Immunochromatography analyzer

Abstract

The utility model provides an immunochromatography analyzer, which relates to the technical field of immunochromatography analysis and comprises a test strip and a photoelectric detection device mounted corresponding to the test strip, the test strip adopts blue latex particles as an indicator, and is provided with a quality control line, a test line and a blank part; the photoelectric detection device comprises an orange light source and a cyan light source, and the orange light source and the cyan light source are both used for irradiating the quality control line, the test line and the blank part. According to the immunochromatography analyzer provided by the utility model, the blue latex particles are used as an indicator to develop blue after a sample is added, so that not only can the color development influence of the wetting degree be eliminated according to the color development condition of a blank part, but also the test can be carried out under cyan and orange light conditions respectively, so that the influence of blood color can be eliminated; and the detection accuracy is improved.

Description

Technical Field

[0001] This utility model relates to the field of immunochromatographic analysis technology, and in particular to an immunochromatographic analyzer. Background Technology

[0002] Colloidal gold immunochromatographic analyzers, as a rapid and convenient diagnostic tool, are widely used in clinical testing and point-of-care testing (POCT). These devices typically utilize burgundy colloidal gold to label antibodies or antigens, using capillary action to move the sample on a solid-phase carrier, thereby achieving qualitative or semi-quantitative detection of the target substance. Specifically, when the sample is added to the sample pad, it sequentially passes through the conjugate pad, the test line (T line) on the nitrocellulose membrane, and the control line (C line), finally reaching the absorbent paper. During this process, if the sample contains the analyte, it will bind to the colloidal gold label on the conjugate pad to form a complex, which will then diffuse forward to the T line for deposition and color development. Regardless of whether the sample contains the analyte, it will continue to the C line and develop color, thus verifying the validity of the test process.

[0003] However, in practical applications, the use of burgundy colloidal gold as the marker results in burgundy colors for both the control and test lines. While this design simplifies the process, it also introduces several problems. Firstly, the varying shades of blood in different samples can interfere with the development of the control and test lines, especially in cases of darker blood, potentially obscuring color changes and making accurate interpretation difficult. Secondly, differences in sample wettability also affect the color development. For example, excessive sample volume or rapid diffusion can lead to overly dark or indistinct lines; conversely, insufficient sample or slow flow can result in pale colors or even failure to form lines, thus impacting the final test accuracy. Utility Model Content

[0004] The purpose of this invention is to provide an immunochromatographic analyzer to alleviate the technical problem that the test results of the immunochromatographic analyzer are affected by blood color and wettability, leading to deviations in the test results.

[0005] In a first aspect, the immunochromatographic analyzer provided by this utility model includes: a test strip and a photoelectric detection device installed corresponding to the test strip;

[0006] The test strip uses blue latex particles as an indicator and has a control line, a test line, and a blank section.

[0007] The photoelectric detection device includes an orange light source and a cyan light source, both of which are used to illuminate the control line, the test line, and the blank area.

[0008] In conjunction with the first aspect, this utility model provides a first possible implementation of the first aspect, wherein the orange light source includes: a first orange LED, a second orange LED, and a third orange LED, wherein the first orange LED, the second orange LED, and the third orange LED are spaced apart and correspond one-to-one with the quality control line, the test line, and the blank portion.

[0009] In conjunction with the first aspect, this utility model provides a second possible implementation of the first aspect, wherein the cyan light source includes: a first cyan LED, a second cyan LED, and a third cyan LED, wherein the first cyan LED, the second cyan LED, and the third cyan LED are spaced apart and correspond one-to-one with the quality control line, the test line, and the blank area.

[0010] In conjunction with the first aspect, this utility model provides a third possible implementation of the first aspect, wherein the immunochromatographic analyzer further includes a photosensitive device, the photosensitive device being used to detect the reflectance of the control line, the test line, and the blank portion.

[0011] In conjunction with the third possible implementation of the first aspect, this utility model provides a fourth possible implementation of the first aspect, wherein the photosensitive device includes: a first photosensitive sensor, a second photosensitive sensor and a third photosensitive sensor, wherein the first photosensitive sensor, the second photosensitive sensor and the third photosensitive sensor are arranged at intervals and correspond one-to-one with the quality control line, the test line and the blank portion.

[0012] In conjunction with the first aspect, this utility model provides a fifth possible implementation of the first aspect, wherein the test strip includes: a base plate, a sample application pad, a nitrocellulose membrane, a conjugate pad, and an absorbent element;

[0013] The sample application pad and the nitrocellulose membrane are respectively attached to the base plate, and the sample application pad is bonded to the nitrocellulose membrane. The sample application pad and the nitrocellulose membrane are respectively connected to the binding pad.

[0014] The absorbent element is attached to one end of the nitrocellulose membrane away from the sample pad, and the nitrocellulose membrane is provided with the quality control line, the test line and the blank area.

[0015] In conjunction with the first aspect, this utility model provides a sixth possible implementation of the first aspect, wherein the wavelength of the orange light source is 590nm to 625nm, and the wavelength of the cyan light source is 485nm to 500nm.

[0016] Secondly, the detection and analysis method provided by this utility model is applied to the immunochromatographic analyzer described in the first aspect, and includes the following steps:

[0017] Control the orange light source to illuminate, and obtain the photosensitive signal values ​​of the quality control line, the test line, and the blank area under orange illumination conditions respectively;

[0018] Control the cyan light source to be lit, and obtain the photosensitive signal values ​​of the quality control line, the test line and the blank area under cyan light illumination conditions respectively;

[0019] To eliminate the influence of wetting degree on the photosensitive signal values ​​of the control line and the test line;

[0020] To remove the influence of red contamination on the photosensitive signal values ​​of the control line and the test line.

[0021] In conjunction with the second aspect, this utility model provides a first possible implementation of the second aspect, wherein the step of removing the influence of the degree of wetting on the photosensitive signal values ​​of the control line and the test line includes:

[0022] According to formula T' 青 =T 青 -B 青 、T' 橙 =T 橙 -B 橙 Calculate the cyan signal value T of the test line after removing the wetting effect. ＇ 青 and the orange signal value T of the test line ＇ 橙 , among which, T 青 B represents the photosensitive signal value of the test line under cyan light illumination. 青 T represents the photosensitive signal value of the blank area under cyan light illumination. 橙 B represents the photosensitive signal value of the test line under orange illumination. 橙 The photosensitive signal value of the blank area under orange illumination;

[0023] According to formula C ＇ 青 =C 青 -B 青 And formula C ＇ 橙 =C 橙 -B 橙 Calculate the cyan signal value C of the quality control line after removing the wetting effect. ＇ 青 And the orange signal value C of the quality control line ＇ 橙 , where C 青 C represents the photosensitive signal value of the control line under cyan illumination.橙 The photosensitive signal value of the quality control line under orange illumination.

[0024] In conjunction with the first possible implementation of the second aspect, this utility model provides a second possible implementation of the second aspect, wherein the step of removing the influence of red contamination on the photosensitive signal values ​​of the control line and the test line includes:

[0025] According to the formula T = T' 青 -T' 橙 ·a·b and the formula C=C' 青 -C' 橙 ·a·b, calculate the test line signal value T and the quality control line signal value C, where a is the ratio of cyan response efficiency to orange response efficiency in the photoelectric characteristics of the photosensitive device, and b is the ratio of the light intensity of the cyan light source to the light intensity of the orange light source.

[0026] This utility model embodiment brings the following beneficial effects: It employs test strips and corresponding photoelectric detection devices. The test strips use blue latex particles as indicators and have control lines, test lines, and blank areas. The photoelectric detection device includes an orange light source and a cyan light source, both used to illuminate the control lines, test lines, and blank areas. Using blue latex particles as indicators allows the control lines and test lines to turn blue after sample addition. This not only eliminates the color influence of moisture levels based on the reflection of the blank area but also allows for testing under cyan and orange light conditions, providing analytical basis for removing the influence of blood color.

[0027] To make the above-mentioned objectives, features and advantages of this utility model more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0028] To more clearly illustrate the technical solutions in the specific embodiments or related technologies of this utility model, the drawings used in the description of the specific embodiments or related technologies will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0029] Figure 1 A schematic diagram of the test strip for the immunochromatographic analyzer provided in this embodiment of the present invention;

[0030] Figure 2 A schematic diagram of an immunochromatographic analyzer provided in an embodiment of this utility model.

[0031] Icons: 100 - Test strip; 101 - Control line; 102 - Test line; 103 - Blank section; 110 - Base plate; 120 - Sample application pad; 130 - Nitrocellulose membrane; 140 - Conjugate pad; 150 - Absorbent element; 200 - Photoelectric detection device; 210 - Orange light source; 211 - First orange LED; 212 - Second orange LED; 213 - Third orange LED; 220 - Cyan light source; 221 - First cyan LED; 222 - Second cyan LED; 223 - Third cyan LED; 230 - Photosensitive device; 231 - First photosensitive sensor; 232 - Second photosensitive sensor; 233 - Third photosensitive sensor. Detailed Implementation

[0032] The technical solution of this utility model will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this utility model. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model.

[0033] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on this utility model. Furthermore, the terms "first," "second," and "third" are only used to describe differences in name and should not be construed as indicating or implying relative importance. Physical quantities in formulas, unless otherwise specified, should be understood as basic quantities of the International System of Units (SI) base units, or derived quantities derived from basic quantities through mathematical operations such as multiplication, division, differentiation, or integration.

[0034] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0035] like Figure 1 and Figure 2As shown, the immunochromatographic analyzer provided in this embodiment of the present invention includes: a test strip 100 and a photoelectric detection device 200 installed on the corresponding test strip 100; the test strip 100 uses blue latex particles as an indicator and has a control line 101, a test line 102 and a blank area 103; the photoelectric detection device 200 includes: an orange light source 210 and a cyan light source 220, both of which are used to irradiate the control line 101, the test line 102 and the blank area 103.

[0036] The quality control line 101 and the test line 102 turn blue after the sample is added. By comparing the reflectance of the blank area 103 after wetting, the influence of wetting degree on color development can be eliminated. The detection is carried out under the illumination conditions of orange light source 210 and cyan light source 220, respectively. This can provide an analytical basis for removing the influence of blood color, which is conducive to improving the detection accuracy.

[0037] In this embodiment of the present invention, the orange light source 210 includes a first orange LED 211, a second orange LED 212, and a third orange LED 213. The first orange LED 211, the second orange LED 212, and the third orange LED 213 are spaced apart and correspond one-to-one with the quality control line 101, the test line 102, and the blank part 103. The first orange LED 211, the second orange LED 212, and the third orange LED 213 are all of the same type of LED to ensure that the quality control line 101, the test line 102, and the blank part 103 receive consistent orange illumination when illuminated by orange light.

[0038] Furthermore, the cyan light source 220 includes a first cyan LED 221, a second cyan LED 222, and a third cyan LED 223. These three LEDs are spaced apart and correspond one-to-one with the control line 101, the test line 102, and the blank area 103. The first cyan LED 221, the second cyan LED 222, and the third cyan LED 223 are all of the same type to ensure that the control line 101, the test line 102, and the blank area 103 receive consistent cyan illumination under orange light.

[0039] In an optional embodiment, the orange light source 210 and the cyan light source 220 may also employ uniform light-diffusing devices to ensure uniform brightness when illuminating the control line 101, the test line 102, and the blank area 103.

[0040] Furthermore, the immunochromatographic analyzer also includes a photosensitive device 230, which is used to detect the reflectance of the control line 101, the test line 102, and the blank area 103.

[0041] The photosensitive device 230 includes a first photosensitive sensor 231, a second photosensitive sensor 232, and a third photosensitive sensor 233. The first photosensitive sensor 231, the second photosensitive sensor 232, and the third photosensitive sensor 233 are arranged at intervals and correspond one-to-one with the quality control line 101, the test line 102, and the blank area 103.

[0042] It should be noted that the first photosensitive sensor 231 is located between the first orange LED 211 and the first cyan LED 221, the second photosensitive sensor 232 is located between the second orange LED 212 and the second cyan LED 222, and the third photosensitive sensor 233 is located between the third orange LED 213 and the third cyan LED 223. The first photosensitive sensor 231, the second photosensitive sensor 232, and the third photosensitive sensor 233 are used one-to-one to detect the reflectivity of the quality control line 101, the test line 102, and the blank area 103 under orange or cyan light conditions.

[0043] In this embodiment, the test strip 100 includes: a base plate 110, a sample application pad 120, a nitrocellulose membrane 130, and an absorbent 150; the sample application pad 120 and the nitrocellulose membrane 130 are respectively attached to the base plate 110, and the sample application pad 120 is joined to the nitrocellulose membrane 130; the absorbent 150 is attached to one end of the nitrocellulose membrane 130 away from the sample application pad 120, and the nitrocellulose membrane 130 is provided with a quality control line 101, a test line 102, and a blank area 103.

[0044] In addition, the test strip 100 also includes a conjugate pad 140, a sample application pad 120 and a nitrocellulose membrane 130 respectively connected to the conjugate pad 140, and the sample application pad 120 and the nitrocellulose membrane 130 are connected through the conjugate pad 140, so that the sample application pad 120 and the nitrocellulose membrane 130 are firmly bonded.

[0045] During testing, the reagent is dropped onto the sample pad 120. The reagent seeps into the sample pad 120 and permeates into the nitrocellulose membrane 130. Excess reagent is eventually absorbed by the absorbent component 150.

[0046] In this embodiment, the wavelength of the orange light source 210 is 590nm to 625nm, and the wavelength of the cyan light source 220 is 485nm to 500nm.

[0047] like Figure 1 and Figure 2 As shown, the detection and analysis method provided in this embodiment of the present invention is applied to the immunochromatographic analyzer described in the above embodiments, and includes the following steps:

[0048] Control the orange light source 210 to light up, and obtain the photosensitive signal values ​​of the quality control line 101, test line 102 and blank part 103 under orange light conditions respectively;

[0049] Control the cyan light source 220 to be lit, and obtain the photosensitive signal values ​​of the quality control line 101, test line 102 and blank part 103 under cyan light illumination.

[0050] The influence of wetting degree on the photosensitive signal values ​​of control line 101 and test line 102 was eliminated;

[0051] To remove the influence of red contamination on the photosensitive signal values ​​of control line 101 and test line 102.

[0052] During testing, the orange light source 210 is first turned on, and the photosensitive signal values ​​of the control line 101, test line 102 and blank area 103 are obtained under orange light illumination; then, the orange light source 210 is turned off and the cyan light source 220 is turned on, and the photosensitive signal values ​​of the control line 101, test line 102 and blank area 103 are obtained under cyan light illumination.

[0053] In this embodiment of the invention, the step of removing the influence of wetting degree on the photosensitive signal values ​​of the control line 101 and the test line 102 includes:

[0054] According to formula T' 青 =T 青 -B 青 、T' 橙 =T 橙 -B 橙 Calculate the cyan signal value T of the test line after removing the wetting effect. ＇ 青 and the orange signal value T of the test line ＇ 橙 , among which, T 青 B represents the photosensitive signal value of test line 102 under cyan light illumination. 青 T represents the photosensitive signal value of blank region 103 under cyan light illumination. 橙 B represents the photosensitive signal value of test line 102 under orange illumination. 橙 The photosensitive signal value of blank area 103 under orange light illumination;

[0055] According to formula C ＇ 青 =C 青 -B 青 And formula C ＇ 橙 =C 橙 -B 橙 Calculate the cyan signal value C of the quality control line after removing the wetting effect. ＇ 青 And the orange signal value C of the quality control line ＇ 橙 , where C 青 C represents the photosensitive signal value of control line 101 under cyan light illumination. 橙The photosensitive signal value of quality control line 101 under orange light conditions.

[0056] Furthermore, the steps to remove the influence of red contamination on the photosensitive signal values ​​of control line 101 and test line 102 include:

[0057] According to the formula T = T' 青 -T' 橙 ·a·b and the formula C=C' 青 -C' 橙 ·a·b, calculate the test line signal value T and the quality control line signal value C, where a is the ratio of cyan response efficiency to orange response efficiency in the photoelectric characteristics of the photosensitive device, and b is the ratio of light intensity of cyan light source 220 to orange light source 210.

[0058] The luminous intensity can be found in the light source manufacturer's datasheet. In this embodiment, the orange light source 210 has a luminous intensity of 150 mcd, and the cyan light source 220 has a luminous intensity of 6500 mcd. The orange light source 210 has a response efficiency of 0.72, and the cyan light source 220 has a response efficiency of 0.59.

[0059] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this utility model, and are not intended to limit it. Although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this utility model.

Claims

1. An immunochromatographic analyzer, characterized in that, include: Test strip (100) and photoelectric detection device (200) installed corresponding to the test strip (100); The test strip (100) uses blue latex particles as an indicator and has a control line (101), a test line (102) and a blank section (103); The photoelectric detection device (200) includes an orange light source (210) and a cyan light source (220), both of which are used to illuminate the quality control line (101), the test line (102), and the blank area (103).

2. The immunochromatographic analyzer according to claim 1, characterized in that, The orange light source (210) includes a first orange LED (211), a second orange LED (212), and a third orange LED (213). The first orange LED (211), the second orange LED (212), and the third orange LED (213) are spaced apart and correspond one-to-one with the quality control line (101), the test line (102), and the blank area (103).

3. The immunochromatographic analyzer according to claim 1, characterized in that, The cyan light source (220) includes a first cyan LED (221), a second cyan LED (222), and a third cyan LED (223). The first cyan LED (221), the second cyan LED (222), and the third cyan LED (223) are spaced apart and correspond one-to-one with the quality control line (101), the test line (102), and the blank area (103).

4. The immunochromatographic analyzer according to claim 1, characterized in that, The immunochromatographic analyzer also includes a photosensitive device (230) for detecting the reflectance of the control line (101), the test line (102), and the blank area (103).

5. The immunochromatographic analyzer according to claim 4, characterized in that, The photosensitive device (230) includes a first photosensitive sensor (231), a second photosensitive sensor (232), and a third photosensitive sensor (233). The first photosensitive sensor (231), the second photosensitive sensor (232), and the third photosensitive sensor (233) are arranged at intervals and correspond one-to-one with the quality control line (101), the test line (102), and the blank area (103).

6. The immunochromatographic analyzer according to claim 1, characterized in that, The test strip (100) includes: a base plate (110), a sample application pad (120), a nitrocellulose membrane (130), and an absorbent element (150); The sample application pad (120) and the nitrocellulose membrane (130) are respectively attached to the base plate (110), and the sample application pad (120) is bonded to the nitrocellulose membrane (130); The nitrocellulose membrane (130) is attached to the absorbent (150) at the end away from the sample pad (120), and the nitrocellulose membrane (130) is provided with the quality control line (101), the test line (102) and the blank part (103).

7. The immunochromatographic analyzer according to claim 6, characterized in that, The test strip (100) also includes a conjugate pad (140), and the sample application pad (120) and the nitrocellulose membrane (130) are respectively connected to the conjugate pad (140).

8. The immunochromatographic analyzer according to claim 1, characterized in that, The wavelength of the orange light source (210) is 590nm to 625nm.

9. The immunochromatographic analyzer according to claim 1, characterized in that, The wavelength of the cyan light source (220) is 485nm to 500nm.

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