CN109239338B - Wide-range immunochromatography detection device and method - Google Patents
Wide-range immunochromatography detection device and method Download PDFInfo
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- CN109239338B CN109239338B CN201811173069.9A CN201811173069A CN109239338B CN 109239338 B CN109239338 B CN 109239338B CN 201811173069 A CN201811173069 A CN 201811173069A CN 109239338 B CN109239338 B CN 109239338B
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Abstract
The invention relates to a wide-range immunochromatography detection device and a method, wherein the device comprises a shell, a measurement control circuit board, a display and a test rod, and is characterized in that: the front of the upper shell is respectively provided with a display window matched with the display, and the end part of the shell is provided with a sample inlet for inserting a test rod and communicating with the test strip; the test rod consists of a suction strip, an upper cover, a base, a high-concentration test strip and a low-concentration test strip, wherein the upper surface of the upper cover is provided with a detection window, a triangular light splitting protrusion is arranged in the detection window, and two test areas of the detection window are respectively a high-concentration test area and a low-concentration test area; the two test strips are respectively arranged below the left side and the right side of the triangular beam-splitting bulge and are positioned in the flowing direction of the tested liquid of the suction strip. The detection device expands the linear range of immunochromatography detection technology by adopting the method of setting two critical values for two test strips on the test rod by adopting the same light source.
Description
Technical Field
The invention relates to a wide-range immunochromatography detection device and a method.
Background
Immunochromatography (immunochromatography) is a rapid diagnostic technique that has been developed in recent years, and the diagnostic mechanism is: fixing a specific antibody (antigen) on a certain zone of a nitrocellulose membrane of a test strip; after one end of the dry nitrocellulose-containing membrane of the test strip is immersed in the liquid to be tested (urine or serum), the liquid sample to be tested permeates forward along the membrane due to capillary action; when the detected liquid permeates into the area solidified with the antibody (antigen), the corresponding antigen in the detected liquid is specifically combined with the antibody; if the immune colloidal gold or the immune enzyme is adopted for dyeing, the region can be made to display a certain color, thereby realizing specific immunodiagnosis.
In early household medical rapid diagnosis technology, a visual inspection method is generally adopted to judge the result of color detection of an immunochromatographic test strip. However, this determination is different from person to person, and the error is large; if the content of the detected object is very low, the color development is very light; or, when the content of the measured object is high and the color development is deep, the measured object is difficult to accurately judge by naked eyes, and a quantified result cannot be given. Therefore, misjudgment on the health condition of the user is caused, or the health condition and the development trend cannot be accurately tracked and judged, so that misdiagnosis is caused. Therefore, a device capable of accurately reading the detection result of the immunochromatographic test strip in a wide range and with high precision is particularly required.
The invention patent ZL200910214016.1 discloses a method and a system for intelligently identifying and reading immunochromatographic test strips and application thereof. The patent realizes quantitative reading of the detection result of the immunochromatographic test strip. However, the above also has the following problems: 1. the operation steps are complex, the test strip is separated from the reading device, and the developed test strip is required to be manually placed into the reading device for reading; therefore, the test strips of different objects to be tested are easily confused. 2. The detection light of the detection area and the detection light of the control area of the test strip are easy to interfere with each other, and the reading result is unreliable.
Chinese patent No. ZL200810060585.0 discloses an optical analysis reading device. In the patent, each test strip adopts a light source to irradiate the test strip. Therefore, the three test strips respectively adopt the light sources of the three corresponding test strips. Namely: the 3 leds detect the strips in the first, second and third areas respectively, but the device contains only one photodetector which can receive reflected light from the three strips (three areas). Although, the patent can realize quantitative reading of the detection result of the immunochromatographic test strip; however, the above patent also has the following problems: 1. a light source composed of three different light emitting diodes, the reference and the characteristics of the work of which are discrete; in order to solve the problems, diode light sources with the same physical characteristics can be selected only through strict device screening so as to achieve the aim of controlling the device characteristics to be relatively close; however, screening of such devices increases production costs. 2. Even though the three leds are more or less discretely biased by device screening, stability and accuracy of the test results are affected. 3. The linear detection range of a single immunochromatographic test strip at a critical value is very limited.
The invention patent ZL201410040407.7 discloses an immunochromatography detection device and an immunochromatography detection method. The detection device of the patent adopts a light-transmitting immunochromatography test strip. The test mechanism of the patent is: and detecting the detection area and the control area from the upper surface and the lower surface of the test strip by utilizing the perspective of the reaction marker on the nitrocellulose membrane, wherein the light path cavity of the detection area and the light path cavity of the control area are mutually independent. The method is characterized in that: mutual interference between detection light of the detection area and detection light of the control area is isolated, and reliability of detection results is enhanced. However, due to limitations of the operating mechanism of the immunochromatographic test strip, one test strip can only set a critical value, and the linear range of the detection accuracy is very limited around the critical value. If the critical value is set to be higher, the detection accuracy of the low concentration end is greatly affected; if the critical value is set to be lower, the detection accuracy of the high concentration end is greatly affected. In addition, the detection device and the test strip are designed into a disposable integrated structure, so that the use cost is high.
Disclosure of Invention
One of the objects of the present invention is to solve the above-mentioned drawbacks and to provide a wide-range immunochromatography detection apparatus.
The second object of the present invention is to provide a detection method of a wide-range immunochromatography detection apparatus.
One of the purposes of the invention is realized in such a way that the immunochromatography detection device with wide range and the test rod thereof comprise a shell, a measurement control circuit board, a display and the test rod, wherein the display is arranged on the measurement control circuit board; the method is characterized in that: the front surface of the shell is respectively provided with a display window matched with the display; the test rod consists of a suction strip, an upper cover, a base, a high-concentration test strip and a low-concentration test strip, wherein the concentration marks of the high-concentration test strip and the low-concentration test strip are different, a detection window is arranged on the upper surface of the upper cover, a triangular light splitting protrusion is arranged in the detection window, and the detection window is divided into two test areas, namely a high-concentration test area and a low-concentration test area; one end of the test rod is provided with a sample injection end for inserting a suction sample strip and communicating with the test strip; the two test strips are respectively arranged below the left side and the right side of the triangular beam splitting protrusion and are positioned in the flowing direction of the tested liquid of the suction strip.
The measuring control circuit board comprises a light source, two light detectors and a microcontroller circuit; the light sources respectively enter detection areas of the two test strips through the triangular light splitting protrusions; the light detector is located in two areas capable of receiving reflected light after detection by the test strip.
The light source is an LED.
The measurement control circuit board also comprises a photomask for preventing the mutual interference of optical path signals.
The detection area is arranged on the same surface of the two test strips.
The light detectors are respectively arranged at the left side and the right side of the light source, and the two detection areas are mutually independent due to the triangular light splitting protrusions and the light cover.
The light source and the light detector on the measurement control circuit board are arranged on a straight line, the light source is positioned between the two light detectors, the light source, the light cover and the light detector are opposite to the detection window of the test rod, and the tip of the triangular light splitting protrusion on the test rod is vertically aligned with the center of the light source of the measurement control circuit board.
The second object of the present invention is thus achieved, a wide-range immunochromatography detection method, characterized in that: the method comprises the following steps:
(1) Inserting the test rod into a detection device of wide-range immunochromatography;
(2) Starting a detection device;
(3) The liquid to be tested is contacted with the suction strip of the test rod, so that the liquid to be tested flows onto the test strip through the suction strip, and the detection device starts to detect;
(4) The two light detectors detect light reflected from the detection window and convert the light into an electric signal, and the electric signal is transmitted to the microcontroller to judge the validity of the detection result;
(5) The microcontroller receives the current signal, performs conversion processing analysis, and displays the processing analysis result through the liquid crystal display screen;
(6) The used test stick is ejected and the next test is waited.
The invention has the advantages that: (1) The two detection areas are respectively arranged on the same surface of the two test strips, and the two photodetectors are respectively arranged on two sides of the light source, so that the three detection areas are arranged in a straight line; thus, the angle of 90 degrees is formed between the flow direction of the sample injection liquid to be measured, and the light detector can completely receive the incident light of the same light source. (2) The same light source is adopted, so that the linear range and the linearity of the immunochromatography detection technology are expanded for the detection method of two critical values set by two test strips on the test rod; thus, the effective detection range is enlarged, and therefore, the detection accuracy of the detection result is increased; and the operation is simple, and the display result is quantized and visual. (3) The test window adopts a triangle light splitting protrusion and a photomask for use, so that the light path cavities of the two detection areas are mutually independent, and mutual interference is avoided.
Description of the drawings:
fig. 1 is: the invention relates to a linear graph of critical values corresponding to two test strips with high concentration and low concentration.
Fig. 2 is: explosion diagram of the present invention.
Fig. 3 is: the invention is a cross-sectional view.
Detailed Description
The working mechanism of the wide-range immunochromatography detection device is as follows: the linear range of the critical value can be effectively butted by adjusting the spraying amount and the concentration of the generated specific reaction antibody (antigen) on the nitrocellulose membrane of the test strip. As shown in fig. 1, if the low limit value of the linearity of the high concentration test strip is a, the high limit value is B; the low limit value of the linearity of the low-concentration test strip is D, and the high limit value is C; the linear high limit value C of the low concentration test strip is close to the linear low limit value A of the high concentration test strip by adjusting the concentration and the spraying amount of the two test strips. Therefore, the DtoC linear range of the low-concentration test strip and the AtoB linear range of the high-concentration test strip are combined and expanded to the DtoB linear range, and the detection accuracy of the full range is improved.
For a further understanding and appreciation of the structural features and advantages achieved by the present invention, reference should be made to the following detailed description taken in conjunction with the accompanying drawings, which are presently preferred embodiments of the present invention:
as shown in fig. 2 and 3, the wide-range immunochromatography detection apparatus of the present invention includes a housing 1, a measurement control circuit board 2, a display 3, and a test stick 4, the housing 1 being constituted by an upper housing 11 and a lower housing 12. The display 3 is arranged on the measurement control circuit board 3 and is matched with a display window 13 on the surface of the upper shell 11; the side of the shell 1 is provided with a sample inlet 14 for inserting the test rod 4.
The test rod 4 is composed of an upper cover 41, a base 42, a high-concentration test strip 43, a low-concentration test strip 44 and a suction strip 40, the upper cover 41 is provided with a test window 411, and a triangular light splitting protrusion 412 is arranged in the middle of the test window 411 and is used for providing the same light source 21 for the high-concentration test strip 43 and the low-concentration test strip 44; one end of the sample sucking strip 40 is inserted through the sample inlet and then contacts with the high-concentration test strip 43 and the low-concentration test strip 44 in the test rod 4, and the other end of the sample sucking strip is left outside the test rod 4. When in detection, the triangular beam splitting protrusion 412 has the function of dividing the light path into two parts, so that the high-concentration test strip 43 and the low-concentration test strip are respectively positioned on two independent light paths, thereby ensuring comparability and referenceability of detection results of the same light source and reducing invalid test results caused by signal source differences of different light sources; and the mutual interference between the detection lights of the two test strip detection areas is avoided.
The measurement control circuit board 2 is composed of a light source 21, two light detectors 22 and a microcontroller circuit, wherein the light source 21 is an LED semiconductor diode, the LED semiconductor diode is arranged in the middle of a detection window, and the two light detectors are arranged on two sides of the light source 21.
In use, the outer end of the strip 40 is immersed in the liquid to be tested so that the liquid sample flows along the strip onto the high concentration strip 43 and the low concentration strip 44, respectively. The light source 21 irradiates the high concentration test strip 43 and the low concentration test strip 44 respectively, and then reflects the light onto the two photodetectors 22. The photoelectric conversion of the photodetector 22 is performed, and the measurement control circuit 2 receives the current signal, performs conversion processing analysis, determines the validity of sample detection, and displays the processing analysis result on the liquid crystal display 2, wherein the processing analysis result may be a quantitative analysis result or a qualitative analysis result.
The invention relates to a wide-range immunochromatography detection method, which comprises the following steps of:
(1) Inserting the test rod 4 into a sample inlet 14 of a detection device of wide-range immunochromatography;
(2) Opening a starting switch and starting the detection device;
(3) Contacting the suction bar 40 of the test bar 4 with the tested liquid for 5-15 seconds; allowing the tested liquid to flow onto the high-concentration test strip 43 and the low-concentration test strip 44 through the suction strip 40 respectively;
(4) Firstly, the light source irradiates the detection areas of the high-concentration test strip 43 and the low-concentration test strip 44 and then reflects the light to the respective detection devices; secondly, respectively carrying out photoelectric conversion on the two detection devices; thirdly, respectively transmitting the two electric signals to a measurement control board 2, and judging the effectiveness of sample detection; fourthly, the microcontroller on the measurement control board 2 receives the current signal, performs conversion processing and analysis, and displays the processing analysis result through a liquid crystal display screen;
(5) The used test stick is ejected and the next test is waited.
Because the detection device adopts the same light source, two test strips marked with the same antibody (antigen) but with different concentrations on the test rod are tested. The test strip expands the linear range of immunochromatography detection technology by adopting a method of setting two critical values. The test method not only expands the effective detection range, but also improves the test precision. The application of the same light source also makes the reference standard of two-section linear detection unified, thereby reducing the deviation of the detection result, enhancing the accuracy and reliability of the detection result, and overcoming the limitation that the detection of the conventional immunochromatography test strip cannot provide a more accurate detection result when the concentration of the detected liquid sample is far away from the critical value. The defects of unstable/uncertain detection results caused by reference deviation and linearity deviation among different light sources in the conventional application are avoided.
Claims (7)
1. The immunochromatography detection device with wide range comprises a shell (1), a measurement control circuit board (2), a display (3) and a test rod (4), wherein the shell (1) consists of an upper shell (11) and a lower shell (12), and the display (3) is arranged on the measurement control circuit board (2); the method is characterized in that: the front of the upper shell (11) is respectively provided with a display window (13) matched with the display (3), and the end part of the shell (1) is provided with a sample inlet (14) for communicating the test rod (4) with the test strip; the test rod (4) is composed of a suction strip (40), an upper cover (41), a base (42), a high-concentration test strip (43) and a low-concentration test strip (44), the concentration marks of the high-concentration test strip (43) and the low-concentration test strip (44) are different, a detection window (411) is arranged on the upper surface of the upper cover (41), and triangular light splitting protrusions (412) are arranged in the detection window (411), so that two test areas of the detection window (411) are respectively a high-concentration test area and a low-concentration test area; the two test strips are respectively arranged below the left side and the right side of the triangular light splitting bulge (412) and are positioned in the flowing direction of the tested liquid of the suction strip;
the measurement control circuit board (2) comprises a light source (21), two light detectors (22) and a microcontroller circuit; the light source (21) is incident to detection areas on two test strips through a triangular light splitting protrusion (412); the light detectors (22) are respectively positioned at two reflected light areas which can accept the detection of the test paper strips;
setting the low limit value of the linearity of the high-concentration test strip as A and the high limit value as B; the low limit value of the linearity of the low-concentration test strip is D, and the high limit value is C; the linear high limit value C of the low concentration test strip is close to the linear low limit value A of the high concentration test strip by adjusting the concentration and the spraying amount of the antibody or antigen of the specific reaction of the two test strips;
the triangular light splitting protrusion (412) has the function of dividing the light path into two parts, so that the high-concentration test strip (43) and the low-concentration test strip are respectively positioned on two independent light paths and are used for providing the same light source for the high-concentration test strip and the low-concentration test strip.
2. The wide-range immunochromatographic detection device according to claim 1, wherein: the light source (21) is an LED.
3. The wide-range immunochromatographic detection device according to claim 1, wherein: the measurement control circuit board (2) further comprises a photomask (23) for preventing the optical path signals from interfering with each other.
4. The wide-range immunochromatographic detection device according to claim 1, wherein: the detection area is arranged on the same surface of the two test strips.
5. The wide-range immunochromatographic detection device according to claim 1, wherein: the photodetectors (22) are respectively arranged at the left side and the right side of the light source (21), and the two detection areas are mutually independent due to the action of the triangular light splitting protrusions (412).
6. The wide-range immunochromatographic detection device according to claim 1, wherein: the light source (21) and the light detector (22) on the measurement control circuit board (2) are arranged on a straight line, the light source (21) is positioned between the two light detectors (22), the light source (21), the photomask (23) and the light detector (22) are opposite to the detection window (411) of the test rod (4), and the tip of the triangular light splitting protrusion (412) on the test rod is vertically aligned with the center of the light source (21) of the measurement control circuit board (2).
7. A method of detecting a wide-range immunochromatographic detection device according to any one of claims 1 to 6, comprising the steps of:
(1) Inserting the test rod into a high-precision wide-range immunochromatography detection device;
(2) Starting a detection device;
(3) The liquid to be tested is contacted with the suction strip of the test rod, so that the liquid to be tested flows onto the test strip through the suction strip, and the detection device starts to detect;
(4) The same light source irradiates 2 test strips with different concentrations on two sides respectively, and the light reflected by the two light detectors from the detection window is converted into an electric signal and transmitted to the microcontroller to judge the validity of the detection result;
(5) The microcontroller receives the current signal, performs conversion processing analysis, and displays the processing analysis result through the liquid crystal display screen;
(6) The used test stick is ejected and the next test is waited.
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