CN104535768B - A kind of microdose urine protein detecting device - Google Patents

Abstract

The invention discloses a kind of microdose urine protein detecting device, including cassette holder, lid and reagent strip, described lid is provided with well and observation panel, described reagent strip includes the chromatography structure supporting substrate and being positioned on described substrate, this chromatography structure headtotail successively is arranged with filter sample paper, the immune colloid gold scraps of paper, immunity nitrocellulose filter and absorbent paper, it is characterized in that: described well is additionally provided with the urine cup of bottom opening, this urine cup bottom opening and described well shape, size is identical, described immunity nitrocellulose filter is provided with quality control band and a plurality of detection line, described quality control band and a plurality of detection line are exposed in described observation panel。The microdose urine protein detecting device of the present invention, have easy and simple to handle, reaction quickly, sensitivity height, high specificity, economical and practical, not easily dirty hands, can quantitatively obtain the advantage such as concentration ranges of microdose urine protein, be suitable for Site Detection and individual's use。

Description

A urine microalbumin detection device

technical field

The invention relates to the technical field of medical clinical diagnosis, in particular to a quantitative urine microalbumin detection device prepared by adopting an immunocolloidal gold rapid detection technology.

Background technique

Microalbumin means that the albumin content in urine exceeds the reference range of healthy people, exists in a small amount abnormally in urine, and the excretion is greater than 30mg/day or 20mg/L. It is usually considered to be a symptom of renal failure, diabetes and An important early clinical marker of cardiovascular disease complications. Therefore, the detection of microalbumin in urine has important reference value and clinical significance for early diagnosis, early treatment and risk reduction of diseases.

The existing urine microalbumin detection method is as follows: use a urine cup to collect urine, then use a dropper to absorb a certain volume of urine and drop it onto the sample pad of the urine microalbumin detection test paper, and then perform color analysis. With this method, additional urine cups and droppers need to be prepared, which increases the cost of sampling, and the urine cups are generally short, which easily contaminates hands during sampling, and there is also the problem of urine spilling during urine transfer.

Contents of the invention

In order to solve the above problems and at the same time accurately know the concentration range of urinary microalbumin, the present invention provides a device for rapid quantitative detection of urinary microalbumin, which has the ability of quantitative detection, simple operation, fast response, economical and practical, and does not require Additional accessories can realize real-time measurement, especially suitable for personal self-test.

The urine microalbumin detection device provided by the present invention comprises a box seat, a box cover and a reagent strip, the box cover is provided with a sample injection hole and an observation port, and the reagent strip includes a supporting substrate and a reagent strip located on the supporting substrate. The chromatographic structure comprises filter paper, immune colloidal gold paper sheet, immune nitrocellulose membrane and absorbent paper arranged head to tail in sequence, and is characterized in that: the bottom is also arranged on the sample loading hole A urine cup with an opening, the bottom opening of the urine cup has the same shape and size as the sample injection hole, the immunonitrocellulose membrane is provided with a quality control band and a plurality of detection lines, the quality control band and the plurality of detection lines The detection line is exposed in the observation port.

Preferably, the urine cup is integrally formed with the lid.

Preferably, the bottom of the urine cup has an outwardly turned edge, and the edge is fixed between the lid and the seat.

Preferably, the side of the urine cup away from the chromatographic structure is further provided with an opening, and the height H from the lowest end of the opening to the sample injection hole is equal to the minimum amount of sample detection/area of the sample injection hole.

Preferably, the opening is connected to a conduit, and the other end of the conduit is opened lower than the box seat.

Preferably, the box cover and the edge of the box seat are matched and bonded to each other, or the box cover and the box seat are provided with corresponding engaging or fastening connecting parts, and through the connecting parts Snap or buckle together.

Preferably, the immunocolloidal gold paper is coated with a colloidal gold label; the quality control strip is coated with an anti-rabbit IgG polyclonal antibody, and the detection line is coated with human albumin.

Preferably, there are 3 detection lines, and the content of human albumin coated on them is increased step by step, and the box cover corresponding to the detection lines has marks of corresponding concentration intervals.

The detection method of the detection device is as follows: when urinating, pinch one end of the absorbent paper, directly urinate the urine in the urine cup, the urine flows into the sample injection hole, and the excess urine is discharged along the opening on one side of the urine cup. Then put the detection device flat, time it, and interpret the result within 3-8 minutes, and determine the concentration range of the sample according to the number of detection lines.

The urine microalbumin detection device of the present invention has the advantages of simple operation, fast response, high sensitivity, strong specificity, economical and practical, not easy to dirty hands, and can quantitatively obtain the concentration range of urinary microalbumin, and is suitable for on-site detection and personal use .

Description of drawings

Fig. 1 is the structure schematic diagram of urine microalbumin detection device of the present invention;

Fig. 2 is the exploded diagram of structure of urine microalbumin detection device of the present invention;

Fig. 3 is the sectional view of the lid of Embodiment 1 of the present invention;

Fig. 4 (a)-(h) is the color development situation of the test strip of embodiment 1 of the present invention;

Fig. 5 is a sectional view of the box cover of Embodiment 2 of the present invention.

detailed description

The present invention will now be described in detail in conjunction with specific embodiments.

Example 1

As shown in Fig. 1, Fig. 2 and Fig. 3, the urinary microalbumin detection device of the present invention comprises a box seat 1, a box cover 2 and a reagent strip 3, and the box cover 2 is provided with a sample injection hole 21 and an observation port 22, The reagent strip 3 includes a support substrate 31 and a chromatographic structure positioned on the support substrate 31. The chromatographic structure includes a filter paper 32, an immunocolloidal gold paper sheet 33, and an immunonitrocellulose membrane 34 arranged head to tail in sequence. and absorbent paper35. A urine cup 23 with an open bottom is arranged on the sample injection hole 21 , and the urine cup 23 and the box cover 2 are integrally formed. The bottom opening of the urine cup 23 has the same shape and size as the sample injection hole 21, and the immunonitrocellulose membrane 34 is provided with a quality control belt 344, a first detection line 341, a second detection line 342, and a third detection line 343. The quality control tape 344 and the first detection line 341 , the second detection line 342 and the third detection line 343 are exposed in the observation port 22 . An opening 24 is also provided on the side of the urine cup 23 away from the chromatographic structure, and the height H of the lowest end of the opening 24 from the sample injection hole 21 is equal to the minimum amount of sample detection/area of the sample injection hole 21 . The opening 24 is connected with a conduit 25 , and the other end opening 26 is lower than the cartridge seat 1 . Preferably, the conduit 25 passes through the hole 36 of the reagent strip 3 and the hole 11 on the cartridge seat 1 . With such a design, the volume of urine in the urine cup 23 can be kept below the level of the opening 24 of the urine cup, and excess urine will flow away along the conduit 25 connected to the opening 24 to prevent spilling and dirty hands. The edge of the box cover 2 and the box seat 1 are matched and adhered to each other, or the box cover 2 and the box seat 1 are provided with corresponding connecting parts for snapping or buckling, and are snapped or snapped together via the connecting parts. Colloidal gold markers are coated on the immune colloidal gold paper sheet 33; anti-rabbit IgG polyclonal antibodies are coated on the quality control tape 344; albumin, the content of human albumin doubled. The concentration inflection points of the first detection line 341 , the second detection line 342 , and the third detection line 343 are set to be 20 mg/mL, 50 mg/mL, and 100 mg/mL, respectively. Marks of corresponding concentration intervals are set on the box cover 2 corresponding to the first detection line 341 , the second detection line 342 , and the third detection line 343 . When the albumin in the urine is negative, that is, less than 20mg/mL, the quality control band 344 and the first detection line 341, the second detection line 342, and the third detection line 343 are all colored, as shown in Figure 4 As shown in (a); when the albumin content in the urine was 20-50mg/mL, the quality control band 344 and the first detection line 341 and the second detection line 342 were colored, as shown in Figure 4 (b); When the urine concentration was 50-100mg/mL, the quality control zone 344 and the first detection line 341 were colored, as shown in Figure 4 (c); when the content of albumin in the urine was greater than 100mg/mL, only the quality The control band 344 develops color, as shown in FIG. 4( d ). In order to realize the detection of the concentration range of human albumin of 0-20mg/mL, 20-50mg/mL, 50-100mg/mL and greater than 100mg/mL, the ratio of each detection line coated on the nitrocellulose membrane is about 2: 3:5.

The detection method of the detection device is: when urinating, pinch one end of the absorbent paper 35, directly urinate the urine in the urine cup 23, the urine flows into the sample injection hole 21, and the excess urine flows along the opening on one side of the urine cup 23 24 discharge. Then the detection device is placed flat, and the urine flows to one end of the absorbent paper 35 through the filter sample paper 32 under the action of chromatography, and reaches the immune colloidal gold paper sheet 33. When the urine sample to be detected does not contain urinary albumin or albumin concentration If it is less than 20 mg/mL, the antigen in the urine reacts with a small amount of gold-labeled antibody, and the gold-labeled antigen that is not bound to the antigen is re-chromatographed to the positions of the first detection line 341, the second detection line 342, and the third detection line 343. The antigen on the nitrocellulose membrane 34 can capture the gold-labeled antibody, so the first detection line 341, the second detection line 342, and the third detection line 343 all develop color, and the quality control line 344 also develops color. What is obtained at this time is A negative result indicates that the albumin content is within the normal range, as shown in Figure 4(a); when the urine albumin content in the urine sample is greater than 100 mg/mL, the albumin in the urine sample is completely combined with the gold-labeled antibody to form When the gold-labeled antigen-antibody complex is chromatographed along the nitrocellulose membrane 34 to the position of the first detection line 341, there is no vacant site for the gold-labeled antibody to bind to human albumin on the first detection line 341, so the first The detection line 341 does not develop color, and similarly, the second detection line 342 and the third detection line 343 do not develop color, but only the quality control line 344 develops color, as shown in FIG. 4( d ). This test result shows that the content of microalbumin is high, and you should go to the hospital for treatment in time; when the content of albumin in the urine is 50-100 mg/mL, after the albumin in the urine binds to the gold-labeled antibody, it will pass along the nitrocellulose The prime film 34 is chromatographed to the first detection line 341, and the gold-labeled antibody still has a free site to bind to human albumin on the first detection line 341, so the first detection line 341 develops color, but there is no room for the gold-labeled antibody The sites on the second detection line 342 and the third detection line 343 are combined with human albumin, so the second detection line 342 and the third detection line 343 do not develop color, but the quality control line 344 develops color, as shown in Figure 4 ( As shown in c), this test result shows that the protein contained in the urine is relatively high, and it should be paid enough attention and go to the hospital for examination in time; when the albumin content in the urine is 20-50mg/mL, the protein in the urine After the albumin is combined with the gold-labeled antibody, the gold-labeled antibody has vacant sites to bind to the albumin on the first detection line 341 and the second detection line 342, so that both the first detection line 341 and the second detection line 342 are displayed. color, the third detection line 343 does not develop color, and the quality control line 344 develops color, as shown in Figure 4 (b), this test result shows that a certain amount of albumin is contained in the urine sample, which belongs to the early stage of microalbuminuria, That is, the early stage of kidney damage, if found for the first time, you should go to the hospital for further examination in time. If the quality control line 344 does not develop color, no matter whether the first detection line 341, the second detection line 342, and the third detection line 343 develop color, as shown in Figure 4 (e), Figure 4 (f), and Figure 4 (g) , as shown in Figure 4(h), all indicate that the detection device is invalid, and the detection results are not credible.

Example 2

This embodiment is a slight deformation of Embodiment 1, and its overall structure and detection belt are the same, the only difference is that the urine cup 23 is not integrally formed with the lid 2 but adopts the following structure: the bottom of the urine cup 23 has a Turn over the edge 27, which is fixed between the lid 2 and the box seat 1.

The urinary microalbumin detection device of the present invention can quickly and accurately detect different concentration ranges of urinary microalbumin, not only can be used for the prevention and regular inspection of early kidney damage, but also can be used for the treatment of microalbuminuria Monitoring, and easy to use, not dirty hands.

Claims (6)

1. A urine microalbumin detection device, comprising a box seat, a lid and a reagent strip, the lid is provided with a sampling hole and an observation port, and the reagent strip includes a support substrate and is positioned on the support substrate. The chromatographic structure comprises filter paper, immune colloidal gold paper sheet, immune nitrocellulose membrane and absorbent paper arranged head to tail in sequence, and is characterized in that: the bottom is also arranged on the sample loading hole A urine cup with an opening, the bottom opening of the urine cup has the same shape and size as the sample injection hole, the immunonitrocellulose membrane is provided with a quality control band and a plurality of detection lines, the quality control band and the plurality of detection lines The detection line is exposed in the observation port, and the urine cup is further provided with an opening on the side away from the chromatographic structure. The area of the sample hole, the opening is connected with a catheter, and the other end of the catheter is lower than the box seat. The detection method of the detection device is to pinch one end of the absorbent paper when urinating, and directly urinate the urine in the urine. In the cup, the urine flows into the sampling hole, and the excess urine is discharged along the opening on one side of the urine cup, then the detection device is placed flat, timed, and the result is interpreted within 3-8 minutes, and the sample is determined according to the number of detection lines. Concentration range. 2 . The urine microalbumin detection device according to claim 1 , wherein the urine cup and the lid are integrally formed. 3 . 3. The urine microalbumin detection device according to claim 1, characterized in that: the bottom of the urine cup has an edge that can be turned outwards, and the edge is fixed between the lid and the seat. 4. The urine microalbumin detection device according to claim 1, characterized in that: the lid matches the edge of the box seat and is bonded to each other, or the lid and the box seat are provided with a There are corresponding connecting parts for snapping or fastening, and are snapped or fastened through the connecting parts. 5. urine microalbumin detection device according to claim 1, is characterized in that: described immune colloidal gold paper sheet is coated with colloidal gold mark; Coated with anti-rabbit IgG polyclonal antibody on the described quality control belt, so The test line described above is coated with human albumin. 6. The urine microalbumin detection device according to claim 5, characterized in that: there are 3 detection lines, and the content of human albumin coated on them is increased step by step, and the detection lines correspond to the The corresponding concentration range is marked on the box cover.