CN217688982U - Improve linear chromatography reagent strip of reagent - Google Patents

Improve linear chromatography reagent strip of reagent Download PDF

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Publication number
CN217688982U
CN217688982U CN202221347721.6U CN202221347721U CN217688982U CN 217688982 U CN217688982 U CN 217688982U CN 202221347721 U CN202221347721 U CN 202221347721U CN 217688982 U CN217688982 U CN 217688982U
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reagent
chromatographic
pad
linearity
antibody
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蒋明君
李学锐
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Sichuan Xinjian Kangcheng Biological Co ltd
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Sichuan Xinjian Kangcheng Biological Co ltd
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Abstract

The utility model discloses an improve linear chromatography reagent strip of reagent, including sample pad, chromatographic membrane, be provided with detection line and quality control line on the chromatographic membrane, the sample pad is connected in the chromatographic membrane, is provided with mark antibody fluorescence microsphere line on the anterior segment that is close to the sample pad on the chromatographic membrane. The utility model discloses a chromatography reagent strip gets rid of the conjugate pad, improves the fluorescence microballon that will mark the antibody for drawing a line structure on the chromatographic film on the conjugate pad is whole, can shorten the antibody in the fluorescence microballon like this greatly and the binding time of antigen in the sample, is equivalent to the volume of antigen in the sample that has reduced according to the proportion, very big promotion reagent's detectable concentration, promotion reagent is linear.

Description

Improve linear chromatography reagent strip of reagent
Technical Field
The utility model relates to a fluorescence immunochromatography detects technical field, particularly, relates to a improve linear chromatography reagent strip of reagent.
Background
Immunochromatography, also known as flow immunoassay (LATERL FLOW IMMUNOASSay), originated in the last 80 th century, was established on chromatographic membranes based on antigen-antibody specific reaction, and widely applied to pathogen detection, food safety measurement, environmental monitoring and other aspects due to the advantages of rapidness, convenience, low interval, high sensitivity and the like, wherein the colloidal gold immunochromatography is the most developed, but is mostly limited to qualitative or semi-quantitative detection. With the rapid development of material science and bioengineering technology, new fluorescence chromatography technology has gradually stabilized the heel in the field of quantitative detection.
The traditional fluorescent chromatography test paper adopts a double-antibody sandwich mode that fluorescent microspheres for marking antibodies are uniformly sprayed on a combination pad, and another antibody is coated on a chromatographic membrane; the mode of spraying the labeled antibody on the bonding pad can prolong the bonding time of the fluorescent microspheres and the antigen in the sample, thereby improving the detection performance. However, when the mode is used for detecting high-sensitivity items (such as CRP, beta-HCG and SAA), the linearity is insufficient; especially, when the concentration of the antigen in the sample is too high, the antibodies in the fluorescent microspheres and the antibodies on the chromatographic membrane are not sufficient to capture the antigen in a gradient manner, which results in poor linearity of the detection result and even a HOOK effect. Therefore, in fluorescence chromatography research, improving the linearity of the reagent is a key point for improving the performance of the reagent.
In view of this, the present application is specifically made.
SUMMERY OF THE UTILITY MODEL
The to-be-solved technical problem of the utility model is to spout fluorescence microsphere in the current fluorescence immunochromatography structure at the conjugate pad, when antigen concentration content is too high in the sample, the antibody above microsphere and the chromatographic membrane is not enough to be the capture antigen of gradient, cause the reagent linear not enough, aim at provides an improve the linear chromatography reagent strip of reagent, get rid of the conjugate pad, the fluorescence microsphere that will mark the antibody improves for ruling out the structure on the chromatographic membrane from traditional peridium on the conjugate pad, can shorten the antibody in the fluorescence microsphere and the binding time of antigen in the sample greatly like this, be equivalent to the volume of antigen in the sample that has reduced according to the proportion, very big detectable concentration of having promoted reagent, it is linear to promote the reagent.
The utility model discloses a following technical scheme realizes:
the utility model provides an improve linear chromatography reagent strip of reagent, includes sample pad, chromatographic membrane, is provided with detection line and quality control line on the chromatographic membrane, and the sample pad is connected in the chromatographic membrane, is provided with mark antibody fluorescence microballon line on the anterior segment that is close to the sample pad on the chromatographic membrane.
At present, in the traditional chromatographic test paper, fluorescent microspheres for marking antibodies are uniformly sprayed on a combination pad, and antigens in a sample completely flow through the combination pad and then enter a chromatographic membrane, so that the combination time of the fluorescent microspheres for marking the antibodies and the antigens in the sample can be prolonged, and the fluorescent microspheres and the antigens are fully combined. However, this is for the detection of high sensitivity items (such as CRP, β -HCG, SAA), especially when the concentration of the antigen in the sample is too high, the antibody labeled by the fluorescent microspheres in the conjugate pad and the antibody coated on the chromatographic membrane are not sufficient to capture the antigen in a gradient manner, which results in poor linearity of the detection result and even a HOOK effect.
The utility model discloses a chromatography reagent strip gets rid of the bonding pad, improves the fluorescence microballon that will mark the antibody for drawing a line structure on the chromatographic film from traditional package on the bonding pad is whole, can shorten the antibody in the fluorescence microballon like this greatly and the binding time of antigen in the sample, is equivalent to the volume of antigen in the sample that has reduced according to the proportion, very big promotion the detectable concentration of reagent, promotion reagent is linear.
In another embodiment, the labeled antibody fluorescent microsphere line is scribed on the chromatographic membrane by using a scribing instrument.
In another specific embodiment, the chromatographic membrane is a nitrocellulose membrane.
In another specific embodiment, the kit further comprises a water absorption pad, and the chromatographic membrane is connected with the water absorption pad.
In another specific embodiment, the fluorescent microsphere line of the labeled antibody is coated with an anti-beta-HCG monoclonal antibody and rabbit IgG which are labeled by the fluorescent microsphere; the detection line is coated with another anti-beta-HCG antibody; the quality control line is coated with goat anti-rabbit IgG.
Serum HCG is a common indicator for the diagnosis of early pregnancy and is also used for early detection and differential diagnosis of abnormal pregnancy diseases. Elevated serum HCG is common in women of childbearing age. After normal pregnancy, the HCG content in blood rapidly increases, the peak is reached after 60-80 days of pregnancy, then gradually decreases, the peak is reduced to the minimum after 160-180 days of pregnancy, but is still obviously higher than normal, and after that, the HCG content slightly rises again and continues to be maintained until parturition; during double-fetus pregnancy, the HCG in serum is doubled compared with that in single fetus, and the abnormal rise of HCG in serum can be seen in choriocarcinoma or hydatidiform mole; during ectopic pregnancy, HCG in serum is lower than that in the same period of normal pregnancy. If the HCG in the serum of the early pregnant woman is obviously low or continuously monitored to be in a descending trend, the early pregnant woman is predicted to have threatened abortion; after the induced abortion operation is carried out, if the HCG value of serum is still obviously higher than normal or in an ascending trend, the incomplete operation is prompted; elevated HCG is also found in patients with germ cell, warm nest, bladder, pancreas, stomach, lung and liver tumors. The Roche's beta-HCG detection linearity is 10000mIU/mL, a reagent strip of colloidal gold is required to be used for initial detection when a hospital performs a test, and the test is performed after a T strip is diluted when the T strip is very red, so that the operation is complicated; if the reagent strip is convenient for patients to use, the linearity should be at least 200000mIU/mL, which is a very high requirement item for linearity, but the current reagent strip cannot achieve such high linearity.
The utility model provides a reagent strip that beta-HCG detected adopts and rules out anti beta-HCG monoclonal antibody and the rabbit IgG of fluorescence microballon mark and is linear structure on the chromatographic carrier, can promote the linearity of reagent strip greatly to accurate detection serum beta-HCG.
In another specific embodiment, the detection line and the quality control line are scribed on the chromatographic membrane by a scribing instrument, and the scribing amount is 1 muL/cm.
In another embodiment, the sample pad, chromatographic membrane and absorbent pad are assembled on a PVC base plate.
In another specific embodiment, the sample pad is a glass fiber pad, and the surface of the sample pad is sprayed with the treatment solution.
Compared with the prior art, the utility model, following advantage and beneficial effect have:
the embodiment of the utility model provides a pair of improve linear chromatography reagent strip of reagent gets rid of the conjugate pad, improves the fluorescence microballon that will mark the antibody for drawing a line structure on the chromatographic film on the conjugate pad is whole from traditional package, can shorten the antibody in the fluorescence microballon like this greatly and the binding time of antigen in the sample, be equivalent to the volume of antigen in the sample that has reduced according to the proportion, very big promotion reagent's detectable concentration, promotion reagent is linear.
Drawings
In order to more clearly illustrate the technical solutions of the exemplary embodiments of the present invention, the drawings that are required to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention, and therefore should not be considered as limiting the scope, and that for those skilled in the art, other related drawings can be obtained from these drawings without inventive effort.
FIG. 1 is a schematic view of a prior art reagent strip;
fig. 2 is a schematic structural diagram of a reagent strip provided by an embodiment of the present invention.
Reference numbers and corresponding part names in the figures:
1-sample pad, 2-chromatographic membrane, 3-detection line, 4-quality control line, 5-labeled antibody fluorescent microsphere line, 6-water absorption pad, 7-PVC bottom plate and 8-combination pad.
Detailed Description
To make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to the following examples and drawings, and the exemplary embodiments and descriptions thereof of the present invention are only used for explaining the present invention, and are not intended as limitations of the present invention.
In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be apparent to one of ordinary skill in the art that: it is not necessary to employ these specific details to practice the invention. In other instances, well-known structures have not been described in detail in order to avoid obscuring the present invention.
Throughout the specification, reference to "one embodiment," "an embodiment," "one example," or "an example" means: the particular features, structures, or characteristics described in connection with the embodiment or example are included in at least one embodiment of the present invention. Thus, the appearances of the phrases "one embodiment," "an embodiment," "one example" or "an example" in various places throughout this specification are not necessarily all referring to the same embodiment or example. Furthermore, the particular features, structures, or characteristics may be combined in any suitable combination and/or sub-combination in one or more embodiments or examples. Further, those of ordinary skill in the art will appreciate that the illustrations provided herein are for illustrative purposes and are not necessarily drawn to scale. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
In the description of the present invention, the terms "front", "back", "left", "right", "up", "down", "vertical", "horizontal", "high", "low", "inner", "outer", etc. indicate orientations or positional relationships based on the orientation or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore, should not be construed as limiting the scope of the present invention.
Example 1
As shown in FIG. 2, the embodiment of the utility model provides an improve linear chromatography reagent strip of reagent, including sample pad 1, chromatographic membrane 2, the pad 6 that absorbs water, be provided with detection line 3 and quality control line 4 on the chromatographic membrane, the sample pad is connected in the chromatographic membrane, and the chromatographic membrane is connected in the pad that absorbs water, is provided with mark antibody fluorescence microballon line 5 on the anterior segment that is close to the sample pad on the chromatographic membrane, and sample pad 1, chromatographic membrane 2 and the pad 6 equipment that absorbs water are on PVC bottom plate 7.
As shown in fig. 1, in the conventional chromatographic test paper, fluorescent microspheres labeled with an antibody are uniformly sprayed on a binding pad 8, and an antigen in a sample completely flows through the binding pad and then enters a chromatographic membrane, so that the binding time between the fluorescent microspheres labeled with the antibody and the antigen in the sample can be increased, and the fluorescent microspheres and the antigen in the sample are fully bound. However, this is for the detection of high sensitivity items (e.g. CRP, β -HCG, SAA), especially when the concentration of the antigen in the sample is too high, the antibody labeled with the fluorescent microspheres in the binding pad and the antibody coated on the chromatographic membrane are not sufficient to capture the antigen in a gradient manner, which results in the detection result having insufficient linearity and even the HOOK effect.
The utility model discloses a chromatography reagent strip gets rid of the bonding pad, improves the fluorescence microballon that will mark the antibody for drawing a line structure on the chromatographic film from traditional package on the bonding pad is whole, can shorten the antibody in the fluorescence microballon like this greatly and the binding time of antigen in the sample, is equivalent to the volume of antigen in the sample that has reduced according to the proportion, very big promotion the detectable concentration of reagent, promotion reagent is linear.
Preferably, the marked antibody fluorescent microsphere line, the detection line and the quality control line are marked on the chromatographic membrane by a membrane marking instrument, and the membrane marking amount is 1 muL/cm.
Preferably, the chromatographic membrane is a nitrocellulose membrane.
Preferably, the sample pad is a glass fiber pad, and the surface of the sample pad is sprayed with the treatment liquid.
Example 1
As shown in fig. 2, the embodiment of the present invention provides a β -HCG chromatography reagent strip for improving reagent linearity, which comprises a sample pad 1, a chromatography membrane 2 and a water absorption pad 6, wherein the chromatography membrane is provided with a detection line 3 and a quality control line 4, the sample pad is connected to the chromatography membrane, the chromatography membrane is connected to the water absorption pad, a labeled antibody fluorescent microsphere line 5 is provided on the front section of the chromatography membrane near the sample pad, and the labeled antibody fluorescent microsphere line 5 is coated with an anti- β -HCG monoclonal antibody labeled with a fluorescent microsphere and rabbit IgG; the detection line 3 is coated with another anti-beta-HCG antibody; the quality control line 4 is coated with goat anti-rabbit IgG, and the sample pad 1, the chromatographic membrane 2 and the water absorption pad 6 are assembled on the PVC bottom plate 7.
Serum HCG is a common indicator for the diagnosis of early pregnancy and is also used for early detection and differential diagnosis of abnormal pregnancy diseases. Elevated serum HCG is common in women of childbearing age. After normal pregnancy, the HCG content in blood rapidly increases, the peak is reached after 60-80 days of pregnancy, then gradually decreases, the peak is reduced to the minimum after 160-180 days of pregnancy, but is still obviously higher than normal, and after that, the HCG content slightly rises again and continues to be maintained until parturition; during double-fetus pregnancy, the HCG in serum is doubled compared with that in single fetus, and the abnormal rise of HCG in serum can be seen in choriocarcinoma or hydatidiform mole; during ectopic pregnancy, HCG in serum is lower than that in the same normal pregnancy. If the HCG in the serum of the early pregnant woman is obviously low or continuously monitored to be in a descending trend, the early pregnant woman is predicted to have threatened abortion; after the induced abortion operation is carried out, if the HCG value of serum is still obviously higher than normal or in an ascending trend, the incomplete operation is prompted; elevated HCG is also found in patients with germ cell, warm nest, bladder, pancreas, stomach, lung and liver tumors. The Roche's beta-HCG detection linearity is 10000mIU/mL, a reagent strip of colloidal gold is required to be used for initial detection when a hospital performs a test, and the test is performed after a T strip is diluted when the T strip is very red, so that the operation is complicated; if the reagent strip is convenient for patients to use, the linearity should be at least 200000mIU/mL, which is a very high requirement item for linearity, but the current reagent strip cannot achieve such high linearity.
The utility model provides a pair of reagent strip that beta-HCG detected adopts and draws the line with beta-HCG monoclonal antibody and the rabbit IgG of fluorescence microballon mark and is linear structure on the chromatographic carrier, can promote the linearity of reagent strip greatly to accurate detection serum beta-HCG.
The above-mentioned embodiments, further detailed description of the objects, technical solutions and advantages of the present invention, it should be understood that the above description is only the embodiments of the present invention, and is not intended to limit the scope of the present invention, and any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the scope of the present invention.

Claims (10)

1. The utility model provides an improve linear chromatography reagent strip of reagent, includes sample pad (1), chromatographic membrane (2), is provided with detection line (3) and matter control line (4) on chromatographic membrane (2), its characterized in that, sample pad (1) are connected in chromatographic membrane (2), are provided with on the anterior segment that is close to sample pad (1) on chromatographic membrane (2) and mark antibody fluorescence microballon line (5).
2. The chromatographic reagent strip for improving the reagent linearity of the claim 1 is characterized in that the marked antibody fluorescent microsphere line (5) is scribed on the chromatographic membrane (2) by a scribing instrument.
3. A reagent strip for improving reagent linearity of claim 1, wherein the chromatographic membrane (2) is a nitrocellulose membrane.
4. A chromatographic reagent strip for improving the linearity of the reagent according to claim 1, which further comprises a water absorption pad (6), wherein the chromatographic membrane (2) is connected to the water absorption pad (6).
5. The chromatographic reagent strip for improving the reagent linearity of claim 1, wherein the fluorescent microsphere line (5) of the labeled antibody is coated with an anti-beta-HCG monoclonal antibody labeled by a fluorescent microsphere and rabbit IgG.
6. A reagent strip for chromatography having improved reagent linearity as claimed in claim 5, wherein the detection line (3) is coated with another anti- β -HCG antibody.
7. The chromatographic reagent strip for improving the reagent linearity of claim 5, wherein the quality control line (4) is coated with goat anti-rabbit IgG.
8. The chromatography reagent strip for improving the reagent linearity according to claim 1, wherein the detection line (3) and the quality control line (4) are scribed on the chromatography membrane (2) by a scribing instrument, and the scribing amount is 1 μ L/cm.
9. A reagent strip for improving reagent linearity as claimed in claim 4, wherein the sample pad (1), chromatographic carrier (2) and absorbent pad (6) are assembled on a PVC base plate (7).
10. The chromatographic reagent strip for improving the linearity of the reagent according to claim 1, wherein the sample pad (1) is a glass fiber pad, and the surface of the sample pad (1) is sprayed with the treatment solution.
CN202221347721.6U 2022-05-31 2022-05-31 Improve linear chromatography reagent strip of reagent Active CN217688982U (en)

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