CN104535768B - A kind of microdose urine protein detecting device - Google Patents
A kind of microdose urine protein detecting device Download PDFInfo
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- CN104535768B CN104535768B CN201410692826.9A CN201410692826A CN104535768B CN 104535768 B CN104535768 B CN 104535768B CN 201410692826 A CN201410692826 A CN 201410692826A CN 104535768 B CN104535768 B CN 104535768B
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- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
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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
Technical field
The present invention relates to medical clinic applications technical field, particularly to a kind of quantitative microdose urine protein detecting device adopting immune colloid gold Fast Detection Technique to prepare。
Background technology
Microalbumin refers to the term of reference beyond Healthy People of the albumin content in urine, improper a small amount of existence in urine, excretion is more than 30mg/ days or 20mg/L, and it is typically considered the important early clinic mark of renal failure, diabetes and cardiovascular disease complication。Therefore, in urine, the early diagnosis of disease, early treatment and reduction risk are had important reference value and clinical meaning by the detection of microalbumin。
The detection mode of existing microdose urine protein is: take urine with urine cup, then drips on the application of sample pad of microdose urine protein Test paper by the urine of dropper absorption certain volume, then carries out chromogenic assay。Adopt the method, it is necessary to additionally prepare urine cup, dropper, add sampling cost, and urine cup is generally shorter, during sampling, easily pollute hands, urine transfer process there is also the problem that urine is unrestrained。
Summary of the invention
In order to solve the problems referred to above, accurately know the concentration range of microdose urine protein simultaneously, the invention provides the device that a kind of quantitative microdose urine protein quickly detects, it has the ability of detection by quantitative, simple to operate, react quick, economical and practical, need not can realize real-time measurement by extra accessory, be particularly suitable for individual and test oneself。
Microdose urine protein detecting device provided by the invention, including cassette holder, lid and reagent strip, described lid is provided with well and observation panel, described reagent strip includes supporting substrate and being positioned at the chromatography structure on described support substrate, this chromatography structure includes the filter sample paper of headtotail arrangement successively, 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, the bottom opening of this urine cup 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 described detection line are exposed in described observation panel。
Preferably, described urine cup is one-body molded with lid。
Preferably, have bottom described urine cup can be turned-out edge, this edge is fixed between described lid and described cassette holder。
Preferably, described urine cup is additionally provided with an opening away from the side of described chromatography structure, and the least significant end of described opening is from the area that height H is sample detection minimum dosage/well of described well。
Preferably, described opening and a conduit connect, and described conduit other end opening is lower than described cassette holder。
Preferably, the edge of described lid and described cassette holder matches and mutually bonds, or described lid is provided with corresponding engaging or fastening connection member with described cassette holder, and fastens through described connection member or fasten。
Preferably, the described immune colloid gold scraps of paper are coated with colloid gold label；Described quality control band is coated with anti-rabbit IgG multi-resistance, described detection line is coated with human albumin。
Preferably, described detection line is 3, and on it, the content of coated human albumin is by increasing again, and the described lid that described detection line is corresponding has the mark of corresponding concentration ranges。
The detection method of described detecting device is: when urinating, hands pinches absorbent paper one end, directly urine is urinated in urine cup, and urine flows into well, and the unnecessary urine opening along urine cup side is discharged。Then detecting device is kept flat, timing, sentence read result in 3-8 minute, determine the concentration ranges of sample according to the bar number of detection line。
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。
Accompanying drawing explanation
Fig. 1 is the microdose urine protein structure of the detecting device schematic diagram of the present invention；
Fig. 2 is the microdose urine protein structure of the detecting device explosive view of the present invention；
Fig. 3 is the lid sectional view of the embodiment of the present invention 1；
Fig. 4 (a)-(h) is the colour developing situation of the embodiment of the present invention 1 strip；
Fig. 5 is the lid sectional view of the embodiment of the present invention 2。
Detailed description of the invention
In conjunction with specific embodiment, the present invention will be described in detail。
Embodiment 1
As shown in Figure 1, Figure 2 and Figure 3, the microdose urine protein detecting device of the present invention, including cassette holder 1, lid 2 and reagent strip 3, lid 2 is provided with well 21 and observation panel 22, reagent strip 3 includes supporting substrate 31 and being positioned at the chromatography structure supported on substrate 31, and this chromatography structure includes the filter sample paper 32 of headtotail arrangement, the immune colloid gold scraps of paper 33, immunity nitrocellulose filter 34 and absorbent paper 35 successively。Being provided with the urine cup 23 of bottom opening on well 21, urine cup 23 is one-body molded with lid 2。The bottom opening of this urine cup 23 and well 21 shape, size are identical, being provided with quality control band 344 and first on immunity nitrocellulose filter 34 and detect line the 341, second detection line the 342, the 3rd detection line 343, quality control band 344 and the first detection line 341, second detect line the 342, the 3rd detection line 343 and are exposed in observation panel 22。Being additionally provided with an opening 24 at urine cup 23 away from the side of chromatography structure, the least significant end of opening 24 is from the area that height H is sample detection minimum dosage/well 21 of well 21。Opening 24 is connected with a conduit 25, and other end opening 26 is lower than cassette holder 1, it is preferable that conduit 25 passes from the hole 11 hole 36 and cassette holder 1 of reagent strip 3。Adopting such design, it is possible to make the volume of urine in urine cup 23 be held below urine cup opening 24 horizontal level, unnecessary urine volume will flow away along the conduit 25 being connected with opening 24, with Anti-spatter, dirty hands。The edge of lid 2 and cassette holder 1 matches and mutually bonds, or lid 2 is provided with corresponding engaging or fastening connection member with cassette holder 1, and is connected parts and fastens or fasten。The immune colloid gold scraps of paper 33 are coated with colloid gold label；Being coated with anti-rabbit IgG multi-resistance on quality control band 344, the first detection line 341, second detects and is coated with human albumin on line the 342, the 3rd detection line 343, and the content of human albumin is by increasing again。First detection line 341, second is set and detects concentration flex point respectively 20mg/mL, 50mg/mL, 100mg/mL of line the 342, the 3rd detection line 343。Detect line 341, second first and detect the mark that corresponding concentration ranges is set on the lid 2 of line the 342, the 3rd detection line 343 correspondence。When the albumin in urine is negative namely less than 20mg/mL, quality control band 344 and the first detection line 341, second detect line the 342, the 3rd detection line 343 totally four articles of developed band and all develop the color, as shown in Fig. 4 (a)；When the albumin content in urine is 20-50mg/mL, quality control band 344 and the first detection line 341, second detect line 342 and develop the color, as shown in Fig. 4 (b)；When urine concentration is 50-100mg/mL, quality control band 344 and the first detection line 341 develop the color, as shown in Fig. 4 (c)；When content albuminous in urine is more than 100mg/mL, only quality control band 344 develops the color, as shown in Fig. 4 (d)。Concentration range in order to realize 0-20mg/mL, 20-50mg/mL, 50-100mg/mL and the human albumin more than 100mg/mL detects, and is coated on the ratio that nitrocellulose filter respectively detects on line and is about 2:3:5。
The detection method of this detecting device is: when urinating, hands pinches absorbent paper 35 one end, directly urine is urinated in urine cup 23, and urine flows into well 21, and the unnecessary urine opening 24 along urine cup 23 side is discharged。Then detecting device is kept flat, urine flows to absorbent paper 35 one end under chromatography effect through filtering sample paper 32, reach the immune colloid gold scraps of paper 33, when in urine sample to be detected without urinaryalbumin or albumin concentration less than 20mg/mL, antigen in urine reacts with a small amount of gold labeling antibody, the gold mark antigen chromatography again being not bound with antigen detects line 341 to first, second detection line 342, during the 3rd detection line 343 position, it is fixed on the antigen on nitrocellulose filter 34 and can catch gold labeling antibody, therefore the first detection line 341, second detection line 342, 3rd detection line 343 all develops the color, nature controlling line 344 also develops the color, what now obtain is negative findings, represent that albumin content belongs to normal range, as shown in Fig. 4 (a)；When the urinary albumin content contained in urine sample is more than 100mg/mL, albumin in urine sample is completely combined with gold labeling antibody, form gold mark antigen antibody complex, when detecting line 341 position along nitrocellulose filter 34 chromatography to first, gold labeling antibody has not had vacant site to be combined with the first human albumin detected on line 341, therefore the first detection line 341 does not develop the color, in like manner, second detection line the 342, the 3rd detects line 343 and does not also develop the color, and only nature controlling line 344 develops the color, as shown in Fig. 4 (d)。This testing result shows that the content of microalbumin is high, should remove hospital treatment in time；When the albumin content in urine is 50-100mg/mL, after albumin in urine is combined with gold labeling antibody, line 341 is detected to first again along nitrocellulose filter 34 chromatography, gold labeling antibody also has the human albumin that vacant site is detected on line 341 with Article 1 to be combined, therefore the first detection line 341 develops the color, but gold labeling antibody does not have vacant site and the second detection line 342, human albumin on 3rd detection line 343 combines, therefore the second detection line 342, 3rd detection line 343 does not develop the color, and nature controlling line 344 develops the color, as shown in Fig. 4 (c), this testing result illustrates that the albumen contained in urine is higher, enough attention should be caused and remove examination in hospital in time；When the albuminous content in urine is 20-50mg/mL, after albumin in urine is combined with gold labeling antibody, gold labeling antibody has vacant site and the first detection line 341, albumin bound on second detection line 342, so that the first detection line 341, second detection line 342 all develops the color, Article 3 detection line 343 does not develop the color, nature controlling line 344 develops the color, as shown in Fig. 4 (b), this testing result illustrates in urine sample containing a certain amount of albumin, belong to the early stage of microalbuminuria, the i.e. early stage of kidney injury pathological changes, if first discovery should go to hospital to do further inspection in time。If nature controlling line 344 does not develop the color, no matter the first detection line 341, second detects line 342, whether Article 3 detection line 343 develops the color, as shown in Fig. 4 (e), Fig. 4 (f), Fig. 4 (g), Fig. 4 (h), all representing that detecting device lost efficacy, testing result is insincere。
Embodiment 2
The present embodiment is the micro-strain to embodiment 1, its overall structure is all identical with detection band, only difference is that, urine cup 23 is not one-body molded with lid 2 but adopts following structure: have bottom urine cup 23 can be turned-out edge 27, this edge 27 is fixed between lid 2 and cassette holder 1。
The microdose urine protein detecting device of the present invention can detect the variable concentrations scope of microdose urine protein quickly and accurately, can be used not only for the prevention of early stage kidney injury pathological changes and make regular check on, and may be used for the monitoring in microalbuminuria therapeutic process, and easy to use, not dirty hands。
Claims (6)
1. a 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 supporting substrate and being positioned at the chromatography structure on described support substrate, this chromatography structure includes the filter sample paper of headtotail arrangement successively, 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, the bottom opening of this urine cup 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 described detection line are exposed in described observation panel, described urine cup is additionally provided with an opening away from the side of described chromatography structure, the least significant end of described opening is from the area that height H is sample detection minimum dosage/well of described well, described opening and a conduit connect, described conduit other end opening is lower than described cassette holder, the detection method of described detecting device pinches absorbent paper one end for the hands when urinating, directly urine is urinated in urine cup, urine flows into well, the unnecessary urine opening along urine cup side is discharged, then detecting device is kept flat, timing, sentence read result in 3-8 minute, bar number according to detection line determines the concentration ranges of sample。
2. microdose urine protein detecting device according to claim 1, it is characterised in that described urine cup is one-body molded with lid。
3. microdose urine protein detecting device according to claim 1, it is characterised in that: have bottom described urine cup can be turned-out edge, this edge is fixed between described lid and described cassette holder。
4. microdose urine protein detecting device according to claim 1, it is characterized in that: the edge of described lid and described cassette holder matches and mutually bonds, or described lid is provided with corresponding engaging or fastening connection member with described cassette holder, and fastens through described connection member or fasten。
5. microdose urine protein detecting device according to claim 1, it is characterised in that: the described immune colloid gold scraps of paper are coated with colloid gold label；Described quality control band is coated with anti-rabbit IgG multi-resistance, described detection line is coated with human albumin。
6. microdose urine protein detecting device according to claim 5, it is characterised in that: described detection line is 3, and on it, the content of coated human albumin is by increasing again, and the described lid that described detection line is corresponding has the mark of corresponding concentration ranges。
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| CN201410692826.9A CN104535768B (en) | 2014-11-25 | 2014-11-25 | A kind of microdose urine protein detecting device |
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| CN201410692826.9A CN104535768B (en) | 2014-11-25 | 2014-11-25 | A kind of microdose urine protein detecting device |
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| CN104535768A CN104535768A (en) | 2015-04-22 |
| CN104535768B true CN104535768B (en) | 2016-06-22 |
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| CN104991059A (en) * | 2015-07-17 | 2015-10-21 | 青岛中创生物科技有限公司 | Gradient colloidal gold immunochromatography quantitative detection apparatus, and method and use thereof |
| CN105527438A (en) * | 2015-12-25 | 2016-04-27 | 广州甘蔗糖业研究所 | Colloidal gold test strip for semi-quantitative detection of alpha-glucan, and detection method thereof |
| CN109490546A (en) * | 2018-12-21 | 2019-03-19 | 广东顺德工业设计研究院(广东顺德创新设计研究院) | Six detection devices of drugs and preparation method thereof |
| CN110609144B (en) * | 2019-09-04 | 2023-08-18 | 泗县微腾知识产权运营有限公司 | Pregnant stick is tested in family planning branch of academic or vocational study special use |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN2224423Y (en) * | 1995-04-04 | 1996-04-10 | 何彩琴 | Body-fluid testing sample cup |
| US7393697B2 (en) * | 2003-06-06 | 2008-07-01 | Advantage Diagnostics Corporation | Diagnostic test for analytes in a sample |
| US8128871B2 (en) * | 2005-04-22 | 2012-03-06 | Alverix, Inc. | Lateral flow assay systems and methods |
| CN2771863Y (en) * | 2005-01-19 | 2006-04-12 | 杨志华 | Medical rapid test cup |
| CN202512121U (en) * | 2012-02-27 | 2012-10-31 | 上海凯创生物技术有限公司 | Micro-albuminuria (MAU) colloidal gold quantitative detection kit |
| CN102707067A (en) * | 2012-05-24 | 2012-10-03 | 蓝十字生物药业（北京）有限公司 | Test strip for semi-quantitative detection of microalbuminuria |
| CN202837045U (en) * | 2012-11-01 | 2013-03-27 | 艾群 | Aseptic urine collector |
| CN103969433A (en) * | 2013-01-29 | 2014-08-06 | 艾博生物医药(杭州)有限公司 | Sample detection apparatus |
| CN203432976U (en) * | 2013-08-07 | 2014-02-12 | 天津中新科炬生物制药有限公司 | Fast semi-quantitative trace urinary albumin detection device |
| CN203894237U (en) * | 2014-06-03 | 2014-10-22 | 浙江省海洋水产研究所 | Furazolidone metabolite immune colloidal gold rapid detection card |
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Effective date of registration: 20191211 Address after: Room 207, main office building, No.118 Longxing Road, Haining Economic Development Zone, Haining City, Jiaxing City, Zhejiang Province Patentee after: Haining Economic Development Industrial Park Development and Construction Co., Ltd Address before: 523112, Dongguan, Guangdong, Dongcheng District Province, main road, Dongcheng, South Road, No. 81, brilliant business building, 8 floor, A03 one Patentee before: Dongguan City Guanxin Enterprise Management Consulting Co., Ltd. |
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