CN103575913B - The urinalysis test card of microdose urine protein/UCr - Google Patents
The urinalysis test card of microdose urine protein/UCr Download PDFInfo
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- CN103575913B CN103575913B CN201310578610.5A CN201310578610A CN103575913B CN 103575913 B CN103575913 B CN 103575913B CN 201310578610 A CN201310578610 A CN 201310578610A CN 103575913 B CN103575913 B CN 103575913B
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- 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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- 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
- G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
- G01N33/6827—Total protein determination, e.g. albumin in urine
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- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/70—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving creatine or creatinine
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/04—Endocrine or metabolic disorders
- G01N2800/042—Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/34—Genitourinary disorders
- G01N2800/347—Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
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Abstract
The present invention relates to a kind of urinalysis test card of microdose urine protein/UCr, comprise sample pad, sample pad arranges well, feature is: in described sample pad, arrange microdose urine protein testing card and UCr test card respectively, microdose urine protein testing card is connected with well respectively with one end of UCr test card.Described microdose urine protein testing card arranges albumin detection line and the first nature controlling line, and albumin detection line is positioned at the one end near well; Described UCr test card arranges UCr detection line and the second nature controlling line, and UCr detection line is positioned at the one end near well.The position corresponding to albumin detection line at the back side of described microdose urine protein testing card arranges the first detect aperture, and the position corresponding to UCr detection line at the back side of UCr test card arranges the second detect aperture.The present invention can solve the interference problem being used alone Urine proteins at present and being subject to as Testing index; Preparation method is simple, easy to operate.
Description
Technical field
The present invention relates to a kind of urinalysis test card, especially a kind of urinalysis test card of microdose urine protein/UCr (ACR), belongs to external diagnosis reagent.
Background technology
Along with the progress of diabetic nephropathy mechanism, the index of early prediction diabetic nephropathy is also found gradually and is applied to clinical, but the goldstandard of current diagnosis diabetic nephropathy is the excretion rate measuring twenty-four-hour urine or the interval urine samples microalbumin that spends the night.And gather twenty-four-hour urine or spend the night the period urine sample reception trouble, time-consuming, patient compliance is poor.Therefore, both application are clinically limited.Research shows Urine proteins/UCr ratio (urinary albumin-to-creatinine ratio, ACR) mensuration is the sensitive indicator of diabetes albuminuria, and can be used to monitoring urinary protein excretion situation, the way utilizing UCr (Ucr) to correct makes the result of random urine microalbumin reliable and stable.First, under normal circumstances or kidney slight impaired time creatinine discharge rate substantially keep constant; Secondly, microdose urine protein all produces fluctuation by identical factor affects with the discharge rate of UCr, and therefore in individuality, microdose urine protein and creatinine ratio then keep relative constancy, avoids the one-sidedness of observing separately some indexs and can produce; And collect the method that single urina sanguinis detects its microdose urine protein/creatinine ratio there is the advantages such as simple, quick.
Current creatinine product mainly contains two classes in form: dry chemical and enzyme process.
The patent of creatinine has: " the creatinine assay kit " of Ningbo Pu Ruibai Bioisystech Co., Ltd, " creatinine urine test paper and the preparation method " of Dirui Industry Co., Ltd., Changchun, Shanghai Zhicheng Biological Technology Co., Ltd.'s " creatinine reagent box ", Aijie Bioscience Co., Ltd., Suzhou's " creatinine diagnosis/determination reagent and creatine concentration determination method ", Aijie Bioscience Co., Ltd., Suzhou's " method for measurement of concentration of creatine diagnosis reagent (box) and creatinine ", Temin Biological Medicine Technology Co., Ltd., Shanghai's " urine methyl amimoacetic acid and creatinine assay kit ", East China Institute of Technology's " isotopic dilution electron spray extraction ionization tandem mass spectrum detects the analytical approach of UCr fast ", Ningbo Meikang Biotechnology Co., Ltd.'s " two step enzyme method assay methods of creatinine in serum and mensuration reagent ", Fujian Hongcheng Biotechnology Pharmaceutical Co., Ltd.'s " chemical luminescent detecting method of creatinine in serum ", Li Li and " two-step enzyme testing method of creatinine in serum ", Dong Li " a kind of kit detecting creatinine ", Suzhou Weiqi Biology Science and Technology Co., Ltd.'s " a kind of urine creatine quantitative test card ", Nanjing University of Technology's " a kind of urine creatinine Test paper and preparation method thereof ", all living creatures' thing development in science and technology company limited " a kind of serum creatinine mensuration kit " etc. are closed in Taide, Tianjin.
The product form of current detection microdose urine protein is mainly dry chemical method.Method comprises: colloidal gold method, immunoturbidimetry, immune turbidimetry, turbidimetry, chemoluminescence method, latex enhancing immune turbidimetry and euzymelinked immunosorbent assay (ELISA).Patent comprises: " test strips of semi-quantitative determination of urinary trace albumin " of biological medicine company (Beijing) company limited of Blue-Cross, " the detecting the resonance scattering spectrometry of trace of albumin in human urine " of Guangxi Normal University, " a kind of colloid selenium test paper for semi-quantitative determination of urinary trace albumin " of Li Hongyu, " a kind of microdose urine protein testing chip and the proving installation thereof " of Yicheng Biological Electronic Technology Co., Ltd., Beijing, " a kind of microdose urine protein liquid quantitative detects reagent and method " of Jiaxing 979 Bioisystech Co., Ltd etc.
Summary of the invention
The object of the invention is to overcome the deficiencies in the prior art, a kind of urinalysis test card of microdose urine protein/UCr is provided, to solve the interference problem being used alone Urine proteins at present and being subject to as Testing index.
According to technical scheme provided by the invention, a kind of urinalysis test card of microdose urine protein/UCr, comprise sample pad, sample pad arranges well, feature is: in described sample pad, arrange microdose urine protein testing card and UCr test card respectively, microdose urine protein testing card is connected with well respectively with one end of UCr test card.
As a further improvement on the present invention, described microdose urine protein testing card arranges albumin detection line and the first nature controlling line, albumin detection line is positioned at the one end near well; Described UCr test card arranges UCr detection line and the second nature controlling line, and UCr detection line is positioned at the one end near well.
As a further improvement on the present invention, the position corresponding to albumin detection line at the back side of described microdose urine protein testing card arranges the first detect aperture, and the position corresponding to UCr detection line at the back side of UCr test card arranges the second detect aperture.
As a further improvement on the present invention, described microdose urine protein testing card and UCr test card can rotate centered by sample pad.
As a further improvement on the present invention, described urine flesh bar test card comprises diffusion layer, reagent layer, indicator layer and supporting layer.
The present invention can determine the ratio (ACR) of microdose urine protein/creatinine in urine, can solve the technical matterss such as existing sensing range is narrow, operation steps is complicated, poor accuracy; The present invention is highly sensitive, and quick and precisely, preparation method is simple, easy to operate, is convenient to popularize, is suitable for large, medium and small Various Hospitals widespread use.
Accompanying drawing explanation
Fig. 1 is structural representation of the present invention.
Fig. 2 is the rear view of Fig. 1.
The schematic diagram of Fig. 3 to be microdose urine protein testing card and UCr test card be 0 ° of angle.
The schematic diagram of Fig. 4 to be microdose urine protein testing card and UCr test card be 180 ° of angles.
Fig. 5 is the schematic cross-sectional view of described UCr test card.
Embodiment
Below in conjunction with concrete accompanying drawing, the invention will be further described.
As shown in Fig. 1 ~ Fig. 5: as described in the urinalysis test card of microdose urine protein/UCr comprise the first nature controlling line 1, albumin detection line 2, second nature controlling line 3, UCr detection line 4, microdose urine protein testing card 7, UCr test card 8, sample pad 9, well 10, first detect aperture 11, second detect aperture 12, diffusion layer 13, reagent layer 14, indicator layer 15, supporting layer 16 etc.
As shown in Figure 1, the present invention includes sample pad 9, sample pad 9 is arranged well 10, sample pad 9 arranges microdose urine protein testing card 7 and UCr test card 8 respectively, microdose urine protein testing card 7 is connected with well 10 respectively with one end of UCr test card 8, can draw the sample at well 10 place, sample spreads along test card respectively then; As shown in Figure 3, Figure 4, described microdose urine protein testing card 7 and UCr test card 8 can rotate centered by sample pad 9, can form the angle of 0 ° or 180 ° between microdose urine protein testing card 7 and UCr test card 8;
As shown in Figure 1, described microdose urine protein testing card 7 arranges albumin detection line 2 and the first nature controlling line 1, albumin detection line 2 is positioned at the one end near well 10; Described UCr test card 8 arranges UCr detection line 4 and the second nature controlling line 3, and UCr detection line 4 is positioned at the one end near well 10; The albumin that described albumin detection line 2 runs in urine can form aubergine response line, if not containing albumin in urine, then albumin detection line 2 does not develop the color or develops the color more shallow; Described urine flesh bar detection line 4 UCr run in urine can form aubergine response line, if not containing UCr in urine, then UCr detection line 4 does not develop the color or develops the color more shallow;
As shown in Figure 2, the position corresponding to albumin detection line 2 at the back side of described microdose urine protein testing card 7 arranges the first detect aperture 11, and the position corresponding to UCr detection line 4 at the back side of UCr test card 8 arranges the second detect aperture 12; The light that sends of detector inside can detect through the first detect aperture 11 and the second detect aperture 12, can according to the reflectivity at albumin detection line 2 and UCr detection line 4 place, detects the content of albumin in urine and UCr;
As shown in Figure 5, described urine flesh bar test card 8 comprises diffusion layer 13, reagent layer 14, indicator layer 15 and supporting layer 16; The how empty polymkeric substance that diffusion layer 13 is made up of cellulose acetate, this capillary reticulate texture can make sample solution be distributed to lower floor fast, equably, and some interference impurity of energy filtering; Reagent layer 14 mainly contains creatinine imido base hydrolase≤1.38U, N-methyl hydantoin enzyme≤0.108U, methyl amimoacetic acid water solution enzyme≤0.439U, flesh ammonia acid oxygen enzyme≤0.475U, crosses oxide enzyme≤2.29U, anti-bad blood acid oxidase≤0.285U, ATP:82.8 μ g, indicator: 19.5 μ g, buffering agent.The dyestuff of reagent layer 14 in indicator layer 15 in conjunction with time, formed coloured complex, it is directly proportional to analyte concentration.Supporting layer 16 supporting functions, and very printing opacity, the light that detector inside sends arrives to be reflected after bottom diffusion layer and then penetrates reagent layer indicator layer and supporting layer arrives receiver through optical filter and demonstrates result.
The present invention adopts microdose urine protein testing card 7 and UCr test card 8 to share a sample pad 9, and sample pad 9 can draw the sample at well 10 place, then spreads along two test cards respectively.
The Cleaning Principle of microdose urine protein testing card 7 is: urine is instilled well 10, wrap by anti human albumin's monoclonal antibody of dissolving colloid gold label in well 10, if containing albumin in urine specimen, compete golden labelled antibody with the human albumin of albumin detection line 2 place bag quilt to react, form aubergine detection line; Collaurum continues to go upward to the first nature controlling line 1 place, forms mauve response line; If albumin-free in urine sample, then albumin detection line 2 does not develop the color.
The Cleaning Principle of UCr test card 8 is: urine is instilled well 10, if containing creatinine in sample, UCr detection line 4 forms aubergine detection line, collaurum continue up in second by nature controlling line 3 place, form mauve response line; If without creatinine in urine sample, then UCr detection line 4 does not develop the color.
Claims (3)
1. the urinalysis test card of microdose urine protein/UCr, comprise sample pad (9), sample pad (9) is arranged well (10), it is characterized in that: in described sample pad (9), arrange microdose urine protein testing card (7) and UCr test card (8) respectively, microdose urine protein testing card (7) is connected with well (10) respectively with one end of UCr test card (8); Described microdose urine protein testing card (7) and UCr test card (8) rotate centered by sample pad (9);
Described microdose urine protein testing card (7) arranges albumin detection line (2) and the first nature controlling line (1), and albumin detection line (2) is positioned at the one end near well (10); Described UCr test card (8) arranges UCr detection line (4) and the second nature controlling line (3), and UCr detection line (4) is positioned at the one end near well (10).
2. the urinalysis test card of microdose urine protein/UCr as claimed in claim 1, it is characterized in that: the position corresponding to albumin detection line (2) at the back side of described microdose urine protein testing card (7) arranges the first detect aperture (11), the position corresponding to UCr detection line (4) at the back side of UCr test card (8) arranges the second detect aperture (12).
3. the urinalysis test card of microdose urine protein/UCr as claimed in claim 1, is characterized in that: described urine flesh bar test card (8) comprises diffusion layer (13), reagent layer (14), indicator layer (15) and supporting layer (16).
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| CN201310578610.5A CN103575913B (en) | 2013-11-18 | 2013-11-18 | The urinalysis test card of microdose urine protein/UCr |
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| CN103575913B true CN103575913B (en) | 2015-08-19 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107219217A (en) * | 2017-05-19 | 2017-09-29 | 十堰市太和医院（湖北医药学院附属医院） | Special check out test set of diabetes |
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| CN106353511A (en) * | 2016-08-19 | 2017-01-25 | 基蛋生物科技股份有限公司 | Urinary microalbumin (U-mALb)/urinary creatinine (U-Cr) integrated assay bigeminy strip and preparation method thereof |
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| CN107091927B (en) * | 2017-06-28 | 2018-11-06 | 安徽惠邦生物工程有限公司 | A kind of kit for diabetogenous nephrosis disease early diagnosis |
| CN107132352B (en) * | 2017-07-07 | 2019-02-19 | 济南齐鲁医学检验有限公司 | A kind of microalbumin creatinine ratio (ARC) detection device |
| CN109239366B (en) * | 2018-11-08 | 2024-03-26 | 北京怡成生物电子技术股份有限公司 | Urine microalbumin/urinary creatinine integrated test card |
| CN110988365A (en) * | 2019-10-31 | 2020-04-10 | 湖南工业大学 | Quantitative immune colloidal gold detection card and kit for cystatin C, microalbuminuria and urinary creatinine |
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