置8显示试条检测结果信息，语音模块18语音提示检测结果信息；
⑤按下发送键，检测结果及信息发送给无线网络系统13，14的远程服务器14或/和移动终端设备14进行数据管理与信息咨询反馈。
（3）乙肝患者血清样品HBsAg最终浓度计算：
血清样品中HBsAg最终浓度(pg/m1)＝所述试条检测系统测得的HBsAg浓度×血清稀释倍数
例如：血清样品经所述试条检测系统检测其HBsAg浓度为205.9563 pg/m1。由此得：
血清样品HBsAg最终浓度(pg/m1)＝205.9563pg/m1×10＝2059.563pg/m1
图22为量子点标记的HBsAg荧光光谱曲线。其中，Ⅰ为检测带中的HBsAg光谱峰，Ⅱ为质控带中的质控物光谱峰。
上面实施例及其附图仅是为了进一步说明本发明，本领域人员不应以此限制本发明的保护范围。特别需要指出的是，本发明所述量子点免疫层析试条检测系统还可以有其他改进，如试条卡1左端也可采用封口方式而将试条安装在试条卡盒中进行检测，此种情况下的试条卡1一般在试条样品垫21对应的卡盒16上表面设置加样孔32进行加样（如图23）；插放入卡盒内的试条15还可替换为生物芯片（包括抗原抗体芯片、蛋白芯片、DNA芯片、微流控芯片）等等。因此，凡是对本发明所述试条检测系统采用任何等同替换或等效变换形成的其它技术方案，均落在本发明权利要求的保护范围中。

Claims (88)

  1. 一种量子点免疫层析试条检测系统，包括量子点免疫层析试条（15）和检测装置（2），量子点免疫层析试条（15）包括顺次相互搭接固定在底衬（26）上的吸样垫（21）、标记垫（22）、分析膜（23）、吸水垫（24），分析膜（23）具有检测带（27）和质控带（28），标记垫（22）包被有一种或多种由量子点标记的用于目标被检物检测用的相关分子，检测带（27）包被有一种或多种与目标被检物检测相关的另一分子，质控带（28）包被有包括二抗的质控物；检测装置（2）包括光学系统（3）、光电检测器（4）、模/数转换器（5）、数据处理装置（6）、输出显示装置（8），光学系统（3）的成像信号端与光电检测器（4）相连，光电检测器（4）的信号输出端经信号放大后与模/数转换器（5）的信号输入端相连，模/数转换器（5）的信号输出端与数据处理装置（6）的信号输入端相连，数据处理装置（6）与输出显示装置（8）相连，其特征在于：
    所述系统的量子点免疫层析试条（15）与包括在其外的试条卡盒（16）构成试条卡（1），试条（15）为试条卡（1）的离式即插结构，试条卡（1）为检测装置（2）的离式即插结构；
    所述试条（15）的检测带（27）为一条或多条；
    所述试条卡盒（16）的任意处安装有一存储有试条（15）检测用信息的电子标签（20），卡盒（16）的一端连同该卡盒端的上盒面开口形成试条插槽口（17），卡盒（16）的上盒面在对应于试条分析膜（23）的位置处开有检测窗（29）；
    所述检测装置（2）还包括电子标签读写模块（10）、语音模块（18）、电源（7）和位于检测装置（2）表面的按键（9）以及备留于检测装置（2）上的多个可供临时外连的通讯接口（31），其分别与数据处理装置（6）相连，电源（7）通过数据处理装置（6）向光学系统（3）、光电检测器（4）、模/数转换器（5）、输出显示装置（8）、语音模块（18）和电子标签读写模块（10）供电，检测装置（2）上有一试条卡插孔（33）；
    所述试条卡（1）在对应于检测装置（2）的试条卡插孔（33）处设有试条卡止插位标志（19）；
    试条（15）插入试条卡（1）后连同试条卡（1）一并插入检测装置（2）的试条卡插孔（33）中对试条上的样品进行检测，插放到卡盒（16）内的试条（15）其吸样垫（21）一端过盈伸出试条卡盒（16）的开口端以浸渍吸取样品，插入到试条卡盒（16）内的试条（15）其分析膜（23）所对应的检测窗（27）对应位于检测装置（2）的光学系统（3）的光照射面，光学系统（3）发出的光激发试条的检测带（27）和质控带（28）的量子点反应信号物发出反射荧光，反射荧光信号被光电检测器（4）接收并被转换成电信号，转换后的电信号经信号放大后传输给模/数转换器（5）转换为数字信号并传输给数据处理装置（6），数据处理装置（6）对传输来的特征频率荧光信号进行自动识别、并结合电子标签读写模块（10）传输来的发送于试条卡电子标签（20）的被检物标准工作曲线或系数参数进行被检物浓度计算和技术分析，将结果传输给输出显示装置（8），语音模块（18）语音提示检测结果信息。
  2. 根据权利要求1所述的试条检测系统，其特征在于：所述试条卡（1）的电子标签（20）包括RFID标签、非接触式识别的IC卡芯片。
  3. 根据权利要求1所述的试条检测系统，其特征在于：所述检测装置（2）的光学系统（3）的光源为发光二极管LED或激光二极管。
  4. 根据权利要求1所述的试条检测系统，其特征在于：所述检测装置（2）的光电检测器（4）为CCD、CMOS、光电倍增管、光电二极管、或光电三极管。
  5. 根据权利要求1所述的试条检测系统，其特征在于：所述检测装置（2）的数据处理装置（6）为具有相应数据处理和控制软件的微处理器、单片机、或PC机。
  6. 根据权利要求1所述的系统，其特征在于：所述检测装置（2）的输出显示装置（8）为字母数字LCD液晶屏、LED、声音装置、触摸显示屏或上位机。
  7. 根据权利要求1所述的试条检测系统，其特征在于：所述检测装置（2）上备留的多个可供临时外连的通讯接口（31）包括USB接口或RS-232接口。
  8. 根据权利要求1所述的试条检测系统，其特征在于：所述电子标签（20）存储的试条检测用信息包括同批次量子点免疫层析试条（15）定量样品被检物浓度用的标准工作曲线或系数参数、试条质控带光密度参考监控值（OD质控带’）、试条名称、试条批号、试条效期、电子标签密码、临床指标参考值、试条生产厂商信息，且可读入被测对象身份信息、检测者信息、样品名称、样品编号、检测日期、检测结果信息。
  9. 据权利要求8所述的试条检测系统，其特征在于：所述电子标签（20）存储的所述被检物标准工作曲线有多种形式可供选择，其包括下述曲线之一：
    被检物标准品系列浓度与OD检测带/OD质控带之间的对应关系曲线；或，
    被检物标准品系列浓度与OD检测带 /（OD检测带 +OD质控带）之间的对应关系曲线；或，
    被检物标准品系列浓度与OD检测带 之间的对应关系曲线；
    所述OD检测带 定义为被检物标准品系列浓度测得的检测带光密度值，OD质控带 定义为被检物标准品系列浓度测得的质控带光密度值。
  10. 根据权利要求1所述的试条检测系统，其特征在于：插放到所述试条卡（1）内的试条（15）为一次性使用试条；用来插放试条（15）的试条卡（1）的卡盒（16）及卡盒（16）上安装的电子标签（20）为同批次试条相配套的使用品；所述检测装置（2）为持续通用品。
  11. 根据权利要求1所述的试条检测系统，其特征在于：其中所述检测装置（2）在整体上为便携式仪器、中/大型仪器、或为与具有相应发射和接收信息功能的无线通讯品的结合包括与移动电话、平板电脑、个人数字助理、移动终端设备或计算机集合中的挑选品的结合。
  12. 根据权利要求1所述的试条检测系统，其特征在于：其中，试条标记垫（22）所述的用于目标被检物检测相关分子标记的量子点包括ZnS、CdS、HgS、ZnSe、CdSe、HgSe、CdTe、ZnTe、ZnO、PbSe、HgTe、CaAs、InP、InAs、InCaAs、CdS/ZnS、CdS/Ag2S、CdS/PbS、CdS/Cd(0H)2、CdS/HgS、CdS/HgS/CdS、ZnS/CdS、ZnS/CdS/ZnS、ZnS/HgS/ZnS/CdS、CdSe/CdS、CdSe/ZnS、CdSe/ZnSe、CdSe/CuSe、CdSe/HgTe、CdSe/HgSe、CdSe/HgSe/CdSe、CdTe/HgS、CdTe/HgTe、InAs/InP、InAs/CdSe、InAs/ZnSe、MgS、MgSe、MgTe、CaS、CaSe、CaTe、SrS、SrSe、SeTe、BaS、BaSe、BaTe、CdS:Mn、ZnS:Mn、CdS:Cu、ZnS:Cu、CdS:Tb、ZnS:Tb中的任意一种或任意几种纳米粒子的组合，以及由上述任意一种量子点为核、二氧化硅为壳的核-壳型纳米复合粒子。
  13. 据权利要求1所述的系统，其特征在于：其中所述光学系统（3）的结构组成有多种方案可供选择，其包括：
    a) 所述光学系统（3）包括一照明系统和成像系统，照明系统包括一激发光源（311），在该光源（311）的输出光路上依次为光纤束（312）、准直照明透镜（313）、分色镜（314）、前镜组（315），直至试条卡（1）；成像系统包括共光轴的前镜组（315）、分色镜（314）、滤光片（316）、后镜组（317），分色镜（314）反射面与光轴夹角成45o角，前镜组（315）和后镜组（317）均采用分离结构，照明系统光路在分色镜（314）之前部分与成像系统的光轴相垂直，照明系统光路在分色镜（314）之后的部分与成像系统共光轴；光电检测器（4）位于后镜组（317）像面上；光纤束（312）将光源（311）发出的光分为具有一定间距且强度相同的激光束，该激光束由准直照明透镜（313）准直为平行光束入射到分色镜（314）表面，经分色镜（314）反射后通过前镜组（315）同步照射到位于前镜组（315）物面试条卡（1）的试条（15）的检测带（27）和质控带（28）上激发渗移到检测带（27）和质控带（28）的量子点反应信号物发出特征频率反射荧光，检测带（27）和质控带（28）反射荧光经同一前镜组（315）、透过分色镜（314）、滤光片（316）滤去杂光后出后镜组（317）进入光电检测器（4）中被检测转换为电信号；或，
    b) 所述光学系统（3）包括一激发光源（321），在该激发光源（321）的输出光路上依次为入射光耦合器（322）、入射光纤（323）、光纤探头（324）、出射光纤（325）、出射光耦合器（326），直至光电检测器（4）；光源（321）发出的光经入射光耦合器（322）分束进入入射光纤（323），入射光纤（323）经试条检测带光纤探头和试条质控带光纤探头分别照射到试条卡（1）的试条（15）的检测带（27）和质控带（28）上以激发试条检测带（27）和质控带（28）的量子点反应信号物发出特征频率反射荧光，反射荧光分别经检测带光纤探头和质控带光纤探头、相应出射光纤（325）、出射光耦合器（326）后进入光电检测器（4）中被检测转换为电信号；光纤探头（324）采用合束共用结构，其中心为入射光纤（323），周缘为出射光纤（325）。
  14. 根据权利要求1所述的试条检测系统，其特征在于：所述电源为外接电源或为可拆换的电池。
  15. 一种如权利要求1所述的试条检测系统，其特征于：其中所述数据处理装置（6）和电子标签读写模块（10）集成在一起构成所述的数据处理装置（6），该所述的数据处理装置（6）对检测带（27）和质控带（28）传输来的特征频率荧光信号进行自动识别、并结合从试条卡电子标签（20）发送来的被检物标准工作曲线或系数参数进行被检物浓度计算和技术分析，将结果传输给输出显示装置（8），语音模块（18）语音提示检测结果信息。
  16. 根据权利要求15所述的试条检测系统，其特征在于：所述试条卡（1）的电子标签（20）包括RFID标签、非接触式识别的IC卡芯片。
  17. 根据权利要求15所述的试条检测系统，其特征在于：所述检测装置（2）的光学系统（3）的光源为发光二极管LED或激光二极管。
  18. 根据权利要求15所述的试条检测系统，其特征在于：所述检测装置（2）的光电检测器（4）为CCD、CMOS、光电倍增管、光电二极管、或光电三极管。
  19. 根据权利要求15所述的试条检测系统，其特征在于：所述检测装置（2）的数据处理装置（6）为具有相应数据处理和控制软件的微处理器、单片机、或PC机。
  20. 根据权利要求15所述的试条检测系统，其特征在于：所述检测装置（2）的输出显示装置（8）为字母数字LCD液晶屏、LED、声音装置、触摸显示屏或上位机。
  21. 据权利要求15所述的试条检测系统，其特征在于：所述检测装置（2）上备留的多个可供临时外连的通讯接口（31）包括USB接口或RS-232接口。
  22. 根据权利要求15所述的试条检测系统，其特征在于：所述电子标签（20）存储的试条检测用信息包括同批次量子点免疫层析试条（15）定量样品被检物浓度用的标准工作曲线或系数参数、试条质控带光密度参考监控值（OD质控带’）、试条名称、试条批号、试条效期、电子标签密码、临床指标参考值、试条生产厂商信息，且可读入被测对象身份信息、检测者信息、样品名称、样品编号、检测日期、检测结果信息。
  23. 据权利要求22所述的试条检测系统，其特征在于：所述电子标签（20）存储的所述被检物标准工作曲线有多种形式可供选择，其包括下述曲线之一：
    被检物标准品系列浓度与OD检测带/OD质控带之间的对应关系曲线；或，
    被检物标准品系列浓度与OD检测带/（OD检测带+OD质控带）之间的对应关系曲线；或，
    被检物标准品系列浓度与OD检测带之间的对应关系曲线；
    所述OD检测带定义为被检物标准品系列浓度测得的检测带光密度值，OD质控带定义为被检物标准品系列浓度测得的质控带光密度值。
  24. 据权利要求15所述的试条检测系统，其特征在于：插放到所述试条卡（1）内的试条（15）为一次性使用试条；用来插放试条（15）的试条卡（1）的卡盒（16）及卡盒（16）上安装的电子标签（20）为同批次试条相配套的使用品；所述检测装置（2）为持续通用品。
  25. 根据权利要求15所述的试条检测系统，其特征在于：其中所述检测装置（2）在整体上为便携式仪器、中/大型仪器、或为与具有相应发射和接收信息功能的无线通讯品的结合包括与移动电话、平板电脑、个人数字助理、移动终端设备或计算机集合中的挑选品的结合。
  26. 根据权利要求15所述的试条检测系统，其特征在于：其中，试条标记垫（22）所述的用于目标被检物检测相关分子标记的量子点包括ZnS、CdS、HgS、ZnSe、CdSe、HgSe、CdTe、ZnTe、ZnO、PbSe、HgTe、CaAs、InP、InAs、InCaAs、CdS/ZnS、CdS/Ag2S、CdS/PbS、CdS/Cd(0H)2、CdS/HgS、CdS/HgS/CdS、ZnS/CdS、ZnS/CdS/ZnS、ZnS/HgS/ZnS/CdS、CdSe/CdS、CdSe/ZnS、CdSe/ZnSe、CdSe/CuSe、CdSe/HgTe、CdSe/HgSe、CdSe/HgSe/CdSe、CdTe/HgS、CdTe/HgTe、InAs/InP、InAs/CdSe、InAs/ZnSe、MgS、MgSe、MgTe、CaS、CaSe、CaTe、SrS、SrSe、SeTe、BaS、BaSe、BaTe、CdS:Mn、ZnS:Mn、CdS:Cu、ZnS:Cu、CdS:Tb、ZnS:Tb中的任意一种或任意几种纳米粒子的组合，以及由上述任意一种量子点为核、二氧化硅为壳的核-壳型纳米复合粒子。
  27. 据权利要求15所述的试条检测系统，其特征在于：其中所述光学系统（3）的结构组成有多种方案可供选择，其包括：
    a) 所述光学系统（3）包括一照明系统和成像系统，照明系统包括一激发光源（311），在该光源（311）的输出光路上依次为光纤束（312）、准直照明透镜（313）、分色镜（314）、前镜组（315），直至试条卡（1）；成像系统包括共光轴的前镜组（315）、分色镜（314）、滤光片（316）、后镜组（317），分色镜（314）反射面与光轴夹角成45o角，前镜组（315）和后镜组（317）均采用分离结构，照明系统光路在分色镜（314）之前部分与成像系统的光轴相垂直，照明系统光路在分色镜（314）之后的部分与成像系统共光轴；光电检测器（4）位于后镜组（317）像面上；光纤束（312）将光源（311）发出的光分为具有一定间距且强度相同的激光束，该激光束由准直照明透镜（313）准直为平行光束入射到分色镜（314）表面，经分色镜（314）反射后通过前镜组（315）同步照射到位于前镜组（315）物面试条卡（1）的试条（15）的检测带（27）和质控带（28）上激发渗移到检测带（27）和质控带（28）的量子点反应信号物发出特征频率反射荧光，检测带（27）和质控带（28）反射荧光经同一前镜组（315）、透过分色镜（314）、滤光片（316）滤去杂光后出后镜组（317）进入光电检测器（4）中被检测转换为电信号；或，
    b) 所述光学系统（3）包括一激发光源（321），在该激发光源（321）的输出光路上依次为入射光耦合器（322）、入射光纤（323）、光纤探头（324）、出射光纤（325）、出射光耦合器（326），直至光电检测器（4）；光源（321）发出的光经入射光耦合器（322）分束进入入射光纤（323），入射光纤（323）经试条检测带光纤探头和试条质控带光纤探头分别照射到试条卡（1）的试条（15）的检测带（27）和质控带（28）上以激发试条检测带（27）和质控带（28）的量子点反应信号物发出特征频率反射荧光，反射荧光分别经检测带光纤探头和质控带光纤探头、相应出射光纤（325）、出射光耦合器（326）后进入光电检测器（4）中被检测转换为电信号；光纤探头（324）采用合束共用结构，其中心为入射光纤（323），周缘为出射光纤（325）。
  28. 根据权利要求15所述的试条检测系统，其特征在于：所述电源为外接电源或为可拆换的电池。
  29. 一种如权利要求1或15所述的试条检测系统，其特征于：所述系统还包括一个与所述系统的数据处理装置（6）相连的无线通信模块（12）和一个与所述无线通信模块（12）信号发射端相通讯的、包括远程服务器（14）或/和移动终端设备（14）在内的无线网络系统（13，14），电源（7）还向无线通信模块（12）供电，数据处理装置（6）对检测带（27）和质控带（28）传输来的特征频率荧光信号进行自动识别、并结合从试条卡电子标签（20）发送来的被检物标准工作曲线或系数参数进行被检物浓度计算和技术分析，将结果传输给输出显示装置（8），语音模块（18）语音提示检测结果信息，检测结果及其相关信息通过无线通信模块（12）发送给无线网络系统（13，14）的远程服务器（14）或/和移动终端设备（14）进行数据管理与信息咨询反馈。
  30. 根据权利要求29所述的试条检测系统，其特征在于：所述试条卡（1）的电子标签（20）包括RFID标签、非接触式识别的IC卡芯片。
  31. 根据权利要求29所述的试条检测系统，其特征在于：所述检测装置（2）的光学系统（3）的光源为发光二极管LED或激光二极管。
  32. 根据权利要求29所述的试条检测系统，其特征在于：所述检测装置（2）的光电检测器（4）为CCD、CMOS、光电倍增管、光电二极管、或光电三极管。
  33. 根据权利要求29所述的试条检测系统，其特征在于：所述检测装置（2）的数据处理装置（6）为具有相应数据处理和控制软件的微处理器、单片机、或PC机。
  34. 根据权利要求29所述的试条检测系统，其特征在于：所述检测装置（2）的输出显示装置（8）为字母数字LCD液晶屏、LED、声音装置、触摸显示屏或上位机。
  35. 根据权利要求29所述的试条检测系统，其特征在于：所述检测装置（2）上备留的多个可供临时外连的通讯接口（31）包括USB接口或RS-232接口。
  36. 根据权利要求29所述的试条检测系统，其特征在于：所述电子标签（20）存储的试条检测用信息包括同批次量子点免疫层析试条（15）定量样品被检物浓度用的标准工作曲线或系数参数、试条质控带光密度参考监控值（OD质控带’）、试条名称、试条批号、试条效期、电子标签密码、临床指标参考值、试条生产厂商信息，且可读入被测对象身份信息、检测者信息、样品名称、样品编号、检测日期、检测结果信息。
  37. 据权利要求36所述的试条检测系统，其特征在于：所述电子标签（20）存储的所述被检物标准工作曲线有多种形式可供选择，其包括下述曲线之一：
    被检物标准品系列浓度与OD检测带/OD质控带之间的对应关系曲线；或，
    被检物标准品系列浓度与OD检测带/（OD检测带+OD质控带）之间的对应关系曲线；或，
    被检物标准品系列浓度与OD检测带之间的对应关系曲线；
    所述OD检测带定义为被检物标准品系列浓度测得的检测带光密度值，OD质控带定义为被检物标准品系列浓度测得的质控带光密度值。
  38. 根据权利要求29所述的试条检测系统，其特征在于：插放到所述试条卡（1）内的试条（15）为一次性使用试条；用来插放试条（15）的试条卡（1）的卡盒（16）及卡盒（16）上安装的电子标签（20）为同批次试条相配套的使用品；所述检测装置（2）为持续通用品。
  39. 根据权利要求29所述的试条检测系统，其特征在于：其中所述检测装置（2）在整体上为便携式仪器、中/大型仪器、或为与具有相应发射和接收信息功能的无线通讯品的结合包括与移动电话、平板电脑、个人数字助理、移动终端设备或计算机集合中的挑选品的结合。
  40. 根据权利要求29所述的试条检测系统，其特征在于：其中，试条标记垫（22）所述的用于目标被检物检测相关分子标记的量子点包括ZnS、CdS、HgS、ZnSe、CdSe、HgSe、CdTe、ZnTe、ZnO、PbSe、HgTe、CaAs、InP、InAs、InCaAs、CdS/ZnS、CdS/Ag2S、CdS/PbS、CdS/Cd(0H)2、CdS/HgS、CdS/HgS/CdS、ZnS/CdS、ZnS/CdS/ZnS、ZnS/HgS/ZnS/CdS、CdSe/CdS、CdSe/ZnS、CdSe/ZnSe、CdSe/CuSe、CdSe/HgTe、CdSe/HgSe、CdSe/HgSe/CdSe、CdTe/HgS、CdTe/HgTe、InAs/InP、InAs/CdSe、InAs/ZnSe、MgS、MgSe、MgTe、CaS、CaSe、CaTe、SrS、SrSe、SeTe、BaS、BaSe、BaTe、CdS:Mn、ZnS:Mn、CdS:Cu、ZnS:Cu、CdS:Tb、ZnS:Tb中的任意一种或任意几种纳米粒子的组合，以及由上述任意一种量子点为核、二氧化硅为壳的核-壳型纳米复合粒子。
  41. 据权利要求29所述的试条检测系统，其特征在于：其中所述光学系统（3）的结构组成有多种方案可供选择，其包括：
    a) 所述光学系统（3）包括一照明系统和成像系统，照明系统包括一激发光源（311），在该光源（311）的输出光路上依次为光纤束（312）、准直照明透镜（313）、分色镜（314）、前镜组（315），直至试条卡（1）；成像系统包括共光轴的前镜组（315）、分色镜（314）、滤光片（316）、后镜组（317），分色镜（314）反射面与光轴夹角成45o角，前镜组（315）和后镜组（317）均采用分离结构，照明系统光路在分色镜（314）之前部分与成像系统的光轴相垂直，照明系统光路在分色镜（314）之后的部分与成像系统共光轴；光电检测器（4）位于后镜组（317）像面上；光纤束（312）将光源（311）发出的光分为具有一定间距且强度相同的激光束，该激光束由准直照明透镜（313）准直为平行光束入射到分色镜（314）表面，经分色镜（314）反射后通过前镜组（315）同步照射到位于前镜组（315）物面试条卡（1）的试条（15）的检测带（27）和质控带（28）上激发渗移到检测带（27）和质控带（28）的量子点反应信号物发出特征频率反射荧光，检测带（27）和质控带（28）反射荧光经同一前镜组（315）、透过分色镜（314）、滤光片（316）滤去杂光后出后镜组（317）进入光电检测器（4）中被检测转换为电信号；或，
    b) 所述光学系统（3）包括一激发光源（321），在该激发光源（321）的输出光路上依次为入射光耦合器（322）、入射光纤（323）、光纤探头（324）、出射光纤（325）、出射光耦合器（326），直至光电检测器（4）；光源（321）发出的光经入射光耦合器（322）分束进入入射光纤（323），入射光纤（323）经试条检测带光纤探头和试条质控带光纤探头分别照射到试条卡（1）的试条（15）的检测带（27）和质控带（28）上以激发试条检测带（27）和质控带（28）的量子点反应信号物发出特征频率反射荧光，反射荧光分别经检测带光纤探头和质控带光纤探头、相应出射光纤（325）、出射光耦合器（326）后进入光电检测器（4）中被检测转换为电信号；光纤探头（324）采用合束共用结构，其中心为入射光纤（323），周缘为出射光纤（325）。
  42. 根据权利要求29所述的试条检测系统，其特征在于：所述电源为外接电源或为可拆换的电池。
  43. 根据权利要求29所述的试条检测系统，其特征在于：所述无线通信模块（12）与无线网络系统（13，14）之间的通讯包括Wifi、蓝牙、短信、微信、或移动电话。
  44. 一种如权利要求1、15或29所述的试条检测系统，其特征于：其中，所述量子点免疫层析试条（15）的吸样垫（21）与标记垫（22）之间还搭接有用于样品分离处理的滤样垫（11）。
  45. 根据权利要求44所述的试条检测系统，其特征在于：所述量子点免疫层析试条（15）的滤样垫（11）包括滤血膜。
  46. 根据权利要求44或45所述的试条检测系统，其特征在于：所述试条卡（1）的电子标签（20）包括RFID标签、非接触式识别的IC卡芯片。
  47. 根据权利要求44或45所述的试条检测系统，其特征在于：所述检测装置（2）的光学系统（3）的光源为发光二极管LED或激光二极管。
  48. 根据权利要求44或45所述的试条检测系统，其特征在于：所述检测装置（2）的光电检测器（4）为CCD、CMOS、光电倍增管、光电二极管、或光电三极管。
  49. 根据权利要求44或45所述的试条检测系统，其特征在于：所述检测装置（2）的数据处理装置（6）为具有相应数据处理和控制软件的微处理器、单片机、或PC机。
  50. 根据权利要求44或45所述的试条检测系统，其特征在于：所述检测装置（2）的输出显示装置（8）为字母数字LCD液晶屏、LED、声音装置、触摸显示屏或上位机。
  51. 根据权利要求44或45所述的试条检测系统，其特征在于：所述检测装置（2）上备留的多个可供临时外连的通讯接口（31）包括USB接口或RS-232接口。
  52. 根据权利要求44或45所述的试条检测系统，其特征在于：所述电子标签（20）存储的试条检测用信息包括同批次量子点免疫层析试条（15）定量样品被检物浓度用的标准工作曲线或系数参数、试条质控带光密度参考监控值（OD质控带’）、试条名称、试条批号、试条效期、电子标签密码、临床指标参考值、试条生产厂商信息，且可读入被测对象身份信息、检测者信息、样品名称、样品编号、检测日期、检测结果信息。
  53. 据权利要求52所述的试条检测系统，其特征在于：所述电子标签（20）存储的所述被检物标准工作曲线有多种形式可供选择，其包括下述曲线之一：
    被检物标准品系列浓度与OD检测带/OD质控带之间的对应关系曲线；或，
    被检物标准品系列浓度与OD检测带/（OD检测带+OD质控带）之间的对应关系曲线；或，
    被检物标准品系列浓度与OD检测带之间的对应关系曲线；
    所述OD检测带定义为被检物标准品系列浓度测得的检测带光密度值，OD质控带定义为被检物标准品系列浓度测得的质控带光密度值。
  54. 根据权利要求44或45所述的试条检测系统，其特征在于：插放到所述试条卡（1）内的试条（15）为一次性使用试条；用来插放试条（15）的试条卡（1）的卡盒（16）及卡盒（16）上安装的电子标签（20）为同批次试条相配套的使用品；所述检测装置（2）为持续通用品。
  55. 根据权利要求44或45所述的试条检测系统，其特征在于：其中所述检测装置（2）在整体上为便携式仪器、中/大型仪器、或为与具有相应发射和接收信息功能的无线通讯品的结合包括与移动电话、平板电脑、个人数字助理、移动终端设备或计算机集合中的挑选品的结合。
  56. 根据权利要求44或45所述的试条检测系统，其特征在于：其中，试条标记垫（22）所述的用于目标被检物检测相关分子标记的量子点包括ZnS、CdS、HgS、ZnSe、CdSe、HgSe、CdTe、ZnTe、ZnO、PbSe、HgTe、CaAs、InP、InAs、InCaAs、CdS/ZnS、CdS/Ag2S、CdS/PbS、CdS/Cd(0H)2、CdS/HgS、CdS/HgS/CdS、ZnS/CdS、ZnS/CdS/ZnS、ZnS/HgS/ZnS/CdS、CdSe/CdS、CdSe/ZnS、CdSe/ZnSe、CdSe/CuSe、CdSe/HgTe、CdSe/HgSe、CdSe/HgSe/CdSe、CdTe/HgS、CdTe/HgTe、InAs/InP、InAs/CdSe、InAs/ZnSe、MgS、MgSe、MgTe、CaS、CaSe、CaTe、SrS、SrSe、SeTe、BaS、BaSe、BaTe、CdS:Mn、ZnS:Mn、CdS:Cu、ZnS:Cu、CdS:Tb、ZnS:Tb中的任意一种或任意几种纳米粒子的组合，以及由上述任意一种量子点为核、二氧化硅为壳的核-壳型纳米复合粒子。
  57. 据权利要求44或45所述的试条检测系统，其特征在于：其中所述光学系统（3）的结构组成有多种方案可供选择，其包括：
    a) 所述光学系统（3）包括一照明系统和成像系统，照明系统包括一激发光源（311），在该光源（311）的输出光路上依次为光纤束（312）、准直照明透镜（313）、分色镜（314）、前镜组（315），直至试条卡（1）；成像系统包括共光轴的前镜组（315）、分色镜（314）、滤光片（316）、后镜组（317），分色镜（314）反射面与光轴夹角成45o角，前镜组（315）和后镜组（317）均采用分离结构，照明系统光路在分色镜（314）之前部分与成像系统的光轴相垂直，照明系统光路在分色镜（314）之后的部分与成像系统共光轴；光电检测器（4）位于后镜组（317）像面上；光纤束（312）将光源（311）发出的光分为具有一定间距且强度相同的激光束，该激光束由准直照明透镜（313）准直为平行光束入射到分色镜（314）表面，经分色镜（314）反射后通过前镜组（315）同步照射到位于前镜组（315）物面试条卡（1）的试条（15）的检测带（27）和质控带（28）上激发渗移到检测带（27）和质控带（28）的量子点反应信号物发出特征频率反射荧光，检测带（27）和质控带（28）反射荧光经同一前镜组（315）、透过分色镜（314）、滤光片（316）滤去杂光后出后镜组（317）进入光电检测器（4）中被检测转换为电信号；或，
    b) 所述光学系统（3）包括一激发光源（321），在该激发光源（321）的输出光路上依次为入射光耦合器（322）、入射光纤（323）、光纤探头（324）、出射光纤（325）、出射光耦合器（326），直至光电检测器（4）；光源（321）发出的光经入射光耦合器（322）分束进入入射光纤（323），入射光纤（323）经试条检测带光纤探头和试条质控带光纤探头分别照射到试条卡（1）的试条（15）的检测带（27）和质控带（28）上以激发试条检测带（27）和质控带（28）的量子点反应信号物发出特征频率反射荧光，反射荧光分别经检测带光纤探头和质控带光纤探头、相应出射光纤（325）、出射光耦合器（326）后进入光电检测器（4）中被检测转换为电信号；光纤探头（324）采用合束共用结构，其中心为入射光纤（323），周缘为出射光纤（325）。
  58. 根据权利要求44或45所述的试条检测系统，其特征在于：所述电源为外接电源或为可拆换的电池。
  59. 一种如权利要求1、15、29、44或45所述的试条检测系统，其特征于：其中，所述试条（15）的吸水垫（24）的尾端还搭接有一试条反应终点指示标签（25），试条卡卡盒（16）在对应于试条反应终点指示标签（25）的位置处开有试条反应终点观察窗（30）。
  60. 根据权利要求59所述的试条检测系统，其特征在于：所述试条反应终点指示标签（25）为pH试纸。
  61. 根据权利要求59或60所述的试条检测系统，其特征在于：所述试条卡（1）的电子标签（20）包括RFID标签、非接触式识别的IC卡芯片。
  62. 根据权利要求59或60所述的试条检测系统，其特征在于：所述检测装置（2）的光学系统（3）的光源为发光二极管LED或激光二极管。
  63. 根据权利要求59或60所述的试条检测系统，其特征在于：所述检测装置（2）的光电检测器（4）为CCD、CMOS、光电倍增管、光电二极管、或光电三极管。
  64. 根据权利要求59或60所述的试条检测系统，其特征在于：所述检测装置（2）的数据处理装置（6）为具有相应数据处理和控制软件的微处理器、单片机、或PC机。
  65. 根据权利要求59或60所述的试条检测系统，其特征在于：所述检测装置（2）的输出显示装置（8）为字母数字LCD液晶屏、LED、声音装置、触摸显示屏或上位机。
  66. 根据权利要求59或60所述的试条检测系统，其特征在于：所述检测装置（2）上备留的多个可供临时外连的通讯接口（31）包括USB接口或RS-232接口。
  67. 根据权利要求59或60所述的试条检测系统，其特征在于：所述电子标签（20）存储的试条检测用信息包括同批次量子点免疫层析试条（15）定量样品被检物浓度用的标准工作曲线或系数参数、试条质控带光密度参考监控值（OD质控带’）、试条名称、试条批号、试条效期、电子标签密码、临床指标参考值、试条生产厂商信息，且可读入被测对象身份信息、检测者信息、样品名称、样品编号、检测日期、检测结果信息。
  68. 据权利要求67所述的试条检测系统，其特征在于：所述电子标签（20）存储的所述被检物标准工作曲线有多种形式可供选择，其包括下述曲线之一：
    被检物标准品系列浓度与OD检测带/OD质控带之间的对应关系曲线；或，
    被检物标准品系列浓度与OD检测带/（OD检测带+OD质控带）之间的对应关系曲线；或，
    被检物标准品系列浓度与OD检测带之间的对应关系曲线；
    所述OD检测带定义为被检物标准品系列浓度测得的检测带光密度值，OD质控带定义为被检物标准品系列浓度测得的质控带光密度值。
  69. 根据权利要求59或60所述的试条检测系统，其特征在于：插放到所述试条卡（1）内的试条（15）为一次性使用试条；用来插放试条（15）的试条卡（1）的卡盒（16）及卡盒（16）上安装的电子标签（20）为同批次试条相配套的使用品；所述检测装置（2）为持续通用品。
  70. 根据权利要求59或60所述的试条检测系统，其特征在于：其中所述检测装置（2）在整体上为便携式仪器、中/大型仪器、或为与具有相应发射和接收信息功能的无线通讯品的结合包括与移动电话、平板电脑、个人数字助理、移动终端设备或计算机集合中的挑选品的结合。
  71. 根据权利要求59或60所述的试条检测系统，其特征在于：其中，试条标记垫（22）所述的用于目标被检物检测相关分子标记的量子点包括ZnS、CdS、HgS、ZnSe、CdSe、HgSe、CdTe、ZnTe、ZnO、PbSe、HgTe、CaAs、InP、InAs、InCaAs、CdS/ZnS、CdS/Ag2S、CdS/PbS、CdS/Cd(0H)2、CdS/HgS、CdS/HgS/CdS、ZnS/CdS、ZnS/CdS/ZnS、ZnS/HgS/ZnS/CdS、CdSe/CdS、CdSe/ZnS、CdSe/ZnSe、CdSe/CuSe、CdSe/HgTe、CdSe/HgSe、CdSe/HgSe/CdSe、CdTe/HgS、CdTe/HgTe、InAs/InP、InAs/CdSe、InAs/ZnSe、MgS、MgSe、MgTe、CaS、CaSe、CaTe、SrS、SrSe、SeTe、BaS、BaSe、BaTe、CdS:Mn、ZnS:Mn、CdS:Cu、ZnS:Cu、CdS:Tb、ZnS:Tb中的任意一种或任意几种纳米粒子的组合，以及由上述任意一种量子点为核、二氧化硅为壳的核-壳型纳米复合粒子。
  72. 据权利要求59或60所述的试条检测系统，其特征在于：其中所述光学系统（3）的结构组成有多种方案可供选择，其包括：
    a) 所述光学系统（3）包括一照明系统和成像系统，照明系统包括一激发光源（311），在该光源（311）的输出光路上依次为光纤束（312）、准直照明透镜（313）、分色镜（314）、前镜组（315），直至试条卡（1）；成像系统包括共光轴的前镜组（315）、分色镜（314）、滤光片（316）、后镜组（317），分色镜（314）反射面与光轴夹角成45o角，前镜组（315）和后镜组（317）均采用分离结构，照明系统光路在分色镜（314）之前部分与成像系统的光轴相垂直，照明系统光路在分色镜（314）之后的部分与成像系统共光轴；光电检测器（4）位于后镜组（317）像面上；光纤束（312）将光源（311）发出的光分为具有一定间距且强度相同的激光束，该激光束由准直照明透镜（313）准直为平行光束入射到分色镜（314）表面，经分色镜（314）反射后通过前镜组（315）同步照射到位于前镜组（315）物面试条卡（1）的试条（15）的检测带（27）和质控带（28）上激发渗移到检测带（27）和质控带（28）的量子点反应信号物发出特征频率反射荧光，检测带（27）和质控带（28）反射荧光经同一前镜组（315）、透过分色镜（314）、滤光片（316）滤去杂光后出后镜组（317）进入光电检测器（4）中被检测转换为电信号；或，
    b) 所述光学系统（3）包括一激发光源（321），在该激发光源（321）的输出光路上依次为入射光耦合器（322）、入射光纤（323）、光纤探头（324）、出射光纤（325）、出射光耦合器（326），直至光电检测器（4）；光源（321）发出的光经入射光耦合器（322）分束进入入射光纤（323），入射光纤（323）经试条检测带光纤探头和试条质控带光纤探头分别照射到试条卡（1）的试条（15）的检测带（27）和质控带（28）上以激发试条检测带（27）和质控带（28）的量子点反应信号物发出特征频率反射荧光，反射荧光分别经检测带光纤探头和质控带光纤探头、相应出射光纤（325）、出射光耦合器（326）后进入光电检测器（4）中被检测转换为电信号；光纤探头（324）采用合束共用结构，其中心为入射光纤（323），周缘为出射光纤（325）。
  73. 根据权利要求59或60所述的试条检测系统，其特征在于：所述电源为外接电源或为可拆换的电池。
  74. 一种如权利要求1、15、29、44、45、59或60所述的试条检测系统，其特征于：其中，存储有试条（15）检测用信息的电子标签（20）安装在试条卡盒（16）内的试条（15）的任意处。
  75. 根据权利要求74所述的试条检测系统，其特征在于：所述试条卡（1）的电子标签（20）包括RFID标签、非接触式识别的IC卡芯片。
  76. 根据权利要求74所述的试条检测系统，其特征在于：所述检测装置（2）的光学系统（3）的光源为发光二极管LED或激光二极管。
  77. 根据权利要求74所述的试条检测系统，其特征在于：所述检测装置（2）的光电检测器（4）为CCD、CMOS、光电倍增管、光电二极管、或光电三极管。
  78. 根据权利要求74所述的试条检测系统，其特征在于：所述检测装置（2）的数据处理装置（6）为具有相应数据处理和控制软件的微处理器、单片机、或PC机。
  79. 根据权利要求74所述的试条检测系统，其特征在于：所述检测装置（2）的输出显示装置（8）为字母数字LCD液晶屏、LED、声音装置、触摸显示屏或上位机。
  80. 根据权利要求74所述的试条检测系统，其特征在于：所述检测装置（2）上备留的多个可供临时外连的通讯接口（31）包括USB接口或RS-232接口。
  81. 根据权利要求74所述的试条检测系统，其特征在于：所述电子标签（20）存储的试条检测用信息包括同批次量子点免疫层析试条（15）定量样品被检物浓度用的标准工作曲线或系数参数、试条质控带光密度参考监控值（OD质控带’）、试条名称、试条批号、试条效期、电子标签密码、临床指标参考值、试条生产厂商信息，且可读入被测对象身份信息、检测者信息、样品名称、样品编号、检测日期、检测结果信息。
  82. 据权利要求81所述的试条检测系统，其特征在于：所述电子标签（20）存储的所述被检物标准工作曲线有多种形式可供选择，其包括下述曲线之一：
    被检物标准品系列浓度与OD检测带/OD质控带之间的对应关系曲线；或，
    被检物标准品系列浓度与OD检测带/（OD检测带+OD质控带）之间的对应关系曲线；或，
    被检物标准品系列浓度与OD检测带之间的对应关系曲线；
    所述OD检测带定义为被检物标准品系列浓度测得的检测带光密度值，OD质控带定义为被检物标准品系列浓度测得的质控带光密度值。
  83. 根据权利要求74所述的试条检测系统，其特征在于：插放到所述试条卡（1）内的试条（15）为一次性使用试条；用来插放试条（15）的试条卡（1）卡盒（16）及检测装置（2）为持续通用品。
  84. 根据权利要求74所述的试条检测系统，其特征在于：其中所述检测装置（2）在整体上为便携式仪器、中/大型仪器、或为与具有相应发射和接收信息功能的无线通讯品的结合包括与移动电话、平板电脑、个人数字助理、移动终端设备或计算机集合中的挑选品的结合。
  85. 根据权利要求74所述的试条检测系统，其特征在于：其中，试条标记垫（22）所述的用于目标被检物检测相关分子标记的量子点包括ZnS、CdS、HgS、ZnSe、CdSe、HgSe、CdTe、ZnTe、ZnO、PbSe、HgTe、CaAs、InP、InAs、InCaAs、CdS/ZnS、CdS/Ag2S、CdS/PbS、CdS/Cd(0H)2、CdS/HgS、CdS/HgS/CdS、ZnS/CdS、ZnS/CdS/ZnS、ZnS/HgS/ZnS/CdS、CdSe/CdS、CdSe/ZnS、CdSe/ZnSe、CdSe/CuSe、CdSe/HgTe、CdSe/HgSe、CdSe/HgSe/CdSe、CdTe/HgS、CdTe/HgTe、InAs/InP、InAs/CdSe、InAs/ZnSe、MgS、MgSe、MgTe、CaS、CaSe、CaTe、SrS、SrSe、SeTe、BaS、BaSe、BaTe、CdS:Mn、ZnS:Mn、CdS:Cu、ZnS:Cu、CdS:Tb、ZnS:Tb中的任意一种或任意几种纳米粒子的组合，以及由上述任意一种量子点为核、二氧化硅为壳的核-壳型纳米复合粒子。
  86. 据权利要求74所述的试条检测系统，其特征在于：其中所述光学系统（3）的结构组成有多种方案可供选择，其包括：
    a) 所述光学系统（3）包括一照明系统和成像系统，照明系统包括一激发光源（311），在该光源（311）的输出光路上依次为光纤束（312）、准直照明透镜（313）、分色镜（314）、前镜组（315），直至试条卡（1）；成像系统包括共光轴的前镜组（315）、分色镜（314）、滤光片（316）、后镜组（317），分色镜（314）反射面与光轴夹角成45o角，前镜组（315）和后镜组（317）均采用分离结构，照明系统光路在分色镜（314）之前部分与成像系统的光轴相垂直，照明系统光路在分色镜（314）之后的部分与成像系统共光轴；光电检测器（4）位于后镜组（317）像面上；光纤束（312）将光源（311）发出的光分为具有一定间距且强度相同的激光束，该激光束由准直照明透镜（313）准直为平行光束入射到分色镜（314）表面，经分色镜（314）反射后通过前镜组（315）同步照射到位于前镜组（315）物面试条卡（1）的试条（15）的检测带（27）和质控带（28）上激发渗移到检测带（27）和质控带（28）的量子点反应信号物发出特征频率反射荧光，检测带（27）和质控带（28）反射荧光经同一前镜组（315）、透过分色镜（314）、滤光片（316）滤去杂光后出后镜组（317）进入光电检测器（4）中被检测转换为电信号；或，
    b) 所述光学系统（3）包括一激发光源（321），在该激发光源（321）的输出光路上依次为入射光耦合器（322）、入射光纤（323）、光纤探头（324）、出射光纤（325）、出射光耦合器（326），直至光电检测器（4）；光源（321）发出的光经入射光耦合器（322）分束进入入射光纤（323），入射光纤（323）经试条检测带光纤探头和试条质控带光纤探头分别照射到试条卡（1）的试条（15）的检测带（27）和质控带（28）上以激发试条检测带（27）和质控带（28）的量子点反应信号物发出特征频率反射荧光，反射荧光分别经检测带光纤探头和质控带光纤探头、相应出射光纤（325）、出射光耦合器（326）后进入光电检测器（4）中被检测转换为电信号；光纤探头（324）采用合束共用结构，其中心为入射光纤（323），周缘为出射光纤（325）。
  87. 根据权利要求74所述的试条检测系统，其特征在于：所述电源为外接电源或为可拆换的电池。
  88. 一种如权利要求1-87任一项所述的试条检测系统应用于生物医学检测领域中。
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