Immunochromatography analyzer and detection analysis method

Abstract

The invention provides an immunochromatography analyzer and a detection and analysis method, and relates to the technical field of immunochromatography analys.The immunochromatography analyzer comprises a test strip and a photoelectric detection device installed 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 and the detection and analysis method provided by the invention, 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 testing can be carried out under cyan and orange illumination conditions respectively, so that the influence of blood color can be eliminated, and the detection and analysis accuracy is improved. And the detection accuracy is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of immunochromatographic analysis, and in particular to an immunochromatographic analyzer and a detection and analysis method. Background Art

[0002] As a fast and simple diagnostic tool, colloidal gold immunochromatography analyzer has been widely used in the field of clinical testing and point-of-care testing (POCT). This type of equipment usually uses wine-red colloidal gold to label antibodies or antigens, and uses capillary action to move the sample on the solid phase carrier to achieve qualitative or semi-quantitative detection of the target substance. Specifically, when the sample is dropped onto the sample pad, it will pass through the conjugate pad, the test line (T line) and the quality control line (C line) on the nitrocellulose membrane in turn, and finally reach the absorbent paper. In this process, if the sample contains the analyte, it will combine with the colloidal gold marker on the conjugate pad to form a complex, and as the sample continues to diffuse forward to the T line, it will be deposited and colored; regardless of whether the sample contains the analyte, the sample will continue to move to the C line position and cause it to develop color, thereby verifying the effectiveness of the test process.

[0003] However, in actual applications, due to the use of wine-red colloidal gold as a marker, the quality control line and the test line are also wine-red in color. Although this design simplifies the operation process, it also brings some problems. On the one hand, the color of different blood samples varies, which will interfere with the color development of the quality control line and the test line. Especially in the case of heavy blood color, it may cover up the color changes that should have appeared, making it difficult to accurately judge the results. On the other hand, the different degrees of sample wetting will also affect the color development effect. For example, if the sample volume is too large or the diffusion speed is too fast, the line may be too thick or blurred; conversely, if the sample is insufficient or flows slowly, the color may be too light or even unable to form a line, thus affecting the final test accuracy. Summary of the invention

[0004] The object of the present invention is to provide an immunochromatographic analyzer and a detection and analysis method to alleviate the technical problem that the detection results of the immunochromatographic analyzer are affected by blood color and wettability, resulting in deviations in the detection results.

[0005] In a first aspect, the present invention provides an immunochromatographic analyzer, comprising: 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 quality control line, a test line and a blank portion;

[0007] The photoelectric detection device comprises: an orange light source and a cyan light source, and both the orange light source and the cyan light source are used to illuminate the quality control line, the test line and the blank portion.

[0008] In combination with the first aspect, the present invention provides a first possible implementation manner of the first aspect, wherein the orange light source includes: a first orange LED, a second orange LED and a third orange LED, and the first orange LED, the second orange LED and the third orange LED are arranged at intervals and correspond one to one to the quality control line, the test line and the blank portion.

[0009] In combination with the first aspect, the present invention 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, and the first cyan LED, the second cyan LED and the third cyan LED are arranged at intervals and correspond one-to-one to the quality control line, the test line and the blank portion.

[0010] In combination with the first aspect, the present invention provides a third possible implementation of the first aspect, wherein the immunochromatographic analyzer further includes a photosensitive device, and the photosensitive device is used to detect the reflectivity of the quality control line, the test line and the blank portion.

[0011] In combination with the third possible implementation of the first aspect, the present invention provides a fourth possible implementation of the first aspect, wherein the photosensor includes: a first photosensor, a second photosensor and a third photosensor, and the first photosensor, the second photosensor and the third photosensor are arranged at intervals and correspond one to one to the quality control line, the test line and the blank portion.

[0012] In combination with the first aspect, the present invention provides a fifth possible implementation of the first aspect, wherein the test strip comprises: a bottom plate, a sample addition pad, a nitrocellulose membrane, a conjugate pad and a water absorbent;

[0013] The sample loading pad and the nitrocellulose membrane are respectively attached to the bottom plate, and the sample loading pad is connected to the nitrocellulose membrane, and the sample loading pad and the nitrocellulose membrane are respectively connected to the binding pad;

[0014] The water absorbent is attached to one end of the nitrocellulose membrane away from the sample pad, and the quality control line, the test line and the blank portion are arranged on the nitrocellulose membrane.

[0015] In combination with the first aspect, the present invention 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] In a second aspect, the detection and analysis method provided by the present invention is applied to the immunochromatographic analyzer described in the first aspect, and comprises the following steps:

[0017] Controlling the orange light source to light up, and respectively obtaining the photosensitive signal values ​​of the quality control line, the test line and the blank portion under orange light conditions;

[0018] Controlling the cyan light source to light up, and respectively obtaining the photosensitive signal values ​​of the quality control line, the test line and the blank portion under cyan light conditions;

[0019] Eliminating the influence of the wetting degree on the photosensitive signal value of the quality control line and the test line;

[0020] The influence of red pollution on the photosensitive signal value of the quality control line and the test line is removed.

[0021] In combination with the second aspect, the present invention provides a first possible implementation manner of the second aspect, wherein the step of removing the influence of the wetting degree on the photosensitive signal value of the quality control line and the test line comprises:

[0023] According to the 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 test line orange signal value T ＇ 橙 , where T 青 is the photosensitivity signal value of the test line under cyan lighting conditions, B 青 is the photosensitivity signal value of the blank portion under cyan illumination, T 橙 is the photosensitivity signal value of the test line under orange light conditions, B 橙 is the photosensitive signal value of the blank portion under orange light conditions;

[0024] 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is the photosensitivity signal value of the quality control line under cyan illumination, C 橙 is the photosensitivity signal value of the quality control line under orange lighting conditions.

[0025] In combination with the first possible implementation manner of the second aspect, the present invention provides a second possible implementation manner of the second aspect, wherein the step of removing the influence of red pollution on the photosensitive signal value of the quality control line and the test line comprises:

[0027] 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 the cyan response efficiency to the orange response efficiency in the photoelectric characteristics of the photosensitive device, and b is the light intensity ratio of the cyan light source to the orange light source.

[0028] The embodiments of the present invention bring the following beneficial effects: a test strip and a photoelectric detection device installed on the corresponding test strip are used, the strip uses blue latex particles as an indicator and has a quality control line, a test line and a blank portion, the photoelectric detection device includes: an orange light source and a cyan light source, both the orange light source and the cyan light source are used to illuminate the quality control line, the test line and the blank portion, and the use of blue latex particles as an indicator can make the quality control line and the test line appear blue after adding the sample, not only can the color development effect of the wetness degree be eliminated according to the reflection of the blank portion, but it can also be tested separately under cyan and orange lighting conditions, so as to provide an analytical basis for removing the influence of blood color.

[0029] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the related technologies, the drawings required for use in the specific embodiments or the related technical descriptions will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0031] Figure 1 A schematic diagram of a test strip of an immunochromatographic analyzer provided in an embodiment of the present invention;

[0032] Figure 2 A schematic diagram of an immunochromatographic analyzer provided in an embodiment of the present invention.

[0033] Icons: 100 - test strip; 101 - quality control line; 102 - test line; 103 - blank part; 110 - bottom plate; 120 - sample pad; 130 - nitrocellulose membrane; 140 - binding pad; 150 - water absorbent; 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 - photosensor; 231 - first photosensor; 232 - second photosensor; 233 - third photosensor. DETAILED DESCRIPTION

[0034] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. In addition, the terms "first", "second", and "third" are only used to describe the difference in names, and cannot be understood as indicating or implying relative importance. The physical quantities in the formula, if not separately marked, should be understood as basic quantities of the basic units of the International System of Units, or derived quantities derived from the basic quantities through mathematical operations such as multiplication, division, differentiation or integration.

[0036] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0037] like Figure 1 and Figure 2As shown, the immunochromatographic analyzer provided by the embodiment of the present invention includes: a test strip 100 and a 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 quality control line 101, a test line 102 and a blank portion 103; the photoelectric detection device 200 includes: an orange light source 210 and a cyan light source 220, and the orange light source 210 and the cyan light source 220 are both used to illuminate the quality control line 101, the test line 102 and the blank portion 103.

[0038] The quality control line 101 and the test line 102 are blue after adding the sample. By comparing the reflectivity of the blank part 103 after infiltration, the influence of the wetting degree on the color development can be eliminated. Testing is performed under the irradiation conditions of the orange light source 210 and the cyan light source 220 respectively, which can provide an analytical basis for eliminating the influence of blood color, thereby helping to improve the detection accuracy.

[0039] In an 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 arranged at intervals and correspond one to one with respect to the quality control line 101, the test line 102 and the blank portion 103. The first orange LED 211, the second orange LED 212 and the third orange LED 213 use LED lamps of the same model to ensure that the quality control line 101, the test line 102 and the blank portion 103 are illuminated with consistent orange light when orange light is applied.

[0040] Further, the cyan light source 220 includes: a first cyan LED 221, a second cyan LED 222, and a third cyan LED 223, which are arranged at intervals and correspond one to one to the quality control line 101, the test line 102, and the blank portion 103. The first cyan LED 221, the second cyan LED 222, and the third cyan LED 223 use the same type of LED lights to ensure that the quality control line 101, the test line 102, and the blank portion 103 are illuminated with the same cyan light when the orange light is applied.

[0041] In an optional embodiment, the orange light source 210 and the cyan light source 220 may also respectively use light homogenizing devices to ensure uniform brightness of the quality control line 101 , the test line 102 and the blank portion 103 .

[0042] Furthermore, the immunochromatographic analyzer further includes a photosensor 230 , which is used to detect the reflectivity of the quality control line 101 , the test line 102 and the blank portion 103 .

[0043] 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 to the quality control line 101, the test line 102 and the blank part 103.

[0044] It should be noted that the first photosensor 231 is located between the first orange LED 211 and the first cyan LED 221, the second photosensor 232 is located between the second orange LED 212 and the second cyan LED 222, and the third photosensor 233 is located between the third orange LED 213 and the third cyan LED 223. The first photosensor 231, the second photosensor 232 and the third photosensor 233 are used one by one to detect the reflectivity of the quality control line 101, the test line 102 and the blank part 103 under orange light or cyan light conditions.

[0045] In this embodiment, the test strip 100 includes: a base plate 110, a sample loading pad 120, a nitrocellulose membrane 130 and a water absorbent 150; the sample loading pad 120 and the nitrocellulose membrane 130 are respectively attached to the base plate 110, and the sample loading pad 120 is connected to the nitrocellulose membrane 130; the water absorbent 150 is attached to one end of the nitrocellulose membrane 130 away from the sample loading pad 120, and the nitrocellulose membrane 130 is provided with a quality control line 101, a test line 102 and a blank portion 103.

[0046] In addition, the test strip 100 further includes a conjugation pad 140 , to which the sample loading pad 120 and the nitrocellulose membrane 130 are respectively connected. The sample loading pad 120 and the nitrocellulose membrane 130 are connected via the conjugation pad 140 , so that the sample loading pad 120 and the nitrocellulose membrane 130 can be firmly combined.

[0047] During the test, the reagent is dropped onto the sample pad 120 , and the reagent penetrates into the sample pad 120 and the nitrocellulose membrane 130 , and the excess reagent is eventually absorbed by the water absorbent 150 .

[0048] In this embodiment, the wavelength of the orange light source 210 is 590 nm to 625 nm, and the wavelength of the cyan light source 220 is 485 nm to 500 nm.

[0049] like Figure 1 and Figure 2 As shown, the detection and analysis method provided in the embodiment of the present invention is applied to the immunochromatographic analyzer described in the above embodiment, and includes the following steps:

[0050] Control the orange light source 210 to light up, and obtain the photosensitive signal values ​​of the quality control line 101, the test line 102 and the blank part 103 under the orange light condition;

[0051] Control the cyan light source 220 to light up, and obtain the photosensitive signal values ​​of the quality control line 101, the test line 102 and the blank part 103 under the cyan light condition respectively;

[0052] Remove the influence of the wetting degree on the photosensitive signal value of the quality control line 101 and the test line 102;

[0053] The influence of red pollution on the photosensitive signal value of the quality control line 101 and the test line 102 is removed.

[0054] During detection, the orange light source 210 is first turned on, and the photosensitive signal values ​​of the quality control line 101, the test line 102 and the blank part 103 are obtained under the irradiation of orange light; 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 quality control line 101, the test line 102 and the blank part 103 are obtained under the irradiation of cyan light.

[0055] In an embodiment of the present invention, the step of removing the influence of the wetness on the photosensitive signal value of the quality control line 101 and the test line 102 includes:

[0057] According to the 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 test line orange signal value T ＇ 橙 , where T 青 is the photosensitivity signal value of the test line 102 under cyan lighting conditions, B 青 is the photosensitive signal value of the blank portion 103 under cyan illumination, T 橙 is the photosensitivity signal value of the test line 102 under orange light conditions, B 橙 is the photosensitive signal value of the blank portion 103 under orange light conditions;

[0058] 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 is the photosensitivity signal value of the quality control line 101 under cyan illumination, C 橙is the photosensitivity signal value of the quality control line 101 under orange lighting conditions.

[0059] Further, the step of removing the influence of red pollution on the photosensitive signal value of the quality control line 101 and the test line 102 includes:

[0061] 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 the cyan response efficiency to the orange response efficiency in the photoelectric characteristics of the photosensitive device, and b is the light intensity ratio of the cyan light source 220 to the orange light source 210.

[0062] The light intensity can be obtained from the data sheet of the light source manufacturer. The light intensity of the orange light source 210 used in this embodiment is 150 mcd, and the light intensity of the cyan light source 220 is 6500 mcd. The response efficiency of the orange light source 210 is 0.72, and the response efficiency of the cyan light source 220 is 0.59.

[0063] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An immunochromatographic analyzer, characterized in that: include: A test strip (100) and a 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 quality control line (101), a test line (102) and a blank portion (103); The photoelectric detection device (200) comprises: an orange light source (210) and a cyan light source (220), wherein the orange light source (210) and the cyan light source (220) are both used to illuminate the quality control line (101), the test line (102) and the blank portion (103).

2. The immunochromatographic analyzer according to claim 1, characterized in that: The orange light source (210) comprises: 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 arranged at intervals and correspond one to one to the quality control line (101), the test line (102) and the blank portion (103).

3. The immunochromatographic analyzer according to claim 1, characterized in that: The cyan light source (220) comprises: 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 arranged at intervals and correspond one to one with respect to the quality control line (101), the test line (102) and the blank portion (103).

4. The immunochromatographic analyzer according to claim 1, characterized in that: The immunochromatographic analyzer further comprises a photosensitive device (230), and the photosensitive device (230) is used to detect the reflectivity of the quality control line (101), the test line (102) and the blank portion (103).

5. The immunochromatographic analyzer according to claim 4, characterized in that: The photosensitive device (230) comprises: 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 respect to the quality control line (101), the test line (102) and the blank portion (103).

6. The immunochromatographic analyzer according to claim 1, characterized in that: The test strip (100) comprises: a base plate (110), a sample adding pad (120), a nitrocellulose membrane (130), a conjugation pad (140) and a water absorbing member (150); The sample loading pad (120) and the nitrocellulose membrane (130) are respectively attached to the bottom plate (110), and the sample loading pad (120) is connected to the nitrocellulose membrane (130), and the sample loading pad (120) and the nitrocellulose membrane (130) are respectively connected to the binding pad (140); The water absorbent (150) is attached to one end of the nitrocellulose membrane (130) away from the sample pad (120), and the quality control line (101), the test line (102) and the blank portion (103) are provided on the nitrocellulose membrane (130).

7. The immunochromatographic analyzer according to claim 1, characterized in that: The wavelength of the orange light source (210) is 590nm-625nm, and the wavelength of the cyan light source (220) is 485nm-500nm.

8. A detection and analysis method, characterized in that: The detection and analysis method is applied to the immunochromatographic analyzer according to any one of claims 1 to 7, and comprises the following steps: Controlling the orange light source (210) to light up, and respectively obtaining the photosensitive signal values ​​of the quality control line (101), the test line (102) and the blank portion (103) under orange light conditions; Controlling the cyan light source (220) to light up, and respectively obtaining the photosensitive signal values ​​of the quality control line (101), the test line (102) and the blank portion (103) under cyan light conditions; Eliminating the influence of the degree of wetting on the photosensitive signal values ​​of the quality control line (101) and the test line (102); The influence of red pollution on the photosensitive signal values ​​of the quality control line (101) and the test line (102) is removed.

9. The detection and analysis method according to claim 8, characterized in that: The step of removing the influence of the degree of wetting on the photosensitive signal value of the quality control line (101) and the test line (102) comprises: According to the 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 test line orange signal value T ＇ 橙 , where T 青 is the photosensitive signal value of the test line (102) under cyan lighting conditions, B 青 is the photosensitive signal value of the blank portion (103) under cyan lighting conditions, T 橙 is the photosensitive signal value of the test line (102) under orange light conditions, B 橙 is the photosensitive signal value of the blank portion (103) under orange light conditions; 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 is the photosensitivity signal value of the quality control line (101) under cyan illumination, C 橙 is the photosensitivity signal value of the quality control line (101) under orange light conditions.

10. The detection and analysis method according to claim 9, characterized in that: The step of removing the influence of red pollution on the photosensitive signal value of the quality control line (101) and the test line (102) comprises: According to the formula T = T' 青 -T' 橙 ·a·b and the formula C=C' 青 -C' 橙 ·a·b, calculating the test line signal value T and the quality control line signal value C, wherein a is the ratio of the cyan response efficiency to the orange response efficiency in the photoelectric characteristics of the photosensitive device, and b is the light intensity ratio of the cyan light source (220) to the orange light source (210).

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