Systems and methods for diagnostic testing of analytes in a sample

Abstract

The present invention relates to a test device for collecting a sample and determining the presence of one or more analytes in the sample. Methods of using the test system for determining the presence of one or more analytes in a sample are also described. The test system comprises a sample collector and an analysis device. The analysis device is adapted to hold one or more test strips for lateral flow analysis. The test system comprises a device activation means adapted to activate the oral fluid test system, and an analysis initiation means for allowing fluid in the mixing chamber to be applied to the test strip.

Description

Technical Field

[0001] The present invention relates to a testing apparatus for collecting samples and determining the presence of one or more analytes in the samples, and a method of using such a testing apparatus. Background Technology

[0002] Lateral flow immunoassay (LFIA) is used in a variety of fields requiring rapid testing for the presence of specific analytes. These analytes can be drugs (for drug testing), hormones (such as in pregnancy tests), or specific microorganisms or components of microorganisms, such as viral components (such as in COVID-19 tests). LFIA devices are particularly well-suited for point-of-care testing, such as drug testing at customs checkpoints, on-site law enforcement testing, and emergency hospital care. Commonly tested drugs include cocaine, benzodiazepines, opioids, amphetamines, methamphetamine, cannabis (e.g., tetrahydrocannabinol (THC)), ketamine, and methadone.

[0003] A commonly known LFIA device is a strip with a conjugate pad, i.e., a pad containing gold particles conjugated, for example, to a specific antibody specific to the analyte being tested. The strip utilizes lateral flow via capillary action or wicking to move the sample along different sections of the strip. Typically, a sample (e.g., a saliva sample) is applied to the sample pad at one end of the strip, and the sample is drawn into the adjacent conjugate pad, where any target analyte will bind to the gold-conjugated antibody. The fluid solution continues to travel along the strip through one or more test lines, each supplied with an immobilized binding conjugate of the target analyte, such as a specific antibody, antigen, or other molecule with high affinity for the analyte, to detect the presence of the desired analyte in the sample. A control line placed after the test lines (one or more) captures any remaining antibody and indicates that the sample has correctly flowed through the different sections of the strip.

[0004] WO 2013 / 131955A1 discloses an example of such a device for detecting an analyte, comprising a test cartridge containing three test strips and including independent wiping elements for acquiring and applying a sample to a sample area. WO 2011 / 134946 discloses a microfluidic device for determining an analyte, comprising various regions arranged to be fluidly connected to each other by a user to control the timing of different steps. AU2014200352B2 shows an example of a saliva collector suitable for an LFIA testing device. AU2015200466B2 discloses a sample preparation and testing system having a mixing container including an indicator element configured to indicate when the reaction mixture has been adequately mixed.

[0005] Saliva is a viscous liquid due to the presence of mucopolysaccharides and mucins. Saliva viscosity is a measure of how thick or sticky saliva is and can vary depending on many factors, such as hydration, mouth breathing, medications, and health conditions. Viscous saliva can cause discomfort and difficulty swallowing, speaking, or breathing. It can also affect the accuracy and reliability of saliva-based analytical tests, such as those using LFIA.

[0006] Some known problems with LFIA devices include poor analyte sensitivity, the need for extensive sample dilution, and cumbersome operation.

[0007] The inventors of this invention have recognized the need for an improved oral fluid testing device that provides better test results and is easy to operate. Summary of the Invention

[0008] The above-mentioned objectives are achieved by the invention according to the independent claims. Preferred embodiments are set forth in the dependent claims.

[0009] According to the present invention, a testing system for collecting samples and determining the presence of one or more analytes in the samples is disclosed. The testing system disclosed herein is described in the case of a saliva sample, and therefore the testing system is an oral fluid testing system. However, it is entirely conceivable that the sample can be any sample that can be obtained on a swab or pad of a sample collector as described herein. Non-limiting examples of samples and sample sites that can be applied to the testing system herein include saliva obtained directly from the human mouth, saliva or other bodily fluids on the human body (e.g., hands, nose, mouth, or face). Further examples of sample sites are surfaces, such as interior or exterior surfaces of a vehicle, tabletops, furniture, etc. Depending on the type of sample collector used, the sample can be fluid or dry. Various sample collectors will be described in further detail herein.

[0010] The testing system has a longitudinal axis A extending from a first end to a second end of the system and defining a proximal-distal direction. In this document, the term proximal generally refers to the direction toward the user during use, while distal generally refers to the direction away from the user during use. The testing system includes a sample collector, an analytical device, a dried particle-antibody conjugate formulation disposed within the testing system, and an elution solution disposed within the system.

[0011] The analytical apparatus includes a mixing chamber and a first receiving opening oriented proximally, the first receiving opening being configured to provide a passage to the mixing chamber for a sample collector. Furthermore, the analytical apparatus includes a holding device for one or more test strips used for lateral flow analysis. The analytical apparatus is configured such that any test strip disposed in the holding device is initially positioned such that a first end of the test strip is positioned such that the first end is not in fluid contact with the mixing chamber. Details of how this is achieved are described below.

[0012] The analytical apparatus also includes an observation device for observing any results indicated on the test strip.

[0013] The testing system also includes a device activation unit adapted to activate the testing system for receiving samples and performing analyses that determine the presence of an analyte (one or more analytes). Actuation of the device activation unit causes or allows the dried particulate-antibody conjugate formulation to contact the eluent solution. Details of how this is achieved are described below.

[0014] The testing system also includes an analysis initiation device, which allows fluid in the mixing chamber to be applied to the first end of the test strip in the holding device. Details of how this is achieved are described below.

[0015] Furthermore, this document discloses a method for using a testing system to determine the presence of an analyte in a sample. Such a method is intended for use with, for example, a testing system generally as disclosed herein, comprising an elution solution, a dried particulate-antibody conjugate formulation, a sample collector, a sample receiving unit, and a testing unit.

[0016] The method includes the following steps: - Activate the device to activate the test system for receiving a sample and performing an analysis to determine the presence of one or more analytes, wherein actuation of the device activation device allows the dried particulate-antibody conjugate formulation to come into contact with the eluent solution; - Insert the sample collector into the mixing chamber of the sample receiving unit in the test system, so that the acquired sample is transferred to the mixing chamber. This step is performed before, simultaneously with or after the step of activating the device activation device. - Allows the sample to react in the mixing chamber; and - Activate the analysis start device to allow any fluid in the mixing chamber to be applied to the first end of any test strip arranged in the holding device of the test unit.

[0017] This disclosure will become apparent from the detailed description given below. The detailed description and specific examples disclose various preferred aspects of this disclosure by way of illustration only. Changes and modifications can be made within the scope of this disclosure based on the guidance in the detailed description.

[0018] Therefore, it should be understood that the disclosure herein is not limited to the specific components of the described apparatus or the steps of the methods, as such apparatus and methods can vary. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. It should be noted that, as used in the specification and appended claims, the articles “a,” “an,” “the,” and “said” are intended to indicate the presence of one or more elements unless the context explicitly specifies otherwise. Thus, for example, references to “a unit” or “unit” can include multiple devices, etc. Furthermore, the words “comprising,” “including,” “containing,” and similar wording do not exclude other elements or steps. Attached Figure Description

[0019] Figure 1 The first aspect of the test system is shown in a three-dimensional diagram.

[0020] Figure 2 Shown in sectional view Figure 1 The test system in which a sample collector is partially inserted.

[0021] Figure 3 A three-dimensional diagram of the sample collector used in the test system is shown.

[0022] Figure 4 It shows Figure 1 An exploded three-dimensional view of the sample receiving unit in the test system.

[0023] Figure 5 It shows Figure 1 An exploded 3D view of the test unit in the test system.

[0024] Figures 6a to 6f It shows the use of Figure 1 The continuous steps of the testing system.

[0025] Figures 7a to 7c They respectively showed the same as Figure 6c , Figure 6e and Figure 6f The corresponding cross-sectional view of the test system.

[0026] Figure 8 Another aspect of the test system is shown in a 3D diagram.

[0027] Figure 9 Shown in sectional view Figure 8 The test system, in which a sample collector is inserted.

[0028] Figure 10a It shows Figure 8 Decomposed stereoscopic view of the sample collector used in the test system.

[0029] Figure 10b It shows Figure 10a A cross-sectional exploded view of the sample collector.

[0030] Figure 11 It shows Figure 8 A three-dimensional view of the sample receiving unit in the test system.

[0031] Figure 12 It shows Figure 8 An exploded 3D view of the test unit in the test system.

[0032] Figures 13a to 13g It shows the use of Figure 8 The continuous steps of the testing system.

[0033] Figures 14a to 14e They respectively showed the differences between the two. Figure 13a , Figure 13b , Figure 13d , Figure 13e and Figure 13g The corresponding cross-sectional view of the test system.

[0034] Figure 15 A three-dimensional diagram of yet another testing system is shown.

[0035] Figure 16a and Figure 16b It is shown in two different states Figure 15 A cross-sectional view of the test system.

[0036] Figure 17a , Figure 17b and Figure 17c A cross-sectional view of another aspect of the test system is shown.

[0037] Figure 18a , Figure 18b and Figure 18c A cross-sectional view of another aspect of the test system is shown.

[0038] Figure 19a , Figure 19b and Figure 19c A cross-sectional view of another aspect of the test system is shown.

[0039] Figure 20 It shows Figure 15 An exploded three-dimensional diagram of the test system.

[0040] Figure 21 It shows Figure 15 A decomposed side view of the test system.

[0041] Figure 22 It shows Figure 15 Top view of the distal end within the test system.

[0042] Figure 23a A three-dimensional diagram of yet another testing system is shown.

[0043] Figure 23b It shows Figure 23a A cross-sectional view of the test system.

[0044] Figure 24 It shows Figure 23a An exploded three-dimensional diagram of the test system.

[0045] Figure 25a and Figure 25b It is shown in two different states Figure 23a A cross-sectional view of the test system.

[0046] Figure 26 It shows Figure 23a An exploded stereoscopic view of the sample collector in the testing system.

[0047] Figures 27a to 27h It shows the use of Figure 23a A three-dimensional diagram of the continuous steps of the testing system.

[0048] Figures 28a to 28h It shows the use of Figure 23a A three-dimensional diagram of the continuous steps of the test system, in which the accommodating elements have been removed for clarity. Detailed Implementation

[0049] According to the present invention, various aspects of a testing system for collecting samples and determining the presence of one or more analytes in the samples are disclosed. It should be understood that the various features described with respect to one aspect can generally be combined with features of other aspects. Therefore, the different aspects described herein are in no way intended to limit the specific combinations relating to the invention.

[0050] The system disclosed herein is designed for use with custom-designed lateral flow immunoassay strips. In conventional LFIA strips, the user typically applies a fluid sample to the sample pad on the test strip, where the sample flows into the conjugate pad to react directly with the particle-antibody conjugate and initiate lateral flow toward the detection zone. However, in contrast, the currently disclosed device provides a delayed reaction for at least one analyte—the presence of which is being analyzed—allowing the sample and particle-antibody conjugate to react before the mixture is applied to the test strip for lateral flow. This results in significantly increased efficiency and, overall, greatly improved test results.

[0051] It is worth noting that, in this document, the term "antibody" encompasses both the complete antibody molecule and a portion of an antibody, as long as the selected molecule binds to the intended target. In a preferred embodiment, the presence of an analyte, which is THC, is being analyzed, and a gold particle-THC antibody conjugate is used in the initial step before being applied to the test strip. In other embodiments, particle-antibody conjugates for two or more analytes are provided in the initial step.

[0052] Therefore, the lateral flow test strips preferably used in this device employ the principle of immunochromatography. As described below in all disclosed aspects, the sample and a particle-antibody conjugate for at least one analyte are mixed and allowed to react before being applied to the test strip. The test area of ​​the lateral flow test strip may have one, two, or more test lines. Each test line has an immobilized specific binding partner for the desired analyte. The binding partner may be another antibody for the same analyte, or an antigen or another suitable binding receptor.

[0053] In some aspects, if particle-antibody conjugates are provided for all analytes tested on a particular test strip, then such test strips do not require a separate conjugate pad before application to the test strip. However, in some preferred aspects, particle-antibody conjugates for one or a selected number of analytes being tested are provided before application to the test strip, and the remaining particle-antibody conjugates can be set in a dedicated conjugate pad on the test strip.

[0054] This document discloses various aspects of a testing system, including a sample collector, an analytical device, a dried particulate-antibody conjugate formulation disposed within the oral fluid testing system, and an eluent solution disposed within the testing system. The analytical device includes a mixing chamber; a first receiving opening adapted to receive the sample collector and provide the sample collector with access to the mixing chamber; and a holding device for one or more test strips for lateral flow analysis. The holding device is configured such that any test strip disposed within the holding device is initially positioned such that a first end of the test strip is not in fluid contact with the mixing chamber. The holding device also includes an observation device for observing any results indicated on the test strip. The dried particulate-antibody conjugate formulation is disposed within the testing system such that the particulate-antibody conjugate formulation is initially not in contact with the eluent solution.

[0055] Furthermore, the testing system includes a device activation unit adapted to activate the testing system for receiving samples and performing an analysis to determine the presence of one or more analytes. Actuation of the device activation unit brings the dried particulate-antibody conjugate formulation into contact with the eluent solution. Additionally, the testing system includes an analysis initiation unit for allowing fluid in the mixing chamber to be applied to the first end of the test strip in the holding device.

[0056] The first important feature is that when the disclosed test system is manufactured and transported to the location where it will be used, the test system is thus in an inactive configuration and requires activation. Therefore, when the user is ready to begin analyzing one or more analytes in a sample, the user activates the device and initiates the sampling and analytical procedure. Another important feature of the device disclosed herein is that, after sampling and allowing the sample to react with the particle-antibody conjugate in the eluent solution, the configuration requires the user to actuate the analytical initiation device. This allows for efficient reaction prior to the initiation of lateral flow of the reaction mixture on the test strip. These features will be described in detail below and with respect to each aspect disclosed herein.

[0057] Therefore, the test system disclosed herein is delivered in a manner that separates the dried particulate-antibody conjugate formulation from the eluent solution, thereby facilitating transport and suitability for long-term storage between device manufacturing and use. Once the user is ready to perform the test, the device is activated to effectively dissolve the dried particulate-antibody conjugate formulation. The device activation device is configured in various ways in different aspects disclosed herein, but all configurations share the common feature that actuation of the device activation device brings the eluent solution into contact with the dried particulate-antibody conjugate formulation disposed within the test system. Notably, in some aspects, allowing the disposed dried particulate-antibody conjugate to completely dissolve within a timeframe of seconds to minutes before contact with a saliva sample appears to improve the effectiveness of the test procedure.

[0058] The sample to be tested can be a bodily fluid and / or tissue sample. The sample can be in dry or fluid form. Furthermore, the sample can be obtained directly from the human body, such as from the mouth or hands. Alternatively, the sample can be obtained from a surface, such as the interior or exterior surfaces of a vehicle, a tabletop, furniture, etc. In a preferred aspect, the sample is a saliva sample. Moreover, the testing system disclosed herein is preferably used to collect samples directly from the mouth of the test subject. For simplicity, the examples and aspects described herein are described in the case of testing saliva samples.

[0059] Once a saliva sample is acquired, it is dissolved in the eluent and allowed to react with the particle-antibody conjugate in the mixing chamber (as described in detail below for each aspect). Due to the analytical initiation device of the test system, a built-in delay period exists. The sample-conjugate mixture remains in the mixing chamber until the user actuates the analytical initiation device. In the various configurations described in detail below for each of the test systems disclosed herein, actuation of the analytical initiation device applies the mixture in the mixing chamber to one end of the test strip in the holding device, thereby initiating the final stage of the test procedure as the reacted sample and conjugate are applied to the test strip and lateral flow toward the detection zone is initiated. Therefore, the setup of the analytical initiation device, intended to be activated by the user, ensures that the sample fully reacts with the particle-antibody conjugate before being allowed to come into contact with the test strip.

[0060] The inventors have discovered that a test system with the following configuration significantly improves the quality and consistency of test results: this configuration eliminates the delay between the reaction of the saliva sample with the gold-antibody conjugate formulation and the application of the sample to the lateral flow assay strip. The results are further enhanced by providing two independent steps: device activation and analytical activation.

[0061] Another advantage of the disclosed system is that it requires a relatively small volume of saliva, as most of the collected sample is effectively used for the testing procedure.

[0062] Figure 1 A first aspect of an oral fluid testing system is shown in perspective. The testing system 100 has a longitudinal axis A extending from a first end 10 to a second end 20 of the system and defining a proximal-distal direction. The oral fluid testing system 100 is preferably adapted for use, at least in part, in a substantially vertical orientation along the longitudinal axis A. Figure 2 Along Figure 1 The sectional view taken along the longitudinal axis A shows Figure 1 Oral fluid testing system. Figure 1 The configuration provided to the user is shown, prior to initial use. Figure 2The sample has been acquired and the sample collector is being inserted into the device. Specific usage steps will be described further in this document.

[0063] The testing system 100 has an overall shape capable of standing vertically on a horizontal surface (i.e., having a longitudinal axis A along the vertical direction) and is suitable for use in an upright orientation. The shape is further preferably adapted to be comfortably held in the user's hand during use. The testing system includes a sample collector 110 and an analysis device 150, wherein the analysis device 150 includes a sample receiving unit 120 and a testing unit 140. Figures 3 to 5 The sample collector 110, sample receiving unit 120, and test unit 140 are shown in exploded view. Test unit 140 is configured to engage with sample receiving unit 120, for example, by inserting at least a portion of sample receiving unit 120 into test unit 140, as will be described in further detail below. Sample collector 110 may initially be disposed separately from sample receiving unit 120 and test unit 140.

[0064] One aspect of sample collector 110 is in Figure 3 As shown in the figure. The sample collector 110 has a generally elongated body 111 with a proximal end 112 and a distal end 113. The sample collector 110 is adapted to be inserted into the sample receiving unit 120 such that the distal end 113 reaches the mixing chamber 122 during use. The distal end 113 is preferably provided with a sample collection element 114, which is adapted to collect saliva samples, for example, from the user's mouth. The sample collection element 114 can be any suitable shape and material for collecting at least 25 to 100 microliters of saliva by wiping the collection element 114 inside the subject's mouth. For example, the sample collection element 114 can be a circular or square ring such that the sample can be captured within a through-hole. Alternatively, the sample collection element 114 can comprise a suitable absorbent pad made of any suitable porous material capable of absorbing and releasing samples, such as saliva, from the subject. Regardless of the material, the sample collection element 114 should preferably not contain any material that would bind any intended target substance to any extent, thereby hindering analytical efficiency.

[0065] Therefore, the oral fluid testing system 100 includes a sample collector 110, an analytical device 150, and dried particulate-antibody conjugate formulation and eluent solution, all disposed within the system. The analytical device 150 includes a mixing chamber 122 and a first receiving opening 123 oriented proximally, the first receiving opening 123 being configured to provide a passage from the sample collector 110 to the mixing chamber 122. Furthermore, the analytical device 150 includes a holding device 143 for one or more test strips 148 for lateral flow analysis. The analytical device 150 is configured such that any test strip disposed in the holding device 143 is initially positioned such that a first end of the test strip 148 is positioned such that the first end is not in fluid contact with the mixing chamber 122. Details of how this is achieved are described below.

[0066] The analysis device 150 also includes an observation device 144 for observing any results indicated on the test strip 148.

[0067] The oral fluid testing system 100 also includes a device activation device adapted to activate the oral fluid testing system 100 for receiving a sample and performing an analysis to determine the presence of one or more analytes. Actuation of the device activation device allows the dried particulate-antibody conjugate formulation to come into contact with the eluent solution. Details of how this is achieved are described below.

[0068] The oral fluid testing system 100 also includes an analysis initiation device for allowing fluid in the mixing chamber 122 to be applied to the first end of the test strip 148 in the holding device 143. Details of how this is achieved are described below.

[0069] For example Figure 4 As shown, the sample receiving unit 120 includes a first receiving element 121 and a mixing chamber 122, wherein the mixing chamber 122 is preferably attached to the first receiving element 121 by, for example, snap-fit ​​or adhesive. Alternatively, the first receiving element 121 and the mixing chamber 122 may be integrally formed. The first receiving element 121 also includes a receiving opening 123 oriented proximally, the receiving opening 123 being adapted to receive a sample collector 110, wherein the receiving opening 123 is configured to provide a passage from the sample collector 110 to the interior of the mixing chamber 122, and specifically to provide a passage from the distal end 113 of the sample collector to the interior of the mixing chamber 122. The mixing chamber 122 is pre-filled with an elution solution before use. In some aspects, the first receiving element 121 has an elongated internal access channel 129 extending from the receiving opening 123 into the sample receiving unit 120. The internal volume of the mixing chamber 122 is initially sealed relative to the test unit 140, i.e., in the distal end of the mixing chamber 122.

[0070] In some aspects, the device activation device includes a destructible seal 127 and a cutting element 128. In one aspect, the sample receiving unit 120 includes a destructible seal 127, such as a membrane or weakened wall, located somewhere between the receiving opening 123 and the mixing chamber 122, for example at the distal end of the internal access channel 129. The destructible seal 127 is adapted to be broken when the sample collector 110 is inserted into the receiving opening 123 to reach the mixing chamber 122. The destructible seal 127 ensures that the eluent initially present in the mixing chamber 122 is contained until the system is used.

[0071] In some aspects, the sample receiving unit 120 includes a cutting element 128, which is slidably mounted within the internal entry channel 129. For example... Figure 2 In optimal visibility, the cutting element 128 is initially positioned at a distance from the destructible seal 127. The cutting element 128 is adapted to be pushed by the inserted saliva collector 110 toward the destructible seal 127 such that the cutting element 128 will rupture the destructible seal 127, and the distal end of the saliva collector having the sample collection element 114 will enter the mixing chamber 122 (see example...). Figure 7b Therefore, any saliva sample in sample collection element 114 will be mixed with the elution solution present in mixing chamber 122.

[0072] Furthermore, the dried particulate-antibody conjugate formulation 119 is disposed in a suitable location such that the particulate-antibody conjugate formulation 119 is not initially in contact with the eluent solution. For example, the dried particulate-antibody conjugate formulation 119 can be disposed at any location within the internal access channel 129, such as on the inner wall and / or placed on a pad within the internal access channel 129.

[0073] In one aspect, the particles in particle-antibody conjugate formulation 119 include gold particles. Alternatively, the particles can be any suitable metal, latex, or carbon particle, as long as they can be conjugated to the selected antibody. Depending on the selected particles, colored bands may be generated when using a test strip for lateral flow immunoassay. In other aspects, staining reagents may be necessary. For ease of description, the aspects herein are described as utilizing gold particles, but these can be substituted with any suitable particles.

[0074] In one aspect, the dried gold particle-antibody conjugate formulation 119 is disposed on the surface of the cutting element 128 such that when the cutting element 128 cuts through the destructible seal 127 and is pushed into the mixing solution, the dried gold particle-antibody conjugate formulation 119 is also dissolved in the eluent and sample mixture. Therefore, by shaking or mixing the entire oral fluid testing system 100, or simply by allowing it to stand for a specified period of time (e.g., 30 seconds, 60 seconds, or 90 seconds), the saliva sample and the gold particle-antibody conjugate formulation are allowed to react in the mixing chamber 122. Further details of the method of use will be described below.

[0075] As mentioned, the antibody in the gold particle-antibody conjugate formulation is selected to react with the desired analyte to be detected in the oral fluid testing system, conjugated with gold nanoparticles, and dried according to standard practice. The dried gold particle-antibody conjugate formulation 119 contains one or more types of antibodies against the desired analyte (one or more analytes). The formulation is prepared by drying the gold particle-antibody conjugate, preferably with a suitable stabilizer and / or reagent to make it readily soluble.

[0076] Examples of analytes that can be tested include cocaine, benzodiazepines, opioids, amphetamines, methamphetamine, cannabis (THC), ketamine, methadone, and other narcotic or non-narcotic drug substances or components.

[0077] The test unit 140 includes a second receiving element 141, which is arranged to receive the sample receiving unit 120 and surround at least the lower end of the mixing chamber 122. Figure 2 As shown, when the sample receiving unit 120 engages with the test unit 140, for example by inserting into the top opening 147, the second receiving element 141 surrounds the mixing chamber 122 and also surrounds at least a portion of the internal access channel 129 of the sample receiving unit 120.

[0078] Reference Figure 2 and Figure 5 , Figure 5 An exploded view of the test unit is shown, in which the second receiving element 141 also forms a test strip application receiver 142 on the distal side of the mixing chamber 122. In other words, the test strip application receiver 142 is positioned downwards, i.e., at the bottom end, opposite to the end into which the sample receiving unit 120 is inserted. When the sample receiving unit 120 engages with the test unit 140, the test strip application receiver 142 will therefore be located below and outside the mixing chamber 122. Figure 2 ).

[0079] like Figure 5As best seen, the second receiving element 141 also includes a holding device 143 for one or more test strips 148 for lateral flow analysis. The holding device 143 is configured such that any test strip 148 disposed in the holding device 143 is arranged such that a first end of the test strip is positioned in the receiving portion 142.

[0080] Lateral flow test strips are preferably disposed in holding device 143. More specifically, test strip 148 is preferably mounted vertically in a groove forming holding device 143, wherein the end of the strip is bent into an L-shape such that one end of the strip is arranged along at least a portion of the bottom of the receiving portion 142. Lateral flow analysis strip 148 has a sample application area, an optional coupling pad, one or more test areas, and a control area, as described above. The sample application area, i.e., the first end of the test strip, is disposed in the receiving portion 142, and the strip can be bent at an angle to be disposed in, for example, a longitudinally open groove forming holding device 143. Holding device 143 can be adapted to hold one, two, three, four, or more strips simultaneously. It is worth noting that prior to actuation of the analysis activation device described further below, analysis device 150 is therefore configured such that any test strip disposed in holding device 143 is initially arranged such that the first end of test strip 148 is positioned such that the first end is not in fluid contact with mixing chamber 122.

[0081] The second receiving element 141 also includes an observation device 144, which is connected to the holding device 143 for observing any results indicated on the test strip 148 from outside the testing apparatus. The observation device may be an open slot along at least a portion of the holding device 143, adapted to observe the strip at least in the test area and control area.

[0082] Furthermore, the test unit 140 is coupled to the sample receiving unit 120, allowing the two units to rotate relative to each other about the longitudinal axis A. This rotation actuates the analysis initiation device, causing any fluid in the mixing chamber 122 to be applied to the first end of any test strip 148 disposed in the holding device 143. The rotation actuation device thus allows fluid in the mixing chamber 122 to be released into the test strip application container 142. Consequently, fluid is applied to the first end of any test strip in the holding device 143, and lateral flow measurement is initiated.

[0083] Therefore, the fluid applied to the sample area of ​​test strip 148 will travel along the strip, passing through one or more test lines in the test area, each test line supplied with immobilized specific antibodies, antigens, or other binding receptors for the analyte, to detect the presence of the desired analyte in the sample. Control lines placed after the test lines (one or more) will capture all antibodies and indicate that the sample has flowed normally through different sections of the strip.

[0084] For example Figure 1 , Figure 2 and Figure 5 It is understood that the sample receiving unit 120 can be configured to be inserted into the top opening 147 and adapted to rotate within the test unit 140 and the top opening 147. The shapes of the sample receiving unit 120 and the test unit 140, especially any interacting portions, can be configured to rotate a specific angular distance when pushed into each other and / or rotated by the user. This will guide the user through the operating steps further described below.

[0085] Reference Figure 2 and Figure 4 In some aspects, the sample receiving unit 120 also includes a permeable portion 125 in the lower end of the mixing chamber 122. In such an aspect, the rotary actuation device includes a penetrating element 145 arranged in the test unit 140, wherein the penetrating element 145 is adapted to penetrate the permeable portion 125 when the first receiving element 121 rotates relative to the second receiving element 141 about a longitudinal axis A (when comparing...). Figure 7b and Figure 7c (Also visible at times). The penetration of the permeable portion 125 allows any fluid present in the mixing chamber 122 to flow out of the mixing chamber 122 and into the test strip application reservoir 142 located below (far side) the mixing chamber 122. (As shown) Figure 2 and Figure 4 As shown, the permeable portion 125 may be a membrane or a destructible seal, which is configured as the bottom of the mixing chamber 122.

[0086] Figures 6a to 6f A perspective view of the sequential steps using an oral fluid testing system is shown. Figures 7a to 7c They respectively showed the same as Figure 6c , Figure 6e and Figure 6f A cross-sectional view of the corresponding oral fluid testing system. In the aspect including the penetrating element 145 in the test unit 140 and the permeable portion 125 forming part of the mixing chamber 122, rotation of the first receiving element 121 relative to the second receiving element 141 causes the penetrating element 145 to move toward and through at least a portion of the permeable portion 125, thereby creating an opening or rupture at the bottom of the mixing chamber 122, allowing fluid to flow out of the mixing chamber 122 and into the test strip application receiving portion 142 located below the mixing chamber 122. This can be achieved by adapting, in particular, the shape of any interacting portion. For example, guide grooves and protrusions can be adapted such that a 90-degree rotation of the first receiving element 121 relative to the second receiving element 141 performs penetration of the permeable portion 125 forming the bottom of the mixing chamber 122.

[0087] As an alternative, or in combination with the above-described scheme, the sample receiving unit and the test unit can be configured such that rotation of the first receiving element 121 relative to the second receiving element 141 causes the permeable portion 125 of the mixing chamber 122 to move toward the penetrating element 145, such that the permeable portion 125 is cut or broken, thereby allowing fluid to flow out of the mixing chamber 122 and into the test strip application seat 142 located below the mixing chamber 122.

[0088] In some aspects, the first receiving element 121 further includes a first external gripping surface 126, and the second receiving element 141 includes a second external gripping surface 146. Therefore, the analysis initiation device can be activated by a user by gripping the first and second gripping surfaces and thereby rotating the sample receiving unit 120 and the test unit 140 relative to each other about the longitudinal axis A. The first and second gripping surfaces may be provided with suitable coatings or surface profiles suitable for a good grip by the user.

[0089] In some aspects, such as Figure 5 As shown, the second receiving element 141 comprises two main parts, a first part 141a and a second part 141b, which together form the main structure of the test unit. One advantage of dividing the receiving element 141 into two parts is for manufacturing and installation reasons, as it allows for the insertion of a test strip holding device during assembly. The first part 141a includes a holding device 143 for one or more test strips and forms a test strip application receiving portion 142. The second part 141b includes a receiving opening 147 for receiving a sample receiving unit. The first part 141a and the second part 141b of the second receiving element 141 are therefore preferably adapted to be tightly attached to each other to form the body of the test unit 140.

[0090] Another aspect of the oral fluid testing system is Figure 8 The test system 200 is shown in a perspective view. The test system 200 has a longitudinal axis A extending from a first end 10 of the system to a second end 20 and defining a proximal-distal direction. The oral fluid test system 200 is preferably adapted for use, at least in part, in a substantially vertical orientation along the longitudinal axis A. Figure 9 Along Figure 8 The sectional view taken along the longitudinal axis A shows Figure 8 Oral fluid testing systems. Generally, unless otherwise stated, the above refers to... Figures 1 to 5 The described features and aspects also apply to the following aspects.

[0091] The testing system 200 has an overall shape that allows it to stand vertically on a horizontal surface (i.e., has a longitudinal axis A along the vertical direction) and is suitable for use in an upright orientation. The shape is further preferably adapted to be comfortably held in the user's hand during use. The testing system includes a sample collector 210 and an analysis device 250, wherein the analysis device 250 includes a sample receiving unit 220 and a testing unit 240. Figures 10a to 10b , Figure 11 and Figure 12 The sample collector 210, sample receiving unit 220, and test unit 240 are shown in exploded view. The test unit is configured to engage with the sample receiving unit, for example by inserting at least a portion of the sample receiving unit 220 into the test unit 240, as will be described in further detail below.

[0092] One aspect of sample collector 210 is in Figure 10a and Figure 10b As shown in the figure, Figure 10a As shown in the exploded diagram, and Figure 10b by Figure 10a A cross-sectional view of the collector is shown. Although the sample collector 210 is described herein in the context of the oral fluid testing system 200, those skilled in the art will understand that the sample collector 210 can also be used with any other oral fluid testing system disclosed herein. The sample collector 210 has a generally elongated body along a longitudinal axis B, having a proximal end 212 and a distal end 213. The sample collector 210 includes a barrel-shaped eluent preparation chamber 211 extending along the longitudinal axis B and including a distal opening 215 for allowing fluid flow.

[0093] The sample collection pad 214 is arranged adjacent to and in fluid communication with the eluent preparation chamber 211 through the distal opening 215. The sample collection pad 214 has an outwardly exposed pad surface for sample acquisition. Such a sample can be acquired by inserting the end of the sample collector with the sample collection pad 214 into a person's mouth and moving it around for a specified time, for example, by wiping or rolling the end against the inner surface of the cheek or tongue.

[0094] The sample collector 210 also includes a piston element 216, which is arranged to apply and enter the eluent preparation chamber 211 from its proximal end 212. The piston element 216 is adapted to slide back and forth within the eluent preparation chamber. Furthermore, the piston element 216 is adapted to fit tightly within the eluent preparation chamber 211, at least at its distal end. This can be achieved by providing a flexible O-ring or similar to the distal end of the piston element 216 to provide a basic fluid seal between the piston element and the eluent preparation chamber 211. Thus, the piston element 216 is configured to draw fluid (e.g., a liquid or gas, such as air) into and out of the eluent preparation chamber 211 through the distal opening 215 and the sample collection pad 214.

[0095] The sample collector 210 also includes a handle element 217, which is connected to the piston element 216 and is arranged to operate the piston element 216 within the eluent preparation chamber 211.

[0096] The fluid testing system with sample collector 210 is preferably configured such that when the handle element 217 of sample collector 210 is pulled proximally or pushed distally, the device activation device is actuated to allow the dried particulate-antibody conjugate formulation 219 to contact the eluent solution. This can be achieved in several different ways.

[0097] In one aspect, the dried particulate-antibody conjugate formulation 219 may be disposed within the eluent preparation chamber 211. In other aspects, the dried particulate-antibody conjugate formulation 219 may be disposed within the mixing chamber 222.

[0098] In one aspect, the particles in particle-antibody conjugate formulation 219 are gold particles. Alternatively, the particles can be any suitable metal, latex, or carbon particles. Depending on the particles selected, colored bands may be generated when using a test strip for lateral flow immunoassay. In other aspects, staining reagents may be required. For ease of description, the aspects herein are described as utilizing gold particles, but these can be substituted with any suitable particles.

[0099] As previously described, an antibody is selected to react with the desired analyte to be detected in the oral fluid testing system, conjugated with gold nanoparticles, and dried according to standard practice. The dried gold nanoparticle-antibody conjugate formulation 219 contains one or more types of antibodies against the desired analyte (one or more analytes). The formulation is prepared by drying the gold nanoparticle-antibody conjugate, preferably with a suitable stabilizer and / or reagent to make it readily soluble.

[0100] Examples of analytes that can be tested include cocaine, benzodiazepines, opioids, amphetamines, methamphetamine, cannabis (THC), ketamine, methadone, and other narcotic or non-narcotic drug substances or components.

[0101] Therefore, the dried gold particle-antibody conjugate formulation 219 is suitable for dissolving in an elution solution, such as in the elution preparation chamber 211 or the mixing chamber 222, before applying a sample in an oral fluid testing system, when the sample collector 210 is activated for sampling. Allowing the gold particle-antibody conjugate formulation to be fully dissolved in the applied elution solution before adding the saliva sample provides improved test reaction efficiency. This differs from known lateral flow immunoassay strips and devices, in which the sample is typically allowed to directly contact the conjugate pad or to be applied while the gold particle-antibody conjugate formulation is dissolved in the elution solution. The currently disclosed system and method ensure complete dissolution and distribution of the gold particle-antibody conjugate formulation before the introduction of the saliva sample.

[0102] It is worth noting that when the dried gold particle-antibody conjugate formulation 219 is indicated in the accompanying drawings, it is actually the initial location of the dried material in the product shown, as the dried material itself is not shown in the drawings. In some aspects, the dried gold particle-antibody conjugate formulation 219 is disposed on the inner wall of the eluent preparation chamber 211, for example, as a drying spot on the inner wall. In other aspects, the dried gold particle-antibody conjugate formulation 219 may be disposed in a recessed portion of the inner wall of the eluent preparation chamber 211. In a preferred aspect, the gold particle-antibody conjugate formulation 219 is disposed in an opening in the wall of the eluent preparation chamber 211, such as, for example... Figure 10b and Figure 14b As seen in the diagram, such an opening is sealed to the outside of the wall by, for example, an adhesive membrane, film, or other structure.

[0103] In other respects, the particle-antibody conjugate formulation 219 may also be disposed in the mixing chamber 222.

[0104] Therefore, the oral fluid testing system 200, including sample collector 210, is suitable for initial provision to the user in an inactive state, wherein the gold particle-antibody conjugate formulation 219 is in a dry formulation state, not exposed to the eluent solution. Activation of the oral fluid testing system 200 requires exposing the gold particle-antibody conjugate formulation 219 to a suitable eluent solution and dissolving the dry formulation in the eluent. Activation is performed before the solution is mixed with a sample (e.g., a saliva sample).

[0105] In the aspect including a dried particulate-antibody conjugate formulation 219 arranged in the eluent preparation chamber 211, the sample collector can be activated by directly immersing the distal opening 215 and the sample collection pad 214 into the eluent solution and drawing the eluent into the eluent preparation chamber 211 by pulling back the piston element 216.

[0106] However, when using the sample collector 210 in an oral fluid testing system as described herein, it is advantageous to configure the sample collector 210 to be at least partially inserted into the sample receiving unit 220, such as... Figure 8 and Figure 9 As shown. At least the sample collection pad 214 can be initially placed within the mixing chamber 222. The eluent solution can be disposed in the distal portion of the eluent preparation chamber 211, distal to the piston element 216.

[0107] For reference, the following steps are required when using an oral fluid testing system. Figures 13a to 13g A three-dimensional diagram of this type of step is shown. Furthermore, Figures 14a to 14e They respectively showed the same as Figure 13a , Figure 13b , Figure 13d , Figure 13e and Figure 13g A cross-sectional view of the corresponding oral fluid testing system. Figure 13a and Figure 14a An oral fluid testing system is shown that is provided to the user before starting the testing procedure.

[0108] The interaction surfaces of the sample collector and sample receiving unit 220 can be adapted such that when the user pulls the handle element 217 backward to withdraw the sample collector 210 from the sample receiving unit 220, the piston element 216 is also pulled backward within the eluent preparation chamber 211. Accordingly, in some aspects, such as Figure 14a and Figure 14b As shown in the differences, sample collector 210 can be activated by removing (e.g., pulling back) the sample receiving unit, thereby pulling the piston element 216 back within the eluent preparation chamber 211. The dried gold particle-antibody conjugate formulation 219, for example initially positioned proximal to the distal end of the piston element 216, i.e., "behind" the end of the piston element 216, is then exposed to the eluent to dissolve the conjugate within the eluent preparation chamber 211. Furthermore, the action of retracting the piston element 216 within the eluent preparation chamber 211 also causes air to be drawn into the eluent preparation chamber 211 through the distal opening 215, thereby creating turbulence, which will enhance the dissolution and melting process of the gold particle-antibody conjugate formulation 219 in the eluent solution.

[0109] Therefore, in some aspects, the sample collector 210 is configured for use with a piston element 216 positioned within the eluent preparation chamber 211, such that the dried gold particle-antibody conjugate formulation 219 is initially located proximal to the distal end of the piston element 216. Preferably, as described above, the dried gold particle-antibody conjugate formulation 219 may be disposed in an opening or recess in the wall of the eluent preparation chamber 211, for example... Figure 14b As shown, it is located behind the distal end of the piston element 216.

[0110] In the case where the dried particle-antibody conjugate formulation 219 is initially placed in the mixing chamber 222, the device activation device can be actuated when the handle element 217 of the sample collector 210 is pushed distally to allow the dried particle-antibody conjugate formulation 219 in the mixing chamber 222 to come into contact with the eluent solution placed in the eluent preparation chamber 211.

[0111] As from Figure 1 a and Figure 1 As further understood in b, the handle element 217 may have a housing 218 configured to slide along at least a portion of the outer surface of the eluent preparation chamber 211 when the piston element 216 is moved within the eluent preparation chamber 211. The housing 218 stabilizes the eluent preparation chamber 211 and provides an outer surface that may have a surface profile to serve as a surface interacting with corresponding interaction surfaces in the sample receiving unit 120 to facilitate activation of the sample collector and also actuate various additional steps, as will be described in further detail below. For example, in the oral fluid testing system 200, the interaction surfaces (e.g., protrusions, ridges, and / or grooves) on the housing 218 and the inner surface of the sample receiving unit 120 may tend to facilitate the steps of activating the sample collector 210 and / or conveying the sample from the sample collector 210 to the sample receiving unit 220.

[0112] Sample collector 210 may also include sample pad mounting element 260, such as Figure 10a and Figure 10b As seen, the sample pad mounting element 260 is arranged in fluid connection with the distal opening 215 of the eluent preparation chamber 211. In this aspect, a sample collection pad 214 may be disposed on the outer perforated surface 261 of the sample pad mounting element 260. This perforated surface 261 is in fluid connection with the distal opening 215. In other words, during assembly, there is a fluid connection from the eluent preparation chamber 211 through the distal opening 215 and through the sample collection pad 214. The sample pad mounting element 260 may be reversibly or permanently attached to the eluent preparation chamber 211 at the distal opening 215.

[0113] like Figure 10aAs shown, the outward-facing surface of the sample collection pad 214 can be arranged with a substantially flat exposed surface, and is arranged parallel to or along the longitudinal axis B. The sample collection pad 214 and its corresponding external perforated surface 261 can be any suitable shape, such as square, rectangular, circular, or elliptical. However, it is advantageous that the sample collection pad 214 and the external perforated surface 261 have the same or similar shape and dimensions. Suitable dimensions for the sample collection pad 214 can range from 0.5 to 2.0 square centimeters.

[0114] The sample collection pad 214 can be made of any suitable porous material capable of absorbing and releasing samples, such as saliva, from the subject. The material should also preferably be one that exhibits good recovery of the analyte to be tested (e.g., cocaine, benzodiazepines, opioids, amphetamine, methamphetamine, cannabis (THC), ketamine, methadone, and other narcotic or non-narcotic drug substances or components). Non-limiting examples of materials for the sample collection pad 214 include porous sintered plastics or glass, sponge, cotton, various synthetic materials, etc.

[0115] The sample collector 210 is also preferably provided with a puncturable element 270, which is arranged to initially close the distal opening 215. The puncturable element 270 may be a membrane or a weakened material portion disposed within the sample pad mounting element 260 and / or covering the distal opening 215. When the puncturable element 270 is punctured or damaged, any fluid in the eluent preparation chamber 211 may be expelled from the eluent preparation chamber 211 through the distal opening 215 and through the sample collection pad 214 by operating the piston element 216.

[0116] As understood from the above, and Figure 9 As seen, the sample collector 210 is adapted to be inserted into the sample receiving unit 220, such that the distal end 213 reaches into the mixing chamber 222. Figure 9 An oral fluid testing device is shown in the configuration provided to the user (i.e., before the start of the test procedure).

[0117] As already described, the oral fluid testing system 200 includes a sample collector 210, an analytical device 250, and dried particulate-antibody conjugate formulation and eluent solution, all disposed within the system. The analytical device 250 includes a mixing chamber 222 and a first receiving opening 223 oriented proximally, the first receiving opening 223 being configured to provide access from the sample collector 210 to the mixing chamber 222. Furthermore, the analytical device 250 includes a holding device 243 for one or more test strips 248 for lateral flow analysis. The analytical device 250 is configured such that any test strip disposed in the holding device 243 is initially positioned such that a first end of the test strip 248 is positioned such that the first end is not in fluid contact with the mixing chamber 222. Details of how this is achieved are described below.

[0118] The analysis device 250 also includes an observation device 244 for observing any results indicated on the test strip 248.

[0119] As described above, the oral fluid testing system 200 also includes a device activation device adapted to activate the oral fluid testing system 200 for receiving a sample and performing an analysis to determine the presence of an analyte (one or more analytes). Actuation of the device activation device allows the dried particulate-antibody conjugate formulation 219 to come into contact with the eluent solution. Details of how this is achieved are described below.

[0120] The oral fluid testing system 200 also includes an analysis initiation device for allowing fluid in the mixing chamber 222 to be applied to the first end of the test strip 248 in the holding device 243. Details of how this is achieved are described below.

[0121] For example Figure 11As shown, the sample receiving unit 220 includes a first receiving element 221 and a mixing chamber 222, wherein the mixing chamber 222 is preferably integrally attached to the first receiving element 221. Alternatively, the mixing chamber 222 may be manufactured separately and attached to the first receiving element 221 during assembly, for example, by snap-fit ​​or adhesive. The first receiving element 221 also includes a receiving opening 223 adapted to receive a sample collector 210, wherein the receiving opening 223 is configured to provide a passage for the sample collector 210 to access the mixing chamber 222. Specifically, when the sample collector 210 is inserted into the receiving opening 223, the distal end 213 of the sample collector, i.e., the sample collection pad 214 and the distal opening 215, is provided with a passage into the interior of the mixing chamber 222. In some aspects, the first receiving element 221 has an elongated internal access channel 229 extending from the receiving opening 223 into the sample receiving unit 220 and into the mixing chamber 222. The internal volume of the mixing chamber 222 is initially sealed relative to the test unit 240, that is, the distal end of the mixing chamber 222 is sealed relative to the test unit 240.

[0122] like Figure 12 As seen in the exploded view, test unit 240 includes a second receiving element 241, which is arranged to receive sample receiving unit 220 and surround at least the lower end of mixing chamber 222. Figure 9 As seen, when the sample receiving unit 220 (e.g., by insertion into the proximal receiving opening 247) engages with the test unit 240, the second receiving element 241 surrounds the mixing chamber 222 and also surrounds at least a portion of the internal access channel 129 of the sample receiving unit 220. Furthermore, when the sample receiving unit 220 engages with the test unit 240, the punctureable element 270 of the sample collector 210 is initially mounted above the puncture protrusion 280 at the bottom of the mixing chamber 222.

[0123] The second receiving element 241 also forms a test strip application receiving portion 242 on the distal side of the mixing chamber 222. In other words, the test strip application receiving portion 242 is positioned downwards, i.e., at the bottom end, opposite to the end into which the sample receiving unit 220 is inserted. When the sample receiving unit 220 engages with the test unit 240, the test strip application receiving portion 242 will therefore be located below and outside the mixing chamber 222. Figure 9 ).

[0124] like Figure 12 As best seen, the second receiving element 241 also includes a holding device 243 for one or more test strips 248 for lateral flow analysis. The holding device is configured such that any test strip disposed in the holding device 243 is arranged such that a first end of the test strip 248 is positioned in the receiving portion 242.

[0125] The lateral flow test strip is preferably disposed in the holding device 243. More specifically, the test strip 248 is preferably vertically mounted in the groove forming the holding device 243, wherein the end of the strip is bent into an L-shape such that one end of the strip is arranged along at least a portion of the bottom of the receiving portion 242. The lateral flow analysis strip 248 has a sample application area, an optional coupling pad, one or more test areas, and a control area, as described above. The sample application area, i.e., the first end of the test strip, is disposed in the receiving portion 242, and the strip can be bent at an angle, such as... Figure 12 As shown, the strips are arranged in, for example, a longitudinally open slot, which forms a holding device 243. The holding device 243 can be adapted to hold one, two, three, four or more strips simultaneously. It is worth noting that, prior to actuation of the analytical activation device described further below, the analytical device 250 is therefore configured such that any test strips arranged in the holding device 243 are initially arranged such that the first end of the test strip 248 is positioned such that the first end is not in fluid contact with the mixing chamber 222.

[0126] The second receiving element 241 also includes an observation device 244, which is connected to the holding device 243 for observing any results indicated on the test strip from outside the testing apparatus. The observation device may be an open slot along at least a portion of the holding device 243, adapted to observe the strip at least in the test area and control area.

[0127] Furthermore, the test unit 140 is coupled to the sample receiving unit 120, allowing the two units to rotate relative to each other about the longitudinal axis A. This rotation actuates the analysis initiation device, causing any fluid in the mixing chamber 122 to be applied to the first end of any test strip 148 disposed in the holding device 143. Thus, rotational actuation allows fluid in the mixing chamber 222 to be released into the test strip application container 242. When released from the mixing chamber 222, fluid is applied to the first end of any test strip in the holding device 243, and lateral flow measurement is initiated.

[0128] Therefore, the fluid applied to the sample area of ​​test strip 248 will travel along the strip, passing through one or more test lines in the test area. Each test line is supplied with immobilized specific antibodies, antigens, or other binding receptors for the analyte to detect the presence of the desired analyte in the sample. Control lines placed after the test lines (one or more test lines) will capture all antibodies and indicate that the sample has flowed normally through different sections of the strip.

[0129] For example Figure 8 , Figure 9 and Figure 12As understood, the sample receiving unit 220 can be configured to insert into the proximal receiving opening 247 and is adapted to rotate within the test unit 240 and the receiving opening 247. The shapes of the sample receiving unit 220 and the test unit 240, particularly any interacting portions, can be configured, for example, to rotate a specific angular distance when pushed into each other. In another aspect, rotation of the sample receiving unit 220 and the test unit 240 can result in longitudinal movement of the two units relative to each other; furthermore, rotation and / or pushing or pulling can actuate subsequent steps of the procedure, such as initiating the application of a lateral flow immunoassay strip. These “semi-automatic” or triggered actions will guide the user through the operational steps further described below, thereby facilitating the execution of the test procedure.

[0130] In some respects, the sample receiving unit 220 also includes a permeable portion 225 in the lower end of the mixing chamber 222. Figure 11 An example is shown. In such an aspect, the rotary actuation device may include a penetrating element 245, which is arranged in the test unit 240, such as... Figure 12 As shown, the penetrating element 245 is adapted to penetrate the penetrable portion 225 when the first receiving element 221 rotates relative to the second receiving element 241 about the longitudinal axis A. The penetrating element 245 can be one, two, or more such protrusions. The penetrating element 245 can be a sharp or pointed protrusion or hook. Penetration of the penetrable portion 225 allows any fluid present in the mixing chamber 222 to flow out of the mixing chamber 222 and into the test strip application reservoir 242 located below the mixing chamber 222. Figure 9 and Figure 11 As seen, the permeable portion 225 may be a weakened portion in the wall of the mixing chamber 222, such as at least a portion of the circumference surrounding the lower end of the mixing chamber 222. Alternatively, the permeable portion 225 may be a membrane or a destructible seal provided as the bottom and / or side of the mixing chamber 222.

[0131] In the aspect including the penetrating element 245 in the test unit 240 and the penetrable portion 225 forming part of the mixing chamber 222, rotation of the first receiving element 221 relative to the second receiving element 241 causes the penetrating element 245 to create an opening or rupture in the mixing chamber wall, thereby allowing fluid to flow out of the mixing chamber 222 and into the test strip application receiving portion 242 located below the mixing chamber 222. In comparison... Figure 13f and Figure 13g or Figure 14d and Figure 14e The steps are illustrated in the figures. It is noteworthy that no liquid transfer is shown in these figures, however the function can be understood. In some respects, the penetrating element 245 is configured to have sharp edges or hooks adapted to cut into the penetrable portion 225.

[0132] In some respects, rotational motion will cause the penetrating element 245 to move toward and through at least a portion of the penetrable portion 225. This can be achieved by adapting to the shape of, in particular, any interacting portion.

[0133] As an alternative, or in combination with the above-described scheme, the sample receiving unit and the test unit can be configured such that rotation of the first receiving element 221 relative to the second receiving element 241 causes the permeable portion 225 of the mixing chamber 222 to move toward the penetrating element 245, such that the permeable portion 225 is cut or broken, thereby allowing fluid to flow out of the mixing chamber 222 and into the test strip application seat 242 located below the mixing chamber 222.

[0134] As another alternative to the penetrating element 245 in test unit 240 and the permeable portion 225 forming part of mixing chamber 222, which is not shown in the figures, other fluid release mechanisms are conceivable within the scope of this disclosure. For example, the bottom of mixing chamber 222 can be configured as a releasable bottom, i.e., constructed to separate from the rest of mixing chamber 222 when sample receiving unit 220 and test unit 240 rotate relative to each other. This can be achieved by using interacting surfaces (e.g., protrusions and grooves) in the two units, wherein the bottom of mixing chamber 222 can, for example, separate from or release from the rest of mixing chamber 222 during rotation.

[0135] In some aspects, the first receiving element 221 further includes a first external gripping surface 226, and the second receiving element 241 includes a second external gripping surface 246, such as, for example... Figure 8 and Figure 13a As shown. Therefore, the analysis initiation device can be activated by the user gripping the first and second gripping surfaces, thereby rotating the sample receiving unit 220 and the test unit 240 relative to each other about the longitudinal axis A. The first and second gripping surfaces may be provided with suitable coatings or surface profiles to achieve a good grip for the user.

[0136] In some aspects, such as Figure 12As shown, the second receiving element 241 comprises two main parts, a first part 241a and a second part 241b, which together form the main structure of the test unit. One advantage of dividing the receiving element 241 into two parts is for easier manufacturing and for installation reasons, as it allows for the insertion of a test strip holding device during assembly. The first part 241a preferably includes a holding device 243 for one or more test strips and forms a test strip application receiving portion 242. The second part 241b preferably includes a receiving opening 247 for receiving a sample receiving unit. Therefore, the first part 241a and the second part 241b of the second receiving element 241 are preferably adapted to be tightly attached to each other to form the body of the test unit 240.

[0137] Another aspect of the oral fluid testing system is Figure 23a The test system 400 is shown in a perspective view. The test system 400 has a longitudinal axis A extending from a first end 10 of the system to a second end 20 and defining a proximal-distal direction. The oral fluid test system 400 is preferably adapted for use, at least in part, in a substantially vertical orientation along the longitudinal axis A. Figure 23b Along Figure 23a The sectional view taken along the longitudinal axis A shows Figure 23a Oral fluid testing system. Typically, the above addresses the previous aspects (at least...) Figures 1 to 5 , Figure 8 , Figure 9 and Figure 12 The features and aspects described in those shown also apply to the following aspects, unless otherwise stated.

[0138] The testing system 400 has an overall shape that allows it to stand vertically on a horizontal surface (i.e., has a longitudinal axis A along the vertical direction) and is suitable for use in an upright orientation. The shape is further preferably adapted to be comfortably held in the user's hand during use. The testing system includes a sample collector 410 and an analysis device 450. Figure 24 The analysis apparatus 450 is shown in an exploded view. The analysis apparatus 450 includes a sample receiving unit 420 and a testing unit 440. The testing unit 440 is configured to engage with the sample receiving unit 420, for example by inserting at least a portion of the sample receiving unit 420 into the testing unit 440, as will be described in further detail below. Figure 26 The sample collector 410 is shown in an exploded view. The sample collector 410 can be initially set up separately from the analysis device 450.

[0139] One aspect of the sample collector 410 is in Figure 26The diagram is shown in an exploded view. Although the sample collector 410 described herein is in the context of an oral fluid testing system 400, those skilled in the art will understand that the sample collector 410 can also be used with any other oral fluid testing system disclosed herein. The sample collector 410 has a generally elongated body 411 along a longitudinal axis C, having a proximal end 412 and a distal end 413. The sample collector 410 is adapted to be inserted along the longitudinal axis A into a sample receiving unit 420 such that the distal end 413 of the sample collector 410 reaches the mixing chamber 422 during use. The distal end 413 is provided with a sample collection element 414 adapted to collect, for example, a saliva sample from a user's mouth. For example, the sample can be obtained by inserting the end of the sample collector 410 with the sample collection element 414 into a person's mouth and moving it around for a specified time, for example, by wiping or rolling the end against the inner surface of the cheek or tongue. Alternatively, a sample can be obtained by wiping the sample collection element 414 along the surface to be tested or the hand or face of the test subject.

[0140] The sample collection element 414 can be of any suitable shape and material for collecting at least 25 to 100 microliters of saliva by wiping the collection element 414 inside the subject's mouth. For example, the sample collection element 414 can be a sponge, cotton swab, or other absorbent material. In some aspects, the sample collection element 414 may include materials suitable for collecting dry or semi-dry samples from, for example, a surface. Regardless of the material, the sample collection element 414 should preferably not contain any material that would bind any intended target substance to any extent, thereby hindering analytical efficiency. In other words, the material, shape, and positioning of the sample collection element 414 are preferably adapted to absorb sufficient sample to produce reliable results when tested in the disclosed testing system, and are further preferably adapted to release the sample from the sample collection element 414 when rinsed with an elution solution (e.g., the elution solution of the testing system). The sample collection element 414 is arranged with outwardly exposed surfaces for obtaining samples.

[0141] In some aspects, the sample collector 410 is equipped with a sample detection device for confirming that a predetermined amount of sample has been acquired, which is sufficient to perform a complete testing procedure. An example of such a sample detection device is... Figure 26As shown in the diagram, the sample collector 410 has at least a partially hollow portion, thus forming an opening oriented toward the distal end 413 of the elongated body 411, in which a detection strip holder 416 can be arranged. Furthermore, a detection strip 415 can be arranged within the detection strip holder 416 and proximal to the sample collection element 414. The detection strip can be a strip of paper or similar material capable of absorbing fluid. The sample collection element 414 is arranged in fluid contact with the detection strip 415 such that when the sample collection element 414 is sufficiently wetted by the fluid sample, a small volume of fluid sample will be drawn into the detection strip 415 by capillary force. The detection strip 415 preferably has a visual indicator 415a, such as a color indicator, configured to change color when the detection strip 415 is filled with fluid (i.e., sample fluid). The color indicator can be, for example, a strip spanning the detection strip 415, wherein the strip is adapted to change color when wetted. Other visual indicator configurations are also possible. The color indicator can be observed through the detection observation window 417 arranged on one side of the elongated body 411.

[0142] Sample collector 410 is adapted to collect a sample, which is then inserted into analytical apparatus 450 to deposit a fluid sample within mixing chamber 422. The configuration and function of mixing chamber 422 will be described in further detail below; however, it is sufficient at this stage to indicate that in mixing chamber 422, the sample is intended to react with the particulate-antibody conjugate dissolved in the elution solution. In some respects, the sample collected in collection element 414 will simply mix with the surrounding solution because the collection element is immersed in the elution solution. In other respects, mixing chamber 422 is provided with a suitable sample release element configured to enhance the release of the sample from collection element 414. This could be, for example, a protrusion, a small mesh, or a perforated element, against which collection element 414 is pressed within the mixing chamber to force the sample from collection element 414 into the solution within mixing chamber 422. In another respect, the shape or configuration of the mixing chamber 422, and optionally any inlet channel, and / or the sample collector 410 itself, are adapted such that the act of inserting the sample collector 410, or more particularly the collection element 414, into the mixing chamber will cause turbulence or movement of the fluid in the mixing chamber, such that the sample in the collection element 414 is more effectively flushed into the surrounding eluent solution.

[0143] Therefore, the oral fluid testing system 400 includes a sample collector 410, an analysis device 450, and dried particulate-antibody conjugate formulation 419 and eluent solution, all arranged within the system. For example... Figure 24As can be seen, the analytical device 450 includes a mixing chamber 422 and a first receiving opening 423 oriented proximally, the first receiving opening 423 being configured to provide a passage to the mixing chamber 422 for a sample collector 410. Furthermore, the analytical device 450 includes a holding device 443 for one or more test strips 448 for lateral flow analysis. The holding device 443 may include a retaining member 443a adapted to hold the test strip 448 in place by securing it within the holding device 443. This can be achieved, for example, by a snap-fit ​​engagement to attach the retaining member 443a to a location adjacent to the holding device 443. The analytical device 450 is configured such that any test strip disposed in the holding device 443 is initially arranged such that a first end of the test strip 448 is positioned such that the first end is not in fluid contact with the mixing chamber 422. Details of how this is achieved are described below.

[0144] like Figure 23a and Figure 23b As best shown, the analysis device 450 also includes an observation device 444 for observing any results indicated on the test strip 448.

[0145] The oral fluid testing system 400 also includes a device activation device adapted to activate the oral fluid testing system 400 for receiving a sample and performing an analysis to determine the presence of one or more analytes. Actuation of the device activation device allows the dried particulate-antibody conjugate formulation 419 to come into contact with the eluent solution. Details of how this is achieved are described below.

[0146] The oral fluid testing system 400 also includes an analysis initiation device for allowing fluid in the mixing chamber 422 to be applied to the first end of the test strip 448 in the holding device 443. Details of how this is achieved are described below.

[0147] As mentioned, Figure 24 It shows Figure 23a An exploded view of the analysis unit 450 of the test apparatus shown. (See diagram below.) Figure 24As seen, the sample receiving unit 420 includes a first receiving element 421 and a mixing chamber 422, wherein the mixing chamber 422 is preferably attached to the first receiving element 421, for example, by snap-fit ​​or adhesive. Alternatively, the first receiving element 421 and the mixing chamber 422 may be integrally formed. The first receiving element 421 also includes a receiving opening 423 oriented proximally, the receiving opening 423 being adapted to receive a sample collector 410, wherein the receiving opening 423 is configured such that the sample collector 410 provides access to the interior of the mixing chamber 422, specifically providing access to the interior of the mixing chamber 422 for the distal end 413 of the sample collector 410. In some aspects, the first receiving element 421 has an elongated internal access channel 429 extending from the receiving opening 423 into the sample receiving unit 420. The internal volume of the mixing chamber 422 is initially sealed relative to the test unit 440, i.e., sealed relative to the test unit 440 at the distal end of the mixing chamber 422.

[0148] like Figure 24 As seen in the exploded view, test unit 440 includes a second receiving element 441, which is arranged to receive sample receiving unit 420 and surround at least the lower end of mixing chamber 422. (See exploded view from...) Figure 24 As understood therein, when the sample receiving unit 420 is engaged with the test unit 440, for example, when the sample receiving unit 420 is inserted into the proximal receiving opening 447, the second receiving element 441 surrounds the mixing chamber 422 and also surrounds at least a portion of the internal access channel 429 of the sample receiving unit 420.

[0149] exist Figure 25a and Figure 25b The diagram illustrates one aspect of the configuration of the device activation device of the oral fluid testing device 400. Figure 25a and Figure 25b The sectional view shown along Figure 23a The test setup shown is arranged along its longitudinal axis A. It is worth noting that... Figure 25a and Figure 25b The section plane in the middle is perpendicular to Figure 23b The planes shown in the cross-sectional view are two planes arranged along the same longitudinal axis A. Figure 25a A cross-sectional view of the device 400 before activation is shown, and Figure 25bA corresponding view of the activated device 400 is shown. In this respect, the oral fluid testing device 400 includes an eluent chamber 491, which may be located adjacent to or arranged on one side of the mixing chamber 422 and slightly closer to it. An eluent solution may be initially disposed in the eluent chamber 491. The eluent chamber 491 has a proximal end 492 and a distal end 493, and a distal opening 495 for allowing fluid flow. An eluent piston 496 is disposed within the eluent chamber 491 and configured to slide back and forth within the eluent chamber 491, thus pushing or pulling the fluid in the eluent chamber 491 through the distal opening 495. Furthermore, the piston element 496 is adapted to fit tightly within the eluent chamber 491, at least at its distal end. This can be achieved by providing a flexible O-ring or similar to the distal end of piston element 496 to provide a substantially fluid seal between piston element 496 and eluent chamber 491. Distal opening 495 is arranged to be in fluid connection with mixing chamber 422, for example via a passage introduced into mixing chamber from one side.

[0150] In one preferred aspect, such as Figure 25a and Figure 25b As shown, the oral fluid testing device 400 also includes a piston actuator 497, which is connected to and arranged to operate the eluent piston 496 within the eluent chamber 491. The piston actuator 497 can be operatively arranged such that longitudinal movement of the sample collector 410 relative to the analysis device 450 actuates the eluent piston 496 to push fluid in the eluent chamber 491 through the distal opening 495 into the mixing chamber 422. (Compare...) Figure 25a and Figure 25b As understood at the time, this can be achieved by configuring the actuator 497 as an extension arm from the proximal end of the eluent piston 496, wherein the end of the extension arm is adapted to slide along the elongated body 411 of the sample collector 410 when the sample collector 410 is inserted into the analyzer 250. The outer surface of the elongated body 411 may be provided with a protrusion 411a of suitable size to push the piston actuator 497 such that the action of pushing the sample collector 410 into the analyzer 250 will cause the eluent piston 496 to move distally within the eluent chamber 491. Other arrangements of the piston actuator 497 are also conceivable.

[0151] Preferably, the eluent chamber 491 is provided with a puncturable element 470, which is arranged to initially close the distal opening 495. This ensures that the eluent solution will be contained within the eluent chamber 491 until the oral fluid testing device 400 is activated. In such an aspect, the eluent piston 496 may have a puncturable element 471 at its distal end, pointing towards the distal opening 495. When the eluent piston 496 is actuated, the puncturable element 471 will puncture the puncturable element 470, and any fluid within the eluent chamber 491 will be expelled from the eluent chamber 491 through the distal opening 495 and pushed into the mixing chamber. The dried particulate-antibody conjugate formulation 419 is preferably disposed in the mixing chamber 422. However, the dried particulate-antibody conjugate formulation 419 may also be disposed in the passage between the distal opening 495 of the eluent chamber 491 and the mixing chamber 422, or in any other location where it can remain dry before activation of the device. Therefore, actuating the device by pushing the eluent solution into the mixing chamber 422 will allow the particle-antibody conjugate formulation 419 to dissolve in the eluent solution in the mixing chamber 422.

[0152] When using Figures 23a to 25b When the oral fluid testing device 400 is shown, the action of moving the sample collector 410 distally so that the sample is released into the mixing chamber 422 is substantially simultaneous with the dissolution of the particle-antibody conjugate formulation 419 in the eluent solution. Therefore, the sample will reach the mixing chamber 422 and dissolve in the eluent solution simultaneously with or immediately after its release into the mixing chamber 422.

[0153] Back Figure 23b and Figure 24 The second receiving element 441 also forms a test strip application receiving portion 442 on the distal side of the mixing chamber 422. In other words, the test strip application receiving portion 442 is positioned downwards, i.e., in the bottom or distal end 20, opposite to the end into which the sample receiving unit 420 is inserted. Therefore, when the sample receiving unit 420 engages with the test unit 440, the test strip application receiving portion 442 will be located below and outside the mixing chamber 422.

[0154] The second receiving element 441 also includes a holding device 443 for one or more test strips 448 for lateral flow analysis. The holding device 443 is configured such that any test strip disposed in the holding device 443 is arranged such that a first end of the test strip 448 is positioned in the receiving portion 442.

[0155] The lateral flow test strip is preferably disposed in the holding device 443. More specifically, the holding device 443 is preferably configured such that the test strip 448 is vertically mounted in the groove forming the holding device 443, wherein the end of the strip is bent into an L-shape or a curved shape, such that one end is arranged along at least a portion of the bottom of the receiving portion 442. The lateral flow analysis strip 448 has a sample application area, an optional coupling pad, one or more test areas, and a control area, as described above. The sample application area, i.e., the first end of the test strip, is disposed in the receiving portion 442, and the strip can be bent at an angle, such as, for example... Figure 23b and Figure 24 As shown, the strips are arranged, for example, in a longitudinally open slot, which forms a holding device 443. The holding device 443 can be adapted to hold one, two, three, four or more strips simultaneously. It is worth noting that, prior to actuation of the analytical activation device described further below, the analytical device 450 is therefore configured such that any test strips arranged in the holding device 443 are initially arranged such that the first end of the test strip 448 is positioned such that the first end is not in fluid contact with the mixing chamber 422.

[0156] The second receiving element 441 also includes an observation device 444, which is connected to the holding device 443 for observing any results indicated on the test strip from outside the testing apparatus. The observation device may be an open slot or a transparent window along at least a portion of the holding device 443, adapted to observe the strip at least in the test area and the control area.

[0157] Furthermore, the test unit 440 is coupled to the sample receiving unit 420, allowing the two units to rotate relative to each other about the longitudinal axis A. This rotation actuates the analysis initiation device, causing any fluid in the mixing chamber 422 to be applied to the first end of any test strip 448 disposed in the holding device 443. Rotation actuation thus allows fluid in the mixing chamber 422 to be released into the test strip application container 442. When released from the mixing chamber 422, fluid is applied to the first end of any test strip in the holding device 443, and lateral flow measurement is initiated.

[0158] In some aspects, such as Figure 24As shown, the second receiving element 441 comprises two main parts, a first part 441a and a second part 441b, which together form the main structure of the test unit. One advantage of dividing the receiving element 441 into two parts is for easier manufacturing and for installation reasons, as it allows for the insertion of the test strip holding device during assembly. The first part 441a preferably includes a holding device 443 for one or more test strips and forms a test strip application receiving portion 442. The second part 441b preferably includes a receiving opening 447 for receiving a sample receiving unit. The first part 441a and the second part 441b of the second receiving element 441 are therefore preferably adapted to be tightly attached to each other to form the body of the test unit 440.

[0159] One aspect of analyzing the starting device and its operation can be seen from... Figure 24 (An exploded view of the different components of the test apparatus 400 is shown) and from Figures 27a to 27h and Figures 28a to 28h (This illustrates different stages of the operation of the test apparatus 400) for understanding.

[0160] like Figure 24 As seen, the oral fluid testing system 400 may further include a support element 485, which is arranged to support and partially surround the distal portion of the mixing chamber 422. The support element 485 is configured in a fixed relationship with the testing unit, for example, by latching or hooking onto a receiving portion 441a containing a receiving portion 442. The support element 485 includes a first side opening 486. Furthermore, the mixing chamber 422 includes a second side opening 487, which is preferably located near the bottom or distal end of the mixing chamber 422. In the illustrated testing device 400, the mixing chamber 422 is preferably cylindrical in shape and has a partial cutout forming the side opening 487. Furthermore, the support element 485 is a matching cylindrical shape, also having a partial cutout forming the side opening 486. The inner surface circumference of the support element 485 is slightly larger than the outer surface circumference of the mixing chamber 422, allowing the mixing chamber to rotate slidably within the support element 485.

[0161] The first side opening 486 and the second side opening 487 may be initially arranged in a first position relative to each other, for example, before actuating the analysis start-up device. In this first position, the first side opening 486 and the second side opening 487 do not overlap, such that any fluid within the mixing chamber 422 is contained within the mixing chamber 422. Therefore, when the two side openings do not overlap, there is a fluid tight seal between the mixing chamber 422 and the support element 485. Furthermore, the two side openings 486, 487 are configured, for example, after actuating the analysis start-up device, to move to a second position relative to each other, in which the two side openings 486, 487 at least partially overlap each other. In other words, the two openings 486, 487 are arranged such that (e.g., by rotating the sample receiving unit 420 and thus the mixing chamber 422 about the longitudinal axis A relative to the test unit 440, and thus relative to the support element 485) actuating the analysis start-up device will cause the two side openings 486, 487 to at least partially overlap. The second position opens the mixing chamber to the lower receiving portion 442 and allows any fluid present in the mixing chamber 422 to flow through the first side opening 486 and the second side opening 487. The complete steps of operating the testing device 400 are described in... Figures 27a to 27h and Figures 28a to 28h As shown in the diagram and will be further detailed below, after the oral fluid testing device 400 is activated and a sample is added, the mixing chamber 422 contains a reaction mixture. Upon actuation of the analysis initiation device, this reaction mixture flows from the mixing chamber 422 into the receiving portion 442 and is applied to the first end of any test strip 448 disposed in the holding device 443. Therefore, as in the preceding aspects, rotation of the sample receiving unit 420 and the testing unit 440 relative to each other actuates the analysis initiation device.

[0162] The fluid applied to the sample area of ​​test strip 448 will thus travel along the corresponding strip, through one or more test lines in the test area, each test line supplied with immobilized specific antibodies, antigens, or other binding receptors for the analyte, to detect the presence of the desired analyte in the sample. Control lines placed after the test lines (one or more test lines) will capture all antibodies and indicate that the sample has flowed normally through different portions of the strip.

[0163] As described above, the sample receiving unit 420 can be configured to insert into the proximal receiving opening 447 and is adapted to rotate within the test unit 440 and the receiving opening 447. The shapes of the sample receiving unit 420 and the test unit 440, particularly any interacting portions, can be configured, for example, to rotate a specific angular distance when pushed into each other. In other respects, rotation of the sample receiving unit 420 and the test unit 440 can result in longitudinal movement of the two units relative to each other; in still other respects, rotation and / or pushing or pulling can actuate subsequent steps of the procedure, such as initiating the application of a lateral flow immunoassay strip. These “semi-automatic” or triggered actions will guide the user through the operational steps further described below, thereby facilitating the execution of the test procedure.

[0164] In some aspects, the first receiving element 421 further includes a first external gripping surface 426, and the second receiving element 441 includes a second external gripping surface 446, such as, for example Figure 23a , Figure 23b and Figure 24 As can be seen, the analysis initiation device can be activated by the user by gripping the first and second gripping surfaces and thereby rotating the sample receiving unit 420 and the test unit 440 relative to each other about the longitudinal axis A. The first and second gripping surfaces may be provided with suitable coatings or surface profiles to achieve a good grip for the user.

[0165] It is worth noting that, in another aspect not specifically shown in the accompanying drawings, the test system may include a sample collector similar to sample collector 210, such as in combination with... Figure 10a and 10b The described, and similar to analysis unit 450, such as in combination Figure 23a , Figure 23b and Figure 24 As described, this sample collector provides eluent in an eluent chamber within the sample collector itself, and the sample is rinsed directly from the sample collector into the mixing chamber 422 after insertion into the analytical device. The dried particle-antibody conjugate formulation can be disposed in the mixing chamber 422 or in the sample collector, as described above for sample collector 210. Therefore, this testing device will not require a separate eluent chamber 491 in the analytical unit. In this respect, the mixing chamber 422 can be arranged with the support element 485 as described above, as well as a first side opening 486 and a second side opening 487.

[0166] This document further discloses a method for using an oral fluid testing system to determine the presence of an analyte in a sample. This method is designed for use with oral fluid testing systems, which typically include, as disclosed herein, an eluent solution, a dried particulate-antibody conjugate formulation, a sample collector, a sample receiving unit, and a testing unit. For example, in… Figures 6a to 6f , Figures 7a to 7c , Figures 13a to 13g , Figures 14a to 14e , Figures 16a to 16b , Figures 17a to 17b , Figures 27a to 27h ,and Figures 28a to 28h The steps of methods for using the various apparatuses described herein are illustrated, each apparatus being described in detail elsewhere herein. A common method of use can be applied to all test systems 100, 200, 300, and 400 described herein.

[0167] A method for using a testing system to determine the presence of an analyte in a sample includes the following steps: - Activate the device to activate the test system for receiving samples and performing analyses that determine the presence of analytes (one or more analytes), wherein actuation of the device activation device allows the dried particulate-antibody conjugate formulation to come into contact with the eluent solution; - Insert the sample collector into the mixing chamber of the sample receiving unit in the test system, so that the acquired sample is transferred to the mixing chamber. This step is performed before, simultaneously with, or after the step of activating the device. - Allows the sample to react in the mixing chamber; and - Activate the analysis start device to allow any fluid in the mixing chamber to be applied to the first end of any test strip arranged in the holding device of the test unit.

[0168] Now refer to Figures 27a to 27h and 28a to Figure 28h The usage method is further described in the context of Test System 400. Methods in the context of other test systems disclosed herein are described elsewhere in this document.

[0169] The steps of the expected test procedure have been described above. Figures 27a to 27h A perspective view of the sequential steps using the oral fluid testing system 400 is shown. Figures 28a to 28h The three-dimensional configuration of the test system 400 is shown, with each configuration in... Figures 27a to 27h In the corresponding steps, however, the accommodating element was removed for illustrative purposes. It should be noted that even... Figures 27a to 27h Each figure in the diagram corresponds to a specific letter. Figures 28a to 28hThe perspectives are not always the same in order to properly show the relative positions of the different parts of the test system 400.

[0170] The oral fluid testing device is delivered to the user in an inactive state, such as Figure 27a and Figure 28a As shown. Already combined, for example... Figure 23a , Figure 23b and Figure 24 Details of the different components of the test apparatus 400 are described. As a first step, the user retracts and removes the sample collector 410. Figure 27b and Figure 28b As an alternative, the sample collector can be delivered separately. Figure 27c and Figure 28c The sample collector is shown before and after sampling, as previously described. The sample collection element 414 thus carries the sample, and the color change of the indicator can be observed through the detection viewing window 417. The actuation device then activates the apparatus. Once the sample has been acquired, the sample collector 410 is pushed into the top opening of the analysis unit (…). Figure 27d As previously combined. Figure 25a and Figure 25b As stated above, and further in Figure 28d As shown, this will release the eluent solution from the eluent chamber 491 via an actuated piston actuator 497, causing the eluent to flow into the mixing chamber 422 and dissolve the particle-antibody conjugate formulation. In some aspects, the user is then instructed to wait for a few minutes, for example, between 1 and 5 minutes. Figure 27e and Figure 28e In other respects, it may not be necessary to wait until it is carried out. The sample collection element 414 will be immersed in the elution solution and will react with the particle-antibody conjugate in the mixing chamber 422.

[0171] Subsequently, in order to activate the analysis start device, the user rotates the top receiving member 421 relative to the bottom receiving member 441 about the longitudinal axis, as follows: Figure 27f As shown. Figure 28f As seen in the corresponding view, this will cause the mixing chamber 422 to rotate within the support element 485, such that the side opening 486 of the support element 485 aligns with the side opening 487 of the mixing chamber 422. The reacted mixture is then allowed to flow into the receiving portion 442 (see [reference]). Figure 24 ) and was applied to test strip 448 ( Figure 27g and Figure 28g This initiates lateral flow, and once the specified time period has elapsed, the results can be seen in the observation window. Figure 27h and Figure 28h ).and Figures 28a to 28b and Figures 28d to 28g compared to, Figure 28h The view in the image is seen from the opposite side of the test setup.

[0172] Other aspects of the methods for using the oral fluid testing system disclosed herein are described below. Some of the steps below are exemplary and, depending on the configuration of the system used, are detailed above.

[0173] Figures 6a-6f and Figures 7a-7c Different steps of using the oral fluid testing system 100 are shown. Figure 6a This shows the configuration provided to the user before initial use. (See reference...) Figures 6a-6f and Figures 7a-7c and specific components of the system Figures 3 to 5 A method of using an oral fluid testing system 100 can be initiated by holding the sample collector 110 and wiping or rolling the sample collection element 114 against the inner surface of the test subject's mouth to collect saliva. Subsequently, the sample collector 110 is inserted into the receiving opening 123 such that the cutting element 128, which contains the dried gold particle-antibody conjugate formulation 119, or other suitable element, is pushed downward by the sample collector and punctures the destructible seal 127. Figure 7a and Figure 7b Thus, the saliva sample on both the gold particle-antibody conjugate formulation 119 and the sample collection element 114 is applied to the eluent solution present in the mixing chamber 122. This actuates the device to activate the apparatus. Alternatively, the dried gold particle-antibody conjugate formulation 119 can be initially positioned in other locations, such as on the destructible seal 127, on a pad within the internal access channel 129, or in another location above the mixing chamber, provided that the insertion of the sample collector allows the eluent in the mixing chamber 122 to reach the gold particle-antibody conjugate. It is also conceivable that the distal end of the sample collector can be configured to cut the destructible seal 127, thus eliminating the need for a separate cutting element.

[0174] The sample collector 110 and the sample receiving unit 120 are preferably configured such that the user pushes the sample collector 110 completely into the sample receiving unit 120, so that the sample collector no longer protrudes from the top of the sample receiving unit 120, as shown below. Figures 6d to 6f As can be seen, this aspect can be achieved by adapting the dimensions and interaction surfaces between the sample collector 110 and the sample receiving unit 120. This provides the user with confirmation that the sample collector 110 has been inserted far enough and also prevents the user from accidentally or intentionally pulling the sample collector 110 back.

[0175] The oral fluid testing system 100 is then held securely in the user's hand and shaken for a specified time to allow the gold particle-antibody conjugate to dissolve appropriately in the eluent, after which it is allowed to react with the saliva sample. Figure 6dIt is worth noting that the fact that the mixture (i.e., the saliva sample and the gold particle-antibody conjugate) is allowed a specified amount of time to react before being applied to the lateral flow test strip results in significantly improved results compared to conventional lateral flow test systems.

[0176] According to another aspect, when using the sample collector 210 as described above, in the oral fluid testing system 200, the validity and usability of the test are greatly improved by first ensuring that the dried gold particle-antibody conjugate formulation is properly dissolved in the eluent solution, and by adding a time delay before exposing it to the saliva sample. Furthermore, the further controlled delay after mixing the reaction mixture and before application to the lateral flow test strip allows for a more complete reaction between the saliva sample and the gold particle-antibody conjugate mixture upon application to the lateral flow test strip. Therefore, using the disclosed sample collector and oral fluid testing system, test results are significantly improved.

[0177] Figures 13a-13g and Figures 14a-14e The different steps of using the oral fluid testing system 200 are shown. (Reference) Figures 13a-13g and Figures 14a-14e and for specific parts of the system Figures 10a to 12 The method of using the oral fluid testing system 200 is described. Figure 13a The configuration supplied to the user is shown, i.e., before initiation of use. The oral fluid testing system 200 is preferably supplied to the user, wherein a sample collector 210 is inserted into a receiving opening 223. An eluent solution is provided at the front of the eluent preparation chamber 211. The user can initiate sampling by pulling out the sample collector 210 via the handle element 217. Figure 13b and Figure 14b This will pull back the piston element 216 within the eluent preparation chamber 211, thereby exposing the dried gold particle-antibody conjugate formulation to the eluent solution (as in comparison). Figure 14a and Figure 14b (As seen at the time). The device activation device is thus actuated. Using the removed sample collector 210 ( Figure 13c User actions during the removal of saliva samples from the test subject's mouth typically allow sufficient time and movement to dissolve the gold particle-antibody conjugate formulation in the eluent. In some cases, the user can dissolve the gold particle-antibody conjugate formulation in the eluent by shaking the sample collector 210 for a specified time. In others, only a short time is allowed to dissolve the gold particle-antibody conjugate formulation in the eluent.

[0178] Therefore, once the sample collector 210 has been prepared, the sample collection pad 214 can be wiped or rolled on the inner surface of the test subject's oral cavity to collect saliva. Afterward, the sample collector 210 is inserted into the receiving opening 223. Figure 13d and Figure 14c This positions the sample collection pad 214 within the mixing chamber 222. The user then continues to press the handle into the sample receiving unit 220, which is connected to the test unit 240. Figure 13e and Figure 14d This will cause the puncture protrusion 280 to break the puncturable element 270, thereby allowing fluid to flow from the eluent preparation chamber 211 into the mixing chamber 222 (as in the comparison). Figure 14c and Figure 14d (As seen at the time). Furthermore, the piston element 216 continues to move distally and forward within the eluent preparation chamber 211, thereby propelling the gold particle-antibody conjugate and eluent solution through the sample collection pad 214, thus rinsing the saliva sample into the mixing chamber 222. This ensures the efficient release of the saliva sample into the reaction mixture.

[0179] When sample collector 210 is provided, it has a sample pad mounting element 260, which includes an external perforated surface 261 for arranging a sample collection pad 214. Pushing the gold particle-antibody conjugate and eluent solution through the perforated surface 261 and the sample collection pad 214 will result in effective mixing of the components with the saliva sample via turbulence in the mixing chamber 222. Therefore, manual shaking may be unnecessary or minimally necessary for mixing. However, it is preferable to allow the mixture to react for a specified amount of time before applying it to the lateral flow test strip.

[0180] Furthermore, since a small amount of air is almost always trapped in the eluent preparation chamber 211, the air bag is also vented through the sample collection pad 214 when the eluent-coupled solution is ejected using the piston element 216, especially when the system is kept substantially upright. This both enhances mixing in the mixing chamber and ensures that as much sample as possible is released from the sample collection pad 214 into the mixing chamber. Therefore, a very small amount of sample remains in the sample collection pad 214 or the eluent preparation chamber 211.

[0181] like Figures 6a to 6f , Figures 7a to 7c , Figures 13a to 13g and Figures 14a to 14e As shown and described for the different aspects above, the oral fluid testing system 100 or 200 allows the saliva sample and the gold particle-antibody conjugate mixture to react in the mixing chambers 122, 222 for a specified amount of time before being applied to the lateral flow test strip. Application to the lateral flow test strip is then activated by a rotary actuator.

[0182] Using the oral fluid testing systems 100 and 200 described herein, a rotary actuator is activated to allow any fluid in the mixing chambers 122 and 222 to be released into the test strip application seats 142 and 242 of the test units 140 and 240, and thereby applied to the first end of any test strip arranged in the holding devices 143 and 243 of the test units.

[0183] Therefore, activating the rotational actuation device includes rotating the sample receiving units 120, 220 and the test units 140, 240 relative to each other about the longitudinal axis A.

[0184] In another aspect, for example, the rotational actuation device is activated by rotating the sample receiving units 120, 220 and the test units 140, 240 relative to each other about a longitudinal axis A, including actuating penetrating elements 145, 245 to penetrate the penetrable portions 125, 225 between the mixing chambers 122, 222 and the test strip application seats 142, 242. Figures 7b-7c and Figures 14d-14e As detailed above, this results in openings or ruptures in the permeable portions 125, 225 of the mixing chambers 122, 222, allowing any fluid present in the mixing chambers 122, 222 to flow into the test strip application reservoirs 142, 242.

[0185] As previously described, the pre-installed test strips for lateral flow immunoassay are positioned such that the sample application area is positioned within the test strip application receptacles 142, 242. The lateral flow phase of the test is initiated by actuating a rotary actuation device, for example by rotating the two units relative to each other. Actuation is further achieved by arranging suitable interaction surfaces, such as grooves, protrusions, and various surface profiles, on each unit. As an example, the sample receiving units 120, 220 may have protrusions at suitable points on their outer surfaces, and the test units 140, 240 may have corresponding helical arrangement grooves such that the two units also move longitudinally relative to each other during rotation.

[0186] Figure 15 Another aspect of the oral fluid testing system 300 is shown in a three-dimensional diagram.

[0187] The testing system 300 has an elongated shape and a longitudinal axis A, which extends from a first end 10 to a second end 20 and defines a proximal-distal direction. The overall shape of the system 300 is preferably adapted to lie flat on a surface, but can also be adapted to be comfortably held in the user's hand. Therefore, the oral fluid testing system is preferably adapted for use in an orientation substantially horizontal with the longitudinal axis A. For orientation purposes, the first end 10 may also be referred to as the proximal end, and the second end 20 herein referred to as the distal end. However, the device can be used in any orientation relative to the user. Figure 15A perspective view of one aspect of the oral fluid testing device 300 is shown, and Figure 16a A cross-sectional view of the apparatus in its initial state when provided for use is shown.

[0188] Corresponding to the preceding aspects, the oral fluid testing system 300 includes a sample collector, an analytical device 350, and dried particulate-antibody conjugate formulation 309 and eluent solution, both disposed within the system. The analytical device 350 includes a mixing chamber 307 and a first receiving opening 314 configured to provide access from the sample collector to the mixing chamber 307. Furthermore, the analytical device 350 includes a holding device 311 for performing lateral flow analysis on one or more test strips 316a. The analytical device 350 is configured such that any test strip disposed in the holding device 311 is initially positioned such that a first end 316a of the test strip is not in fluid contact with the mixing chamber 307. Details of how this is achieved are described below.

[0189] The analysis device 350 also includes an observation device 303 for observing any results indicated on the test strip.

[0190] As previously mentioned, the oral fluid testing system 300 also includes a device activation device adapted to activate the oral fluid testing system 300 for receiving a sample and performing an analysis to determine the presence of an analyte (one or more analytes). Actuation of the device activation device allows the dried particulate-antibody conjugate formulation 309 to come into contact with the eluent solution. Details of how this is achieved are described below.

[0191] The oral fluid testing system 300 also includes an analysis initiation device for allowing fluid in the mixing chamber 307 to be applied to the first end 316a of the test strip in the holding device 311. Details of how this is achieved are described below.

[0192] Figure 16a and Figure 16b A sectional view taken along the longitudinal axis A of the figure shows... Figure 15 The oral fluid testing system 300, among which, Figure 16a It describes the initial state of the system when it is provided for use. Figures 17a-17c , Figures 18a-18c and Figures 19a-19c Various cross-sectional views depict specific features of the oral fluid testing system 300; however, the overall configuration of the oral fluid testing system 300 disclosed herein is similar in any corresponding aspect not specifically described as different.

[0193] For example, refer to Figure 16aThe oral fluid testing system 300 includes an eluent preparation chamber 305, a mixing chamber 307, and an eluent channel 308 configured to fluidly connect the eluent preparation chamber 305 and the mixing chamber 307. The oral fluid testing system 300 also includes a device activation device adapted to activate the oral fluid testing system 300 for receiving a sample and performing an analysis to determine the presence of an analyte (one or more analytes). Figures 15 to 21 In all disclosed aspects, eluent reservoirs 306a, 306b, 306c, and 306d are arranged within or adjacent to the eluent preparation chamber 305. The eluent reservoirs 306a, 306b, 306c, and 306d contain an eluent solution and are configured to release the eluent solution into the mixing chamber 307 upon actuation of the device activation device. When provided to the user, the eluent reservoirs 306a, 306b, 306c, and 306d are sealed, ensuring that the eluent initially contained in the eluent reservoirs 306a, 306b, 306c, and 306d is contained, and the dried particulate-antibody conjugate formulation 309 remains dry until the system is used.

[0194] According to the combination Figures 15 to 21 In the disclosed aspect, the dried particulate-antibody conjugate formulation 309 is disposed at any location within one or more of the eluent preparation chamber 305, the mixing chamber 307, and the eluent channel 308. When the oral fluid testing system 300 is provided to a user, the particulate-antibody conjugate formulation 309 is provided as a dried formulation and is initially not in contact with the eluent solution. In a preferred aspect, the particulate-antibody conjugate formulation 309 is disposed on the bottom of the mixing chamber 307, as will be further described below, and... Figures 15 to 22 Further details are provided below. However, several other placements are conceivable, such as the particle-antibody conjugate formulation 309 being arranged in the eluent preparation chamber 305 and / or the eluent channel 308, provided that it is arranged such that the particle-antibody conjugate formulation 309 is initially separated from the eluent, i.e., before the actuation of the device activation device.

[0195] The device activation apparatus preferably includes an actuator configured to activate the release of the eluent solution from the eluent reservoir into the eluent preparation chamber 305. Various alternative arrangements of the device activation apparatus will be detailed herein; however, all arrangements are compatible with and can be combined with any oral fluid testing system 300 as described herein. Figures 16a-16b , Figures 17a-17c , Figures 18a-18c ,and Figures 19a-19c The diagram illustrates some of the various arrangements of the device activation device. In one aspect, such as... Figure 16aAs shown, the eluent reservoir 306a may be a sealed blister or a similar puncture-resistant container, disposed above one or more puncture protrusions 317a arranged in the eluent preparation chamber 305. An activation button 302a is configured to activate the release of eluent solution from the blister 306a into the eluent preparation chamber 305 by pressing the eluent blister 306a against one or more puncture protrusions 317a disposed within the eluent preparation chamber 305.

[0196] exist Figure 22 The top view of the eluent preparation chamber 305 with the piercing protrusion 317a is seen, in which the eluent blister 306a and the activation button 302a have been removed for clarity.

[0197] Therefore, when the user is ready to use the oral fluid testing system 300, the user presses the activation button 302a, which breaks the blister and the eluent solution flows into the eluent preparation chamber 305, then into the eluent channel 308, and further into the mixing chamber 307. Figure 16a An oral fluid testing system 300 is shown before system activation, and... Figure 16b The system is shown once the user has pressed the activation button 302a, as indicated by the dashed arrow. Figure 16b The manually activated analysis start device 313 is also shown, which will be described in further detail below.

[0198] Activate button 302a Figure 16a and Figure 16b The device is shown in a substantially cylindrical shape, and the eluent preparation chamber 305 is also substantially cylindrical. However, any cross-sectional shape of the activation button 302a and the eluent preparation chamber 305 is conceivable, provided they are matching shapes to ensure effective pressure on the blister 306a. Furthermore, the fit between the activation button 302a and the eluent preparation chamber 305 preferably prevents fluid from escaping from the device, for example, through the button 302a. In some aspects, a fluid tight seal can be applied between the activation button 302a and the eluent preparation chamber 305.

[0199] On the other hand, such as Figure 17a , Figure 17b and Figure 17cAs shown, the device activation device includes a rotary knob 302b for activating the oral fluid testing system 300. Similarly, in this respect, the eluent reservoir 306b may be a sealed blister or a similar puncturable container arranged above one or more puncture protrusions 317b disposed in the eluent preparation chamber 305. The rotary knob 302b is configured to be rotated by the user, and thus activates the release of the eluent solution from the eluent reservoir 306b into the eluent preparation chamber 305 by pressing the eluent reservoir 306b against one or more puncture protrusions 317b.

[0200] On the other hand, such as Figure 18a , Figure 18b and Figure 18c As shown, the device activation device includes a rotary knob 302c, which is used to activate the oral fluid testing system 300. Figure 18a The distal half of the oral fluid testing system 300 before activation is shown, and Figure 18b The system is shown in a semi-activated state. Figure 18c The same oral fluid testing system 300, as seen from the distal direction, is shown once the user has fully actuated the rotary knob 302c. In this respect, the rotary knob 302c includes an eluent reservoir 306c within the rotary knob 302c itself, i.e., the eluent reservoir 306c is a hollow space within the rotary knob 302c. The bottom of the eluent reservoir 306c is preferably a suitable puncture-resistant element 320, such as a membrane or a layer of weakening material. The puncture-resistant element 320 is arranged above one or more puncture protrusions 317c disposed in the eluent preparation chamber 305.

[0201] In some aspects, for example, Figure 17a , Figure 17b and Figure 17c As shown, or Figure 18a , Figure 18b and Figure 18c As shown, the rotary knobs 302b and 302c are preferably substantially cylindrical in shape, and the eluent preparation chamber 305 is also substantially cylindrical in shape to allow easy rotation of the knobs within the chamber. Furthermore, the fit between the rotary knobs 302b and 302c and the eluent preparation chamber 305 preferably prevents fluid from escaping from the device, for example, through the rotary knobs 302b and 302c. In some aspects, a fluid tight seal can be applied between the two components.

[0202] Rotating knobs 302b and 302c moves the knob a specified distance into the eluent preparation chamber 305, that is, moves it a specified distance along the central axis of the cylindrical knob. For example... Figure 17a , Figure 17b and Figure 17c or Figure 18a , Figure 18b and Figure 18c As can be seen, this can be actuated by, for example, a protrusion 318a provided on the rotary knobs 302b, 302c along the outer side of the cylindrical knob. The protrusion 318a is adapted to interact with a corresponding helically arranged groove 318b in the sidewall of the eluent preparation chamber 305, such that rotation also causes axial movement of the rotary knobs 302b, 302c. Other arrangements of interacting surface profiles, such as threads, can be used.

[0203] Therefore, when the user is ready to use the oral fluid testing system 300, the user rotates the activation rotary knobs 302b and 302c, which respectively break the blister 306b or the punctureable element 320, and the eluent solution flows into the eluent preparation chamber 305, then into the eluent channel 308, and further into the mixing chamber 307.

[0204] exist Figure 19a , Figure 19b ,and Figure 19c The image shows another aspect of the device activation mechanism. This aspect is similar to the previous one in many ways. A rotary knob 302d is configured to activate the oral fluid testing system 300. Figure 19a The distal half of the oral fluid testing system 300 before activation is shown, and Figure 19b The system is shown in a semi-activated state. Figure 19c The same oral fluid testing system 300, as seen from the distal direction, is shown once the user has fully actuated the rotary knob 302d. In this aspect, the rotary knob 302d includes an eluent reservoir 306d within the rotary knob 302d itself; that is, the eluent reservoir 306d is a hollow space within the rotary knob 302d. In this aspect, a bottom wall 322 is provided for initially containing the eluent in the eluent reservoir 306d. The bottom of the bottom wall 322 itself or the bottom of the cylindrical sidewall of the eluent reservoir 306d is provided with a weakened circumferential or semi-circumferential tearable portion 321, such as a film or a layer of weakened material. The eluent preparation chamber 305 is provided with corresponding penetrating or tearing protrusions 317d. The tear protrusion 317d may be, for example, sharp and / or pointed, or include a hook shape, such that rotation of the rotary knob 302d within the eluent preparation chamber 305 will cause the tearable portion 321 to break, thereby allowing eluent to flow out into the eluent preparation chamber 305.

[0205] Similar to the aforementioned aspects, for example, Figure 19a , Figure 19b and Figure 19cAs shown, the rotary knob 302d is preferably substantially cylindrical in shape, and the eluent preparation chamber 305 is also substantially cylindrical in shape to allow easy rotation of the knob within the chamber. Furthermore, the fit between the rotary knob 302d and the eluent preparation chamber 305 preferably prevents fluid from escaping from the device, for example, through the rotary knob 302d. In some aspects, a fluid tight seal can be applied between the two components.

[0206] The rotary knob 302d can be initially set in a substantially fully inserted position within the eluent preparation chamber 305, such as... Figure 19a As shown. Alternatively, the rotary knob 302d can be positioned in a semi-inserted position within the eluent preparation chamber 305, and / or the bottom wall 322 can be positioned a distance above the bottom of the eluent preparation chamber 305. As mentioned, rotation of the rotary knob 302d within the eluent preparation chamber 305 will cause the tearable portion 321 to break.

[0207] Therefore, when the user is ready to use the oral fluid testing system 300, the user rotates the activation rotary knob 302d, which breaks the tearable part 321, and the eluent solution flows into the eluent preparation chamber 305, then into the eluent channel 308, and further into the mixing chamber 307.

[0208] In combination Figures 15 to 21 In the disclosed aspects including rotary knobs, rotary knobs 302b, 302c, and 302d may preferably be provided with a gripping handle 319 for the user to grip and rotate. As an example of this procedure, Figure 17b , Figure 18b and Figure 19b This shows that when knobs 302b, 302c, and 302d have been turned from... Figure 17a , Figure 18a ,or Figure 19a The initial position is rotated 90 degrees. In some respects, the rotary knobs 302b and 302c have been partially moved downward into the eluent preparation chamber 305. In other respects, the rotary knob 302d has not yet moved axially within the eluent preparation chamber 305 because the activation of the system (i.e., the release of the eluent into the mixing chamber) is actuated by lateral penetration rather than bottom penetration.

[0209] Figure 17c , Figure 18c , Figure 19c This shows when knobs 302b, 302c, and 302d have been rotated an additional distance in each corresponding aspect. The specific angle of rotation required to release the eluent can vary in different aspects. In some aspects, rotating knobs 302b and 302c have therefore moved completely into the eluent preparation chamber 305, as shown... Figure 17c and Figure 18cAs observed, the eluent reservoirs 306b and 306c have been opened by puncture. Figure 19c In this case, rotation of the rotary knob 302d has caused the tearing protrusion 317d to tear the tearable portion 321. Therefore, in all three aspects, the eluent reservoirs 306b, 306c, and 306d have been opened, thereby allowing fluid to flow out into the eluent preparation chamber 305, into the eluent channel 308, and further into the mixing chamber 307.

[0210] Furthermore, the rotary knobs 302b, 302c, 302d, the corresponding eluent reservoirs 306b, 306c, 306d, and the eluent preparation chamber 305 can be arranged such that rotating the knobs to a specified angle is required to release the eluent. For example, as seen in each of the illustrated event sequences, such as Figures 17a-17c , Figures 18a-18c ,or Figures 19a-19c As seen in the diagram, a total rotation of approximately 180 degrees by rotary knobs 302b, 302c, and 302d moves the rotary knobs substantially to a position within the eluent preparation chamber 305, where the initially sealed eluent reservoirs 306b, 306c, and 306d have been broken. The activation device can be configured such that this corresponds to a knob reaching the bottom of the eluent preparation chamber 305, or, for example, by providing specific stop protrusions in the chamber or on the rotary knobs. This then provides the user with a clear indication that the eluent reservoirs 306b and 306c have been emptied and the system has been properly activated.

[0211] In addition to the aspects shown and described above regarding the device activation device, it is conceivable to arrange the device activation device in another orientation, for example, such that the device activation device can be actuated from the distal end and second end 20 of the oral fluid testing system, or from one side or the other side of the oral fluid testing system. For example, a suitable actuator, such as a rotary or push-actuated knob, button, or lever, can be arranged on the distal end and second end 20 of the oral fluid testing system, i.e., protruding along the longitudinal axis A. Such an actuator can be arranged to pierce or destroy the eluent reservoir, similar to... Figures 16a to 19c Examples of eluent release from the eluent reservoir, or other methods.

[0212] In combination Figures 15 to 21 In a preferred aspect of the disclosed oral fluid testing system, a dried gold particle-antibody conjugate formulation 309 may be disposed on the bottom of the mixing chamber 307. (See example...) Figures 15 to 18. Once the device activation device has been activated by the user, the released eluent will flow into the mixing chamber 307, and the particle-antibody conjugate formulation 309 will dissolve in the eluent. The dried particle-antibody conjugate formulation 309 is therefore suitable for dissolving in the eluent solution within the eluent preparation chamber 305 when the device activation device is activated and before the sample is applied to the oral fluid testing system. Allowing the particle-antibody conjugate formulation to be completely dissolved in the applied eluent before adding the saliva sample provides improved test reaction efficiency and better results. This differs from known lateral flow immunoassay strips and devices, in which the sample is typically allowed to directly contact the conjugate pad containing the particle-antibody conjugate, or to be applied while the gold particle-antibody conjugate formulation is dissolved in the eluent solution. The currently disclosed system and method ensure complete dissolution and distribution of the particle-antibody conjugate formulation before the introduction of the saliva sample.

[0213] To further illustrate the different parts of the oral fluid testing system Figure 20 It shows Figure 15 An exploded view of the oral fluid testing system, for example, before use. Figure 21 It shows Figure 15 An exploded side view of an oral fluid testing system. For example, in... Figures 15 to 21 As seen, the oral fluid testing system 300 also includes a sample collector channel 310, which is configured to hold a sample collector 330, such as a swab, such that the distal sample end of the swab is positioned in the mixing chamber 307. For clarity, the sample collector 330 itself is only... Figure 20 and Figure 21 As shown in the diagram, a first receiving opening 314 oriented proximally provides a passage for the sample collector 330 to the sample collector channel 310, and thus to the mixing chamber 307. The sample collector 330 can be any suitable collector swab, including absorbent swabs or pads made of any suitable porous material capable of absorbing and releasing samples, such as saliva, from the test subject. Regardless of the material, the sample collector 330 should preferably not contain any material that would bind any intended target substance to any extent, thereby hindering analytical efficiency. As will be further detailed later, once the sample collector 330 is fully inserted into the oral fluid testing system 300, the distal absorbent swab or pad will be immersed in the eluent containing the particulate-antibody conjugate formulation in the mixing chamber 307.

[0214] In combination Figures 15 to 21 In some of the disclosed aspects, an oral fluid testing system 300 is provided to a user, the oral fluid testing system 300 having a sample collector 330 adapted to collect saliva samples and inserted into a sample collector channel 310.

[0215] The sample collector 330 is preferably adapted to be effectively rotated or twisted once inserted into the mixing chamber 307 to enhance the release of the sample from the swab into the fluid within the mixing chamber 307. For example, the elongated portion of the sample collector 330 may be made of a robust yet flexible material and preferably has a proximal end adapted for easy twisting between the user's fingers. Furthermore, in combination Figures 15 to 21 In some of the disclosed aspects, the mixing chamber 307 may be provided with one or more protrusions (not shown) to generate turbulence when the swab is twisted within the mixing chamber 307, thereby enhancing the release of the sample into the fluid within the mixing chamber 307.

[0216] It is also conceivable that the sample collector channel or insertion opening may be configured with other orientations relative to the device, provided that the sample collector 330 can be inserted such that the distal sample end of the swab is positioned in the mixing chamber 307. For example, an oral fluid testing system may be configured such that the sample collector is inserted from the side, from the top, or even at any acute angle relative to the longitudinal axis A of the elongated device. Other parts of the device may need to be repositioned to achieve the intended functionality and analytical procedure described herein.

[0217] The oral fluid testing system 300 also includes a test strip compartment 311, which is configured to hold one or more test strips 316 for lateral flow analysis, such that the sample area end 316a of such test strips 316 is initially positioned adjacent to and outside the mixing chamber 307.

[0218] The lateral flow test strip 316 is preferably disposed in the test strip compartment 311. In combination Figures 15 to 21 In some of the disclosed aspects, an oral fluid testing system 300 is provided to a user, wherein one or more test strips 316 for lateral flow analysis have been arranged in a test strip compartment 311. The test strips (one or more) 316 are then positioned such that the sample area end 316a of the test strip 316 is initially positioned adjacent to and outside the mixing chamber 307, as, for example... Figure 16a , Figure 17a , Figure 18a , Figure 19a As shown in the figures. As can be understood from the figures, the test strips will initially be arranged substantially flat within the test strip compartment 311, wherein the distal sample area ends (one or more) 316a are freely suspended above the mixing chamber 307. This is, for example, in Figure 20 and Figure 21 It is shown in the figure, which shows the basis. Figure 15 An exploded view of the oral fluid testing system 300 in Figure 16.

[0219] In combination Figures 15 to 21In other aspects disclosed, the user can insert the test strip 316 into the test strip compartment 311 (not shown) via the insertion opening before use.

[0220] The lateral flow analysis strip 316 includes a sample application area 316a, an optional coupling pad, one or more test areas, and a control area, as described above. The sample application area is initially positioned above the mixing chamber 307.

[0221] As mentioned, in combination Figures 15 to 21 In one aspect, the dried particulate-antibody conjugate formulation 309 is disposed at any location within one or more of the eluent preparation chamber 305, the mixing chamber 307, and the eluent channel 308. In one aspect, the dried particulate-antibody conjugate formulation 309 is disposed in the mixing chamber 307, such as, for example... Figure 16a , Figure 18a , Figure 19a , Figure 20 As shown in Figure a. However, the dried particulate-antibody conjugate formulation 309 may also be supplied on the walls or bottom, pads, or as particulate matter within any chamber or eluent channel of the eluent preparation chamber 305 and / or eluent channel 308, provided that the released eluent effectively dissolves the formulation upon system activation. The particulate-antibody conjugate formulation 309 is configured such that it is initially not in contact with the eluent solution. As mentioned, the eluent solution is initially (i.e., prior to activation) contained in eluent reservoirs 306a, 306b, 306c, 306d arranged within or adjacent to the eluent preparation chamber 305.

[0222] In a preferred embodiment, the particle-antibody conjugate formulation 309 comprises gold particles. Alternatively, the particles can be any suitable metal, latex, or carbon particle, as long as the particles can be conjugated to the selected antibody. Depending on the selected particles, colored bands may be generated when the test strip is used for lateral flow immunoassay. In other aspects, staining reagents may be required. For ease of description, this aspect is described as utilizing gold particles; however, these can be substituted with any suitable particles.

[0223] As mentioned, the antibody in the particle-antibody conjugate formulation is selected to react with the desired analyte to be detected in the oral fluid testing system, conjugated with nanoparticles, and dried according to standard practice. The dried particle-antibody conjugate formulation contains one or more types of antibodies against the desired analyte (one or more analytes). The formulation is prepared by drying the particle-antibody conjugate, preferably making it readily soluble with a suitable stabilizer and / or reagent.

[0224] Examples of analytes that can be tested include cocaine, benzodiazepines, opioids, amphetamines, methamphetamine, cannabis (THC), ketamine, methadone, and other narcotic or non-narcotic drug substances or components.

[0225] Furthermore, the oral fluid testing system 300 includes a manual analysis initiation device. When activated by the user, the analysis initiation device moves the sample area end 316a of one or more test strips 316 from an initial position near and outside the mixing chamber 307 to a position where the sample area is located within the mixing chamber 307. This is, for example... Figure 16a and Figure 16b or Figure 17b and Figure 17c The differences between them are shown in the diagram.

[0226] The fluid applied to the sample area 316a of the test strip will thus travel along the test strip, i.e., towards the proximal end 10 of the system, through one or more test lines 316b in the test area. Each test line is supplied with immobilized specific antibodies, antigens, or other binding receptors for the analyte to detect the presence of the desired analyte in the sample. A control line 316c, placed proximal to the test line (one or more test lines) 316b, will capture all antibodies and indicate that the sample has flowed correctly through the different portions of the strip.

[0227] In some aspects, the manual analysis initiation device includes an analysis initiation actuator 313, which is adapted to move the sample area end 316a of any one or more test strips 316 present in the test strip compartment 311 into the mixing chamber 307. An example of an actuated analysis initiation actuator 313 is shown below. Figure 16b and Figure 17c Actuator 313 can be configured as a suitable button, knob, toggle switch, etc. Furthermore, such as... Figure 16b and Figure 17c As seen, the actuator can be configured as the hinged portion of the receiving element.

[0228] For example, through comparison Figure 16a and Figure 16b It is understood that if one or more test strips 316 are disposed in test strip compartment 311, and the user presses down to form the hinge portion of the analysis initiation actuator 313, the distal sample area end 316a of the test strip (one or more test strips) will be pushed into the mixing chamber 307. Therefore, any fluid in the mixing chamber 307 is applied to such a test strip 316, and lateral flow along the test strip is initiated.

[0229] As further understood from the above and shown in the accompanying drawings, the oral fluid testing system 300 is preferably adapted for use in a substantially horizontal orientation with longitudinal axis A, wherein the eluent preparation chamber 305 is located near the second end 20. The sample collector channel 310 is provided with an opening 314 configured for insertion of a sample collector from the first end 10. The mixing chamber 307 is thus positioned such that the sample collector channel 310 is arranged on the side of the mixing chamber 307 substantially opposite to the eluent channel 308. This allows easy insertion of the sample collector 330 through the sample collector channel 310, such that the distal swab end of the sample collector 330 enters the mixing chamber 307 on the separate side of the mixing chamber 307 relative to the eluent channel 308.

[0230] The oral fluid testing system 300 includes an observation device 303 for observing any results indicated on any test strip 316 positioned in the test strip compartment 311. This observation device can be any suitable window or opening, as long as the test line 316b and control line 316c are visible from the outside of the system. For example, the observation device 303 can be an open window in a receiving element, such as... Figure 15 , Figures 16a-16b , Figures 17a-17c , Figures 18a-18c , Figures 19a-19c or Figure 20 As shown, or alternatively, the observation device is a groove along at least a portion of the receiving element (not shown). In other respects, the observation device 303 may be a transparent component of the receiving element, such as a transparent window in a receiving element that is otherwise opaque.

[0231] In addition, in combination Figures 15 to 21 In the disclosed aspect, the mixing chamber 307 is preferably provided with a pierceable cover 312, such as Figure 16a and 16b As shown. In this aspect, when the oral fluid testing system 300 is initially provided to the user, the test strip compartment 311 is configured to hold one or more test strips 316 such that the sample area 316a of such test strips 316 is initially positioned adjacent to the punctureable cover 312, i.e., positioned above the punctureable cover 312, and thus outside and isolated from the mixing chamber 307. The analysis initiation actuator 313 includes a puncture element 315, which is configured to both push the test strip downward and puncture or cut the punctureable cover 312 when the analysis initiation actuator 313 is actuated.

[0232] like Figures 15 to 20As seen, the oral fluid testing system 300 also preferably includes a container 301 adapted to at least surround the eluent preparation chamber 305, the mixing chamber 307, and the test strip compartment 311. The container may also form other components of the system, such as the analytical initiation actuator 313 described above.

[0233] like Figure 20 and Figure 21 The diagram shows an exploded perspective view and a side view of an oral fluid testing system 300. The receiving element 301 can be formed from two or more custom-designed components, such as a cap portion 301a, a middle portion 301b, and a base portion 301c. The different receiving element portions are adapted to attach to each other such that, when assembled, the eluent preparation chamber 305, the mixing chamber 307, the sample collector channel 310, and the test strip compartment 311 are all formed from the assembled receiving portions 301a, 301b, and 301c.

[0234] This document also discloses a method for using an oral fluid testing system 300 to determine the presence of an analyte in a sample. Such a method can preferably be used with oral fluid testing systems typically disclosed herein. One advantage of using the disclosed system and method is that a relatively small volume of saliva is required due to the delay between the reaction of the saliva sample with the gold-antibody conjugate formulation and the application of the sample to the lateral flow assay strip. Furthermore, essentially the entire collected sample is efficiently used in the testing procedure.

[0235] A method for using an oral fluid testing system to determine the presence of an analyte in a sample includes the following steps: - The oral fluid testing system is activated by an actuation device to release the eluent solution from the eluent reservoir to the eluent preparation chamber; - Allows the eluent solution to flow from the eluent preparation chamber, through the eluent channel, to the mixing chamber; - Allows the particulate-antibody conjugate formulation to dissolve in the elution solution; - Insert the sample collector into the sample collector channel so that the distal sample end of the sample collector is positioned in the mixing chamber; - Allows any sample on the sample collector to react with the particle-antibody conjugate and elution solution in the mixing chamber; and - The manual analysis start device is activated, causing the sample area end of any one or more test strips present in the test strip compartment to move from an initial position adjacent to the mixing chamber and outside the mixing chamber to a position where the sample area is positioned in the mixing chamber, thereby initiating lateral flow analysis on one or more test strips.

[0236] The disclosed method precedes a sampling step, depending on the sample collector used. Various additional aspects of the method using the oral fluid testing system disclosed herein are described below.

[0237] As previously described, the particle-antibody conjugate formulation 309 is preferably disposed in the mixing chamber 307. However, it may also be disposed in the eluent preparation chamber 305 and / or the eluent channel 308. In some aspects, once the system is activated by releasing the eluent, the user can be instructed to wait a short period of time to allow complete dissolution of the particle-antibody conjugate formulation 309. Subsequently, a sample collector 330 with a saliva sample is inserted and mixed with the eluent and the particle-antibody conjugate formulation in the mixing chamber 307. One advantage of the system is that it allows the eluent to completely dissolve the particle-antibody conjugate formulation before the addition of the saliva sample.

[0238] Furthermore, the system allows saliva samples to fully react before the mixture is applied to the strips (one or more). In some respects, once the sample has been added via the sample collector, the user can be instructed to wait a short period of time before actuating the manual analysis start device. For example, the user can be instructed to wait for a specified time period, such as 30 seconds, 60 seconds, or 90 seconds, thereby allowing the saliva sample and the gold particle-antibody conjugate formulation to react.

[0239] As previously described, the pre-installed test strip for lateral flow immunoassay is positioned with a sample application area 316a initially above the mixing chamber. The lateral flow phase of the test is initiated by actuating the manual analysis start device. The lateral flow phase of the test ends once the control lines are visible on the test strip (one or more test strips).

[0240] Once the lateral flow phase of the test is allowed to occur, the user can observe the results of the lateral flow analysis on one or more test strips 316 via the observation device 303, which is used to observe any results indicated on the test strips 316 positioned in the test strip compartment 311.

[0241] As previously described, the actuation manual analysis start device may include a movable piercing element 315 to pierce or cut a pierceable cover 312 that separates one or more test strips 316 from the mixing chamber 307 and thereby presses the sample area end 316a of one or more test strips 316 into a position that positions the sample area in the mixing chamber 307.

[0242] The oral fluid testing systems 100, 200, 300, and 400 described herein share many common features and are based on the same general principles of use. The configuration of the various units and the analysis initiation device provide an easy-to-use system that guides the user through the steps and provides rapid and reliable results even for those without experience with these types of tests. One advantage of the disclosed system is the requirement for a relatively small volume of saliva, due to the efficient use of the entire collected sample for the testing procedure and the delay between the reaction of the saliva sample with the gold antibody-drug conjugate preparation and the application of the sample to the lateral flow assay strip. Another advantage when using the device activation device is that, after activating the oral fluid testing device and in conjunction with the sampling step from the subject's mouth, the dried particulate-antibody conjugate preparation is allowed to dissolve effectively. Yet another advantage when using, for example, sample collectors 210 or 410, is the efficient rinsing of the saliva sample from the sample collector and simultaneous mixing of the sample in the mixing chamber.

[0243] This invention is not limited to the preferred embodiments described above. Various alternatives, modifications, and equivalents may be used. Therefore, the above embodiments should not be considered as limiting the scope of the invention, which is defined by the appended claims.

Claims

1. A testing system (100, 200, 300, 400) for collecting samples and determining the presence of one or more analytes in the samples, the testing system (100, 200, 300, 400) having a longitudinal axis A extending from a first end (10) of the system to a second end (20) and defining a proximal-distal direction, the testing system (100, 200, 300, 400) comprising: Sample collectors (110, 210, 330, 410); Analytical apparatus (150, 250, 350, 450); Dry particulate-antibody conjugate formulations (219, 309, 419), said dry particulate-antibody conjugate formulations (219, 309, 419) are arranged within the test system (100, 200, 300, 400); and The eluent solution is disposed within the test system (100, 200, 300, 400). The analytical apparatus (150, 250, 350, 450) includes: Mixing chambers (122, 222, 307, 422); First receiving openings (123, 223, 314, 423) adapted to receive the sample collectors (110, 210, 410), and the first receiving openings (123, 223, 314, 423) configured such that the sample collectors (110, 210, 310, 410) provide access to the mixing chambers (122, 222, 307, 422); Holding devices (143, 243, 311, 443) for one or more test strips (148, 248, 316, 448) for lateral flow analysis, the analytical devices (150, 250, 350, 450) being configured such that any test strip arranged in the holding devices (143, 243, 311, 443) is initially arranged such that a first end of the test strip (148, 248, 316a, 448) is positioned such that the first end is not in fluid contact with the mixing chambers (122, 222, 307, 422); and Observation devices (144, 244, 303, 444) are used to observe any results indicated on the test strips (148, 248, 316, 448); The dried particulate-antibody conjugate formulations (219, 309, 419) are arranged within the test system (100, 200, 300, 400) such that the particulate-antibody conjugate formulations (219, 309, 419) do not initially come into contact with the elution solution. The test systems (100, 200, 300, 400) further include a device activation device adapted to activate the test systems (100, 200, 300, 400) for receiving samples and performing analyses to determine the presence of one or more of the analytes, wherein actuation of the device activation device contacts the dried particulate-antibody conjugate formulation (219, 309, 419) with the eluent solution; and The testing system (100, 200, 300, 400) further includes an analysis initiation device for allowing fluid in the mixing chamber (122, 222, 307, 422) to be applied to the first end of the test strip (148, 248, 316a, 448) in the holding device (143, 243, 311, 443).

2. The testing system (100, 200, 400) according to claim 1, wherein, The analytical apparatus (150, 250, 450) includes: Sample receiving units (120, 220, 420); and Test units (140, 240, 440) are configured to be coupled to the sample receiving units (120, 220, 420). The test units (140, 240, 440) are engaged with the sample receiving units (120, 220, 420) such that the sample receiving units (120, 220, 420) and the test units (140, 240, 440) can rotate relative to each other about the longitudinal axis A to actuate the analysis initiation device, such that any fluid in the mixing chambers (122, 222, 307, 422) is applied to the first end of any test strip (148, 248, 316a, 448) arranged in the holding device (143, 243, 311, 443).

3. The test system (100, 200, 400) according to any of the preceding claims, wherein, The sample receiving unit (120, 220, 420) includes a first receiving element (121, 221, 421), the first receiving element (121, 221, 421) including a first receiving opening (123, 223, 423), the first receiving opening (123, 223, 423) being adapted to receive the sample collector (110, 210, 410), the first receiving opening (123, 223, 423) being configured such that the sample collector (110, 210, 410) provides a passage to the mixing chamber (122, 222, 422), the first receiving opening (123, 223, 423) being oriented proximally; The test units (140, 240, 440) include second receiving elements (141, 241, 441), each including a second receiving opening (147, 247, 447) oriented proximally. The second receiving openings (147, 247, 447) are arranged to receive the sample receiving units (120, 220, 420) and surround at least the lower end of the mixing chambers (122, 222, 422). The second receiving elements (141, 241, 421) also form test strip application seats (142, 242, 442) distal to and outside the mixing chambers (122, 222, 422). The second receiving element (141, 241, 441) further includes the holding device (143, 243, 443), the holding device (143, 243, 443) for one or more test strips (148, 248, 448) for lateral flow analysis, the holding device (143, 243, 443) being configured such that any test strip disposed in the holding device (143, 243, 443) is arranged such that a first end of the test strip (148, 248, 448) is positioned in the receiving portion (142, 242, 442); The second accommodating element (141, 241, 441) further includes the observation device (144, 244, 444), which is used to observe any results indicated on the test strip (148, 248, 448); and The analysis initiation device includes a rotary actuator for allowing fluid in the mixing chambers (122, 222, 422) to be released into the test strip application receptacle (142, 242, 442) and thereby applied to the first end of any test strip (148, 248, 448) arranged in the holding device (143, 243, 443).

4. The test system (400) according to any of the preceding claims, wherein, The device activation device is configured such that the test system (400) is further provided with: An eluent chamber (491) is initially provided with the eluent solution, the eluent chamber (491) includes a proximal end (492) and a distal end (493), the eluent chamber (491) includes a distal opening (495) for allowing fluid to flow through; An eluent piston (496) is disposed within the eluent chamber (491) and is configured to pull or push fluid in the eluent chamber (491) through the distal opening (495); and A piston actuator (497) is connected to the eluent piston (496) and is arranged to operate the eluent piston (496) within the eluent chamber (491).

5. The test system (400) according to claim 4, wherein the piston actuator (497) is operatively arranged such that longitudinal movement of the sample collector (410) relative to the analysis device (450) actuates the eluent piston (496) to push fluid in the eluent chamber (491) into the mixing chamber (422) through the distal opening (495).

6. The test system (400) according to claim 4 or 5, wherein, The eluent chamber (491) is provided with a puncturable element (470) which is arranged to initially close the distal opening (495). Furthermore, the eluent piston (496) is provided with a piercing element (471) at its distal end, the piercing element (471) being arranged such that when the eluent piston (496) is actuated, the piercing element (471) will pierce the pierceable element (470), and any fluid in the eluent chamber (491) will be ejected from the eluent chamber (491) through the distal opening (495).

7. The test system (400) according to any of the preceding claims, wherein, The analysis initiation device is configured such that the test system (400) further includes: A support element (485) is arranged to support and partially surround the distal portion of the mixing chamber (422), wherein the support element (485) includes a first side opening (486). The mixing chamber (422) includes a second side opening (487), which is preferably arranged near the bottom or distal end of the mixing chamber (422). The first side opening (486) and the second side opening (487) are adapted to be arranged in a first position relative to each other, wherein the first side opening (486) and the second side opening (487) do not overlap each other, and wherein any fluid in the mixing chamber (422) is substantially contained within the mixing chamber (422). The first side opening (486) and the second side opening (487) are further adapted to be moved to a second position relative to each other, wherein the first side opening (486) and the second side opening (487) at least partially overlap each other; and The actuation of the analysis start device causes the first side opening (486) and the second side opening (487) to move from the first position to the second position.

8. The test system (100, 200, 300, 400) according to any of the preceding claims, wherein, The sample collector (410) extends along the longitudinal axis C and includes a proximal end (412) and a distal end (413). The sample collector (410) further includes: A sample collection element (414), the sample collection element (414) being disposed at the distal end (413) and having an outwardly exposed surface for acquiring a sample; and A sample detection device for confirming that a predetermined amount of sample has been obtained, the sample detection device including a detection strip (415), the detection strip (415) including a visual indicator, The sample collection element (414) is arranged to be fluidly connected to the detection strip (415) such that when the sample collection element (414) is fully wetted by a predetermined volume of fluid sample, a small volume of the fluid sample is pulled from the sample collection element (414) into the detection strip (415) by capillary force, and the visual indicator is activated to indicate that a sufficient volume of fluid sample has been acquired.

9. The test system (100, 200) according to claim 3, wherein, The analysis initiation device is configured as follows: The sample receiving units (120, 220) further include permeable portions (125, 225) located at the lower end of the mixing chambers (122, 222). The analysis initiation device includes a rotary actuation device, which includes penetrating elements (145, 245) arranged in the test unit (140, 240) and adapted to penetrate the penetrable portion (125, 225) when the first receiving element (121, 221) rotates relative to the second receiving element (141, 241) about the longitudinal axis A; and The penetration of the permeable portions (125, 225) allows any fluid present in the mixing chambers (122, 222) to flow into the test strip application seat (142, 242).

10. The test system (100, 200, 400) according to any one of claims 3 to 9, wherein, The first accommodating element (121, 221, 421) further includes a first external gripping surface (126, 226, 426); and The second accommodating element (141, 241, 441) includes a second external gripping surface (146, 246, 446); and The analysis initiation device is configured to be activated by a user by gripping the first gripping surface and the second gripping surface and rotating the sample receiving unit (120, 220, 420) and the testing unit (140, 240, 440) relative to each other about the longitudinal axis A.

11. The test system (100, 200, 400) according to any one of claims 3 to 10, wherein, The second accommodating element (141, 241, 441) includes: The first part (141a, 241a, 441a) includes a holding device (143, 243, 443) for one or more test strips (148, 248, 448) and forms a test strip application receiving portion (142, 242, 442); and The second part (141b, 241b, 441b) includes a second receiving opening (147, 247, 447) for receiving the sample receiving unit (120, 220, 420). The first portion (141a, 241a, 441a) and the second portion (141b, 241b, 441b) of the second accommodating element (141, 241, 441) are adapted to be attached to each other to form the test unit (140, 240, 440).

12. The test system (100) according to any one of claims 3 to 11, wherein, The first receiving element (121) of the sample receiving unit (120) includes an elongated internal access channel (129) extending from the first receiving opening (123) into the sample receiving unit (120), and the first receiving element (121) also includes a destructible seal (127) disposed at any location within the sample receiving unit (120) such that the elongated internal access channel (129) is initially sealed relative to the mixing chamber (122).

13. The test system (100) of claim 12 further includes a cutting element (128) slidably mounted within the internal access channel (129) and configured to be pushed toward and destroy the destructible seal (127).

14. The test system (100, 200, 300, 400) according to any of the preceding claims, wherein, The sample collector (210) extends along the longitudinal axis B and includes a proximal end (212) and a distal end (213). The sample collector (210) further includes: A barrel-shaped eluent preparation chamber (211) extends along the longitudinal axis B and includes a distal opening (215) for allowing fluid to flow through it; A sample collection pad (214) is arranged adjacent to the distal opening (215) of the eluent preparation chamber (211) and is in fluid communication with the eluent preparation chamber (211) through the distal opening (215), wherein the sample collection pad (214) is provided with an outwardly exposed pad surface for obtaining a sample. A piston element (216) is arranged to be applied from the proximal end (212) of the eluent preparation chamber (211) and enter the eluent preparation chamber (211), wherein the piston element (216) is also adapted to slide back and forth within the eluent preparation chamber (211) and is configured to pull or push fluid in the eluent preparation chamber (211) through the distal opening (215) and through the sample collection pad (214); and A handle element (217) is connected to the piston element (216) and is arranged to operate the piston element (216) within the eluent preparation chamber (211). The test system (100, 200, 300, 400) is configured such that when the handle element (217) of the sample collector (210) is pulled proximally or pushed distally, the device activation device is actuated to allow the dried particle-antibody conjugate formulation (219, 309, 419) to come into contact with the elution solution.

15. The test system (100, 200, 300, 400) according to claim 14, wherein, The dried particle-antibody conjugate formulation (219) is placed in the eluent preparation chamber (211) and in a proximal position at the distal end of the piston element (216) before the device activation device is actuated, such that activation of the device activation device includes retraction of the piston element (216) in the proximal direction, thereby exposing the particle-antibody conjugate formulation (219, 309, 419) to the eluent solution.

16. The test system (100, 200, 300, 400) according to claim 15, wherein, The dried particle-antibody conjugate formulation (219) is disposed in a recess or opening in the inner wall of the elution preparation chamber (211).

17. The test system (100, 200, 300, 400) according to any one of claims 14 to 16, further comprising a punctureable element (270) arranged to close the distal opening (215) such that, upon puncture, any fluid in the eluent preparation chamber (211) can be expelled from the eluent preparation chamber (211) through the distal opening (215) and through the sample collection pad (214) by operating the piston element (216).

18. The test system (300) according to claim 1, further comprising: Eluent preparation room (305); Eluent channel (308), the eluent channel (308) being configured to fluidly connect the eluent preparation chamber (305) and the mixing chamber (307); An eluent reservoir (306) is disposed within or adjacent to the eluent preparation chamber (305), the eluent reservoir (306) comprising the eluent solution, and wherein the eluent reservoir (306) is configured to release the eluent solution into the mixing chamber (307) when the device activation device is actuated; and A sample collector channel (310) is configured to hold the sample collector (330) such that the distal sample end of the sample collector (330) is positioned in the mixing chamber (307); The holding device (311) is a test strip compartment (311), which is configured such that, prior to actuation of the analysis initiation device, the sample area end (316a) of the test strip (316) is positioned adjacent to and outside the mixing chamber (307); and The dried particle-antibody conjugate formulation (309) is disposed at any location within one or more of the eluent preparation chamber (305), the mixing chamber (307), and the eluent channel (308), wherein the particle-antibody conjugate formulation (309) is initially not in contact with the eluent solution. The analysis initiation device is configured such that, when actuated by a user, the sample area end (316a) of any one or more test strips (316) present in the test strip compartment (311) moves from an initial position adjacent to and outside the mixing chamber (307) to a position where the sample area is located in the mixing chamber (307).

19. The test system (300) according to claim 18, wherein, The test system (300) is adapted for use in a substantially horizontal orientation along the longitudinal axis A, wherein the sample collector channel (310) is provided with an opening (314) configured for insertion of a sample collector from the first end (10), and wherein the eluent preparation chamber (305) is located near the second end (20), and the mixing chamber (307) is positioned such that the sample collector channel (310) is arranged on the side of the mixing chamber (307) substantially opposite to the eluent channel (308).

20. The test system (300) according to any one of claims 18 to 19, wherein, The device activation apparatus includes an actuator configured to activate the release of the eluent solution from the eluent reservoir (306a, 306b, 306c, 306d) into the eluent preparation chamber (305).

21. The test system (300) according to any one of claims 18 to 20, wherein, The device activation device includes: An activation button (302a) is arranged to move axially within the eluent preparation chamber (305) to activate the test system (300); and One or more piercing protrusions (317a) are arranged within the eluent preparation chamber (305). The activation button (302a) is configured to activate the release of the eluent solution from the eluent reservoir (306a) into the eluent preparation chamber (305) by pressing the eluent reservoir (306a) against one or more piercing protrusions (317a).

22. The test system (300) according to any one of claims 18 to 20, wherein, The device activation device includes: Rotary knobs (302b, 302c, 302d) are arranged to rotate within the eluent preparation chamber (305) to activate the test system (300); and One or more puncture or tear protrusions (317b, 317c, 317d) are arranged in the eluent preparation chamber (305). The rotary knobs (302b, 302c, 302d) are configured such that when the rotary knobs (302b, 302c, 302d) are rotated, the eluent solution is released from the eluent reservoirs (306b, 306c, 306d) into the eluent preparation chamber (305) by causing the eluent reservoirs (306b, 306c, 306d) to rupture against the puncture or tear protrusions (317b, 317c, 317d).

23. The test system (300) according to any one of claims 18 to 22, wherein, The analysis initiation device includes an analysis initiation actuator (313) adapted to move the sample area end of one or more test strips (316) positioned in the test strip compartment (311) into the mixing chamber (307) such that any fluid in the mixing chamber (307) is applied to the test strip (316).

24. The test system (300) according to claim 23, wherein, The mixing chamber (307) is provided with a piercing cover (312), and the test strip compartment (311) is configured to hold one or more test strips (316) such that the sample area end of the test strip (316) is initially positioned adjacent to the piercing cover (312) and outside the mixing chamber (307), and wherein the analysis initiation actuator (313) includes a piercing element (315) configured to pierce or cut the piercing cover (312) when the analysis initiation actuator (313) is actuated.

25. The test system (100, 200, 300, 400) according to any of the preceding claims, wherein, The particle-antibody conjugate formulations (219, 309, 419) include gold particles.

26. The test system (100, 200, 300, 400) according to any of the preceding claims, wherein, The dried particulate-antibody conjugate formulations (219, 309, 419) are disposed in the mixing chambers (122, 222, 307, 422).

27. The test system (100, 200, 300, 400) according to any of the preceding claims further includes one or more test strips arranged in the holding device (143, 243, 311, 443), and the test strips are initially arranged such that a first end of the test strip (148, 248, 316a, 448) is positioned such that the first end is not in fluid contact with the mixing chamber (122, 222, 307, 422).

28. A method for using a testing system to determine the presence of an analyte in a sample, said testing system comprising an elution solution, a dried particulate-antibody conjugate formulation, a sample collector, a sample receiving unit, and a testing unit, said method comprising the steps of: - Activate the device activation device to activate the test system for receiving the sample and performing an analysis to determine the presence of one or more of the analytes, wherein actuation of the device activation device allows the dried particulate-antibody conjugate formulation to contact the eluent solution; - Insert the sample collector into the mixing chamber of the sample receiving unit in the test system, such that the acquired sample is transferred to the mixing chamber, the step being performed before, simultaneously with, or after the step of activating the device activation apparatus; - Allowing the sample to react in the mixing chamber; and - Activate the analysis start device to allow any fluid in the mixing chamber to be applied to the first end of any test strip arranged in the holding device of the test unit.

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