HK1063841A - In line test device and methods of use - Google Patents

Description

Pipelined assay device and method of use

This application claims the rights of prior U.S. utility application No. 09/860,408. The utility model entitled "In Line Test Device" and method of use thereof was filed 2001, month 5, 18 and is herein incorporated by reference.

Technical Field

The present invention relates generally to assay devices including sample collection chambers and assay platforms and methods of use thereof. The sample receiving chamber may preferably be used to extract, prepare or dilute a sample for analysis by the test platform. The test platform may include a test element, such as a test strip. The test strip may be used as an analyte of interest, such as a disease state, medical state, or pathogen. This application incorporates by reference the following applications or patents in their entirety: U.S. patent application No. 09/579,673 filed on 26/5/2000; us patent No. 09/579,672 filed on 26/5/2000; united states patent No. 09/653,032 filed on 9/1/2000 and united states design application No. 29/133,183 filed on 11/21/2000.

Background

Many sample collection and extraction assay devices for clinical and home applications are described in the literature. These assay devices employ one of the collection devices to obtain a sample and deliver it to a container, from which the sample can be extracted and diluted or mixed with one or more reagents in the container. The sample may then be transferred to an assay unit to determine the presence or absence of a substance, such as analyte detection. The above-described devices may be used for classification purposes, including drug detection or detection of biological compounds such as glucose or hormones, antibodies or pathogens. Many of the above devices are inefficient in sample extraction by the collection device. Furthermore, many of these devices are complex in design and manufacture and the materials from which they are made are quite expensive. The present invention addresses these problems and provides corresponding benefits.

Drawings

FIG. 1 shows a portion of the structure of an assay device used in the present invention, and a sample receiving chamber 1 is connected to an assay platform 2 containing an assay unit, in this case an immunochromatographic test strip 3. The swab 4 with the sample on the swab head 5 is inserted through a hole 6 in the top or proximal end of the sample collection well 1. Reagents 7 containing components for the desired assay are discharged through the proximal wells 6 into the sample receiving chamber 1, wherein the sample is injected into the reagents in the container 1. The fluid mixture is brought into fluid contact with the sample application zone of the test strip 3 and is carried along the test strip 3 by capillary flow 8, and when viewed through the opening 10 of the test platform 2, the presence of a visible line on the detection zone 9 of the test strip 3 indicates the presence of analyte in the sample. The presence of a line in the monitoring zone 11 of the strip 3 indicates successful assay.

FIG. 2A shows an embodiment of the test device of the present invention, in which the sample receiving chamber 1 is separated from the test platform 2, and the test platform 2 is provided with an immunochromatographic test strip 3. The valve means 20 is located at the distal end of the detached sample receiving container 1 so that when it is in the closed position, fluid does not flow out of the bottom or distal end 21 of the sample receiving chamber 1. The reagent 7 containing the components for the desired assay is discharged into the sample receiving chamber 1 through a proximal well 6, the swab 4 with the sample on its head 5 is inserted through the top or proximal well 6 of the sample receiving chamber 1, and the distal end 21 of the sample receiving chamber 1 is connected to the test platform 2 at an aperture 22 such that it is substantially perpendicular to the test platform 2. After incubation of the sample in the reagent, the valve 20 is rotated to open and the fluid contents are discharged at a controlled flow rate to the sample application zone of the strip 3. Fluid is drawn along the strip 3 by capillary action of capillary flow 8 and a visible line on the detection zone 9 of the strip 3, as viewed through the opening 10 of the test platform 2, indicates the presence of a particular analyte in the sample. The presence of a line in monitoring zone 11 of test strip 3 indicates that the assay was successful.

FIG. 2B shows a test platform 2 having an aperture 23 which in this example is partially circular on one side and triangular on the other side, so that the aperture 23 can only receive and support a sample collection well having a specific keying feature at its distal end.

FIG. 3 shows a test strip, which is a single layer test strip or a test strip consisting of multiple regions that are in fluid communication, which can be housed in a test platform. FIG. 3A is a cross-sectional view of the test platform 2 of the present invention along axis A-A, in which a test element, in this case, a single-layer test strip of the immunochromatographic test strip 3, is mounted. The aperture 22 and the opening 10 are shown in section, and the detection and monitoring zone of the immunoassay test strip 3 is visible through the opening 10. The strip 3 shown in fig. 3B consists of a plurality of regions, in this case a plurality of superposed regions, which are in fluid communication when the fluid is moved by capillary flow. The test strip has a coated zone 30 in fluid communication with an optional second test strip 31 having a reagent zone 32 thereon. Second zone 31 is in turn in fluid communication with a third zone 33, which has sample testing zone 9 and optional monitoring zone 11, third zone 33 being superposed with fourth zone 34 to promote capillary flow across the strip. The strip 3 of figure 3C consists of a plurality of regions, in this case end to end or stacked, to facilitate fluid communication as fluid moves along the strip by capillary flow. The strip has a coating zone 30, the downstream region of which is optionally marked with indicia 32. Second test strip 33 has a detection zone 9 and optionally a monitoring zone 11, which may be adjacent to and in fluid communication with first zone 30. While the third zone 34 overlying the second zone 33 facilitates capillary flow of fluid through the strip.

Figure 4 shows several mechanical structures which, as shown, may be located at or near the distal end of the sample collection well. The contents are retained within the sample collection well when in the closed position. When in the open or partially open position, the contents of the sample collection well of the present invention discharge the sample, or sample and reagent, at a regulated flow rate. For example, fig. 4A shows a twist valve 40 with the valve opening not aligned with the outlet 41, and the valve is closed. Alternatively, the valve may be rotated so that the valve opening is aligned with the outlet 42 so that the valve is in the open position. Any intermediate position may be used as a means of regulating the flow. Figure 4B shows a film and piercing mechanism wherein a pierceable film 43 retains the contents at the distal end of the sample collection well and an optional piercing member 44 can contact the pierceable film to rupture the membrane 45. Figure 4C shows a slide valve in which the aperture at the distal end of the sample collection well is covered by a slide 46 with the outlet 47 closed and when the slide is slid into the second position the aperture is opened providing the outlet 48 for the contents and figure 4D shows a stopcock arrangement in which the stopcock 49 is rotated to provide the outlet 50 for the contents of the sample collection well.

Figure 5 illustrates the sample collection well 1 of the present invention showing the longitudinal internal ribs 51 that can alternately compress the inside of the collection well.

Figure 6 shows a portion of the structure of a sample collection well 1 of the present invention. FIG. 6A is a front view and FIG. 6B is a side view of the insert 60 of the sample collection well 1. A grooved ridge 61 surrounds the bore or proximal end 6 of the insert 60. A pin 63 extends from the side wall of the cylindrical shaft 62 of the insert 60 and a hole or outlet 64 is located in the side wall. On the upper and lower sides of the outlet 64 there are O-rings 65 which surround the cylindrical shaft 62 of the insert 60. Fig. 6C is a front view and fig. 6D is a side view of the socket 66 of the sample collection well 1. The socket 66 has a base 67 with a recess 68 for correct placement on the testing device of the present invention. An open channel 69 is provided along the side of the receptacle 66. FIG. 6E shows the sample collection well in the closed position with the insert 60 coupled to the socket 66 such that the pin 63 is captured at the top of the channel 69 and the outlet 64 faces the inner wall of the socket 66 so that fluid cannot flow out of the sample collection well 1. Figure 6F shows the sample collection well 1 in the open position, in which the guide channel 69 guides the pin 63, i.e. the insert 60, downwards as the insert 60 is rotated, so that the outlet 64 is located below the inner side wall surface of the socket 66.

Figure 7 shows several shapes of keys that may be used with the present invention that are preferred for the engagement or positioning of the sample receiving chamber 1 with the test platform 2. For example, FIG. 7A shows a key 71 having a single orientation of the sample collection well 1, while FIG. 7B shows a key 71 having multiple orientations, essentially infinite multiple orientations, because the configuration of this key 71 is circular. FIG. 7C shows a key 71 where the sample receiving chamber 1 can have 1-5 orientations, while the key 71 and sample receiving chamber 1 of FIG. 7D can have 1-4 orientations, the key 71 and sample receiving chamber 1 of FIG. 7E can have 1-7 orientations, and the key 71 and sample receiving chamber 1 of FIG. 7F can have 1-3 orientations. As shown in fig. 7D, the key 71 may comprise a plurality of sample collection wells 1, which may be loaded with samples or unloaded. As shown in FIG. 7F, the keys 71 may be color-coded, with blue on the left and red on the right as in the previous figures. Such a colour number may match a colour number or other number on the second device so that the sample collection well 1 is properly aligned with the second device. Such orientation numbering may also be accomplished in the manner shown in FIG. 7G, in which case the key 71 may be attached to the test platform in an orientation that aligns the sample receiving chamber 1 with the predetermined position. The present invention is advantageous in this respect when more than one sample receiving chamber 1 of the present invention is connected to a test platform, such as a device capable of collecting or analyzing a wide variety of analytes. For example, more than one test element may be mounted on the test platform 2, each element dedicated to a different analyte, such as two different test strips 3. The two different strips are chemically different and therefore may have different reagents in the sample receiving chamber. Thus, with only color numbers, orientation numbers, or a combination thereof, the worker may engage the sample receiving chamber 1 with the testing platform 2 to discharge the sample at a determined or predetermined location. The cross section of the outlet of the key is shown in the figure.

FIG. 8A is a top view of an attachment structure 80 on the test platform 2 that can be attached to the key 71 shown in FIG. 7A. The coupling structure may lock the key 71, i.e. the sample collection well 1, by either a reversible coupling or an irreversible coupling. The dashed lines show the guiding grooves under the surface of the structure for guiding the rotation of the key 71 in fig. 7A.

Fig. 8B is a cross-sectional view taken along the axis of fig. a-a, showing the interface structure 80 and the test platform 2, with the test strip 3 in the platform 2 including a sample application zone 30, and optionally a sample detection zone 9 and a monitoring zone 11, as is well known in the art, as described in U.S. patent application 09/579,673 filed on 5/26 of 2000 assigned to the same assignee, the entire contents of which are hereby incorporated by reference.

FIGS. 9A-9F show an assay platform 2 that includes one or more attachment structures 80 that can mate with one or more keys 71 of a sample collection well of the present invention. The test platform 2 in this example is a multi-channel test device comprising a plurality of test strips 90 for a plurality of analytes including Streptococcus (Strep), human chorionic gonadotropin (hCG), cocaine (COC) and Human Immunodeficiency Virus (HIV), as shown by surface marker 91. I.e. assays for pathogens, pregnancy and drugs of abuse. As shown in fig. 9B-9F, the sample collection and discharge devices of the present invention can be numbered with a variety of keys 71 for attachment to corresponding mating structures 80. The reagents in the sample receiving chamber 1 may be assayed on assay units which may be numbered by means of keys 71 and connecting structures 80.

Disclosure of Invention

The present invention shows that it is feasible for the sample receiving chamber to be integral with or connected to a test platform, such as a test platform containing a test strip. The sample receiving chamber is preferably, but not necessarily, separate or separable from the test platform, and a flow control or regulation device or structure, such as a valve, separates the sample receiving chamber from the test platform. The present invention provides such devices and methods of use thereof.

A first aspect of the invention is an assay device comprising a sample receiving receptacle and an assay platform, the assay platform preferably comprising an assay unit, the sample collection well preferably being connected to the assay platform and being freely separable.

A second aspect of the invention is a method of detecting an analyte in a sample, the method comprising: providing a sample, interfacing the sample with an assay device, and detecting an analyte in the sample. The assay device preferably comprises a sample collection well and an assay platform with an assay unit. The sample receiving chamber is connected to the test platform and the sample receiving chamber is separable from the test platform.

Detailed Description

Definition of

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In general, the terminology used herein and the manufacturing methods or laboratory procedures described below are well known and commonly used in the industry. These programs apply conventional methods, such as those provided in the industry and in various references. Directional terms such as upward and downward, above and below, and the like, refer to the orientation of the components during use of the device. When a term is in the singular, the inventors also contemplate the plural of that term. The terminology used herein and the laboratory procedures described below are well known and commonly used in the art. As used throughout this disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings:

when one unit and another unit of the present invention are processed into a single workpiece, one unit is "integrated" into the other unit.

The two units of the invention are "separated" from each other when they are machined into discrete workpieces.

"proximal" means the upper end of the sample collection well and has an aperture therein for inserting, for example, a sample collection member, and reagents into the sample collection well.

"distal" refers to the end opposite and furthest from the proximal end of the sample collection well and is the end that provides the outlet of the sample collection well.

"directly" means that one structure is in physical contact with another structure; in procedural applications it means that a process affects another process or another structure without involving intermediate processes or intermediate components.

"indirectly" means that one structure is not in direct physical contact with another structure, but rather in first contact with an intermediate structure, which in turn is in contact with another structure. "indirect," when used in connection with a process, means that one process affects another process or structure through intervening processes or components.

"agent" refers to any chemical species, including organic and inorganic compounds, and combinations thereof. The reagents may be provided in gaseous, solid or liquid form or a combination thereof and may be one component of a solution or suspension. The reagent is preferably a liquid, such as a buffer used in the method of detecting the analyte to be detected in the sample, such as an anticoagulant, a diluent, a buffer, a test reagent, a specific binding member, a detectable label, an enzyme, or the like. The reagents may also include an extraction agent, a buffer or a chemical that extracts the analyte from the sample or sample collection device. For example, the buffer may be used to free biological compounds, such as cells or pathogens on or in a sample collection device such as a swab. Alternatively, an extractant, such as an acid, may be used to extract an analyte in a sample, such as LPS extracted from bacteria.

A "baffle" is a thin sheet of material that is not rigid. By "thin" is meant that the sheet of material has a thickness less than either the length or the width. The pierceable baffle of the present invention can be pierced by contacting the pierceable baffle with a piercing mechanism with sufficient force. The punching mechanism can penetrate through the baffle capable of punching, and the baffle can be made of metal sheets, plastics and metal sheet/plastic composite plates.

The present invention "key for attaching to a test platform" or "key" of a sample collection well refers to a structural means for attaching a second device (e.g., a test platform). The key may be formed integrally with the sample collection well of the present invention or separate from but capable of mating with the sample collection well of the present invention. The sample collection well of the present invention can be positioned by keying the sample collection well to the chemical platform so that the sample can be discharged into the corresponding area of the second device.

An "assay unit" is used to analyze a sample. The assay unit may be used to detect the presence and/or concentration of an analyte in a sample, or to determine the presence and/or amount of one or more components of a sample, or to perform a qualitative assessment of a sample. The assay units of the present invention include, but are not limited to, cuvettes, slides, lateral flow assay devices, such as test strip devices, and columns.

A "lateral flow assay device" can determine the presence and or quantity of an analyte in a liquid sample as it flows through a matrix or material due to lateral flow.

By "sample application well" is meant a well in the test platform that provides access to the portion that receives the sample. For example, the sample application aperture can provide access to the sample application zone of one or more test strips of the lateral flow assay device.

An "analyte" is a compound or mixture of compounds that is measured to specifically bind to a ligand, receptor, or enzyme, and generally refers to an antibody or antigen, such as a protein or drug or metabolite. The precise nature of the antigen and drug analyte and its various samples are disclosed in Litman et al, U.S. patent 4,299,916, columns 16-23, and U.S. patent 4,275,149, columns 17, 18, the contents of which are incorporated herein by reference. Analytes may include antibodies and receptors, including active fragments or fragments thereof. The analyte may include an analog of the analyte which is a derivative of the analyte, e.g., an analyte that is chemically or biologically altered by the action of an active chemical agent, such as a dopant or an enzymatic activity.

An "antibody" is an immunoglobulin G, or a derivative, fragment or active fragment thereof, to which is attached on its surface or in its cavity another molecule of specifically cavitated tissue, also referred to as its complement. The antibodies can be monoclonal or polyclonal and can be prepared using known techniques, such as host artificial immunization techniques, serum collection techniques, or mixed cell line techniques.

A "control analyte" is a compound present in a sample or reagent container that can be detected by an analytical instrument. Detection of a control analyte in the control zone indicates that fluid has flowed through the analytical device.

A "sample" is a substance to be assayed for the presence and concentration of an analyte therein, i.e., for the determination of the presence and amount of one or more components therein, or for qualitative assessment of the sample. Examples of liquid samples that may be assayed by the assay device of the invention include: body fluids including blood, serum, saliva, urine, ocular fluid, semen and spinal fluid; water quality samples such as samples of deep sea water, lake water, river water, or the like, or samples of residential, municipal, industrial water, surface runoff, or sewage; and food samples such as milk or wine. Viscous liquid, semi-solid or solid samples can be used to produce liquid solutions, eluates, suspensions or extracts that can be samples. For example, a swab of the throat or genitalia may be suspended in a liquid solution from which a sample is made to produce a sample. The sample may comprise a liquid, a solid, a gas system, or any combination thereof, such as cells suspended in a buffer or solution, and the sample may comprise biological materials, such as cells, microorganisms, running devices, and biochemical complexes. Liquid samples can be obtained from homogeneous, semi-solid, or high viscosity materials, such as soil, fecal matter, tissue, organs, biological fluids, or other samples that are not liquid in nature. For example, these solid or semi-solid samples can be mixed with an appropriate solution, such as a buffer, diluent, extraction buffer, or reagent. The sample may be dipped, frozen and thawed, or extracted to form a fluid sample. The remaining particles can be removed or reduced by conventional means, such as filtration or centrifugation.

Other technical terms used in the present invention have their common technical meanings and can be described in various technical dictionaries.

Introduction to the word

It is contemplated that the sample receiving chamber may be integral with or integral with a test platform, such as a test platform containing a test strip. The sample collection well is preferably, but not necessarily, self-contained or separable from the test platform. Means or structure for controlling or regulating fluid flow, such as a valve, preferably separates the sample collection well from the test platform. More preferably, the valve structure is positionable on the test platform, i.e., at a distal, i.e., outlet, end of the sample receiving chamber, and the valve structure controls or regulates flow from the sample receiving chamber to the test platform when the container is attached to the platform. The invention provides the device and the using method thereof.

By way of non-limiting introduction to the spirit of the invention, the invention includes several general effective aspects:

1) the testing device comprises a sample collecting cavity and a testing platform with a testing unit, wherein the sample collecting cavity is connected with the testing platform and can be detached; and

2) a method of detecting an analyte in a sample, the method comprising: providing a sample, contacting the sample with an assay device of the invention, and detecting an analyte, if present, in the sample.

These and other aspects of the invention described herein can be achieved using the methods, articles of manufacture, and compositions of matter described herein. In order that the scope of the invention may be fully understood, several aspects of the invention may be combined to form preferred embodiments of the invention.

Assay device

The invention comprises an assay device having a sample receiving chamber 1 and an assay platform 2 preferably containing an assay unit. The sample receiving chamber 1 is connected to and separable from the test platform 2 as shown in figures 1 and 2. The sample receiving chamber 1 is preferably substantially perpendicular to the test platform 2 when attached. The sample collection well 1 can receive the sample directly or through a sample collection device such as, but not limited to, a stick, spoon, spatula, knife, brush, braid, but preferably a swab 4. The sample receiving chamber 1 may also contain one or more reagents prior to sample entry. In another aspect of the invention, one or more reagents 7 may be added before, during or after the sample is added to the sample collection well 1. The sample may be incubated with one or several reagents 7 for a certain or special time before entering the sample collection well 1, or may be incubated in the sample collection well 1. When the sample receiving chamber 1 is connected to the test platform 2, the contents may be discharged to the test platform 2 by a structure such as, but not limited to, a valve opening or by penetration of a breakable barrier of the sample receiving chamber 1. A sample discharged from sample receiving chamber 1 with or without one or more reagents may be brought into fluid contact with a test platform 2 to contact a test element, such as (but not limited to) an immunochromatographic test strip 3, associated with the test platform.

Sample collection chamber

The sample receiving chamber 1 has a proximal end 6 and a distal end 21, wherein the proximal end 6 is adapted to receive a sample and the distal end 21 is adapted to be directly or indirectly connected to the test platform 2 of the present invention. In one aspect, the contents of the sample receiving chamber 1 may be discharged through its distal end to the test platform 2, as shown in FIG. 1. The shape and size of the sample collection well 1 may be any shape, such as, but not limited to, triangular, spherical, elliptical, square, rectangular, pentagonal, hexagonal, heptagonal, octagonal, or other polygonal or non-geometric shapes such as kidney-shaped or bean-shaped, but is preferably substantially cylindrical. The dimensions of the sample receiving chamber 1, including the width, height and diameter of the sample receiving chamber 1, may be such that any or predetermined volume of sample may be efficiently introduced into the sample receiving chamber 1, or the sample or sample collection device 5 may be conveniently inserted, and one or more reagents 7 may be inserted if desired. The proximal end of the sample receiving chamber 1, i.e. the receiving end 6, may be, but need not be, shaped as a wide mouth, funnel or other shaping to allow convenient and accurate entry of the sample into the sample receiving chamber 1. Alternatively, a separate drogue fitting may be used to connect directly or indirectly to the proximal end 6 of the sample collection well 1.

Suitable materials for the sample collection well 1 are, for example, but not limited to, glass, ceramic, metal, plastic, polymers or copolymers, or any combination thereof, but are preferably fracture-resistant plastics, polymers or copolymers, such as polypropylene, homoisomorphous polymers, polycarbonates, or cycloolefins and copolymers of cycloolefins. The sample collection well 1 may be manufactured by a corresponding method, such as, but not limited to, injection molding, blow molding, machining, or pressure forming.

The sample may be a fluid, solid or gas, or any combination thereof. According to one aspect of the invention, a sample may enter, flow through, or be held within the sample collection well 1 and then be expelled from the sample collection well 1. The sample may be introduced into the sample receiving chamber 1 by a variety of methods, such as, but not limited to, pipetting, microwell permeation, pouring, dripping, or flowing. The sample may be mixed with one or more reagents and may be mixed prior to entering the sample collection well, but it is preferred that the sample is mixed with one or more reagents 7 in the sample collection well 1. The reagent may include one or more salts, chelating agents, anticoagulants, detergents, stabilizers, diluents, buffers, enzymes, cofactors, specific binding components, labels, and the like. The one or more reagents may be a compound that facilitates analysis of the sample, but this is not a requirement of the invention.

In another aspect of the invention, the sample may be moved into the sample collection well 1 by a sample collection device such as, but not limited to, a spoon, spatula, knife, brush, braid or the like, but preferably a swab 4. In embodiments of the invention, the sample may be collected on the sample collection device, for example by dipping, immersing, soaking, dabbing, wiping, scraping or swabbing. The sample collection device with the sample thereon may then be moved, or placed or inserted into the sample collection well 1, and the sample collection well 1 may have one or more reagents, which may also be added subsequently.

In a preferred aspect of the invention, one or more concentric or longitudinal ribs, ridges or ridges 51 may be disposed within the interior of the sample collection well 1, as shown in FIG. 5. The one or more structures 51 facilitate the extraction of a sample from the sample receiving chamber 1 and the mixing with one or more reagents in the sample receiving chamber 1. For example, when collecting a sample with the swab 4, such as by dipping the swab head 5 into a blood sample, the swab 4 may be inserted along the sidewall into a sample collection chamber 1 having one or more longitudinal ridges 51. By rotating the swab 4, portions of the swab head 5 are alternately squeezed and decompressed by the longitudinal ridge or ridges 51, causing a blood sample to be introduced into the sample collection well 1.

In another embodiment, one or more filters may be placed in the sample receiving chamber 1, preferably at or near the distal end 21 of the sample receiving chamber 1. As the sample or sample and reagents flow through or are expelled from the sample collection well 1, the aggregates or particulates can be captured by one or more filter devices, preventing their flow out of the sample collection well 1. For example, the blood cells of a whole blood sample may be filtered by one or more layers of filter media. The filter sheet may be composed of a material such as, but not limited to, paper, cellulose and cellulose derivatives, nitrocellulose, polymers, carbon, glass fibers, organic fibers, cotton, hair, wool, wood, fur, or lint, or any combination thereof.

In one aspect of the assay device of the present invention, the sample receiving chamber 1 may be separate from the assay platform 2. The distal end 21 of the sample receiving chamber 1 is connected to the test platform 2, preferably at a hole or aperture 22 in the test platform 2, such that they are substantially perpendicular to each other (see figure 2). The sample receiving chamber 1 may be inserted into the aperture 22 of the test platform 2 to facilitate connection of the test platform 2. The sample receiving chamber 1 may be inserted into the aperture 22 of the test platform 2 by a variety of means, such as, but not limited to, sliding, pushing, snapping (snap), twisting, bayonet fitting or threaded engagement of the distal end 21 of the sample receiving chamber 1 into the aperture 22. For example, the inner wall of the orifice 22 may be internally threaded, while the exterior of the distal region of the sample collection well 1 is externally threaded, so that they can be connected by screwing or twisting. In the case of a snap-in, there is a groove along the inner wall of the aperture 22 and a ridge around the outside of the distal region of the sample receiving chamber 1, so that the sample collection chamber 1 can be slid into the aperture 22 and the ridge snaps or locks into the groove of the aperture 22. Alternatively, the aperture 22 may surround a ridge with or without grooves or threads, over which the sample receiving chamber 1 may be slid, snapped, or otherwise attached to the test platform 2 in a screw-on manner. The grooves or threads can be machined in the corresponding parts by means of customary technical methods. The snap or snug fit may produce a reassuring sound and feel that the operator can be assured that the sample receiving chamber 1 is properly connected to the test platform 2. Optionally, one or more structures, such as one or more gaskets, or one or more O-rings 65, or a combination of these structures, may be placed at the interface of the sample receiving chamber 1 and the test platform 2 to reduce or prevent any leakage.

In a preferred aspect of the assay device of the present invention, one or more valve means 20 may be provided such that the one or more valve means can control the flow from the sample receiving chamber 1 into the assay platform 2 of the assay device. One embodiment may be provided with a valve means 20 which may separate the sample collection well 1 and the test platform 2 and act as an intermediate or cooperating structure therebetween. For example, the underside or lower end of the valve assembly, separate from the sample receiving chamber 1 and test platform 2, may be positioned at the aperture 22 and attached to the test platform 2, while the distal or outlet end of the sample receiving chamber 1 may be inserted into the upper portion of the valve assembly and secured thereto. Alternatively, the valve means may be connected directly to the aperture 22 of the test platform 2. The valve means 20 may also be connected directly to the distal or outlet end of the sample receiving chamber 1, i.e. the sample receiving chamber 1 itself may comprise the valve means, so that when it is connected to the test platform 2, the valve means controls the flow from the sample receiving chamber 1 to the test platform 2.

The valve may be of any type known in the art, such as, but not limited to, a rotary valve, a gate valve, a ball valve, a needle valve, a butterfly valve, a pinch valve, a bellows valve, a piston valve, a slide valve, a plug valve, a reversing valve, or a control valve. The sample or sample and reagent may be retained in the sample receiving chamber 1 when the valve is in the closed position as shown in several examples in figure 4 and when the sample receiving chamber 1 is held in a sufficiently upright position. When the valve is in the open position, the contents of the sample receiving chamber 1 can be discharged, for example by gravity flow. In a preferred embodiment of the invention, the valve structure 20 is openable to allow the contents of the sample receiving chamber 1 to be discharged from its distal end, i.e. its outlet end 21, so that the flow rate can be controlled, regulated or adjusted. In another aspect of the present invention, the valve mechanism 20 may be closed, thereby allowing the sample or sample and one or more reagents to be retained in the sample collection well 1 for any length of time. The valve structure 20 may then be mechanically opened, in whole or in part, to place the contents at a controlled and regulated rate into the test platform 2 of the testing device through the distal or outlet end 21 of the collection chamber 1. In a preferred embodiment, the sample receiving chamber 1 may be connected to a second device, for example, a test platform 2 of the present invention, so that the valve structure 20 may discharge the contents to the second device. The distal valve structure 20 of the sample receiving container 1 may be opened by various methods to discharge the contents. Such as, but not limited to, an open stopcock, or a reversing, rotating, twisting or sliding valve structure to open the valve to allow fluid to reach the assay platform 2 (see fig. 4 for example)

Figure 6 illustrates an example of a sample collection well 1 comprising a valve. In this embodiment, the sample collection well 1 is comprised of a plug 60 and socket 66. The socket 66 is a tubular structure having a base 67 that can be attached to the testing device in the aperture 22. The insert 60 is cylindrical with the distal end, i.e., distal end, closed or blocked during manufacture, and the distal or lower end of the sidewall 62 of the insert 60 has an outlet 64. When the insert 60 is inserted into the socket 66, the pins 63 protruding from the side of the insert 60 just get caught in the guide grooves 69 of the socket 66. In the closed position, the pins 63 of the insert 60 are located at the top of the upper region of the socket channels 69. In this position, the outlet 64, which is fitted with one or two O-rings 65 on either side, faces the inner wall of the socket 66, so that fluid is retained in the sample collection well 1, in order to reduce or prevent leakage. To open the valving structure of the sample receiving chamber 1, the operator can rotate the upper region of the insert 60 whereby the guide channel 69 slides the pin 63 to move the insert 60 downwardly and, as a result, the outlet 64 is exposed beneath the socket 66 to discharge the contents of the sample receiving chamber 1 into the test platform 2, preferably onto the sample application zone 30 of the test element, preferably a test strip 3.

In another aspect of the assay device of the present invention, the distal end 21 of the sample receiving chamber 1 may include a baffle to retain the contents in the sample receiving chamber 1 in an upright position. The baffle may be flush with the distal end 21 of the sample collection well 1 or recessed inwardly. In a preferred embodiment, the baffle is punched with a membrane punch, and the material of the pierceable membrane is any material that can be pierced by the punch or baffle punch of the present invention, which is substantially water-impermeable, substantially air-impermeable, or air-impermeable. Corresponding materials include polymers or copolymers such as polypropylene, polycarbonate, cycloolefin and cycloolefin copolymer, metal films, and plastic/metal film composite sheets. In a more preferred embodiment, one or more baffle punches may be associated with the test platform 2 of the present invention so that when the distal or outlet end 21 of the sample receiving chamber is engaged with the test platform 2, the baffle is ruptured or torn so that the contents of the sample receiving chamber 1 are discharged into the test platform 2. See for example fig. 4.

In another embodiment, the membrane at or near the distal end 21 of the sample collection well 1 will dissolve after a certain period of time in flowing contact with the sample, or sample and reagent. Such film pieces may be made of materials such as, but not limited to, polysaccharides, starches, gels, plastics and the like, or any combination thereof. The thickness of the membrane may influence the rate at which the membrane is dissolved, thereby allowing a latency period (incubation period) before the sample and one or more reagents are released from the sample collection well 1.

In another aspect of the invention, the sample receiving chamber 1 may be pre-packaged with a predetermined amount of one or more reagents. In one aspect, the valve structure 20 at the distal end of the sample collection well 1 may be closed, and the proximal or insertion end 6 of the container 1 may be sealed with a removable or pierceable closure, lid, or sealing gasket. In another embodiment, one or more of the pierceable barriers located within the sample receiving chamber 1 may separate or isolate one or more predetermined amounts of one or more reagents. The extractable lid may for example be a top lid or a screw lid. The cap and screw cap may be made of corresponding materials such as, but not limited to, metal or plastic, or any combination thereof. The pierceable barrier, lid or sealing gasket may be made of, but not limited to, plastic, metal foil, film or cellophane or any combination thereof. In one aspect, the pierceable sealing gasket may be at or near the proximal end of the sample collection well 1, e.g., recessed within the sample collection well 1. The pierceable barrier, cover or sealing gasket is substantially water-soluble, water-permeable, substantially air-permeable or air-permeable. Corresponding materials for the pierceable membrane or film include: polymers or copolymers, such as polypropylene, polycarbonate, cycloolefins and copolymers of cycloolefins, foils and composites of plastics and foils. Alternatively, one or more reagents may be packaged separately in a rupturable or tearable material, such as a capsule, pouch (pouch) or bladder, so that one or more reagent containing packages may be inserted into the sample collection well 1 and may be punched or torn by a barrier tearing device or sample collection device.

In one aspect of the invention, the punch means, such as, but not limited to, a rod, needle, lance or similar lance-like structure, may be inserted and withdrawn one or more times into or out of the proximal or insertion end 6 of the sample collection well 1 to punch, tear, sever or remove the sealing gasket or pierceable barrier to allow the sample to enter the container. In another embodiment, a punch device may be used to tear one or more pierceable barriers in the sample receiving chamber 1 and allow the sample or samples and one or more additional reagents to be added to the sample receiving chamber 1. In a preferred embodiment, the sample collection device with the sample may be used as a punch device and the sample collection device with the sample may be used as said punch device, whereby the sample and the sample collection device are inserted into the sample collection well 1, allowing the sample to be mixed with one or several reagents. In another embodiment, the package containing one or more reagents, such as a capsule, pouch or balloon, may be punctured prior to introduction into the sample collection well, and they may release the contents of the respective package upon rupture, breakage or tearing. For example, a pouch may be torn to allow reagent 7 to enter the sample collection well 1 from the pouch. Any technique may be used for pipetting, such as, but not limited to, pipette pipetting, microwell permeation, pouring, dripping, to add one or more reagents to the proximal or insertable end 6 of the sample receiving container. In another embodiment, a capsule containing the reagent may be positioned over the proximal end of the sample collection well 1 and squeezed between the operator's thumb and forefinger, thus injecting the reagent into the sample collection well 1.

The sample receiving chamber 1 of the present invention may optionally further comprise a key for attachment of a second device. The second device is preferably an assay platform 2 of the present invention. The use of keys to connect the sample receiving chamber 1 to the test platform 2 allows the sample receiving chamber 1 and the test platform 2 of the present invention to be positioned so that a sample can be selectively mixed with one or more reagents and applied to a corresponding area of a second device, preferably the test platform 2.

The keys may be integral with the sample collection well 1 of the present invention or may be separate components but capable of mating with the sample collection well 1. The key is preferably located at or near the distal end 21 of the sample collection well 1. The key is preferably insertable into the aperture 23 of the test platform 2 of the present invention and is preferably capable of being rotated or pushed into a position to lock or secure the sample receiving chamber 1 and test platform 2 so that the contents of the sample receiving chamber 1 are applied to the test platform 2, i.e. to a test element. The key may be of any shape, regular or irregular, but preferably the shape is such that the key fits into or around or adjacent or immediately adjacent to the aperture 23 of the test platform 2 of the present invention which is designed to engage with the key and receive the sample. A possible design shape of the key is shown in fig. 7.

In certain preferred embodiments, the key may be shaped so that a particular sample collection well 1 can mate with a particular type of assay device, or fit into a particular aperture 23 of an assay device, such as an assay platform 2. For example, the sample receiving chamber 1 of the present invention may contain one or more reagents suitable for a particular assay to detect the presence of an analyte of interest. Such a sample receiving chamber 1 may have a key shaped to cooperate with an analytical device, such as the test platform 2 of the present invention, for the specific detection of an analyte of interest. On the one hand, the keys of the sample receiving chamber 1 do not allow the sample receiving chamber 1 to be placed into an analysis device or test platform 2 for the detection of the presence of another analyte. Alternatively, the sample receiving chamber 1 for detecting the presence or absence of one or more analytes may be placed in one or more analytical devices, preferably one or more test stations 2 with one or more test elements.

Alternatively, the test platform 2 may have one or more test areas that mark different test contents. A key may be used to indicate where a sample receiving chamber 2 having a particular sample (which may optionally be mixed with a particular reagent(s) 7) may be inserted, positioned and arranged in the test platform 2 for a particular analytical test.

Furthermore, an analysis device or test platform 2 capable of testing for the presence and quantity and quality of more than one analyte may have several sample application apertures 23 for use with different test contents. An orifice 22 or orifices in the test platform 2 allow a sample (which may also be mixed with a particular reagent or reagents) to be applied to a particular sample. The aperture 23, or a surrounding or adjacent or immediate area thereof, may have a variety of shapes, wherein the characteristic shape of the aperture 23, or the shape of the surrounding or adjacent or immediate area of the aperture 23, defines the particular shape of the key receivable at the test platform 2 and therefore where a particular sample collection well 1 may be attached. See fig. 8 and 9 for an example. It follows that a particular user of a sample collection well can avoid smearing a sample onto an unintended test platform 2, or can use the correct assay unit to detect an analyte of interest, or can avoid making a large number of tests at incorrect test locations on the test platform 2.

In some preferred embodiments, the keys of the sample receiving chamber 1 of the present invention can only fit into or onto or over the sample application aperture 23 of the assay device in a unique orientation. For example, the key may be shaped to have a rounded end and a protruding end, and the sample application hole 23 may be similarly shaped so that the key can only be connected to the analysis device when the protruding end of the key is aligned with the extended end of the sample application hole.

The bonds can be made of any suitable material, but preferably are non-breakable elastic plastics or polymers or copolymers, such as polypropylene, homoisomorphous polymers, polycarbonates or cyclic olefins and cyclic olefin copolymers. The key can be manufactured by a corresponding processing method, such as injection molding, blow molding, machining or pressure forming.

Assay table

The test platform 2 of the test device of the present invention may comprise one or more test elements such as, but not limited to, a lateral flow detection device such as a test strip 3, as shown in fig. 3. The test platform 2 has at least one aperture 22 to which the distal end 21 of the sample receiving chamber 1 may be directly or indirectly attached, as shown in figure 2. The contents of the sample receiving chamber 1 are discharged or flow into the test platform 2 through the aperture 21. Preferably at or near the aperture 21 of the test platform 2 there is at least one sample application zone 30 of more than one test element to allow the fluid contents of the sample receiving chamber 1 to come into flowing contact with the test elements.

The test platform 2 of the test device of the present invention may be made of any suitable material such as, but not limited to, glass, ceramic, metal, paper, pressed cardboard, or a polymer, but is preferably a fracture resistant plastic, polymer and copolymer such as polypropylene, a homomorphic polymer, polycarbonate, or a cyclic olefin and cyclic olefin copolymer. The test platform 2 may be of any shape or thickness, but preferably acts as a base for supporting the sample receiving chamber 1 when the chamber 1 is attached to the test platform 2.

In a preferred embodiment of the invention, the test platform 2 may be directly or indirectly connected to a distal portion of the sample receiving chamber 1 such that the sample receiving chamber 1 is preferably perpendicular to the test platform 2. Examples are shown in fig. 1 and 2. The sample receiving chamber 1 is placed into the aperture 22 of the test platform 2 for connection to the test platform 2. The connection may be made by various means, such as, but not limited to, sliding, pushing, snapping, twisting, bayonet fitting, or threaded fitting, to connect the sample collection well 1 to the test platform 2. In the case of a snap fit, a groove is provided along the inner wall of the aperture 22 and the exterior of the distal region of the sample receiving chamber 1 is surrounded by a ridge, such that the sample collection chamber 1 can be slid into the aperture 22 and the ridge can snap or lock into the groove of the aperture 22. Conversely, the aperture 22 may be surrounded by a ridge with or without grooves or threads, over which the sample receiving chamber 1 may be slid, snapped or otherwise connected to the test platform 2 in a screw-on manner. The grooves or threads can be machined in the corresponding parts by means of customary technical methods. The snap or snug fit may produce a reassuring sound and feel that the operator can be assured that the sample receiving chamber 1 and the test platform 2 have been properly connected.

In another aspect of the testing device of the present invention, the test platform 2 can accommodate one or more test elements, preferably one or more test strips 3, so that the test elements are ready for use. In one embodiment, the test platform 2 has one or more grooves substantially along its top surface. These recesses or grooves may be sized to match the dimensions of the assay unit, which is preferably a test strip 3. One or more of such grooves or channels may be uncovered openings 10 or one or more viewing windows that may be positioned to cover the one or more grooves and the assay unit so that different flow and visual results may be observed as the assay differs from assay to assay unit. The viewing window may be made of any transparent material, such as glass, plastic, or mylar, but is preferably fracture resistant. More preferably, at least one viewing window covering at least one of the more than one recess of the test platform 2 is moisture-tight, thereby isolating one or more test elements from external moisture.

In another aspect, the test platform of the present invention may have one or more ports 22, which ports 22 are capable of receiving a sample, or a sample and one or more reagents 7, into the test platform. In an embodiment, the sample or the sample and one or more reagents may be distributed from the first device, preferably from the sample receiving chamber 1, into the aperture 22 of the assay platform 2. In a preferred embodiment, at least one or several of the apertures 22 is/are located at the end of at least one groove of the test platform 2 of at least one test element. More preferably, one or more of the orifices 22 are located at the end of one or more grooves or slots so that the sample application zone 30 of one or more of the assay units, preferably test strips 3, is accessible for fluid communication with the sample, or the sample and one or more reagents (see, for example, FIG. 3). The one or more grooves or slots may be open, i.e. uncovered, or one or more viewing windows may be provided which are positioned to cover the one or more grooves or slots and the assay unit, so that different flow and visual results may be observed from assay to assay unit.

Another embodiment of the present invention is that it may be provided with an assay platform 2 with one or more orifices 22, the orifices 22 opening into a common sample application zone of an assay unit. Alternatively, a plurality of test strips 3 may be placed in a single test platform 2, with only one opening 22 per test strip. These test pieces may be arranged in parallel (as shown in FIG. 9) or in parallel in any manner. Alternatively, a single orifice 22 may be used to mate with multiple test strips. For example, a sample or a sample and reagent may flow through a single orifice 22 to each test strip so that a sample can be in fluid communication with the test strips to detect the presence or absence of different analytes. The test strips may extend in all directions with the single orifice 22 as the center, or may be arranged in a radial pattern in a predetermined array, or a combination of both. The test platform 2 may have one or more openings leading to the sample application zone of one or more test strips.

The test strip 3 of the present invention optionally further comprises a mark, wherein the mark comprises the name of the assay completed by using the test strip 3. The mark can be printed on the test strip by known techniques. Alternatively, the indicia may be printed on another sheet, such as plastic or paper, and then affixed to the test strip 3, such as with an adhesive. The test platform 2 may comprise one or more labelled test strips. When the test platform 2 has a plurality of marked test strips, the test strips may include reagents for different analytes and an adhesive sheet so that a user can simultaneously determine the presence or absence of more than one analyte. The test strips with directly printed indicia or "stick" indicia may be integrated into platform 2 in any number of patterns or combinations so that a given test device may have a number of test strips for detecting a quantity of analyte without changing the design of platform 2. In these embodiments, the test platform 2 may include one or more grooves or slots that allow the use of a strip or strips that are capable of reading the indicia on the test strip 3.

In another embodiment of the test platform 2 of the present invention, the inner wall of the aperture 22 of the test platform 2 may be directly or indirectly connected to one or more baffle punch means such that the baffle punch means protrudes upwardly from the test platform 2. The projections may be vertical or may be angled appropriately. For example, a sample collection well 1 having a pierceable barrier at or near its distal or outlet end 21 may be inserted into or into an aperture in a test platform 2. The pierceable barrier of the sample receiving chamber 1 may be ruptured by one or more barrier piercing devices to allow the sample or the sample and at least one reagent to be discharged to the test platform 2. If one or more of the baffle punches are mounted at an angle to the baffle being punched, greater damage to the baffle will occur and more fluid will flow from the sample collection well 1 during operation of the device. The end of the flapper perforating device that remains in a state that causes the pierceable flapper to perforate may have a variety of configurations, preferably those known in the weapons art, including but not limited to pointed, serrated, flat-headed, oval or circular, with or without grooves in various shapes, and may have a sharp edge such as a razor blade that cuts through the flapper of the sample collection well 1. The punch structure may be any shape including, but not limited to, a double-edged knife, a spike, a dart, an arrow, a cutter, a spade, or a blade. The punch structure may be bent at an angle and/or attached to the inner wall of the aperture 22 so that when the baffle punch is punched with the punch structure, the area of the baffle surface that is broken is greater to increase the flow rate of the contents of the sample receiving chamber 1 into the test platform 2.

The punching structure can be manufactured to break the baffle plate by one-time punching action or arc tearing. The punching is accomplished by the action of the punching structure punching the baffle at a right angle or near a right angle. Angles other than right angles can cause greater damage to the baffle. Tearing of the barrier by the punch structure may be accomplished by rotating the sample collection well 1 during attachment to the test platform 2 with the barrier in contact with the punch structure. The punch structure may be made to cause additional damage to the baffle by adding barbs on at least a portion of the punch structure or by other means. The punch structure may be made of any material and should be sufficiently hard and sharp at its head surface so that it will rupture the barrier of the sample collection well 1 when it is in forced contact with the barrier of the sample collection well 1. The punch structure may be made of one or more materials such as glass, ceramic, metal, polymer, and the like.

In another aspect of the invention, one or more of the apertures 22 of the test platform 2 is shaped to receive a key which can be used to orient and/or attach the sample receiving chamber 1. An example is shown in figure 8. In one embodiment, one or more of the apertures 22 of the test platform 2 is designed to receive a key attached to the proximal end of the sample receiving chamber 1 of the present invention. In some preferred embodiments, the key is shaped to enable the distal end of a particular sample receiving chamber 1 to fit into or at one aperture 23 of a test platform 2, or into or at least one particular aperture 23 of several apertures of a test platform 2, as shown in figure 9. For example, the sample receiving chamber 1 of the present invention may contain a sample and one or more reagents specific for the presence or absence of an analyte of interest. Such a sample receiving chamber 1 may have a key shaped to fit the aperture 23 of the test platform 2 containing a particular test element for performing a particular detection of an analyte of interest. On the one hand, the keys of the sample receiving chamber 1 do not allow the sample receiving chamber 1 to be placed in the aperture 23 of such a test platform 2: the port 23 is connected to an assay unit which detects the presence of different analytes. On the other hand, the keys of the sample receiving chamber 1 allow the sample receiving chamber 1 to be placed in the aperture 23 of such one or more test stations 2: the port 23 is connected to one or more assay units that detect the presence of one or more analytes. In this case, one or more reagents mixed with or supplied from the sample receiving chamber 1 may be suitable for more than one assay, detecting more than one analyte.

Assay unit

The test element disposed in the test platform 2 of the test device of the present invention may be any one of those known in the art, and is preferably a lateral flow assay device, such as a test strip 3, which is preferably an immune test strip (see, for example, FIG. 3). The test platform 2 of the present invention can hold one or more test strips, which are arbitrary in shape and size, but preferably rectangular test strips 3.

The test strip 3 of the assay device of the present invention is at least partially made of any material that absorbs or does not absorb moisture, such as nylon, paper, fiberglass, polyester, nitrocellulose, polystyrene, olefin, or other thermoplastic materials, such as polyvinyl chloride, polyvinyl acetate, copolymers of vinyl acetate and vinyl chloride, polyamide, polycarbonate, polystyrene, etc. In a preferred embodiment, the material of at least one test strip 3 is nitrocellulose having a pore size of at least about 1 micron, more preferably greater than about 5 microns, or about 8 to 12 microns. Very suitable nitrocellulose sheets having a nominal pore size of up to about 12 microns are commercially available, for example, from the companies Schleicher and Schuell GmbH.

The test strip 3 may comprise one or several materials. If the test strip comprises more than one material, one or more of the materials thereof is preferably in fluid communication, as shown in FIGS. 3B and 3C. One material of the test strip 3 can be stacked on another material of the test strip, such as filter paper on nitrocellulose. Alternatively or additionally, the strip 3 may also comprise a section consisting of one or several materials, followed by a section consisting of one or several different materials. In this case, the sections are in fluid communication and may or may not be partially superposed on each other.

The material of the test strip 3 may be adhered to a support or solid surface as seen in thin layer chromatography and may have a moisture absorbing pad as the main part or as a liquid contact strip. For example, the test strip 3 may comprise a nitrocellulose sheet which is "supported", for example, by a support plate such as a plastic plate, to improve its durability and strength. This can be made by forming a thin layer of nitrocellulose in a sheet of supporting material. The actual pore size of the nitrocellulose when supported in this manner will tend to be smaller than the pore size of the corresponding unsupported material. Alternatively, at least one support sheet May be provided with a preformed nitrocellulose sheet and/or one or more other hygroscopic or non-hygroscopic materials, such as a polymer support sheet (see U.S. patent 5,656,503 issued to May et al, 8/12 of 1997). The support plate may be transparent, translucent or opaque. In one aspect of the invention, wherein the support plate is transparent, the support plate is preferably moisture impermeable but moisture resistant or moisture permeable. Test strip 3 can be assembled in test platform 2 of the present invention such that the support plate is selectively positioned at one side of test strip 3, such that test strip 3 can be viewed from above test platform 2. In this way, the test strip 3 is visible along the opening 10 or uncovered groove of the test platform 2 and the test strip 3 can be protected from moisture. In another embodiment of the invention, the test piece 3 is visible through a viewing window made of a transparent material such as glass, plastic or mylar, but preferably is fracture resistant.

In the following description the material of each strip 3 will be discussed by way of illustrative but non-limiting example.

Generally, the test strip 3 of the assay device of the present invention comprises a sample application zone 30 and an assay result detection zone 33. Assay result detection zone 33 may include one or more analyte detection zones 9 or one or more control zones 11, or both, and test strip 3 may also include reagent zone 32.

The entire thickness of the hygroscopic or non-hygroscopic material in test result assay zone 33 may be impregnated into one or more specific binding members of test result chamber zone 33 of test strip 3. (e.g., a particular binding composition for one or more analytes may penetrate the entire thickness of the test strip material in one or more analyte detection zones 9, while the binding composition for one or more analyte control agents may penetrate the entire thickness of the test strip material in one or more control zones 11, but this need not be the case). Such saturation may extend the range of capture of analytes present in a migrating sample by the non-flowing reagent. Alternatively, the agent may be applied to the surface of an absorbent or non-absorbent material, the agent comprising the specific binding components and constituents of the signal generating system. Either the impregnation of the specific adhesive composition into the test strip or the application of the specific adhesive composition onto the test strip can be accomplished manually or by machine.

Nitrocellulose has the advantage that the specific binding component in the assay result assay area 9 cannot flow without pre-chemical treatment. If the porous solid phase material is paper, non-migration of antibodies, for example, in assay result assay areas 9 may be achieved by chemical coupling using, for example, cyanogen bromide (CNBr), carbonyldiimidazole, or trifluorides.

After applying the specific binding composition to the assay result assay area, the remainder of the porous solid phase material should be treated to block any remaining binding sites. This can be done by treatment with proteins such as bovine serum albumin or milk protein, or with polyvinyl alcohol or ethanolamine, or any combination of these agents. The labeled reagents of the reagent zone 32 can be applied to a dry support in which they can flow in the wet state, and the porous solid phase material should be dry between each of these processing steps (sensitizing, applying the unlabeled reagent, applying and blocking the labeled reagent).

To facilitate free flow of the labelled reagent when the test strip is wetted with the sample, the labelled reagent should be applied as a surface layer to the hygroscopic or non-hygroscopic material rather than being impregnated into the thickness of the hygroscopic material, thereby reducing the interaction of the hygroscopic or non-hygroscopic material with the labelled reagent. For example, the hygroscopic or non-hygroscopic material may be pre-treated by applying a glazing material to the area to be coated with the labelled reagent. Glazing May be carried out by applying to the relevant areas of the carrier, for example, a sugar or cellulose solution, such as sucrose or lactose, and drying (see U.S. patent 5,656,503 to May et al, 8/12 in 1997). The marked agent is then applied to the glazed portion. The remainder of the carrier material need not be glazed.

The agents can be applied to the carrier material by various methods. Various "printing" techniques have been previously proposed for applying liquid reagents to a carrier, such as with miniature syringes, pens using metering pumps, direct printing and ink jet printing, and any of the techniques of this type that can be used herein. For ease of manufacture, the carrier (e.g. plate) may be treated with the reagent and then divided into smaller portions (e.g. thin narrow pieces each containing the desired reagent-containing region) to provide a plurality of identical carrier units.

In some embodiments where the analyte is detected using a signal generating system, such as one or more enzymes that specifically react with the analyte, one or more components of the signal generating system are attached to the analyte detection zone 9 of the strip material in the same manner as the specific binding member is attached to the strip material as described above. Alternatively or additionally, the components contained in the sample application zone 30, reagent zone 32, or analyte detection zone 9 of the test strip 3, or the components of the signal generating system contained throughout the test strip 3, may be impregnated into one or more of the materials of the test strip 3. This can be achieved either by surface coating a solution of the component or by dipping one or more test pieces into a solution of the component. The coupon material was dried after coating or immersion. Alternatively or additionally, the components of the sample application zone 30, reagent zone 32 or analyte detection zone 9 contained on the strip 9, or the components of the signal generating system contained throughout the strip 3, may be applied to the surface of one or more of the strip materials of the strip 3 as described with respect to the labeled reagent.

Sample application zone

The sample application zone 30 is the area on the test strip 3 where a sample, such as a fluid sample, such as a biological fluid sample, such as blood, serum, saliva, or urine, or a fluid of a biological sample taken from a throat or genital swab, or the like, is applied. The sample application zone 30 may include hygroscopic or non-hygroscopic materials such as filter, nitrocellulose, glass fiber, polyester, or other related materials. One or more of the materials of the sample application zone 30 may act as a filter to prevent large particles or cells from passing through the strip 3. Sample application zone 30 may be in fluid communication with the remainder of test strip 3, including assay result detection zone 9, either directly or indirectly. Such direct or indirect fluid communication may be end-to-end as shown in fig. 3C, stacked as shown in fig. 3B and 3C, or stacked or end-to-end including another element, such as filter paper or the like.

The sample application zone 30 may also include compounds or molecules, such as buffers, stabilizers, surfactants, salts, reducing agents, or enzymes, as needed or desired for optimal detection.

Reagent zone

The strip 3 may also include a reagent zone 32 in which a reagent useful for detecting an analyte may be non-migratory (covalent or non-covalent non-migratory) or non-migratory, particularly when in a fluid state. The reagent zone 32 may be on a reagent pad that is a separate piece of hygroscopic or non-hygroscopic material on the test strip 3, or it may be a zone of hygroscopic or non-hygroscopic material of the test strip 3, the test strip 3 further comprising other zones, such as the analyte detection zone 9. In one aspect of the invention, the reagent zone 32 may include a label specific binding member, such as an antibody or active fragment thereof affixed or linked to a label. Such labeled specific binding members may be made by known techniques. The specific binding component may bind the analyte and/or may bind the control compound.

In a preferred embodiment involving the detection of human chorionic gonadotropin, reagent zone 32 comprises two colored beads. One color bead is attached to an immunoglobulin G (IgG) antibody or an active fragment thereof for rickets, and the other color bead is attached to an anti-human chorionic gonadotropin beta chain antibody or an active fragment thereof. The labeled rickets IgG antibody or antibody fragment is used for visual detection of signal in the control region 11 of the test strip 9. The colored signal in the control zone 11 indicates that the sample has passed the detection zone 9. Labeling the anti-human chorionic gonadotropin beta chain antibody or fragment thereof provides a visual signal in the detection zone 9 indicating the presence of human chorionic gonadotropin in the sample.

Other preferred embodiments have anti-drug-abuse antibodies or active fragments thereof bound to a colored bead. As in the previous example, more than one bead may be used to provide one visual signal in the detection zone 9 and another visual signal in the control zone 9. The two beads may be of the same or different color, or a mixture of colors. Alternatively or additionally, different beads with different antibodies or antibody fragments attached thereto may be used to indicate the presence of more than one analyte in the sample by generating one or more visible signals in one or more detection zones 9.

In another aspect of the invention, reagent zone 32 comprises an analyte or analog thereof bound to a colored bead. In this case, the analyte in the sample competes with the labeled analyte or analyte analog in reagent zone 32 for binding to a specific binding member in the assay result assay zone. A weak visual signal indicates the presence of analyte in the sample compared to the analyte in the control sample. As with the previous examples, more than one bead is used to provide a visual signal in analyte detection region 9 and a second visual signal in control region 11. Alternatively or additionally, beads binding different analytes or analyte analogs may be used to indicate the presence of more than one analyte in the sample by one or more visual signals generated in the detection zone 9.

Preferred labels are beads, which are for example metal particles such as gold beads, or polymer beads such as coloured beads, or carbon black particles. Other labels include, for example, enzymes, chromophores, or fluorophores, all of which are well known or later developed in the art, particularly in immunoassays. The beads are formed in powder form on the reagent zone 32, which may include a hygroscopic material such as filter paper, glass fiber, nylon, or nitrocellulose. These reagents can reversibly bind to reagent zone 32 because they can migrate (immobilized) when they come into contact with a fluid, such as a fluid sample, through test strip 3.

In another embodiment of the invention, the reagent zone 32 may include components of a signal generating system, such as an enzyme, a cofactor, a catalyst such as an electron donor or acceptor, and/or an indicator compound.

Reagent zone 32 can also include compounds or molecules, such as buffers, stabilizers, surfactants, salts, reducing agents, or enzymes, etc., as needed or desired for optimal performance of the assay.

Assay result verification zone

The assay result detection zone includes non-migratory or non-migratory reagents that are capable of detecting the presence or absence of the analyte to be detected, such as, but not limited to, drugs of abuse, hormones, metabolites and antibodies. Such reagents are preferably in a dry state, and may be covalently non-migratory, non-covalently non-migratory, or non-migratory in a fluid state. The assay result detection zone may comprise one or more analyte detection zones 9 and one or more control zones 11, or both.

Depending on the particular format and analyte to be detected, various reagents may be present in the assay result detection zone. For example, the assay result assay region may include a specific binding member such as an antibody, an enzyme, a catalytic substrate for an enzyme, a coenzyme, an enhancer, a second enzyme, an activator, a cofactor, an inhibitor, a scavenger, a metal ion, and the like. One or more reagents provided in the assay result detection zone may be bound to the strip material. Test strips 3 comprising such reagents are well known in the art and are suitable for use in the assay device of the present invention.

In a preferred aspect of the invention, one or more of the analyte detection zones 9 of the assay result assay region comprise one or more non-migratory (covalent or non-covalent non-migratory) specific binding members, such as one or more drugs, hormones, antibodies, metabolites, or infectious agents (infectious agents), which bind to the one or more analytes of interest as provided in the reagent zone 32 when the analyte is also bound to the label by the specific binding member. Thus, in embodiments where reagent zone 32 contains one or more specific binding members for the analyte, the specific binding members of reagent zone 32 and analyte detection zone 9 should bind to different epitopes (epitopes) on the analyte to be detected. For example, when labeled specific binding elements within reagent zone 32 bind to beta chain human chorionic gonadotropin, the non-migrating specific binding elements in analyte detection zone 9 should bind to another region of human chorionic gonadotropin, such as alpha chain human chorionic gonadotropin. Thus, when human chorionic gonadotropin is present in the sample, the human chorionic gonadotropin will bind labeled anti-beta human chorionic gonadotropin carried to the assay result assay region of analyte detection region 9, and analyte detection region 9 will bind non-migrating anti-alpha human chorionic gonadotropin, thereby forming a visual readout at that location.

Analyte detection region 9 may include a substrate (substrate) whose optical properties (e.g., color, chemiluminescence, or fluorescence) are altered in the presence of an analyte. Such matrices are well known in the art, such AS, but not limited to, 1, 2-phenylenediamine, 5-aminosalicylic acid, 3 ', 5, 5' tetramethylbenzidine, or tolidine of peroxidase, nitrotetrazolium of 5-bromo-4-chloro-3-indolyl phosphate/saltwater phosphatase, and 4-methyl-umbelliferyl-beta-D-galactopyranoside of 5-bromo-4-chloro-3-indolyl beta-D-galactopyranoside, O-nitrophenyl-beta-D-galactopyranoside, naphthol-AS-BI-beta-D-galactopyranoside, and beta-galactopyranoside.

In embodiments where the signal generating system is used to detect an analyte, one or more components of the signal generating system, such as an enzyme, matrix, and/or indicator, may be formed in the analyte detection zone 9. Alternatively, components of the signal producing system can be formed on strip 3 and can flow to analyte detection zone 9.

The assay result detection zone may also optionally include a control zone 11. Control zone 11 may be upstream or downstream of or integrated with assay result detection zone 9. In the latter case, the control zone 11 and the analyte detection zone 9 can form a label when the analyte reacts positively with the control, with a positive reaction being a "+" sign and a negative reaction being a "-" sign, depending on the specific assay format of the assay.

Control zone 11 provides a result indicating that the test on strip 3 has been completed correctly. In a preferred aspect of the invention, reagent zone 32 includes a specific binding component that binds with a known analyte that is different from the analyte to be detected. For example, a rabbit immunoglobulin G (rabbit-IgG) may be provided in reagent region 32. The control region 11 may comprise a non-migratory (covalent or non-covalent non-migratory) antibody against rickets immunoglobulin G (anti-rabbitt-IgG). In operation, when the labeled rabbit IgG in the reagent zone 32 is carried to the assay result detection zone and the control zone 11, the labeled rabbit IgG binds to the non-migratory rickets-resistant IgG and produces a detectable signal.

Analyte detection region 9 may include a matrix whose optical properties (e.g., color, chemiluminescence, or fluorescence) can be altered in the presence of an analyte.

In one aspect of the invention, strip 3 may include a dopant control region that can detect a doped analyte or a doped indicator. This dopant control region may be added to control region 11 or assay result assay region 9, or may be substituted therefor, as described herein. In one aspect of the present invention, strip 3 may include a doped control region and control region 11, and may optionally detect other analytes, such as drugs. Where test strip 3 includes doped control region and control region 11 but does not detect additional analyte, test strip 3 can be used as a separate control strip that can be placed in a separate recess of test platform 2 of the present invention.

The doped control regions may be used to detect the analyte using any suitable method, such as a specific binding method or chemical probing. Such detection methods are well known and described herein. For example, a specific binding method such as an antibody assay as described herein. Furthermore, methods for detecting analytes by signal detection, by chemical or enzymatic methods are also described herein.

The doping control region preferably detects the presence and amount of an analyte that reflects the doping of the sample, such as by dilution, i.e., replacement or addition of a material to the sample that is attributable to another species, host, or non-human resource. The control requirements for doping are different depending on the control obtained on the sample, the sample chain of custody and the method of sample preparation. For example, samples of blood, serum, and plasma are difficult to remove from a subject for adulteration because such samples are often drawn by phlebotomists or other health care professionals and the chain of custody of such samples is often relatively rigorous. On the other hand, samples of urine or other bodily fluids are not easily and precisely controlled, but this need not necessarily be the case. The choice of doping control can be selected according to the particular circumstances of the sample collection and associated subject chain.

Appropriate doping control for each type of sample can be selected by the practitioner, for example, preferred analytes for blood or blood-derived sample dilutions include, but are not limited to, hematocrit, protein concentration, hemoglobin (particularly, hemocyte lysis), and analytes for urine or urine-derived sample dilutions include, but are not limited to, sarcosine. Preferred analytes of blood or blood-derived samples include, but are not limited to, cell surface antigens or any class or subclass of immunoglobulins, such as immunoglobulin G, M, A, E, D, while analytes of urine or urine-derived samples include, but are not limited to, cell surface antigens or any class or subclass of immunoglobulins, such as immunoglobulin G, M, A, E, D, while analytes of subjects of urine or urine-derived samples include, but are not limited to, hormones such as testosterone, estrogen, or cell surface antigens. Analytes that are preferred for use as dopants in blood or blood-derived samples include, but are not limited to, phosphate (pH), hemoglobin, and nitrite. Preferred analytes for dopants include, but are not limited to, phosphates and doping-based dopants or derivatives thereof, such as cleavage products, which are typically present or absent in the sample in the absence of doping-based dopants or cleavage products. Preferred dopants include, but are not limited to hypochlorite (bleach), chlorine, gluteraldehyde, soap, detergent, drano (TM), visine (TM), Golden Seal Tea (TM), citrus products such as lemon or lime juice, nitrate, urea Luck (TM), and chlorochromate.

The doping control regions can be made by methods known in the art and described herein, such as making assay result assay regions for detecting an analyte. The doped control region may be considered to be an assay result assay region for doped analyte, and thus, the reagent region may include a corresponding reagent to complete the determination of the doped analyte. For example, strip 3 may include a visually labeled rabbit (rabbit) anti-human igg antibody, and the doped control region may include a non-migratory goat (coat) anti-human igg antibody. Thus, in use of the test strip 3, the sample doping control region having the detectable label bound thereto indicates that the sample contains human IgG, and thus the sample is presumed to be of human origin (humanorigin). For example, if a putative human serum sample is used as the sample on such a test strip 3, if there is no detectable label in the sample doping control zone, this indicates that the sample is not derived from a human and the assay is incorrect. In those cases, the assay result will indicate that the sample is adulterated, e.g. by serum samples provided by other species or by replacement of the sample such that human igg is broken down or not present. Doping assays may be qualitative or semi-quantitative, so that dilution of a sample from a human will result in a detectable range of visible markers that is less than the standard range for undiluted samples. The doping test may be used to detect one or more dopants in one or more test strips. For example, a single doped coupon can detect one or more dopants.

In a preferred aspect of the invention, strip 3 may include a result assay region comprising control region 11 and analyte detection region 9, as well as a sample doping control region. In another aspect of the invention, strip 3 may include a result assay region, which optionally includes control region 11, and optionally a doping control region. The second test piece 3 may include a doping control region, and optionally a control region 11. The second test strip 3 preferably comprises both doped and control regions 11, but this need not necessarily be the case, and when one or more first test strips are used to detect analyte that is not doped and one or more second test strips are used to detect doped analyte, the test strips can be placed on a single test platform 2 of the present invention, such as a multi-well test platform 2.

Orientation of the respective zones

The zones of the strip 3 include a sample application zone 30, one or more reagent zones 32, and one or more assay result assay zones, including one or more analyte detection zones 9 and optionally one or more control zones 11 and one or more doped zones, all of which may be on a piece of strip material such as filter paper or nitrocellulose, or on separate pieces of material. The different zones may be made of the same or different materials or combinations of materials, but the materials are preferably selected from hygroscopic materials such as filter paper, glass fiber mesh and nitrocellulose. The sample application zone 30 preferably comprises fiberglass, polyester, or filter paper; reagent zone 32 preferably comprises glass fibers, polyester, or filter paper; and the assay result detection zone, including one or more analyte detection zones 9 and optionally one or more control zones 11, preferably comprises nitrocellulose.

Optionally, a fluid absorbent region may also be included. The fluid uptake region preferably comprises a blotting paper that is used to absorb fluid from the sample in order to drive fluid from the sample application zone 30 through the reagent zone 32 and the detection zone.

These regions are preferably arranged as follows: a sample application zone 30, one or more reagent zones 32, one or more assay result assay zones, one or more control zones 11, one or more doping zones, and a fluid uptake zone. If the assay result detection zone comprises a control zone 11, it is preferably followed by an analyte detection zone 9 of the assay result detection zone. All of these regions, or a combination thereof, can be provided on a single piece of test strip of a single material. In addition, these regions may be made of different materials and be in fluid communication. For example, the different regions may be in fluid communication, directly or indirectly. These different zones can then be connected end to end in fluid communication (see, for example, fig. 3C); the stacked connection is in fluid communication (see, for example, fig. 3B) or is in communication through another element such as a connecting material that is preferably hygroscopic, such as filter paper, glass fiber, or nitrocellulose. In applying the joining material, the joining material may be in fluid communication from end-to-end regions or from materials that include such regions, including such regions that are not in fluid communication, or joining regions or materials that overlap (e.g., without limitation, top-to-bottom) regions that are not in fluid communication.

When and if the test strip 3 comprises a doping control region, the doping control region may be placed before or after the result detection region. When a control zone is present in the resulting assay zone on this test strip 3, the doping control zone is preferably, but not necessarily, in front of the control zone. In this aspect of the invention, the test strip is a control test strip for the determination of a doped analyte and/or a control analyte, so that the doped control region can be located before or after the control region, but is preferably located before the control region.

Fluid circulation

In a preferred aspect of the assay device of the present invention, a sample receiving chamber 1 containing a sample, or a sample and one or more reagents, is connected to the assay unit such that the distal or outlet end 21 of the sample receiving chamber 1 is inserted into or otherwise secured to or within the aperture 22 of the assay platform 2. The contents of the sample receiving chamber 1 may drain into the aperture 22 of the test platform 2 and contact at least one test element, which is preferably a sample application zone of a test strip 3. The sample, or sample and one or more reagents, flows along the strip by capillary action and optionally contacts specific one or more analyte antibodies or analyte labeling elements or combinations thereof, which are free to flow in a wet state within the bibulous material. In a preferred aspect of the invention, the contents of the assay, i.e., the sample or the sample and one or more reagents and optional elements of the test strip 3, are in fluid contact with the assay region of the test strip, which contact indicates the presence or absence of a particular analyte in the sample.

Second, method for detecting analyte in sample

The device of the invention may be used for taking a sample, feeding the sample into the sample receiving chamber 1, and mixing the sample with one or more reagents 7. The sample or sample and one or more reagents may then be directed to an assay element in the test platform 2, preferably the sample application zone 30 of the test strip 3, for the detection of one or more analytes in the sample. The sample may be gaseous, liquid, colloidal or solid. Examples of liquid or fluid samples that can be inserted into the sample collection well 1 of the present embodiment may include water from pools, lakes, rivers, or "surface flow (runoff) water," or biological samples such as blood, serum, saliva, or urine. Other biological samples are fecal samples and throat and genital swabs. Examples of solid samples may include materials such as dirt, pellets, granules, powders or granules.

To collect a sample in the sample collection well 1, a fluid or gel sample can be inserted by various methods, such as pipetting, pouring, or using a pipette. Alternatively, a sample collector may be used to collect the sample and inject it into the sample receiving chamber 1. The sample collector apparatus may have different configurations, but it is preferably a swab 4. The swab 4 may collect the sample onto the swab head 5 using different methods of implementation, such as dipping, swabbing or wiping. The swab 4 with the sample may be inserted into the sample receiving chamber 1 and the container may contain one or more reagents, i.e. one or more reagents 7 may be added to the sample receiving chamber 1 during or after insertion of the sample into the sample collector. In each case the sample may be mixed or extracted into the sample collection well 1 by an extraction solution, which may include one or more diluents, buffers or reagents. Optionally one or more structures, such as one or more ribs or ridges 51 disposed longitudinally in the interior wall of the sample collector, may assist in the removal of the sample from the swab 4 by rotating the swab 4, such one or more ribs or ridges 51 and one or more spaces therebetween alternately compressing and decompressing different portions of the swab head 5 to expel the sample into the sample receiving volume.

The sample receiving chamber 1 may be fixed to or integral with the aperture 22 of the test platform 2 or may be separate from the test platform 2 and selectively connectable to the aperture 22 of the test platform 2. In each case, the sample receiving chamber 1 is in a vertical position and is substantially at right angles to the test platform 2. When separated, the sample collection device and sample and one or more reagents may be added to the sample collection well 1 either before or after the sample collection container 1 is attached to the test platform 2.

The sample receiving chamber 1 may be attached to the test platform 2 in a number of ways, for example, the sample receiving chamber 1 may be slid, screwed or snapped into the aperture 22 of the test platform 2. The sample receiving chamber 1 may also be oriented using a keying arrangement and locked into position with the test platform 2. The user may also choose to lock the sample receiving chamber 1 into place by positioning the distal end of the chamber 1 into the aperture 23 of the test platform 2 such that the key engages the aperture 23. Alternatively, the orifice 22 of the test platform 2 may be surrounded by a rib, which may or may not have a groove or thread, and the sample receiving chamber 1 may be slid or snapped or screwed onto the rib.

The contents of the sample collection well 1 may be stored and mixed or incubated therein (incubation) for a specified period of time. To preserve and incubate the mixture, a mechanical structure such as a closed valve 20, or a physical structure such as a membrane, may be used to prevent the mixture from flowing out of the distal end of the sample receiving chamber 1 (the end connected to the test platform). The contents of the sample collection well 1 can be expelled into the orifice 22 of the assay platform 2 by fully or partially opening the valve 20 at the distal end of the sample collection well. The operation of opening the valve may be accomplished by a twist or slide mechanism or by a faucet mechanism (see, e.g., fig. 4). So that the contents can be expelled from the sample collection well 1 in a controlled or adjustable manner.

Alternatively, a pierceable membrane may be provided at or near the distal end of the sample receiving chamber when spaced from the test platform 2. In this case, the means for rupturing or punching the membrane may be mounted directly or indirectly in or adjacent to the aperture 22 of the assay platform 2. The user applies the sample or sample and one or more reagents to the test platform 2 by inserting the distal or outlet end 21 of the sample receiving chamber 1 into the orifice 22 of the test device. The user can slide, twist or screw the sample collection well 1 into the aperture 22 with the diaphragm rupturing or punching means. The membrane is punched or torn by the membrane punching or rupturing means so that the contents of the sample receiving chamber 1 are expelled through the aperture 22 into the test platform 2. Alternatively, a filter may be placed in the sample receiving chamber 1, whereby the filter filters out unwanted aggregates or particles of the sample, or of the sample and one or more reagents, entering the test platform 2 when the valve is opened or the membrane is pierced to vent the contents.

The test platform 2 of the present invention may comprise a test element, which is preferably an immune test strip 3. Thus, the assay device of the present invention can be used to determine the presence or absence of a particular analyte in a sample. The analytes of interest can be of various kinds, for example: biological components such as antibodies or surface antigens or hormones such as hCG (human chorionic gonadotropin); a drug or chemical component; pathogens or extracts thereof, such as Strep (streptococcus) or HIV (human immunodeficiency virus). The sample application zone 30 of one or more test strips 3 may be positioned immediately below or adjacent to the aperture 22 of the test platform 2. The user has the option of discharging the contents of the sample receiving chamber 1 onto the sample application zone 30 of one or more test strips 3 in a controlled manner. The sample, and the sample and reagent move along the immunochromatographic strip 3 by capillary flow, and depending on the strip 3 used, whether or not there is a visible line in the detection zone 9 of the strip 3 is viewed from the opening 10 or the observation window of the test platform 2, thereby determining the presence or absence of the analyte in the sample.

Examples of the invention

Example 1: method of using the disease examination device: streptococcus A (Strep-A)

A throat sample of a patient showing signs and symptoms of pharyngitis is obtained using a standard-sized rayon or dacron swab. The tonsillar region of the throat was swabbed. The sample receiving chamber of the assay device was mounted on a test platform containing a lateral flow test strip and 4 drops of about 160 microliters of reagent a (2 moles sodium nitrate) and 4 drops of about 160 microliters of reagent B (0.2 moles acetic acid) were added to the extraction device. The swab containing the throat swab was inserted into the sample collection well and rotated repeatedly for about 10 seconds, and then the swab was incubated in the solution for 60 seconds. Thereafter, the valve structure is actuated while the swab remains in the sample collection well. Approximately 200 microliters of the contents of the sample collection well were transferred to the sample pad of the assay device for examining Strep-a antigen. The sample begins to flow on the assay device by capillary action and the result of the assay is viewed through the assay result viewing window 5 minutes after actuation of the valve of the extraction device.

Example 2: method of using the disease examination device: chlamydia

Endocervical samples were collected using either a rayon or dacron swab with a plastic rod, or a cytobrush. The keys on the sample receiving chamber of the test device are secured to corresponding key holes on the test platform which houses the lateral flow test strip device. 150 microliters of 1 equivalent potassium hydroxide is placed in the sample collection chamber of the device, the swab or cytobrush is placed in a container, rotated for 10-20 seconds and incubated for 5 minutes, after which 150 microliters of 1 molar acetic acid (containing 0.1% nonionic active agent 20) is added to the container. The swab or cytobrush is then rotated for 10-20 seconds. The valve structure is actuated and the swab or cytobrush remains in the extraction device. About 150-250 microliters of the contents of the extraction container were filtered through a 1 micron filter located at the bottom of the sample collection well and transferred to the sample pad of the assay device for examining chlamydia antibodies, depending on whether a swab or a cytobrush was used. The swab or cytobrush is removed from the device and disposed of as hazardous waste. The sample flows by capillary action over the assay device and the assay result is viewed from the assay result viewing window 10 after 10 minutes of actuation of the sample collection well valve.

Example 3: the use method of the gene improved crop inspection equipment comprises the following steps: BTK proteins

To determine whether grain seeds or grain crops have been genetically modified to produce a bacillus thuringiensis subspecies. (BtK) protein, selecting 5-10 g of cereal kernels from seed donors or from various cereal ears randomly. The samples were thoroughly ground to ensure homogeneity. A portion of the ground sample is placed into the sample collection well of the testing device until the sample fills 3/4 the volume of the extraction container. 500 microliters of physiological saline was added. The mixture of ground cereal and physiological saline was incubated for 2 minutes. The sample collection well is carefully transferred to the test platform without spilling the contents. The key structure of the sample collection well is inserted into a corresponding key hole located on the assay platform, which contains a lateral flow test strip device for detecting BtK protein. The valve means is actuated to allow the liquid contents to flow from the sample collection well through the two 5 micron and 1 micron filters at the bottom of the sample collection well to the sample pad of the lateral flow test strip device. This volume may vary depending on the grain variety and the particle size of the milled grain. After 5 minutes, the assay result is determined from the result viewing window, preferably with a control line to indicate that the particular sample has flowed.

Example 4: the use method of the food inspection device comprises the following steps: clostridium (liquid sample)

To check for the presence of clostridium in a liquid food product, the key structure of the sample collection well of the test device is first inserted into a corresponding key hole located on a test platform containing a lateral flow test strip device. 250 microliters of sample was added to the sample collection chamber followed by 50 microliters of 500 millimolar sodium phosphate buffer, pH7.4 containing 9 grams/liter sodium chloride, 1 gram/liter bovine serum albumin and 5 milligrams/liter ethylenediaminetetraacetic acid. The solution was allowed to incubate for 30 seconds. The valve assembly was actuated to allow the liquid contents to flow from the sample collection well through the two 5 micron and 1 micron filters at the bottom of the sample collection well to the sample pad of the lateral flow assay device for detection of clostridial antibodies. About 250-300 microliters of sample is transferred onto the sample pad. After 15 minutes, the assay results were determined through a results viewing window. Preferably there is a control line to indicate that correct flow has occurred.

All publications, including patent documents and scientific articles, and the contents of patent documents and attachments, referred to in this application are incorporated by reference herein in their entirety, and the sole purpose of the individual publications is to be incorporated by reference herein in their entirety.

The addition of each title is for the convenience of the reader and should not be used to limit the meaning of the text below the title unless otherwise indicated.

Claims (48)

1. An assay device, comprising:

(a) a sample collection chamber;

(b) an assay platform comprising an assay unit;

wherein the sample collection well is engaged with the assay platform;

wherein said sample receiving chamber, when separate from and fluid-filled with said test platform, is engageable with and discharges said fluid onto said test platform such that said fluid contacts said test element; and

wherein the discharge of said fluid is controlled or regulated by a fluid control device or a fluid regulating device.

2. The testing device of claim 1, wherein said sample receiving chamber comprises an open proximal end and a distal end, wherein said proximal end is adapted to receive a sample and said distal end engages said test platform.

3. The testing device of claim 2, wherein said proximal end of said collection chamber is optionally flared.

4. The testing device of claim 1, wherein said sample receiving chamber is substantially cylindrical.

5. The testing device of claim 1, wherein said sample receiving chamber optionally includes a structure inside to facilitate sample extraction.

6. The testing device of claim 1, wherein said sample receiving chamber is capable of receiving a sample on a sample collection device.

7. The testing device of claim 1, wherein said sample receiving chamber comprises a keying structure for engaging said testing device.

8. The test device of claim 1, wherein said sample receiving chamber contains a reagent.

9. The testing device of claim 1, wherein said testing platform comprises a recess.

10. The test device of claim 1, wherein said test platform comprises an aperture or viewing window for viewing said test element.

11. The test device of claim 1, wherein said test platform comprises a keying structure for engaging said sample receiving chamber.

12. The assay device according to claim 1, wherein said assay unit comprises a test strip.

13. The test device of claim 1, wherein said test element comprises an immune test strip.

14. The assay device according to claim 1, wherein the assay unit detects a biological component.

15. The test device of claim 1, wherein said test element detects a hormone, drug, protein, pathogen, or a portion thereof.

16. The test device of claim 1, wherein said test element comprises a sample application zone.

17. The test device of claim 1, wherein said test element comprises a detection zone.

18. The test device of claim 1, wherein said test element comprises a solid matrix capable of supporting lateral flow or capillary flow.

19. The test device of claim 1, wherein said test element is in direct or indirect fluid communication with said sample collection well.

20. The test device of claim 1, wherein said sample receiving chamber is separable from said test platform.

21. The testing device of claim 1, wherein the discharge of fluid is controlled or regulated by a dissolvable membrane or a baffle.

The testing device of claim 1, wherein the discharge of said fluid is controlled or regulated by a valve or valve means.

23. The test device of claim 1, further comprising a valve means for controlling or regulating the flow of fluid between said sample receiving chamber and said test platform.

24. The assay device according to claim 1, further comprising one or more filters to reduce particulate matter from contacting the assay unit.

25. The assay device according to claim 1, further comprising a reagent.

26. The testing device of claim 1, further comprising an indicator.

27. The test device of claim 1, wherein said sample receiving chamber is substantially perpendicular to said test platform when said sample receiving chamber is in operative engagement with said test platform.

A method of detecting an analyte in a sample, comprising:

providing a sample;

contacting said sample with an assay device according to claim 1; and is

Detecting the analyte in the sample.

29. The method according to claim 28, wherein the sample is a biological sample.

30. The method of claim 28, wherein the sample is placed on a sample collection device.

31. The method of claim 28, wherein said sample is placed on a swab.

32. The method of claim 28, wherein the sample is extracted into the sample collection well.

33. The method of claim 28, wherein the sample is extracted into the sample receiving receptacle using an extraction solution.

34. The method of claim 28, wherein the analyte is a biological or chemical substance.

35. The method of claim 28, wherein the analyte is extracted from the sample.

36. The method of claim 28, wherein said analyte is a pathogen derived from or extracted from a pathogen.

37. The method of claim 28, wherein the sample is placed in the sample collection well optionally with a reagent; wherein when the reagent is present, the reagent may be added to the sample collection well before or after the sample is placed in the sample collection well.

38. The method of claim 37, wherein the sample collection well is selectively engageable with the assay platform.

39. The method of claim 38, wherein the sample is contacted with the sample collection well with a reagent.

40. The method of claim 37, wherein the sample and the reagent in the sample collection well can be mixed or incubated in the sample collection well.

41. The method of claim 37, wherein when said sample receiving chamber is separated from said test platform, a sample is placed in said sample receiving chamber with reagents and then said sample receiving chamber is brought into operative engagement with said test platform.

42. The method of claim 37, wherein when said sample receiving chamber is separated from said test platform, a sample is placed in said sample receiving chamber without reagent and then said sample receiving chamber is engaged with said test platform.

43. A method according to claim 42 wherein a reagent is added after the sample receiving chamber has been engaged with the assay platform.

44. The method of claim 37, wherein the sample is allowed to flow through a filter before contacting the assay unit.

45. The method of claim 37, wherein the flow of fluid between the sample collection well and the assay platform is controlled or regulated by a valve arrangement.

46. The method of claim 37, wherein the flow between the sample collection well and the assay platform is regulated by a rupturable barrier.

47. A method according to claim 46, wherein a rupturing structure ruptures the rupturable barrier to permit fluid flow.

48. The method of claim 47, wherein the disruption structure is disposed on the assay platform.