CN212111448U - Detection reagent strip and kit for rapidly determining microalbuminuria - Google Patents

Abstract

The utility model discloses a spot test urine microalbumin detects reagent strip and kit: the detection reagent strip is a urine microalbumin test strip and comprises a substrate, and a sample pad, a gold label pad, an NC membrane and an absorption pad which are sequentially adhered on the substrate; the gold label pad is marked with a urine microalbumin colloidal gold antibody; a detection line T line and a quality control line C line are marked on the NC membrane, wherein the T line is coated with a urine microalbumin monoclonal antibody, and the C line is coated with a goat anti-mouse antibody; the detection kit comprises: a test reagent strip, and a fixed test card for testing the test reagent strip, wherein the test card comprises: an upper clamping shell and a lower clamping shell; the upper clamping shell is provided with a sample adding hole and an observation port, and the lower clamping shell is provided with a clamping groove for placing a detection reagent strip; the corresponding position of sample pad is located to the application of sample hole, the corresponding position of NC membrane is located to the observation mouth. The utility model discloses the sample of test paper is once, just can accurate detection go out the albumen content value, instant diagnosis, and the reaction is rapid, and is atraumatic.

Description

Detection reagent strip and kit for rapidly determining microalbuminuria

Technical Field

The utility model belongs to the technical field of medical science detects, concretely relates to spot test urine trace albumin detect reagent strip and kit.

Background

Diabetes is a group of metabolic diseases characterized by hyperglycemia, and chronic damage and dysfunction of various tissues, particularly eyes, kidneys, heart, blood vessels and nerves, caused by hyperglycemia, are called diabetic complications. Among many diabetic complications, chronic renal failure or uremia in diabetic patients, which is caused by chronic hypertension and poorly controlled hyperglycemia, is a leading cause of death in end-stage diabetic patients.

Diabetic nephropathy is one of the most major complications of diabetes and the most harmful, is the primary cause (about 44%) of end-stage nephropathy in developed countries such as europe and america, and is the second cause of end-stage nephropathy in China, and has hidden onset and reversible early stage after treatment, and the end-stage nephropathy develops in the late stage.

Diabetic nephropathy is mainly characterized by glomerular damage, and when the permeability of a glomerular filtration membrane is increased, obvious proteinuria is caused, so that the detection of urine microalbumin has important significance on diagnosis of diabetic renal damage.

The multi-purpose qualitative method in the prior art carries out single detection on the urinary microalbumin index, cannot accurately and quantitatively detect the index simultaneously, is complex in operation steps, complex in biochemical detection, long in time consumption, inconvenient for doctors and patients to operate, not beneficial to local hospitals, low in accuracy and sensitivity and incapable of serving as an accurate detection and diagnosis basis.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a spot test urine microalbumin detect reagent, a sample just can detect out the albumen content value, adopts the dry-type method, and instant diagnosis need not manage extra reaction liquid, and the reaction is rapid, can single sample along with doing and follow away, need not the pretreatment, adopts urine detection, and is atraumatic.

In order to achieve the above object, the utility model provides a following technical scheme:

a test reagent strip for rapidly determining urine microalbumin is a urine microalbumin test strip and comprises a substrate, and a sample pad, a gold label pad, an NC membrane and an absorption pad which are sequentially adhered on the substrate;

the gold label pad is marked with a urine microalbumin colloidal gold antibody, and the marked antibody is a urine microalbumin monoclonal antibody;

and a detection line T line and a quality control line C line are marked on the NC membrane, wherein the T line is coated with the urine microalbumin monoclonal antibody, and the C line is coated with the goat anti-mouse antibody.

Preferably, the width of the test strip is 3.9 mm.

Preferably, one end of the sample pad is aligned with the substrate and the other end is pressed against the gold label pad.

Preferably, the gold label pad is pasted on the substrate close to the T line side and is pressed on the NC film.

Preferably, the absorption pad is adhered to the substrate near the C line side, one end of the absorption pad is pressed on the NC film, and the other end of the absorption pad is aligned with the substrate.

A test kit for rapid determination of urinary microalbumin, the test kit comprising:

i) the detection reagent strip, and

ii) a test card holding said test reagent strip, wherein said test card comprises: an upper clamping shell and a lower clamping shell;

the upper clamping shell is provided with a sample adding hole and an observation port, and the lower clamping shell is provided with a clamping groove for placing the detection reagent strip; the corresponding position of sample pad is located to the application of sample hole, the corresponding position of NC membrane is located to the observation mouth, and T line and C line are located the middle part of observing the mouth.

Preferably, the size and shape of the clamping groove are matched with those of the detection reagent strip.

Compared with the prior art, the beneficial effects of the utility model are that: the utility model discloses the test paper is once taken a sample (urine, be patient morning urine better), just can accurately detect out the protein content value, and this product adopts the dry-type method, and instant diagnosis need not manage extra reaction liquid, and the reaction is rapid, can single sample along with doing and follow away, need not the pretreatment, adopts the urine to detect, and is atraumatic.

Drawings

FIG. 1 is a sectional view of the structure of a test kit for rapid measurement of microalbuminuria in an embodiment of the present invention;

FIG. 2 is a schematic view of a test strip in an embodiment of the present invention;

fig. 3 is a schematic view of an NC film in an embodiment of the present invention.

In the figure: a substrate-1, a sample pad-2, a gold label pad-3, an NC membrane-4, an absorption pad-5, a T line-41 and a C line-42; an upper clamping shell-6, a lower clamping shell-7, a sample adding hole-61, an observation port-62 and a clamping groove-71.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative work belong to the protection scope of the present invention.

Referring to fig. 1-3, the present invention provides a technical solution:

a test reagent strip for rapidly measuring urine microalbumin is a urine microalbumin test strip with the width of 3.9mm and comprises a substrate 1, and a sample pad 2, a gold label pad 3, an NC membrane 4 and an absorption pad 5 which are sequentially adhered on the substrate 1;

the gold label pad 3 is marked with a urine microalbumin colloidal gold antibody, and the marked antibody is a urine microalbumin monoclonal antibody;

a detection line T line 41 and a quality control line C line 42 are marked on the NC membrane 4, wherein the T line 41 is coated with a urinary microalbumin (mALB) monoclonal antibody A, and the C line 42 is coated with a goat anti-mouse antibody;

specifically, the sample pad 2 is made of a glass cellulose membrane, one end of the glass cellulose membrane is aligned with the substrate 1, and the other end of the glass cellulose membrane is pressed on the gold label pad 3; the gold label pad 3 is a glass cellulose membrane marked by a urine microalbumin colloidal gold antibody, the marked antibody is a urine microalbumin (mALB) monoclonal antibody B, and the gold label pad 3 is stuck on the substrate 1 close to the side of the T line 41 and is pressed on the NC membrane 4; the material of the absorption pad 5 is absorbent paper for absorbing urine samples, and the absorption pad is adhered on the substrate 1 close to the C line 42 side, one end of the absorption pad is pressed on the NC membrane 4, and the other end of the absorption pad is aligned with the substrate 1.

A detection kit for rapidly determining microalbuminuria: the detection kit comprises:

the test reagent strip, and a test card for fixing the test reagent strip, wherein the test card comprises: an upper clamping shell 6 and a lower clamping shell 7; the upper clamping shell 6 is provided with a sample adding hole 61 and an observation port 62, the sample adding hole 61 is arranged at the corresponding position of the sample pad 2, the observation port 62 is arranged at the corresponding position of the NC membrane 4, and the T line 41 and the C line 42 are positioned in the middle of the observation port 62, so that the sensitivity of the NC membrane is improved, and the overall detection effect is improved; the lower clamping shell 7 is provided with a clamping groove 71 for placing the detection reagent strip, and the size and the shape of the clamping groove are matched with those of the detection reagent strip.

Colloidal gold labeling principle: under alkaline condition, the surface of colloidal gold particle is negatively charged, and can form non-covalent electrostatic attraction and firm combination with the positively charged group of target protein, and the combination has no obvious influence on the biological activity of the target protein, i.e. has no influence on the performance of antigen or antibody. The antigen or antibody adsorbed on the surface of the colloidal gold can directionally carry the colloidal gold particles to the position of the corresponding antibody or antigen on the solid phase carrier in tissues or cells. Due to the high electron density of gold particles, these markers appear as macroscopic red spots when they are aggregated to a certain density at the antigen-antibody reaction sites. The success of the binding of colloidal gold and protein depends on the pH value, the optimum pH value is generally close to or slightly larger than the isoelectric point of the labeled substance to be firmly bound, the dosage of the labeled substance depends on the size of gold particles, and meanwhile, the labeled substance needs to be subjected to pretreatment of complete desalting.

The utility model discloses the inspection principle: using a double-antibody sandwich immunochromatography to detect that urine microalbumine (mAB) in a sample is chromatographed upwards under a capillary effect and is combined with a colloidal gold-labeled mAB monoclonal antibody B on a gold-labeled pad, and then a combination is captured and combined by the mAB monoclonal antibody A coated on a T line to form a red strip; the quality control antibody coated on the C line is combined with the compound to form a red strip. Meanwhile, the concentration of mAB in the sample is positively correlated with T/C (ratio of T line signal to C line signal). And inserting the detection card into a matched instrument for measurement, and quantitatively obtaining the concentration of the mAB of the detected substance.

Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims (7)

1. A test reagent strip for rapidly measuring microalbumin in urine is characterized in that the test reagent strip is a test strip for microalbumin in urine and comprises a substrate (1), and a sample pad (2), a gold label pad (3), an NC membrane (4) and an absorption pad (5) which are sequentially adhered on the substrate (1);

the gold label pad (3) is marked with a urine microalbumin colloidal gold antibody, and the marked antibody is a urine microalbumin monoclonal antibody;

and a detection line T line (41) and a quality control line C line (42) are marked on the NC membrane (4), wherein the T line (41) is coated with a urine microalbumin monoclonal antibody, and the C line (42) is coated with a goat anti-mouse antibody.

2. The test strip for rapid determination of urinary microalbumin as claimed in claim 1, wherein the width of the test strip is 3.9 mm.

3. The test strip for rapid determination of urinary microalbumin as claimed in claim 1 wherein the sample pad (2) has one end aligned with the substrate (1) and the other end pressed against the gold pad (3).

4. The test strip for rapid determination of urinary microalbumin according to any of claims 1 or 3, wherein the gold pad (3) is adhered to the substrate (1) on the side close to the T line (41) and pressed against the NC membrane (4).

5. The test strip for rapid measurement of urinary microalbumin as claimed in claim 1, wherein the absorbent pad (5) is adhered to the substrate (1) on the side close to the C line (42), one end of which is pressed against the NC film (4), and the other end of which is aligned with the substrate (1).

6. A detection kit for rapidly determining microalbuminuria, which is characterized by comprising:

i) the test strip of any of claims 1-5, and

ii) a test card holding the test reagent strip according to any one of claims 1 to 5, wherein the test card comprises: an upper clamping shell (6) and a lower clamping shell (7);

the upper clamping shell (6) is provided with a sample adding hole (61) and an observation port (62), and the lower clamping shell (7) is provided with a clamping groove (71) for placing the detection reagent strip according to any one of claims 1-5; the corresponding position of sample pad (2) is located to application of sample hole (61), the corresponding position of NC membrane (4) is located to observation mouth (62), and middle part that just T line (41) and C line (42) are located observation mouth (62).

7. The kit as claimed in claim 6, wherein the size and shape of the slot (71) are adapted to fit the test strip.

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