CN110596368A - Fluorescence immunoassay appearance - Google Patents
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- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
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- 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
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- G06K—GRAPHICAL DATA READING; PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
- G06K7/00—Methods or arrangements for sensing record carriers, e.g. for reading patterns
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- G06K7/14—Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation using light without selection of wavelength, e.g. sensing reflected white light
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Abstract
The invention provides a fluorescence immunoassay analyzer, which comprises an optical detection module, an electronic unit and a signal processing module, wherein the optical detection module comprises an optical unit and an electronic unit, the optical unit comprises an excitation light source and a receiver, a laser beam excited by the excitation light source irradiates on a test strip, the receiver is used for receiving a fluorescence signal excited by the test strip, the electronic unit adopts a light source modulation technology, and the fluorescence signal to be detected is filtered by a band-pass filter to obtain a data signal and is output; the data storage processing module is used for receiving the data signal output by the optical detection module and outputting detection data after storage processing; the display module is used for displaying the detection data output by the storage processing module or printing the detection data out; and the central control module is used for scheduling the optical detection module, the data storage processing module and the display module. By adopting a light source modulation technology, the detection signal is filtered by a corresponding band-pass filter to eliminate an interference signal, so that the immunofluorescence semi-quantitative detection is more sensitive and accurate.
Description
Technical Field
The invention relates to the technical field of medical inspection, in particular to a fluorescence immunoassay analyzer.
Background
The immunochromatography technology is a rapid, simple, sensitive, visual and cheap detection method which can really realize on-site detection. Has the advantages that a plurality of instrument detection methods such as gas chromatography, high performance liquid chromatography, gas chromatography-mass spectrometry, liquid chromatography-mass spectrometry, capillary electrophoresis and the like and other traditional methods can not reach. The method is of special importance in the field of detection, and is also a good complement of traditional detection and instrumental detection. Especially in the present days of high-speed economic development and improved living standard, the problems of serious human diseases, environmental pollution, food safety and the like are increasingly concerned, so that the immunochromatography detection technology has great potential and vigorous vitality. Compared with the rapid mature development of the fluorescence immunochromatographic technology, the development of the corresponding fluorescence rapid diagnosis immunochromatographic test paper detection instrument is lagged, mainly because the fluorescence detection is easily interfered by background light, and if the anti-interference technology is difficult to break through, the detection precision is difficult to improve.
Disclosure of Invention
The invention provides a fluorescence immunoassay analyzer, aiming at solving the problems of fluorescence immunoassay analyzers in the prior art.
In order to solve the above problems, the technical solution adopted by the present invention is as follows:
a fluorescence immunoassay analyzer comprising: the system comprises an optical detection module, a data storage processing module, a central control module and a display module; the optical detection module comprises an optical unit and an electronic unit, the optical unit comprises an excitation light source and a receiver, a laser beam excited by the excitation light source irradiates on the test strip, the receiver is used for receiving a fluorescence signal excited by the test strip, the electronic unit adopts a light source modulation technology, and the fluorescence signal to be detected is filtered through a band-pass filter to obtain a data signal and is output; the data storage processing module is used for receiving the data signal output by the optical detection module and outputting detection data after storage processing; the display module is used for displaying the detection data output by the storage processing module or printing and outputting the detection data; the central control module is used for scheduling the optical detection module, the data storage processing module and the display module.
Preferably, the excitation light source includes: the light-emitting diode is used for emitting the laser beam, and the high-transmittance narrow-band filter is used for conditioning the laser beam.
Preferably, the light emitting diode is an ultraviolet LED lamp.
Preferably, the receiver is an industrial camera comprising an undistorted lens provided with a narrow band light-acceptance filter.
Preferably, the data storage processing module comprises a dual-channel strip chamber for placing the strip to collect the fluorescent signal.
Preferably, the data storage processing module is internally provided with a print output unit.
Preferably, the system further comprises a two-dimensional code scanner for reading the information of the quality control card.
Preferably, a USB interface for transmitting data is further included.
Preferably, the display module is a touch liquid crystal display screen.
Preferably, the central control module is externally connected with a power adapter.
The invention has the beneficial effects that: the fluorescence immunoassay analyzer adopts a light source modulation technology, and a detection signal is filtered by a corresponding band-pass filter to eliminate an interference signal, so that immunofluorescence semi-quantitative detection is more sensitive and accurate.
Drawings
FIG. 1 is a schematic diagram of the operation of the fluorescence immunoassay analyzer according to the embodiment of the present invention.
FIG. 2 is a schematic view showing the structure of a fluorescence immunoassay analyzer according to an embodiment of the present invention.
The device comprises a light source module, a receiver module, a 3-PC (personal computer), an excitation light source module, a high-transmittance narrow-band filter and a light source module, wherein the light source module is 1-the excitation light source module, the receiver module is 2-the PC, the excitation light source module is 4-and the high-transmittance narrow-band; 6-an industrial camera; 7-narrow band light-receiving filter; 8-detection card; 9-a sample addition hole; 10-detection zone.
Detailed Description
In order to make the technical problems, technical solutions and advantageous effects to be solved by the embodiments of the present invention more clearly apparent, the present invention is further described in detail below with reference to the accompanying drawings and the embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be indirectly connected to the other element. The connection may be for fixation or for circuit connection.
It is to be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like are used in an orientation or positional relationship indicated in the drawings for convenience in describing the embodiments of the present invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed in a particular orientation, and be in any way limiting of the present invention.
Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the embodiments of the present invention, "a plurality" means two or more unless specifically limited otherwise.
Example 1
As shown in fig. 1 and 2, the present invention provides a fluorescence immunoassay analyzer comprising: the system comprises an optical detection module, a data storage processing module, a central control module and a display module; the optical detection module comprises an optical unit and an electronic unit, the optical unit comprises an excitation light source assembly 1 and a receiver assembly 2, the excitation light source assembly 1 is used for emitting an excitation light beam A to the test strip detection area 10, and the receiver assembly 2 is used for receiving fluorescence B reflected by the test strip. The laser beam excited by the excitation light source 4 irradiates on the test strip, the receiver is used for receiving a fluorescence signal excited by the test strip, the electronic unit adopts a light source modulation technology, and the fluorescence signal to be detected is filtered by a band-pass filter to obtain a data signal and is output; the data storage processing module is used for receiving the data signals output by the optical detection module and outputting detection data after storage processing; the display module is used for displaying the detection data output by the storage processing module or printing and outputting the detection data; and the central control module is used for scheduling the optical detection module, the data storage processing module and the display module.
The sample to be detected is added into the detection card 8 through the sample adding hole 9, and then the test paper strip in the detection area 10 is detected. The excitation light source includes: the light-emitting diode is used for emitting the laser beam, and the high-transmittance narrow-band filter 5 is used for conditioning the laser beam. The excitation light source is a light emitting diode. Further preferably, the light emitting diode is an ultraviolet LED lamp. The ultraviolet LED lamp has high light-emitting performance and high stability.
In one embodiment of the invention, the receiver is an industrial camera 6, the industrial camera 6 comprising an undistorted lens provided with a narrow band light-absorbing filter 7. The optical part adopts a light-emitting ultraviolet LED with high performance and high stability as an excitation light source, the ultraviolet LED irradiates a detection area of the test paper card after conditioning the light source through a high-light-transmission narrow-band filter, and the receiver is used for receiving a fluorescent signal reflected by the test paper strip and is matched with the narrow-band light-receiving filter, so that the discrimination of the fluorescent signal and a background signal is improved.
The data storage processing module comprises a two-channel test strip chamber, and the test two-channel test strip chamber is used for placing test strips to collect fluorescence signals. The data storage processing module is internally provided with a printing output unit which is a printer and can be used for printing a detection result by a user.
In another embodiment of the present invention, the fluorescence immunoassay analyzer further comprises a two-dimensional code scanner for reading the information of the quality control card, and the two-dimensional code scanner can be used for importing the standard parameters of the detection card.
The fluorescence immunoassay analyzer also comprises a USB interface for transmitting data, and the USB interface is connected with the display module and the data storage processing module. And transmitting the image signals acquired by the camera to a windows operating system through a USB (universal serial bus) to provide a driving program for data processing. The image signal is processed by a program driven by a windows operating system and then stored on a hard disk so as to ensure the speed and reliability of storing and inquiring a large amount of data results.
In another embodiment of the present invention, the display module is a touch liquid crystal display, and can be used for instruction input and data display. Touch liquid crystal display has guaranteed the clarity of demonstration result, has the touch-sensitive screen function simultaneously, and the user can control the instrument work to show the testing result, guaranteed the human-computer interaction and experienced, the user can be familiar with the use operation of instrument more rapidly.
In yet another embodiment of the present invention, the central control module is externally connected to a power adapter. The power adapter is used for providing power. Power supply voltage of power adapter: AV 220V (allowable error ± 10%), power supply frequency: 50-60 Hz.
The data storage processing module is internally provided with a printing output unit. The printout unit is a printer. The data storage processing module is externally connected with a scanning input unit. And the data storage processing module receives the fluorescent signal picture shot by the high-definition industrial camera 6, stores the fluorescent signal picture and transmits the fluorescent signal picture to the PC for data processing. The central control module is controlled by relying on a PC. The electronic part adopts a light source modulation technology to filter the detection signal through a corresponding band-pass filter so as to improve the precision; the data storage processing module stores the signal B acquired by the receiver and transmits the signal B to a PC for data processing, and the PC is provided with a standard windows operating system and a corresponding driving program and can finish the acquisition and processing of fluorescence data and store the fluorescence data on a hard disk; the central control module uses each function module depending on PC scheduling, so that each module can work normally, and data can be stably transmitted to the control PC through USB according to the appointed protocol.
The working temperature range of the fluorescence immunoassay analyzer is 5-40 ℃, the working temperature range of the fluorescence immunoassay analyzer is 20-28 ℃, the relative humidity of the fluorescence immunoassay analyzer is not more than 90%, the atmospheric pressure of the fluorescence immunoassay analyzer is 70-106 kPa, the fluorescence immunoassay analyzer is arranged on a dry and clean horizontal surface to avoid direct sunlight, strong electromagnetic fields, strong vibration, strong impact and strong corrosive gases do not exist, the fluorescence immunoassay analyzer does not need to work in an over-humid environment or an over-temperature difference environment, and enough space is reserved around the fluorescence immunoassay analyzer to guarantee air circulation.
As mentioned above, the fluorescence immunoassay analyzer is an immunofluorescence detection system based on the photoelectric detection principle, which is developed and designed on the basis of researching the action rule of monochromatic light of the fluorescence immunochromatography reagent strip, wherein fluorescent substances can generate fluorescence signals with stable light intensity under the excitation of an excitation light source, and semi-quantitative detection and analysis can be performed by detecting the amplitude of the fluorescence signals. Has the following beneficial effects:
(1) high performance: compared with the traditional colloidal gold and other modes, the dry type fluorescence immunochromatography detection principle has the characteristics of high detection limit, high sensitivity and the like. Therefore, the dry fluoroimmunoassay analyzer matched with the dry fluoroimmunoassay analyzer is required to have the characteristics of high stability, repeatability and wide detection range. According to the requirements, the deep consideration and review are carried out on the selection of the optical components and the selection of the electronic components, and the instrument can meet the performance requirements required by detection.
(2) And (3) fast: the single-channel detection is single and time-consuming, the improvement of the detection efficiency is considered at the beginning of the design of the instrument, a double-channel detection chamber is designed, and the detection efficiency is obviously improved.
(3) The operation is simple and easy: hospital instrument operators often need to operate and use different types of instruments of different companies at the same time, so that the functional design of the instruments needs to be ensured to meet the requirements of standardized instruments, and the operating habits and the use experiences need to be similar to those of other instruments. The dry type fluorescence immunoassay analyzer adopts software on a general Windows platform to control the analyzer, provides a good man-machine interaction mode, provides functions such as warning prompt and the like, and ensures that an operator can not operate mistakenly as quickly as possible in the using process.
Example 2
The invention provides a repeatability investigation of the fluorescence immunoassay analyzer. Repeated investigation is carried out by measuring the conformity degree of the quality inspection of the result of the same sample in parallel for several times.
The verification method comprises the following steps: 2 quality control cards with different fluorescence intensities are randomly selected, measurement is respectively repeated for 10 times to obtain a measurement result (T/C), and the coefficient of variation (CV,%) is calculated according to the following formula.
CV％＝α/μ×100％
In the formula: alpha is the standard deviation; n is 10, xiThe results of each measurement.
The fluorescent immunoassay of the invention meets the repeatability requirement after verification.
Example 3
The stability is represented by the maximum relative bias value obtained by measuring the detection result of the same sample for a plurality of times at certain time intervals. The stability of the detection of the instrument is mainly investigated.
The method comprises the following steps: the relative bias of the test results of the 4 th h and the 8 th h after the analyzer is started in the stable working state and the test results at the beginning of the stable working state is not more than +/-10%.
The verification method comprises the following steps: and after the analyzer is started for 5 minutes and is in a stable working state, randomly testing on a machine by using a quality control card adapted to the analyzer, repeating the test for 3 times, calculating the average value of the measurement result (T/C), repeating the test for 3 times after 4 hours and 8 hours, calculating the average value of the measurement result (T/C), and calculating the relative bias (a,%) according to the following formula by taking the first measurement result as a reference value.
Wherein,mean values of the 4 th and 8 th measured values;mean of the first measurements.
The fluorescence immunoassay analyzer meets the stability requirement through verification.
Example 4
The accuracy of the fluorescence immunoassay analyzer of the present invention was verified.
The method comprises the following steps: and (3) detecting by using a known negative and positive fluorescence quality control card, wherein the detection result of the fluorescence immunoassay analyzer is consistent with the result of the quality control card.
The verification method comprises the following steps: detecting by using a positive fluorescent quality control card, wherein the detection result is positive; and detecting by using a negative fluorescent quality control card, wherein the detection result is negative.
The fluorescence immunoassay analyzer of the invention meets the requirements.
Example 5
The noise of the fluorescence immunoassay analyzer of the present invention was verified.
The method comprises the following steps: the operating noise should be no more than 50db (a).
The verification method comprises the following steps: sound pressure levels in the front direction, the rear direction, the left direction and the right direction are respectively tested by a sound level meter (A weighting network) at a position 1m away from the analyzer and 1m away from the ground, and the maximum value is taken.
The present invention satisfies the above-mentioned requirements and exhibits a high industrial utilization value.
Example 6
The analyzer analyzes the concentration of an object to be detected by an industrial camera photographing and signal value light intensity principle, and the working process is as follows: the light emitted by the light source irradiates the test strip, the fluorescent substances on the T line and the C line on the test strip are excited to emit fluorescence, and other parts on the test strip have small attenuation effect on incident light. In an ideal situation, the luminescence spectrum has two peaks on the test strip; the spectral band, which reflects the detected fluorescence signal, should have two large peaks, which are otherwise level with the baseline.
Ideally, the slope of the baseline is 0. Calculating a C line peak integral value SC and a T line peak integral value ST by an area integration method, and setting the concentration of the object to be measured as C, the method comprises the following steps:
wherein the constant coefficient K can be obtained by experimental calibration.
In actual measurement, the detection system may be affected by various noises such that the baseline slope is not 0. The software algorithm of the fluorescence immunoassay analyzer adopts a method based on least square method to correct the base line and adopts a method based on wavelet transformation to remove noise. The method comprises the following basic steps:
(a) least squares method calibration baseline
Assuming that the value before fitting is denoted by x and the value after fitting is denoted by y, if x and y substantially satisfy a linear relationship, that is, y is ax + b, the sum of squares of errors between the fitted curve and the original curve is D (a, b), and (xi, yi) is n points on the original curve, then:
the method of solving the multivariate extreme value comprises the following steps:
solving the above system of linear equations with a and b to obtain:
(b) wavelet transform method for removing noise
A model of the signal containing noise is as follows:
s(t)＝f(t)+e(t)
where f (t) is the original signal, i.e. the signal desired to be obtained, e (t) is the noise signal, s (t) is the signal actually obtained, and the noise reduction process is to suppress the noise signal, i.e. strive to obtain f (t) from s (t). Denoising using wavelet transform, the most common method is threshold denoising. The basic idea is to process the coefficients with the modulus larger or smaller than a certain threshold value in each layer of coefficient after wavelet decomposition of the signal, and then to reconstruct the de-noised signal by inverse transformation. Generally, noise signals exist in details with high frequency coefficients, so that the decomposed wavelet coefficients are processed by a threshold method, and then the processed coefficients are used for reconstructing signals, so that the effects of suppressing noise and recovering useful signals can be achieved.
The foregoing is a more detailed description of the invention in connection with specific preferred embodiments and it is not intended that the invention be limited to these specific details. For those skilled in the art to which the invention pertains, several equivalent substitutions or obvious modifications can be made without departing from the spirit of the invention, and all the properties or uses are considered to be within the scope of the invention.
Claims (10)
1. A fluorescence immunoassay analyzer, comprising: the system comprises an optical detection module, a data storage processing module, a central control module and a display module;
the optical detection module comprises an optical unit and an electronic unit, the optical unit comprises an excitation light source and a receiver, a laser beam excited by the excitation light source irradiates on the test strip, the receiver is used for receiving a fluorescence signal excited by the test strip, the electronic unit adopts a light source modulation technology, and the fluorescence signal to be detected is filtered through a band-pass filter to obtain a data signal and is output;
the data storage processing module is used for receiving the data signal output by the optical detection module and outputting detection data after storage processing;
the display module is used for displaying the detection data output by the storage processing module or printing and outputting the detection data;
the central control module is used for scheduling the optical detection module, the data storage processing module and the display module.
2. The fluoroimmunoassay analyzer of claim 1, wherein the excitation light source comprises:
a light emitting diode for emitting the laser beam,
and the high-light-transmission narrow-band filter is used for conditioning the laser beam.
3. The fluoroimmunoassay analyzer of claim 2, wherein the light emitting diode is an ultraviolet LED lamp.
4. The fluoroimmunoassay analyzer of claim 1, wherein the receiver is an industrial camera comprising an undistorted lens provided with a narrow band light-receiving filter.
5. The fluoroimmunoassay analyzer of claim 1, wherein said data storage and processing module comprises a dual channel strip chamber for housing said strip for collecting fluorescent signals.
6. The fluoroimmunoassay analyzer of claim 1, wherein the data storage processing module has a print output unit built therein.
7. The fluoroimmunoassay analyzer of claim 1, further comprising a two-dimensional code scanner for reading the control card information.
8. The fluoroimmunoassay analyzer of claim 1, further comprising a USB interface for transmitting data.
9. The fluoroimmunoassay analyzer of claim 1, wherein the display module is a touch liquid crystal display.
10. The fluoroimmunoassay analyzer of claim 1, wherein the central control module is externally connected to a power adapter.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111077306A (en) * | 2019-12-30 | 2020-04-28 | 长沙协大生物科技有限公司 | Quantitative detection analyzer for fluorescence immunoassay reagent and detection method thereof |
| CN111190004A (en) * | 2020-01-10 | 2020-05-22 | 上海泰辉生物科技有限公司 | Instant detection system for immunochromatography test strip |
| CN111795959A (en) * | 2020-07-24 | 2020-10-20 | 芯动森林(重庆)医疗科技有限公司 | Colloidal gold and fluorescence two-in-one data acquisition device and method |
| CN113376384A (en) * | 2021-05-19 | 2021-09-10 | 棒糖科技(杭州)股份有限公司 | Method for calculating hormone concentration of fluorescent test paper |
| CN114092740A (en) * | 2021-11-11 | 2022-02-25 | 成都云芯医联科技有限公司 | AI-assisted analysis method for immune lateral flow sensing |
| CN114217055A (en) * | 2021-12-02 | 2022-03-22 | 极瞳生命科技(苏州)有限公司 | Portable fluorescence scanning detection device and method |
| CN116559421A (en) * | 2023-04-03 | 2023-08-08 | 杭州臻稀生物科技有限公司 | Automatic fluorescence immunoassay analyzer and analysis method |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110596368A (en) * | 2019-08-15 | 2019-12-20 | 深圳市亿立方生物技术有限公司 | Fluorescence immunoassay appearance |
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