CN102103140A - Multilayer film dry plate used in biochemical analysis - Google Patents
Multilayer film dry plate used in biochemical analysis Download PDFInfo
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- CN102103140A CN102103140A CN2010105494870A CN201010549487A CN102103140A CN 102103140 A CN102103140 A CN 102103140A CN 2010105494870 A CN2010105494870 A CN 2010105494870A CN 201010549487 A CN201010549487 A CN 201010549487A CN 102103140 A CN102103140 A CN 102103140A
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Abstract
The invention discloses a multilayer film dry plate used in biochemical analysis, comprising an upper support layer, a lower support layer, a diffusion layer and a reagent layer, wherein, the upper support layer is adhered with the lower support layer mutually; a test area of the upper support layer is provided with a sampling hole; the corresponding position of the lower support layer is provided with a test hole; the diffusion layer and the reagent layer are adhered together through a coating process, and are arranged between the upper support layer and the lower support layer on the sampling hole and the test hole; and the multilayer film dry plate also comprises an euphotic layer which is arranged on the test hole to be coincided with the reagent layer. By the multilayer film dry plate used in biochemical analysis provided by the invention, the accuracy and the precision of detection can be improved, and the retention time of the dry plate also can be improved.
Description
Technical field
The invention belongs to technical field of in-vitro clinical diagnostic reagent, be specifically related to the multilayer film dry plate that is used for biochemical analysis with a kind of.
Background technology
The analysis room of biofluid is very important in the diagnosis of disease, as blood, urine, cerebrospinal fluid etc.That conventional biochemical analysis has been widely used in is clinical, sample examination etc.Existing biochemical analyzer and matched reagent and a lot of products are arranged, as Olympus AU5400 series automatic clinical chemistry analyzer, Beckman SYNCHRONization-LX20 series automatic clinical chemistry analyzer, Hitachi's 7180 serial automatic clinical chemistry analyzers, the module-integrated analytic system of Luo Shi MODULAR, auspicious Omlab BS-300 automatic clinical chemistry analyzer advanced in years etc., and portray various semiautomatic biochemistries such as L-3280 semi-automatic biochemical analyzer, magnificent more YS-2000III type semi-automatic biochemical analyzer and analyze series.Yet these instruments all need to use various liquid reagents, and this makes troubles to some use occasion.The one, the liquid reagent retention time can not be long; The 2nd, liquid reagent is not easy to transportation.So the dry type biochemical analysis also grows up gradually, as a kind of means of dealing with problems.At present, various blood glucose meter are exactly typical case's representative, need not additional agents.
The employed dry chemical product of clinical emergency treatment biochemical indicator is The foreign chicken products basically, and three types product is probably arranged.The first kind is to be the dry chemical technology of the multilayer film dry plate of representative with the Johson ﹠ Johnson, utilizes the coating technology of sensitive film that reagent such as diffusion layer, reflection horizon, reagent layer are coated on the clear support layer, measures the variation of optical density from the reverse side of supporting layer.Second class is the dry chemical technology of kyoto, Japan company, and it consists of a plastic support layer, and an end is that reaction zone comprises sample layer and reagent layer, and reagent layer is that certain fabric is as reagent carrier.Application of sample and test are carried out on top simultaneously.The 3rd class is the dry chemical product of Roche Holding Ag, reagent layer is coated on the fiber or fabric of multifibres, whole blood laterally filters back and last reagent layer contact reaction by glass fibre, cover on the transparent supporting layer by top and to scribble reagent layer and reflection horizon, topmost covers one deck synthon screen cloth as the application of sample layer.With the Johson ﹠ Johnson is the multilayer film dry plate complex manufacturing of representative, material installation is required high; With kyoto, Japan company is that the dry plate of representative has some defective, as being easy to generate certain bubble, excess liq etc. at the application of sample end, and application of sample and be determined at same test sample product and may cause interference.
Domestic have company to apply for the dry chemical patent, the patent 200720072185.2 and 200720073442.4 of Shanghai Ke Hua bio-engineering corporation application, the patent 200610161430.7 of Shen, Wuxi auspicious biological products company limited, the dry chemistry test paper slip of the mensuration of AMS and alanine aminotransferase has wherein been described, the method of using in these patents is that the detection liquid that will prepare directly is immersed on the filter paper, be bonded on the plastic basis material then and test, this method is similar to the pH test paper, lacks accuracy and accuracy.
Dry chemical is used more and more widely in present biochemical analysis, and improving dry plate is vital to the diffusion of sample and the influence factor that suppresses in the chemical reaction in the overall performance that improves dry plate.
Summary of the invention
For overcoming deficiency of the prior art, the object of the present invention is to provide a kind of multilayer film dry plate that is used for biochemical analysis, this multilayer film dry plate can improve the accuracy and the precision of detection, the holding time that can also improve dry plate simultaneously.
In order to solve the problems of the technologies described above, realize above-mentioned purpose, the present invention is achieved through the following technical solutions:
A kind of multilayer film dry plate that is used for biochemical analysis, comprise upper support layer, lower support layer, diffusion layer and reagent layer, upper support layer and lower support layer are bonded together mutually, test section at the upper support layer has well, the correspondence position of lower support layer has instrument connection, after diffusion layer and reagent layer are bonded together by coating process, is arranged between the upper support layer and lower support layer at well and instrument connection place, also comprise a photic zone, photic zone is arranged on the instrument connection place and reagent layer coincides.
Preferably, the gap between described upper support layer and the lower support layer is provided with a middle support layer.
Above-mentioned multilayer film dry plate, the main sample that uses is serum, blood plasma and urine, if be to use whole blood, needs in advance whole blood to be handled, and obtains serum.Preferably, a filtering layer can be set, to filter out haemocyte on diffusion layer.
Further, described photic zone can be prepared from by various transparent plastics (as polythene PE, polypropylene PP, polyethylene terephtalate, polycarbonate etc.), glass etc., especially is best with PET.The thickness of photic zone 1 is 20-300 μ m, is the best with 100-200 μ m.The visible-range transmittance is best more than 95% more than 80%.Light source is from instrument connection incident, and sees through photic zone.
Further, sample can directly join in the diffusion layer by well.The effect of diffusion layer is uniformly with sample diffusion and be penetrated into down in one deck, and plays catoptrical effect.In some test index, diffusion layer also plays the effect of reaction in advance, wherein also includes some reaction reagent, as cholesterol, transaminase etc.In addition, diffusion layer also plays the effect that detects factor of influence of removing.Diffusion layer is each perforated membrane to equal property of layer of even, by hydrophilic high molecular material, and as cellulose acetate, and white reflection material formation, as titanium dioxide, barium sulphate powder etc.The diffusion layer wet-film thickness is generally 100-300 μ m, and build is generally in the scope of 100-200 μ m.
Further, reagent layer is the zone that chemical reaction mainly takes place, when sample after the upper strata arrives reagent layer, cause series of chemical, mainly be change color.Reagent layer can be one deck, also can be multilayer, mainly by concrete chemical reaction decision.Reagent layer generally is made of water-soluble material such as gelatin, agar and the reagent that participates in chemical reaction, as buffer system, enzyme, protective agent, stabilizing agent etc.Wet-film thickness is generally 50-200 μ m, and build generally is best about 10-100 μ m.When sample behind reagent layer generation chemical reaction, can detect by instrument connection.
Further, lower support layer, middle support layer and upper support layer are for the ease of fixing multilayer film dry plate and design.Supporting layer can be two-layer, also can be three layers, and protection is the multilayer film dry plate fixedly, is convenient to use on the dry analysis instrument.
By the utilization of above technology, the multilayer film dry plate that is used for biochemical analysis of the present invention can improve the accuracy and the precision of detection, the holding time that can also improve dry plate simultaneously.
Above-mentioned explanation only is the general introduction of technical solution of the present invention, for can clearer understanding technological means of the present invention, and can be implemented according to the content of instructions, below with preferred embodiment of the present invention and conjunction with figs. describe in detail as after.The specific embodiment of the present invention is provided in detail by following examples and accompanying drawing thereof.
Description of drawings
The present invention is further detailed explanation below in conjunction with drawings and embodiments.
Fig. 1 is the stratiform synoptic diagram of an embodiment of the multilayer film dry plate that is used for biochemical analysis of the present invention.
Fig. 2 is the stratiform synoptic diagram of another embodiment of the multilayer film dry plate that is used for biochemical analysis of the present invention.
Number in the figure explanation: 1, photic zone, 2, reagent layer, 3, diffusion layer, 4, instrument connection, 5, well, 6, the lower support layer, 7, middle support layer, 8, the upper support layer, 9, filtering layer.
Embodiment
Referring to shown in Figure 1, a kind of multilayer film dry plate that is used for biochemical analysis, comprise upper support layer 8, lower support layer 6, diffusion layer 3 and reagent layer 2, upper support layer 8 and lower support layer 6 are bonded together mutually, have well 5 in the test section of upper support layer 8, the correspondence position of lower support layer 6 has instrument connection 4, after diffusion layer 3 and reagent layer 2 are bonded together by coating process, be arranged between the upper support layer 8 and lower support layer 6 at well 5 and instrument connection 4 places, also comprise a photic zone 1, photic zone 1 is arranged on instrument connection 4 places and reagent layer 2 coincides.
Preferably, the gap between described upper support layer 8 and the lower support layer 6 is provided with a middle support layer 7.
Preferably, described referring to Fig. 2, a filtering layer 9 is set on the described diffusion layer 3.
Example 1: the multilayer film dry plate that is used to test blood sugar
Table 1 configuration reagent layer coating liquid proportioning:
| Reagent | Concentration |
| Gelatin | 120g/L |
| Glucose oxidase | 77KU/L |
| The peroxide oxidation enzyme | 360KU/ |
| 1, the 7-dihydroxy naphthlene | 6.7g/L |
| The amino antipyrine of 4- | 11g/L |
Table 2 diffusion layer proportioning:
| Material | Concentration |
| Cellulose acetate | 29g/L |
| BaSO4 | 360g/L |
| Zeyssatite | 100g/L |
| Surfactant | 7g/L |
The foregoing description just is to allow the one of ordinary skilled in the art can understand content of the present invention and enforcement according to this for technical conceive of the present invention and characteristics being described, its objective is, can not limit protection scope of the present invention with this.The variation or the modification of every equivalence that the essence of content has been done according to the present invention all should be encompassed in protection scope of the present invention.
Claims (10)
1. multilayer film dry plate that is used for biochemical analysis, comprise upper support layer (8), lower support layer (6), diffusion layer (3) and reagent layer (2), upper support layer (8) and lower support layer (6) are bonded together mutually, have well (5) in the test section of upper support layer (8), the correspondence position of lower support layer (6) has instrument connection (4), after diffusion layer (3) and reagent layer (2) coincide successively, be arranged between the upper support layer (8) and lower support layer (6) that well (5) and instrument connection (4) locate, it is characterized in that: also comprise a photic zone (1), photic zone (1) is arranged on instrument connection (4) and locates to coincide with reagent layer (2).
2. the multilayer film dry plate that is used for biochemical analysis according to claim 1 is characterized in that: the gap between described upper support layer (8) and the lower support layer (6) is provided with a middle support layer (7).
3. the multilayer film dry plate that is used for biochemical analysis according to claim 1 is characterized in that: be provided with a filtering layer (9) on the described diffusion layer (3).
4. according to claim 1 or the 2 or 3 described multilayer film dry plates that are used for biochemical analysis, it is characterized in that: described photic zone (1) adopts the visible-range transmittance to form at transparent plastic more than 80% or glass preparation, and thickness is 20-300 μ m.
5. the multilayer film dry plate that is used for biochemical analysis according to claim 4 is characterized in that: the thickness of described photic zone (1) is 100-200 μ m.
6. according to claim 1 or the 2 or 3 described multilayer film dry plates that are used for biochemical analysis, it is characterized in that: described reagent layer (2) is made of the reagent of water-soluble material and participation chemical reaction.
7. the multilayer film dry plate that is used for biochemical analysis according to claim 6 is characterized in that: described reagent layer (2) wet-film thickness is 50-200 μ m.
8. the multilayer film dry plate that is used for biochemical analysis according to claim 6 is characterized in that: described reagent layer (2) build 10-100 μ m.
9. according to claim 1 or the 2 or 3 described multilayer film dry plates that are used for biochemical analysis, it is characterized in that: described diffusion layer (3) is each perforated membrane to equal property of layer of even, be made of hydrophilic high molecular material and white reflection material, wet-film thickness is 100-300 μ m.
10. the multilayer film dry plate that is used for biochemical analysis according to claim 9 is characterized in that: the build of described diffusion layer (3) is 100-200 μ m.
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102323399A (en) * | 2011-09-16 | 2012-01-18 | 苏州生物医学工程技术研究所 | Multilayer film dry chemical reagent tablet for detecting alanine aminotransferase |
| CN107402209A (en) * | 2017-09-15 | 2017-11-28 | 光景生物科技(苏州)有限公司 | It is a kind of to be used to detect test strips of LDL-C and preparation method thereof in serum |
| WO2018120855A1 (en) * | 2016-12-28 | 2018-07-05 | 广州瑞博奥生物科技有限公司 | Time-resolved fluorescent immunochromatographic test strip and kit for detecting myo, and preparation method therefor |
| CN110095592A (en) * | 2019-05-05 | 2019-08-06 | 北京石油化工学院 | A kind of c reactive protein monofilm detection dry plate |
| CN110172496A (en) * | 2019-05-28 | 2019-08-27 | 北京石油化工学院 | A kind of Multilayer film dry plate for surveying hdl concentration |
| CN110187106A (en) * | 2019-05-31 | 2019-08-30 | 北京石油化工学院 | A kind of Multilayer film dry plate and its measuring method quantitative determining alpha-amylase activity |
| CN110794128A (en) * | 2019-10-31 | 2020-02-14 | 无锡锦帛诚医疗器械科技有限公司 | Dry chemical method multi-layer membrane reagent for in vitro biochemical diagnosis |
| CN111879591A (en) * | 2020-09-01 | 2020-11-03 | 中科嘉睿(天津)医疗科技发展有限公司 | Dry chemical standard reagent tablet and preparation method thereof |
| CN114002422A (en) * | 2021-10-15 | 2022-02-01 | 乐凯医疗科技有限公司 | Multilayer film dry chemical reagent sheet for biochemical analysis |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102323399A (en) * | 2011-09-16 | 2012-01-18 | 苏州生物医学工程技术研究所 | Multilayer film dry chemical reagent tablet for detecting alanine aminotransferase |
| WO2018120855A1 (en) * | 2016-12-28 | 2018-07-05 | 广州瑞博奥生物科技有限公司 | Time-resolved fluorescent immunochromatographic test strip and kit for detecting myo, and preparation method therefor |
| CN107402209A (en) * | 2017-09-15 | 2017-11-28 | 光景生物科技(苏州)有限公司 | It is a kind of to be used to detect test strips of LDL-C and preparation method thereof in serum |
| CN107402209B (en) * | 2017-09-15 | 2020-04-07 | 光景生物科技(苏州)有限公司 | Test strip for detecting low-density lipoprotein cholesterol in serum and preparation method thereof |
| CN110095592A (en) * | 2019-05-05 | 2019-08-06 | 北京石油化工学院 | A kind of c reactive protein monofilm detection dry plate |
| CN110172496A (en) * | 2019-05-28 | 2019-08-27 | 北京石油化工学院 | A kind of Multilayer film dry plate for surveying hdl concentration |
| CN110187106A (en) * | 2019-05-31 | 2019-08-30 | 北京石油化工学院 | A kind of Multilayer film dry plate and its measuring method quantitative determining alpha-amylase activity |
| CN110794128A (en) * | 2019-10-31 | 2020-02-14 | 无锡锦帛诚医疗器械科技有限公司 | Dry chemical method multi-layer membrane reagent for in vitro biochemical diagnosis |
| CN111879591A (en) * | 2020-09-01 | 2020-11-03 | 中科嘉睿(天津)医疗科技发展有限公司 | Dry chemical standard reagent tablet and preparation method thereof |
| CN114002422A (en) * | 2021-10-15 | 2022-02-01 | 乐凯医疗科技有限公司 | Multilayer film dry chemical reagent sheet for biochemical analysis |
| CN114002422B (en) * | 2021-10-15 | 2024-03-29 | 乐凯医疗科技有限公司 | Multi-layer membrane dry chemical reagent tablet for biochemical analysis |
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Application publication date: 20110622 |