• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The test strip (1) has a support layer (2) on which are arranged several test layers which are at least partially in contact with one another to permit fluid exchange. …<??>Arranged side by side in this sequence on the support layer (2) are an application zone (3) for application of a sample of the body fluids, a detection zone (5) for generating a characteristic signal which can be detected for the analytical determination, which zone contains a reaction layer (11, 12), and an absorbent zone (7) with an absorbent layer of an absorbent material. …<??>Between the application zone (3) and the absorbent zone (7) there is a capillary transport section (8) which connects the application zone (3) and the absorbent zone (7). The reaction layer (11, 12) is arranged parallel to the transport section (8) between the application zone (3) and the absorbent zone (7) in such a way that it is in liquid contact with a liquid transported in the transport section (8). …<IMAGE>…
    公开号:SU1743372A3
    申请号:SU874203863
    申请日:1987-12-18
    公开日:1992-06-23
    发明作者:Бергер Дитер；Кнаппе Вольфганг-Райнхольд；Лоренц Роберт；Мартин Граж Генри；Теофил Скарстедт Марк；Сойка Бернвард；Бляйштайнер Манфред
    申请人:Берингер Маннхайм Гмбх (Фирма)；
    IPC主号:
    专利说明:

    The invention relates to medical technology, more specifically to a carrier for analytically determining the constituent parts of the suction fluids and the intake volume.
    The purpose of these measures is to ensure that the liquid in the transfer area is at least as long as the reaction layer absorbs the reproducible amount of liquid. After that, the fluid connection between the transfer section in the reaction layer should be interrupted.
    FIG. 1 shows a carrier, a longitudinal section; in fig. 2 - also, option, longitudinal section; in fig. 3 shows the carrier layer in a partially mounted state, top view; in fig. 4 shows section A-A in FIG. 2; in fig. 5 is a curve of the function of the relationship between the percentage of remission of the reaction layer of the carrier and the glucose content in the sample.
    The device contains a carrier 1 consisting of a carrier layer 2 and test layers arranged on it. Bearing layer 2 is made elongated. It has a length of 100 mm, a width of 5-6 mm and a thickness of 0.3-0.4 mm.
    with
     go
    The carrier can be divided in length into the feeding zone 3, the transfer zone 4, the unloading zone 5, the transition zone 6 and the suction zone 7.
    In FIG. 1, the capillary-active transfer section 8 is formed by extending from the beginning of the feeding zone 3 to the end of the suction zone 7 by a transfer layer 8a of fibrous material (for example, felt or fabric). It is sufficient if the transfer layer 8 connects the supply zone 3 and the suction zone 7. Polyamide has been shown to be a particularly suitable material for a transfer layer of fabric or felt.
    The transfer layer 8 and the protective net 9 in the delivery zone above it are together secured to the base layer 2 by means of a strip of melting paste 10.
    In the region of the detection zone 5 parallel to the transfer layer 8, the reaction layers 11 and 12 are reinforced in parallel and immediately adjacent to it. They may, for example, be attached to transfer layer 8a or to carrier layer 2. Although two reaction layers are shown everywhere. The device can be made with one or more than two reaction layers. Each of the reaction layers may consist of a multilayer system, which is considered as one whole.
    In the region of the suction zone 7, there is a suction layer 13 parallel to the transfer layer between it and the carrier layer 2, which consists of a material that, due to its good wettability, has a high suction force. Particularly suitable for this was fiberglass or felt.
    In the embodiment shown in FIG. 2, the capillary-active transfer section 8 is made in the form of a channel-shaped slot. The slot (Fig. 3) is formed by two thin strips 14 of double-sided adhesive tape, which is glued along to the carrier layer 2. On top, the canal-shaped slot is covered with a cover film 15 or reaction layers 11 and 12. The suction zone 7 consists of (Fig. 2- 4) the form of execution mainly from a single bar-shaped suction layer 16.
    For the analysis, a small amount of liquid sample is applied to the supply zone 3. For example, a drop of blood with a volume of about 15 µl is sufficient, as it is easily removed by stabbing the finger from the finger. The sample passes through the protective grid 9 into the supply zone 3 and through the transfer zone 4 due to the capillary activity of transfer section 8 — into the detection zone 5 and further to the suction zone 7.
    When passing through the detection zone 5, liquid contact is formed by the reaction layers 11 and 12, so that they are completely saturated. Suction power
    the suction rate and the intake volume of the reaction layers 11 m 12 of the transfer layer 8 and the suction zone 7 (which are mainly determined by the properties of the suction layer 13, 16) are so consistent with each other,
    0 that the liquid in the detection zone 5 is at least as long as the reaction layers 11 and 12 do not absorb a certain amount of liquid, but then the suction zone 7 sucks so much liquid that
    5, the liquid contact between the reaction layers 11 and 12 and the transfer section 8 is interrupted.
    In order to determine if the donated amount of blood was sufficient for analysis, between the detection zone 5 and the suction zone 7 a sample recognition zone can be located which, when in contact with the sample liquid, indicates that a sufficient amount has been applied to the carrier.
    5 samples.
    The transfer rate of the sample fluid in the capillary-active transfer section 8 is determined by the capillary forces and flow resistance. The thinner the capillaries in section 8, the higher the capillary force, but the greater the resistance to flow. In a carrier with a channel-shaped slot (Fig. 2), the slot channel is filled with liquid, for example, with a channel width of 0.35 mm in 4 seconds, with a slot width of 0.2 mm in about 6 seconds, and with a slot width of about 0.1 mm - in 30 seconds, with a slit width of 0.05 mm, the filling time of the channel is above 30 seconds. It can be seen that in this area the effect of increasing flow resistance outweighs the increase in capillary forces. therefore, the flow rate decreases with decreasing capillary size.
    The rate of absorption with which the reaction layers 11 and 12 are filled depends on their properties. Depending on the use case, highly different reaction layers are used in the carriers. For example, reagents can permeate
    0 paper, felt or matrix of porous plastic. Reaction layers of swellable carriers, for example gel or gelatin, can also be used. The rate of absorption with which the reactionary
    5 the layers are soaked with sample liquid, can always be determined empirically. The sample liquid must be in the capillary-active transfer section 8 for at least as long as the reaction layers 11 and 12 are saturated to the desired extent. This depends primarily on the rate at which the suction zone takes the sample fluid and on the amount of the sample. If we proceed from the maximum amount of sample liquid that can be analyzed by the carrier, it is advisable that the entire amount of liquid that the suction layers 13 and 16 can absorb is greater than the maximum amount of liquid in the sample.
    The suction zone 7 takes the liquid much slower than the transfer area. As soon as the front of the fluid reaches the beginning of the suction zone 7, the flow of the liquid slows down dramatically. The further flow in the transfer section 8 is determined by the rate of suction of the suction zone, i.e. by how fast the suction zone takes fluid. This process must be so slow that the reaction layers 11 and 12 have enough time to fill the sample with liquid.
    When the amount of sample liquid deposited in the supply zone 3 is used, the suction zone 7 begins to empty the capillary-active transfer section 8. For this, it is required that the suction force of the suction zone 7 is larger than the capillary forces of the transfer section 8. This can be achieved, for example, by the fact that the suction layers 13 and 16 present on the suction side 7 consist of a capillary-active material with a particularly high wettability for a sample liquid, for example glass fibers.
    When the capillary-active transfer section 8 is empty, liquid contact with reaction layers 1 and 12 should be interrupted without these layers losing a significant (affecting the accuracy of the analysis) amount of liquid. Therefore, it is preferable that reaction layers 11 and 12 have a greater the suction force than the capillary active transfer portion 8.
    An additional transfer section 4 between the feeding zone 3 and the detecting zone 5 may be expedient if a carrier is wanted in which the feed zone 3 and the detection zone 5 are located very close to each other.
    Example. Carrier for measuring glucose.
    The carrier is modeled on FIG. 2-4.
    The carrier layer 2 consists of a polyester film (thickness 0.5 mm, length 77 mm, width 6 mm). On it, two sided adhesive films (thickness 0.1 mm, length 43 mm, width 1.5 mm) are arranged in parallel, closing the edges of the covering film 15 and the reaction layers 11 and 12.
    The protective mesh 5 is a polyester mesh (PE 280 NS. Tale, Switzerland), cells 280 microns, thickness 0.2 mm, length 8 mm, width 6 mm. It is reinforced on one side by a melting paste-like plane 10 on polyester film (2). The coating film 15 is an agarose-coated polyester film (Gelf-Fix, Heidelberg, West Germany), thickness 0.18
    0 mm, length 10 mm, width 6 mm, whose coated side is directed towards carrier layer 2.
    The reaction layers 12 and 11 are made as follows. 198g copolymer dispersion of ester of acrylic acid (Acronal 14 D of the company BASG, Ludvkggshafen, Germany, 55% aqueous solution).
    174 g of swollen high viscosity methyl hydroxystil cellulose (0.5% in water), 336 g of kieselguhr, 336 g of titanium dioxide, 0.95 g
    0 tetraethylammonium perfluorooctanesulfonate, 40 g of a semolar phosphate buffer solution pH 5.5, 23 g of methanol, 46 g of 1-hexanol, 69 g of acetone, 65 g of water are processed into a homogeneous first mass for
    5 coatings and applied from 0.18 mm height of the slit onto a 0.2 mm thick polyester filter cloth (2F 777, Tale, Switzerland) and dried.
    The resulting coated carrier was coated with a second coating layer consisting of 102 g of a copolymer dispersion of acrylic ester (Acronal 14D, BASF, Ludwigshafen, Germany, 55% solution), 38 g of swollen high viscosity methyl hydroxyethylcellulose (0.5 % in water), 3 g of nitridodecylbenzene sulfonate, 36 KU glucose oxidase, 1050 KU peroxidase, 1 48 g 3,3,5,5, -tetramethylbenzidine, 0.53 g of 1-phenylsemicarbacide, 28 g of 1-label 0 sy- 2-propanol, 40 g of 1-hexanol, 38 g of water, which are processed into a homogeneous mass, are applied from a gap height of 0.02 mm and dried.
    Two applied reaction layer 11
    5 and 12 each is 6 mm long and 6 mm wide. They are so reinforced with one another that there is no gap between them.
    The suction layer 16 consists of fiberglass ferrite with a specific gravity of 60
    0 mg / m2 (thickness 0.3 mm, length 12 mm, width 6 mm).
    To measure the glucose content, 20 µL of blood is applied to the area 3 of the carrier feed. After two minutes at room temperature, the reaction layers 11 and 12 are measured at a wavelength of 660 nm by a reflective photometer.
    Using samples with known glucose content, we construct a functional curve (Fig. 5), in which the measured value
    the percentage of remission is applied depending on the concentration of glucose. Samples with an unknown glucose content can also be quantitatively analyzed using this curve.
    权利要求:
    Claims (2)
    [1]
    Claim 1. Device for determining component parts of liquids, containing a carrier with a carrier layer and several test layers arranged on it, which at least partially are in contact with each other for exchanging liquid, and the supply zones are sequentially arranged on the carrier layer for liquid supply
    five
    The detection layer, which contains the reaction layer, has a suction zone with a suction layer of suction material, characterized in that, in order to improve the accuracy, a transfer section is made in the form of a capillary between the feed zone and the suction zone, which interconnects the feed zone and a reaction layer, wherein the suction zone rate of the reaction layer is greater than the suction rate of the suction zone.
    [2]
    2. The device according to claim 1, characterized in that the transfer section is made of a fibrous material.
    Va
    12 11 8 8a
    FIG. one
    BUT
    76 72. G
    2
    FIG. four
    YU
    eleven
    8 I3 №
    Fig 3 A-A
    /
    P L
    t
    no. about
    90.0
    80.0 70.0 60.0 50.0 SHO
    that
    20.0 10.0
    About MO, then 150.0 200.0 250.0 ZOOD 350.0 SHO No. 0SOQ.O
    5
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    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    DE19863643516|DE3643516A1|1986-12-19|1986-12-19|TEST CARRIER FOR THE ANALYTICAL DETERMINATION OF INGREDIENTS OF BODY LIQUIDS|
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