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HK1174386A - Rapid test apparatus and method of using the same - Google Patents

Rapid test apparatus and method of using the same Download PDF

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Publication number
HK1174386A
HK1174386A HK13101238.5A HK13101238A HK1174386A HK 1174386 A HK1174386 A HK 1174386A HK 13101238 A HK13101238 A HK 13101238A HK 1174386 A HK1174386 A HK 1174386A
Authority
HK
Hong Kong
Prior art keywords
sample
detection
chamber
reagent
receiving chamber
Prior art date
Application number
HK13101238.5A
Other languages
Chinese (zh)
Other versions
HK1174386B (en
Inventor
梁亚红
G.梁
Original Assignee
奎多公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 奎多公司 filed Critical 奎多公司
Publication of HK1174386A publication Critical patent/HK1174386A/en
Publication of HK1174386B publication Critical patent/HK1174386B/en

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Abstract

Provided herein are methods and devices for rapid testing of solid, semi-solid, or liquid specimens, such as stool, blood, urine, saliva, or swab specimens of the cervix, urethra, nostril, and throat, and for environmental testing.

Description

Device for detecting a sample and method of using the same
The application is a divisional application of Chinese patent application with the application number of 200780006542.8, the application date of 2007, 1-23.1, and the invention name of 'quick detection device'.
Cross Reference to Related Applications
The present application claims priority from U.S. provisional application No.60/761580 entitled Rapid Test Apparatus, filed on 23.1.2006 by Greg Liang and yang Liang, which is hereby incorporated by reference in its entirety.
Technical Field
The present invention relates generally to methods and devices for rapid detection of solid, semi-solid, or liquid samples, such as stool, blood, urine, saliva, or a swab specimen of the cervix, urethra, nasal cavity, and throat, and for rapid detection of environmental samples.
Background
The testing of solid, semi-solid or liquid samples (e.g., stool, blood, urine, saliva or exudate samples from the cervix, urethra, nasal cavity and throat) as well as environmental samples (e.g., food, soil or dust) typically requires pretreatment with test buffers. Pre-processing the sample can help dilute the sample, extract a substance to be tested from the sample, or otherwise alter the sample or substance. A new sample solution more suitable for the detection of the substance to be detected is obtained by the pretreatment. Typically, the collected sample is premixed with the test buffer in a container that is separate from the test device used to detect the presence of the particular test substance. In most assay protocols, a portion of the resulting sample solution is transferred to a second assay site for reaction with a reagent to obtain an assay result that indicates the presence or quantity of the test substance in the sample. For example, in fecal occult blood testing, plastic tubes are used to suspend fecal samples in a detection buffer that dissolves the blood components in the sample. The frangible portion of the plastic tube is then severed and a portion of the sample solution is released from the tube into a second device for performing an immunohemoglobin test. The detection result is read in the detection area of the detection device.
The process for severing the sample processing tube and transferring the sample solution from the sample processing tube to the detection device complicates the detection method by requiring multiple steps. Due to the need to transfer the sample, the working area may be contaminated by sample leakage. Also, transferring the sample solution may result in inaccurate results because the transferred detection volume may be inaccurate. These methods are inconvenient for field testing by users who are not trained in the experiment. What is needed is a simpler, safer, and more accurate method of detecting solid, semi-solid, or liquid samples.
Disclosure of Invention
The present invention provides a simpler, safer to use, and more accurate device and method for handling and testing samples. In certain embodiments of the present invention, a test assembly is provided that can be used for rapid testing of solid, semi-solid, or liquid samples. In one non-limiting embodiment, a rapid test device for detecting the presence of fecal occult blood is provided. In this embodiment of the invention, the collection, handling and detection of the fecal sample is accomplished in one device. For example, the detection buffer is pre-stored in the sample receiving chamber of the device and at least one rapid lateral flow test strip for the determination of hemoglobin is stored in a separate test chamber, i.e., the test chamber. A sampling wand is attached to the upper cover of the device for collection of the fecal sample, which is then transferred to the detection buffer chamber using the sampling wand. The device is then shaken to disperse the fecal sample into the buffer solution and then the lid on the bottom of the device is tightened to initiate the test, allowing the sample solution to contact the lateral flow test strip. Visual test results can be read from the lateral flow test strip in about 5 minutes.
In one embodiment, a detection device is provided that includes a detection assembly, wherein the detection assembly (e.g., longitudinally) can have: a lower end, a sample-receiving chamber having an opening at the upper end of the test assembly, a test chamber having an opening at the lower end of the test assembly and capable of receiving a reagent member from the opening, a base connectable to the opening of the test chamber and sealing the lower end of the test assembly with the reagent member in the test chamber, and means for placing the sample-receiving chamber in fluid communication with the test chamber when the base is connected to the test assembly; the detection assembly includes a reagent member within the detection chamber. The test assembly for sample collection and testing may be any shape having various suitable dimensions, such as a cup or tube shape. The test device (e.g., test assembly) of the present invention can be made of any suitable material, including, for example, a plastic selected from the group consisting of polyethylene, polypropylene, polystyrene, ethylene polymer, and acrylonitrile beta-tetracaine styrene.
Also disclosed is a diagnostic test device comprising: a longitudinal sensing assembly having an upper end and a lower end; a sample receiving chamber having an opening at the upper end of the detection assembly; a testing chamber having an opening at the lower end of the testing assembly and capable of receiving a reagent member from the opening; a reagent member within the detection chamber; a base connected to the opening of the detection chamber, wherein the base seals a lower end of the detection assembly by a reagent member within the detection chamber; and means for placing the sample receiving chamber in fluid communication with the detection chamber.
The method of manufacturing a diagnostic test device using the test assembly includes: introducing into said detection chamber from the lower end of said detection assembly a reagent member capable of reacting with an assay sample and of generating a signal indicative of the presence or quantity of an analyte in said assay sample; and connecting the base to a lower end of the detection chamber.
The method for using the detection device comprises the following steps: introducing a sample solution into the sample receiving chamber, activating a means for communicating the sample from the sample receiving chamber to the detection chamber, and reading the detection result of the reagent member.
The detection device of the present invention may be used, for example, to detect analytes selected from the group of analytes including, but not limited to, drugs of abuse, hormones, tumor markers, cardiac markers, infectious agents and environmental contaminants. The test sample solution is a solution that may include some order of magnitude of analyte. The sample solution is selected from the group of solutions comprising body fluids (including urine, saliva, plasma or serum), blood and spinal fluid. The sample solution may also include a treatment solution, such as distilled water, PH, or protein buffer. For example, dust or powder may include drugs, explosives, or infectious agents.
Drawings
Fig. 1 is a side view of the apparatus of the present invention.
Fig. 2 is an exploded view of the device shown in fig. 1.
FIG. 3 is a top view of the detection assembly of the present invention.
Fig. 4 is a bottom view of the component shown in fig. 3.
Fig. 5 is an elevated perspective view of another device of the present invention.
Fig. 6 is an exploded view of the device shown in fig. 5.
Fig. 7 is an elevated perspective view of the device shown in fig. 5 in a testing position.
Fig. 8 is a perspective view of the device of the present invention.
Fig. 9 is an exploded view of the device shown in fig. 8.
Detailed Description
Fig. 1 (in conjunction with fig. 2-4) depicts an apparatus of the present invention. The sample collection and testing device includes a test assembly 110 and a base 120.
The test assembly 110 is a membrane wall 114 having an outer wall 111, an upper end 112, a lower end 113, and a longitudinal direction that separates the interior of the test assembly into two chambers, a sample receiving chamber 115 and a test chamber 116. The diaphragm wall has a bottom 117 bent away from the outer wall 111 and a top 118 connected to the outer wall 111. The bottom 117 of the membrane wall includes an aperture 119, the bottom of the sample receiving chamber being open. The outer wall has a thread 109 on the inside of the bottom end.
The base 120 comprises a handle portion 121, an insert portion 122 having threads 123 and a plug 125 for sealing the bottom opening of the sample receiving chamber. A rubber O-ring 124 surrounds the insert portion 122 as a seal.
In this embodiment, reagent member 140 includes a core 141 and a detection zone 142 that includes assay reagents 143. When a sample solution contacts the core of the reagent member, the sample solution is drawn from the core to the detection zone and reacts with the reagent. Thus, the presence or amount of the detection substance in the sample solution is determined.
A rubber O-ring 126 is provided as a seal closing the hole 119.
Optional cap 130 includes a handle 131 and a sampling needle 132.
With the test agent piece 140 inserted into the test chamber 116, the base can be tightly fitted to the bottom end of the test assembly, sealing the bottom end of the test assembly, and the plug 125 and O-ring 126 can seal the bottom opening of the sample receiving chamber.
When sample solution is introduced into the sample receiving chamber, the base 120 is released, opening the plug 125 and the O-ring 126 from the aperture 119, allowing the sample solution to flow through the aperture 119 and contact the reagent member 140 of the detection chamber 116. On the assay reagent member 140, the assay result of the sample solution can be read through the outer wall 111 of the detection chamber portion.
There are many options for such devices to suit particular needs. First, with the reagent member inserted into the test chamber, the base is mounted to the bottom end of the test assembly, and the plug 125 seals the bottom opening of the sample receiving chamber, sample solution can be stored or stored in the sample receiving chamber for later testing. Thus, the sample solution can be prepared and subjected to the detection operation later. For example, a patient may obtain a sample, and the device may then be sent to a laboratory technician or other trained personnel for their testing and interpretation of the results. Alternatively, a buffer solution for processing or diluting the test sample may be stored in the sample-receiving chamber prior to introduction of the sample into the sample-receiving chamber. Second, the plug 125 or O-ring of the base 120 can be omitted from the device or the base remains loose to allow the passage between the sample receiving chamber and the detection chamber to remain open. When a sample solution is introduced into the sample receiving chamber, a volume of the solution automatically flows from the sample receiving chamber into the detection chamber through the sample channel or the hole at the bottom of the detection assembly.
An optional lid 130 seals the top opening of the sample receiving chamber. The optional sampling needle of the cap 130 is capable of taking a liquid or non-liquid sample and introducing the sample into the sample receiving chamber. Liquid samples include, but are not limited to, for example, blood, urine, saliva, water, mucus, or other fluid samples. Non-liquid samples include, for example, powders, feces, dust, and other dry or semi-dry samples.
Other methods of allowing fluid communication from the sample-receiving chamber to the detection chamber may also be used on the device. For example, in one embodiment, a simple modification to the device of FIG. 1 is a test assembly of the present invention in which the aperture 119 is sealed or plugged, the test assembly comprising a needle or other sharp edge or protrusion attached to the top surface of the base that can break the seal or remove the plug when the base is rotated or squeezed relative to the test assembly. In this embodiment, the sample solution flows through the aperture once the seal is broken or the plug is removed, or in another embodiment, the solution flows through the aperture after the seal is broken or the plug is removed. In such an embodiment, for example, the hole is sealed when the cap is loosely installed and unsealed when the cap is closed, the seal being broken by the needle.
Fig. 5 (in conjunction with fig. 6 and 7) depicts another embodiment of the present invention. The device 200 includes a detection assembly 201, a sample receiving chamber 204, and a detection chamber 206. The test assembly 201 comprises an upper end 202 and a lower end 203, the sample receiving chamber 204 comprises a test buffer 205, and the test chamber 206 comprises a reagent member 207. A bottom 208 closes the lower end of the test assembly 201 and a lid 209 closes the upper end of the test assembly, and means (e.g. a needle cover 210) is provided for allowing liquid to flow from the sample-receiving chamber 204 into the test chamber 206. The detection assembly 201 comprises a plastic tubular structure comprising a tubular inner wall 211 and an outer wall 212 connected together at a neck 227. The double-walled side wall forms an interior sample receiving chamber 204 and a detection chamber 206. A frangible seal 213 seals the lower end opening of the inner wall 211. The bottom 208, which is sized to fit the lower end of the sensing assembly, seals the sensing assembly 206 from the lower end. The base 208 includes an upper end 214 and a lower end 215, a sidewall 216 for internal engagement with the lower end of the test assembly, and a through-hole 217 sealed at the lower end 214 by a frangible seal 218. The needle cover 210 includes a stem 219, the stem 219 being sized to fit into the bottom through bore 217 and the stem 219 being capable of breaking the frangible seals 218 and 213 when the stem 219 is pushed into the through bore from the lower end thereof.
The lid 209 includes a handle portion 220 and an insert portion 221 sized to fit into the upper opening 202 of the test assembly, and the lid 209 closes the upper end of the assembly.
The reagent member 207 comprises an upper end 222 and a lower end 223, a detection zone 224 proximate the upper end 222, and a core 225 proximate the lower end 223. The detection zone includes at least one reagent 226. Liquid in contact with the wick 225 can wick through the wick to the detection zone 224 and contact the reagent 226. Reagent spare sets up inside detecting the chamber, and the upper end orientation of reagent spare the determine module upper end, the lower extreme orientation of reagent spare the determine module lower extreme.
The frangible seal of the detection assembly is a hydrophobic barrier selected from the group consisting of plastic, rubber, and metal foil, the frangible seal being attached to a sidewall of the sample-receiving chamber. Seal breaking means for breaking the frangible seal include any means capable of piercing, tearing or removing a portion of the frangible seal when the device is in the testing position. In one embodiment of the invention, the seal breaking means is a stick inserted from the upper end of the sample receiving chamber and capable of breaking the seal. In an exemplary embodiment, the stick is designed to be clean, i.e., not contaminate the sample or sample solution. In another embodiment of the invention, the seal-breaking means is a structure attached to the test assembly container that breaks the seal from the lower end of the sample-receiving chamber.
Fig. 8 (in conjunction with fig. 9) depicts an apparatus according to another embodiment of the present invention. The device 300 includes an assembly 310, the assembly 310 including a cup-shaped transparent portion 311 having an outer wall or sidewall 312, an upper aperture 313, a lower aperture 314, and a diaphragm 315. The diaphragm 315 is attached to the sidewall 312 and divides the interior of the cup into an upper portion 316 and a lower portion 317, which are connected by a through hole 318. The membrane comprises one part 319 which is at an angle to the side wall and another part 320 which is bent upwards to form a pocket 321 (reagent member receptacle) with the side wall. The reagent pack receptacle 321 includes a reagent pack, an absorbent test strip including a core 331, and a test zone 332 including a reagent 333. The bottom 340 is sized to fit the lower opening of the cup portion and the reagent member is located inside the reagent member receptacle. The air vent 341 is a through hole of the bottom 340. A porous plug 342, which is permeable to air but impermeable to the sample solution, is filled in the through-hole 341. An optional cap 350 is sized to fit entirely within the upper opening 313.
The porous plug comprises a porous material of the desired properties (permeable to air but impermeable to the sample solution). These basic techniques of the prior art are similar to the materials used to form porous plastic plugs, such as, but not limited to, polyethylene and polytetrafluoroethylene. In porous plastic plugs, the median pore size varies from 3 microns to an upper limit determined by the hydrophobicity of the plug material. The air and water permeability of a porous plug depends on the size of the pores and the surface characteristics of the porous material. To achieve the above characteristics, the pores of the plug are typically less than 30 microns in size, for example 10 to 20 microns. Another way to achieve the desired properties is to coat the surface of the porous material with a coating that melts and forms a gel when contacted with the sample solution. Such gel-forming materials are selected from the group of materials comprising resins, gels, long-chain polysaccharides and proteins.
The reagent member may comprise more than one detection reagent for detecting more than one detection substance in the sample solution. For example, the device 300 may include more than one absorbent test strip, each for detecting a different test substance (e.g., drug of abuse). When a sample solution (e.g., a urine sample) is introduced into the device from the upper opening, the sample flows into the lower portion of the device and reacts with the reagent. Thus, multiple test substances (e.g., drugs of abuse) can be simultaneously detected. When the liquid level at the lower portion of the device reaches the porous plug, air is vented through the porous plug. The flow of additional liquid from the upper portion to the lower portion is stopped. This arrangement provides for automatic control of the volume of liquid flowing into the detection chamber.
For example, the device of the present invention may be used to detect body fluid samples, environmental samples, stool and other samples. Substances that can be detected using the device of the invention include drugs of abuse, therapeutic drugs, infectious agents, antibodies, blood components, environmental contaminants (e.g., microorganisms), explosives, and poisons. The device of the invention is suitable for testing samples selected, for example, from the group comprising stool, blood, urine and saliva, microbiological culture media, samples of animal surface (such as cervix, urethra, nasal cavity and throat) secretions and environmental samples (such as food, soil and dust samples). An animal represents any living or dead animal, including, for example, a mammal, such as a human. The test substances in these samples include, but are not limited to, fecal occult blood components, hemoglobin-haptoglobin complexes, antibodies, bacteria, viruses, enzymes, proteins, drugs, substances of abuse, allergens, pesticides, and contaminants.
The reagent member may be in liquid or dry form. In one embodiment of the invention, the reagent member of the device is a liquid solution comprising a reagent capable of reacting with an analyte of the sample solution being tested and generating an assay signal indicative of the presence or amount of at least one analyte of the sample solution. In another embodiment of the invention, the assay reagent is a dry reagent comprising a reagent capable of reacting with an analyte of a sample solution being tested and generating an assay signal indicative of the presence or amount of at least one analyte of the sample solution. Dry reagents (air dried or lyophilized) have a longer shelf life than liquid reagents. Preferred dry assay reagents are, for example, but not limited to, dry reagent pads, porous matrices containing dry assay reagents. The dry reagent is used for detecting various detection objects, such as urine glucose, pH, creatinine and alcohol. Another example of a preferred dry reagent member is a lateral flow test strip. The reagent members are dry reagents (e.g., test strips) and, as will be appreciated by those skilled in the relevant art, the test assembly may comprise more than one reagent member, e.g., each reagent member containing reagents for a different analyte testing assay. For example, a device for fecal occult blood testing may include a reagent member for detecting hemoglobin and another reagent member for detecting hemoglobin-haptoglobin complex.
The invention also provides kits for detecting solid, semi-solid, or liquid sample analytes. For example, kits are provided that include the devices of the present invention. The kit may further comprise instructions for detecting the presence of a substance in the sample, and may further comprise instructions for obtaining the sample. The kit may further comprise a reference sample to compare the test result with the sample.
Example 1: detection cavity device for stool occult blood detection
Fecal occult blood testing is an immunoassay-based test method for the determination of blood in a fecal sample. The presence of hemoglobin in the stool in combination with bleeding phenomena can be indicative of gastrointestinal conditions such as colorectal cancer, colonic polyps, crohn's disease, and ulcerative colitis. The present embodiments provide a two-in-one sample preparation and detection device that does not require a pipetting operation or the transfer of a sample or sample solution. Stool samples are collected and prepared for testing using a stool collection probe (or sample stick) that is attached to the lid of the test assembly of the present invention. The collection probes are inserted into different spots of a stool sample. The remaining sample was gently wiped from the stick with absorbent tissue. The probe is reinserted into the tube and the cap is securely closed. The tube was shaken vigorously to obtain a liquid suspension sample. The tube was held upright and the bottom of the chamber assembly was loosened approximately 1 turn (360). This allows the sample solution in the sample receiving chamber to flow into the detection chamber. The device remains in the vertical position for 5 minutes after which the results can be read. Waiting for more than 10 minutes may cause data reading inaccuracies. A light pink band when present in the control zone is indicated as negative, meaning that the fecal sample does not contain a detectable level of human hemoglobin. When two pink bands appeared, one in the detection (T) and one in the control (C) region, a positive was indicated. A positive result indicates that the sample carries human hemoglobin. If no band appears after five minutes, or if a band appears in the detection region and no band appears in the control region, an invalid result is indicated.
Each patent, patent application, publication, and document referred to herein is incorporated by reference in its entirety. Citation of the above patents, patent applications, publications and documents is not an admission that any of the foregoing is pertinent prior art, nor does it constitute any admission as to the contents or timing of such publications or documents.
The singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to "a subset" includes a plurality of subsets, reference to "a nucleic acid" includes one or more nucleic acids and equivalents thereof as understood by those skilled in the relevant art, and so forth. The word "or" does not mean that only one or the word is specified. For example, the phrase "A or B" structure used may refer to A alone, B alone, or A and B together.
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. Although methods and systems similar or equivalent to some described herein can be used in the practice or testing of the present invention, methods, devices, and materials are described. All publications mentioned herein are incorporated herein by reference to describe and disclose the procedures, systems and methods described in the publications and which may be related to the invention. Nothing herein is to be construed as an admission that the invention is not entitled to antedate such disclosure by virtue of prior art.
Modifications may be made to the foregoing without departing from the basic aspects of the invention. While the present invention has been described in sufficient detail with respect to one or more specific embodiments, those skilled in the relevant art will recognize that changes may be made to the embodiments specifically disclosed in this application, and that such changes and modifications are intended to be within the scope and spirit of the present invention. The invention described herein may suitably be practiced in the absence of some element which is not specifically disclosed herein. Thus, for example, in each instance any of the words "comprising," "consisting essentially of …," and "consisting of …" can be substituted for any of the other two. The words and expressions which have been employed are therefore intended to be illustrative and not restrictive, rather than to exclude the equivalents of the features shown and described and portions thereof, and it is recognized that various modifications are possible within the scope of the invention. Embodiments of the invention are set forth in the following claims.

Claims (12)

1. An apparatus for testing a sample, the apparatus comprising: a detection assembly, the detection assembly comprising:
i) a sample receiving chamber;
ii) a detection chamber;
iii) a septum wall separating the sample receiving chamber and the detection chamber;
iv) a hole formed in the membrane wall to enable the sample receiving chamber to be in fluid communication with a detection chamber;
v) a reagent member located in the detection chamber, the reagent member having a core and a detection zone comprising at least one assay reagent;
vi) a frangible seal for preventing flow of sample solution from the sample receiving chamber to the detection chamber; and
vii) means for breaking the frangible seal to allow the sample to flow from the sample-receiving chamber to the detection chamber.
2. The device of claim 1, wherein the sample receiving chamber comprises a detection buffer.
3. The device of claim 1, wherein the means for breaking the frangible seal is attached to a lower end of the sample receiving chamber.
4. The device of claim 1, wherein the detection assembly is made of a plastic selected from the group consisting of polyethylene, polypropylene, polystyrene, ethylene polymer, and acrylonitrile β -cocaine styrene.
5. The device of claim 1, further comprising a cover comprising a handle and an insertion portion sized to fit within the upper end of the detection assembly.
6. The device of claim 1, wherein the reagent member is a lateral flow test strip.
7. The device of claim 1, wherein the device comprises at least 2 reagent members.
8. The device of claim 1, wherein the device comprises 3 to 5 reagent members.
9. The device of claim 1, wherein the assay reagent is for detecting hemoglobin.
10. The device of claim 1, wherein the assay reagent is for a hemoglobin-haptoglobin complex.
11. A method of using the apparatus of claim 1, the method comprising:
introducing a sample solution into the sample receiving chamber;
mixing the sample and buffer in the sample-receiving chamber;
breaking the seal;
introducing the sample into the detection chamber through the aperture; and
reacting the sample with an assay reagent of the reagent member located within the detection chamber.
12. The method of claim 11, wherein the device further comprises a cover comprising a handle and an insertion portion sized to fit within the upper end of the detection assembly, the method further comprising:
lowering the handle such that the insertion portion is inserted into the test assembly to move the means for breaking the frangible seal, thereby breaking the frangible seal.
HK13101238.5A 2006-01-23 2009-09-11 Rapid test apparatus and method of using the same HK1174386B (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US60/761,580 2006-01-23
US11/625,813 2007-01-22

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
HK09108337.6A Addition HK1128764A (en) 2006-01-23 2007-01-23 Rapid test apparatus

Related Child Applications (1)

Application Number Title Priority Date Filing Date
HK09108337.6A Division HK1128764A (en) 2006-01-23 2007-01-23 Rapid test apparatus

Publications (2)

Publication Number Publication Date
HK1174386A true HK1174386A (en) 2013-06-07
HK1174386B HK1174386B (en) 2019-07-05

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