JPH04502961A - Dual absorption analyte detection - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Duplex absorption analyte detection Background of the invention The present invention relates to devices and methods for detecting analytes using, for example, immunoassays. It is something to do.

The analyte in the sample contains a labeled immunological binding partner for the analyte and a label. detection by treating the sample with various reagents, such as reagents that make it detectable. can be released. Often, samples must be washed between treatments with various reagents. Must be.

Accurate assays depend on the amount of reactant that is injected into the sample and the time to perform the reaction. often depends on the control of Assay kits can be used by people of varying skill levels and experience. These variables can be controlled so that differences in individual techniques are virtually It is desirable to avoid changing the results. Color indicators must be evaluated - consistency and accuracy are difficult, especially when background colors occur. There is a possibility. Test reagents to determine whether they may degrade over time. These activities must be confirmed. Also, when necessary to perform the assay. It is desirable to reduce the time between Very small volume with relatively low analyte concentration samples and/or to detect relatively small differences in analyte concentration. It is desirable to have the ability to Finally, the use of complex centrifugation equipment It is preferable to test a whole blood sample.

One method for adding and washing reagents in immunoassays is to use absorbent materials. liquid detergents and reagents are passed through a solid substrate (e.g. membrane) where other reactants are solidified. This is to move it to the specified part.

In Cole et al., U.S. Pat. No. 4,246,339, the bottom of the test vessel 20 an immunoassay having an adsorbent material 18 for aspirating liquid through the microporous membrane 22 of the A test device is disclosed. The adsorbent material is tilted elastically away from the membrane. The liquid will pass through the membrane only when a force is applied to both of them to overcome the tilt. Suction the body. The adsorbent material 18 has a hydrophobic surface layer 36 and a wettable bulk portion 3 I am raising 8. Reagents are added to the test wall in succession, with each reagent remaining in the container for a predetermined amount of time. After residence, a force is applied to the membrane and adsorbent material together before the next reagent is added. Aspirate the liquid.

Tom's U.S. Pat. No. 4,366.241 describes two moisture-absorbing zones ( bibulous zone), first zone (immunological absorption zone (i+n munoabsorbing zone >> is the portion fixed non-diffusively within it. a second zone with a binding partner for analysis; is a layer in the receiving zone that directly or indirectly receives liquid from the first zone. a second layer, which is in the zone and receives the liquid that has passed through the first zone; An epidemiological assay device is disclosed. The immunological absorption zone is created by pores in the protective coating. This is a part of a horizontal specimen exposed to

U.S. Pat. No. 4,623,461 to Hosin describes Test device with a filter that feeds the sample into a horizontal absorbent material with a reaction zone Disclose. An annular ring 40 of absorbent material is located surrounding the peripheral zone; The liquid flows radially, leaving the reaction zone, passing through surrounding zones, and passing through the absorbent material. flows into the fee.

Bagshine's U.S. Pat. No. 3,888,629 is a binding partner that can be pretreated. Open the assay device with a matrix pad (matrix pad) 17 that can be Show.

The absorbent material 23 increases the rate of filtration through the matrix pad. in direct contact with the box pad 17.

Kondo's U.S. Pat. No. 4,270,920 provides a A plurality of reactant layers are disclosed. Porous dispersion layer r:IL (40 in Figure 1 or 41 and 44 in Figure 3) Even relatively small amounts of sample can be dispersed evenly throughout the reactant layer. distributed.

Lawrence, U.S. Pat. No. 4,365,970, Oaksman, U.S. Pat. No. 4. No. 578.358, Brewer U.S. Pat. No. 4,486,540, and G. Andano, U.S. Pat. No. 4,541,987, discloses that A test device having positive and negative control spots is disclosed.

The applicant, Agritech Systems Co., Ltd., provides positive and negative control systems. We have been selling immunoassay devices with pots. Separation of spots is reactants are maintained by spotting them well apart from each other.

Numerous companies (e.g. Syntex, Acbel, and Hybrida Kuzua) Icon) is a self-contained immunoassay using membranes as a solid support. We have been selling fixed equipment. Te1ss and Blankstein, Am erican　C11nical　ProducμHRview,　May/ See June (1987). Latex particles retaining reaction reagents have a flocculating effect It is used in agglutination assays. There, Brangs, American C11nical Product s Review, May/June (1987).

One embodiment of the invention is generally water permeable, liquid-transferable into the water-insoluble reaction zone. a test device having a control absorber in contact with a The analyte formed when the analyte in the sample is treated with at least one liquid reagent. Suitable for holding reaction products that can be released. This control absorber is has a defined, limited, standard, liquid absorption capacity and the sample passes through the reaction zone. After that, it is suitable to absorb a predetermined amount of liquid from the sample. the A predetermined, limited, standard amount is determined by the volume and concentration of reagents present, reaction products By taking into account the method of detection of the analyte and the concentration of the analyte for which identification is desired, selected to allow reliable detection of the analyte. control absorber and the means for forming the reaction zone are arranged in the test device as follows. That is, to receive the liquid sample by filling the volume with a control absorber. a first reaction zone exposed to and a control remote from this first reaction zone. a predetermined and defined region between the absorbent body and the second region in liquid transferable relationship; The arrangement is such that the flow is efficiently metered.

Other aspects of the invention feature an apparatus that generally comprises: sand i.e., fluidly connected to the absorber reservoir, control absorber or reaction zone. means for retaining the absorbent reservoir in a first position spaced from the position; The absorber reservoir is in liquid transferable contact with the control absorber and/or reaction zone from the location. means for moving the absorbent reservoir to a second position where the absorbent reservoir is connected to the absorbent reservoir.

The two aspects can be combined into a single device. By doing so, control The roll absorber absorbs a predetermined amount of sample while the absorber reservoir is in the first position. Draw the pull into the reaction zone, then move the absorber reservoir to the second position and , the means to form a reaction zone are small (both contacting one liquid reagent and causing this reagent to react). It can be drawn into the absorber reservoir through the reaction area.

Preferred embodiments of the invention include the following features. In the first position there is an adsorbent reservoir is held at the top of the reaction zone, and from the first position, the stationary and moving solution is held in contact with the top of the reaction zone. Move to a second position where it remains submerged. Most of the solution reagents are It passes through the upper part of the reaction zone and is pulled up into the adsorbent reservoir without movement. The hanging The latch means are such that the adsorbent reservoir is secured in the second position. to prevent the adsorber reservoir from moving from the second position to the first position while It is used for The device includes a means for unlatching after the detection product has formed. The adsorbent reservoir returns to the first position while containing and reaction products are being detected. inspection Participating in the reaction to form the product (at least one reactant is included in the reaction zone) Rare; for example, a specific binder for the analyte can be contained in the reaction zone and keep it there.

The reaction zone is impermeable to the analyte. The reaction area is partitioned onto a flat member. and the two regions of reaction zone are on opposite sides of the member. Reaction products are characterized by product characteristics. For example, dye intensity, optical density, reflection density, pH, fluorescence or conductivity can be detected. I can get it out. For example, it can be detected by the appearance of the means defining the reaction zone. Above reaction area The contrast area around the detection area by contrasting the reaction area with respect to the characteristic detection assist. Measures of intensity include aiding in the quantitative detection of sample analytes. Ru. The reaction zone is contained in the test head and the adsorbent reservoir is located in the test head. Transfer of adsorbent reservoirs located concentrically with respect to each other and folded with respect to the test head. enable movement. The test head includes at least one control area and at least one also one reaction zone with a separator separating each control zone and each reaction zone. Also included. The test head also has at least one an opening and at least one second opening through which the solution can reach the control zone. Consists of a water-impermeable face plate. This test device is suitable for most reagents in reagent packaging size. is provided to the reaction zone. Detect the reaction products that can be detected In order to Also includes selected developments.

Thirdly, the present invention provides an analyte (ana)yte in at least one liquid. a component in a sample that is characterized by reacting with a reagent to form a detectable reaction product; This is a method for detecting precipitates. Connect the sample to the reaction zone. a predetermined constant sample volume, thereby defining a reaction zone. Let it flow through the means.

Preferably, it is done as follows. That is, a container of absorbent nt reservoir) in the first position, place the sample in contact with the reaction zone. the reaction zone by allowing a predetermined constant sample volume to flow through the pass the means to do so. Then move the absorbent container to the control absorbent ( control (absorbent). Absorbent container and control the reaction zone with at least one liquid reagent while maintaining contact with the absorbent material. Upon contact, the reagents flow through the reaction zone and into the absorbent container.

While maintaining the container of absorbent in the second position, the reaction zone is contact with one or more additional reagents that can flow through the absorbent container. It is possible to do so. The sample is used to react the analyte with the reactant in the reaction zone. After absorbing the absorbent material and before moving the absorbent container to the second position, Check the time. Once a detectable product is formed, detection of the reaction product is possible. The container of absorbent may be returned to the first position to enable the 1 position, i.e. continuous access to the reaction zone provided by the absorbent container. The location is such that there is no significant inflow. Absorbent container selected to control desired reaction and can be maintained in the first position for a predetermined length of time, resulting in As a result, both the volume of sample brought into contact with the reaction zone and the duration of that contact are controlled. Ru. The test head of this device is at one end and is used to hold the sample and Place down for immersion in liquid reagent(s). Then, detect After a possible product is formed, the device is turned upside down while detecting the product. and place the test head upward.

The present invention includes extremely rapid Includes various assays. According to the assay of the present invention, enhanced background Read reliable test results with sound controls and reliable specimens. Can be done. The test equipment is designed to be simple while avoiding errors during assembly and use. Can be simply assembled. Overall, the cost of our assay is Generally much less is required. The reaction zone is minimal so no flow is lost outside the zone. Therefore, the amount of reagents used is minimal. Also, the number of steps required This reduces the chance for the operator to make a mistake. Additionally, mix the reagents. This eliminates the need for simultaneous measurements and uses internal preparations that work effectively during testing. The reliability of the test results is high.

Other features and advantages of the invention can be found in the following description of preferred embodiments of the invention. It will be clear from the description, drawings, and claims.

FIG. 1 is a diagram showing an immunoassay kit.

FIG. 2 is an exploded view of the dipstick of FIG.

Figure 2a shows the cap and barrel of the dipstick of Figure 2; just However, part of the dipstick is not depicted.

FIG. 3 is a diagram showing the dipstick of FIG. 2 in an assembled state. however, Some of the outer walls have been removed.

FIG. 4 is a cross-sectional view of the dipstick of FIG. 2 taken along line 4-4 of FIG. . However, some parts have been omitted for ease of understanding.

FIG. 5 is a cross-sectional view of the dipstick of FIG. 2 taken along line 5-5 in FIG. 2a. Ru. However, some parts have been omitted for ease of understanding.

FIG. 6 is a cross-sectional view taken along line 6-6 in FIG.

7A and B show two operating states of the dipstick of FIG. 2, respectively. It is a diagram.

Figure 8 shows, in very general terms, the five steps of the assay performed using the kit in Figure 1. FIG.

FIG. 9 is a diagram showing points for determining the results of the assay in FIG. 8.

structure In FIG. 1, an immunoassay kit 10 includes a dipstick 1 2 and a reagent tray 14 having a transparent lid 16. Tray 1 There are four wells 18a-18d in 4, detailed below. Tray 14 is It also has a long slot 15 that receives the dipstick 12 and a sample. It also includes a circular sample well 19.

2-6, the dipstick 12 is connected to the test head 20. Barre 24 and a cap 40. Test head 20 (best seen in Figure 6) ) can be immersed in sample well 19 and wells 18a-18d. It is large enough to accommodate. The test head 20 has three liquid-receiving openings in its face 22. do. The circular openings 21a and 21b are positive and negative, respectively, as described later. It is an opening for sexual control. The opening 23 is an opening for detecting an analyte. It is. Opposite the positive control opening 21a is a test strip for reading test results. An index notch is used to determine the exact position of the head. There are 25.

2-5, the dipstick barrel 24 has three axially extending It has two fins (fin-like parts) 35, which are arranged at equal intervals on the inner peripheral surface of the barrel. and is integral with the barrel. As shown in FIGS. 4 and 5, the fins 35 are Extends to the head area of the dipstick, at which point it is detailed in Figures 2 and 5. It terminates in the form of radial fins 26 as shown in detail. Fin 26 is the main (or Control) The absorber 30 is arranged so as to fit into the three radial recesses 28 of the absorber 30. and each sharp point designed to penetrate the depth matrix 32 during assembly. It ends in the shape of Edge 27.

A cylindrical absorbent reservoir 38 is present within the barrel 24 and will be described in detail below. . An axial rib 35 is present in the center of the absorbent reservoir. Is the barrel 24 its outer periphery? It also includes a positioning block (indexing block) 52 that protrudes outward.

The depth matrix 32 is a graphite that can absorb fine particles as described below. membrane made of fiber (e.g. Gelman A/E: Pa1l 0-10). That's fine.

The control absorber 30 is a hydrophilic polyethylene material in which It has a slot 28. Optimum desired sample volume for each test and select the depth and porosity of the control absorber appropriately.

The typical amount desired for samples moving 21 times through the reaction zone is less than 400μ. definitely less than 1 ml (most preferably less than 150-200 μl) stomach).

A suitable control absorber for quantities of 100-150 μJ is 0.410 in diameter. inch and 0.100 inch thick porous polyethylene (average pore size 40μ) be. Such materials are available from Fairburn's Porex Tech Chromex In, Plutzklin, New York, USA Available from C1.

The absorbent reservoir 38 is made of 3.5 to 4.5 denier drawn cellulose acetate fibers. Become. The fibers are attached to the barrel axis to increase penetration rate and reduce overall assay time. (along the direction of liquid movement). The fiber is triactene (t It is treated with plasticizers, such as chlorine reacten, to stiffen and improve flow. Absorber The reservoir is sized to allow room for the entire volume of liquid to move through the reaction zone. For example, at least about 5 ml is required.

The cap 40 includes a plurality of cross members 46 and an absorbent reservoir 38 shown in FIG. It includes offset ribs 43 to hold it tightly in place (FIG. 5).

The indexing void 50 inside the cap 40 is Indexing block 52 on the outside of the barrel 24 Compatible with The ridge 47 extends around the inner circumference of the cap 40 and The circumferential ridges 44 and 54 on the outer periphery of 4 are matched.

assembly The solid part of the dipstick (dipStick) is an injection molded pot. A suitable plastic such as lipropylene. Its barrel and test head are separate molded as a part. The reservoir 38 is a cross member 4 6 and the rib 43, so that the reservoir is separated from the control absorber 30. and retained. Attach the cap 40 to the end of the barrel 24 with a cap indexing void ( Position the indexing void) 50 on the indexing block 52 and press it. Cover. Let ridge 47 bite over ridge 44, but do not bite over ridge 54. stomach. For this reason, the absorber reservoir 38 is located at the control point, as shown in position A in FIG. The roll absorber 30 is held apart from the roll absorber 30.

After assembly, insert microparticles (micropart 1cles) into the test spot into the assay area through the opening of the head. Specifically, anti-analyte Latex microparticles with antibodies are inserted into the depth matrix through the analyte detection aperture. It can be spotted on the depth matrix. Black Latex particles containing a chromagen label (e.g. enzyme) is spotted through the positive control 21a. Non-reactive with samples or reagents particles are spotted through the shadow control 21b. latex microparticles Can be manufactured from polystyrene. Proteins are immobilized on the particles using known methods. become For example, Uniform Latex Particles (Unif) by Bangs. orm Latex Particles), Ceragen Diagnostic See Seragen Diagnostics. This particle is suspended in a buffer solution to be added dropwise to the reaction zone (e.g. 0.0 in an appropriate standard saline buffer. Add 5-1.0% by weight).

use The user inserts the dipstick 12 and tray 14 into the slot 15. The kit 10 including the cap 16 is received. After removing the lid, remove the sample and assay The sample is added to the well 14 according to the draft, which depends on the exact nature.　Dipste 12 from the slot. At this stage, remove the cap 40 and Separate the collection tank 38 from the control absorber by a certain distance (position A in Figure 7) .

The test head 20 is immersed in the sample well 19 (step 1 in FIG. 8). From reaction zone 32 The amount of sample removed is determined by the control absorber 30. Specifically, The porosity and size of the Troll absorber control the sample volume drawn into the reaction zone.

The capacity of the control absorber 30 is limited, i.e. the control absorber 30 has a limited capacity; The body does not absorb all the sample in the well 19. Rather, the absorber 30 When fully filled, the flow of sample into the reaction zone (i.e., the inlet face of the reaction zone (to the outflow surface) stops. In this way, the volume of the control absorber 30 is transferred to the reaction zone. (experimentally) measure the extent of predetermined sample flow to give reliable detection. . This flow depends on the amount of reagent available in the reaction zone, the intensity of the parameter being sensed, Depends on the level of analyte, sample viscosity and sample volume obtained as to what differentiation is desired. do.

Once the dipstick has absorbed the desired sample volume (e.g. 10 seconds) (see Figure 8) Step 2), remove the test head from the sample well (step 3 in Figure 8). User press the cap inward (toward the test head). The raised portion 47 and the raised portion 54 When engaged, you will hear a click. At this position (position B in Figure 7), the absorption The body storage tank 38 is brought into contact with the control absorbent body (Step 4 in Figure 8), and the liquid is assayed. 32 and control absorbent body 30 into a reservoir 38 .

Next, insert the dipstick into the reagent holes 18a to 18d in sequence (as shown in Figure 8). Step 5). Each hole is sized to allow friction to hold the dipstick upright belongs to. The amount of each reagent supplied to the assay area can be controlled by one of the following two methods. Can be performed by either: (1) Control the immersion time in each hole: (2) Limit the amount of reagent put into the hole and ensure sufficient soaking time to absorb the entire amount in the hole.

The microspheres are trapped in the depth matrix and the colored product remains on the microspheres. Color development occurs within the depth matrix.

Read the results as shown in FIG. 9A.

The following examples describe sample assays for enzyme-linked immunosorbents, but are within the scope of the present invention. It is not intended to limit.

Example Deep maturation of antiviral antibodies conjugated to latex microparticles using standard techniques 23 of the analyte detection portion of the box 32. Similar products containing enzymes Latex fine particles are passed through the positive control part 21a of the analysis area 32. Spot. Spot the particles through the negative control section 21a .

Fill the reagent groove as follows: 18a: Antibody-enzyme binding (30 seconds - 2 minutes) 18b: Washing solution (60 seconds) 18C: Enzyme substrate (30-60 seconds) 18d: Stop solution - stops enzyme activity and/or adjusts pH or iodine either by varying the strength of the inhibitor or by precipitating the substrate by adding an inhibitor. liquid solution.

Suitable systems include the well-known alkaline phosphatase system and the horseradish system. oxidase H2O2 system.

Each groove 18a-18d releases reagent when loaded into the test head. containing a slight excess of the reagent absorbed within the sponge particles 56a-56d.

In this way, loss of reagents due to evaporation during shipping and storage is avoided .

Other specific examples Other embodiments are within the scope of the following claims. For example, in the test head, from the barrel Separate pieces are fine. Control absorber and depth matrix are a single element It can be manufactured by For example, absorbent porous polyethylene supports contain cellulosic materials. can be used to have compressed pores in the top surface.

The test tray can be packaged in shrink-wrapped plastic film without the cover.

The test tray can be varied by changing the arrangement of the wells. For example, sump The well 19 can be moved to one end of the dipstick slot 1.5, and the well 18a -18cl are placed apart by grooves included between each well and dropped Avoid contaminating the wells.

The scope of immunoassay techniques includes colorimetric, radiological and fluorescent techniques described in this patent application. carried out by equipment including technology. The size of the device can be adjusted according to the test capacity. Wear. Prefilters can be used to filter out substances that interfere with the assay, such as blush cells in whole blood samples. Undesirable elements of the sample can be removed. In the test head The number of openings and holes can be increased. For example, different analyte binders during different openings By spotting , many assays can be performed on the same sample.

For example, the test can be read by an automatic reading device. Visual inspection This can also be done by inspection.

FIG./ FIG. 6 Engraving (no changes to the content) FIG, 7a FIG, 7b Position fA Position B Engraving (no changes to the content) FIG.8 Engraving (no changes to the content) FIG.9 Yin Yang -111-^----1 track PCτ/'JSla/C"OZ9

Claims (31)

[Claims] 1. Treatment of an analyte in a liquid sample with at least one liquid reagent to produce a detectable product A test device for detecting said analyte by forming a ) a first region exposed to receive said liquid sample; and a distance from said first region; a second spaced apart region retaining the detectable reaction product; means for defining a water-permeable, water-insoluble reaction zone adapted to b) A predetermined and restricted area in a liquid transfer relationship with the second area of the reaction zone defining means. and a control absorber having a standard, liquid absorption capacity; The absorber and reaction zone defining means are arranged until the control absorber is filled to its capacity. Now, in order to effectively meter a predetermined limited flow rate between the first and second regions, is located in the device and defines the predetermined, limited, standard volume. The test device is selected to allow reliable detection of the analyte. 2. c) absorbent reservoir; d) a first contact with the control absorber and away from the liquid transfer location; means for retaining the absorbent reservoir in position; and e) means for retaining the absorbent reservoir from the first position; moving the absorbent reservoir to a second position in contact with the roll absorbent and transferring liquid; further comprising means for controlling the absorbent reservoir while the absorbent reservoir is in the first position. , the control absorber controls the sample volume absorbed by the reaction zone defining means; , then move the absorber storage section to the second position, and then move the absorber storage section to the second position, and is in contact with at least one liquid reagent drawn into said absorbent reservoir. Test device according to item 1. 3. c) absorbent reservoir; d) located away from and above the area where the control absorber contacts and causes liquid movement; and e) means for retaining the absorbent reservoir in a first position that is a second position for moving said absorbent reservoir from said reaction zone and for liquid transfer; 2. The test device of claim 1, further comprising means for holding the test device in place. 4. Treatment of an analyte in a liquid sample with at least one liquid reagent to produce a detectable product A test device for detecting said analyte by forming a ) water-permeable, water-insoluble, adapted to retain detectable reaction products; means for defining the reaction zone; b) absorbent reservoir; c) located away from and above the place where the liquid is moved by contacting the reaction zone defining means; and d) means for retaining the absorbent reservoir in a first position from said first position; A second unit for moving the absorbent storage unit and contacting the reaction zone defining means to move the liquid. means for holding the absorbent reservoir in the first position; The sample is introduced into the reaction zone defining means while the absorber reservoir is in the position of moving the liquid reagents to the second position and separately applying the plurality of liquid reagents to the reaction zone defining means. The test device is brought into contact and pulled upwardly towards the absorbent reservoir. 5. Treatment of an analyte in a liquid sample with at least one liquid reagent to produce a detectable product A test device for detecting said analyte by forming a ) water-permeable, water-insoluble, adapted to retain detectable reaction products; means for defining the reaction zone; b) in a liquid transfer relationship with the second region of the reaction zone defining means and having a predetermined and restricted , a standard, control absorber having liquid absorption capacity, and the control absorber having a liquid absorption capacity. The body and reaction zone delimiting means are used until the control absorbent body is filled to its full capacity. , so as to effectively meter a predetermined limited flow rate between the first and second regions; disposed in the device and distributing the predetermined, limited, standard volume to the subject; selected to allow reliable detection of the precipitate; c) absorber reservoir; d) located away from and above the area where the control absorber contacts and causes liquid movement; e) means for retaining said absorbent reservoir in said first position; e) said first position; the absorber storage section is moved from the contact point with the reaction zone defining means to cause the liquid to move. and f) means for retaining the suction from the second position to the first position. latching means for restricting movement of the collection storage section; Thereby, the sample is transferred to the reaction while the absorber reservoir is in the first position. the absorbent reservoir to the second position; The liquid reagents are separately brought into contact with the reaction zone defining means and directed toward the absorber reservoir. said test device by pulling upwards. 6. The means for defining a reaction zone is related to the reaction to produce the detectable product. 5. A test device according to claim 1 or 4, comprising at least one reactant that provides a test device. 7. 2. The method according to claim 1, wherein said means for defining a reaction zone is impermeable to said analyte. is the device described in 4. 8. The first region and the second region of the means defining a reaction zone are located on both sides of the surface of the planar member. Test device according to claim 1 or 4, located on the side. 9. The reaction product is visually detected, and the means for defining the reaction zone is externally visible. 5. The test device according to claim 1 or 4. 10. The reaction products are characterized by color intensity, optical density, reflection density, pH, fluorescence and conductivity. claim detected by determining a characteristic of said reaction zone selected from the group consisting of The test device according to item 1 or 4. 11. determining the properties by contrasting the reaction zone with respect to the properties of the reaction zone; From means of defining a control area surrounding the reaction zone to assist in The test device according to claim 10, comprising: 12. Claim 1 further comprising an intensity scale for quantitative detection of sample analytes. The test device described in 0. 13. The means defining the reaction zone are in the test head and the absorber reservoir is arranged concentrically with respect to the test head; The test according to claim 2 or 4, wherein the server can operate in a nested manner. Experimental equipment. 14. Preventing the absorber reservoir from moving from the first position to the second position. consisting of a latching means for With the absorber reservoir latched in the second position, a plurality of A test device according to claim 3 or 4, wherein a liquid reagent is introduced into the reaction zone. 15. comprising means for releasing the latch after the detectable product has been formed; the law of nature, The absorber reservoir returns to the first position when a reaction product is detected. 15. The test device according to claim 14. 16. The means for defining the reaction zone is an accumulation of the control absorbers. The test device according to claim 1 or 4. 17. The means for defining the reaction zone is provided on the surface of the control absorber. The test device according to claim 1 or 4. 18. The means for defining reaction zones includes at least one reaction zone and at least one reaction zone. It defines the control area, and each control area is The test according to claim 1 or 4, comprising means for isolating the reaction area from the reaction area. utensils. 19. The means for defining reaction zones and the control area are located between each reaction zone. at least one opening for allowing liquid to flow through the opening, and a respective control water-impermeable material having at least one opening for fluid communication between the roll areas; 19. The test device of claim 18, comprising a permeable plate. 20. Claim 1 further comprising a reagent container for supplying a plurality of reagents to the reaction zone. or the test device described in 4. 21. The means for defining a reaction zone includes a part for forming a specific bond with the analyte. 5. The test device according to claim 1, comprising: 22. The liquid reagent comprises a means for generating a detectable reaction product. The test device according to claim 1 or 4. 23. Analytes in a sample are reacted with at least one liquid reagent to produce a detectable reaction. A method for detecting an analyte by forming a reaction product, the method comprising: How to: a) a control in liquid transfer relationship with the second region of the means for limiting the reaction zone; A roll absorber, The control absorber has a predetermined limited standard liquid absorption capacity. and the control absorber and the means for limiting the reaction zone are included in the apparatus. , the control absorber filled to its full capacity is located between the first region and the second region. Effectively meter a predetermined and limited flow to and from the area, and Select a predetermined, limited, standard volume to ensure reliable coverage of the above analytes. an absorber positioned to allow detection; b) to limit the reaction zone to the sample; contacting said means for causing said predetermined sample volume to be brought into contact with said means for flowing through said means for limiting the reaction zone; c) forming said detectable reaction product; and d) detecting said reaction product. To put out. 24. The device comprises: an absorbent reservoir; a liquid transporter in contact with the control absorbent; means for retaining the absorbent reservoir in a first position remote from the row; and a reservoir from said first position to a liquid transition area in contact with said control absorber; 24. The method of claim 23, further comprising means for moving the Method consisting of floors: a) said means for confining said sample to a reaction zone while the absorber reservoir is in the first position; contact with; b) then moving the absorber reservoir in contact with the control absorber; and hand c) while the absorbent reservoir remains in contact with said control absorbent; contacting the reaction zone with at least one of the liquid reagents described above to pass the reagent through the reaction zone. Pass into the absorbent reservoir. 25. Further, the reaction is performed while the absorbent reservoir is in contact with the control absorbent. Claim 24 comprising contacting the reaction zone with another of said liquid reagents. the method of. 26. One of the above liquid reagents is supplied in a predetermined amount, and a substantial portion of said amount is step c) of claim 21 is carried out until all of the 25. The method of claim 24, wherein: 27. One of the liquid reagents is supplied in excess and step c) of claim 21 is performed. 25. The method of claim 24, wherein the method is performed for a predetermined period of time. 28. the means for defining the reaction zone contains at least one reactant; After step a) of claim 21 in order to react the analyte with said reactant. and a predetermined period of time before step c) of claim 21. 25. The method of claim 24, comprising: 29. said detectable product is formed, and then said absorbent reservoir is placed in said first position. through the reaction zone with the absorber reservoir in the first position. while the absorbent reservoir is in the first position without causing continuous liquid flow; 25. The method of claim 24, which allows detection of reaction products. 30. The absorber reservoir is preselected to control the desired reaction. maintained in the first position for a determined length of time, thereby contacting the reaction zone. A claim in which both the volume of the sample and the duration of contact between the sample and the reaction zone are controlled. The method of item 24 within the scope of. 31. The apparatus has at one end a test head comprising means for defining a reaction zone. 25. The method of claim 24, comprising the steps of: a) Immerse the device in the sample and liquid reagent with the storage head facing downward. And b) After said detectable reaction product is formed, said device is rotated to detect said product. During detection, the test head is positioned at its apex.